Petition to Request an Exemption from 100‑Percent Identity Testing of Dietary Ingredients

“Part 111 (21 CFR part 111) establishes the minimum Current Good Manufacturing Practice (CGMP) necessary for activities related to manufacturing, packaging, labeling, or holding dietary supplements to ensure the quality of the dietary supplement.”  21 CFR 111.75(a)(1) of these regulations provides a process whereby a dietary supplement manufacturer can petition the Agency for an exemption for 100% identity testing for dietary ingredients.  This is much the same as a qualification program for the reduced testing of an inactive ingredient or active ingredient based on the performance of vendors for components of drug products, although no petition is required for the pharmaceutical industry.

The FDA will approval a petition for the exemption if sufficient data is presented to establish that the program in place will meet the intended outcome of this regulation (i.e., assurance of the identity and quality of the dietary ingredient and providing regulatory flexibility).  Today, the FDA issued a Federal Register Notice (here) requesting a proposed collection of information (an interesting term that really satisfies the Office of Management and Budget that the collection of information is properly announced to the public and is current), and in that document we found the following statement:

Since OMB’s last approval of the information collection, we have received no petitions.  We therefore retain the currently approved estimated burden which assumes no more than one petition will be submitted annually.

This is quite surprising as one might think that dietary manufacturers (like drug manufacturers) would want to lower their regulatory burden and, at the same time, reduce their analytical testing costs.  Given the current state of the dietary supplement industry, one might conjure up some rather nefarious scenarios as to why we have not seen more of these petitions submitted, but we will leave it at that.

We will also be interested to see what regulatory and potential statutory actions occur after the departure of Senator Orin Hatch, the lead sponsor of the Dietary Supplement Health and Education Act of 1994 (“DSHEA”), the legislation under which the dietary supplement industry is regulated.