Is the product a conventional food or a dietary supplement?  Would FDA consider it a cosmetic or a drug?  These are common regulatory questions in planning meetings for manufacturers of FDA-regulated products. The questions are asked because the answers have consequences. Inclusion of the wrong ingredient, or product claim, could result in an expensive label change, an undesirable product classification that invokes premarket hurdles that are inconsistent with the desired business model for a product, or even enforcement ranging from a public warning letter to criminal and civil penalties.

FDA reminded companies of the importance of these conversations on Monday, when it issued warning letters to five companies alleging that certain products marketed as dietary supplements were misbranded because one of their “dietary ingredients” (Picamilon) did not meet the statutory definition of a “dietary ingredient” under the FDCA.  According to FDA, Picamilon is not a dietary ingredient because it is not a vitamin; mineral; herb or other botanical; amino acid; dietary substance for use by man to supplement the diet by increasing the total dietary intake; or a concentrate, metabolite, constituent, extract, or combination of the preceding substances—the statutory definition of “dietary ingredient” under section 201(ff) of the FDCA.Rather, Picamilon “is a unique chemical entity synthesized from the dietary ingredients niacin and gamma-aminobutyric acid“ that “crosses the blood-brain barrier and accumulates in the brain as a separate chemical entity.“ 

FDA’s announcement did more than give the “warned” companies 15 days to respond.  It put industry on notice that (1) FDA is continuing to monitor the products with novel ingredients (and claims) and (2) FDA fully intends to use its authorities to enforce the statutory definitions of product and ingredient classifications under the FDCA. Earlier this year, FDA sent similar notices regarding the improper designations of synthetic chemical entities as “dietary ingredients” in supplement products (specifically BMPA and DMBA).  And it has continued to crack down on the inclusion of drug ingredients in dietary supplement products and the use of “drug” claims to promote products labeled as cosmetics.  Other agency priorities include clarifying the differences between conventional foods and dietary supplements, and the unique statutory definition for medical foods.

In short, as we get ready for 2016, it may be prudent for companies that sell FDA-regulated products to remind their product research & development teams of the importance of thoroughly vetting proposed product ingredients (and claims) to ensure that they are appropriate for the product classification of interest.  If not, FDA may do it for you.