Dietary Supplements
FDA Should Take Further Actions to Improve Oversight and Consumer Understanding Gao ID: GAO-09-250 January 29, 2009Dietary supplements and foods with added dietary ingredients, such as vitamins and herbs, constitute multibillion dollar industries. Past reports on the Food and Drug Administration's (FDA) regulation of these products raised concerns about product safety and the availability of reliable information. Since then, FDA published draft guidance on requirements for reporting adverse events--which are harmful effects or illnesses--and Current Good Manufacturing Practice regulations for dietary supplements. GAO was asked to examine FDA's (1) actions to respond to the new serious adverse event reporting requirements, (2) ability to identify and act on concerns about the safety of dietary supplements, (3) ability to identify and act on concerns about the safety of foods with added dietary ingredients, and (4) actions to ensure that consumers have useful information about the safety and efficacy of supplements.
FDA has made several changes in response to the new serious adverse event reporting requirements and has subsequently received an increased number of reports. For example, FDA has modified its data system, issued draft guidance, and conducted outreach to industry. Since mandatory reporting went into effect on December 22, 2007, FDA has seen a threefold increase in the number of all adverse event reports received by the agency compared with the previous year. For example, from January through October 2008, FDA received 948 adverse event reports--596 of which were mandatory reports submitted by industry--compared with 298 received over the same time period in 2007. Although FDA has received a greater number of reports since the requirements went into effect, underreporting remains a concern, and the agency has further actions planned to facilitate adverse event reporting. FDA has taken some steps to identify and act upon safety concerns related to dietary supplements; however, several factors limit the agency's ability to detect concerns and remove products from the market. For example, FDA has limited information on the number and location of dietary supplement firms, the types of products currently available in the marketplace, and information about moderate and mild adverse events reported to industry. Additionally, FDA dedicates relatively few resources to oversight activities, such as providing guidance to industry regarding notification requirements for products containing new dietary ingredients. Also, once FDA has identified a safety concern, the agency's ability to remove a product from the market is hindered by a lack of mandatory recall authority and the difficult process of demonstrating significant or unreasonable risk for specific ingredients. Although FDA has taken some actions when foods contain unsafe dietary ingredients, certain factors may allow potentially unsafe products to reach consumers. FDA may not know when a company has made an unsupported or incorrect determination about whether an added dietary ingredient in a product is generally recognized as safe until after the product becomes available to consumers because companies are not required to notify FDA of their self-determinations. In addition, the boundary between dietary supplements and conventional foods containing dietary ingredients is not always clear, and some food products could be marketed as dietary supplements to circumvent the safety standard required for food additives. FDA has taken limited steps to educate consumers about dietary supplements, and studies and experts indicate that consumer understanding is lacking. While FDA has conducted some outreach, these initiatives have reached a relatively small proportion of dietary supplement consumers. Additionally, surveys and experts indicate that consumers are not well-informed about the safety and efficacy of dietary supplements and have difficulty interpreting labels on these products. Without a clear understanding of the safety, efficacy, and labeling of dietary supplements, consumers may be exposed to greater health risks associated with the uninformed use of these products.
RecommendationsOur recommendations from this work are listed below with a Contact for more information. Status will change from "In process" to "Open," "Closed - implemented," or "Closed - not implemented" based on our follow up work.
Director: Team: Phone:GAO-09-250, Dietary Supplements: FDA Should Take Further Actions to Improve Oversight and Consumer Understanding
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Report to Congressional Requesters:
United States Government Accountability Office:
GAO:
January 2009:
Dietary Supplements:
FDA Should Take Further Actions to Improve Oversight and Consumer
Understanding:
GAO-09-250:
GAO Highlights:
Highlights of GAO-09-250, a report to congressional requesters.
Why GAO Did This Study:
Dietary supplements and foods with added dietary ingredients, such as
vitamins and herbs, constitute multibillion dollar industries. Past
reports on the Food and Drug Administration‘s (FDA) regulation of these
products raised concerns about product safety and the availability of
reliable information. Since then, FDA published draft guidance on
requirements for reporting adverse events”which are harmful effects or
illnesses”and Current Good Manufacturing Practice regulations for
dietary supplements. GAO was asked to examine FDA‘s (1) actions to
respond to the new serious adverse event reporting requirements, (2)
ability to identify and act on concerns about the safety of dietary
supplements, (3) ability to identify and act on concerns about the
safety of foods with added dietary ingredients, and (4) actions to
ensure that consumers have useful information about the safety and
efficacy of supplements.
What GAO Found:
FDA has made several changes in response to the new serious adverse
event reporting requirements and has subsequently received an increased
number of reports. For example, FDA has modified its data system,
issued draft guidance, and conducted outreach to industry. Since
mandatory reporting went into effect on December 22, 2007, FDA has seen
a threefold increase in the number of all adverse event reports
received by the agency compared with the previous year. For example,
from January through October 2008, FDA received 948 adverse event
reports”596 of which were mandatory reports submitted by
industry”compared with 298 received over the same time period in 2007.
Although FDA has received a greater number of reports since the
requirements went into effect, underreporting remains a concern, and
the agency has further actions planned to facilitate adverse event
reporting.
FDA has taken some steps to identify and act upon safety concerns
related to dietary supplements; however, several factors limit the
agency‘s ability to detect concerns and remove products from the
market. For example, FDA has limited information on the number and
location of dietary supplement firms, the types of products currently
available in the marketplace, and information about moderate and mild
adverse events reported to industry. Additionally, FDA dedicates
relatively few resources to oversight activities, such as providing
guidance to industry regarding notification requirements for products
containing new dietary ingredients. Also, once FDA has identified a
safety concern, the agency‘s ability to remove a product from the
market is hindered by a lack of mandatory recall authority and the
difficult process of demonstrating significant or unreasonable risk for
specific ingredients.
Although FDA has taken some actions when foods contain unsafe dietary
ingredients, certain factors may allow potentially unsafe products to
reach consumers. FDA may not know when a company has made an
unsupported or incorrect determination about whether an added dietary
ingredient in a product is generally recognized as safe until after the
product becomes available to consumers because companies are not
required to notify FDA of their self-determinations. In addition, the
boundary between dietary supplements and conventional foods containing
dietary ingredients is not always clear, and some food products could
be marketed as dietary supplements to circumvent the safety standard
required for food additives.
FDA has taken limited steps to educate consumers about dietary
supplements, and studies and experts indicate that consumer
understanding is lacking. While FDA has conducted some outreach, these
initiatives have reached a relatively small proportion of dietary
supplement consumers. Additionally, surveys and experts indicate that
consumers are not well-informed about the safety and efficacy of
dietary supplements and have difficulty interpreting labels on these
products. Without a clear understanding of the safety, efficacy, and
labeling of dietary supplements, consumers may be exposed to greater
health risks associated with the uninformed use of these products.
What GAO Recommends:
GAO recommends that the Secretary of Health and Human Services direct
the Commissioner of the FDA to request additional authority to oversee
dietary supplements, issue guidance on new dietary ingredients and to
clarify the boundary between dietary supplements and foods with added
dietary ingredients, and take steps to improve consumer understanding
of dietary supplements. In commenting on this report, FDA generally
agreed with GAO‘s recommendations.
To view the full product, including the scope and methodology, click on
[hyperlink, http://www.gao.gov/products/GAO-09-250]. For more
information, contact Lisa Shames at (202) 512-3841 or shamesl@gao.gov.
[End of section]
Contents:
Letter:
Results in Brief:
Background:
FDA Has Made Changes in Response to the New Serious Adverse Event
Reporting Requirements and Has Received an Increased Number of Reports:
Although FDA Has Taken Some Steps to Identify and Act on Concerns about
the Safety of Dietary Supplements, Several Factors Limit Its Oversight:
While FDA Has Taken Some Actions When Foods Contain Unsafe Dietary
Ingredients, Certain Factors May Allow Unsafe Products to Reach
Consumers:
FDA Has Taken Limited Steps to Educate Consumers about Dietary
Supplements, and Consumers Remain Largely Uninformed:
Conclusions:
Recommendations for Executive Action:
Agency Comments and Our Evaluation:
Appendix I: Objectives, Scope, and Methodology:
Appendix II: Data on FDA's Actions to Identify and Respond to Safety
Concerns Related to Dietary Supplements:
Appendix III: Comparison of Select Foreign Countries' Regulation of
Dietary Supplements with the United States:
Appendix IV: Comments from the Department of Health and Human Services:
Appendix V: GAO Contact and Staff Acknowledgments:
Tables:
Table 1: Key Events in the Regulation of Dietary Supplements:
Table 2: Number of Cases with Mandatory Reported Adverse Event Outcomes
by Dietary Supplement Product Classification, from December 22, 2007,
through October 31, 2008:
Table 3: Examples of FDA Surveillance to Identify Safety Concerns:
Table 4: Examples of FDA Actions in Response to Identified Safety
Concerns:
Table 5: Examples of FDA Actions Taken on Dietary Supplement
Ingredients That Have Been Banned in Other Countries:
Table 6: Comparison of the Number of Adverse Event Reports Received and
Entered into FDA's Databases for Review Related to Dietary Supplements
and Drugs and Biologics, January 1, 2003, through December 31, 2007:
Table 7: Number of Dietary Supplement-Related Adverse Event Cases
Characterized as Serious, January 1, 2003, through October 31, 2008:
Table 8: Number of Dietary Supplement-Related Adverse Event Complaint
(AEC) Outcomes for all Adverse Event Cases, January 1, 2003, through
October 31, 2008:
Table 9: Number of All Dietary Supplement-Related Cases with Reported
Adverse Event Outcomes by Product Classification, January 1, 2003,
through October 31, 2008:
Table 10: Number of Dietary Supplement-Related Consumer Complaints by
Adverse Event Result, Fiscal Year 2001 through July 3, 2008:
Table 11: Number of Dietary Supplement-Related Consumer Complaints with
Adverse Symptoms Present by Adverse Event Result and Product
Classification, Fiscal Year 2001 through July 3, 2008:
Table 12: FDA Foreign and Domestic Inspections and State Domestic
Inspections, Fiscal Years 2000 through 2008:
Table 13: Share of Dietary Supplement Inspections Where Investigators
Identified Problems, Fiscal Year 2002 through May 6, 2008:
Table 14: Number of Violations in the Federal Food, Drug, and Cosmetic
Act Cited in 293 FDA Dietary Supplement-Related Warning Letters, Fiscal
Years 2002 through 2007:
Table 15: FDA Dietary Supplement-Related Warning Letters and All Other
FDA Warning Letters Issued, Fiscal Years 2002 through 2007:
Table 16: Examples of Dietary Supplement-Related Class I Recalls,
Fiscal Years 2003 through 2008:
Table 17: Dietary Supplement-Related Detentions without Physical
Examination (DWPE) by General Violation Categories, Fiscal Year 2002
through March 24, 2008:
Table 18: Dietary Supplement-Related DWPE by Product Classification,
Fiscal Year 2002 through March 24, 2008:
Table 19: Number of Violations of the Federal Food, Drug, and Cosmetic
Act Cited in 3,605 Dietary Supplement-Related Import Refusals, Fiscal
Year 2002 through March 24, 2008:
Table 20: Dietary Supplement-Related Import Refusals by Product
Classification, Fiscal Year 2002 through March 24, 2008:
Table 21: FDA Seizures and Injunctions Related to Dietary Supplement
Products, Fiscal Year 2002 through July 18, 2008:
Table 22: Number of Criminal Investigations Related to Dietary
Supplements Resulting in a Conviction or Charges Filed from 2002
through July 31, 2008:
Table 23: Comparison of Dietary Supplement Regulations: United States,
Canada, United Kingdom, and Japan:
Figures:
Figure 1: Total Sales of Dietary Supplements in the United States from
1997 through 2007:
Figure 2: The Number of Dietary Supplement-Related Adverse Event
Reports to CAERS from January 1, 2003, to October 31, 2008:
Abbreviations:
AEC: adverse event complaint:
CAERS: CFSAN Adverse Event Reporting System:
CFSAN: Center for Food Safety and Applied Nutrition:
DSHEA: Dietary Supplement Health and Education Act of 1994:
DWPE: detentions without physical examination:
EC: European Community:
FDA: Food and Drug Administration:
FNFC: Food with Nutrient Function Claims:
FOSHU: Foods for Specified Health Uses:
GRAS: generally recognized as safe:
NIH: National Institutes of Health:
UK: United Kingdom:
[End of section]
United States Government Accountability Office:
Washington, DC 20548:
January 29, 2009:
The Honorable Henry A. Waxman:
Chairman:
The Honorable John D. Dingell:
Chairman Emeritus:
Committee on Energy and Commerce:
House of Representatives:
The Honorable Bart Stupak:
Chairman:
Subcommittee on Oversight and Investigations:
Committee on Energy and Commerce:
House of Representatives:
The Honorable Richard J. Durbin:
United States Senate:
Dietary supplements and foods containing added dietary ingredients,
such as vitamins and herbs, constitute growing multibillion dollar
industries. Sales of dietary supplements alone reached approximately
$23.7 billion in 2007, and data from the 2007 National Health Interview
Survey show that over half of all U.S. adults consume dietary
supplements. In 1994, there were approximately 4,000 dietary supplement
products on the market, whereas an industry source estimated that, in
2008, about 75,000 dietary supplement products were available to
consumers. Similarly, food products--such as fortified cereals and
energy drinks--that contain added dietary ingredients are in the
marketplace in unprecedented numbers, and consumers are expected to
spend increasing amounts on these products over the next several years.
The Food and Drug Administration (FDA) regulates dietary supplements
under provisions of the Federal Food, Drug, and Cosmetic Act, as
amended by the Dietary Supplement Health and Education Act of 1994
(DSHEA). DSHEA defines dietary supplements as products that, among
other things, are intended for ingestion to supplement the diet,
labeled as a dietary supplement, and not represented as a conventional
food or as a sole item of a meal or diet. They must also contain one or
more dietary ingredients. DSHEA does not require manufacturers to
register with FDA or identify the products they manufacture or the
ingredients of those products. However, all food facilities, including
manufacturers and distributors of dietary supplements, were required to
register with FDA no later than December 12, 2003, under the Public
Health Security and Bioterrorism Preparedness and Response Act of 2002
and implementing regulations. This includes an initial registration
with FDA and updates within 60 days of any changes in information.
Registration must include the name and address of the facility and an
emergency contact, and facilities that manufacture or sell certain
types of products, such as vitamins, must self-identify as such.
Under DSHEA, dietary supplements are broadly presumed safe, and FDA
does not have the authority to require them to be approved for safety
and efficacy before they enter the market, as it does for drugs.
However, a dietary supplement manufacturer or distributor of a
supplement with a "new dietary ingredient"--an ingredient that was not
marketed in the United States before October 15, 1994--may be required
to notify FDA at least 75 days before marketing the product, depending
on the history of use of the ingredient. For the most part, FDA relies
on post-market surveillance efforts--such as monitoring adverse event
reports it receives from companies, health care practitioners, and
individuals; reviewing consumer complaints; and conducting facility
inspections--to identify potential safety concerns related to dietary
supplements. Once a safety concern is identified, FDA must demonstrate
that the dietary supplement presents a significant or unreasonable
risk, or is otherwise adulterated, before it can be removed from the
market. According to several experts we spoke with, this regulatory
approach has fallen short in protecting U.S. consumers in the past. For
example, while FDA was successful, in 2004, in banning ephedrine
alkaloids (ephedra)--a dietary ingredient used for weight loss and
bodybuilding, among other things--the ban became effective only after
FDA had received thousands of reports of adverse events, including a
number of deaths, and 10 years after the agency issued its first
advisory.
Since ephedra was banned, several changes have occurred in the
regulation of dietary supplements. For example, the Federal Food, Drug,
and Cosmetic Act, as amended by the Dietary Supplement and
Nonprescription Drug Consumer Protection Act, requires companies that
receive a serious adverse event report to submit information about the
event to FDA, beginning in December 2007. As defined in the act,
serious adverse events include any health-related events that result
in, for example, a death, life-threatening experience, inpatient
hospitalization, birth defect, or which require, based on reasonable
medical judgment, a medical or surgical intervention to prevent these
serious outcomes. While the act does not require companies to report
moderate or mild adverse events, such as gastrointestinal distress or
headaches, companies may do so voluntarily. In addition, health care
practitioners and consumers can submit voluntary reports of serious,
moderate, and mild adverse events. Additionally, in an effort to
improve the consistency and safety of dietary supplements, in June
2007, FDA established its Current Good Manufacturing Practice
regulations describing the conditions under which supplements must be
manufactured, packed, and held. These requirements are being
implemented in phases, based on company size, and will be fully in
effect by 2010.
In addition to regulating the safety and labeling of dietary
supplements, FDA also conducts outreach to consumers about these
products. While the Federal Food, Drug, and Cosmetic Act does not
explicitly require FDA to conduct consumer education, according to the
agency, it has some responsibility for doing so.
FDA also regulates foods with added dietary ingredients under
provisions set out in the Federal Food, Drug, and Cosmetic Act. The act
generally requires that when a company adds an ingredient to a food
product, that ingredient must either be generally recognized as safe
(GRAS) or go through FDA's review and approval process as a food
additive. With some exceptions, the company is responsible for
determining that the ingredient meets the GRAS standard or, failing
this, for having it approved as a food additive. The GRAS standard is
defined as a general recognition among qualified experts that the
substance is reasonably certain to not be harmful under its intended
conditions of use; such recognition can come through scientific
procedures, or for substances in use prior to 1958, through experience
based on common use in food. If the added ingredient is GRAS, the
company may add the ingredient to a food product without notifying FDA,
although some do so voluntarily. In most instances, if the ingredient
does not meet the GRAS standard, the company must petition FDA for
approval of the ingredient as a food additive, which also requires
companies to demonstrate a reasonable certainty that the ingredient is
not harmful under the intended conditions of use. According to FDA,
meeting the safety standard for a food additive requires the same
quantity and quality of scientific evidence as is needed to satisfy the
GRAS standard.
In July 2000, we reported concerns about the safety of dietary
supplements and foods with added dietary ingredients, as well as about
the accuracy of health-related claims on product labels and in
advertising.[Footnote 1] More specifically, we reported that consumers
faced health risks because federal laws and agencies' efforts did not
effectively and consistently ensure that products were safe.
Furthermore, we found that consumers did not consistently receive
clear, scientifically supported information concerning products' health
benefits so they could make informed dietary choices. To help ensure
that dietary supplements and related products are safe and that
consumers receive accurate information about the products, we made six
recommendations to FDA. FDA has implemented two of these
recommendations but has not fully implemented the remaining four, which
deal largely with providing regulations or other information clarifying
industry responsibilities.
At your request, this report examines FDA's (1) actions to respond to
the new serious adverse event reporting requirements; (2) ability to
identify and act on concerns about the safety of dietary supplements;
(3) ability to identify and act on concerns about the safety of foods
with added dietary ingredients; and (4) actions to educate consumers
about the safety, efficacy, and labeling of dietary supplements.
For this report, dietary supplement means a product intended for human
consumption and does not include products for veterinary use.
Additionally, for this report, dietary ingredient means an ingredient
that is included in the dietary supplement definition in DSHEA, such as
vitamins, minerals, and herbs or other botanicals. To identify FDA's
actions to respond to the new serious adverse event reporting
requirements, we reviewed FDA's guidance on reporting requirements for
industry and internal procedures for compiling and tracking adverse
event reports; analyzed the number of reports received before and after
the requirements went into effect; and reviewed plans for improving
adverse event reporting. To examine FDA's ability to identify and act
on safety concerns associated with dietary supplements, we assessed
FDA's laws and regulations; analyzed data on FDA's oversight actions,
such as inspections, import screenings and enforcement activities; and
reviewed FDA resources dedicated to dietary supplements. To examine
FDA's ability to identify and act on concerns about the safety of foods
with added dietary ingredients, we reviewed laws and regulations
regarding food additives, as well as FDA's procedures for identifying
and acting on concerns about the safety of foods with added dietary
ingredients. To determine what FDA has done to educate consumers about
the safety, efficacy, and labeling of dietary supplements, we reviewed
FDA's consumer outreach initiatives and analyzed FDA's and others' data
on consumer understanding of dietary supplements. In addition, to
address all of our objectives, we interviewed a wide range of
stakeholders, including officials from federal and state agencies,
industry and trade organizations, consumer advocacy groups, academia,
poison control centers, and foreign governments. To assess the
reliability of the data from FDA's databases used in this report, we
reviewed related documentation, examined the data to identify obvious
errors or inconsistencies, and worked with agency officials to identify
any data problems. We determined the data to be sufficiently reliable
for the purposes of this report. A more detailed description of our
objectives, scope, and methodology is presented in appendix I.
