Professor Lietzan continues to write about the FDA regulation of CBD products

In a recent editorial for Drug Discovery Today, “A special exception for CBD in foods and supplements?”, Professor Erika Lietzan and co-author Patricia J. Zettler,  write about the emerging cannabidiol (CBD) market. They explain that most foods and dietary supplements containing CBD – even CBD from hemp — violate FDA’s “drug exclusion rules.” FDA has not been taking enforcement action, however, and it is apparently considering whether to exempt CBD from the drug exclusion rules altogether. Lietzan and Zettler argue that FDA should explore the implications of enforcement, on the one hand, and exemption, on the other hand, rather than simply defaulting into exemption because of the large number of CBD products already on the market. This editorial follows on the heels of Lietzan’s exhaustive article, with co-author Sean M. O’Connor, on FDA regulation of the full range of possible cannabis products, The Surprising Reach of FDA Regulation of Cannabis, Even after Descheduling. As a recent InvestorPlace article pointed out, Lietzan and O’Connor explain that the success of the cannabis industry hinges on decriminalization of cannabis (under the Controlled Substances Act) as well as public perception of the acceptability of the product. The thrust of their article, however, is that advocates of legalization may not be fully aware of the comprehensive FDA regulatory framework – including the drug exclusion rules – that also apply to cannabis derived products.