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“Grandfathered” Dietary Ingredients – It’s About Time

The Dietary Supplement Health and Education Act (DSHEA) was enacted in 1994 – almost a quarter century ago.  It amended the Federal Food, Drug, and Cosmetic Act (FD&C Act) in a number of significant ways that set the stage for present marketing of this important category of consumer goods.  However, aspects of DSHEA never were fully implemented.  To its credit, FDA is revisiting this lapse.

The agency just announced that on October 3, 2017, from 8 a.m. to 5 p.m., at CFSAN/FDA’s Wiley Auditorium in College Park, MD, it will hold a public meeting, entitled “Development of a List of Pre-DSHEA Dietary Ingredients.”

Section 413 of the FD&C Act requires that a new dietary ingredient (NDI) notification (i.e., a 75-day, pre-market safety notification)  be submitted to FDA if the dietary ingredient (i.e., active substance in a dietary supplement) was not marketed in the U.S. before October 15, 1994.  21 U.S.C. § 350b; see also 21 U.S.C. § § 321(ff) (definition of “dietary supplement”), 21 C.F.R. § 190.6 (NDI notifications), Dietary Supplements: New Dietary Ingredient Notifications and Related Issues: Draft Guidance for Industry (Aug. 2016) (Q&A 3-11 are especially pertinent).  These dietary ingredients, marketed in the U.S. before October 15, 1994, for which a NDI notification need not be submitted, are the “pre-DSHEA” dietary ingredients that are the subject of the upcoming public meeting.

Some trade associations have established lists of dietary ingredients believed to be pre-DSHEA.  E.g., Council for Responsible Nutrition (CRN) List of Dietary Ingredients “Grandfathered” Under DSHEA (Sept. 1998); National Nutritional Foods Association (NNFA) List of Dietary Supplement Ingredients In Use Before October 15, 1994 (Apr. 1996).  However, FDA never adopted these lists nor acknowledged their accuracy.

The purpose of the public meeting is to give interested persons an opportunity to discuss issues related to FDA’s planned development of a list of pre-DSHEA dietary ingredients.  Topics to be covered during the meeting will include (i) what evidence is necessary to show that an ingredient was marketed before October 15, 1994, and (ii) what process should be used to develop the list.  An authoritative list would provide benefits to both industry and FDA.

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