We conducted this performance audit from December 2007 to January 2009,
in accordance with generally accepted government auditing standards.
Those standards require that we plan and perform the audit to obtain
sufficient, appropriate evidence to provide a reasonable basis for our
findings and conclusions based on our audit objectives. We believe that
the evidence obtained provides a reasonable basis for our findings and
conclusions based on our audit objectives.
Results in Brief:
In 2007, FDA took several actions in response to the new serious
adverse event reporting requirements for dietary supplements and has
subsequently received an increased number of reports. Specifically, FDA
has incorporated the mandatory reports into its existing data system
for compiling, tracking, and reviewing adverse event reports. FDA has
also issued draft guidance and conducted outreach to industry regarding
the new reporting requirements. For example, in October 2007, FDA
provided companies with a form and instructions for submitting
mandatory serious adverse event reports and issued draft guidance
outlining requirements and recommendations for reporting,
recordkeeping, and records access. Furthermore, FDA has worked with
industry associations to increase awareness of the new reporting
requirements. Since mandatory reporting requirements went into effect,
the agency has seen a threefold increase in the number of all adverse
events reported compared with the previous year. For example, from
January through October 2008, FDA received 948 adverse event reports,
compared with 298 received over the same time period in 2007. Of the
948 adverse event reports, 596 were mandatory reports of serious
adverse events submitted by industry; the remaining 352 were voluntary
reports, which include all moderate and mild adverse events reported
and any serious adverse events reported by health care practitioners
and consumers directly to FDA. However, FDA recently estimated that the
actual number of total adverse events--including mild, moderate, and
serious--related to dietary supplements per year is over 50,000, which
suggests that underreporting of adverse events limits the amount of
information FDA receives. To facilitate adverse event reporting for all
FDA-regulated products, FDA is currently developing MedWatchPlus, an
interactive Web-based portal intended to simplify the reporting process
and reduce the time and cost associated with reviewing paper reports.
Although FDA has used varied approaches--such as analyzing adverse
events and conducting inspections--to identify safety concerns and has
taken some actions--such as detaining certain potentially unsafe
imported products--in response to these concerns, several factors limit
FDA's ability to further identify and act on safety concerns. First,
FDA's ability to identify safety concerns is hindered by a lack of
information. For example, while all dietary supplement companies must
register with FDA as food facilities to provide their name and address,
some companies--such as those specializing exclusively in herbal
products--are not required to identify themselves as dietary supplement
companies. In addition, companies are not required to provide FDA with
information on the products they sell, such as the product name and
ingredients. As a result, FDA has limited information on the companies
and products it is required to regulate, and more complete information
could help FDA analyze adverse event reports. Moreover, dietary
supplement companies are required to report only serious adverse
events. FDA officials have noted that receiving adverse event reports
for moderate and mild events could improve the agency's ability to
assess safety-related signals from adverse event data. Second, in
comparison to other regulated products, FDA dedicates relatively few
resources to dietary supplement oversight activities. For example, FDA
has conducted relatively few dietary supplement inspections and has not
developed guidance for industry regarding key safety-related aspects of
DSHEA in a timely manner. In particular, FDA has not yet issued
guidance to clarify new dietary ingredient notification requirements.
Third, once FDA has identified a safety concern, its ability to
efficiently and effectively remove a product from the market is
limited. For example, FDA lacks mandatory recall authority, and FDA's
ability to ban an unsafe ingredient has proven difficult because the
Federal Food, Drug, and Cosmetic Act requires that the agency
demonstrate a significant or unreasonable risk or that the dietary
supplement is otherwise adulterated. This statutory requirement is
exacerbated by limited scientific research and underreporting of
adverse events. Although FDA has taken some steps, such as drafting
guidance for industry on reporting serious adverse events and
establishing its Current Good Manufacturing Practice regulations, to
improve the oversight of dietary supplements over the past several
years, consumers remain vulnerable to risks posed by potentially unsafe
products.
Similar to dietary supplements, while FDA has taken some actions, such
as issuing warnings, when foods contain unsafe dietary ingredients,
certain factors may allow some unsafe products to reach consumers. For
example, FDA may not know when a company has made an unsupported or
incorrect GRAS determination about an added dietary ingredient in a
product until after the product becomes available to consumers because
companies are not required to notify FDA of their self-determinations.
In addition, the boundary between dietary supplements and foods with
added dietary ingredients is not always clear, and some food products
could be marketed as dietary supplements to circumvent the safety
standard required for food additives. For example, in August 2007, FDA
identified a company marketing an iced tea mix containing stevia--an
herb that has not been approved as a food additive because of potential
safety concerns, including reproductive and cardiovascular effects. FDA
issued a warning to the company, and the company changed the product
label to classify the product as a dietary supplement rather than a
food so that it could continue to add stevia to its product. As a
dietary supplement, FDA does not have the authority to require that the
safety of the product be approved. Finally, FDA conducts limited
monitoring of foods with added dietary ingredients. According to FDA,
it does not track these products separately from other conventional
foods, and the current regulatory framework is sufficient to identify
and act on safety concerns related to these products. Some stakeholders
we spoke with noted that safety risks associated with foods containing
added dietary ingredients that meet the GRAS standard or have been
approved as food additives are generally low. However, some
stakeholders expressed concerns about certain products, such as energy
drinks, and adding botanicals to foods.
FDA has taken limited steps to educate consumers about the safety,
efficacy, and labeling of dietary supplements, and studies and experts
indicate that consumer understanding about these products is lacking.
While FDA has conducted some consumer outreach, such as distributing
brochures and providing information its Web site, these initiatives
have reached a relatively small proportion of consumers using dietary
supplements. For instance, a 2004 brochure developed in conjunction
with the National Institutes of Health (NIH) had a distribution of
40,000 paper copies and received approximately 171,000 page views on
the Web. However, data from the 2007 National Health Interview Survey
show that over half of U.S. adults--or at least 114 million
individuals--take dietary supplements. While officials noted that the
agency must continually market its desired messages to effectively
educate consumers, FDA's Center for Food Safety and Applied Nutrition
(CFSAN) currently is not planning any new consumer education
initiatives for dietary supplements. In addition, agency officials
stated that FDA does not evaluate the effectiveness of its outreach
efforts; however, surveys and experts indicate that consumers are not
well-informed about factors that can affect the safety and efficacy of
dietary supplements. For example, a 2002 Harris Poll indicated that a
majority of adults believe that a government agency approves dietary
supplements before products are marketed to consumers. Studies also
suggest that the labeling of dietary supplements can be confusing to
consumers. For example, in 2003, the Department of Health and Human
Services' Inspector General reported that dietary supplement labels
often do not present information in a manner that facilitates consumer
understanding.[Footnote 2] Without a clear understanding of the safety,
efficacy, and labeling of dietary supplements, consumers are exposed to
risks--such as potentially harmful drug-supplement interactions--
associated with the uninformed use of these products.
To improve the information available to FDA for identifying safety
concerns, we are recommending that the Secretary of the Department of
Health and Human Services direct the Commissioner of FDA to seek
additional authority to require dietary supplement facilities to self-
identify as part of existing registration requirements, provide a list
of their products and a copy of the labels, and report all adverse
events related to dietary supplements. To better enable FDA to regulate
dietary supplements with new dietary ingredients, we are recommending
that the Secretary of the Department of Health and Human Services
direct the Commissioner of FDA to issue guidance to clarify when an
ingredient is considered a new dietary ingredient, what evidence is
needed to document the safety of new dietary ingredients, and
appropriate methods for establishing ingredient identity. To help
ensure that companies follow the appropriate laws and regulations, we
are recommending that the Secretary of the Department of Health and
Human Services direct the Commissioner of FDA to provide guidance to
industry to clarify when products should be marketed as either dietary
supplements or conventional foods formulated with added dietary
ingredients. We made a similar recommendation in our July 2000 report,
but, according to FDA, it did not implement the recommendation because
of resource constraints and competing agency priorities and activities.
To improve consumer understanding about dietary supplements and better
leverage existing resources, we are recommending that the Secretary of
the Department of Health and Human Services direct the Commissioner of
FDA to coordinate with stakeholder groups to identify additional
mechanisms to educate consumers, implement these mechanisms, and assess
their effectiveness. In commenting on our draft report, FDA generally
agreed with our recommendations.
Background:
According to the Nutrition Business Journal, the dietary supplement
industry is growing, and total sales were about $23.7 billion in 2007,
as shown in figure 1. Top selling supplements in 2007 included
multivitamins, sports nutrition powders and formulas, and calcium,
according to the Nutrition Business Journal. In addition, one of the
areas of greatest growth in supplements within the United States in
2007 was among weight loss products. Projections through 2011 show that
growth in the industry is expected to continue, in large part because
of the aging population and an increasing interest in personal health
and wellness.
Figure 1: Total Sales of Dietary Supplements in the United States from
1997 through 2007:
[Refer to PDF for image: vertical bar graph]
Year: 1997;
Total Sales: $13.95 billion.
Year: 1998;
Total Sales: $15.45 billion.
Year: 1999;
Total Sales: $16.46 billion.
Year: 2000;
Total Sales: $17.27 billion.
Year: 2001;
Total Sales: $18.08 billion.
Year: 2002;
Total Sales: $18.75 billion.
Year: 2003;
Total Sales: $19.81 billion.
Year: 2004;
Total Sales: $20.39 billion.
Year: 2005;
Total Sales: $21.32 billion.
Year: 2006;
Total Sales: $22.46 billion.
Year: 2007;
Total Sales: $23.7 billion.
Source: GAO analysis of Nutrition Business Journal data.
[End of figure]
Over time, several key events have shaped the regulation of dietary
supplements, as shown in table 1. Significantly, Congress passed DSHEA,
which amended the Federal Food, Drug, and Cosmetic Act and created a
new regulatory category, safety standard, and other requirements for
supplements. Under DSHEA, dietary supplements are generally presumed
safe. With the exception of the banned dietary ingredient, ephedra,
companies may sell otherwise lawful products containing any dietary
ingredient that was marketed in the United States prior to October 15,
1994--referred to as "grandfathered ingredients"--without notifying
FDA. Ingredients that were not marketed before this date are considered
new dietary ingredients. A dietary supplement containing a new dietary
ingredient must meet one of the two following requirements: (1) it
contains only dietary ingredients that have been "present in the food
supply as an article used for food in a form in which the food has not
been chemically altered" or (2) there is evidence that the dietary
ingredient is reasonably expected to be safe under the conditions of
use recommended or suggested in the product's labeling. In addition,
companies planning to market a dietary supplement with a new dietary
ingredient that only meets the second requirement must notify FDA of
the evidence that is the basis of the determination at least 75 days
before marketing the supplement.
Table 1: Key Events in the Regulation of Dietary Supplements:
Year: 1990;
Key event: The Nutrition Labeling and Education Act of 1990 amended the
Federal Food, Drug, and Cosmetic Act to require most foods, including
dietary supplements, to bear nutrition labeling.
Year: 1994;
Key event: DSHEA amended the Federal Food, Drug, and Cosmetic Act to
create a new regulatory category, safety standard, labeling
requirements, and other rules for dietary supplements. Under DSHEA,
dietary supplements are generally presumed to be safe.
Year: 2002;
Key event: The Public Health Security and Bioterrorism Preparedness and
Response Act of 2002 amended the Federal Food, Drug, and Cosmetic Act
to require all food companies, including dietary supplement companies,
to register with FDA no later than December 12, 2003, to provide
information on the name and address of the facility and, to some
extent, the types of products they manufacture or sell.
Year: 2004;
Key event: FDA was successful in banning ephedra after thousands of
adverse events, including a number of deaths, and a lengthy legal
process.
Year: 2006;
Key event: The Dietary Supplement and Nonprescription Drug Consumer
Protection Act amended the Federal Food, Drug, and Cosmetic Act to
require dietary supplement companies that receive a serious adverse
event report to submit information about the event to FDA.
Year: 2007;
Key event: FDA finalized its Current Good Manufacturing Practice
regulations to establish quality control standards for dietary
supplements. The final rule became effective on August 24, 2007, but
companies have 10, 22, or 34 months from the effective date of the rule
to comply, depending on company size.
Year: 2007;
Key event: Serious adverse event reporting requirements for dietary
supplement companies became effective on December 22.
Source: GAO.
[End of table]
As of December 22, 2007, dietary supplement companies are required to
submit any report received about a serious adverse event to FDA, as
mandated by the Dietary Supplement and Nonprescription Drug Consumer
Protection Act. In addition, companies can voluntarily submit reports
about moderate and mild adverse events. Others, such as consumers and
health care practitioners, can submit reports of serious, moderate, and
mild adverse events on a voluntary basis to FDA. Prior to implementing
the mandatory reporting requirements, FDA's Center for Food Safety and
Applied Nutrition--which, in part, is responsible for promoting and
protecting the public's health by ensuring that the nation's food
supply is safe, sanitary, wholesome, and honestly labeled--had a system
in place to receive voluntary reports of adverse events involving
dietary supplements from all parties.
As stated in the Federal Food, Drug, and Cosmetic Act, FDA is also
responsible for protecting the public health by ensuring that the
labels of dietary supplements are not false or misleading. As noted in
table 1, the Nutrition Labeling and Education Act of 1990 amended the
Federal Food, Drug, and Cosmetic Act to require that most foods,
including dietary supplements, bear nutrition labeling. In addition,
DSHEA amended the Federal Food, Drug, and Cosmetic Act to add specific
labeling requirements for dietary supplements and provided for optional
labeling statements. Federal regulations require the following
information on the labels of dietary supplements: (1) product identity
(name of the dietary supplement), (2) net quantity of contents
statement (amount of the dietary supplement in the package), (3)
nutrition labeling, (4) ingredient list (when appropriate), and (5)
name and place of business of the manufacturer, packer, or distributor.
In addition, DSHEA specifies that supplements with labeling that makes
disease or health-related claims must contain a disclaimer that FDA has
not evaluated the claim and the product is not intended to diagnose,
treat, cure, or prevent any disease.
Similar to dietary supplements, the market for foods with added dietary
ingredients has been growing, and this trend is expected to continue.
Foods with added dietary ingredients vary greatly, including such
products as orange juice with added calcium, pasta with Omega 3, and
sunflower seeds with guarana. Terms such as "functional foods" and
"nutraceuticals" are sometimes used to describe foods with added
dietary ingredients. However, there are no regulatory definitions for
these terms, and some of these terms include foods with naturally
beneficial properties beyond nutrition, such as pomegranate juice.
FDA Has Made Changes in Response to the New Serious Adverse Event
Reporting Requirements and Has Received an Increased Number of Reports:
FDA has made several changes in response to the new serious adverse
event reporting requirements established by law in 2006 and has
subsequently received an increased number of reports. FDA has modified
its existing data system and internal procedures for compiling,
tracking, and reviewing adverse event reports to incorporate mandatory
reporting by industry. Additionally, FDA has issued draft guidance and
conducted outreach to industry regarding the new requirements. Since
mandatory reporting went into effect on December 22, 2007, FDA has seen
a threefold increase in the number of all adverse event reports
received by the agency compared with the previous year. Although FDA
received more reports overall since the reporting requirements went
into effect, underreporting of adverse events remains a concern, and
the agency has further actions planned to facilitate adverse event
reporting by consumers, health care practitioners, and industry.
FDA Has Taken Several Actions in Response to the New Serious Adverse
Event Reporting Requirements:
In 2007, FDA took several actions in response to the new serious
adverse event reporting requirements for dietary supplements.
Specifically, FDA modified its existing database for compiling,
tracking, and reviewing adverse event reports--the CFSAN Adverse Event
Reporting System (CAERS)--to include data fields and instructions
specifically for compiling and tracking mandatory reports. In addition,
CFSAN established procedures for reviewing mandatory serious adverse
event reports to determine if they meet the minimum data requirements
for mandatory reports outlined in guidance to the industry.
FDA has also issued draft guidance and conducted outreach to industry
regarding the new reporting requirements. In October 2007, FDA provided
companies with a form and instructions for submitting mandatory serious
adverse event reports and issued draft guidance describing statutory
requirements and agency recommendations for reporting, recordkeeping,
and records access. Additionally, in December 2007, FDA issued draft
guidance on labeling requirements.
Statutory requirements outlined in draft guidance include the
following:
* The manufacturer, packer, or distributor whose name appears on the
dietary supplement label (responsible party) must report all serious
adverse events to FDA, as well as follow up medical information
received within 1 year after the initial report, within 15 business
days of receipt.
* Mandatory serious adverse event reports must be submitted to FDA
using the MedWatch 3500A form and should contain the following minimum
data elements: an identifiable injured person, name of the person who
first notified the responsible party, identity and contact information
for the responsible party, a suspect dietary supplement, and a serious
adverse event or fatal outcome.
* The responsible party must include a copy of the dietary supplement
label related to the serious adverse event.
* The responsible party must maintain records of all adverse events
reported for 6 years and must provide FDA officials with access to the
records upon request during an inspection.
* Labels for dietary supplements marketed in the United States must
provide a complete domestic mailing address or phone number where the
responsible party may receive adverse event reports.
In addition to these requirements, FDA recommended that firms include
an introductory statement on dietary supplement labels to inform
consumers that the contact information provided may be used to report a
serious adverse event. According to comments submitted to FDA by the
three major dietary supplement industry associations, although the
industry broadly supports the new mandatory reporting requirements, it
disagrees with the recommended labeling changes. These industry
associations cite the following three key reasons for their opposition
to FDA's recommendation: (1) in their view, the changes are unnecessary
and beyond Congress' intent; (2) the introductory statement may draw
undue attention to the possibility of an adverse event and confuse
consumers; and (3) redesigning and replacing product labels is a
substantial added expense for dietary supplement companies and should
have been proposed through a formal rulemaking process rather than
guidance. According to an FDA official, the draft guidance regarding
reporting, recordkeeping, and records access requirements is close to
being finalized. In December 2008, FDA issued a revision of the draft
guidance regarding labeling changes. According to FDA, before this
guidance is finalized, it will need to be reviewed by the Office of
Management and Budget because of its potential economic impact on
industry.
FDA has also worked with industry associations to increase awareness of
the new reporting requirements. For instance, FDA officials have spoken
at industry-sponsored conferences and seminars to increase awareness
and answer questions about the new reporting requirements.
Representatives from two of the leading industry associations we spoke
with stated that they were generally satisfied with FDA's outreach
efforts regarding mandatory reporting.
FDA Has Received an Increased Number of Adverse Event Reports Since
Mandatory Reporting Went into Effect:
Since mandatory reporting requirements went into effect, the agency has
seen a threefold increase in the number of all adverse events reported
compared with the previous year. For example, from January through
October 2008, FDA received 948 adverse event reports, compared with 298
received over the same time period in 2007. Of the 948 adverse event
reports, 596 were mandatory reports of serious adverse events submitted
by industry; the remaining 352 were voluntary reports, which include
all moderate and mild adverse events reported and any serious adverse
events reported by health care practitioners and consumers directly to
FDA. As shown in figure 2, FDA received more serious adverse event
reports between January 1, 2008, and October 31, 2008, than previous
years, including 2003 and 2004, when FDA was receiving adverse event
reports related to ephedra. Adverse event reports from January 1, 2008,
through October 31, 2008, include 596 serious adverse event reports
submitted by industry, 163 serious adverse events reported by others on
a voluntary basis, and 189 moderate and mild adverse event reports.
Figure 2: The Number of Dietary Supplement-Related Adverse Event
Reports to CAERS from January 1, 2003, to October 31, 2008:
[Refer to PDF for image: stacked vertical bar graph]
Year: 2003;
Voluntary reports characterized as serious: 510;
Mandatory reports (all serious): 0;
Voluntary reports characterized as non-serious: 229;
Total: 739.
