As many are aware, the 2018 Farm Bill legalized hemp (cannabis with 0.3% THC or less) and hemp-derived products at the federal level by removing such products from the Controlled Substances Act (although individual states remain largely free to implement their own prohibitions). One of the major hemp-derived products in commerce today is CBD, which has achieved remarkable growth in the marketplace due to its perceived therapeutic benefits. However, despite the popularity of myriad CBD-based products, the legality of supplying CBD to consumers for ingestion is precarious.
Despite legalizing hemp-derived products generally, the 2018 Farm Bill explicitly preserved the FDA’s authority when it comes to the regulation of cannabis as an ingredient in traditionally FDA-regulated products such as food, dietary supplements, cosmetics, and drugs. The FDA, for its part, has determined that CBD is not a legal food additive or dietary supplement, a conclusion reached by relying upon a prohibition against certain food ingredients and dietary supplements that were previously studied as drugs. Specifically, the FDA determined that it could exclude CBD as a food ingredient because CBD was clinically studied as a drug and is the active ingredient in an FDA-approved seizure medication called Epidiolex, and because CBD was not previously marketed as a dietary supplement prior to the approval of Epidiolex.
What this means is that even though as a practical matter CBD is regularly being sold for human consumption, the FDA considers it illegal to add CBD to food or market it as a dietary supplement. The FDA has simply refrained, to date, from widespread enforcement actions despite explicitly stating that such products currently violate the law. The FDA’s toleration could change at any time, especially when it comes to the addition of CBD to food products.
However, on May 19, 2021, Senators Paul (R-Kentucky), Merkley (D–Oregon), and Wyden (D-Oregon) introduced a bipartisan bill that would create an exemption for “hemp, hemp-derived cannabidiol, or a substance containing any other ingredient derived from hemp.” The bill essentially excludes such products from the prohibitions upon which the FDA had previously relied. Although it is possible that the FDA could try to find another basis for excluding such products, the bill appears aimed to effectively overrule the FDA. The bill would also authorize the Secretary of Health and Human Services to establish labeling and packaging requirements for food products and dietary supplements that contain such ingredients.
If the bill passes into law, it is likely that the FDA would concede the legality of CBD and other hemp-derived products as food additives and dietary supplements going forward. Accordingly, the bill’s passage would mark a watershed moment in the development of the CBD and hemp industry.