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FDA Regulation: Compliance by Dietary Supplement and Conventional Food Establishments

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Report Type Reports and Testimonies
Report Date June 13, 1994
Report No. HEHS-94-134
Subject
Summary:

The Food and Drug Administration (FDA) regulates dietary supplements, which include vitamins, proteins, herbs, and fish oils, on a case-by-case basis, generally responding to complaints or other information on health risks. It takes action only when it is concerned about a product's safety or labeling. The frequency of inspections at dietary supplement establishments is somewhat less when compared with conventional food establishments. FDA takes official enforcement actions against dietary supplement establishments almost twice as often because FDA finds that they violate the regulations more often. FDA does not maintain data on the costs that dietary supplement establishments incur to comply with FDA regulations. However, limited cost data provided to GAO from dietary supplement establishments show that such establishments incur a wide range of costs. Finally, GAO found that the resources FDA uses to regulate the dietary supplement industry represent a small percentage of its total workforce.

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