Food Safety

To what extent do agencies' efforts and federal laws ensure the (1) safety of functional foods and dietary supplements and (2) the accuracy of health-related claims on product labels and in advertising? GAO found that FDA's efforts and federal laws provide limited assurances of the safety of functional foods and dietary supplements. Weaknesses in three areas increase the likelihood of such occurrences. First, potentially unsafe products can reach consumers for various reasons, such as the lack of clearly defined safety standards for new ingredients in dietary supplements. Second, some products lack safety information on their labels, such as warnings about drug interactions. Third, FDA cannot accurately assess whether a functional food or dietary supplement is harming consumers' health because it does not investigate most reports of health problems potentially caused by these products. FDA officials say a lack of resources has precluded them from taking actions to correct these weaknesses. GAO found that agencies' efforts and federal laws concerning health-related claims on product labels and in advertising provide limited assistance to consumers and do little to protect them against inaccurate or misleading claims.

GAO noted that: (1) the Food and Drug Administration's (FDA) efforts and federal laws provide limited assurances of the safety of functional foods and dietary supplements; (2) while the extent to which unsafe products reach consumers is unknown, GAO believes weaknesses in three areas of the regulatory system increase the likelihood of such occurrences; (3) potentially unsafe products may reach consumers for a variety of reasons, including the lack of a clearly defined safety standard for new dietary ingredients in dietary supplements; (4) some products do not have safety-related information on their labels, which could endanger some consumers; (4) this occurs because FDA has not issued regulations or guidance on the information required; (5) FDA cannot effectively assess whether a functional food or dietary supplement is adversely affecting consumers' health because, among other things, it does not investigate most reports it receives of health problems potentially caused by these products; (6) FDA officials recognize these weaknesses but say a lack of resources has precluded them from taking actions to correct them; (6) GAO also found that agencies' efforts and federal laws concerning health-related claims on product labels and in advertising provide limited assistance to consumers in making informed choices and do little to protect them against inaccurate and misleading claims; (7) FDA has not clearly established the nature and extent of evidence companies need to adequately support structure/function claims and has taken no actions against companies making claims that the agency believes to be questionable; (8) according to a FDA official, the agency has chosen to use its limited resources on regulating product safety rather than on taking enforcement actions against problematic label claims; (9) furthermore, federal agencies operate under different statutes for regulating claims on product labels and in advertising, which has led to claims being made in products' advertisements that were not allowed on product labels; (10) for example, a product that FDA does not allow to claim to lower cholesterol on its label is permitted by the Federal Trade Commission to make this claim in its advertising, provided the claim is truthful, not misleading, and supported by reliable scientific evidence; (11) consumers may not understand the different purposes of health claims and structure/function claims; and (12) as a result, they may incorrectly view structure/function claims as claims to reduce the risk of or treat a disease.

Recommendations

Our 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.

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