FDA has been busy in the past few months, publishing several draft guidance documents and proposed rules for food safety—including a proposal that would ban partially hydrogenated oils in foods. They also published updated guidance on cosmetic GMPs but have been relatively quiet about dietary supplements. However, in September FDA’s Center for Food Safety and Applied Nutrition (CFSAN) published their “Plan for Program Priorities, 2013-2014” that included quite a list of goals for the dietary supplement program (http://tinyurl.com/nx6hsse). Since there are less than 30 days left in 2013, it will be interesting to see whether FDA will publish a flurry of proposed rules or miss their proposed deadline.
CFSAN’s overall plan for the dietary supplement industry is to “take steps to improve the safety and labeling of dietary supplements and the supply chain.” It is interesting that the supply chain was mentioned since many dietary supplement manufacturers have complained that the dietary supplement GMPs do not extend to the suppliers, making it difficult for manufacturers to convince raw material suppliers of the importance of good documentation and record keeping that would help manufacturers comply with the GMPs (http://tinyurl.com/lj3z35f).
The CFSAN Plan for Program Priorities goes on to list 5 planned steps to address the safety and labeling of dietary supplements:
- Modernize the postmarket surveillance system for regulating dietary supplements.This was a recommendation from the Department of Health & Human Services Inspector General’s 2012 report, “Dietary Supplements: Structure/Function Claims Fail To Meet Federal Requirements” (http://tinyurl.com/keq4b27). By the way, this document details a study in which the Inspector General’s Office reviewed label claims and the manufacturer’s substantiation dossiers for 72 dietary supplement products.
- Develop and implement risk-based compliance and regulatory strategies to address dietary supplement safety issues. FDA typically takes a risk-based approach in their oversight and regulatory enforcement actions in regulated industries. In the past FDA had indicated that they were particularly interested in monitoring the marketplace for claims relating to cancer, diabetes and influenza H1N1; they also watch for supplements that claim to affect memory, sexual function and weight loss. It is unclear whether FDA will publish their regulatory strategies but we will be watching for updates to their compliance policy and inspection manuals.
- Publish revised draft guidance on new dietary ingredients (NDIs) to increase premarket oversight of dietary supplements. This highly anticipated guidance could prove to be very interesting. The first draft was published in July of 2011. FDA received over 12,000 comments on this document that appeared to the dietary supplement industry to be a substantial overreach by the agency that in effect, would put into place a premarket approval process for dietary supplements; a proposal that appears to violate the enabling legislation of the dietary supplement regulations. It is unlikely that publication of the revised draft guidance would be received as good wishes for a prosperous new year by industry.
4. Publish final guidance on new dietary ingredients (NDIs) to increase premarket oversight of dietary supplements. While this step is set for 2014, the short timeline indicates that the agency does not expect as many comments as there were for the first draft. Perhaps they have thoughtfully considered the industry’s previous comments and the document will be something that both industry and regulators will find workable.
5. Publish final guidance to help dietary supplement and beverage manufacturers and distributors determine whether a liquid food product (such as energy drinks) may be labeled and marketed as a dietary supplement. In December of 2009 FDA published a guidance document on “Factors that Distinguish Liquid Dietary Supplements from Beverages…” (http://tinyurl.com/nxjuswg). FDA issued the guidance at a time when many ‘functional beverages’ were making their way to store shelves. The apparent aim was to rein in the industry; however the plethora of liquid products available that claim to be dietary supplements but look like beverages is testament to the fact that the 2009 guidance has been largely ignored.
If CFSAN does publish all those proposed documents, we will do our best to keep you up to date without inundating your inbox. In the meantime, the associates at FDALabels.com and Bioscience Translation & Application are ready to help you ensure that your products are compliant with FDA regulations so that you can enjoy uninterrupted market success.