Herbal Dietary Supplements
Examples of Deceptive or Questionable Marketing Practices and Potentially Dangerous Advice Gao ID: GAO-10-662T May 26, 2010Recent studies have shown that use of herbal dietary supplements--chamomile, echinacea, garlic, ginkgo biloba, and ginseng--by the elderly within the United States has increased substantially. Sellers, such as retail stores, Web sites, and distributors, often claim these supplements help improve memory, circulation, and other bodily functions. GAO was asked to determine (1) whether sellers of herbal dietary supplements are using deceptive or questionable marketing practices and (2) whether selected herbal dietary supplements are contaminated with harmful substances. To conduct this investigation, GAO investigated a nonrepresentative selection of 22 storefront and mail-order retailers of herbal dietary supplements. Posing as elderly consumers, GAO investigators asked sales staff (by phone and in person) at each retailer a series of questions regarding herbal dietary supplements. GAO also reviewed written marketing language used on approximately 30 retail Web sites. Claims were evaluated against recognized scientific research published by the National Institutes of Health (NIH) and the Food and Drug Administration (FDA). GAO also had an accredited lab test 40 unique popular single-ingredient herbal dietary supplements for the presence of lead, arsenic, mercury, cadmium, organichlorine pesticides, and organophosphorous pesticides.
Certain dietary supplements commonly used by the elderly were deceptively or questionably marketed. FDA statutes and regulations do not permit sellers to make claims that their products can treat, prevent, or cure specific diseases. However, in several cases, written sales materials for products sold through online retailers claimed that herbal dietary supplements could treat, prevent, or cure conditions such as diabetes, cancer, or cardiovascular disease. When GAO shared these claims with FDA and the Federal Trade Commission (FTC), both agreed that the claims were improper and likely in violation of statutes and regulations. In addition, while posing as elderly customers, GAO investigators were often told by sales staff that a given supplement would prevent or cure conditions such as high cholesterol or Alzheimer's disease. To hear clips of undercover calls, see http://www.gao.gov/products/GAO-10-662T. Perhaps more dangerously, GAO investigators were given potentially harmful medical advice. For example, a seller stated it was not a problem to take ginkgo biloba with aspirin to improve memory; however, FDA warns that combining aspirin and ginkgo biloba can increase a person's risk of bleeding. In another case, a seller stated that an herbal dietary supplement could be taken instead of a medication prescribed by a doctor. GAO referred these sellers to FDA and FTC for appropriate action. GAO also found trace amounts of at least one potentially hazardous contaminant in 37 of the 40 herbal dietary supplement products tested, though none in amounts considered to pose an acute toxicity hazard. All 37 supplements tested positive for trace amounts of lead; of those, 32 also contained mercury, 28 cadmium, 21 arsenic, and 18 residues from at least one pesticide. The levels of heavy metals found do not exceed any FDA or Environmental Protection Agency (EPA) regulations governing dietary supplements or their raw ingredients, and FDA and EPA officials did not express concern regarding any immediate negative health consequences from consuming these 40 supplements. While the manufacturers GAO spoke with were concerned about finding any contaminants in their supplements, they noted that the levels identified were too low to raise any issues internal product testing.
GAO-10-662T, Herbal Dietary Supplements: Examples of Deceptive or Questionable Marketing Practices and Potentially Dangerous Advice
This is the accessible text file for GAO report number GAO-10-662T
entitled 'Herbal Dietary Supplements: Examples of Deceptive or
Questionable Marketing Practices and Potentially Dangerous Advice'
which was released on May 26, 2010.
This text file was formatted by the U.S. Government Accountability
Office (GAO) to be accessible to users with visual impairments, as
part of a longer term project to improve GAO products' accessibility.
Every attempt has been made to maintain the structural and data
integrity of the original printed product. Accessibility features,
such as text descriptions of tables, consecutively numbered footnotes
placed at the end of the file, and the text of agency comment letters,
are provided but may not exactly duplicate the presentation or format
of the printed version. The portable document format (PDF) file is an
exact electronic replica of the printed version. We welcome your
feedback. Please E-mail your comments regarding the contents or
accessibility features of this document to Webmaster@gao.gov.
This is a work of the U.S. government and is not subject to copyright
protection in the United States. It may be reproduced and distributed
in its entirety without further permission from GAO. Because this work
may contain copyrighted images or other material, permission from the
copyright holder may be necessary if you wish to reproduce this
material separately.
Testimony:
Before the Special Committee on Aging, U.S. Senate:
United States Government Accountability Office:
GAO:
For Release on Delivery:
Expected at 2:00 p.m. EDT:
Wednesday, May 26, 2010:
Herbal Dietary Supplements:
Examples of Deceptive or Questionable Marketing Practices and
Potentially Dangerous Advice:
Statement of Gregory D. Kutz, Managing Director:
Forensic Audits and Special Investigations:
GAO-10-662T:
GAO Highlights:
Highlights of GAO-10-662T, a testimony before the Special Committee on
Aging, U.S. Senate.
Why GAO Did This Study:
Recent studies have shown that use of herbal dietary supplements”
chamomile, echinacea, garlic, ginkgo biloba, and ginseng”by the
elderly within the United States has increased substantially. Sellers,
such as retail stores, Web sites, and distributors, often claim these
supplements help improve memory, circulation, and other bodily
functions. GAO was asked to determine (1) whether sellers of herbal
dietary supplements are using deceptive or questionable marketing
practices and (2) whether selected herbal dietary supplements are
contaminated with harmful substances.
To conduct this investigation, GAO investigated a nonrepresentative
selection of 22 storefront and mail-order retailers of herbal dietary
supplements. Posing as elderly consumers, GAO investigators asked
sales staff (by phone and in person) at each retailer a series of
questions regarding herbal dietary supplements. GAO also reviewed
written marketing language used on approximately 30 retail Web sites.
Claims were evaluated against recognized scientific research published
by the National Institutes of Health (NIH) and the Food and Drug
Administration (FDA). GAO also had an accredited lab test 40 unique
popular single-ingredient herbal dietary supplements for the presence
of lead, arsenic, mercury, cadmium, organichlorine pesticides, and
organophosphorous pesticides.
What GAO Found:
Certain dietary supplements commonly used by the elderly were
deceptively or questionably marketed. FDA statutes and regulations do
not permit sellers to make claims that their products can treat,
prevent, or cure specific diseases. However, in several cases, written
sales materials for products sold through online retailers claimed
that herbal dietary supplements could treat, prevent, or cure
conditions such as diabetes, cancer, or cardiovascular disease. When
GAO shared these claims with FDA and the Federal Trade Commission
(FTC), both agreed that the claims were improper and likely in
violation of statutes and regulations. In addition, while posing as
elderly customers, GAO investigators were often told by sales staff
that a given supplement would prevent or cure conditions such as high
cholesterol or Alzheimer‘s disease. To hear clips of undercover calls,
see [hyperlink, http://www.gao.gov/products/GAO-10-662T]. Perhaps more
dangerously, GAO investigators were given potentially harmful medical
advice. For example, a seller stated it was not a problem to take
ginkgo biloba with aspirin to improve memory; however, FDA warns that
combining aspirin and ginkgo biloba can increase a person‘s risk of
bleeding. In another case, a seller stated that an herbal dietary
supplement could be taken instead of a medication prescribed by a
doctor. GAO referred these sellers to FDA and FTC for appropriate
action. The table below includes several deceptive claims made by
sellers.
Table: Deceptive Marketing Claims for Herbal Supplements Found by GAO
Investigators:
Claim: Garlic prevents obesity and diabetes and cures cardiovascular
disease.
Comments: NIH does not recognize this herbal supplement as a treatment
for obesity, diabetes, or cardiovascular disease.
Claim: Ginseng cures diseases, including cancer.
Comments: NIH specifically recommends that breast and uterine cancer
patients avoid this product, as it may have an adverse interaction
with some cancer drugs.
Claim: Garlic can be taken in lieu of prescribed high blood pressure
medication.
Comments: Evidence that this product reduces high blood pressure is
unclear, and both NIH and FDA state that no dietary supplement can
take the place of prescribed medicines.
Claim: Ginkgo biloba can be taken with a daily aspirin prescription.
Comments: Taking this product with aspirin may increase the risk of
bleeding.
Claim: Ginkgo biloba treats Alzheimer‘s disease, depression, and
impotence.
Comments: No clear scientific evidence supports any of these treatment
claims.
Source: GAO.
[End of table]
GAO also found trace amounts of at least one potentially hazardous
contaminant in 37 of the 40 herbal dietary supplement products tested,
though none in amounts considered to pose an acute toxicity hazard.
All 37 supplements tested positive for trace amounts of lead; of
those, 32 also contained mercury, 28 cadmium, 21 arsenic, and 18
residues from at least one pesticide. The levels of heavy metals found
do not exceed any FDA or Environmental Protection Agency (EPA)
regulations governing dietary supplements or their raw ingredients,
and FDA and EPA officials did not express concern regarding any
immediate negative health consequences from consuming these 40
supplements. While the manufacturers GAO spoke with were concerned
about finding any contaminants in their supplements, they noted that
the levels identified were too low to raise any issues internal
product testing.
View [hyperlink, http://www.gao.gov/products/GAO-10-662T] or key
components. For more information, contact Gregory D. Kutz at (202) 512-
6722 or kutzg@gao.gov.
[End of section]
Mr. Chairman and Members of the Committee:
Thank you for the opportunity to discuss findings from our
investigation into the manufacture and marketing of selected herbal
dietary supplements commonly used by the elderly.[Footnote 1] The
Dietary Supplement Health and Education Act of 1994 (DSHEA) defines
dietary supplements as products that, among other things, are intended
for ingestion to supplement the diet, labeled as dietary supplements,
and not represented as conventional foods or as a sole items of a meal
or diet.[Footnote 2] Recent studies have shown that use of herbal
dietary supplements, such as chamomile, echinacea, garlic, ginkgo
biloba, and ginseng, by the elderly in the United States has increased
substantially.[Footnote 3]
In 2000, we reported that consumers did not consistently receive
clear, scientifically supported information concerning products'
health benefits so they could make informed dietary choices. Further,
we have reported that consumers faced health risks because federal
laws and agencies' efforts did not effectively and consistently ensure
that dietary supplements were safe.[Footnote 4] Most recently, we
expressed concern that 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.[Footnote 5] At your request,
we determined (1) whether sellers of herbal dietary supplements are
using deceptive or questionable marketing practices to encourage the
use of these products and (2) whether selected herbal dietary
supplements are contaminated with harmful substances.
