FDA Considering Lawful Pathways for Dietary CBD Supplements While Continuing to Enforce Current law
If you’re cannabis producer thinking about adding a dietary supplement, food or beverage to your product line … or a dietary supplement, food or beverage producer considering venturing into the world of cannabis-infused products, you’ll want to keep your ears to the ground on FDA’s forward momentum in this area. It is one in which the agency is moving quickly and looking to make decisions.
One of the first opportunities for awareness and input is a public hearing to be held May 31 to discuss “whether CBD can be marketed as a dietary supplement in foods and beverages.” As described by FDA, the hearing is an opportunity for the public to provide FDA with input on its regulatory strategy related to existing products, as well as lawful pathways by which products containing cannabis or cannabis-derived compounds can be marketed, and how the agency can make these legal pathways more predictable and efficient. As the title of the hearing shows, FDA also is seeking “Scientific Data and Information About Products Containing Cannabis or Cannabis-Derived Compounds.” FDA also has formed a high-level internal working group to explore potential pathways for the lawful marketing of dietary supplements and/or conventional foods containing CBD, including consideration of statutory or regulatory changes and the impact of such marketing would be on the public health.
Some had expected that the hemp allowances of the 2018 Farm Bill would open the door to the federal legalization of CBD foods and supplements. However that was quickly tamped down with the explicit preservation of FDA’s authority to regulate food and dietary supplement products containing cannabis or cannabis-derived compounds, and FDA’s announcement that it remains “unlawful under the [Federal Food, Drug and Cosmetic Act] to introduce food containing added CBD or THC into interstate commerce, or to market CBD or THC products as, or in, dietary supplements, regardless of whether the substances are hemp-derived.”
Thus, while it is considering potential options for regulatory change, FDA is aggressively enforcing current law, including the issuance of multiple warning letters to companies marketing CBD products with egregious and unfounded claims aimed at vulnerable populations, and stressing that unless FDA issues a regulation allowing such uses, it remains unlawful to introduce food containing added CBD or THC into interstate commerce, or to market CBD or THC products as dietary supplements. This has not occurred, at least in part, because of FDA’s having identified certain safety risks in its review of Epidiolex (a treatment for two rare forms of childhood epilepsy), and its seeing unresolved questions regarding the cumulative exposure to CBD and whether some threshold level of CBD could be allowed in foods without undermining the drug approval process or diminishing commercial incentives for further clinical study of the relevant drug substance.
And, as noted in its statement, “FDA would only consider this path if the agency were able to determine that all other requirements in the FD&C Act are met, including those required for food additives or new dietary ingredients.” That said, FDA also stated that it hopes the information it receives through the public hearing and the written public comment process, will help inform its consideration of these and other scientific, technical and policy questions.
Led by Dr. David Acheson, HashTAG is part of The Acheson Group (TAG), a food safety consulting group that provides guidance and expertise worldwide for companies throughout the food supply chain. With a focus on the Cannabis Edibles Industry, the HashTAG team brings in-depth industry knowledge combined with real-world experience to help companies more effectively mitigate risk, improve operational efficiencies, and ensure regulatory and standards compliance. To learn more about HashTAG services and expertise, please visit: www.HashTAG.global