Year: 2004;
Voluntary reports characterized as serious: 483;
Mandatory reports (all serious): 0;
Voluntary reports characterized as non-serious: 174;
Total: 657.
Year: 2005;
Voluntary reports characterized as serious: 364;
Mandatory reports (all serious): 0;
Voluntary reports characterized as non-serious: 127;
Total: 491.
Year: 2006;
Voluntary reports characterized as serious: 213;
Mandatory reports (all serious): 0;
Voluntary reports characterized as non-serious: 104;
Total: 317.
Year: 2007;
Voluntary reports characterized as serious: 213;
Mandatory reports (all serious): 0;
Voluntary reports characterized as non-serious: 137;
Total: 350.
Year: January 1 - October 31, 2008;
Voluntary reports characterized as serious: 163;
Mandatory reports (all serious): 596;
Voluntary reports characterized as non-serious: 189;
Total: 948.
Source: GAO analysis of FDA data.
Note: There were 36 reports that did not include information about
seriousness in 2003. FDA officials noted that, prior to the ban on
ephedra in 2004, the agency received a heightened number of adverse
event reports due to products containing ephedra. Although mandatory
reporting went into effect on December 22, 2007, FDA did not receive
its first mandatory report until January 2008.
[End of figure]
Since mandatory reporting went into effect, FDA had received 596
mandatory reports of adverse events, such as serious cardiac,
respiratory, and gastrointestinal disorders, as of October 31, 2008.
Among other results, these events involved 9 deaths, 64 life-
threatening illnesses, and 234 patient hospitalizations. As shown in
table 2, 66 percent of serious adverse event reports were associated
with dietary supplements that either contained a combination of types
of products, such as a product containing both vitamins and herbals, or
could not be categorized under one of FDA's other product
classifications, and 40 percent were associated with vitamins. However,
according to FDA, because of variability in the quality and detail of
information in reports and the lack of a control group, the agency
cannot necessarily determine a causal relationship between an adverse
event and the dietary supplement associated with the event. Appendix II
provides further detail on adverse event reports related to dietary
supplements received by FDA from January 1, 2003 through August 6,
2008.
Table 2: Number of Cases with Mandatory Reported Adverse Event Outcomes
by Dietary Supplement Product Classification, from December 22, 2007,
through October 31, 2008:
Dietary supplement product classification: Combination products and
products not elsewhere classified;
Number of serious adverse events reported, from December 22, 2007,
through October 31, 2008: 391;
Percentage of all serious adverse events reported: 65.6%.
Dietary supplement product classification: Vitamin;
Number of serious adverse events reported, from December 22, 2007,
through October 31, 2008: 240;
Percentage of all serious adverse events reported: 40.3%.
Dietary supplement product classification: Mineral;
Number of serious adverse events reported, from December 22, 2007,
through October 31, 2008: 111;
Percentage of all serious adverse events reported: 18.6%.
Dietary supplement product classification: Fats and lipid substances;
Number of serious adverse events reported, from December 22, 2007,
through October 31, 2008: 55;
Percentage of all serious adverse events reported: 9.2%.
Dietary supplement product classification: Herbal and botanical (other
than tea);
Number of serious adverse events reported, from December 22, 2007,
through October 31, 2008: 24;
Percentage of all serious adverse events reported: 4.0%.
Dietary supplement product classification: Fiber;
Number of serious adverse events reported, from December 22, 2007,
through October 31, 2008: 20;
Percentage of all serious adverse events reported: 3.4%.
Dietary supplement product classification: Herbal and botanical teas;
Number of serious adverse events reported, from December 22, 2007,
through October 31, 2008: 15;
Percentage of all serious adverse events reported: 2.5%.
Dietary supplement product classification: Protein;
Number of serious adverse events reported, from December 22, 2007,
through October 31, 2008: 9;
Percentage of all serious adverse events reported: 1.5%.
Dietary supplement product classification: Animal by-products and
extracts;
Number of serious adverse events reported, from December 22, 2007,
through October 31, 2008: 1;
Percentage of all serious adverse events reported: 0.2%.
Dietary supplement product classification: Total;
Number of serious adverse events reported, from December 22, 2007,
through October 31, 2008: 596[A].
Source: FDA.
[A] Total does not add because some adverse event reports involved more
than one product and are counted in more than one subcategory. For
example, according to FDA, if a consumer was taking both a vitamin C
supplement and an echinacea supplement when the adverse event took
place, the event would be classified under both "vitamin" and "herbal
and botanical." If the consumer was taking a single product containing
both vitamin C and echinacea, the event would be classified under
"combination products."
[End of table]
Although FDA has received a greater number of reports since mandatory
reporting requirements went into effect, FDA recently estimated that
the actual number of total adverse events--including serious, moderate,
and mild--related to dietary supplements per year is over 50,000.
[Footnote 3] This estimate suggests that underreporting of adverse
events limits the amount of information that FDA receives regarding
safety concerns related to dietary supplements or their ingredients
and, according to FDA, this can negatively impact the agency's ability
to identify safety concerns.
Experts have cited several possible reasons for underreporting related
to dietary supplements, including reduced attribution of adverse
effects to supplements due to the assumption that all dietary
supplements are safe, the reluctance of consumers to report dietary
supplement use to physicians, the failure to recognize chronic or
cumulative toxic effects from their use, and a cumbersome reporting
process. To facilitate adverse event reporting for any FDA-regulated
products, FDA is currently developing MedWatchPlus, an interactive Web-
based portal intended to simplify the reporting process and reduce the
time and cost associated with reviewing paper reports. For example,
according to FDA planning documents, MedWatchPlus would simplify the
reporting process by providing a single Internet portal for consumers,
health care providers, and industry to report an adverse event.
Furthermore, the proposed interactive format will prompt reporters to
provide relevant information based on the type of products involved in
the adverse event--thereby facilitating reporting and improving the
quality of information FDA receives. Once an event is reported, the
information would be automatically routed to the relevant FDA centers
based on the type of product involved. Testing and release of the
interactive questionnaire phase of the project is currently expected in
2009.
Although FDA Has Taken Some Steps to Identify and Act on Concerns about
the Safety of Dietary Supplements, Several Factors Limit Its Oversight:
FDA has taken some steps--such as analyzing adverse event reports and
detaining certain potentially unsafe imported products--to identify and
act upon safety concerns related to dietary supplements. However,
several factors limit the agency's ability to detect concerns and
efficiently and effectively remove products from the market. For
example, FDA has limited information on the number and location of
dietary supplement firms, the identity and ingredients of products
currently available in the marketplace, and mild and moderate adverse
events reported to industry. Additionally, FDA dedicates relatively few
resources to dietary supplement oversight activities compared with
other FDA-regulated products. Moreover, once the agency has identified
a safety concern, the agency's ability to efficiently and effectively
remove a product from the market is hindered by a lack of mandatory
recall authority and the difficulty of establishing adulteration for
dietary supplement products under the significant or unreasonable risk
standard. Although FDA has taken some steps, such as drafting guidance
for industry on reporting serious adverse events and establishing its
Current Good Manufacturing Practice regulations, to improve the
oversight of dietary supplements over the past several years, consumers
remain vulnerable to risks posed by potentially unsafe products.
FDA Has Taken Some Actions to Identify and Act on Concerns about the
Safety of Dietary Supplements:
FDA uses a variety of approaches to identify potential safety concerns
related to dietary supplements. For example, FDA may identify concerns
through surveillance actions such as monitoring adverse event reports
and consumer complaints, screening imports, and conducting inspections.
For instance, during almost half of the 909 inspections conducted at
dietary supplement firms from fiscal year 2002 through May 6, 2008, FDA
and its partners at the state level identified potential problems, such
as a lack of quality control and unsanitary conditions. Table 3
provides examples of FDA surveillance related to dietary supplements.
For more detailed information on FDA's actions to identify potential
safety concerns, see appendix II.
Table 3: Examples of FDA Surveillance to Identify Safety Concerns:
Surveillance action: Monitoring adverse events;
FDA received 3,502 adverse event reports related to dietary supplements
from January 1, 2003 through October 31, 2008. The top three outcomes
associated with these cases were hospitalization (32 percent),
nonserious illness or injury (28 percent), and serious illness or
injury (25 percent).[A]
Surveillance action: Monitoring consumer complaints;
FDA received 1,018 consumer complaints from fiscal year 2001 through
July 3, 2008. Forty-two percent of these complaints involved adverse
symptoms. Consumer complaints involving adverse symptoms triggered 236
active surveillance operations, including inspections and sample
collections.
Surveillance action: Screening imports;
FDA reviewed 616,464 import entry lines of dietary supplements from
fiscal year 2002 through March 24, 2008, and either sampled or
examined, on average, approximately 3 to 5 percent of the imported
entry lines entering the country.[B]
Surveillance action: Conducting inspections;
FDA conducted 804 inspections, and state partners conducted 105
inspections, of domestic dietary supplement firms from fiscal years
2002 through 2008. Investigators identified potential problems, such as
a lack of quality control and unsanitary conditions, in 49 percent of
these inspections.
Source: GAO analysis of FDA data.
[A] An adverse event report case may have more than one reported
outcome.
[B] According to FDA, an entry line is each portion of an import
shipment that is listed as a separate item on an entry document. Items
in an import entry having different tariff descriptions must be listed
separately.
[End of table]
In addition, FDA monitors the Internet to identify products that
purport to be dietary supplements but may be fraudulently promoted for
treating diseases. According to FDA, such products pose a threat to
public health because the disease prevention and treatment claims often
persuade consumers to delay or forgo medical diagnosis and treatment.
FDA officials also told us they identify safety concerns by obtaining
information from other agencies at the state, federal, and
international level; reviewing scientific literature; sponsoring safety-
related research; and targeting safety-related investigations on
particular classes of products. For instance, according to FDA, the
agency used adverse event information from the Florida Department of
Health to issue a consumer warning about the product "Total Body
Formula." FDA officials also described current safety-related
investigations it initiated targeting specific classes of products,
such as ephedra substitutes; male potency enhancers that contain
undeclared active pharmaceutical ingredients; and products making
misleading health claims to prevent or cure serious illnesses such as
diabetes, sudden acute respiratory syndrome, and influenza. For
example, officials said they are currently contracting with the
University of California at Los Angeles to monitor adverse event
reporting related to ephedra substitutes. In addition, FDA is
conducting animal testing through the National Center for Toxicological
Research to examine interactions among weight loss supplement
ingredients, according to agency officials.
Once FDA has identified a potential safety concern, the agency has
several options available for taking action. According to FDA
officials, products or ingredients of greatest concern for public
health generally will be subject to either administrative or judicial
enforcement actions, whereas FDA will take advisory actions against
products of lower public health risk. FDA officials also noted that, if
a firm does not correct violations in response to an advisory action,
FDA may pursue an enforcement action against the firm. Table 4 provides
examples of FDA administrative and enforcement actions related to
dietary supplements. For more detailed information on FDA's actions in
response to identified safety concerns, see appendix II.
Table 4: Examples of FDA Actions in Response to Identified Safety
Concerns:
Advisory action: Hold regulatory meeting with the firm;
FDA officials may meet with firm representatives to discuss concerns
and request voluntary action; however, FDA does not collect agencywide
data on these meetings.
Advisory action: Issue firm a warning;
FDA issued 293 warning letters citing 534 violations regarding dietary
supplements from fiscal years 2002 through 2007. Seventy percent of
these violations related to dietary supplements that FDA determined
were either unapproved new drugs or misbranded drugs.
Advisory action: Issue consumer alerts;
FDA had posted 12 consumer alerts on its Web site since 1999, including
warnings for kava, aristolochic acid, and St. John's wort, among
others, as of November 21, 2008.
Advisory action: Issue advisory to industry;
FDA had posted letters to industry advising against the marketing of
products containing aristolochic acid, comfrey, androstenedione,
Lipokinetix, and ephedra, as of November 21, 2008.
Administrative and judicial enforcement actions to remove a product
from the market: Work with company on a voluntary product recall;
At least 45 recalls related to dangerous or defective dietary
supplement products that posed a serious health concern were initiated
from fiscal years 2003 through 2008. Of these recalls, 27 were due to
the unapproved presence of pharmaceutical ingredients in the supplement
products.
Administrative and judicial enforcement actions to remove a product
from the market: Detain/refuse the product if imported;
FDA detained 3,225 dietary supplement import entry lines from fiscal
year 2002 through March 24, 2008. Fifty percent of the detentions were
due to the potential presence of a poisonous or unsafe substance. Over
this same period, FDA refused 3,604 lines of dietary supplements,
citing 5,560 violations. Twenty-five percent of the violations were due
to the potential presence of an unsafe substance.
Administrative and judicial enforcement actions to remove a product
from the market: Pursue legal action against the firm;
FDA initiated action for 27 seizures and 6 injunctions from fiscal year
2002 through July 18, 2008. Nineteen of the seizures and 6 of the
injunctions regarded products promoted to treat, cure, or prevent
diseases. FDA had filed criminal charges or won convictions in 19 cases
since fiscal year 2002, as of July 31, 2008.
Administrative and judicial enforcement actions to remove a product
from the market: Ban ingredient;
FDA banned one ingredient--ephedra--in 2004, almost 10 years after
issuing its first advisory. FDA has not banned any other dietary
supplement ingredients.
Source: GAO analysis of FDA data.
[End of table]
In addition to taking enforcement action on its own, FDA may pursue
enforcement action in conjunction with another federal agency, such as
the Federal Trade Commission, which has enforcement responsibility with
regard to dietary supplement advertising. For example, as part of the
FDA's Consumer Health Information for Better Nutrition initiative
launched in 2002, FDA and the Federal Trade Commission took joint
enforcement actions against several marketers of dietary supplement
products making unsubstantiated treatment claims for diseases such as
emphysema, diabetes, Alzheimer's disease, cancer, and multiple
sclerosis. In addition, industry has also initiated some measures to
address unsubstantiated claims. For example, based on monitoring
efforts and company referrals, the National Advertising Division of the
Council of Better Business Bureaus reviews advertising claims for
accuracy and then recommends changes to companies as necessary. This
program is currently funded through a series of multiyear grants from
the Council for Responsible Nutrition.
FDA officials also noted that the agency plans to expand dietary
supplement oversight in the near term. In particular, FDA will add
dietary supplement inspections as an option for its formal state
contract agreements in 2009, which should increase the number of
dietary supplement inspections performed by state officials on FDA's
behalf, according to FDA officials.[Footnote 4] To further increase the
number of inspections, FDA is also exploring third-party certification
as part of its Food Protection Plan: An Integrated Strategy for
Protecting the Nation's Food Supply.[Footnote 5] To improve the
agency's Internet surveillance, FDA has plans to implement a
sophisticated computer program that will search the Web for
unauthorized disease treatment claims, potentially searching hundreds
of thousands of Web sites per minute compared with a manual search by
FDA staff, according to an FDA official. Moreover, although agency
officials stated it was too early to determine the effectiveness of the
newly established Current Good Manufacturing Practice regulations and
serious adverse event reporting requirements, these new tools could
improve the agency's ability to oversee the dietary supplement
industry. While several stakeholders generally agreed that the new
regulations could improve FDA's ability to oversee the dietary
supplement industry, some stakeholders raised concerns about FDA's
ability to enforce the new requirements given its limited resources.
Several Factors Limit FDA's Ability to Identify and Act on Safety
Concerns Related to Dietary Supplements:
Although FDA has taken some steps to identify and act on safety
concerns, limited information hinders FDA's oversight of the dietary
supplement industry. In addition, FDA dedicates relatively few
resources to dietary supplement oversight. Furthermore, FDA is limited
by a lack of authority to efficiently and effectively remove products
from the market.
FDA's Ability to Identify Safety Concerns Is Hindered by a Lack of
Information:
FDA's ability to identify safety concerns is hindered by a lack of
information in three key areas: the identity and location of dietary
supplement firms; the types and contents of products on the market; and
product safety information, such as adverse event data. First, FDA
lacks complete information on the names and location of dietary
supplement firms within the agency's jurisdiction. Although all dietary
supplement firms must register with FDA as food facilities to provide
information on their name and location, firms specializing in certain
product categories, such as herbal products, are not required to self-
identify as dietary supplement firms under current law. For example, a
firm manufacturing products containing only herbs, such as echinacea
and ginseng, would not be required to identify itself as a dietary
supplement firm during the registration process. Consequently, FDA may
not be aware of all dietary supplement firms that are currently
operating. In addition, there is little assurance that FDA's existing
inventory of dietary supplement firms is accurate because this
information is not updated in a systematic fashion. As one FDA official
explained, a thorough review of FDA's firm inventory would probably
require dedicating 10 to 15 staff within each field office to the task
for a year--which is unlikely given FDA's current workload. However,
FDA officials did indicate that modifying the existing registration
categories to better reflect FDA's inspection responsibilities could
provide the agency with more complete information on the number and
location of dietary supplement firms within its regulatory
jurisdiction, provided industry complies with the new requirements. In
FDA's Food Protection Plan, the agency requested statutory changes to
allow modifying existing registration categories and require biannual
renewals for food facilities, stating that such changes would ensure
FDA has accurate, up-to-date information and would help the agency
assess and respond to potential threats to the food supply.
Second, FDA does not have comprehensive information on the types and
contents of dietary supplement products that are on the market or their
ingredients. In addition, FDA officials noted that, if a dietary
supplement firm reformulates a product to include different ingredients
and/or changes the amounts of the ingredients without renaming the
product, FDA may not be aware of the changes. Although drug
manufacturers are required by law, with some exceptions, to register
the identity and active ingredients of their products with FDA, the
agency lacks the authority to require similar product information from
dietary supplement manufacturers. Detailed product information could
help the agency more efficiently and effectively analyze the adverse
event reports it receives. For example, according to FDA, voluntary
reports often contain inaccurate or incomplete information on product
ingredients. Complete information on product ingredients could help the
agency establish links between mandatory and voluntary reports on
products containing the same ingredient. Furthermore, a database of
marketed products and their ingredients could help the agency respond
more quickly to safety concerns. For instance, if FDA identified a
particular ingredient of concern, officials could quickly determine
which products on the market contained the ingredient and tailor the
agency's response accordingly.
Third, FDA's ability to identify safety concerns is undermined by a
lack of information on product safety, such as data on the frequency
and characteristics of adverse events related to dietary supplements.
As we noted earlier in this report, although dietary supplement firms
are required to report all serious adverse event reports they have
received to FDA, they are not required to report mild or moderate
adverse events.[Footnote 6] Additional information on adverse events
could be particularly beneficial because there is a limited amount of
scientific data available on the safety of dietary supplements compared
with other regulated products such as drugs, which require premarket
approval. For instance, FDA officials noted that mandatory reporting of
mild and moderate events could assist the agency by increasing the
amount of data available for signal detection, as well as provide
additional support for safety-related conclusions regarding particular
products or ingredients. Although some stakeholders have pointed out
that mandatory manufacturer reporting of mild and moderate events won't
fully address the issue of underreporting--particularly for consumers
and health care providers--most medical researchers we interviewed
agreed that mandatory reporting of all adverse events would be
beneficial to the agency.
FDA Dedicates Relatively Few Resources to Dietary Supplement Oversight:
FDA dedicates relatively few resources to dietary supplement oversight
activities, including conducting inspections and developing guidance
for industry on key safety-related aspects of DSHEA. Our analysis of
FDA expenditure data found that FDA dedicated approximately 4 percent
of CFSAN resources and 1 percent of its field resources--which are
dedicated to FDA's Office of Regulatory Affairs--to dietary supplement
programs from fiscal years 2006 through 2007.[Footnote 7] FDA uses its
field resources to, for example, monitor industry compliance by
conducting surveillance actions such as inspections and import
screenings. As FDA officials explained, limited inspection resources
are prioritized according to public health risk, and dietary
supplements are generally considered to be a lesser risk than, for
example, foods that could be contaminated with foodborne pathogens.
Consequently, although FDA conducted 973 inspections of foreign food
firms from fiscal year 2002 through fiscal year 2008, FDA conducted no
foreign inspections of dietary supplement firms during this time
period.[Footnote 8] Similarly, although FDA increased the number of
domestic inspections of dietary supplement firms in fiscal years 2004
and 2005, overall, these inspections represented less than 1 percent of
total food establishment inspections conducted by FDA and its state
partners from fiscal years 2002 through 2008. With few resources
dedicated to dietary supplement inspections, FDA's ability to identify
potential safety concerns through this key surveillance activity is
limited.