To determine whether sellers of herbal dietary supplements are using
deceptive or questionable marketing practices to encourage the use of
these products, we investigated a nonrepresentative selection of 22
storefront and mail-order retailers. We identified these retailers by
searching online using search terms likely to be used by actual
consumers and by observing newspaper advertisements. Posing as elderly
potential consumers, we asked sales staff at each retailer a series of
questions regarding the potential health benefits of herbal dietary
supplements as well as potential interactions with other common over-
the-counter and prescription drugs. We also reviewed written marketing
language used on approximately 30 retail Web sites.[Footnote 6] We
evaluated the accuracy of product marketing claims against health
benefit evaluations published through the National Institutes of
Health (NIH) and Food and Drug Administration (FDA). While our work
focused on herbal dietary supplements, we also evaluated claims made
regarding nonherbal supplement products recommended to us during
undercover storefront visits and telephone calls.
To determine whether selected herbal dietary supplements are
contaminated with harmful substances, we purchased 40 unique single-
ingredient herbal supplement products from 40 different manufacturers
and submitted them to an accredited laboratory for analysis. We
selected the types of herbs to purchase based on recent surveys about
the supplements usage of the elderly. These surveys identified the
most commonly used herbs among the elderly as chamomile, echinacea,
garlic, ginkgo biloba, ginseng, peppermint, saw palmetto, and St.
John's wort. We purchased these 40 unique products from a combination
of retail chain storefronts and online or mail-order retailers; these
retailers were selected independently from those selected for
evaluation of marketing practices. For each online retailer, we
selected brands based primarily on relative popularity according to
the site's list of top sellers. One unopened, manufacturer-sealed
bottle of each of these 40 products was submitted to an accredited
laboratory where they were screened for the presence of common
hazardous contaminants: lead, arsenic, mercury, cadmium, and residues
from organichlorine and organophosphorous pesticides. These
contaminants were selected based on prevalence and the likelihood of
negative health consequences as a result of consumption. We did not
independently validate the results received with another lab, or
through any other mechanism. The likely negative health consequences
from consumption of these contaminants were determined based on a
review of relevant health standards and discussions with FDA and
Environmental Protection Agency (EPA) experts. For a complete
discussion of our scope and methodology, see appendix I. See appendix
II for the complete list of contaminants we reviewed.
Our investigative work, conducted from September 2009 through March
2010, was performed in accordance with standards prescribed by the
Council of the Inspectors General on Integrity and Efficiency.
Background:
Herbal dietary supplements are traditionally used to alleviate certain
medical conditions, such as anxiety, digestive problems, and
depression, and to improve general quality of life. However, for many
traditional uses, there is not clear scientific evidence to show that
they prevent or treat underlying diseases or conditions. Further, some
herbal dietary supplements may interact in a potentially harmful
manner with some prescription drugs. For example, according to NIH,
St. John's wort can negatively affect the efficacy of antidepressants,
HIV treatments, cancer drugs, and anticoagulants, though this is not
always noted on product labels. The possibility of adverse drug
interactions is one of the reasons that FDA recommends that consumers
check with their health practitioners before beginning any supplement
regimen. The elderly are particularly at risk from these interactions
since recent studies have found that approximately 85 percent of the
elderly take at least one prescription drug over the course of a year
and 58 percent take three or more. Many herbal supplements have not
been exhaustively tested for hazardous interactions with prescription
drugs, other supplements, or foods.[Footnote 7]
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.[Footnote 8] Also, all
domestic and foreign companies that manufacture, package, label, or
hold dietary supplements must follow FDA's current good manufacturing
practice regulations, which outline procedures for ensuring the
quality of supplements intended for sale.[Footnote 9]
Marketing Claims:
Under DSHEA, a firm, not FDA, is responsible for determining that any
representation or claims made about the dietary supplements it
manufactures or distributes are substantiated by adequate evidence to
show that they are not false or misleading. Except in the case of a
new dietary ingredient, where premarket review for safety data and
other information is required by law, a firm does not have to provide
FDA with the evidence it relies on to substantiate effectiveness
before or after it markets its products. For the most part, FDA relies
on postmarket 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.[Footnote 10] 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.
A product sold as a dietary supplement cannot suggest on its label or
in labeling that it treats, prevents, or cures a specific disease or
condition without specific approval from FDA.[Footnote 11] Under FDA
regulations, a manufacturer may submit a health claim petition in
order to use a claim on its product labeling that characterizes a
relationship between the product and risk of a disease, and FDA may
authorize it provided the claims meet certain criteria and are
authorized by FDA regulations[Footnote 12] (e.g., diets high in
calcium may reduce the risk of osteoporosis).[Footnote 13] However,
manufacturers may make "qualified health claims" when there is
emerging evidence for a relationship between a dietary supplement and
reduced risk of a disease or condition, subject to FDA's enforcement
discretion. The claim must include specific qualifying language to
indicate that the supporting evidence is limited.[Footnote 14],
[Footnote 15]
Dietary supplement labeling may include other claims describing how a
dietary ingredient is intended to affect the normal structure or
function of the body (e.g. fiber maintains bowel regularity). The
manufacturer is responsible for ensuring the accuracy and truthfulness
of such claims, but must submit a claim to FDA for review no later
than 30 days after marketing it.[Footnote 16] Because FDA does not
confirm the claim--a lack of objection allows the manufacturer to use
it--the following disclaimer must be included: "This statement has not
been evaluated by the FDA. This product is not intended to diagnose,
treat, cure, or prevent any disease." The manufacturer does not need
to provide FDA with documentation, and FDA does not test to determine
if the claim is true.
In addition, these claims generally may not state that a product is
intended to diagnose, mitigate, treat, cure, or prevent a disease or
the adverse effects associated with a therapy for a disease, either by
naming or describing a specific disease.[Footnote 17] A claim also
cannot suggest an effect on an abnormal condition associated with a
natural state or process, such as aging.[Footnote 18] Context is a
consideration; a product's name and labeling cannot imply such an
effect by use of pictures or scientific or lay terminology. Finally, a
product cannot claim to be a substitute for a product that is a
therapy for a disease, or claim to augment a therapy or drug. To make
any of these claims, a manufacturer must submit and receive
authorization of a health claim petition.
The Federal Trade Commission (FTC) regulates advertising for dietary
supplements and other products sold to consumers. FTC receives
thousands of consumer complaints each year related to dietary
supplements and herbal remedies. FTC has, in the past, taken action
against supplement sellers and manufacturers whose advertising was
deemed to pose harm to the general public. FDA works with FTC in this
area, but FTC's work is directed by different laws.
Harmful Substance Contamination:
Consuming high levels of the contaminants for which we tested the 40
products can lead to severe health consequences, such as increased
risk of cancer, as noted in table 1. The negative health effects
described are, unless otherwise noted, for the acute toxicity in the
human body. However, the exact effects of these contaminants on an
individual are based on an individual's specific characteristics. For
instance, since lead can build up in the human body, the effect of
consuming a potentially dangerous level of lead by a 55-year-old man
depends on the amount of lead that man has consumed during his
lifetime, among other factors.
Table 1: Potential Negative Health Effects of Contaminants Tested for
in Selected Herbal Dietary Supplements:
Contaminant: Arsenic;
Negative health effects: Known to increase risk of lung and skin
cancer. Long-term exposure can cause skin pigment changes and a
thickening of the skin of the hands and feet.
Contaminant: Cadmium;
Negative health effects: Known to cause increased risk of leukemia and
testicular tumors. Long-term exposure to lower levels can lead to
kidney disease, lung damage, and fragile bones.
Contaminant: Lead;
Negative health effects: May cause increased risk of lung, stomach,
and bladder cancer.
Contaminant: Mercury;
Negative health effects: May cause fever, insomnia, and mood shifts.
High levels may cause blindness, deafness, and long-term exposure may
cause severe renal damage.
Contaminant: Carbofuran;
Negative health effects: Cholinesterase inhibitor.[A].
Contaminant: Chlorpyrifos;
Negative health effects: Light exposure may cause headaches, blurred
vision, watery eyes, dizziness, confusion, diarrhea, and change in
heart rate. Heavy exposure may cause seizures, coma, and death.
Contaminant: p,p-DDE[B];
Negative health effects: May increase risk of liver and thyroid tumors.
Contaminant: gamma-HCH;
Negative health effects: May cause liver or kidney problems.
Contaminant: HCB;
Negative health effects: May cause liver, thyroid, and kidney damage;
may increase risk of liver, kidney, and thyroid cancer.
Sources: Agency for Toxic Substances and Disease Registry, EPA risk
assessments, and National Toxicology Program.
Note: All pesticides sold or distributed in the United States must be
registered by EPA, based on scientific studies showing that they can
be used without posing unreasonable risks to people or the
environment. Because of advances in scientific knowledge, the law
requires that pesticides that were first registered before November 1,
1984, be reregistered to ensure that they meet today's more stringent
standards. In evaluating pesticides for reregistration, EPA obtains
and reviews a complete set of studies from pesticide producers,
describing the human health and environmental effects of each
pesticide.
[A] A cholinesterase inhibitor behaves similarly to a neurotoxin and
may cause abdominal cramps, diarrhea, nausea, and vomiting.
[B] Dichlorodiphenyldichloroethylene (p,p-DDE) is a breakdown product
of the pesticide dichlorodiphenyltrichloroethane (DDT).
[End of table]
FDA has not issued any regulations addressing safe or unsafe levels of
contaminants in dietary supplements, but both FDA and EPA have set
certain advisory levels for contaminants in other foods. The human
body's absorption of many contaminants is governed by intake method,
so advisory levels for other foods (e.g., drinking water) cannot be
strictly applied to dietary supplements. In addition, EPA sets limits
on how much pesticide residue can remain on food and feed products.
These pesticide residue limits are known as tolerances and are
enforced by FDA. If no residue tolerance has been set for a particular
pesticide, any product containing that pesticide residue is considered
adulterated and its sale is prohibited by law. See table 2 for a
summary of the regulations issued by FDA or EPA regarding some of the
contaminants we tested for.
Table 2: Regulatory Information for Selected Contaminants:
Contaminant: Arsenic;
Regulatory information: FDA has limited arsenic in bottled drinking
water to .010 parts per million (ppm).[A].
