FDA indicates it will continue to enforce regulations on CBD and delta-8 in the absence of the Farm Bill
The U.S. FDA and the CBD Conundrum
With the U.S. Farm Bill not likely to be updated until September 2024, the regulation of CBD and other hemp-derived compounds remains in limbo. This uncertainty has led the U.S. Food and Drug Administration (FDA) to continue its enforcement efforts through warnings to producers, while awaiting Congress to establish clear rules.
FDA playbook
The FDA has recently issued a warning to a North Carolina company for selling products containing CBD that are deemed illegal under the Federal Food, Drug, and Cosmetic Act. The agency has consistently maintained that adding CBD to food renders those products adulterated. In addition, the company was also cautioned about its products containing delta-8 THC – synthetic, high-potency compounds made from CBD – which have not been evaluated for safe use and have resulted in adverse event reports. The unregulated nature of these products has caused them to proliferate rapidly, being sold openly in various retail outlets and online.
Not GRAS
The FDA has emphasized that delta-8 THC is not considered generally recognized as safe (GRAS), and any food containing this compound is also considered adulterated. The company in question, doing business under several names, produces a range of products containing CBD and/or delta-8 THC, including cookies, gummies, candies, and honey.
Worries over minors
Legal expert Rend Al-Mondhiry has highlighted the FDA’s concern over minors’ access to delta-8 products, especially those that may appeal to children. The potential for accidental consumption by children and over-consumption by adults has prompted the FDA to focus on products representing the greatest risk.
Targeting
Earlier this year, both the FDA and the Federal Trade Commission (FTC) targeted companies in several states for their online sales of products containing delta-8 THC, a psychoactive compound found in hemp. This compound is being manipulated by some producers to create high-concentration delta-8 through a lab-based process using hemp-derived CBD. The effects of delta-8 are reportedly milder than those associated with the more common variety of THC found in marijuana, delta-9 THC.
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