Furthermore, despite identifying the need to provide industry with
guidance on key aspects of DSHEA, FDA has not done so in a timely
manner. For example, DSHEA authorized FDA to establish Current Good
Manufacturing Practices specific to dietary supplements in 1994;
however, the agency did not publish a proposed rule until 2003 and did
not finalize the rule until 2007. FDA officials noted that it first
issued an advance notice of proposed rulemaking in 1997 and went
through a number of steps, such as conducting public meetings, to
develop an overall strategy for regulating dietary supplements and then
submitted its rule to the Office of Management and Budget for clearance
before finalizing the rule. Because these Current Good Manufacturing
Practices are phased in over time, they will not fully be in effect
until 2010--16 years after FDA was authorized to establish them.
In addition, although FDA recognized the need to develop guidance on
the new dietary ingredient provisions of DSHEA, FDA has yet to issue
this guidance--an omission previously highlighted in our 2000 report.
As an FDA official explained, new dietary ingredient guidance is
critical for dietary supplement safety because, without formal
guidance, firms may not notify FDA before marketing products that have
drastically different safety profiles than their historical use. For
example, this official was concerned that a firm could use bitter
orange's historical use as a flavoring in marmalade as justification
for not submitting a new dietary ingredient notification to FDA when it
uses bitter orange to create a product that is 95 percent synephrine--
a powerful stimulant. Similarly, a firm might choose to market dietary
supplement products that contain nano-sized particles of grandfathered
ingredients without notifying FDA in advance. According to the FDA
official, this raises concerns because potential health risks
associated with nano-sized particles are unknown. According to this
official, FDA has started to develop draft guidance for new dietary
ingredients that would clarify what factors FDA will use when
determining if a substance is a new dietary ingredient. More
specifically, the guidance would clarify what changes to grandfathered
ingredients would require a new dietary ingredient notification to FDA
and what information should be included in the notification, among
other items. However, this draft guidance has been under legal review
for over a year, and FDA did not provide us with a time frame for its
issuance.
FDA's Lack of Authority Limits Its Ability to Remove Products from the
Market:
Once FDA has identified a safety concern, the agency's ability to
efficiently and effectively remove a product from the market is
hindered by a lack of mandatory recall authority. For instance, FDA
officials commented that FDA's ability to protect consumers through its
voluntary recall authority is limited because it relies on industry
exercising its responsibility rather than enforceable requirements. As
FDA noted in its Food Protection Plan, mandatory recall authority would
allow the agency to ensure the prompt and complete removal of unsafe
products from distribution channels in cases where a firm was unwilling
to cooperate voluntarily.
Additionally, agency officials and other stakeholders have acknowledged
the difficulty of banning a dietary supplement because FDA must
establish adulteration under the significant or unreasonable risk
standard. For example, it took FDA almost 10 years after issuing its
first advisory about ephedra to gather sufficient data to meet the
statutory burden of proof for banning ephedra from the market. The
difficulty of establishing significant or unreasonable risk is
compounded by limited scientific research on the safety of dietary
supplements--which are generally presumed safe under the law, and firms
are not required to provide FDA with evidence of product safety for
ingredients marketed prior to October 15, 1994, such as ephedra.
Underreporting of adverse events also limits FDA's ability to meet its
burden of proof. In the case of ephedra, one firm withheld information
from FDA on thousands of serious adverse event reports related to its
product--which hindered FDA's investigation, and prompted support for
establishing mandatory reporting requirements. As previously mentioned
in this report, although mandatory serious adverse event reporting
requirements for industry are now in effect, underreporting of all
adverse events from consumers, health care providers, and industry
remains a concern. According to an agency official, given these data
limitations and the agency's difficult and costly experience with
ephedra, banning an ingredient is not a very viable option. However,
according to some experts, the difficult process of establishing
significant or unreasonable risk for dietary supplement ingredients
with known safety concerns has raised doubts about FDA's ability to
adequately protect the public. For example, table 5 summarizes FDA
actions for certain dietary supplement ingredients that have been
banned in other countries.
Table 5: Examples of FDA Actions Taken on Dietary Supplement
Ingredients That Have Been Banned in Other Countries:
Ingredient: Aristolochic acid;
Reported uses: Aphrodisiac, immune stimulant;
Dangers: Kidney damage, cancers, deaths reported;
Regulatory actions in other countries: Banned in seven European
countries, Japan, Venezuela, and Egypt;
FDA actions: In 2000 and 2001, FDA listed aristolochic acid as a
"Botanical Ingredient of Concern" and issued letters to industry and
health care professionals. In 2001, FDA issued an "Import Alert" for
products containing the ingredient and issued a consumer advisory. FDA
has also taken some enforcement or advisory actions against individual
products.
Ingredient: Kava;
Reported uses: Anxiety, stress;
Dangers: Abnormal liver function or damage, deaths reported;
Regulatory actions in other countries: Banned in Canada, Germany,
Singapore, South Africa, and Switzerland;
FDA actions: FDA issued letters to health care professionals in 2001
and 2002 and a consumer advisory in 2002.
Ingredient: Lobelia;
Reported uses: Asthma, bronchitis;
Dangers: Tremor, overdose may cause coma and possibly death;
Regulatory actions in other countries: Banned in Bangladesh and Italy;
FDA actions: No action.
Source: GAO analysis of FDA and Consumer's Union data.
Note: GAO did not independently verify regulatory actions in other
countries.
[End of table]
While FDA Has Taken Some Actions When Foods Contain Unsafe Dietary
Ingredients, Certain Factors May Allow Unsafe Products to Reach
Consumers:
Although FDA has taken some actions, such as issuing warnings, when
foods contain unsafe dietary ingredients, certain factors may allow
unsafe products to reach consumers. FDA may not know when a company has
made an unsupported or incorrect GRAS determination about an added
dietary ingredient in a product until after the product becomes
available to consumers because companies are not required to notify FDA
of their self-determinations. In addition, the boundary between dietary
supplements and foods containing added dietary ingredients is not
always clear, and some food products could be marketed as dietary
supplements to circumvent the safety standard required for food
additives. Finally, according to FDA officials, the agency conducts a
limited amount of monitoring for safety concerns associated with foods
containing added dietary ingredients.
Companies Are Not Required to Notify FDA When They Make a Self-
Determination That an Added Ingredient Is GRAS:
The Federal Food, Drug, and Cosmetic Act allows companies to market a
conventional food product with added dietary ingredients if the company
determines that the added dietary ingredient meets the GRAS standard.
These companies do not have to notify FDA before selling the product to
consumers, although some may do so voluntarily. If a company makes an
unsupported or incorrect GRAS determination about an added dietary
ingredient in a product, FDA may not know about the product until after
it becomes available to consumers. This was the case, for example, for
several food products containing such herbs as kava, ginkgo, and
echinacea. Specific examples are as follows:
* In 2004, during a food inspection of a juice company, FDA found that
the company was marketing a product that contained kava. According to
FDA, it is not aware of a basis for concluding that kava is GRAS, and
it has not approved kava as a food additive. In addition, kava was the
subject of a public health advisory issued by FDA in March 2002, which
warned consumers of the potential risk of severe liver injury
associated with the use of kava.
* In 2001, FDA identified a company marketing cereals with ginkgo
biloba and Siberian ginseng. According to FDA, it is not aware of a
basis for concluding that these ingredients are GRAS, and it has not
approved them as food additives. FDA sent a warning letter to the
company, and the product was subsequently removed from the market.
* Also in 2001, FDA identified a company marketing juices with added
echinacea. FDA sent a warning to the company noting that it has not
approved echinacea as a food additive and is not aware of a basis for
concluding that echinacea is GRAS.
FDA learned of these products after they were available to consumers.
If FDA wanted to remove these products from the market, and the
companies did not do so voluntarily, FDA would have to initiate
enforcement actions.
The Boundary between Dietary Supplements and Foods with Added Dietary
Ingredients Is Not Always Clear:
The boundary between dietary supplements and foods containing added
dietary ingredients is not always clear. FDA officials have noted, for
example, that a tea with an identical mix of herbal ingredients could
be considered either a dietary supplement or a food product. FDA
determines how to classify the tea based on the product labeling. More
specifically, according to FDA, if the tea is labeled as a dietary
supplement and is not represented as a conventional food, FDA would
consider the tea to be a dietary supplement and regulate it as such. On
the other hand, if the tea is labeled as a food or is represented as a
conventional food with terms such as "drink" or "beverage," FDA
officials noted that they would consider the tea to be a food.
The way FDA classifies a product is important because the safety
standard that applies to the product varies based on that
classification. If the product is classified as a conventional food,
the added dietary ingredient must meet the GRAS standard or be approved
by FDA as a food additive, except in certain circumstances as
authorized in law. If the product is classified as a dietary
supplement, the added dietary ingredient is presumed safe if it was
marketed in the United States before October 15, 1994; otherwise, it is
considered a new dietary ingredient, and the manufacturer or
distributor may be required to notify FDA 75 days before the product
with the added dietary ingredient enters the market and provide some
basis for concluding that the ingredient is reasonably expected to be
safe. According to FDA and industry officials, this is a less stringent
standard than that for food additives. However, FDA does not have the
authority to require that the safety of dietary supplements be approved
before entering the market.
These differences in how products are regulated may lead to
circumstances when an ingredient would not be allowed to be added to a
product if it was labeled as a conventional food but would be allowed
in the identical product if it was labeled as a dietary supplement.
This was the case, for example, in August 2007, when FDA identified a
company marketing an iced tea mix containing stevia--an herb that had
not been approved as a food additive because of potential safety
concerns, including reproductive and cardiovascular effects. FDA issued
a warning to the company; however, rather than discontinue using stevia
in its product, the company changed the label to classify the product
as a dietary supplement rather than a food, and the product remains on
the market. We identified other products that also fall within the gray
area between dietary supplements and foods with added dietary
ingredients that are being marketed as dietary supplements. For
example, we identified several nutrition bars, teas, and energy drinks,
some produced by large companies with national distribution, which
contain herbs such as kava, St. John's wort, and echinacea. If these
ingredients are added to conventional foods and are not GRAS and have
not been approved as food additives, then they would violate the
Federal Food, Drug, and Cosmetic Act. An FDA official told us that FDA
is unaware of a basis for concluding that these ingredients are GRAS,
and they have not been approved as food additives. However, these
products may remain on the market because they are labeled as dietary
supplements. Such a process might allow companies to circumvent the
safety standard required for food additives.
In FDA's 10-year plan to implement DSHEA, issued in January 2000, the
agency identified the need to clarify the boundary between conventional
foods and dietary supplements but did not indicate when or how the
agency planned to address this issue. Moreover, we highlighted this
particular issue in our July 2000 report and recommended FDA take
action to clarify the boundary between conventional foods and dietary
supplements. As of November 2008, the agency had not issued regulations
or guidance to clarify this boundary.
FDA Conducts Limited Monitoring of Foods with Added Dietary
Ingredients:
According to FDA officials, the agency conducts limited monitoring for
safety concerns associated with food products that contain added
dietary ingredients. These officials explained that FDA does not track
these products separately from foods, and the agency generally relies
on trade complaints and adverse event reports to identify concerns
about these types of products. FDA officials told us that the current
regulatory framework is sufficient to identify and act on safety
concerns regarding foods with added dietary ingredients. FDA held a
public meeting in 2006 regarding these products and, according to FDA
officials, the agency is currently evaluating the comments made during
that meeting.
Some stakeholders told us that safety risks associated with foods
containing added dietary ingredients that meet the GRAS standard or
have been approved as food additives are generally low. For example,
stakeholders were generally not concerned about vitamin-fortified
products, such as cereal, unless individuals consume these products in
high doses. However, some stakeholders we spoke with raised concerns
about certain products--such as energy drinks that contain stimulants
and have the potential to cause adverse cardiac effects. In addition,
some stakeholders expressed concern about adding botanicals to foods
due, in part, to the potential for an adverse physiological response.
In contrast, an industry official noted that companies sometimes add
dietary ingredients to foods for labeling or marketing purposes--not to
elicit a physiological effect--and, therefore, the amounts included are
low.
FDA Has Taken Limited Steps to Educate Consumers about Dietary
Supplements, and Consumers Remain Largely Uninformed:
While FDA has conducted some consumer outreach, these initiatives have
reached a relatively small proportion of consumers using dietary
supplements. Additionally, surveys and experts indicate that consumers
are not well-informed about the safety and efficacy of dietary
supplements and have difficulty interpreting labels on these products.
Without a clear understanding of the safety, efficacy, and labeling of
dietary supplements, consumers may be exposed to greater health risks
associated with the uninformed use of these products.
FDA Has Conducted Some Consumer Education about Dietary Supplements,
but these Efforts Have Been Limited:
FDA has taken some steps to educate consumers about the safety,
efficacy, and labeling of dietary supplements. According to FDA
officials, the agency primarily educates the public about dietary
supplements through publications such as brochures and articles, as
well as the agency's Web site. For example, agency officials
highlighted the following efforts:
* FDA and the NIH's Office of Dietary Supplements jointly published a
brochure in 2004 to educate consumers about the importance of
disclosing their dietary supplement usage to doctors.
* In March 2006, FDA developed a document entitled, "Food Facts:
Dietary Supplements--What You Need to Know" with general information
about dietary supplements.
* In August 2008, FDA distributed an article via e-mail and its Web
site entitled "FDA 101: Dietary Supplements" that contained information
on the regulation of dietary supplements, as well as information on the
safety, efficacy, and labeling of these products.
* FDA's Web site provides warnings about certain ingredients and
products, how to report an adverse event, and general consumer
information about dietary supplements, including descriptions of the
types of label claims permitted on dietary supplement products. FDA's
Web site also links consumers to the NIH, Federal Trade Commission,
United States Department of Agriculture, and National Academies'
Institute of Medicine Web pages that contain information about the
safety and efficacy of certain dietary supplement ingredients and how
to interpret dietary supplement labels.
* FDA has worked jointly with industry, consumer groups, and other
federal agencies to provide consumers with information about label
claims.
However, these outreach efforts can only be as effective as the number
of dietary supplement users they reach. While data from the 2007
National Health Interview Survey show that over half of the U.S. adult
population--or at least 114 million individuals--consume dietary
supplements, we found that FDA's outreach efforts have limited
potential to reach the majority of U.S. adults using dietary
supplements. For example, according to FDA and NIH officials, since
2004, the brochure regarding disclosure of supplement use to doctors
had a distribution of 40,000 paper copies and received about 171,000
total visits on the FDA and NIH Web sites--which represent less than 1
percent of estimated dietary supplement users. Other FDA publications
on dietary supplements have also reached a relatively small proportion
of dietary supplement consumers. For example, according to FDA
officials, it distributed about 61,000 English copies and approximately
35,000 Spanish copies of its document entitled "Food Facts: Dietary
Supplements--What You Need to Know." In addition, according to FDA
officials, its consumer article on dietary supplements called "FDA 101:
Dietary Supplements" was sent via e-mail to almost 32,500 subscribers
to FDA's "Consumer Health Information" and, as of October 21, 2008,
FDA's Web site had logged about 3,800 page views of the HTML version
and approximately 2,100 page views of the printer-friendly PDF of the
article.
While agency officials stated that FDA does not evaluate the
effectiveness of its outreach efforts, officials also noted that the
agency must continually market its desired messages to effectively
educate consumers. Additionally, consumer education was highlighted as
an important part of the agency's 10-year plan for dietary supplements,
published in 2000. In the November 2004 update to this plan, FDA
identified the need to provide consumers with access to reliable
scientific information about the safety of ingredients and supplements
so that consumers may make more informed choices. Currently, according
to FDA, CFSAN has no ongoing or new consumer education initiatives
being planned for dietary supplements. FDA recently announced a
partnership with WebMD to expand consumer access to timely and reliable
health information; however, it is not clear to what extent FDA will
use this partnership to increase consumer understanding about dietary
supplements. When asked about plans for consumer education initiatives,
FDA officials explained that the agency has been directing its limited
resources toward activities that can have the greatest public health
impact, such as responding to foodborne illness outbreaks.
Consumers Are Not Well-Informed about the Safety, Efficacy, and
Labeling of Dietary Supplements:
Several studies indicate that consumers are not well-informed about the
safety, efficacy, and labeling of dietary supplements. For example, a
2002 Harris Poll indicated that a majority of adults are misinformed
about the extent to which government regulates the safety of vitamins,
minerals, and food supplements. According to the poll, over half of
respondents believed that dietary supplements are approved by a
government agency. A 2002 FDA-sponsored health and diet survey also
estimated that a majority of respondents who used vitamin or mineral
supplements believed that the government approves dietary supplement
products before they are marketed to consumers. However, FDA does not
have the authority to require that supplements be approved for safety
and effectiveness prior to marketing, and, unless a product contains a
new dietary ingredient, FDA does not need to be notified by the
manufacturer prior to marketing a dietary supplement. Additionally, the
2002 Harris Poll estimated that about two-thirds of respondents believe
that the government requires dietary supplement labels to contain
warnings about potential side effects, or dangers, similar to drugs.
However, unlike drug manufacturers, who are required to include
warnings related to adverse effects and contraindications on their
product labels, dietary supplement manufacturers are required to
include few such warnings on their product labels. Consequently,
dietary supplement manufacturers may not necessarily include warnings
about potential adverse effects on the labels of their products. For
example, in the course of our review, we identified several dietary
supplements that contained ingredients with known or suspected adverse
effects, such as kava and black cohosh, that did not include warnings
on their labels. In addition, in 2003, an analysis of 100 dietary
supplement labels by the Department of Health and Human Services'
Office of Inspector General found that the dietary supplement labels
were limited in their ability to guide the informed and appropriate use
of dietary supplements among consumers and often did not present
information in a manner that facilitates consumer understanding.
[Footnote 9]
Furthermore, during the course of our review, most experts we spoke
with noted that, generally, consumers are not well-informed about the
safety and efficacy of dietary supplements. These experts explained
that many consumers believe various myths about dietary supplements.
For example, consumers may believe that if a product is natural, it
must be safe; if a little is good, then more must be better; and if a
product does not have a warning label, it must be safe. Without a clear
understanding of the safety, efficacy, and labeling of dietary
supplements, consumers are exposed to potential health risks associated
with the uninformed use of these products. For example, several experts
stated that misconceptions about dietary supplements could cause
consumers to incorrectly assess the risks and benefits of these
products and, in some cases, substitute supplements for prescribed
medicine. In addition, several experts noted that consumers may not be
aware that taking combinations of some supplements or using certain
products in conjunction with prescription drugs could lead to harmful
and potentially life-threatening results. In particular, some
supplements--such as garlic, ginkgo biloba, ginseng, and vitamin E--may
cause blood thinning and lead to life-threatening complications during
surgical procedures. Therefore, consumer education is critical to
mitigate the potential risks associated with the uninformed use of
dietary supplements.
Conclusions:
Americans are widely interested in maintaining health and wellness and,
with an aging population, we expect that consumers' interest in dietary
supplements will continue to grow. These consumers confront an
extensive variety of dietary supplements available in the marketplace,
but little is known about the safety and efficacy of these products.
Yet, most dietary supplements are presumed safe under current law, and
companies do not need premarket approval for any dietary supplement. If
FDA has concerns about a particular dietary supplement product or
ingredient, the agency bears the burden of proof to require removal of
the product from the market. In the case of ephedra--which was
implicated in thousands of adverse events and a number of deaths--FDA
faced a long and arduous process before finally banning the product in
2004.
At the same time, while more and more products are entering the market
each year, FDA is dedicating a small percentage of its resources to
regulating the dietary supplement industry and educating consumers
about dietary supplements. FDA does not have comprehensive knowledge of
dietary supplement manufacturers or the products on the market and has
little information about potential side effects of various products. In
addition, consumers are not well-informed about dietary supplements,
may not be aware of potential side effects of supplements, and might
not consider a dietary supplement as a factor if experiencing an
adverse reaction. Weaknesses in the regulatory system may increase the
likelihood of unsafe products reaching the market, and a lack of
consumer knowledge increases the potential health risks associated with
uninformed consumption.
