2012 could have had a profound impact on the dietary supplement industry with the possibility of a new president, the resultant changes at FDA and FTC associated with a new administration, as well as the possibility of mandatory GMO labeling in the largest U.S. market as the result of California’s Proposition 37. However, with the re-election of President Obama and the defeat of Proposition 37, the regulatory landscape for dietary supplements in 2013 will probably not be that much different than it was in 2012.
In addition to the re-election of President Obama and the defeat of Proposition 37, the past year also saw the implementation of the Food Safety Modernization Act (FSMA). The FSMA requires all domestic and foreign food facilities to renew their food facility registrations with the FDA between October 1st and December 31st, beginning in 2012 and continuing thereafter each even-numbered year.
Additionally, we have seen, and expect the trend to continue, increasing numbers of inspections of dietary supplement companies and manufacturers by the FDA to ensure they are complying with the GMPs (Good Manufacturing Practices) as set forth in 21 CFR 111. Unfortunately, the FDA is reporting that only 27% of companies have passed inspection. The FDA has aggressively begun to seek injunctions to stop manufacturing operations against those manufacturers that fail to comply with the GMPs and the FDA has also been seizing adulterated products. With regard to GMP compliance, the FDA has stated that its number one concern is the failure of companies to do basic identity testing on raw materials to confirm the raw materials are what they purport to be. The most common violation reported by the FDA is the failure by manufacturers to have the necessary quality control processes in place. The past year has also brought a corresponding increase in import detentions at the border for dietary supplements and raw materials that are mislabeled, misbranded, or suspected of adulteration.
Hopefully, 2013 brings a new NDI Draft Guidance and a final guidance from FDA on Factors that Distinguish Liquid Supplements from Beverages. The dietary supplement industry can certainly expect the number of GMP inspections to continue to increase and the FDA to continue to ratchet-up its enforcement actions against those companies that fail to comply. Daniel Fabricant, head of the FDA’s Division of Dietary Supplement Programs, made that point abundantly clear when he spoke at SupplySide West in Las Vegas. According to Dr. Fabricant, the failure of dietary supplement companies to comply with GMPs is the largest problem facing our industry and it’s an issue that is front and center for the Agency in their effort to ensure the safety of dietary supplements. Additionally, the FDA will be seeking to charge those companies that fail their initial GMP inspection an hourly fee of $255 plus expenses for time spent by the FDA to re-inspect a facility that failed the initial inspection. The FDA has also promised that it will be focusing more of its attention in the coming year on labeling claims for dietary supplements, specifically whether companies have the required scientific substantiation necessary to support the claims on their labels. Adverse Event Reports (AERs) will also be an issue gaining increasing attention. No doubt we can expect long-time industry foes Senator Dick Durbin and Congressman Henry Waxman to continue asking for tighter and increasingly more onerous regulation of the dietary supplement industry.
The dietary supplement industry is a multi-billion dollar industry that continues to see growth despite the economic downturn. Those companies that are compliant can expect 2013 to be a year of continued prosperity while those neglecting their obligations have an even greater chance of making the FDA’s naughty list.