- Under section 201(ff)(3)(B)(ii) of the Federal Food, Drug, and Cosmetic Act (FD&C Act), the definition of a “dietary supplement” specifically excludes articles that are approved as new drugs, certified as antibiotics, or licensed as biologics, as well as articles that have been investigated for therapeutic uses for which “substantial clinical investigations have been instituted and for which the existence of such investigations has been made public.” A product would not be excluded from the definition of a dietary supplement if it was marketed as a dietary supplement or as a food prior to formal regulatory approval or regulatory authorization to begin therapeutic investigations. FDA has cited to the “drug exclusion” in section 201(ff)(3) on numerous occasions in Warning Letters to companies marketing approved drugs in dietary supplements. Several Warning Letters addressed the marketing of dietary supplements containing sibutramine, a drug approved to treat weight loss (since withdrawn from the U.S. market). In each case, FDA indicated that sibutramine was authorized for investigation as a new drug prior to its marketing as a dietary supplement or as a food. Recently some have questioned FDA’s views regarding the permissible marketing of cannabidiol (CBD) products (containing substances derived from the marijuana plant) as dietary supplements. CBD has been shown to have therapeutic promise and a drug company filed an investigational new drug application (IND) to investigate its use in the treatment of childhood epilepsy in 2013.
- In a Q&A that FDA recently issued to address marijuana products, the Agency specifically states that “[based] on [the] available evidence” it has concluded that CBD products are excluded from the dietary supplement definition under section 201(ff)(3)(B)(ii) of the FD&C Act. Recognizing this qualification, at least one company promoting CBD for dietary supplement use has openly challenged FDA’s conclusion and has asserted the existence of a CBD-based dietary supplement on the market since 2012, which would predate the filing of the IND.
- In February 2015, FDA issued several Warning Letters to firms marketing CBD products as unapproved new drugs, based primarily on the claims made for such products. In light of the Agency’s recently publicized view that CBD does not fit the dietary supplement definition, it remains to be seen whether future Warning Letters will target CBD-based dietary supplements on this basis. Perhaps significantly, although FDA states that CBD products may not be sold as dietary supplements, the Q&A invites interested parties to “present the agency with any evidence that they think has bearing on this issue.” The possibility exists that sufficiently robust evidence about the marketing of CBD products as dietary supplements prior to the investigation of therapeutic uses may change the Agency’s views on this point, although the practical likelihood of this happening is fairly low.