Recommendations for Executive Action:
Overall, we are making four recommendations to enhance FDA's oversight
of dietary supplements and foods with added dietary ingredients.
1. To improve the information available to FDA for identifying safety
concerns and better enable FDA to meet its responsibility to protect
the public health, we recommend that the Secretary of the Department of
Health and Human Services direct the Commissioner of FDA to request
authority to require dietary supplement companies to:
* identify themselves as a dietary supplement company as part of the
existing registration requirements and update this information
annually,
* provide a list of all dietary supplement products they sell and a
copy of the labels and update this information annually, and:
* report all adverse events related to dietary supplements.
2. To better enable FDA to meet its responsibility to regulate dietary
supplements that contain new dietary ingredients, we recommend that the
Secretary of the Department of Health and Human Services direct the
Commissioner of FDA to issue guidance to clarify when an ingredient is
considered a new dietary ingredient, the evidence needed to document
the safety of new dietary ingredients, and appropriate methods for
establishing ingredient identity.
3. To help ensure that companies follow the appropriate laws and
regulations and to renew a recommendation we made in July 2000, we
recommend that the Secretary of the Department of Health and Human
Services direct the Commissioner of FDA to provide guidance to industry
to clarify when products should be marketed as either dietary
supplements or conventional foods formulated with added dietary
ingredients.
4. To improve consumer understanding about dietary supplements and
better leverage existing resources, we recommend that the Secretary of
the Department of Health and Human Services direct the Commissioner of
FDA to coordinate with stakeholder groups involved in consumer outreach
to (1) identify additional mechanisms--such as the recent WebMD
partnership--for educating consumers about the safety, efficacy, and
labeling of dietary supplements; (2) implement these mechanisms; and
(3) assess their effectiveness.
Agency Comments and Our Evaluation:
We provided a draft copy of this report to the Department of Health and
Human Services for review and comment. We received a written response
from the Acting Assistant Secretary for Legislation that included
comments from FDA. FDA generally agreed with each of the report's
recommendations and welcomed the report as a means of calling attention
to the challenges FDA faces with respect to regulating dietary
supplements and conventional foods formulated with added dietary
ingredients. FDA noted that although receiving information on all
adverse events related to dietary supplements could enhance FDA's
ability to detect signals of potential toxicity over time, FDA raised
concerns about its ability to efficiently and effectively analyze the
information to identify unsafe dietary supplements. However, FDA stated
that it is working on methodologies to mitigate this concern and
improve data mining for safety-related signals if FDA were to receive
all adverse event reports. In addition, FDA recognized the need for
guidance to industry clarifying when products should be marketed as
conventional foods or dietary supplements and stated that the agency
will consider this recommendation and its implementation in light of
FDA's limited resources and competing priorities. Furthermore, FDA
noted that the agency's resources for consumer education are extremely
limited and that it may not be able to effectively conduct consumer
education on its own. FDA commented that collaborating with NIH's
Office of Dietary Supplements may be an efficient and cost-effective
way to expand FDA's current outreach activities. FDA also stated that
the agency is identifying appropriate content for the recently
announced FDA/WebMD partnership referenced in the report and
anticipates that information on dietary supplements will be included.
FDA's comments are presented in appendix IV of this report. FDA also
provided technical comments on the draft report, which we incorporated
as appropriate.
As agreed with your offices, unless you publicly announce the contents
of this report earlier, we plan no further distribution until 30 days
from the report date. At that time, we will send copies to the
appropriate congressional committees; the Secretary of the Department
of Health and Human Services; the Commissioner of FDA; the Director of
the Office of Management and Budget; and other interested parties. The
report also will be available at no charge on the GAO Web site at
[hyperlink, http://www.gao.gov].
If you or your staffs have any questions about this report, please
contact me at (202) 512-3841 or shamesl@gao.gov. Contact points for our
Offices of Congressional Relations and Public Affairs may be found on
the last page of this report. GAO staff who made major contributions to
this report are listed in appendix V.
Signed by:
Lisa Shames:
Director, Natural Resources and Environment:
[End of section]
Appendix I: Objectives, Scope, and Methodology:
We were asked to examine the Food and Drug Administration's (FDA)
oversight of dietary supplements and foods that contain added dietary
ingredients. Specifically, we were asked to examine FDA's (1) actions
to respond to the new serious adverse event reporting requirements; (2)
ability to identify and act on concerns about the safety of dietary
supplements; (3) ability to identify and act on concerns about the
safety of foods with added dietary ingredients; and (4) actions to
educate consumers about the safety, efficacy, and labeling of dietary
supplements. Our work included dietary supplements for human use only.
We did not assess FDA's regulation of dietary supplements for animal
use.
To identify FDA's actions to respond to the new serious adverse event
reporting requirements, we reviewed FDA's guidance on reporting
requirements for industry and internal procedures for compiling and
tracking adverse event reports. In addition, we obtained and analyzed
data on the number and type of reports received before and after the
requirements went into effect. We verified our methodology for
analyzing these data with FDA officials, and FDA verified our results.
We also reviewed FDA's plans for improving adverse event reporting.
To examine FDA's ability to identify and act on safety concerns
associated with dietary supplements, we assessed FDA's laws, rules,
regulations, planning documents and guidance, such as the Dietary
Supplement Health and Education Act of 1994, Current Good Manufacturing
Practice regulations, and guidance on reporting adverse events. In
addition, we obtained and analyzed data on FDA's internal procedures
and activities to identify safety concerns, such as conducting
inspections and import screenings and receiving consumer complaints. We
also obtained and analyzed FDA's internal procedures and data on the
agency's actions once a safety concern is identified, including issuing
warning letters, seizing products, and banning ingredients. We analyzed
these data to determine the range and extent of actions FDA has taken
to identify and act on safety concerns associated with dietary
supplements. We verified our methodology for analyzing these data with
FDA officials, and FDA verified our results. Furthermore, we reviewed
data on FDA resources dedicated to dietary supplements.
To examine FDA's ability to identify and act on concerns about the
safety of foods with added dietary ingredients, we reviewed laws and
regulations regarding food additives. In addition, we reviewed FDA's
procedures for identifying and acting on safety concerns of foods with
added dietary ingredients. We also identified and analyzed instances of
actions taken by FDA to act on safety concerns associated with the
addition of dietary ingredients to foods.
To determine FDA's actions to educate consumers about the safety,
efficacy, and labeling of dietary supplements, we reviewed FDA's
consumer outreach initiatives. We also obtained and analyzed data on
the extent to which these outreach initiatives were distributed. In
addition, we analyzed data from FDA and others on consumer
understanding of dietary supplements.
To compare FDA's regulation of dietary supplements with select other
countries' regulation of these products, we spoke with representatives
from the governments of Canada, Japan, and the United Kingdom. In
addition, we reviewed documents about the regulation of dietary
supplements in these countries. We did not independently verify
descriptions of foreign laws. We selected these countries because they
had been identified in prior GAO work as having comparable food safety
systems and covered a relatively diverse geographic area (Europe, North
America, and Asia.)
To assess the reliability of the data from FDA's databases used in this
report, we reviewed related documentation, examined the data to
identify obvious errors or inconsistencies, and worked with agency
officials to identify any data problems. We determined the data to be
sufficiently reliable for the purposes of this report.
To obtain insights on all four objectives, we met with a wide range of
experts, including officials from federal and state agencies, industry
and trade organizations, consumer advocacy groups, academia, and poison
control centers. Through these efforts, we obtained documents and
information related to all four objectives. At the federal level, we
met with officials from FDA, including headquarters and regional and
district level officials, to discuss the agency's regulatory
authorities, actions taken to implement the mandatory adverse event
reporting system, steps taken to regulate the safety of dietary
supplements and foods with added dietary ingredients, and consumer
education responsibilities and actions. In addition, we met with
officials from the National Institutes of Health, Federal Trade
Commission, and Department of Agriculture. At the state level, we met
with officials from the California Department of Public Health's Food
and Drug Branch and Environmental Protection Agency and the New York
State Task Force on Life and the Law. To obtain insights from the
dietary supplement and food industries, we met with officials from the
American Beverage Association, American Herbal Products Association,
Consumer Healthcare Products Association, Council for Responsible
Nutrition, Grocery Manufacturers Association, National Advertising
Division of the Council of Better Business Bureaus, and Natural
Products Association. In addition, we met with officials from a large
dietary supplement manufacturer in Maryland, a multinational food and
consumer products firm, and two small, herbal products manufacturers in
California. To obtain insights from consumer advocacy groups, we met
with officials from the Center for Science in the Public Interest,
Consumers Union, and Public Citizen. To obtain insights from public
health organizations, the health care community, and academia, we met
with officials from the American Association of Poison Control Centers;
American Medical Association; California Poison Control System; New
York City Poison Control Center; U.S. Pharmacopoeia; Baylor College of
Medicine; Critical Path Institute; Center for Advanced Food Technology,
Rutgers University; Stony Brook University; Center for Consumer Self
Care, Department of Clinical Pharmacy, and Osher Center for Integrative
Medicine, University of California, San Francisco; and the University
of California, Berkeley.
We conducted this performance audit from December 2007 through January
2009, in accordance with generally accepted government auditing
standards. Those standards require that we plan and perform the audit
to obtain sufficient, appropriate evidence to provide a reasonable
basis for our findings and conclusions based on our audit objectives.
We believe that the evidence obtained provides a reasonable basis for
our findings and conclusions based on our audit objectives.
[End of section]
Appendix II: Data on FDA's Actions to Identify and Respond to Safety
Concerns Related to Dietary Supplements:
This appendix provides additional detail on FDA's actions to identify
and respond to safety concerns related to dietary supplements.
Data on FDA's Actions to Identify Safety Concerns Related to Dietary
Supplements:
FDA actions to identify safety concerns related to dietary supplements
include receiving and analyzing adverse event reports and consumer
complaints and conducting inspections.
Data on Adverse Events Related to Dietary Supplements:
Table 6 compares the number of adverse event reports received and
entered into FDA's databases for review related to dietary supplements
and drugs and biologics from January 1, 2003, through December 31,
2007.
Table 6: Comparison of the Number of Adverse Event Reports Received and
Entered into FDA's Databases for Review Related to Dietary Supplements
and Drugs and Biologics, January 1, 2003, through December 31, 2007:
Total dietary supplement reports received and entered for review:
[Empty].
Description: Total dietary supplement reports received and entered for
review;
Year: 2003: 739;
Year: 2004: 657;
Year: 2005: 491;
Year: 2006: 317;
Year: 2007: 350;
Total: 2,554;
Average: 511.
Description: Total drugs and biologics reports received and entered for
review;
Year: 2003: 226,217;
Year: 2004: 273,601;
Year: 2005: 323,384;
Year: 2006: 337,155;
Year: 2007: 364,449;
Total: 1,524,806;
Average: 304,961.
Source: GAO analysis of FDA data.
Notes: Dietary Supplement Reports includes both voluntary and mandatory
adverse event reports. If a report is incomplete, it is not entered
into the report database. FDA receives roughly 30 incomplete reports
related to dietary supplements per month. According to FDA, reporting
rates were higher in 2003 and 2004 due to adverse events related to
ephedra. FDA requires firms to report serious and nonserious adverse
events for new drugs.
[End of table]
Table 7 compares the number of dietary supplement-related adverse event
cases characterized as serious from January 1, 2003, through October
31, 2008, and the total number of dietary supplement-related adverse
event cases.
Table 7: Number of Dietary Supplement-Related Adverse Event Cases
Characterized as Serious, January 1, 2003, through October 31, 2008:
Description: Cases characterized as serious;
Year: 2003: 510[A];
Year: 2004: 483;
Year: 2005: 364;
Year: 2006: 213;
Year: 2007: 213;
Year: 2008: 759;
Total: 2,542.
Description: Total number of dietary supplement-related cases;
Year: 2003: 739;
Year: 2004: 657;
Year: 2005: 491;
Year: 2006: 317;
Year: 2007: 350;
Year: 2008: 948;
Total: 3,502.
Source: FDA.
[A] Thirty-six reports did not contain information about seriousness in
2003.
[End of table]
Table 8 shows the number and types of outcomes for all dietary
supplement-related adverse event cases received by FDA from January 1,
2003, through October 31, 2008.
Table 8: Number of Dietary Supplement-Related Adverse Event Complaint
(AEC) Outcomes for all Adverse Event Cases, January 1, 2003, through
October 31, 2008:
Description: Hospitalization;
Year: 2003: 245;
Year: 2004: 217;
Year: 2005: 165;
Year: 2006: 86;
Year: 2007: 93;
Year: 2008: 301;
Total: 1,107;
Percentage of dietary supplement-related cases: 31.6%.
Description: Nonserious injuries/illness;
Year: 2003: 310;
Year: 2004: 259;
Year: 2005: 149;
Year: 2006: 72;
Year: 2007: 77;
Year: 2008: 109;
Total: 976;
Percentage of dietary supplement-related cases: 27.9%.
Description: Serious injuries/illness;
Year: 2003: 35;
Year: 2004: 100;
Year: 2005: 113;
Year: 2006: 38;
Year: 2007: 43;
Year: 2008: 540;
Total: 869;
Percentage of dietary supplement-related cases: 24.8%.
Description: Visited a health care provider;
Year: 2003: 200;
Year: 2004: 171;
Year: 2005: 100;
Year: 2006: 81;
Year: 2007: 97;
Year: 2008: 218;
Total: 867;
Percentage of dietary supplement-related cases: 24.8%.
Description: Other serious (important medical events);
Year: 2003: 0;
Year: 2004: 0;
Year: 2005: 13;
Year: 2006: 92;
Year: 2007: 99;
Year: 2008: 407;
Total: 611;
Percentage of dietary supplement-related cases: 17.4%.
Description: Visited an emergency room;
Year: 2003: 114;
Year: 2004: 98;
Year: 2005: 78;
Year: 2006: 44;
Year: 2007: 52;
Year: 2008: 152;
Total: 538;
Percentage of dietary supplement-related cases: 15.4%.
Description: Life-threatening;
Year: 2003: 89;
Year: 2004: 108;
Year: 2005: 51;
Year: 2006: 41;
Year: 2007: 64;
Year: 2008: 118;
Total: 471;
Percentage of dietary supplement-related cases: 13.4%.
Description: Requires intervention to prevent permanent impairment;
Year: 2003: 82;
Year: 2004: 127;
Year: 2005: 68;
Year: 2006: 24;
Year: 2007: 28;
Year: 2008: 40;
Total: 369;
Percentage of dietary supplement-related cases: 10.5%.
Description: Death;
Year: 2003: 52;
Year: 2004: 35;
Year: 2005: 26;
Year: 2006: 11;
Year: 2007: 7;
Year: 2008: 11;
Total: 142;
Percentage of dietary supplement-related cases: 4.1%.
Description: Disability;
Year: 2003: 33;
Year: 2004: 37;
Year: 2005: 14;
Year: 2006: 17;
Year: 2007: 14;
Year: 2008: 19;
Total: 134;
Percentage of dietary supplement-related cases: 3.8%.
Description: Other;
Year: 2003: 13;
Year: 2004: 3;
Year: 2005: 3;
Year: 2006: 0;
Year: 2007: 0;
Year: 2008: 0;
Total: 19;
Percentage of dietary supplement-related cases: 0.5%.
Description: Congenital anomaly;
Year: 2003: 2;
Year: 2004: 3;
Year: 2005: 1;
Year: 2006: 0;
Year: 2007: 2;
Year: 2008: 0;
Total: 8;
Percentage of dietary supplement-related cases: 0.2%.
Description: Total number of cases with AEC outcome[A];
Year: 2003: 739;
Year: 2004: 657;
Year: 2005: 491;
Year: 2006: 317;
Year: 2007: 350;
Year: 2008: 948;
Total: 3,502.
Source: FDA.
[A] Cases may have more than one adverse event reported outcome;
therefore, the sum of outcomes exceeds the total number of cases per
year.
[End of table]
Table 9 shows the number of dietary supplement-related adverse event
cases by product type from January 1, 2003, through October 31, 2008.
Table 9: Number of All Dietary Supplement-Related Cases with Reported
Adverse Event Outcomes by Product Classification, January 1, 2003,
through October 31, 2008:
Product classification: Combination products and products not elsewhere
classified;
Cases: 1,566;
Percentage of dietary supplement-related cases: 44.7%.
Product classification: Herbal and botanical (other than teas);
Cases: 1,017;
Percentage of dietary supplement-related cases: 29.0%.
Product classification: Vitamin;
Cases: 658;
Percentage of dietary supplement-related cases: 18.8%.
Product classification: Mineral;
Cases: 373;
Percentage of dietary supplement-related cases: 10.7.
Product classification: Fats and lipid substances;
Cases: 108;
Percentage of dietary supplement-related cases: 3.1%.
Product classification: Herbal and botanical teas;
Cases: 92;
Percentage of dietary supplement-related cases: 2.6%.
Product classification: Protein;
Cases: 78;
Percentage of dietary supplement-related cases: 2.2%.
Product classification: Fiber;
Cases: 53;
Percentage of dietary supplement-related cases: 1.5%.
Product classification: Unknown;
Cases: 14;
Percentage of dietary supplement-related cases: 0.4%.
Product classification: Animal by-products and extracts;
Cases: 11;
Percentage of dietary supplement-related cases: 0.3%.
Product classification: Total number of cases[A];
Cases: 3,502.
Source: FDA.
[A] Cases may have more than one product classification; therefore, the
sum of cases by product classification may exceed the total number of
cases.
[End of table]
Data on Consumer Complaints Related to Dietary Supplements:
Table 10 shows the number of dietary supplement-related consumer
complaints by adverse event result for fiscal year 2001 through July 3,
2008.
Table 10: Number of Dietary Supplement-Related Consumer Complaints by
Adverse Event Result, Fiscal Year 2001 through July 3, 2008:
No adverse events or symptoms reported[A]: [Empty].
Description: No adverse events or symptoms reported[A];
Year: 2001: 111;
Year: 2002: 98;
Year: 2003: 81;
Year: 2004: 69;
Year: 2005: 64;
Year: 2006: 60;
Year: 2007: 50;
Year: 2008: 53;
Total: 586;
Percentage of total dietary supplement-related consumer complaints:
57.6%.
Description: Nonlife-threatening illness;
Year: 2001: 39;
Year: 2002: 23;
Year: 2003: 31;
Year: 2004: 14;
Year: 2005: 9;
Year: 2006: 12;
Year: 2007: 21;
Year: 2008: 20;
Total: 169;
Percentage of total dietary supplement-related consumer complaints:
16.6%.
Description: Nonlife-threatening--no adverse event reporting (adverse
symptoms present)[B];
Year: 2001: 10;
Year: 2002: 20;
Year: 2003: 25;
Year: 2004: 20;
Year: 2005: 17;
Year: 2006: 22;
Year: 2007: 27;
Year: 2008: 23;
Total: 164;
Percentage of total dietary supplement-related consumer complaints:
16.1%.
Description: Life-threatening illness;
Year: 2001: 19;
Year: 2002: 8;
Year: 2003: 27;
Year: 2004: 10;
Year: 2005: 3;
Year: 2006: 2;
Year: 2007: 10;
Year: 2008: 6;
Total: 85;
Percentage of total dietary supplement-related consumer complaints:
8.3%.
Description: Death;
Year: 2001: 1;
Year: 2002: 2;
Year: 2003: 4;
Year: 2004: 2;
Year: 2005: 2;
Year: 2006: 2;
Year: 2007: 1;
Year: 2008: 0;
Total: 14;
Percentage of total dietary supplement-related consumer complaints:
1.4%.
Description: Total;
Total: 1018;
Percentage of total dietary supplement-related consumer complaints:
100.0%.
Source: GAO analysis of FDA data.
Note: FDA pulled these data from its FACTS database. These data are a
subset of the data provided in table 9. At the time the complaint is
entered into FACTS, there is no verification that a death, illness, or
injury was a direct consequence of the dietary supplement consumed.
[A] This category includes complaints where the adverse event result
was "None," blank, or "Nonlife-threatening--no adverse event reporting"
when there were no adverse symptoms present.
[B] According to an FDA official, "Nonlife-threatening--no adverse
event reporting" does not mean that an adverse event is not present;
rather, this category is selected by field staff when they do not have
enough information initially to fill all of the required fields in the
adverse event reporting screen within FDA's database for consumer
complaints.
