Barak Cohen, Andrew Kline, Thomas (Tommy) Tobin
As 2022 drew to a close, the Wall Street Journal reported that the FDA is finally considering releasing potential guidance regarding cannabidiol (“CBD”) in the coming year. While the exact timeline and scope of the FDA’s potential action is unclear, the Journal asserts that the agency will decide “within months” regarding the appropriate regulation of CBD and whether that regulation would require Congressional action or new agency rulemaking. Concurrently, the FDA continues to explore potential CBD safety risks.
The agency has generally pursued limited enforcement activity to-date regarding CBD, with a focus on products in foods and beverages that make unsubstantiated health claims, such as claims that CBD could treat or prevent cancer or Covid. Stopping short of taking aggressive action, the FDA has only issued warning letters on CBD, despite the widespread availability of largely-unregulated food and beverage products containing the hemp-derived cannabinoid.
In recent months, the FDA has taken additional steps ramping up its internal and external activity regarding hemp and cannabis in FDA-regulated products. The agency hired Norman Birenbaum, a former cannabis regulator in both New York and Rhode Island, as a senior advisor. The FDA also issued warning letters to certain manufacturers of products containing Delta-8 THC, an intoxicating hemp-derived cannabinoid that is currently being sold in the unregulated market without testing or age verification. Just last month, the FDA issued five warning letters to CBD beverage manufacturers for “selling CBD containing products that people may confuse for traditional foods or beverages which may result in unintentional consumption or overconsumption of CBD.” The agency emphasized that it was especially concerned with CBD-containing products in forms that are appealing to children, such as gummies, hard candies and cookies.
The Journal article represents the first media interview with the FDA’s Birenbaum, who emphasized that the agency cannot allow “the perfect [to] be the enemy of the good when we’re looking at such a vast market that is so available and utilized.” Birenbaum also underscored that the agency’s concern is with the widely-unregulated CBD market and cannabinoid products posing an immediate health risk.
In the coming months, the hemp and cannabis industries will closely monitor the agency for any hints for potential CBD guidance. Whether the FDA will focus solely on cannabinoid products presenting health concerns, or whether the agency will take a more comprehensive approach remains to be seen. But the hard truth is that hemp-derived products are currently being sold in the open marketplace with very little oversight. And, the lack of federal oversight is not a net positive for the health and safety of American consumers.