Contaminant: Cadmium;
Regulatory information: FDA has limited cadmium in bottled drinking
water to .005 ppm.
Contaminant: Lead;
Regulatory information: FDA has limited lead in bottled drinking water
to .005 ppm.
Contaminant: Mercury;
Regulatory information: FDA has limited mercury in bottled drinking
water to .002 ppm.
Contaminant: Carbofuran;
Regulatory information: Carbofuran's use is restricted in the United
States due to ecological and health risks. FDA has limited carbofuran
in bottled drinking water to .04 ppm.
Contaminant: Chlorpyrifos;
Regulatory information: EPA residue tolerances for chlorpyrifos in
food commodities range from .01 to 20.0 ppm.
Contaminant: p,p-DDE;
Regulatory information: The use of the parent chemical for this
breakdown product has been banned in the United States since 1972.
Contaminant: gamma-HCH;
Regulatory information: EPA National Primary Drinking Water
Regulations limit the level of this pesticide in tap water to .0002
ppm. EPA residue tolerances for gamma-HCH in food commodities range
from 4.0 to 7.0 ppm.
Contaminant: HCB[B];
Regulatory information: EPA National Primary Drinking Water
Regulations limit the level of this pesticide in tap water to .001 ppm.
Source: GAO analysis of FDA and EPA regulations.
[A] Parts per million is a measure equivalent to milligrams of
contaminant per kilogram of carrier material or milligrams of
contaminant per liter of carrier material.
[B] Hexachlorobenzene (HCB) is subject to a voluntary usage ban by
U.S. companies. It is not currently used commercially in the United
States, though it was previously used to make fireworks, ammunition,
and synthetic rubber.
[End of table]
Deceptive or Questionable Marketing Claims May Lead to Harm for
Elderly Consumers of Herbal Supplements:
Our investigation found examples of deceptive or questionable
marketing and sales practices for dietary supplements popular among
the elderly (see table 3). The most egregious practices included
suspect marketing claims that a dietary supplement prevented or cured
extremely serious diseases, such as cancer and cardiovascular disease.
Other dietary supplements were claimed to mitigate age-related medical
conditions, such as Alzheimer's disease and diverticular disorder. We
also found some claims that followed FDA's labeling regulations and
guidelines, but could still be considered deceptive or questionable
and provide consumers with inaccurate information. In addition, while
conducting in-person and telephone conversations with dietary
supplements sellers, our investigators, posing as elderly consumers,
were given potentially harmful medical advice by sales staff,
including that they could take supplements in lieu of prescription
medication. In making these claims, sellers put the health of
consumers at risk. A link to selected audio clips from these calls is
available at: [hyperlink, http://www.gao.gov/products/GAO-10-662T].
Table 3: Cases of Deceptive Marketing and Questionable Practices:
Case: 1;
Product: Ginkgo biloba;
Deceptive or questionable marketing claim/practice: Product labeling
states it "Effectively treats Alzheimer's Disease, depression,
impotence, memory...and more";
Comment: Several NIH studies have shown ginkgo to be ineffective at
reducing the risk of Alzheimer's, or otherwise enhancing memory. Other
studies have shown that there may be minor alleviation of depression
in elderly patients taking ginkgo, but overall, there is not enough
evidence to form a clear conclusion.
Case: 2;
Product: Garlic;
Deceptive or questionable marketing claim/practice: Product labeling
states that it prevents and/or cures cardiovascular disease, cancer,
obesity, and diabetes;
Comment: Only a drug can claim to cure a disease, according to FDA and
NIH. As a treatment for these conditions, experts typically recommend
healthy eating, regular physical activity, and in some cases FDA-
approved drugs, not this herbal dietary supplement. In addition, no
studies suggest that this product can cure or prevent any of these
conditions.
Case: 3;
Product: Ginseng;
Deceptive or questionable marketing claim/practice: Product labeling
states that it possesses a "Powerful Anti-cancer Function" and can
prevent diabetes, among other questionable claims;
Comment: NIH states that there is no clear evidence to support that
this supplement can prevent cancer or cardiovascular diseases, and
more research is needed. While this supplement may lower blood sugar
levels in patients with type 2 diabetes, the long-term effects are not
clear, and NIH recommends that patients should instead use more proven
therapies.
Case: 4;
Product: Garlic;
Deceptive or questionable marketing claim/practice: Product labeling
states that "it is extremely helpful in treating any form of flu or
colds, from a mild head cold to pneumonia. [It] is useful for
bronchial conditions such as inflammatory disease, asthma,
tuberculosis...";
Comment: Some research suggests that this herb may reduce the severity
of upper respiratory tract infections. However, according to NIH,
better studies need to be performed to confirm this effect in humans.
Case: 5;
Product: Garlic;
Deceptive or questionable marketing claim/practice: Product labeling
states that "Hundreds of scientific studies have proven [this product]
to be number one, working to enhance the body's immune function,
protect cells from free radical damage, and reduce cardiovascular risk
factors, including issues with blood pressure, cholesterol...";
Comment: While this herb may help with certain conditions, enhancement
of the body's immune function is not a recognized benefit. Studies
have shown that this herb may lower bad cholesterol and blood pressure
by a small amount, but the long-term effects are not known. In
addition, the effects on good cholesterol are unclear. Further, the
seller does not disclose details about the "hundreds of scientific
studies" cited in the product labeling.
Case: 6;
Product: Chamomile;
Deceptive or questionable marketing claim/practice: Product labeling
states that possible benefits of chamomile include the alleviation of
insomnia, diverticular disorder, gum disease, and gingivitis;
Comment: Dietary supplements are not a recommended course of treatment
for any of these conditions, according to FDA. While chamomile has
traditionally been used as a sleep aid, there is a lack of scientific
evidence supporting its effectiveness in treating insomnia, according
to NIH. For the other conditions, recommended treatments often include
lifestyle changes, drugs, and surgery.
Case: 7;
Product: Enzyme[A];
Deceptive or questionable marketing claim/practice: Publicity
materials for this product include a rebuttal of an FDA disclaimer
regarding the product's claim to guard against memory issues;
Comment: FDA reviewed the supplement and determined that there is
little scientific evidence that it reduces the risk of dementia or
cognitive dysfunction in the elderly.
Case: 8;
Product: Garlic;
Deceptive or questionable marketing claim/practice: Sales staff
informed us that this herbal dietary supplement could be taken in lieu
of high blood pressure medicine;
Comment: While this herb may lower blood pressure, better studies are
needed to confirm this benefit, and NIH does not recommend it as a
treatment for high blood pressure.
Case: 9;
Product: Ginkgo biloba;
Deceptive or questionable marketing claim/practice: Sales staff
informed us that there are no side effects to taking the product with
aspirin;
Comment: FDA warns that if this product is taken with certain drugs
(including aspirin), it can increase the potential for internal
bleeding.
Case: 10;
Product: Ginkgo biloba;
Deceptive or questionable marketing claim/practice: Sales staff
informed us that by using this supplement, the use of aspirin is no
longer needed;
Comment: NIH advises consumers to talk to their health care providers
before taking any herbal medicines or supplements and before starting
or ending any drug regimen.
Source: GAO.
[A] The product described here is not an herbal dietary supplement,
but was recommended by sales staff at several retailers to help with
memory issues.
[End of table]
Below are details on several cases in which herbal supplement
marketing practices were deceptive or questionable and sometimes posed
health risks to consumers. All cases of deceptive or questionable
marketing and inappropriate medical advice have been referred to FDA
and FTC for appropriate action.
Case 2: In online materials, this garlic supplement included claims
that it would (1) prevent and cure cardiovascular disease, (2) prevent
and cure tumors and cancer, (3) prevent obesity, and (4) reduce
glycemia to prevent diabetes. According to NIH, all these claims are
unproven, and garlic is not recommended for treating these conditions.
In fact, for several of these conditions, garlic may interact
adversely with common FDA-approved drug treatments. Nowhere in this
product's marketing materials does the seller suggest that consumers
should consult their health care providers prior to taking its
supplement. While NIH recognizes that garlic may have some anticancer
properties, the agency notes that additional clinical trials are
needed to conclude whether these properties are strong enough to
prevent or treat cancer. Further, studies have shown that garlic may
alter the levels of some cancer drugs in the human body, lessening
their effectiveness. For diabetes, there are no studies that confirm
that garlic lowers blood sugar or increases the release of insulin in
humans. In fact, NIH recommends caution when combining garlic with
medications that lower blood sugar, and further suggests that patients
taking insulin or oral drugs for diabetes be monitored closely by
qualified health care professionals.
Case 3: According to its labeling, this ginseng supplement--which
costs $500 for a 90-day supply--cures diseases, effectively prevents
diabetes and cardiovascular disease, and prevents cancer or halts its
progression. These claims are unproven--no studies confirm that
ginseng can prevent or cure any disease. In fact, NIH recommends that
breast and uterine cancer patients avoid ginseng. In addition, ginseng
may adversely interact with cancer drugs. The product labeling claims
do not differentiate between type 1 and type 2 diabetes. According to
NIH, ginseng's effect on patients with type 1 diabetes is not well
studied. While ginseng may lower blood sugar levels in patients with
type 2 diabetes, the long-term effects of such a treatment program are
unclear, and it is not known what doses are safe or effective. NIH
specifically recommends that consumers with type 2 diabetes use proven
therapies instead of this supplement.
Case 7: While our investigators posed as consumers purchasing dietary
supplements, sales staff provided them with an informational booklet
regarding an enzyme that claims to "[defend] us against dementia and
Alzheimer's, exhibiting a truly miraculous capacity to optimize mental
performance and fight off cognitive decline." In fact, FDA reviewed
the scientific evidence for the active ingredient of this supplement
and found that it was not adequate to make such a claim. Because the
agency considered such a health claim potentially misleading, FDA
provided for the use of a qualified health claim that contains a
disclaimer that must accompany the health claim in all labeling in
which these claims appear. While the booklet we received does state
the FDA disclaimer on the first page, the manufacturer follows it with
a rejoinder: "The very cautious language of these claims, which FDA
mandates can only be stated word for word, is at best a grudging
concession to the extensive clinical research done with [this
supplement]. Considering this agency's legendary toughness against
dietary supplements, FDA's willingness to go this far with the
[disclaimer] suggests that the FDA must be sure it is safe to take and
also that the FDA is unable to deny [this supplement] can improve
human brain function."