[End of table]
Table 11 shows the number of dietary supplement-related consumer
complaints with adverse symptoms present by adverse event result and
FDA product class from fiscal year 2001 through July 3, 2008.
Table 11: Number of Dietary Supplement-Related Consumer Complaints with
Adverse Symptoms Present by Adverse Event Result and Product
Classification, Fiscal Year 2001 through July 3, 2008:
Description: Death;
FDA product classification: Herbal and botanical (other than teas): 8;
FDA product classification: Animal by-products and extracts: 1;
FDA product classification: Herbal and botanical teas: 1;
FDA product classification: Combination products and products not
elsewhere classified: 3;
FDA product classification: Vitamin: 1;
FDA product classification: Mineral: 0;
FDA product classification: Protein: 0;
FDA product classification: Fats and lipid substances: 0;
FDA product classification: Other (all other classes): 0;
Total: 14.
Description: Life-threatening illness;
FDA product classification: Herbal and botanical (other than teas): 40;
FDA product classification: Animal by-products and extracts: 0;
FDA product classification: Herbal and botanical teas: 3;
FDA product classification: Combination products and products not
elsewhere classified: 26;
FDA product classification: Vitamin: 5;
FDA product classification: Mineral: 4;
FDA product classification: Protein: 2;
FDA product classification: Fats and lipid substances: 1;
FDA product classification: Other (all other classes): 4;
Total: 85.
Description: Nonlife-threatening illness;
FDA product classification: Herbal and botanical (other than teas): 48;
FDA product classification: Animal by-products and extracts: 1;
FDA product classification: Herbal and botanical teas: 5;
FDA product classification: Combination products and products not
elsewhere classified: 72;
FDA product classification: Vitamin: 14;
FDA product classification: Mineral: 8;
FDA product classification: Protein: 11;
FDA product classification: Fats and lipid substances: 3;
FDA product classification: Other (all other classes): 7;
Total: 169.
Description: Nonlife-threatening--no adverse event reporting (adverse
symptoms present)[A];
FDA product classification: Herbal and botanical (other than teas): 43;
FDA product classification: Animal by-products and extracts: 1;
FDA product classification: Herbal and botanical teas: 7;
FDA product classification: Combination products and products not
elsewhere classified: 54;
FDA product classification: Vitamin: 21;
FDA product classification: Mineral: 14;
FDA product classification: Protein: 11;
FDA product classification: Fats and lipid substances: 6;
FDA product classification: Other (all other classes): 7;
Total: 164.
Description: Total in product class for complaints with adverse events
or systems reported;
FDA product classification: Herbal and botanical (other than teas):
139;
FDA product classification: Animal by-products and extracts: 3;
FDA product classification: Herbal and botanical teas: 16;
FDA product classification: Combination products and products not
elsewhere classified: 155;
FDA product classification: Vitamin: 41;
FDA product classification: Mineral: 26;
FDA product classification: Protein: 24;
FDA product classification: Fats and lipid substances: 10;
FDA product classification: Other (all other classes): 18;
Total: 432.
Description: Percentage of total product classes for complaints with
adverse events or symptoms reported;
FDA product classification: Herbal and botanical (other than teas):
32.2%;
FDA product classification: Animal by-products and extracts: 0.7%;
FDA product classification: Herbal and botanical teas: 3.7%;
FDA product classification: Combination products and products not
elsewhere classified: 35.9%;
FDA product classification: Vitamin: 9.5%;
FDA product classification: Mineral: 6.0%;
FDA product classification: Protein: 5.6%;
FDA product classification: Fats and lipid substances: 2.3%;
FDA product classification: Other (all other classes): 4.2%;
Total: 100.0%.
Source: GAO analysis of FDA data.
Note: FDA pulled these data from its FACTS database. These data are a
subset of the data provided in table 9. At the time the complaint is
entered into FACTS, there is no verification that a death, illness, or
injury was a direct consequence of the dietary supplement consumed.
[A] According to an FDA official, "Nonlife-threatening--no adverse
event reporting" does not mean that an adverse event isn't present;
rather, this category is selected by field staff when they do not have
enough information initially to fill all of the required fields in the
adverse event reporting screen within FDA's database for consumer
complaints.
[End of table]
Data on Inspections Related to Dietary Supplements:
Table 12 shows the number of foreign and domestic inspections of
dietary supplement facilities compared with food inspections and total
inspections conducted by FDA and states from fiscal years 2000 through
2008.
Table 12: FDA Foreign and Domestic Inspections and State Domestic
Inspections, Fiscal Years 2000 through 2008:
Description: FDA foreign: Dietary supplement inspections[A];
Fiscal year: 2000: 0;
Fiscal year: 2001: 0;
Fiscal year: 2002: 0;
Fiscal year: 2003: 0;
Fiscal year: 2004: 0;
Fiscal year: 2005: 0;
Fiscal year: 2006: 0;
Fiscal year: 2007: 0;
Fiscal year: 2008: 0;
Total: 0.
Description: FDA foreign: Foods inspections;
Fiscal year: 2000: 177;
Fiscal year: 2001: 211;
Fiscal year: 2002: 169;
Fiscal year: 2003: 148;
Fiscal year: 2004: 153;
Fiscal year: 2005: 132;
Fiscal year: 2006: 125;
Fiscal year: 2007: 96;
Fiscal year: 2008: 150;
Total: 1,361.
Description: FDA foreign: All FDA inspections;
Fiscal year: 2000: 878;
Fiscal year: 2001: 892;
Fiscal year: 2002: 791;
Fiscal year: 2003: 757;
Fiscal year: 2004: 932;
Fiscal year: 2005: 844;
Fiscal year: 2006: 789;
Fiscal year: 2007: 1,005;
Fiscal year: 2008: 933;
Total: 7,821.
Description: FDA domestic: Dietary supplement inspections[A];
Fiscal year: 2000: 60;
Fiscal year: 2001: 71;
Fiscal year: 2002: 66;
Fiscal year: 2003: 87;
Fiscal year: 2004: 163;
Fiscal year: 2005: 167;
Fiscal year: 2006: 137;
Fiscal year: 2007: 119;
Fiscal year: 2008: 65;
Total: 935.
Description: FDA domestic: Foods inspections;
Fiscal year: 2000: 6,728;
Fiscal year: 2001: 9,811;
Fiscal year: 2002: 8,742;
Fiscal year: 2003: 11,295;
Fiscal year: 2004: 11,013;
Fiscal year: 2005: 8,775;
Fiscal year: 2006: 7,510;
Fiscal year: 2007: 6,500;
Fiscal year: 2008: 6,559;
Total: 76,933.
Description: FDA domestic: All FDA inspections;
Fiscal year: 2000: 14,257;
Fiscal year: 2001: 17,785;
Fiscal year: 2002: 17,854;
Fiscal year: 2003: 21,812;
Fiscal year: 2004: 20,898;
Fiscal year: 2005: 19,013;
Fiscal year: 2006: 16,869;
Fiscal year: 2007: 14,623;
Fiscal year: 2008: 14,328;
Total: 157,439.
Description: State domestic: Dietary supplement inspections[A,B];
Fiscal year: 2000: 0;
Fiscal year: 2001: 0;
Fiscal year: 2002: 4;
Fiscal year: 2003: 1;
Fiscal year: 2004: 33;
Fiscal year: 2005: 39;
Fiscal year: 2006: 18;
Fiscal year: 2007: 9;
Fiscal year: 2008: 1;
Total: 105.
Description: State domestic: Foods inspections;
Fiscal year: 2000: 6,546;
Fiscal year: 2001: 7,667;
Fiscal year: 2002: 7,921;
Fiscal year: 2003: 8,252;
Fiscal year: 2004: 8,763;
Fiscal year: 2005: 9,388;
Fiscal year: 2006: 8,918;
Fiscal year: 2007: 9,751;
Fiscal year: 2008: 9,183;
Total: 76,389.
Description: State domestic: All state inspections;
Fiscal year: 2000: 16,312;
Fiscal year: 2001: 18,078;
Fiscal year: 2002: 21,160;
Fiscal year: 2003: 20,625;
Fiscal year: 2004: 21,894;
Fiscal year: 2005: 22,381;
Fiscal year: 2006: 23,935;
Fiscal year: 2007: 25,146;
Fiscal year: 2008: 23,373;
Total: 192,904.
Source: FDA.
Note: Food inspections, all FDA inspections, and all state inspections
categories include dietary supplement inspections that were conducted
during the designated time period.
[A] Dietary supplement inspections excludes those inspections related
to dietary supplements with drug or veterinary uses. Data is current as
of November 19, 2008. Because FDA's inspection database is continuously
updated, these numbers may change as state and district offices enter
new information or existing information is corrected.
[B] According to an FDA official, dietary supplement inspections
conducted by states during this time period were performed under a
partnership agreement rather than a FDA contract.
[End of table]
Table 13 shows the percentage of dietary supplement inspections where
investigators identified problems, from fiscal year 2002 through May 6,
2008.
Table 13: Share of Dietary Supplement Inspections Where Investigators
Identified Problems, Fiscal Year 2002 through May 6, 2008A:
Description: Inspections where problems were identified[B];
Fiscal year: 2002: 40;
Fiscal year: 2003: 47;
Fiscal year: 2004: 86;
Fiscal year: 2005: 116;
Fiscal year: 2006: 82;
Fiscal year: 2007: 52;
Fiscal year: 2008: 25;
Total: 448.
Description: Total number of inspections;
Fiscal year: 2002: 70;
Fiscal year: 2003: 88;
Fiscal year: 2004: 196;
Fiscal year: 2005: 206;
Fiscal year: 2006: 155;
Fiscal year: 2007: 128;
Fiscal year: 2008: 66;
Total: 909.
Description: Percentage of inspections where investigators identified
problems;
Fiscal year: 2002: 57.1%;
Fiscal year: 2003: 53.4%;
Fiscal year: 2004: 43.9%;
Fiscal year: 2005: 56.3%;
Fiscal year: 2006: 52.9%;
Fiscal year: 2007: 40.6%;
Fiscal year: 2008: 37.9%;
Total: 49.3%.
Source: GAO analysis of FDA data.
[A] Dietary supplement inspections excludes those inspections related
to dietary supplements with drug or veterinary uses.
[B] Problems identified includes both potential violations, as well as
observations of problems by investigators that may fall below FDA's
threshold for regulatory action.
[End of table]
Data on FDA's Actions to Respond to Safety Concerns Related to Dietary
Supplements:
FDA actions to respond to safety concerns related to dietary
supplements include issuing warning letters to dietary supplement
firms, requesting recalls, and detaining and refusing imports.
Data on Dietary Supplement-Related Warning Letters:
Table 14 shows the number of Federal Food, Drug, and Cosmetic Act
violations cited in 293 dietary supplement-related warning letters
issued from fiscal years 2002 through 2007.
Table 14: Number of Violations in the Federal Food, Drug, and Cosmetic
Act Cited in 293 FDA Dietary Supplement-Related Warning Letters, Fiscal
Years 2002 through 2007:
Violation description: Unapproved new drug--product lacks FDA approval
to manufacture and sell as a drug;
Federal Food, Drug, and Cosmetic Act section: 505;
Number of violations in the 293 letters: 219;
Percentage of total violations: 41.0%.
Violation description: Misbranded drug--product label is false or
misleading, lacks adequate directions for use, or otherwise does not
meet other drug labeling requirements;
Federal Food, Drug, and Cosmetic Act section: 502;
Number of violations in the 293 letters: 153;
Percentage of total violations: 28.7%.
Violation description: Misbranded food--product label is false or
misleading, bears unauthorized claims, does not list all ingredients,
lacks required nutrition information, or does not meet other food
labeling requirements;
Federal Food, Drug, and Cosmetic Act section: 403;
Number of violations in the 293 letters: 136;
Percentage of total violations: 25.5%.
Violation description: Adulterated food--product contains ingredients
that are unsafe, fraudulent, unapproved, or otherwise unfit for food;
Federal Food, Drug, and Cosmetic Act section: 402;
Number of violations in the 293 letters: 9;
Percentage of total violations: 1.7%.
Violation description: Unapproved food additive--product contains a
food additive that lacks FDA approval or that is not used in conformity
with the regulation prescribing conditions for safe use of the
additive;
Federal Food, Drug, and Cosmetic Act section: 409;
Number of violations in the 293 letters: 4;
Percentage of total violations: 0.7%.
Violation description: Drug facility registration--firm failed to
register its manufacturing facility with FDA as a drug facility;
Federal Food, Drug, and Cosmetic Act section: 510;
Number of violations in the 293 letters: 4;
Percentage of total violations: 0.7%.
Violation description: Import or export violations--product violates
import or export requirements;
Federal Food, Drug, and Cosmetic Act section: 801;
Number of violations in the 293 letters: 3;
Percentage of total violations: 0.6%.
Violation description: Food contaminated with pesticides--product
contains unsafe type or level of pesticides;
Federal Food, Drug, and Cosmetic Act section: 408;
Number of violations in the 293 letters: 2;
Percentage of total violations: 0.4%.
Violation description: New dietary ingredient--product contains a new
dietary ingredient that lacks adequate information to provide
reasonable assurance of safety;
Federal Food, Drug, and Cosmetic Act section: 413;
Number of violations in the 293 letters: 2;
Percentage of total violations: 0.4%.
Violation description: Food facility registration--firm failed to
register as a food facility;
Federal Food, Drug, and Cosmetic Act section: 415;
Number of violations in the 293 letters: 1;
Percentage of total violations: 0.2%.
Violation description: Prescription needed--firm failed to require
dispensation of product by prescription;
Federal Food, Drug, and Cosmetic Act section: 503;
Number of violations in the 293 letters: 1;
Percentage of total violations: 0.2%.
Total violations:
Number of violations in the 293 letters: 534;
Percentage of total violations: 100.0%.
Source: GAO analysis of FDA's online database of warning letters.
Note: Because FDA's online database may not include all the warning
letters issued by FDA, these numbers represent minimums only.
[End of table]
Table 15 shows the number of dietary supplement-related warning letters
compared with total warning letters issued by FDA from fiscal years
2002 through 2007.
Table 15: FDA Dietary Supplement-Related Warning Letters and All Other
FDA Warning Letters Issued, Fiscal Years 2002 through 2007:
Dietary supplement letters: [Empty].
Description: Dietary supplement letters;
Fiscal year: 2002: 23;
Fiscal year: 2003: 67;
Fiscal year: 2004: 38;
Fiscal year: 2005: 52;
Fiscal year: 2006: 70;
Fiscal year: 2007: 43;
Total: 293.
Description: Total warning letters;
Fiscal year: 2002: 806;
Fiscal year: 2003: 761;
Fiscal year: 2004: 730;
Fiscal year: 2005: 519;
Fiscal year: 2006: 526;
Fiscal year: 2007: 434;
Total: 3,776.
Description: Percentage of total warning letters;
Fiscal year: 2002: 2.9%;
Fiscal year: 2003: 8.8%;
Fiscal year: 2004: 5.2%;
Fiscal year: 2005: 10.0%;
Fiscal year: 2006: 13.3%;
Fiscal year: 2007: 9.9%;
Total: 7.8%.
Source: GAO analysis of FDA's online database of warning letters.
Note: Because FDA's online database may not include all the warning
letters issued by FDA, these numbers represent minimums only. In
addition to warning letters, FDA also sent untitled letters to dietary
supplement companies for violations that did not meet the threshold of
regulatory significance to trigger a warning letter. According to FDA,
the agency sent approximately 240 untitled letters from 2003 through
2007.
[End of table]
Data on Recalls Related to Dietary Supplements:
Table 16 provides information on examples of Class I recalls related to
dietary supplement products from fiscal years 2003 through 2008.
According to FDA, Class I recalls are related to products that are
dangerous and defective and pose a serious health concern. A firm may
initiate a recall independently of FDA, or FDA may request a firm
recall a product upon identifying a problem with a product.
Table 16: Examples of Dietary Supplement-Related Class I Recalls,
Fiscal Years 2003 through 2008:
Fiscal year by recall date: 2003;
Reason for recall: Misbranded--product claims to be dairy-free when it
contains a milk derivative;
Product description: Calcium/vitamin D supplement.
Fiscal year by recall date: 2003;
Reason for recall: Unapproved new drug--product contains pharmaceutical
for erectile dysfunction;
Product description: Supplements promoted for sexual function.
Fiscal year by recall date: 2003;
Reason for recall: Unapproved new drug--product contains pharmaceutical
for erectile dysfunction;
Product description: Supplements promoted for sexual function.
Fiscal year by recall date: 2003;
Reason for recall: Unapproved new drug--product contains pharmaceutical
for erectile dysfunction;
Product description: Herbal supplement promoted for sexual function.
Fiscal year by recall date: 2003;
Reason for recall: Unapproved new drug--product contains pharmaceutical
for erectile dysfunction;
Product description: Herbal supplement promoted for sexual function.
Fiscal year by recall date: 2003;
Reason for recall: Unapproved new drug--product contains pharmaceutical
for erectile dysfunction;
Product description: Herbal supplement promoted for sexual function.
Fiscal year by recall date: 2004;
Reason for recall: Misbranded--product contains excessive level of
vitamin D;
Product description: Multivitamin.
Fiscal year by recall date: 2005;
Reason for recall: Unapproved new drug--product contains pharmaceutical
for erectile dysfunction;
Product description: Supplement promoted for sexual function.
Fiscal year by recall date: 2005;
Reason for recall: Adulterated--products contain aristolochic acid, a
potent carcinogen and toxin;
Product description: Herbal supplements.
Fiscal year by recall date: 2005;
Reason for recall: Unapproved new drug--product contains pharmaceutical
for erectile dysfunction;
Product description: Supplement promoted for sexual function.
Fiscal year by recall date: 2005;
Reason for recall: Misbranded--product contains undeclared milk
derivative;
Product description: Children's chewable calcium tablets.
Fiscal year by recall date: 2005;
Reason for recall: Unapproved new drug--product prescription drug for
treating Type 2 diabetes;
Product description: Herbal supplement.
Fiscal year by recall date: 2005;
Reason for recall: Adulterated--product contains ephedrine alkaloids;
Product description: Supplement promoted for energy increase.
Fiscal year by recall date: 2006;
Reason for recall: Adulterated--product contains ephedrine alkaloids;
Product description: Supplement promoted for weight loss.
Fiscal year by recall date: 2006;
Reason for recall: Misbranded--product contains undeclared milk
derivatives;
Product description: Calcium supplement.
Fiscal year by recall date: 2006;
Reason for recall: Unapproved new drug--product contains analog of
pharmaceutical for erectile dysfunction;
Product description: Herbal supplement promoted for sexual function.
Fiscal year by recall date: 2006;
Reason for recall: Unapproved new drug--product contains analog of
pharmaceutical for erectile dysfunction;
Product description: Herbal supplement promoted for sexual function.
Fiscal year by recall date: 2007;
Reason for recall: Unapproved new drug--product contains analog of
pharmaceutical for erectile dysfunction;
Product description: Herbal supplement promoted for sexual function.
Fiscal year by recall date: 2007;
Reason for recall: Unapproved new drug--product contains pharmaceutical
for erectile dysfunction;
Product description: Supplement promoted for sexual function.
Fiscal year by recall date: 2007;
Reason for recall: Unapproved new drug--product contains analog of
pharmaceutical for erectile dysfunction;
Product description: Herbal supplement promoted for sexual function.
Fiscal year by recall date: 2007;
Reason for recall: Misbranded--product may contain undeclared milk
protein;
Product description: Protein supplement.
Fiscal year by recall date: 2007;
Reason for recall: Misbranded--product contains undeclared milk;
Product description: Protein supplement.
Fiscal year by recall date: 2007;
Reason for recall: Misbranded--product contains undeclared milk
derivative;
Product description: Protein supplement.
Fiscal year by recall date: 2007;
Reason for recall: Unapproved new drug--product contains analog of
pharmaceutical for erectile dysfunction;
Product description: Supplement promoted for sexual function.
Fiscal year by recall date: 2007;
Reason for recall: Misbranded--product contains undeclared fish
gelatin;
Product description: Multivitamin.
