United States Government Publishing Office publisher pbl distributor dst United States Government Accountability Office Resources, Community, and Economic Development Division author aut Government Organization text government publication eng GAOREPORTS Legislative Agency Publications gao legislative 2010-08-12 U.S. Government Printing Office 2000-07-11 monographic deposited born digital 47 p. GA 1.13:RCED-00-156 https://www.govinfo.gov/app/details/GAOREPORTS-RCED-00-156 P0b002ee180386e98 f:rc00156 DGPO 2010-08-12 2011-03-23 GAOREPORTS-RCED-00-156 machine generated eng fdlp REPORT GAOREPORTS-RCED-00-156 RCED-00-156 Product safety Health hazards Safety standards Safety regulation Advertising Consumer protection Labeling law Food and drug law Food industry Letter Report RCED GAO examined the extent to which agencies' efforts and federal laws ensure the: (1) safety of functional foods and dietary supplements; and (2) accuracy of health-related claims on product labels and in advertising.<p/>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) first, 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 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. https://www.govinfo.gov/content/pkg/GAOREPORTS-RCED-00-156/html/GAOREPORTS-RCED-00-156.htm https://www.govinfo.gov/content/pkg/GAOREPORTS-RCED-00-156/pdf/GAOREPORTS-RCED-00-156.pdf GAO/RCED-00-156 https://www.govinfo.gov/app/details/GAOREPORTS-RCED-00-156 Letter Report GAO/RCED-00-156; Food Safety: Improvements Needed in Overseeing the Safety; Product safety Health hazards Safety standards Safety regulation Advertising Consumer protection Labeling law Food and drug law Food industry