On November 16, 2022, the Food and Drug Administration (FDA) issued five new warning letters to various companies making edible products containing cannabidiol (CBD) and/or Delta-8-tetrahydrocannabinol (THC). The companies were directed by the FDA to respond within 15 days to defend how their products do not violate the Food, Drug, and Cosmetic Act (FDCA) and how they plan to bring their products into compliance with the FDCA. Failure to address the issue to the agency’s satisfaction could plausibly result in enforcement actions, including seizure and/or an injunction.
The FDA’s most recent set of warning letters builds upon warning letters sent earlier this year targeting CBD and Delta-8 THC products. Previously, FDA has largely focused on CBD products that made health claims. These new warning letters are not, however, limited to those prior concerns. The FDA now appears to be particularly concerned about CBD and Delta-8 THC products that appeal to children.
While CBD was de-scheduled in the Agriculture Improvement Act of 2018 (“2018 Farm Bill”), the FDA has repeatedly noted that marketing CBD, typically produced from hemp, as a food additive in interstate commerce violates federal law, namely the FDCA. Relatedly, Delta-8 THC is one of many cannabinoids produced in the cannabis plant (also typically hemp), and it can have psychoactive and intoxicating effects. Products containing Delta-8 are available in numerous forms, such as edibles, extracts, and tinctures. Manufacturers of intoxicating Delta-8 products are taking advantage of a loophole in the 2018 Farm Bill that de-schedules derivatives of hemp that test below 0.3% Delta-9 THC on a dry weight basis. However, it was clearly not the intent of the U.S. Congress to legalize intoxicating hemp products without regulation or oversight.
FDA’s letter to 11-11-11 Brands claims that the company’s herbal teas containing CBD are adulterated because they contain an unsafe food additive. The letter also asserts that the CBD-containing products could be confused with traditional foods, as the label fails to list CBD as an ingredient. Notably, the agency’s letter also asserts that the products violate the FDCA under its drug preclusion rule, as CBD is the active ingredient in the FDA-approved drug Epidiolex. Under the drug preclusion rule, active ingredients in FDA-approved drugs may not be added to food products. In the agency’s letter to Naturally Infused LLC, FDA indicated that the company is selling products containing CBD as well as products containing Delta-8 THC. Here FDA alleges, among other things, that these products are adulterated, misbranded, and unapproved new drugs sold in violation of FDCA. The agency focused its attention on the fact that the products, including lollipops and gummies, are potentially appealing to children and could be confused with traditional food products. FDA’s letters to Newhere Inc dba CBDFX, Infusionz LLC, and CBD American Shaman, LLC make similar assertions.
Over the past several years, FDA has warned the public regarding various illegally marketed CBD-infused products. We have written about the FDA’s prior CBD warning letters here and here. In addition, FDA has recently expressed serious concerns about products containing the hemp-derived cannabinoid Delta-8 THC. Specifically, the FDA issued a consumer update earlier this year concluding that Delta-8 THC has “serious health risks” and advising that consumers should know the following:
- Delta-8 THC products have not been evaluated or approved by FDA for safe use and may be marketed in ways that put the public health at risk.
- FDA has received adverse event reports involving Delta-8 THC-containing products.
- Delta-8 THC has psychoactive and intoxicating effects.
- FDA is concerned about the processes used to create the concentrations of Delta-8 THC claimed in the marketplace.
- FDA is concerned about Delta-8 THC products that may be consumed by children, as some packaging and labeling may appeal to children.
For the time being, it is unlawful federally to add CBD and Delta-8 THC to food products. Congress is debating multiple proposals to advance a legislative solution to the use of CBD in foods. For example, HR 6134 would ensure that foods and beverages containing hemp-derived CBD conform with FDA requirements for food additives or be generally recognized as safe (GRAS). A Senate bill, S 1698, permits hemp-derived CBD to be added to foods, beverages, and dietary supplements.
While federal officials continue to debate the appropriate regulation of CBD and Delta-8 THC in food products, we will continue to monitor FDA enforcement activity and the agency’s warning letters.
[View source.]