Fiscal year by recall date: 2007;
Reason for recall: Unapproved new drug--product contains analogs of
various pharmaceuticals for erectile dysfunction;
Product description: Herbal supplement promoted for energy increase and
male sexual function.
Fiscal year by recall date: 2007;
Reason for recall: Unapproved new drug--product contains analog of
pharmaceutical for erectile dysfunction;
Product description: Herbal supplement promoted for sexual function.
Fiscal year by recall date: 2007;
Reason for recall: Adulterated--product may contain salmonella;
Product description: Shark cartilage supplement.
Fiscal year by recall date: 2007;
Reason for recall: Adulterated--product may contain salmonella;
Product description: Shark cartilage supplement.
Fiscal year by recall date: 2007;
Reason for recall: Misbranded--product contains undeclared soy;
Product description: Calcium supplement.
Fiscal year by recall date: 2007;
Reason for recall: Unapproved new drug--product contains pharmaceutical
for erectile dysfunction;
Product description: Supplement promoted for sexual function.
Fiscal year by recall date: 2007;
Reason for recall: Adulterated--product may contain salmonella;
Product description: Shark cartilage supplement.
Fiscal year by recall date: 2007;
Reason for recall: Unapproved new drug--product contains pharmaceutical
for weight loss;
Product description: Supplement promoted for weight loss.
Fiscal year by recall date: 2007;
Reason for recall: Unapproved new drug--product contains analogs of
various pharmaceuticals for erectile dysfunction;
Product description: Supplements promoted for increasing sexual
function.
Fiscal year by recall date: 2007;
Reason for recall: Unapproved new drug--product contains analogs of
various pharmaceuticals for erectile dysfunction;
Product description: Supplements promoted for increasing sexual
function.
Fiscal year by recall date: 2007;
Reason for recall: Adulterated--product contains cryptosporidium, a
parasite that can cause intestinal infection, reported illness
associated with product;
Product description: Herbal supplement promoted for treating upset
stomach in infants.
Fiscal year by recall date: 2008;
Reason for recall: Adulterated--product may be contaminated with mold;
Product description: Folic acid liquid supplement.
Fiscal year by recall date: 2008;
Reason for recall: Unapproved new drug--product contains analog of
pharmaceutical for erectile dysfunction;
Product description: Supplement promoted for sexual function.
Fiscal year by recall date: 2008;
Reason for recall: Unapproved new drug--product contains analog of
pharmaceutical for erectile dysfunction;
Product description: Supplement promoted for sexual function.
Fiscal year by recall date: 2008;
Reason for recall: Adulterated--product contains elevated levels of
selenium and chromium, reported illnesses associated with the product;
Product description: Liquid dietary supplement.
Fiscal year by recall date: 2008;
Reason for recall: Unapproved new drug--product contains various
pharmaceuticals for erectile dysfunction;
Product description: Herbal supplement promoted for sexual function.
Fiscal year by recall date: 2008;
Reason for recall: Unapproved new drug--product contains analog of
pharmaceutical for erectile dysfunction;
Product description: Supplement promoted for sexual function.
Fiscal year by recall date: 2008;
Reason for recall: Unapproved new drug--product contains analog of
pharmaceutical for erectile dysfunction;
Product description: Herbal supplement promoted for sexual function.
Fiscal year by recall date: 2008;
Reason for recall: Unapproved new drug--product contains pharmaceutical
for erectile dysfunction;
Product description: Herbal supplement promoted for sexual function.
Fiscal year by recall date: 2008;
Reason for recall: Unapproved new drug--product contains analog of
pharmaceutical for erectile dysfunction;
Product description: Herbal supplement promoted for sexual function.
Source: GAO analysis of FDA data available on FDA's Web site.
Note: These recalls are only examples of Class I recalls during this
time period. We could not provide complete data on the number of
recalls because FDA's official recalls database was not sufficiently
reliable for the purposes of this report.
[End of table]
Data on Imports Related to Dietary Supplements:
Table 17 shows the number of detentions without physical examination of
imported dietary supplement products by general violation categories
from fiscal year 2002 through March 24, 2008.
Table 17: Dietary Supplement-Related Detentions without Physical
Examination (DWPE) by General Violation Categories, Fiscal Year 2002
through March 24, 2008A:
Violation description: Adulterated--product appears to contain an
unsafe substance, or appears to have been prepared under insanitary
conditions or in a facility that lacks manufacturing controls or does
not otherwise meet FDA regulations;
Dietary supplement entry lines DWPE: 1,623;
Percentage of total violations for dietary supplement import entry
lines DWPE: 50.3%.
Violation description: Misbranded--product label appears to be false or
misleading, or appears to not meet labeling requirements;
Dietary supplement entry lines DWPE: 1,109;
Percentage of total violations for dietary supplement import entry
lines DWPE: 34.4%.
Violation description: Unapproved new drug--product appears to lack FDA
approval to manufacture and sell as a drug;
Dietary supplement entry lines DWPE: 324;
Percentage of total violations for dietary supplement import entry
lines DWPE: 10.0%.
Violation description: Other;
Dietary supplement entry lines DWPE: 162;
Percentage of total violations for dietary supplement import entry
lines DWPE: 5.0%.
Violation description: Adulterated--firm appears to have unlawfully
omitted or substituted an ingredient in the product;
Dietary supplement entry lines DWPE: 7;
Percentage of total violations for dietary supplement import entry
lines DWPE: 0.2%.
Violation description: Total;
Dietary supplement entry lines DWPE: 3,225;
Percentage of total violations for dietary supplement import entry
lines DWPE: 100.0%.
Source: GAO analysis of FDA data.
[A] When identifiable, this table excludes products for animal uses,
topical products, cosmetics, and other products that do not meet the
statutory definition of a dietary supplement. Data includes dietary
supplement products for drug uses.
[End of table]
Table 18 shows the number of detentions without physical examination of
imported dietary supplement products by product classification from
fiscal year 2002 through March 24, 2008.
Table 18: Dietary Supplement-Related DWPE by Product Classification,
Fiscal Year 2002 through March 24, 2008A:
Product classification[B]: Herbal and botanical (other than teas);
Dietary supplement entry lines DWPE: 1,049;
Percentage of dietary supplement entry lines DWPE: 32.5%.
Product classification[B]: Herbal and botanical teas;
Dietary supplement entry lines DWPE: 750;
Percentage of dietary supplement entry lines DWPE: 23.3%.
Product classification[B]: Vitamin;
Dietary supplement entry lines DWPE: 628;
Percentage of dietary supplement entry lines DWPE: 19.5%.
Product classification[B]: Protein;
Dietary supplement entry lines DWPE: 527;
Percentage of dietary supplement entry lines DWPE: 16.3%.
Product classification[B]: Animal by-products and extracts;
Dietary supplement entry lines DWPE: 136;
Percentage of dietary supplement entry lines DWPE: 4.2%.
Product classification[B]: Combination products and products not
elsewhere classified;
Dietary supplement entry lines DWPE: 54;
Percentage of dietary supplement entry lines DWPE: 1.7%.
Product classification[B]: Mineral;
Dietary supplement entry lines DWPE: 36;
Percentage of dietary supplement entry lines DWPE: 1.1%.
Product classification[B]: Other;
Dietary supplement entry lines DWPE: 25;
Percentage of dietary supplement entry lines DWPE: 0.8%.
Product classification[B]: Fats and lipid substances;
Dietary supplement entry lines DWPE: 20;
Percentage of dietary supplement entry lines DWPE: 0.6%.
Product classification[B]: Total;
Dietary supplement entry lines DWPE: 3,225;
Percentage of dietary supplement entry lines DWPE: 100.0%.
Source: GAO analysis of FDA data.
[A] When identifiable, this table excludes products for animal uses,
topical products, cosmetics, and other products that do not meet the
statutory definition of a dietary supplement. Data includes dietary
supplement products for drug uses.
[B] Product classifications for import entry lines are submitted by
customs brokers and are not determined by FDA unless reviewed and
corrected during an examination. Accordingly, some entry lines may be
incorrectly classified.
[End of table]
Table 19 shows the number of Federal Food, Drug, and Cosmetic Act
violations cited in 3,605 dietary supplement-related import refusals
from fiscal year 2002 through March 24, 2008.
Table 19: Number of Violations of the Federal Food, Drug, and Cosmetic
Act Cited in 3,605 Dietary Supplement-Related Import Refusals, Fiscal
Year 2002 through March 24, 2008A:
Violation description: Misbranded--product label appears to be false or
misleading, or appears to not meet labeling requirements;
Number of violations for the 3,605 lines refused: 3,193;
Percentage of total violations: 57.4%.
Violation description: Adulterated--product appears to contain an
unsafe substance, or appears to have been prepared under insanitary
conditions or in a facility that lacks manufacturing controls or does
not otherwise meet FDA regulations;
Number of violations for the 3,605 lines refused: 1,366;
Percentage of total violations: 24.6%.
Violation description: Unapproved new drug--product appears to lack FDA
approval to manufacture and sell as a drug;
Number of violations for the 3,605 lines refused: 730;
Percentage of total violations: 13.1%.
Violation description: Other;
Number of violations for the 3,605 lines refused: 258;
Percentage of total violations: 4.6%.
Violation description: Adulterated--firm appears to have unlawfully
omitted or substituted an ingredient in the product;
Number of violations for the 3,605 lines refused: 13;
Percentage of total violations: 0.2%.
Violation description: Total;
Number of violations for the 3,605 lines refused: 5,560;
Percentage of total violations: 100.0%.
Source: GAO analysis of FDA data.
[A] When identifiable, this table excludes products for animal uses,
topical products, cosmetics, and other products that do not meet the
statutory definition of a dietary supplement. Data includes dietary
supplement products for drug uses.
[End of table]
Table 20 shows the number of refused imports of dietary supplement
products by product classification from fiscal year 2002 through March
24, 2008.
Table 20: Dietary Supplement-Related Import Refusals by Product
Classification, Fiscal Year 2002 through March 24, 2008A:
Product classification[B]: Herbal and botanical (other than teas);
Dietary supplement entry lines refused: 1,378;
Percentage of dietary supplement entry lines refused: 38.2%.
Product classification[B]: Combination products, and products not
elsewhere classified;
Dietary supplement entry lines refused: 900;
Percentage of dietary supplement entry lines refused: 25.0%.
Product classification[B]: Herbal and botanical teas;
Dietary supplement entry lines refused: 569;
Percentage of dietary supplement entry lines refused: 15.8%.
Product classification[B]: Vitamin;
Dietary supplement entry lines refused: 408;
Percentage of dietary supplement entry lines refused: 11.3%.
Product classification[B]: Animal by-products and extracts;
Dietary supplement entry lines refused: 111;
Percentage of dietary supplement entry lines refused: 3.1%.
Product classification[B]: Protein;
Dietary supplement entry lines refused: 71;
Percentage of dietary supplement entry lines refused: 2.0%.
Product classification[B]: Mineral;
Dietary supplement entry lines refused: 65;
Percentage of dietary supplement entry lines refused: 1.8%.
Product classification[B]: Other;
Dietary supplement entry lines refused: 59;
Percentage of dietary supplement entry lines refused: 1.6%.
Product classification[B]: Fats and lipid substances;
Dietary supplement entry lines refused: 43;
Percentage of dietary supplement entry lines refused: 1.2%.
Product classification[B]: Total;
Dietary supplement entry lines refused: 3,604;
Percentage of dietary supplement entry lines refused: 100.0%.
Source: GAO analysis of FDA data.
[A] When identifiable, this table excludes products for animal uses,
topical products, cosmetics, and other products that do not meet the
statutory definition of a dietary supplement. Data includes dietary
supplement products for drug uses.
[B] Product classifications for import entry lines are submitted by
customs brokers and are not determined by FDA unless reviewed and
corrected during an examination. Accordingly, some entry lines may be
incorrectly classified.
[End of table]
Data on FDA Enforcement Actions Related to Dietary Supplements:
FDA's enforcement actions related to dietary supplements include
seizures, injunctions, and criminal investigations. Table 21 shows
information about dietary supplement-related seizure and injunction
actions taken from fiscal year 2002 through July 18, 2008.
Table 21: FDA Seizures and Injunctions Related to Dietary Supplement
Products, Fiscal Year 2002 through July 18, 2008A:
Fiscal year: 2002;
Type of action: Seizure;
Date filed: 10/22/2001;
Individual/company: Biogenics Inc.; E'OLA International; and Nature's
Energy, Inc.;
Product description: Various weight-loss products;
Reason: Unapproved new drug/misbranded drug;
Note: [Empty].
Fiscal year: 2002;
Type of action: Seizure;
Date filed: 2/5/2002;
Individual/company: Spectramin, Inc.;
Product description: Various products for joint health, vitality,
energy, and weight loss, among others;
Reason: Unapproved new drug/misbranded drug;
Note: [Empty].
Fiscal year: 2002;
Type of action: Seizure;
Date filed: 6/10/2002;
Individual/company: Dandy Day Corporation;
Product description: Product promoted for weight loss;
Reason: Unapproved new drug/misbranded drug;
Note: [Empty].
Fiscal year: 2002;
Type of action: Seizure;
Date filed: 9/25/2002;
Individual/company: Zibo Fuxing PharmacyCo, Ltd./Sino King
International Development and Management Group, Inc.;
Product description: Herbal product to treat or prevent mental
development disorders and diseases;
Reason: Misbranded food, unapproved new drug/misbranded drug;
Note: [Empty].
Fiscal year: 2003;
Type of action: Seizure;
Date filed: 10/15/2002;
Individual/company: Humphrey Laboratories, Inc., Kirkman Laboratories;
Product description: Product to treat or prevent autism;
Reason: Misbranded food, unapproved new drug/misbranded drug;
Note: [Empty].
Fiscal year: 2003;
Type of action: Seizure;
Date filed: 12/13/2002;
Individual/company: Halo Supply, Co.;
Product description: Product to treat or prevent cold, flu, and other
viral conditions;
Reason: Unapproved new drug/misbranded drug;
Note: [Empty].
Fiscal year: 2003;
Type of action: Seizure;
Date filed: 2/4/2003;
Individual/company: Global Source Management and Consulting Inc.;
Product description: Various products promoted to treat or prevent
medical conditions, including enlarged prostate, joint health, and
cholesterol reduction;
Reason: Unapproved new drug/misbranded drug;
Note: [Empty].
Fiscal year: 2003;
Type of action: Seizure;
Date filed: 6/16/2003;
Individual/company: Seasilver USA, Inc.(Southern District of
California);
Product description: Product promoted to treat or prevent hypoglycemia,
diabetes, cancer, psoriasis, hepatitis, and arthritis;
Reason: Misbranded food, unapproved new drug/misbranded drug;
Note: Related consent decree of condemnation and permanent injunction
filed 3/9/04. Product was also seized from Ohio on 6/24/03.
Fiscal year: 2003;
Type of action: Seizure;
Date filed: 6/19/2003; Individual/company: Shop America;
Product description: Product promoted to treat or prevent cancer, heart
disease, and various degenerative diseases;
Reason: Misbranded food, unapproved new drug/misbranded drug;
Note: Related consent decree of condemnation and permanent injunction
filed 12/17/03.
Fiscal year: 2003;
Type of action: Injunction;
Date filed: 9/16/2003; Individual/company: Hi-Tech Pharmaceuticals,
National Urological Group, National Institute for Clinical Weight Loss,
American Weight Loss Clinic, United Metabolic Research Center, and
Jared R. Wheat;
Product description: Various products promoted to treat or prevent
obesity and erectile dysfunction;
Reason: Unapproved new drug/misbranded drug;
Note: [Empty].
Fiscal year: 2003;
Type of action: Seizure;
Date filed: 9/18/2003;
Individual/company: Jean's Greens;
Product description: Herbal product promoted to treat or prevent
serious diseases, such as cancer;
Reason: Unapproved new drug/misbranded drug;
Note: [Empty].
Fiscal year: 2004;
Type of action: Seizure;
Date filed: 1/22/2004;
Individual/company: EAS/Musclemaster.com, Inc., NVE Pharmaceuticals,
Inc.;
Product description: Various products promoted to build muscle mass;
Reason: Misbranded food;
Note: [Empty].
Fiscal year: 2005;
Type of action: Seizure;
Date filed: 11/22/2004;
Individual/company: Asia MedLabs, Inc.;
Product description: Herbal product to treat or prevent flu, poisoning,
allergies, blood pressure, and other heart ailments;
Reason: Adulterated food, unapproved new drug/misbranded drug;
Note: [Empty].
Fiscal year: 2005;
Type of action: Seizure;
Date filed: 12/15/2004;
Individual/company: FCC Products, Inc.;
Product description: Ginseng contaminated with pesticides;
Reason: Adulterated food;
Note: [Empty].
Fiscal year: 2005;
Type of action: Seizure;
Date filed: 2/11/2005;
Individual/company: ATF Fitness Products, Inc.;
Product description: Weight-loss products containing ephedra;
Reason: Adulterated food and misbranded food;
Note: [Empty].
Fiscal year: 2006;
Type of action: Injunction;
Date filed: 10/14/2005;
Individual/company: Vita-ERB, Ltd. Mary and Moses Barnes and Fred
Paulicka;
Product description: Herbal product marketed with disease claims;
Reason: Unapproved new drug/misbranded drug, adulterated drug;
Note: [Empty].
Fiscal year: 2006;
Type of action: Seizure;
Date filed: 11/28/2005;
Individual/company: Nature's Treat, Inc.;
Product description: Product containing ephedra promoted for increasing
energy;
Reason: Adulterated food;
Note: Products also seized at distributor on the same date.
Fiscal year: 2006;
Type of action: Seizure;
Date filed: 1/9/2006; Individual/company: ATF Fitness Products, Inc.;
Product description: Product containing ephedra;
Reason: Adulterated food;
Note: [Empty].
Fiscal year: 2006;
Type of action: Injunction;
Date filed: 2/3/2006;
Individual/company: Natural Ovens Bakery, Paul and Barbara Stitt,
Matthew Taylor;
Product description: Various supplement mixes;
Reason: Misbranded food, unapproved new drug/misbranded drug;
Note: Injunction included food products as well.
Fiscal year: 2006;
Type of action: Seizure;
Date filed: 2/22/2006;
Individual/company: Hi-Tech Pharmaceuticals, Inc.;
Product description: Products containing ephedra;
Reason: Adulterated food;
Note: [Empty].
Fiscal year: 2006;
Type of action: Seizure;
Date filed: 9/5/2006;
Individual/company: Advantage Nutraceuticals, LLC;
Product description: Various products including those promoted to treat
or prevent cancer and arthritis;
Reason: Unapproved new drug/misbranded drug;
Note: [Empty].
Fiscal year: 2007;
Type of action: Seizure;
Date filed: 12/29/2006;
Individual/company: Vitality Products Co., Inc.;
Product description: Various products promoted to treat or prevent
serious diseases, such as cancer, heart disease, Alzheimer's disease,
and others;
Reason: Unapproved new drug/misbranded drug;
Note: [Empty].
Fiscal year: 2007;
Type of action: Seizure;
Date filed: 8/22/2007;
Individual/company: Charron Nutrition;
Product description: Various products promoted to treat or prevent
diabetes, arthritis, and other serious medical conditions;
Reason: Unapproved new drug/misbranded drug;
Note: [Empty].
Fiscal year: 2008;
Type of action: Seizure;
Date filed: 10/18/2007;
Individual/company: FulLife Natural Options, Inc.;
Product description: Various products promoted to treat or prevent
diabetes, anemia, and hypertension, among other conditions;
Reason: Unapproved new drug/misbranded drug;
Note: [Empty].
Fiscal year: 2008;
Type of action: Seizure;
Date filed: 10/29/2007;
Individual/company: General Therapeutics, Corporation;
Product description: Products manufactured under insanitary conditions;
Reason: Unapproved new drug, adulterated drug, adulterated food;
Note: [Empty].
Fiscal year: 2008;
Type of action: Injunction;
Date filed: 2/12/2008;
Individual/company: Brownwood Acres Foods Inc., Cherry Capital
Services, Inc., Stephen de Tar, Robert Underwood;
Product description: Various products promoted to treat or prevent
cancer, arthritis, gout, heart disease, and Alzheimer's disease, among
others;
Reason: Unapproved new drug/misbranded drug, misbranded food;
Note: [Empty].
