Is 2021 The Year CBD Becomes A Lawful Dietary Ingredient?

Industry leaders and major herbal products associations have expressed strong support for a bipartisan bill.

A few months ago, I discussed why hemp-derived cannabidiol (CBD) products should be regulated as dietary supplements despite the fact that the FDA deems the marketing of these products as unlawful. If you recall, this rationale stems from an exclusion clause in the definition of “dietary supplement” under the Food, Drug and Cosmetic Act (FDCA) that generally disallows the use of an FDA-approved “drug” as a dietary supplement (the Drug Exclusion Rule). Because CBD was investigated and approved as a new drug ingredient — Epidiolex — before CBD was marketed as a dietary supplement, the sale and marketing of these products violates the FDCA.

In that article, I also mentioned that Congress shared my views and introduced bipartisan bills, namely H.R. 5587 and H.R. 8179, that proposed to exempt CBD products from the Drug Exclusion Rule so they could be regulated as dietary supplements.

Though these bills died in the 2020 legislative session, Representatives Kurt Schrader (D-OR) and Morgan Griffith (R-VA), along with 18 bipartisan co-sponsors, recently reintroduced H.R. 8179, also known as The Hemp and Hemp-Derived CBD Consumer Protection and Market Stabilization Act (the Act).

If enacted in its current form, the Act 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 FDCA.

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” (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 — this includes following stringent manufacturing requirements known as “Current Good Manufacturing Practices” (CGMPs) — and must notify the FDA about that ingredient prior to marketing.

To meet this standard, manufacturers and distributors 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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If the manufacturers or distributors were to receive a no-objection letter from the FDA, or no response at all, they could lawfully market their Hemp Products after the 75-day notification period is over, assuming there is in fact a history of use or other evidence of safety establishing that the Hemp Products, when used under the conditions recommended or suggested in the labeling, are reasonably expected to be safe.

When it comes to labeling requirements, manufacturers and distributors of Hemp Products would need to ensure their product packaging contains specific labeling elements, such as an identity statement and a supplement facts panel, but also contain no medical claims about the therapeutic values of their products. Inclusion of medical claims would suggest that the Hemp Products’ intended use is that of a drug, and thus, would violate the FDCA and warrant FDA and Federal Trade Commission (FTC) enforcement actions — the FDA and the Federal Trade Commission both regulate the marketing of dietary supplements.

In sum, the enactment of the Act would help alleviate regulatory uncertainties surrounding the legality of Hemp Products, which have hindered market opportunities for hemp farmers and businesses. In addition, the passage of this bipartisan bill would help raise the quality and safety of Hemp Products, and thus, assure consumers that these products are safe.

Industry leaders, such as the U.S. Hemp Roundtable, the U.S. Hemp Authority, and the National Association of State Departments of Agriculture (NASDA), as well as major herbal products associations like the American Herbal Products Association (AHPA), have expressed strong support for the bipartisan bill, which suggest the significant likelihood that CBD and Hemp Products will finally be regulated this year.


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Nathalie practices out of Harris Bricken’s Portland office and focuses on the regulatory framework of hemp-derived CBD (“hemp CBD”) products. She is an authority on FDA enforcement, Food, Drug & Cosmetic Act and other laws and regulations surrounding hemp and hemp CBD products. She also advises domestic and international clients on the sale, distribution, marketing, labeling, importation and exportation of these products. Nathalie frequently speaks on these issues and has made national media appearances, including on NPR’s Marketplace. For two consecutive years, Nathalie has been selected as a “Rising Star” by Super Lawyers Magazine, an honor bestowed on only 2.5% of eligible Oregon attorneys.  Nathalie is also a regular contributor to her firm’s Canna Law Blog.