Case 8: One of our fictitious consumers visited a supplement specialty
store looking for a product that would help with high blood pressure.
The sales representative recommended a garlic supplement and stated
that the product could be taken in lieu of prescribed blood pressure
medication. According to NIH, while this herb may lower blood pressure
by a small amount, the scientific evidence is unclear. NIH does not
recommend this supplement as a treatment for high blood pressure and
warns patients to use caution while taking this product with other
drugs or supplements that can lower blood pressure. Further, it is not
recommended that a consumer start or stop a course of treatment
without consulting with his or her health care provider. Even if a
sales representative is licensed to dispense medical advice, he or she
still does not know the consumer's patient history, including other
drug programs, allergies, and medical conditions, making it
potentially dangerous for the sales representative to provide medical
advice.
Case 9: At a supplement specialty store, one of our investigators
posed as an elderly consumer who was having difficulty remembering
things. A sales representative recommended one of the store's ginkgo
biloba supplements. The consumer told the representative that he takes
aspirin everyday and asked if it was safe to take aspirin and ginkgo
biloba together. The sales representative told him that it is
completely safe to take the two together. However, according to FDA,
if aspirin is taken with the recommended product, it can increase the
potential for internal bleeding.
We spoke to FDA and FTC regarding these 10 claims, and they agreed
that the statements made in product labeling for cases 1 through 6 are
largely improper, as the labeling suggests that each product has an
effect on a specific disease. For case 7, FDA stated that while the
specific claims discussed here are allowable, depending on the context
in which they were made, FDA might consider the totality of marketing
materials to be improper. FDA also agreed that the claims made to our
undercover investigators in cases 8 and 10 were questionable or likely
constituted improper disease claims, but that to take action,
additional information as to the prevalence and context of the claims
would be necessary. For case 9, FDA noted that, since the statement
made by sales staff was safe usage information, not a claim about the
product's effects, it would not violate FDA regulations, unless the
agency could develop other evidence to show that the claim was false
or misleading or constituted an implied disease claim. In addition,
FDA and NIH both noted that by definition, no dietary supplement can
treat, prevent, or cure any disease.
Trace Contaminants Found in Selected Herbal Dietary Supplements, but
None Pose an Acute Toxicity Hazard to Humans:
We found trace amounts of at least one potentially hazardous
contaminant in 37 of the 40 herbal dietary supplement products we
tested, though none of the contaminants were found in amounts
considered to pose an acute toxicity hazard to humans.[Footnote 19]
Specifically, all 37 supplements tested positive for trace amounts of
lead. Thirty-two also contained mercury, 28 contained cadmium, 21
contained arsenic, and 18 contained residues from at least one
pesticide.[Footnote 20] See appendixes III and IV for the complete
results of these tests.
The levels of contaminants found do not exceed any FDA or EPA
regulations governing dietary supplements or their raw ingredients,
and FDA and EPA officials did not express concern regarding any
immediate negative health consequences from consuming these 40
supplements. However, because EPA has not set pesticide tolerance
limits for the main ingredients of the herbal dietary supplements we
tested, the pesticide contaminants exceed FDA advisory levels. FDA
agreed that 16 of the 40 supplements we tested would be considered in
violation of U.S. pesticide tolerances if FDA, using prescribed
testing procedures, confirmed our results. We note that 4 of the
residues detected are from pesticides that currently have no
registered use in the United States.[Footnote 21] According to FDA,
scientific research has not been done on the long-term health effects
from consumption of such low levels of many of these specific
contaminants, as current technology cannot detect these trace
contaminants when they are diluted in human bloodstreams. We have
referred these products to FDA for its review.
After reviewing test results with EPA and FDA officials, we also spoke
with several of the manufacturers of supplements that had trace
amounts of contaminants.[Footnote 22] The manufacturers we spoke with
stated that they ensure that their products are tested for
contamination, and that these tests have shown that their products do
not contain contaminants in excess of regulatory standards.
Manufacturers also stated that they comply with all FDA regulations
and follow good manufacturing practices as defined by the agency.
While the manufacturers we spoke with were concerned about finding any
contaminants in their supplements, they noted that the levels
identified were too low to raise any issues during their own internal
product testing processes.
Mr. Chairman, this concludes my statement. I would be pleased to
answer any questions that you or other members of the committee may
have at this time.
Contacts and Acknowledgments:
For further information about this testimony, please contact Gregory
D. Kutz at (202) 512-6722 or kutzg@gao.gov. Contact points for our
Offices of Congressional Relations and Public Affairs may be found on
the last page of this testimony. Individuals who made major
contributions to this testimony were Jonathan Meyer and Andrew
O'Connell, Assistant Directors; John Ahern; Dennis Fauber; Robert
Graves; Cristian Ion; Elizabeth Isom; Leslie Kirsch; Barbara Lewis;
Flavio Martinez; James Murphy; Ramon Rodriguez; Tim Walker; and John
Wilbur.
[End of section]
Appendix I: Scope and Methodology:
To determine whether sellers of herbal dietary supplements are using
deceptive or questionable marketing practices to encourage the use of
these products, we investigated a nonrepresentative selection of 22
storefront and mail-order retailers selling herbal dietary
supplements. We identified these retailers by searching online using
search terms likely to be used by actual consumers and by observing
newspaper advertisements. Posing as elderly customers, we asked sales
staff at each company a series of questions regarding the potential
health benefits of herbal dietary supplements as well as potential
interactions with other common over-the-counter and prescription
drugs.[Footnote 23] While our work focused on herbal dietary
supplements, we also evaluated claims made regarding nonherbal
supplement products during undercover storefront visits and telephone
calls. We also reviewed written marketing language used on
approximately 30 retail Web sites. We evaluated the accuracy of
product marketing claims against health benefit evaluations published
through the National Institutes of Health and Food and Drug
Administration (FDA).
To determine whether selected herbal dietary supplements were
contaminated with harmful substances, we purchased 40 unique single-
ingredient herbal supplement products from 40 different manufacturers
and submitted them to an accredited laboratory for analysis. We
selected the types of herbs to purchase based on recent surveys about
the supplements usage of the elderly, defined for this report as
individuals over the age of 65. These surveys identified the most
commonly used herbs among the elderly as chamomile, echinacea, garlic,
ginkgo biloba, ginseng, peppermint, saw palmetto, and St. John's wort.
We purchased these 40 unique products from a combination of retail
chain storefronts and online or mail-order retailers. For each online
retailer, we selected products based primarily on relative popularity
according to the site's list of top sellers. At each retail chain
storefront, because of limited selection, we selected only items that
would be expected to be sold at all chain locations. All 40 products
were submitted to an accredited laboratory where they were screened
for the presence of lead, arsenic, mercury, cadmium, and residues from
organichlorine and organophosphorous pesticides. These contaminants
were selected based on prevalence and the likelihood of negative
health consequences due to consumption. The recommended daily intake
levels of these contaminants and the likely negative health
consequences because of consumption were determined based on a review
of relevant health standards and discussions with FDA and
Environmental Protection Agency experts.
For each herbal dietary supplement product, we submitted one unopened,
manufacturer-sealed bottle to the laboratory for analysis. To identify
levels of arsenic, cadmium, lead, and mercury, products were analyzed
using inductively coupled plasma mass spectrometry according to method
AOAC 993.14. Detection limits for these contaminants were .075
milligrams/kilogram, .010 milligrams/kilogram, .005 milligrams/
kilogram, and .050 nanograms/gram, respectively. To identify levels of
pesticide residues, products were analyzed using a variety of residue-
specific methods, including those methods published in the FDA
Pesticide Analytical Manual. We did not independently validate the
results received with another lab or through any other mechanism. See
appendix II for a complete list of analytes and their related
detection levels.
[End of section]
Appendix II: Full List of Analytes and Detection Limits:
Analyte: (2-Ethylhexyl)-Diphenylphosphate;
Detection limit (ppm)[A]: 0.01;
Analyte: Acrinathrin;
Detection limit (ppm)[A]: 0.01.
Analyte: Aldrin;
Detection limit (ppm)[A]: 0.01.
Analyte: Allethrin;
Detection limit (ppm)[A]: 0.01.
Analyte: alpha-BHC;
Detection limit (ppm)[A]: 0.01.
Analyte: Ametryn;
Detection limit (ppm)[A]: 0.01.
Analyte: Aminocarb;
Detection limit (ppm)[A]: 0.01.
Analyte: Amitraz;
Detection limit (ppm)[A]: 0.05.
Analyte: Aniten/Flurecol Butyl Ester;
Detection limit (ppm)[A]: 0.05.
Analyte: Arsenic;
Detection limit (ppm)[A]: 0.075.
Analyte: Atrazine;
Detection limit (ppm)[A]: 0.01.
Analyte: Azinphos-methyl;
Detection limit (ppm)[A]: 0.01.
Analyte: Azoxystrobin;
Detection limit (ppm)[A]: 0.01.
Analyte: Benalaxyl;
Detection limit (ppm)[A]: 0.01.
Analyte: Bendiocarb;
Detection limit (ppm)[A]: 0.01.
Analyte: Benfluralin;
Detection limit (ppm)[A]: 0.01.
Analyte: beta-BHC;
Detection limit (ppm)[A]: 0.01.
Analyte: Bifenthrin;
Detection limit (ppm)[A]: 0.01.
Analyte: Biphenyl;
Detection limit (ppm)[A]: 0.02.
Analyte: Bromopropylate;
Detection limit (ppm)[A]: 0.01.
Analyte: Bufencarb;
Detection limit (ppm)[A]: 0.01.
Analyte: Bupirimate;
Detection limit (ppm)[A]: 0.01.
Analyte: Buprofezin;
Detection limit (ppm)[A]: 0.01.
Analyte: Butylate;
Detection limit (ppm)[A]: 0.01.
Analyte: Cadmium;
Detection limit (ppm)[A]: 0.01.
Analyte: Carbaryl;
Detection limit (ppm)[A]: 0.01.
Analyte: Carbofuran;
Detection limit (ppm)[A]: 0.01.
Analyte: Carbofuran 3-OH;
Detection limit (ppm)[A]: 0.01.
Analyte: Carbosulfan;
Detection limit (ppm)[A]: 0.02.
Analyte: Carboxin;
Detection limit (ppm)[A]: 0.01.
