FDA Regulation of Dietary Supplements

HRD-93-28R: Published: Jul 2, 1993. Publicly Released: Jul 2, 1993.

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Pursuant to a legislative requirement, GAO reviewed the Food and Drug Administration's (FDA) management activities related to the regulation of dietary supplements. GAO noted that: (1) although FDA has the authority to regulate dietary supplements to ensure that they are safe and not misleading, it does not regulate dietary supplements in the same manner as food additives or other products unless there is concern over public health safety or misbranding; (2) FDA inspects alleged dietary supplement violations on a case-by-case basis rather than scheduling routine periodic inspections of dietary companies; (3) of the 290 enforcement actions FDA initiated against dietary supplement manufacturers and marketers between 1989 and 1992, 250 were a result of product mislabeling and the remainder were a result of product safety violations; (4) FDA allocation of resources for dietary supplement actions is determined by the information it receives about problem products and its public health risk assessment; and (5) between 1988 and 1992, FDA estimated that the resources expended to address reported problems ranged from 13 to 57 full-time-equivalent employees.

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