Hemp products would be deemed “new dietary ingredients” or “NDIs”
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 ingredients” or “NDIs”.
Pursuant to Section 413 of the FDCA, if a dietary supplement contains an NDI, its manufacturer and distributor must ensure that the NDI is adequately substantiated as being safe and must notify the FDA about that ingredient prior to marketing.
To meet this standard, manufacturers and distributor of Hemp Products would have to provide the FDA with information that is the basis on which they have concluded that their Hemp Products are reasonably expected to be safe under the conditions recommended or suggested in the labeling.
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