Analyte: Chlordene, beta;
Detection limit (ppm)[A]: 0.02.
Analyte: Chlordene, gamma;
Detection limit (ppm)[A]: 0.02.
Analyte: Chlordimeform (CDF);
Detection limit (ppm)[A]: 0.01.
Analyte: Chlorfenvinphos (Total Isomers E, Z);
Detection limit (ppm)[A]: 0.01.
Analyte: Chlorobenzilate;
Detection limit (ppm)[A]: 0.01.
Analyte: Chloroneb;
Detection limit (ppm)[A]: 0.01.
Analyte: Chloropropylate;
Detection limit (ppm)[A]: 0.01.
Analyte: Chlorothalonil;
Detection limit (ppm)[A]: 0.01.
Analyte: Chlorpyrifos (Dursban);
Detection limit (ppm)[A]: 0.01.
Analyte: Chlorpyrifos-methyl;
Detection limit (ppm)[A]: 0.01.
Analyte: Chlorpyrifos-O-analogue;
Detection limit (ppm)[A]: 0.01.
Analyte: cis-Chlordane;
Detection limit (ppm)[A]: 0.01.
Analyte: Clomazone;
Detection limit (ppm)[A]: 0.01.
Analyte: Coumaphos;
Detection limit (ppm)[A]: 0.01.
Analyte: Cyanazine;
Detection limit (ppm)[A]: 0.01.
Analyte: Cyanophos;
Detection limit (ppm)[A]: 0.01.
Analyte: Cycloate/Ro Neet;
Detection limit (ppm)[A]: 0.01.
Analyte: Cycluron;
Detection limit (ppm)[A]: 0.01.
Analyte: Cyhalothrin lambda;
Detection limit (ppm)[A]: 0.01.
Analyte: Cymiazole;
Detection limit (ppm)[A]: 0.01.
Analyte: Cypermethrin;
Detection limit (ppm)[A]: 0.02.
Analyte: Cyproconazole;
Detection limit (ppm)[A]: 0.01.
Analyte: Cyprodinil;
Detection limit (ppm)[A]: 0.01.
Analyte: Dacthal (DCPA);
Detection limit (ppm)[A]: 0.01.
Analyte: DEF;
Detection limit (ppm)[A]: 0.02.
Analyte: delta-BHC;
Detection limit (ppm)[A]: 0.01.
Analyte: Deltamethrin;
Detection limit (ppm)[A]: 0.01.
Analyte: Desmedipham;
Detection limit (ppm)[A]: 0.01.
Analyte: Desmetryn;
Detection limit (ppm)[A]: 0.01.
Analyte: Di-allate;
Detection limit (ppm)[A]: 0.01.
Analyte: Diazinon;
Detection limit (ppm)[A]: 0.01.
Analyte: Diazinon (O Analog);
Detection limit (ppm)[A]: 0.01.
Analyte: Dichlobenil;
Detection limit (ppm)[A]: 0.05.
Analyte: Dicloran;
Detection limit (ppm)[A]: 0.02.
Analyte: Dieldrin;
Detection limit (ppm)[A]: 0.01.
Analyte: Diethofencarb;
Detection limit (ppm)[A]: 0.01.
Analyte: Difenoconazole;
Detection limit (ppm)[A]: 0.01.
Analyte: Dimethachlor;
Detection limit (ppm)[A]: 0.01.
Analyte: Dimethoate;
Detection limit (ppm)[A]: 0.01.
Analyte: Diniconazole;
Detection limit (ppm)[A]: 0.01.
Analyte: Dioxacarb;
Detection limit (ppm)[A]: 0.01.
Analyte: Dioxathion;
Detection limit (ppm)[A]: 0.05.
Analyte: Diphenamid;
Detection limit (ppm)[A]: 0.01.
Analyte: Disulfoton;
Detection limit (ppm)[A]: 0.01.
Analyte: d-Phenothrin;
Detection limit (ppm)[A]: 0.01.
Analyte: Edifenphos;
Detection limit (ppm)[A]: 0.01.
Analyte: Endosulfan I (alpha-endosulfan);
Detection limit (ppm)[A]: 0.01.
Analyte: Endosulfan II (beta-Endosulfan);
Detection limit (ppm)[A]: 0.01.
Analyte: Endosulfan sulphate;
Detection limit (ppm)[A]: 0.01.
Analyte: Endrin;
Detection limit (ppm)[A]: 0.01.
Analyte: EPN;
Detection limit (ppm)[A]: 0.01.
Analyte: Epoxiconazole;
Detection limit (ppm)[A]: 0.01.
Analyte: EPTC/Eptam;
Detection limit (ppm)[A]: 0.01.
Analyte: Esfenvalerate-2;
Detection limit (ppm)[A]: 0.01.
Analyte: Etaconazole;
Detection limit (ppm)[A]: 0.01.
Analyte: Ethafluralin;
Detection limit (ppm)[A]: 0.03.
Analyte: Ethiofencarb;
Detection limit (ppm)[A]: 0.01.
Analyte: Ethiolate;
Detection limit (ppm)[A]: 0.01.
Analyte: Ethion;
Detection limit (ppm)[A]: 0.01.
Analyte: Ethofumesate;
Detection limit (ppm)[A]: 0.01.
Analyte: Ethoprop (Ethoprophos);
Detection limit (ppm)[A]: 0.01.
Analyte: Ethoxyquin;
Detection limit (ppm)[A]: 0.01.
Analyte: Etobenzanid;
Detection limit (ppm)[A]: 0.01.
Analyte: Etofenprox;
Detection limit (ppm)[A]: 0.01.
Analyte: Etridiazole;
Detection limit (ppm)[A]: 0.01.
Analyte: Fenamiphos;
Detection limit (ppm)[A]: 0.01.
Analyte: Fenarimol;
Detection limit (ppm)[A]: 0.01.
Analyte: Fenazaquin;
Detection limit (ppm)[A]: 0.01.
Analyte: Fenbuconazole;
Detection limit (ppm)[A]: 0.01.
Analyte: Fenchlorphos;
Detection limit (ppm)[A]: 0.01.
Analyte: Fenitrothion;
Detection limit (ppm)[A]: 0.02.
Analyte: Fenobucarb;
Detection limit (ppm)[A]: 0.01.
Analyte: Fenoxycarb;
Detection limit (ppm)[A]: 0.01.
Analyte: Fenpropimorph;
Detection limit (ppm)[A]: 0.01.
Analyte: Fenthion;
Detection limit (ppm)[A]: 0.01.
Analyte: Fenvalerate;
Detection limit (ppm)[A]: 0.01.
Analyte: flopet;
Detection limit (ppm)[A]: 0.01.
Analyte: Fluchloralin;
Detection limit (ppm)[A]: 0.04.
Analyte: Flucythrinate (Total Isomers);
Detection limit (ppm)[A]: 0.01.
Analyte: Fludioxonil;
Detection limit (ppm)[A]: 0.01.
Analyte: Flusilazole;
Detection limit (ppm)[A]: 0.01.
Analyte: Flutolanil;
Detection limit (ppm)[A]: 0.01.
Analyte: Fluvalinate;
Detection limit (ppm)[A]: 0.02.
Analyte: Fonofos;
Detection limit (ppm)[A]: 0.01.
Analyte: Gamma-cyhalothrin;
Detection limit (ppm)[A]: 0.01.
Analyte: gamma-HCH (Lindane);
Detection limit (ppm)[A]: 0.01.
Analyte: Heptachlor;
Detection limit (ppm)[A]: 0.01.
Analyte: Heptachlor Epoxide (cis, trans);
Detection limit (ppm)[A]: 0.01.
Analyte: Heptenophos;
Detection limit (ppm)[A]: 0.01.
Analyte: Hexachlorobenzene (HCB);
Detection limit (ppm)[A]: 0.01.
Analyte: Hexaconazole;
Detection limit (ppm)[A]: 0.01.
Analyte: Hexazinone;
Detection limit (ppm)[A]: 0.01.
Analyte: Iprodione;
Detection limit (ppm)[A]: 0.02.
Analyte: Isocarbamid;
Detection limit (ppm)[A]: 0.01.
Analyte: Isofenphos;
Detection limit (ppm)[A]: 0.01.
Analyte: Isoprocarb;
Detection limit (ppm)[A]: 0.01.
Analyte: Isopropalin;
Detection limit (ppm)[A]: 0.01.
Analyte: Isoprothiolane;
Detection limit (ppm)[A]: 0.01.
Analyte: Isoproturon;
Detection limit (ppm)[A]: 0.01.
Analyte: Kresoxim-methyl;
Detection limit (ppm)[A]: 0.01.
Analyte: Lead;
Detection limit (ppm)[A]: 0.005.
Analyte: Lenacil;
Detection limit (ppm)[A]: 0.01.
Analyte: Linuron;
Detection limit (ppm)[A]: 0.01.
Analyte: Malathion;
Detection limit (ppm)[A]: 0.01.
Analyte: Malathion OA (Malaoxon);
Detection limit (ppm)[A]: 0.01.
Analyte: Mercury;
Detection limit (ppm)[A]: 0.05[B].
Analyte: Metalaxyl;
Detection limit (ppm)[A]: 0.01.
Analyte: Methidathion;
Detection limit (ppm)[A]: 0.01.
Analyte: Methiocarb;
Detection limit (ppm)[A]: 0.01.
Analyte: Methoprotryne;
Detection limit (ppm)[A]: 0.01.
Analyte: Methoxychlor, o,o';
Detection limit (ppm)[A]: 0.01.
Analyte: Methoxychlor, p,p';
Detection limit (ppm)[A]: 0.01.
Analyte: Methyl Parathion;
Detection limit (ppm)[A]: 0.02.
Analyte: Metolachlor;
Detection limit (ppm)[A]: 0.01.
Analyte: Metolcarb;
Detection limit (ppm)[A]: 0.01.
Analyte: Metribuzin;
Detection limit (ppm)[A]: 0.01.
Analyte: Mevinphos;
Detection limit (ppm)[A]: 0.01.
Analyte: Mexacarbate;
Detection limit (ppm)[A]: 0.01.
Analyte: MGK-264;
Detection limit (ppm)[A]: 0.01.
Analyte: Mirex;
Detection limit (ppm)[A]: 0.01.
Analyte: Molinate;
Detection limit (ppm)[A]: 0.01.
