2023, Not The Year CBD Gets Regulated

It will have taken the FDA the receipt of over 4,500 public comments and the issuance of 83 warning letters since the enactment of the Agriculture Improvement Act of 2018 (the Farm Bill) to conclude it lacked the authority to adequately regulate these products.

In a press release dated January 26, the FDA formally shared its regulatory assessment of cannabidiol (CBD) and concluded the existing regulatory channels governing food ingredients and dietary supplements were inappropriate for hemp-derived products. Alternatively, the agency is asking Congress to pass new legislation that would afford the agency a supposedly more suitable framework to address the marketing and safety concerns surrounding these products. The press release specifically mentioned the need for additional scientific studies to assess the long-term effects of CBD as well as potential safety measures like clear labels, content limits on CBD, a minimum purchase age, and prevention of contaminants.

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Yet, despite receiving a broad range of safety studies showing that standard CBD serving sizes are safe, the FDA’s continued assertions regarding the safety of CBD rely on pharmaceutical studies that show risk at significantly larger doses that are not commonly found in CBD products sold at retail.

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In addition, all of the safety measures presented by the FDA could be adequately addressed under the Federal Food, Drug and Cosmetic Act (the FDCA), which consists of robust, comprehensive requirements aimed at ensuring the safety and quality of products, and covers the manufacturing, labeling, and marketing of products. That being said, a legislative solution will in fact be required to lawfully market CBD foods and dietary supplements.

In spite of strong bipartisan support for the hemp industry and growing impatience with the agency’s inaction with CBD, Congress is now more divided than ever. This political polarization could result in delaying the passage of new CBD legislation, which in turn would further hold up the implementation of a regulatory pathway for these products.

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The FDA’s recent announcement suggests a continued lack of interest and a bad-faith effort to regulate these products. The FDA’s reluctance to act these past four years has led to the creation of a confusing marketplace for consumers, who have been deprived access to safe CBD products, and for businesses, which have had to self-regulate and navigate a patchwork of confusing state regulations.

What is also disappointing about this announcement is that the FDA has had ample time to consider the existing scientific evidence and assess its ability to regulate these products. The agency should have been able to reach this conclusion a lot sooner and help avoid a regulatory debacle that may very well last for a few more years. In asking Congress to intervene years after the passage of the 2018 Farm Bill, the FDA is continuing to jeopardize the health and safety of consumers and the ability of CBD companies to achieve economic growth and success. What a shame.

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Nathalie Bougenies focuses her practice on health and wellness, in addition to corporate transactions and regulatory compliance. For the past four years, Nathalie has helped clients navigate the complex regulatory landscape of hemp products intended for human consumption and advises domestic and international clients on the sale, distribution, marketing, labeling, and importation of these products. Nathalie frequently speaks on these issues and has made national media appearances, including on NPR’s “Marketplace.” She also authors a weekly column for “Above the Law” that features content on cannabis policy and regulation. For four consecutive years, Nathalie has been named Rising Star by Super Lawyers.

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Cannabidiol (CBD), Marijuana, Nathalie Bougenies