FDA Regulation:

Compliance by Dietary Supplement and Conventional Food Establishments

HEHS-94-134: Published: Jun 13, 1994. Publicly Released: Jun 13, 1994.

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Pursuant to a congressional requirement, GAO reviewed the Food and Drug Administration's (FDA) oversight of the dietary supplement industry.

GAO found that: (1) FDA regulates dietary supplements on a case-by-case basis, generally responding to complaints or other information regarding health risks, and takes action only when it has a concern about a product's safety or labeling; (2) the frequency of inspections at dietary supplement establishments is somewhat less when compared with conventional food establishments; (3) FDA takes official enforcement actions against dietary supplement establishments more often because they are more frequently in violation of safety regulations; (4) although FDA does not maintain data on the costs that dietary supplement establishments incur to comply with FDA regulations, data from dietary supplement establishments show that they incur a wide range of costs; and (5) FDA uses a small percentage of its resources to regulate the dietary supplement industry.

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