The Department of Health and Human Services Office of Inspector General released two reports (see here and here) critical of dietary supplements in the weight loss and immune support categories. OIG focused on those categories because they were reported by experts to be among the most popular. (Perhaps not coincidentally, products marketed in the weight loss and immune support categories have also been of keen interest to the FTC.)
The first report focused on compliance with substantiation and notification requirements for structure/function claims, and concluded as follows:
Overall, substantiation documents for the sampled supplements were inconsistent with FDA guidance on competent and reliable scientific evidence. FDA could not readily determine whether manufacturers had submitted the required notification for their claims. Seven percent of the supplements lacked the required disclaimer, and 20 percent included prohibited disease claims on their labels. These results raise questions about the extent to which structure/function claims are truthful and not misleading.
Based on those conclusions, OIG recommended that FDA “seek explicit statutory authority to review” structure/function claim substantiation, improve its notification system, and “expand market surveillance.” FDA generally agreed with the latter two recommendations. As for seeking an expansion of its authority, FDA agreed to consider the matter, but noted that “certain aspects of the OIG’s recommendation could place considerable demands on FDA’s resources” – likely an understatement of the burden FDA would be taking on if it were saddled with a mandate to review substantiation for structure/function claims.
Although the report acknowledges that manufacturers have a statutory obligation to substantiate their claims, it implies that the obligation has little meaning because FDA’s interpretation of the substantiation standard is set forth in guidance, and not in a regulation (“Manufacturers must have competent and reliable scientific evidence to show that claims are truthful and not misleading, but they do not have to submit the substantiation to FDA, and FDA has only voluntary standards for it.”) This will come as news to manufacturers who have been subjected to enforcement action based on FDA interpretations of the FDC Act articulated in guidance.
In addition, the report states that “[d]ietary supplement manufacturers must notify FDA of any structure/function claims no later than 30 days after first introducing a product into the market” (emphasis added). However, this firm submitted a citizen petition to FDA in February 2000 (Docket No. 1998N-0044) challenging this very interpretation of the structure/function claim notification provision in the FDC Act as overbroad and directly contradicted by the language of the statute. That petition is still pending.
The second OIG report focused on compliance with requirements for facility registration and inclusion of adverse event reporting information on product labels. That report concluded as follows:
Twenty-eight percent of contacted companies had facilities that failed to register with FDA as required. Of the companies with facilities that did register, 72 percent failed to provide the complete and accurate information required in the registry. Finally, 20 percent of dietary supplement labels in our sample did not provide the required telephone numbers or addresses.
Based on those conclusions, OIG recommended that FDA improve the accuracy of the registration database, educate industry about the applicable requirements, and “seek authority to impose civil monetary penalties on companies that do not comply with registration requirements.” FDA generally agreed with OIG’s recommendations. However, FDA noted that Congress is unlikely to provide FDA with authority to impose civil monetary penalties given that those penalties were excluded from the Food Safety Modernization Act.