Last week, Oregon Representative Kurt Schrader (D) and Virginia Representative Morgan Griffith (R) introduced The Hemp and Hemp-Derived CBD Consumer Protection and Market Stabilization Act of 2020 (“H.R. 8179”). If enacted in its current form, H.R. 8179 would legalize the manufacture, sale and marketing of hemp, hemp-derived cannabidiol and other hemp extracts (collectively referred to as “Hemp Products”) as dietary supplements under the Federal Food, Drug and Cosmetic Act (“FDCA”).
This means that these products would be exempt from the FDCA’s “Drug Exclusion Rule,” which, as we previously discussed, currently prevents the sale and marketing of any substance that has been approved or investigated by the FDA as a new drug as a conventional food or dietary supplement – In July 2018, the FDA approved CBD as a drug ingredient in Epidiolex.
To be compliant with the FDCA, these Hemp Products would need to meet the existing regulatory framework imposed on dietary supplements. This comprehensive regulatory framework mandates, in part, that these products be safe as well as properly labeled and marketed.
Because Hemp Products were not sold and marketed in the U.S. as dietary supplements or conventional foods before October 15, 1994, they would be deemed “new dietary