Analyte: Monocrotophos;
Detection limit (ppm)[A]: 0.01.
Analyte: Monolinuron;
Detection limit (ppm)[A]: 0.01.
Analyte: Myclobutanil;
Detection limit (ppm)[A]: 0.01.
Analyte: Naphthalene Acetamide;
Detection limit (ppm)[A]: 0.01.
Analyte: Napropamide;
Detection limit (ppm)[A]: 0.01.
Analyte: Nitralin;
Detection limit (ppm)[A]: 0.01.
Analyte: Nitrofen;
Detection limit (ppm)[A]: 0.01.
Analyte: Nitrothal-isopropyl;
Detection limit (ppm)[A]: 0.02.
Analyte: nonachlor cis-;
Detection limit (ppm)[A]: 0.01.
Analyte: Nonachlor trans-;
Detection limit (ppm)[A]: 0.01.
Analyte: Norea;
Detection limit (ppm)[A]: 0.02.
Analyte: Nuarimol;
Detection limit (ppm)[A]: 0.01.
Analyte: o,p-DDT;
Detection limit (ppm)[A]: 0.01.
Analyte: o,p-DDE;
Detection limit (ppm)[A]: 0.01.
Analyte: Oxydemeton Methyl Sulfone;
Detection limit (ppm)[A]: 0.05.
Analyte: p,p-DDE;
Detection limit (ppm)[A]: 0.01.
Analyte: p,p-DDT;
Detection limit (ppm)[A]: 0.01.
Analyte: Parathion-ethyl;
Detection limit (ppm)[A]: 0.01.
Analyte: Penconazole;
Detection limit (ppm)[A]: 0.01.
Analyte: Pendimethalin;
Detection limit (ppm)[A]: 0.01.
Analyte: Pentachloroaniline;
Detection limit (ppm)[A]: 0.01.
Analyte: Pentachlorobenzene;
Detection limit (ppm)[A]: 0.01.
Analyte: Pentachlorobenzonitrile;
Detection limit (ppm)[A]: 0.01.
Analyte: Pentachlorothioanisole;
Detection limit (ppm)[A]: 0.01.
Analyte: Permethrin-cis;
Detection limit (ppm)[A]: 0.01.
Analyte: Permethrin-trans;
Detection limit (ppm)[A]: 0.01.
Analyte: Phenmedipham;
Detection limit (ppm)[A]: 0.01.
Analyte: Phorate;
Detection limit (ppm)[A]: 0.01.
Analyte: Phorate-sulfone;
Detection limit (ppm)[A]: 0.02.
Analyte: Phorate-sulfoxide;
Detection limit (ppm)[A]: 0.01.
Analyte: Phosalone;
Detection limit (ppm)[A]: 0.01.
Analyte: Phosmet;
Detection limit (ppm)[A]: 0.01.
Analyte: Pirimicarb;
Detection limit (ppm)[A]: 0.01.
Analyte: Pirimifos-methyl;
Detection limit (ppm)[A]: 0.01.
Analyte: Prochloraz;
Detection limit (ppm)[A]: 0.01.
Analyte: Procymidon;
Detection limit (ppm)[A]: 0.01.
Analyte: Profenofos;
Detection limit (ppm)[A]: 0.01.
Analyte: Profluralin;
Detection limit (ppm)[A]: 0.01.
Analyte: Promecarb;
Detection limit (ppm)[A]: 0.01.
Analyte: Prometon;
Detection limit (ppm)[A]: 0.01.
Analyte: Prometryn;
Detection limit (ppm)[A]: 0.01.
Analyte: Propachlor;
Detection limit (ppm)[A]: 0.01.
Analyte: Propanil;
Detection limit (ppm)[A]: 0.01.
Analyte: Propargite;
Detection limit (ppm)[A]: 0.01.
Analyte: Propham;
Detection limit (ppm)[A]: 0.01.
Analyte: Propiconazole;
Detection limit (ppm)[A]: 0.01.
Analyte: Prothiofos;
Detection limit (ppm)[A]: 0.01.
Analyte: Pyracarbolid;
Detection limit (ppm)[A]: 0.01.
Analyte: Pyrazophos;
Detection limit (ppm)[A]: 0.01.
Analyte: Pyridaphenthion;
Detection limit (ppm)[A]: 0.01.
Analyte: Pyrimethanil;
Detection limit (ppm)[A]: 0.01.
Analyte: Pyriproxyfen;
Detection limit (ppm)[A]: 0.01.
Analyte: Quinalphos;
Detection limit (ppm)[A]: 0.01.
Analyte: Quinoxyfen;
Detection limit (ppm)[A]: 0.01.
Analyte: Quintozene (PCNB);
Detection limit (ppm)[A]: 0.02.
Analyte: Resmethrin;
Detection limit (ppm)[A]: 0.01.
Analyte: S 421 (Octachlordipropylether);
Detection limit (ppm)[A]: 0.02.
Analyte: Sethoxydim;
Detection limit (ppm)[A]: 0.02.
Analyte: Simazine;
Detection limit (ppm)[A]: 0.01.
Analyte: Simetryn;
Detection limit (ppm)[A]: 0.01.
Analyte: Sulfotep;
Detection limit (ppm)[A]: 0.01.
Analyte: Sulprofos;
Detection limit (ppm)[A]: 0.01.
Analyte: Tebuconazole;
Detection limit (ppm)[A]: 0.01.
Analyte: Tebufenpyrad;
Detection limit (ppm)[A]: 0.01.
Analyte: Tebutam;
Detection limit (ppm)[A]: 0.01.
Analyte: Tebuthiuron;
Detection limit (ppm)[A]: 0.01.
Analyte: Tecnazene;
Detection limit (ppm)[A]: 0.01.
Analyte: Terbufos;
Detection limit (ppm)[A]: 0.01.
Analyte: Terbumeton;
Detection limit (ppm)[A]: 0.01.
Analyte: Terbuthylazine;
Detection limit (ppm)[A]: 0.01.
Analyte: Terbutryn;
Detection limit (ppm)[A]: 0.01.
Analyte: Tetrachloroaniline, 2,3,4,6-;
Detection limit (ppm)[A]: 0.01.
Analyte: Tetrachlorvinphos;
Detection limit (ppm)[A]: 0.01.
Analyte: Tetraconazole;
Detection limit (ppm)[A]: 0.01.
Analyte: Tetradifon;
Detection limit (ppm)[A]: 0.01.
Analyte: Tetramethrin;
Detection limit (ppm)[A]: 0.01.
Analyte: Thiabendazole;
Detection limit (ppm)[A]: 0.01.
Analyte: Tolclofos-methyl;
Detection limit (ppm)[A]: 0.01.
Analyte: Tolylfluanid;
Detection limit (ppm)[A]: 0.01.
Analyte: Tralkoxydim;
Detection limit (ppm)[A]: 0.05.
Analyte: trans-Chlordane;
Detection limit (ppm)[A]: 0.01.
Analyte: Triadimefon;
Detection limit (ppm)[A]: 0.01.
Analyte: Triadimenol;
Detection limit (ppm)[A]: 0.01.
Analyte: Triallate;
Detection limit (ppm)[A]: 0.01.
Analyte: Triazophos;
Detection limit (ppm)[A]: 0.01.
Analyte: Tricyclazol;
Detection limit (ppm)[A]: 0.01.
Analyte: Trifloxystrobin;
Detection limit (ppm)[A]: 0.01.
Analyte: Triflumizole;
Detection limit (ppm)[A]: 0.01.
Analyte: Trifluralin;
Detection limit (ppm)[A]: 0.01.
Analyte: Trimethacarb 2.3.5-;
Detection limit (ppm)[A]: 0.01.
Analyte: Trimethacarb 3.4.5-;
Detection limit (ppm)[A]: 0.01.
Analyte: Triticonazole;
Detection limit (ppm)[A]: 0.01.
Analyte: Vinclozolin;
Detection limit (ppm)[A]: 0.02.
Source: GAO, based on laboratory methodology.
[A] Parts per million is a measure equivalent to milligrams per
kilogram or milligrams per liter.
[B] Mercury results appear as parts per billion.
[End of table]
[End of section]
Appendix III: Contaminants Found in Selected Herbal Dietary
Supplements (in Parts per Million):
Sample: 1;
Herb: Saw palmetto;
Arsenic[A,B]: nd;
Cadmium[A,B]: 0.011;
Lead[A,B]: 0.024;
Mercury[B,C]: 1.210;
Number of pesticides[D]: 0.
Sample: 2;
Herb: Echinacea;
Arsenic[A,B]: 0.090;
Cadmium[A,B]: 0.348;
Lead[A,B]: 0.106;
Mercury[B,C]: 1.170;
Number of pesticides[D]: 0.
Sample: 3;
Herb: Echinacea;
Arsenic[A,B]: 0.093;
Cadmium[A,B]: 0.030;
Lead[A,B]: 0.043;
Mercury[B,C]: nd;
Number of pesticides[D]: 0.
Sample: 4;
Herb: Echinacea;
Arsenic[A,B]: 0.226;
Cadmium[A,B]: 0.069;
Lead[A,B]: 1.290;
Mercury[B,C]: 6.960;
Number of pesticides[D]: 1.
Sample: 5;
Herb: St. John's wort;
Arsenic[A,B]: 0.391;
Cadmium[A,B]: 0.090;
Lead[A,B]: 0.353;
Mercury[B,C]: 0.980;
Number of pesticides[D]: 2.
Sample: 6;
Herb: St. John's wort;
Arsenic[A,B]: 0.153;
Cadmium[A,B]: 0.033;
Lead[A,B]: 0.587;
Mercury[B,C]: 2.330;
Number of pesticides[D]: 0.
Sample: 7;
Herb: Ginkgo biloba;
Arsenic[A,B]: nd;
Cadmium[A,B]: nd;
Lead[A,B]: 0.564;
Mercury[B,C]: 1.340;
Number of pesticides[D]: 1.
Sample: 8;
Herb: Garlic;
Arsenic[A,B]: nd;
Cadmium[A,B]: nd;
Lead[A,B]: 0.046;
Mercury[B,C]: 0.810;
Number of pesticides[D]: 1.
Sample: 9;
Herb: Ginkgo biloba;
Arsenic[A,B]: 0.151;
Cadmium[A,B]: nd;
Lead[A,B]: 0.036;
Mercury[B,C]: 1.480;
Number of pesticides[D]: 2.
