FDA Regulation

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.

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.