FDA Shares Insights on Potential Pathway to Regulate CBD Products

Foley Hoag LLP - Cannabis and the Law
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Foley Hoag LLP - Cannabis and the Law

The Food and Drug Administration (FDA) held a stakeholder call on May 25, 2023 to provide additional information related to the agency’s January 26 announcement that it believes a new regulatory framework for cannabidiol (CBD) products is needed. FDA has regulatory authority over a variety of products (including food, drugs, medical devices, dietary supplements, cosmetics, and tobacco products) but as we explained previously, FDA has identified risks associated with the use of CBD in certain products that it does not believe it can effectively manage under its current regulatory authorities. For example, FDA has determined that CBD cannot be safely used as an ingredient in food and dietary supplements under the current regime and that a new framework is also needed to ensure that inhalable hemp products are subject to FDA regulation. So, the agency is working with Congress to develop a new pathway that provides appropriate safeguards and oversight to manage and minimize these risks.

FDA shared some insights during the stakeholder call about the potential features of the proposed framework. For example, the framework could provide basic oversight, measures to mitigate the risk of contaminants, and additional safeguards to address specific risks, such as CBD content limits, clear labeling requirements, and measures to reduce the risk of ingestion by children. The panelists described the concept as a “harm reduction” rather than a “harm elimination” approach that would potentially provide guardrails for some types of products without the need for a product-by-product premarket approval process. Although the panel focused on CBD, it is possible that the new framework would encompass other hemp-derived products, but it would not be necessary for products that are already regulated through existing means, such as hemp seeds. Additionally, FDA does not seek to include marijuana in this new framework.

Until the new pathway is developed, FDA plans to continue enforcing against the products that it believes pose the most risk to consumers. Products of most concern to the agency continue to include foods or caffeinated beverages with added CBD, and products that contain Delta-8 tetrahydrocannabinol (THC), make egregious disease treatment claims, are administered through ophthalmic, inhalation, or injection routes, are appealing to children, or are intended to be consumed by food-producing animals.

DISCLAIMER: Because of the generality of this update, the information provided herein may not be applicable in all situations and should not be acted upon without specific legal advice based on particular situations.

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