FDA suggests willingness to acknowledge dietary supplement GMP compliance and hints that revised NDI draft guidance may be coming soon.

  • FDA has regulatory authority over dietary supplements and dietary ingredients.  In recent years, the industry has grappled with negative publicity regarding compliance with the dietary supplement good manufacturing practices (GMPs) set forth in 21 CFR Part 111.  The industry also has faced significant confusion in the aftermath of FDA’s issuance — and subsequent informal withdrawal — of a 2011 draft guidance document regarding notification requirements for new dietary ingredients (NDIs).
  • At a recent meeting hosted by a dietary supplement trade association, the American Herbal Product Association, the acting deputy director of FDA’s Division of Dietary Supplement Programs, Dr. Cara Welch, indicated some upcoming changes and developments of relevance to the supplement industry.  Regarding GMP compliance, Dr. Welch stated that FDA plans to begin highlighting positive examples of supplement GMP compliance as part of its efforts to monitor and incentivize compliance.  Rather than focusing solely on the industry’s alleged shortcomings, FDA plans to begin identifying and highlighting “the good players.”  Regarding the NDI draft guidance, Dr. Welch indicated her hopes that a revised document can be released “soon” and noted that re-issuance of the document will reopen the comment period.
  • Both a shift in FDA’s GMP publicity policy and new insight into FDA’s views regarding the regulation of NDIs will be of significant interest to the dietary supplement industry.  However, because FDA’s dietary supplement division has only 26 full-time employees — a figure that Dr. Welch does not anticipate will change in the near future — it remains to be seen how quickly these developments actually will materialize.