A bipartisan bill was introduced in the U.S. House of Representatives on January 13, 2020, that (1) would allow hemp-derived cannabidiol (CBD) to be regulated as a dietary supplement, if all other applicable requirements for a dietary supplement are met, and (2) would not prohibit CBD from being included in foods that are introduced into interstate commerce. The bill was filed by the Chairman of the House Agricultural Committee, Representative Collin Peterson (D-MN), and co-sponsored by Representatives Thomas Massie (R-KY), James Comer (R-KY) and Chellie Pingree (D-ME).
The bill, H.R.5587, would amend the Federal Food, Drug and Cosmetic Act (FFDCA) as follows, inserting the language that is italicized below into 21 USC 321(ff)(3)(B)(i) and (ii):
(ff) The term “dietary supplement” …does…not include-
(i) an article (other than hemp-derived cannabidiol or a hemp-derived cannabidiol containing substance) that is approved as a new drug under section 355 of this title, certified as an antibiotic under section 357 of this title, or licensed as a biologic under section 262 of title 42, or
(ii) an article (other than hemp-derived cannabidiol or a hemp-derived cannabidiol containing substance) authorized for investigation as a new drug, antibiotic, or biological for which substantial clinical investigations have been instituted and for which the existence of such investigations has been made public, which was not before such approval, certification, licensing, or authorization marketed as a dietary supplement or as a food unless the Secretary, in the Secretary’s discretion, has issued a regulation, after notice and comment, finding that the article would be lawful under this chapter.
The proposed amendment in H.R.5587 provides that a hemp-derived, CBD-containing product would not be excluded from the statutory definition of “dietary supplement” on the basis (1) that CBD was an article that was approved as a new drug, antibiotic or biologic, or (2) that CBD was an article authorized for investigation as a new drug, antibiotic or biologic, for which substantial clinical investigations have been instituted and have been made public.
Similarly, with regard to foods, the bill would amend 21 USC 331(ll) to exclude hemp-derived CBD and hemp-derived, CBD-containing substances from the prohibition on the introduction of foods into interstate commerce to which an FDA-approved drug or biological product has been added, or to which has been added a drug or biological product for which substantial clinical investigations have been instituted and made public.
The bill is significant because the FDA has approved a CBD-containing prescription drug (Epidiolex), and taken the position with regard to CBD-containing foods and dietary supplements that “under current law, such products violate the FD&C Act because CBD is an active ingredient in an approved drug and has been the subject of substantial clinical investigations.”
The bill also contains a provision requiring the U.S. Department of Agriculture (USDA) to research certain market and regulatory barriers faced by the hemp industry. As required by the 2018 Farm Bill, the USDA is responsible for the administration of hemp production, and in October 2019 introduced an interim final rule establishing the U.S. Domestic Hemp Production Program.
The bill was referred to the Energy and Commerce Committee and the House Agriculture Committee, which subsequently referred it to the Subcommittee on Biotechnology, Horticulture and Research, on January 23, 2020.