Fiscal year: 2008;
Type of action: Seizure;
Date filed: 3/25/2008;
Individual/company: Shangai Distributor, Inc.;
Product description: Various products promoted for sexual enhancement
and to treat erectile dysfunction;
Reason: Unapproved new drug/misbranded drug;
Note: [Empty].
Fiscal year: 2008;
Type of action: Seizure;
Date filed: 4/2/2008;
Individual/company: LG Sciences, LLC;
Product description: Products promoted for bodybuilding and containing
unapproved dietary ingredients and unapproved food additives;
Reason: Adulterated food;
Note: [Empty].
Fiscal year: 2008;
Type of action: Seizure;
Date filed: 7/18/2008;
Individual/company: Sei Pharmaceuticals, Inc.;
Product description: Various products promoted for sexual enhancement
and to treat erectile dysfunction;
Reason: Unapproved new drug/misbranded drug;
Note: [Empty].
Source: GAO analysis of FDA data.
[A] In some cases, FDA may have initiated multiple actions for a
particular product such as seizing the same product from different
companies or locations (e.g., distributor). These related actions are
listed in the notes column.
[End of table]
Table 22 summarizes dietary supplement-related criminal investigations
resulting in at least one conviction or with charges filed from 2002
through July 31, 2008.
Table 22: Number of Criminal Investigations Related to Dietary
Supplements Resulting in a Conviction or Charges Filed from 2002
through July 31, 2008:
Description: Cases resulting in at least one conviction (state or
federal);
Number of cases: 14.
Description: Cases with charges filed (state or federal);
Number of cases: 5.
Description: Total;
Number of cases: 19.
Source: GAO analysis of FDA data.
Note: Cases with charges filed includes cases where specific charges
have been filed within the judicial system and indictments. This
category excludes cases where charges may have been filed but the case
was not pursued further (e.g., prosecution declined or case dismissed).
[End of table]
[End of section]
Appendix III: Comparison of Select Foreign Countries' Regulation of
Dietary Supplements with the United States:
In comparison with the United States, Canada and Japan have more
regulatory requirements in place for dietary supplements and related
products. On the other hand, the United States has developed specific
good manufacturing practices for dietary supplements while the United
Kingdom has not. Table 23 compares the regulatory framework for dietary
supplement products in these foreign countries with the U.S. regulatory
system.
Table 23: Comparison of Dietary Supplement Regulations: United States,
Canada, United Kingdom, and Japan:
Country: United States;
Product registration: [Empty];
Manufacturer registration: [Check] (limited);
Premarket approval of products: [Empty];
Specific good manufacturing practices: [Check];
Serious mandatory adverse event reporting by industry: [Check].
Country: Canada;
Product registration: [Check];
Manufacturer registration: [Check][A];
Premarket approval of products: [Check];
Specific good manufacturing practices: [Check];
Serious mandatory adverse event reporting by industry: [Check].
Country: United Kingdom;
Product registration: [Empty];
Manufacturer registration: [Check]
Premarket approval of products: [Check][B] (limited);
Specific good manufacturing practices: [Empty];
Serious mandatory adverse event reporting by industry: [Check][C].
Country: Japan[D];
Product registration: [Check];
Manufacturer registration: [Check];
Premarket approval of products: [Check];
Specific good manufacturing practices: [Check][E];
Serious mandatory adverse event reporting by industry: [Empty].
Source: GAO.
Note: GAO did not independently verify descriptions of foreign laws.
[A] Manufacturers, packagers, labelers, and importers of natural health
products must obtain a site license to perform these activities.
[B] Under European Community (E.C.) law, novel supplements without a
history of consumption in the European Union prior to May 1997, or
foods containing genetically-modified ingredients are subject to
premarket approval for safety.
[C] According to a U.K. official, under E.C. law, firms must report any
problems with products to the local and national authorities.
[D] Foods for Specified Health Uses (FOSHU) products only.
[E] According to a Japanese official, Japan does not have separate good
manufacturing practice regulations for dietary supplement products;
however, firms applying to use a FOSHU claim on a product must provide
evidence that quality control procedures are in place for that
particular product.
[End of table]
In Canada, companies are required to obtain a product license to market
natural health products, which include a range of products, such as
vitamin and mineral supplements, herbal remedies, and other products,
based upon their medicinal ingredients and intended uses. The product
licensing application must include detailed information about the
product, ingredients, potency, intended use, and evidence supporting
the product's safety and efficacy. Approved products are assigned a
license number that is displayed on the product label. Manufacturers,
packagers, labelers, and importers of natural health products must
obtain a site license to perform these activities. To obtain a site
license, a firm must provide evidence of quality control procedures
that meet government standards for good manufacturing practices. Firms
are required to report any serious adverse reactions associated with
their products within 15 days and must provide information summarizing
all adverse reactions, including mild or moderate events, on an annual
basis.
In the United Kingdom (U.K.), dietary supplements are legally termed
"food supplements" and are regulated under food law--most of which is
European Community (E.C.) legislation implemented at the national
level, according to a U.K. official. Food supplements are generally not
subject to premarket approval. For example, any supplement that either
meets the guidelines established under E.U. law for specific vitamins
and minerals, or does not include a new or genetically modified
ingredient, does not require approval prior to marketing. According to
a U.K. official, most direct oversight of the dietary supplement
industry in the United Kingdom occurs at the local level of government.
For example, all investigations, enforcement actions, and monitoring
activities such as inspections are undertaken at the local level. Food
supplement firms are required to register with local authorities and
should detail the specific activities undertaken at each establishment
as part of this process. However, centralized information on registered
firms is not collected or maintained at a national level. Additionally,
there is no centralized registry of food supplement products in the
U.K. Although government standards for food good manufacturing
practices apply to food supplement manufacturing, there are no good
manufacturing practice guidelines specific for food supplements. Under
E.C. law, firms are required to report any problems with food products
to the local and national authorities and, if the product is injurious
to health, the firm must remove it from the market.
In Japan, products are regulated based on their product claims. There
are two types of claims: Food with Nutrient Function Claims (FNFC),
which are standardized, preapproved claim statements for certain
vitamins and minerals with established benefits, and Food for Specified
Health Uses (FOSHU) claims, which require government approval for
safety and efficacy prior to marketing a product advertised as having a
physiological effect on the body. Since FNFC claims are standardized
and preapproved, firms do not need to notify the government prior to
marketing a product using an approved FNFC claim, provided the product
meets established ingredient content specifications. To use a FOSHU
claim on a product, a firm is required to provide the government with
evidence supporting the product's physiological effect and safety prior
to marketing. Additionally, a firm must provide information on the firm
and its product to the government, as well as evidence of quality
control processes.
[End of section]
Appendix IV: Comments from the Department of Health and Human Services:
Department of Health and Human Services:
Office of The Secretary:
Assistant Secretary for Legislation:
Washington, DC 20201:
January 22, 2009:
Lisa Shames:
Director, Natural Resources and Environment:
U.S. Government Accountability Office:
441 G Street N.W.
Washington, DC 20548:
Dear Ms. Shames:
Enclosed are comments on the U.S. Government Accountability Office's
(GAO) report entitled: "Dietary Supplements: FDA Should Take Further
Actions to Improve Oversight and Consumer Understanding," (GAO-09-250).
The Department appreciates the opportunity to review this report before
its publication.
Sincerely,
Signed by:
Barbara Pisaro Clark:
Acting Assistant Secretary for Legislation:
Attachment:
[End of letter]
Department of Health and Human Services:
Food and Drug Administration:
Silver Spring, MD 20993:
January 22, 2009:
To: Assistant Secretary for Legislation:
From: FDA Chief of Staff:
Subject: FDA's General Comments to the U.S. Government Accountability
Office's (GAO) Draft Report Entitled: Dietary Supplements: FDA
Should Take Further Actions to Improve Oversight and Consumer
Understanding (GAO-09-250).
FDA is providing the attached general comments to the U.S. Government
Accountability Office's draft report entitled, Dietary Supplements: FDA
Should Take Further Actions to Improve Oversight and Consumer
Understanding (GAO-09-250).
We appreciate the opportunity to review and comment on this draft
correspondence before it is published.
Signed by:
Susan C. Winckler, R. Ph., Esq.
FDA's General Comments to the U.S. Government Accountability Office's
(GAO) Draft Report Entitled: Dietary Supplements: FDA Should Take
Further Actions to Improve Oversight and Consumer Understanding (GAO-09-
250):
The Food and Drug Administration (FDA or the Agency) welcomes the GAO
report as a means of calling attention to the challenges that the
Agency faces with respect to regulating dietary supplements and
conventional foods formulated with added dietary ingredients.[Footnote
10]
As part of its responsibility to protect the general public health from
unnecessary risks associated with FDA-regulated products, FDA has taken
action to alert the public to potential problems associated with
products marketed as dietary supplements. Last year, for example
* FDA warned consumers not to purchase or consume Total Body Formula, a
liquid multivitamin-multimineral supplement, because it contained
unsafe levels of selenium and chromium that could lead to illness.
* FDA warned against the use of the products Blue Steel and Hero,
marketed as dietary supplements, because they contained undeclared drug
ingredients that could present a serious risk of harm to consumers
using the products.
* FDA initiated seizure actions against several dietary supplement
products because of the presence of undeclared drug ingredients or
because they contained steroid ingredients that were not legal to
market in dietary supplements.
* FDA issued 23 warning letters in December 2008 to marketers of
purported dietary supplements because they contained an undeclared drug
ingredient used to treat diabetes.
* FDA continued to identify and take enforcement action against dietary
supplements making illegal disease treatment claims. For example,
between June and September 2008 FDA issued 28 warning letters to firms
that were marketing fake cancer cures, many of which were marketed as
dietary supplements.
* FDA continues to make progress toward accomplishing other related
tasks, even though funding is limited. As noted in the current draft
report, FDA issued draft guidance to implement the labeling, reporting,
and recordkeeping provisions of the Dietary Supplement and
Nonprescription Drug Consumer Protection Act, and FDA took steps to
update internal systems and processes for collecting and analyzing
serious adverse event reports submitted to FDA.
GAO Recommendation 1:
To improve the information available to FDA for identifying safety
concerns and better enable FDA to meet its responsibility to protect
the public health, we recommend that the Secretary of the Department of
Health and Human Services direct the Commissioner of FDA to request
authority to require dietary supplement companies to:
* Identify themselves as a dietary supplement company as part of the
existing registration requirements and update this information
annually,
* Provide a list of all dietary supplement products they sell and a
copy of the labels and update this information annually, and,
* Report all adverse events related to dietary supplements.
FDA Response to Recommendation 1:
In general, FDA agrees that the Agency's ability to ensure the safety
of dietary supplements used by consumers could be improved if FDA had
more information on the identity of firms marketing dietary supplements
as well as the identity and composition of the products they market.
However, it is not clear that all the information would actually
enhance product safety. For example, the GAO draft report recommends
that FDA require firms to report all adverse events related to dietary
supplements. Although receiving all adverse events on dietary
supplements could theoretically enhance our ability to detect signals
of potential toxicity over time, we are uncertain whether, in practice,
such information would advance the Agency's ability to identify unsafe
dietary supplements or to do so quickly. For example, an unintended
outcome of receiving such reports might be that the huge increase in
minor adverse event reports might make it more difficult to filter out
signals of potential toxicity generated by reports of serious adverse
events and thus delay the identification of safety problems with
dietary supplements. However, FDA is working on methodologies to try to
mitigate this concern and improve data mining for safety-related
signals if the Agency were to receive all adverse event reports.
GAO Recommendation 2:
To better enable FDA to meet its responsibility to regulate dietary
supplements that contain new dietary ingredients, we recommend that the
Secretary of the Department of Health and Human Services direct the
Commissioner of FDA to issue guidance to clarify when an ingredient is
considered a new dietary ingredient, the evidence needed to document
the safety of new dietary ingredients, and appropriate methods for
establishing ingredient identity.
FDA Response to Recommendation 2:
FDA agrees that guidance would be helpful to clarify when an ingredient
is considered a new dietary ingredient (NDI), the evidence needed to
document the safety of NDIs, and appropriate methods for establishing
the identity of a NDI. The Agency held a public meeting in November
2004 to seek public comment on several issues related to the NDI
requirements of section 413(a)(2) of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 350b(a)(2)). FDA specifically asked for
information that would enable the Agency to identify ways to assist
submitters of NDI notifications to ensure that they contain the
information the Agency needs to evaluate the notification and to
clarify statutory requirements in the Dietary Supplement Health and
Education Act of 1994 (DSHEA) that pertain to NDIs. The Agency has
reviewed the information submitted by interested parties on this
subject and has developed draft guidance addressing the NDI
notification requirements of the Federal Food, Drug, and Cosmetic Act.
The guidance is currently undergoing internal FDA review.
GAO Recommendation 3:
To help ensure that companies follow the appropriate laws and
regulations and renew a recommendation we made in July 2000, we
recommend that the Secretary of the Department of Health and Human
Services direct the Commissioner of FDA to provide guidance to industry
to clarify when products should be marketed as either dietary
supplements or foods with added dietary ingredients.
FDA Response to Recommendation 3:
As we noted in our comment to the GAO July 2000 report, FDA's Dietary
Supplement Strategic Plan recognized the need to clarify the boundaries
between dietary supplements and conventional foods, including
conventional foods with added dietary ingredients. As we noted when the
Plan was released in January 2000, FDA acknowledged its inability to
set timeframes for all the activities listed in the Plan because of
resource limitations. FDA will consider this recommendation and the
priority and timing to implement this recommendation in light of the
Agency's limited resources and competing priorities.
GAO Recommendation 4:
To improve consumer understanding about dietary supplements and better
leverage existing resources, we recommend that the Secretary of the
Department of Health and Human Services direct the Commissioner of FDA
to coordinate with stakeholder groups involved in consumer outreach to
(1) identify additional mechanisms-such as the recent WebMD partnership-
for educating consumers about the safety, efficacy, and labeling of
dietary supplements, (2) implement these mechanisms, and (3) assess
their effectiveness.
FDA Response to Recommendation 4:
In principle, FDA agrees that more information about the use of dietary
supplements would help consumers who are trying to determine whether
the use of a particular supplement is safe or desirable in light of
their personal health. However, the Agency is unsure that FDA is best
situated to meet this consumer need. Although FDA does, as the report
notes, engage in some consumer education and outreach, our resources
available for this type of activity are extremely limited. Moreover,
DSHEA recognized that the National Institutes of Health (NIH) is well
situated to undertake the resource-intensive task of conducting and
compiling scientific research on dietary supplements, dietary
ingredients, and their effects on the body. In fact, the NIH's Office
of Dietary Supplements offers a number of consumer-oriented Fact
Sheets, databases of dietary supplement research activities, and
literature citations, for the purpose of educating the public to foster
an enhanced quality of life and health for the U.S. population. Thus,
FDA believes that it may be useful to explore a possible collaboration
between FDA and NIH as an efficient and cost-effective way to expand
and further our current outreach activities on dietary supplements. FDA
also believes that collaboration with other stakeholders may be useful
for communicating information on the safety and uses of dietary
supplements to the general public. In this regard, FDA is identifying
areas of consumer information appropriate for the recently announced
FDA/WebMD partnership, referenced in the GAO report. We anticipate that
information on dietary supplements will be included.
r/d: ONLDS, BMoore, BFrankos: 1/5/09:
Clearance ONLDS, MPoos: 1/5/09:
Edits: NYanish: 1/6/09:
Edits: HSeltzer: 1/6/09:
Edits: DCooper: 1/6/09:
Edits: TMattia: 1/6/09:
Edits: ACrawford: 1/6/09:
Edits & Review: ONLDS, BMoore, BFrankos, MPoos: 1/7/09:
Edits & EOS Clearance: BHarden, 1/7/09:
Edit: MPoos/BFrankos, 1/8/09:
Edits/Clearance: MLanda, 1/9/09:
Edits/CGrillo 1/14/09:
Edited LNickerson 1/15/09:
Reviewed CGrillo 1/16/09:
Edits and OFP Clearance CNelson 1/21/09:
Edited D.Foellmer 1/21/09:
Edited P. Quest at NIH 1/22/09:
[End of section]
Appendix V: GAO Contact and Staff Acknowledgments:
GAO Contact:
Lisa Shames, (202) 512-3841, shamesl@gao.gov:
Staff Acknowledgments:
In addition to the individual named above, José Alfredo Gómez,
Assistant Director; Kevin Bray; Nancy Crothers; Michele Fejfar; Alison
Gerry Grantham; Barbara Patterson; Minette Richardson; Lisa Van
Arsdale; and Chloe Wardropper made key contributions to this report.
[End of section]
Footnotes:
[1] GAO, Food Safety: Improvements Needed in Overseeing the Safety of
Dietary Supplements and "Functional Foods," [hyperlink,
http://www.gao.gov/products/GAO/RCED-00-156] (Washington, D.C.: July
11, 2000).
[2] Department of Health and Human Services Office of Inspector
General, Dietary Supplement Labels: An Assessment (Washington, D.C.:
March 2003).
[3] FDA's estimate was published in the Federal Register on September
15, 2008, in accordance with the Paperwork Reduction Act of 1995. The
estimate is based on a 2000 FDA-commissioned study that examined
factors affecting adverse event reporting for drugs and vaccines and
then qualitatively assessed the potential impact of those factors for
voluntary dietary supplement adverse event reporting.
[4] For more information on food inspections performed under state
contract agreements, see GAO, Food Labeling: FDA Needs to Better
Leverage Resources, Improve Oversight, and Effectively Use Available
Data to Help Consumers Select Healthy Foods, GAO-08-597 (Washington,
D.C.: Sept. 9, 2008).
[5] Department of Health and Human Services, U.S. Food and Drug
Administration, Food Protection Plan: An Integrated Strategy for
Protecting the Nation's Food Supply (Washington, D.C.: November 2007).
[6] Reports of mild or moderate reactions to dietary supplements may be
considered a serious adverse event report if, based on reasonable
medical judgment, a medical intervention was necessary to prevent a
serious outcome.
[7] For more information on FDA resources by Center, see GAO, Food
Safety: Improvements Needed in FDA Oversight of Fresh Produce,
[hyperlink, http://www.gao.gov/products/GAO-08-1047] (Washington, D.C.:
Sept. 26, 2008).
[8] For more information on foreign inspections conducted by FDA, see
GAO, Federal Oversight of Food Safety: FDA Has Provided Few Details on
the Resources and Strategies Needed to Implement its Food Protection
Plan, [hyperlink, http://www.gao.gov/products/GAO-08-909T] (Washington,
D.C.: June 12, 2008).
[9] Department of Health and Human Services' Office of Inspector
General, Dietary Supplement Labels: An Assessment (Washington, D.C.:
March 2003).
[10] The term "dietary ingredient" is not generally used to refer to
ingredients added to conventional foods, as it refers to a category of
ingredients that, by definition, are for use in dietary supplements.
The Federal Food, Drug, and Cosmetic Act defines "dietary supplement"
as a product intended to supplement the diet that (among other
requirements) bears or contains one or more dietary ingredients (21
U.S.C. 321(ff)( I )). The dietary supplement definition defines
"dietary ingredient" to mean vitamins, minerals, herbs and other
botanicals, amino acids, and "dietary substances," as well as
concentrates, metabolites, constituents, extracts, and combinations of
such ingredients (21 U.S.C. 321(ft)(1)).
Although the statute uses "dietary ingredient" only for ingredients
that are used or intended for use in dietary supplements, GAO uses the
term more broadly to include the same category of ingredients when
added to a conventional food. Consistent with GAO's broader use of
"dietary ingredient," these comments also use "dietary ingredient" to
include all the types of ingredients listed in 21 U.S.C. 321(ff)(I),
whether they are intended for use in dietary supplements or in
conventional foods.
When added to conventional foods, dietary ingredients are not regulated
under the legal requirements for dietary ingredients used in a dietary
supplement. Rather, a dietary ingredient added to a conventional food
is regulated under the same legal requirements as any other ingredient
added to a conventional food (i.e., as a food additive requiring FDA
approval unless the ingredient is generally recognized as safe (GRAS)
for its intended use in food or otherwise excepted from the food
additive definition in 21 U.S.C. 321(s)).
[End of section]
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