In the last few weeks, we have received a growing number of inquiries pertaining to the legality of smokable products infused with cannabidiol derived from industrial hemp (“CBD Smokables”), including vape pens and pre-rolled hemp flower joints. This post provides a brief overview of the current legal status of these products.
As we have discussed on several occasions (here and here), the U.S. Food and Drug Administration (“FDA”) has yet to promulgate clear guidelines on CBD-infused products. While we know the FDA deems the sale and use of CBD in food and dietary supplements unlawful, the agency has yet to address its sale and use in tobacco products.
Indeed, the FDA has the authority to regulate the sale, manufacture, and marketing of tobacco products under the 2009 Family Smoking Prevention and Tobacco Control Act (“TCA”). The TCA defines “tobacco product” as a “product made or derived from tobacco that is intended for human consumption, including any component, part, or accessory of a tobacco product.”
In 2016, the FDA expanded its regulatory authority to all products meeting the TCA’s statutory definition of a tobacco product, such as e-cigarettes, cigars, pipes and waterpipes.
However, the various statements published on the FDA’s website (here and here) seem to suggest that the agency currently refuses to interpret “tobacco products” so broadly as to include products free of nicotine or tobacco. Accordingly, it seems unlikely that CBD Smokables devoid of these substances would be considered “tobacco products.”
Although the federal agency is not likely to regulate most CBD Smokables as tobacco products at the moment, it could potentially regulate them as a drug under the Food, Drug and Cosmetic Act (“FDCA”).
Under the FDCA, a drug is defined as “intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease” or “intended to affect the structure or any function of the body . . . .” Accordingly, the agency’s jurisdiction is triggered by the intended use of the product. Generally, intended use is determined on the basis of claims made in labeling, advertising and other promotion of the product. Therefore, any health claim made about CBD-infused products, including CBD Smokables, will be treated by the FDA as a drug.
Drugs are tightly regulated by the FDA and are subject to pre-market approval. Yet, as of the date of this post, the FDA has only approved CBD as a pharmaceutical drug in the treatment of epilepsy (Epidiolex). Accordingly, any health claim made about any CBD Smokable would lead the FDA to treat the product as a drug, and thus, would require the distributor to submit their product to the agency for pre-market approval before they can begin selling it in interstate commerce.
Until the agency makes a final determination and issues guidelines for CBD Smokables, no distributor will technically comply with current FDA rules. However, based on the FDA’s recent statements and past enforcement actions, said distributors can mitigate the risk of FDA enforcement by avoiding medical claims all together.
For additional information on CBD Smokables, please contact our team.
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Author: Nathalie Bougenies