A bipartisan bill introduced by Representatives Morgan Griffith (R-Virginia) and Kurt Schrader (D-Oregon) seeks to regulate hemp-derived cannabidiol (CBD) as a dietary supplement, said The Fresh Toast. This would make many hemp-related activities legal under the Federal Food, Drug, and Cosmetic Act (FDCA).
The bill called The Hemp and Hemp-Deprived CBD Consumer Protection and Market Stabilization Act of 2020 or HR 8179, would make the manufacture, sale, and marketing of Hemp Products legal.
Particularly, HR 8179 aims “to make hemp, cannabidiol derived from hemp, and any other ingredient derived from hemp lawful for use under the Federal Food, Drug, and Cosmetic Act as a dietary ingredient in a dietary supplement, and for other purposes.”
The passage of this bill exempts Hemp products from the Drug Exclusion Rule enforced by the FDCA. The Rule “prevents the sale and marketing of any substance or products that have been approved or investigated by the FDA as a new drug as a conventional food or dietary supplement. This means that any substance or product that has been deemed a new drug by the FDA cannot be sold or marketed as a conventional food or dietary supplement.
In the case of CBD, the FDA has already investigated and approved the cannabinoid as an ingredient in a drug called Epidiolex in July 2018.
However, Hemp Products still need to be compliant with the FDCA, which states that legal products should “meet the existing regulatory framework imposed on dietary supplements,” as per The Fresh Toast. This framework, providing comprehensive requirements, says that such items should be safe and have proper labels. Marketing should also comply with policies.
The report explained that hemp-derived products do not qualify as dietary supplements or conventional foods as they were not sold and marketing in the United States as such before October 15, 1994. Because of this, they would be considered “new dietary ingredients” or NDIs.
The FDCA’s Section 413 indicates that any supplement that contains NDI should have ample evidence of being safe before being manufactured and distributed. Manufacturers and distributors should also inform the FDA before marketing and selling these products.
In compliance with this, manufacturers and distributors of Hemp Products should obtain information that will serve as a basis that the items are “reasonably expected to be safe under the conditions recommended or suggested in the labeling.” The applicant would be able to market their products should they receive a no-objection letter from the FDA or if they receive no response within after the 75-day notification period.
As per HR 8179, these items would also be covered by the Fair Packaging and Labeling Act, which states that packaging should have labels outlining the nutrition facts and elements of the items. Moreover, it should not contain any claims about the therapeutic potentials of the products.
This bipartisan bill came at a time when the House of Representatives has been contemplating a vote on marijuana legalization. The vote, scheduled this week, has been postponed due to criticisms from moderates.