A Bipartisan Bill Would Regulate Hemp CBD as a Dietary Supplement
September 21, 2020 by AggregatedNews
by Nathalie Bougenies, Attorney at Harris Bricken
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.
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 nutrition facts panel and 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.
In sum, the enactment of H.R. 8179 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, protect consumers.
Source: CANNABIS BUSINESS EXECUTIVE Newsletter
September 21, 2020 by AggregatedNews
by Nathalie Bougenies, Attorney at Harris Bricken
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.
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 nutrition facts panel and 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.
In sum, the enactment of H.R. 8179 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, protect consumers.
Source: CANNABIS BUSINESS EXECUTIVE Newsletter
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