Sample: 10;
Herb: Ginkgo biloba;
Arsenic[A,B]: 0.162;
Cadmium[A,B]: 0.017;
Lead[A,B]: 0.037;
Mercury[B,C]: 3.420;
Number of pesticides[D]: 1.
Sample: 11;
Herb: Garlic;
Arsenic[A,B]: nd;
Cadmium[A,B]: 0.026;
Lead[A,B]: 0.026;
Mercury[B,C]: 0.620;
Number of pesticides[D]: 2.
Sample: 12;
Herb: Ginseng;
Arsenic[A,B]: 0.123;
Cadmium[A,B]: 0.057;
Lead[A,B]: 0.126;
Mercury[B,C]: 10.700;
Number of pesticides[D]: 5.
Sample: 13;
Herb: Peppermint;
Arsenic[A,B]: nd;
Cadmium[A,B]: nd;
Lead[A,B]: 0.007;
Mercury[B,C]: 2.170;
Number of pesticides[D]: 1.
Sample: 14;
Herb: Saw palmetto;
Arsenic[A,B]: nd;
Cadmium[A,B]: nd;
Lead[A,B]: 0.011;
Mercury[B,C]: nd;
Number of pesticides[D]: 0.
Sample: 15;
Herb: Echinacea;
Arsenic[A,B]: 0.116;
Cadmium[A,B]: 0.016;
Lead[A,B]: 0.109;
Mercury[B,C]: 4.110;
Number of pesticides[D]: 0.
Sample: 16;
Herb: Ginkgo biloba;
Arsenic[A,B]: 0.222;
Cadmium[A,B]: 0.030;
Lead[A,B]: 0.112;
Mercury[B,C]: 6.090;
Number of pesticides[D]: 0.
Sample: 17;
Herb: Garlic;
Arsenic[A,B]: nd;
Cadmium[A,B]: 0.040;
Lead[A,B]: 0.029;
Mercury[B,C]: 1.090;
Number of pesticides[D]: 0.
Sample: 18;
Herb: Saw palmetto;
Arsenic[A,B]: nd;
Cadmium[A,B]: nd;
Lead[A,B]: 0.026;
Mercury[B,C]: nd;
Number of pesticides[D]: 0.
Sample: 19;
Herb: St. John's wort;
Arsenic[A,B]: nd;
Cadmium[A,B]: 0.011;
Lead[A,B]: 0.026;
Mercury[B,C]: 0.860;
Number of pesticides[D]: 3.
Sample: 20;
Herb: Ginseng;
Arsenic[A,B]: 0.078;
Cadmium[A,B]: 0.127;
Lead[A,B]: 0.439;
Mercury[B,C]: 1.510;
Number of pesticides[D]: 0.
Sample: 21;
Herb: Garlic;
Arsenic[A,B]: nd;
Cadmium[A,B]: 0.062;
Lead[A,B]: 0.030;
Mercury[B,C]: 0.640;
Number of pesticides[D]: 0.
Sample: 22;
Herb: Chamomile;
Arsenic[A,B]: nd;
Cadmium[A,B]: 0.375;
Lead[A,B]: 0.049;
Mercury[B,C]: 2.900;
Number of pesticides[D]: 0.
Sample: 23;
Herb: Chamomile;
Arsenic[A,B]: 0.094;
Cadmium[A,B]: 0.146;
Lead[A,B]: 0.375;
Mercury[B,C]: 2.420;
Number of pesticides[D]: 4.
Sample: 24;
Herb: Peppermint;
Arsenic[A,B]: nd;
Cadmium[A,B]: nd;
Lead[A,B]: nd;
Mercury[B,C]: nd;
Number of pesticides[D]: 0.
Sample: 25;
Herb: Chamomile;
Arsenic[A,B]: nd;
Cadmium[A,B]: nd;
Lead[A,B]: nd;
Mercury[B,C]: nd;
Number of pesticides[D]: 0.
Sample: 26;
Herb: Chamomile;
Arsenic[A,B]: nd;
Cadmium[A,B]: nd;
Lead[A,B]: nd;
Mercury[B,C]: nd;
Number of pesticides[D]: 0.
Sample: 27;
Herb: St. John's wort;
Arsenic[A,B]: 0.155;
Cadmium[A,B]: 0.054;
Lead[A,B]: 0.111;
Mercury[B,C]: 0.530;
Number of pesticides[D]: 0.
Sample: 28;
Herb: Garlic;
Arsenic[A,B]: nd;
Cadmium[A,B]: 0.050;
Lead[A,B]: 0.305;
Mercury[B,C]: 0.780;
Number of pesticides[D]: 0.
Sample: 29;
Herb: St. John's wort;
Arsenic[A,B]: 0.180;
Cadmium[A,B]: 0.062;
Lead[A,B]: 0.148;
Mercury[B,C]: 0.760;
Number of pesticides[D]: 2.
Sample: 30;
Herb: Peppermint;
Arsenic[A,B]: nd;
Cadmium[A,B]: nd;
Lead[A,B]: 0.023;
Mercury[B,C]: nd;
Number of pesticides[D]: 1.
Sample: 31;
Herb: Chamomile;
Arsenic[A,B]: 0.286;
Cadmium[A,B]: 0.058;
Lead[A,B]: 0.802;
Mercury[B,C]: 4.260;
Number of pesticides[D]: 0.
Sample: 32;
Herb: Ginkgo biloba;
Arsenic[A,B]: 0.524;
Cadmium[A,B]: 0.054;
Lead[A,B]: 0.487;
Mercury[B,C]: 77.800;
Number of pesticides[D]: 2.
Sample: 33;
Herb: Ginseng;
Arsenic[A,B]: 0.229;
Cadmium[A,B]: 0.105;
Lead[A,B]: 1.290;
Mercury[B,C]: 32.900;
Number of pesticides[D]: 6.
Sample: 34;
Herb: Ginseng;
Arsenic[A,B]: 0.172;
Cadmium[A,B]: nd;
Lead[A,B]: 0.032;
Mercury[B,C]: 2.110;
Number of pesticides[D]: 2.
Sample: 35;
Herb: Ginseng;
Arsenic[A,B]: 0.154;
Cadmium[A,B]: 0.156;
Lead[A,B]: 0.408;
Mercury[B,C]: 5.990;
Number of pesticides[D]: 3.
Sample: 36;
Herb: Saw palmetto;
Arsenic[A,B]: nd;
Cadmium[A,B]: nd;
Lead[A,B]: 0.008;
Mercury[B,C]: 1.100;
Number of pesticides[D]: 0.
Sample: 37;
Herb: Saw palmetto;
Arsenic[A,B]: nd;
Cadmium[A,B]: 0.012;
Lead[A,B]: 0.125;
Mercury[B,C]: 1.710;
Number of pesticides[D]: 0.
Sample: 38;
Herb: St. John's wort;
Arsenic[A,B]: nd;
Cadmium[A,B]: 1.150;
Lead[A,B]: 0.138;
Mercury[B,C]: 3.000;
Number of pesticides[D]: 0.
Sample: 39;
Herb: Echinacea;
Arsenic[A,B]: 0.152;
Cadmium[A,B]: 0.032;
Lead[A,B]: 0.649;
Mercury[B,C]: 6.930;
Number of pesticides[D]: 0.
Sample: 40;
Herb: Ginkgo biloba;
Arsenic[A,B]: 0.115;
Cadmium[A,B]: 0.025;
Lead[A,B]: 0.061;
Mercury[B,C]: nd;
Number of pesticides[D]: 2.
Source: GAO, based on laboratory analysis.
[A] Parts per million is a measure equivalent to milligrams per
kilogram or milligrams per liter.
[B] Results marked as "nd" indicate that the contaminant was not
detected in excess of the underlying tests' detection limit (.075
mg/kg for arsenic, .010 mg/kg for cadmium, .005 mg/kg for lead, and
.050 ng/g for mercury). A result of "nd" does not mean that a
contaminant does not exist in a sample. It means that if a contaminant
is in the product, it appears at a level below the detection limit for
that particular test method.
[C] Mercury results appear as parts per billion, a measure equivalent
to nanograms per gram or nanograms per milliliter.
[D] For additional details on pesticide residues found, see appendix
IV.
[End of table]
[End of section]
Appendix IV: Pesticide Residues Identified in Selected Herbal Dietary
Supplements (in Parts per Million):
Sample no.: 4[A];
Herb: Echinacea;
Pesticide residue: Chlorpyrifos (Dursban);
Detected level: 0.01.
Sample no.: 5[A];
Herb: St. John's wort;
Pesticide residue: Amitraz;
Detected level: 0.05.
Sample no.: 5[A];
Herb: St. John's wort;
Pesticide residue: Propargite;
Detected level: 0.04.
Sample no.: 7[A];
Herb: Ginkgo biloba;
Pesticide residue: Phorate-sulfoxide;
Detected level: 0.06.
Sample no.: 8[A];
Herb: Garlic;
Pesticide residue: Triadimenol;
Detected level: 0.03.
Sample no.: 9[A];
Herb: Ginkgo biloba;
Pesticide residue: Phorate-sulfoxide;
Detected level: 0.10.
Sample no.: 9[A];
Herb: Ginkgo biloba;
Pesticide residue: Triadimenol;
Detected level: 0.26.
Sample no.: 10[A];
Herb: Ginkgo biloba;
Pesticide residue: Phorate-sulfoxide;
Detected level: 0.06.
Sample no.: 11[A];
Herb: Garlic;
Pesticide residue: Carbofuran;
Detected level: 0.04.
Sample no.: 11[A];
Herb: Garlic;
Pesticide residue: gamma-HCH (Lindane);
Detected level: 0.08.
Sample no.: 12[A];
Herb: Ginseng;
Pesticide residue: Azoxystrobin[B];
Detected level: 0.02.
Sample no.: 12[A];
Herb: Ginseng;
Pesticide residue: Difenoconazole;
Detected level: 0.02.
Sample no.: 12[A];
Herb: Ginseng;
Pesticide residue: Flutolanil;
Detected level: 0.03.
Sample no.: 12[A];
Herb: Ginseng;
Pesticide residue: Tebuconazole;
Detected level: 0.02.
Sample no.: 12[A];
Herb: Ginseng;
Pesticide residue: Tolclofos-methyl;
Detected level: 0.05.
