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Cannabis as an ingredient in food or supplements (USA)

Since 2018, cannabis and cannabis-derived ingredients have become increasingly common in food and dietary sup-plements sold in the United States largely due to the statutory removal of “hemp” from the definition of marijuana. However, “cannabis” is not a defined term or otherwise carved out of the Federal Food, Drug, and Cosmetic Act (“FDCA”). As a result, these ingredients remain regulated by the Food and Drug Administration (“FDA”) under its ex-isting statutory and regulatory authorities for foods and dietary supplements, just like any other ingredient. To date, FDA has stated it has “no questions” on GRAS notifications for specified uses of hulled hemp seed, hemp seed protein powder, and hemp seed oil. However, FDA has concluded that THC and CBD may not be added to con-ventional foods based on 21 U.S.C. § 331(ll), known as the “prior drug exclusion.” That provision prohibits the distribu-tion or sale of food (including animal foods and feeds) containing the active ingredient in an approved drug product or a drug for which “substantial clinical investigations” have been undertaken and where the existence of such inves-tigations has been made public. Other cannabis-derived compounds that have not been previously approved as drugs, or subject to “substantial clinical investigations,” are theoretically not prohibited from use in foods under the prior drug exclusion clause, but the food additive provisions of the FDCA pose significant barriers to entry. FDA’s position regarding the use of cannabis and its derivatives in dietary supplements generally parallels its stance for use in food since the “dietary supplement” definition in 21 U.S.C. § 321(ff), contains a provision that is nearly iden-tical to the above referenced prior drug exclusion clause. In January 2023, after convening a high-level internal working group to explore potential regulatory pathways for cannabidiol products, FDA concluded that the existing statutory and regulatory framework for foods and supple-ments do not provide a path forward for most of these ingredients under the applicable safety standards and looked to the U.S. Congress for legislative assistance in this regard. Currently, the FDA is prioritizing its enforcement atten-tion on products that are labeled or advertised for therapeutic or medical uses because: 1) they may induce patients to disregard approved therapies and 2) their safety and effectiveness have not been established. Other authorities with jurisdiction over the production, sale, and marketing of cannabis and cannabis containing products include, on the federal level, the Drug Enforcement Administration (DEA), the U.S. Department of Agricul-ture (USDA), and the Federal Trade Commission. There is further complexity on the state level where there are dif-fering, and in some cases contradictory, laws on testing, packaging, labeling.

This is general information rather than legal advice and is current as of 30 May 2024. We recommend you contact a specialised food lawyer for legal advice for your particular circumstances to support commercial decisions which could impact your product or business.


Suzan Onel

USA
KLEINFELD, KAPLAN & BECKER