Background
Since Congress removed hemp containing less than 0.3 percent delta-9 THC and its derivatives, including CBD, from the federal definition of marijuana in late 2018, FDA has sent multiple rounds of Warning Letters to companies marketing products in edible and topical forms that contain CBD.1 For the most part, FDA has focused its enforcement activity on products bearing aggressive drug claims (e.g., “May alleviate cancer-treatment symptoms. CBD may help with nausea, vomiting, and pain.”).2 In instances involving food products, FDA has consistently taken the position that CBD may not be legally added to conventional foods because of the ‘exclusionary clause’ in section 301(ll) of the FD&C Act. That clause prohibits the introduction into interstate commerce of any food containing the active ingredient in an approved drug or a drug for which substantial clinical investigations have been instituted and made public.3 Because FDA has approved a drug containing CBD, namely Epidiolex, FDA contends the addition of CBD to a food product is prohibited under the exclusionary clause.
Recent Warning Letters
On November 21, 2022, FDA made public five Warning Letters issued to companies for selling adulterated food products. According to FDA, the products -- which include gummies, fruit snacks, lollipops, cookies, teas and other beverages -- are adulterated under section 402(a)(2)(C)(i) of the FD&C Act because they contain CBD which is neither an authorized food additive nor generally recognized as safe.
The Warning Letters emphasize the safety concerns FDA has about CBD use, especially over the longer term. FDA notes that publicly available evidence suggests CBD may have potentially harmful effects on the male reproductive system and liver and interact harmfully with certain medications. FDA stresses the potential risks to children and comments that CBD-containing products that are sold in forms that are appealing to children (e.g., gummies, hard candies and cookies) are “especially concerning.”4 However, the agency’s focus is not limited to products sold in those forms. Other products named in the letters include infused tea, coffee and sparkling water, beverage “shots,” and honey, which FDA describes as “products that consumers may confuse with traditional foods for humans” posing a “risk of unintended consumption of the CBD ingredient by consumers.”
As noted earlier, FDA does not raise concerns about marketing claims in all of the letters. In several, FDA’s objections appear to rest solely on the presence of CBD in the product. That represents a departure from prior rounds of Warning Letters. In addition, the structure of these letters appears to have shifted. In the past, FDA’s legal objection to the presence of CBD in conventional foods rested in the first instance on the exclusionary clause. These letters focus first on adulteration, i.e., CBD is an unauthorized food additive that is not GRAS, and make only a secondary reference to the exclusionary clause.
Next Steps
We will continue to monitor federal regulatory developments involving the addition of CBD to food. Please contact us if we can be of assistance with this or similar topics.
Authored by Elizabeth Fawell, Andrea Bruce, and Molly Mulligan.
References
1 Section 10113 of the 2018 Farm Bill, Pub. L. 115-334 (December 20, 2018) (codified at 7 U.S.C. § 1639o-1639s).
3 21 U.S.C. § 331 (ll). A largely parallel provision bars the addition of an approved drug or drug for which substantial clinical investigations have been instituted and made public to dietary supplements. 21 U.S.C. § 321(ff)(3)(B).