Sample no.: 13;
Herb: Peppermint;
Pesticide residue: Propargite[B];
Detected level: 0.16.
Sample no.: 19[A];
Herb: St. John's wort;
Pesticide residue: Azoxystrobin;
Detected level: 0.01.
Sample no.: 19[A];
Herb: St. John's wort;
Pesticide residue: Chlorpyrifos (Dursban);
Detected level: 0.01.
Sample no.: 19[A];
Herb: St. John's wort;
Pesticide residue: Hexazinone;
Detected level: 0.06.
Sample no.: 23[A];
Herb: Chamomile;
Pesticide residue: Flusilazole;
Detected level: 0.01.
Sample no.: 23[A];
Herb: Chamomile;
Pesticide residue: Metolachlor;
Detected level: 0.02.
Sample no.: 23[A];
Herb: Chamomile;
Pesticide residue: Tebuconazole;
Detected level: 0.04.
Sample no.: 23[A];
Herb: Chamomile;
Pesticide residue: Trifloxystrobin;
Detected level: 0.01.
Sample no.: 29[A];
Herb: St. John's wort;
Pesticide residue: Amitraz;
Detected level: 0.06.
Sample no.: 29[A];
Herb: St. John's wort;
Pesticide residue: Triadimefon;
Detected level: 0.02.
Sample no.: 30;
Herb: Peppermint;
Pesticide residue: Propargite[B];
Detected level: 0.62.
Sample no.: 32[A];
Herb: Ginkgo biloba;
Pesticide residue: Phorate-sulfoxide;
Detected level: 0.01.
Sample no.: 32[A];
Herb: Ginkgo biloba;
Pesticide residue: Triadimenol;
Detected level: 0.06.
Sample no.: 33[A];
Herb: Ginseng;
Pesticide residue: Hexachlorobenzene (HCB);
Detected level: 0.02.
Sample no.: 33[A];
Herb: Ginseng;
Pesticide residue: Metalaxyl[B];
Detected level: 0.01.
Sample no.: 33[A];
Herb: Ginseng;
Pesticide residue: p,p-DDE;
Detected level: 0.02.
Sample no.: 33[A];
Herb: Ginseng;
Pesticide residue: Pentachloroaniline;
Detected level: 0.28.
Sample no.: 33[A];
Herb: Ginseng;
Pesticide residue: Pentachlorothioanisole;
Detected level: 0.05.
Sample no.: 33[A];
Herb: Ginseng;
Pesticide residue: Pyrimethanil;
Detected level: 0.03.
Sample no.: 34[A];
Herb: Ginseng;
Pesticide residue: Metalaxyl[B];
Detected level: 0.03.
Sample no.: 34[A];
Herb: Ginseng;
Pesticide residue: Propiconazole;
Detected level: 0.02.
Sample no.: 35[A];
Herb: Ginseng;
Pesticide residue: Azoxystrobin[B];
Detected level: 0.03.
Sample no.: 35[A];
Herb: Ginseng;
Pesticide residue: Dacthal (DCPA)[B];
Detected level: 0.07.
Sample no.: 35[A];
Herb: Ginseng;
Pesticide residue: Pyrimethanil;
Detected level: 0.11.
Sample no.: 40[A];
Herb: Ginkgo biloba;
Pesticide residue: Phorate-sulfoxide;
Detected level: 0.01.
Sample no.: 40[A];
Herb: Ginkgo biloba;
Pesticide residue: Triadimenol;
Detected level: 0.10.
Source: GAO, based on laboratory analysis.
[A] Product would be considered in violation of U.S. pesticide
tolerances, should these results be confirmed.
[B] Pesticide residue detected is not considered, by the Food and Drug
Administration, to be of regulatory significance.
[End of table]
[End of section]
Footnotes:
[1] For purposes of this testimony, we defined elderly as people 65
years of age and older.
[2] Pub. L. No. 103-417, § 3, 108 Stat. 4325, 4327 (codified at 21
U.S.C. § 321(ff)).
[3] Herbal supplements are one type of dietary supplement. An herb is
a plant or plant part (such as leaves, flowers, or seeds) that is used
for its flavor, scent, therapeutic properties, or a combination of
these. "Botanical" is often used as a synonym for "herb." An herbal
supplement may contain a single herb or mixtures of herbs.
[4] 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).
[5] GAO, Dietary Supplements: FDA Should Take Further Actions to
Improve Oversight and Consumer Understanding, [hyperlink,
http://www.gao.gov/products/GAO-09-250] (Washington, D.C.: Jan. 29,
2009).
[6] Our findings are limited to the individual retailers and sales
staff we investigated. Our findings cannot be projected to any other
retailers or sales representatives.
[7] FDA does not require that herbal supplement manufacturers conduct
such testing.
[8] For the products reviewed as part of this testimony, most of the
dietary ingredients involved were marketed prior to October 15, 1994,
and therefore were not subject to the "new dietary ingredient"
approval requirement.
[9] 21 U.S.C. § 342(g) and 21 C.F.R. §§ 111.1 - .610
[10] 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. (Pub. L. No. 109-462, § 3(a),120 Stat. 3469,
3472 (codified at 21 U.S.C. § 379aa-1)). 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.
[11] Labeling refers to the label as well as accompanying material
that is used by a manufacturer to promote and market a specific
product.
[12] FDA authorizes these types of health claims under the Nutrition
Labeling and Education Act of 1990 (Pub. L. No. 101-535, § 3(a), 104
Stat. 2353, 2357-60 (codified at 21 U.S.C. § 321(r))) based on
extensive review of the scientific literature, generally as a result
of the submission of a health claim petition, using the significant
scientific agreement standard to determine that the nutrient/disease
relationship is well established.
[13] A manufacturer may, alternately, obtain FDA approval to market
its product as a drug intended for the treatment, prevention, cure,
mitigation, or diagnosis of a specific disease.
[14] Dietary supplement labeling may contain nutrient content claims,
which describe the level of a nutrient or dietary substance in the
product using terms such as "free," "high," and "low," or compare the
level of a nutrient in a food to that of another food, using terms
such as "more," "reduced," and "lite."
[15] The constitutionality of some of FDA's health claim regulations
for dietary supplements have been successfully challenged in court. In
Pearson v. Shalala, 164 F.3d 650 (DC Cir. 1999), the United States
Court of Appeals for the District of Columbia Circuit held that while
inherently or actually misleading information could be absolutely
prohibited, the First Amendment did not permit such a restriction on
information that is only potentially misleading. The determination of
whether regulation of potentially misleading information is
permissible instead requires an analysis of the level of government
interest, the potential advancement of the government interest by the
regulation, and the reasonableness of the means chosen to accomplish
the government's goals.
[16] FDA receives approximately 4,000 such claims submissions per year
for one or more claims for one or more products.
[17] FDA defines a disease as "damage to an organ, part, structure, or
system of the body such that it does not function properly (e.g.,
cardiovascular disease), or a state of health leading to such
dysfunctioning (e.g., hypertension); except that diseases resulting
from essential nutrient deficiencies (e.g., scurvy, pellagra) are not
included in this definition."
[18] Some natural states or processes such as aging, menopause, and
the menstrual cycle, are not themselves diseases but can be associated
with abnormal conditions that are diseases. Two criteria determine if
such a condition will be considered a disease: (1) if the condition is
uncommon or (2) if the condition can cause significant or permanent
harm.
[19] Our results are limited by the tests performed. Since we only
tested a single bottle of each sample, our results cannot be projected
beyond the single bottle tested. Our results also cannot be projected
to any other products from the same manufacturers.
[20] Different forms of mercury have distinctly different adverse
effects. The tests we performed to identify mercury levels in
supplements do not differentiate between these different forms of
mercury.
[21] EPA canceled all registrations of carbofuran, gamma-HCH
(Lindane), and dichlorodiphenyltrichloroethane (DDT), the parent
chemical of p,p-DDE. As of December 31, 2009, all related residue
tolerances had been revoked. Tolclofos-methyl has never had a U.S.
registration, but it is approved for use in other countries.
[22] Discussions with these manufacturers were limited to their
manufacturing and quality control processes. We did not question these
manufacturers regarding the marketing of their products.
[23] Our findings are limited to the individual retailers and sales
staff we investigated. Our findings cannot be projected to any other
retailers or sales representatives.
[End of section]
GAO's Mission:
The Government Accountability Office, the audit, evaluation and
investigative arm of Congress, exists to support Congress in meeting
its constitutional responsibilities and to help improve the performance
and accountability of the federal government for the American people.
GAO examines the use of public funds; evaluates federal programs and
policies; and provides analyses, recommendations, and other assistance
to help Congress make informed oversight, policy, and funding
decisions. GAO's commitment to good government is reflected in its core
values of accountability, integrity, and reliability.
Obtaining Copies of GAO Reports and Testimony:
The fastest and easiest way to obtain copies of GAO documents at no
cost is through GAO's Web site [hyperlink, http://www.gao.gov]. Each
weekday, GAO posts newly released reports, testimony, and
correspondence on its Web site. To have GAO e-mail you a list of newly
posted products every afternoon, go to [hyperlink, http://www.gao.gov]
and select "E-mail Updates."
Order by Phone:
The price of each GAO publication reflects GAO‘s actual cost of
production and distribution and depends on the number of pages in the
publication and whether the publication is printed in color or black and
white. Pricing and ordering information is posted on GAO‘s Web site,
[hyperlink, http://www.gao.gov/ordering.htm].
Place orders by calling (202) 512-6000, toll free (866) 801-7077, or
TDD (202) 512-2537.
Orders may be paid for using American Express, Discover Card,
MasterCard, Visa, check, or money order. Call for additional
information.
To Report Fraud, Waste, and Abuse in Federal Programs:
Contact:
Web site: [hyperlink, http://www.gao.gov/fraudnet/fraudnet.htm]:
E-mail: fraudnet@gao.gov:
Automated answering system: (800) 424-5454 or (202) 512-7470:
Congressional Relations:
Ralph Dawn, Managing Director, dawnr@gao.gov:
(202) 512-4400:
U.S. Government Accountability Office:
441 G Street NW, Room 7125:
Washington, D.C. 20548:
Public Affairs:
Chuck Young, Managing Director, youngc1@gao.gov:
(202) 512-4800:
U.S. Government Accountability Office:
441 G Street NW, Room 7149:
Washington, D.C. 20548:
