The cannabis industry is rapidly expanding around the world. Much of this expansion is due to innovation related to, and interest in, products containing cannabidiol (CBD). Despite widespread interest, the industry has largely been operating without any real federal regulation and guidance specific to CBD, and with only a patchwork of inconsistent and incomplete state regulations. That may be changing soon. Over the last month, the CBD industry has been the subject of a lot of regulatory activity, specifically from the Food and Drug Administration (FDA), which may be signaling forthcoming federal CBD regulations.

Zane Gilmer
Authored By: Zane Gilmer
Zane Gilmer is a partner with the national law firm of Stinson LLP. Zane practices out of the firm’s Denver, Colorado office. He represents individuals and companies in high-stakes litigation involving business and investment disputes. He handles class actions and cases involving fraud, mismanagement and regulatory compliance. He is also the chair of the firm’s cannabis practice group.

FDA Provided Report to Congress on the State of the CBD Marketplace
On July 8, 2020, the FDA submitted a report titled “Sampling Study of the Current Cannabidiol Marketplace to Determine the Extent that Products are Mislabeled or Adulterated” to the U.S. House and U.S. Senate Committees on Appropriations. This report identified two separate studies the FDA conducted related to products containing cannabis or CBD. The first study was conducted prior to the enactment of the 2018 Farm Bill. In this report, the FDA tested the CBD content of 74 CBD-related products sold for human consumption and 4 products sold for consumption by pets. In determining which products to select for testing, the FDA considered the following factors:- Products that made serious disease or medical claims;
- Products that were sold in multiple states (i.e., interstate commerce);
- Products that were readily accessible to consumers and available for online purchase; and
- Products that were the subject of previous consumer complaints or an adverse event report.
FDA Released Guidance Related to Conducting Research into Cannabis for Drug Development
On July 21, 2020, the FDA issued its “Cannabis and Cannabis-Derived Compounds: Quality Considerations for Clinical Research, Draft Guidance for Industry,” which sets forth the FDA’s positions concerning topics related to clinical research and development of drugs containing cannabis or cannabis-derived compounds. The draft guidance seeks comments and suggestions from interested parties, which must be submitted within 60 days. The guidance addresses the following issues:- Sources of Cannabis. Cannabis testing for purposes of clinical drug testing must meet all FDA requirements. The National Institute on Drug Abuse (NIDA) Drug Supply Program (DSP) is the only domestic federally legal source for cannabis containing over 0.3 percent THC to be used for clinical research. In light of the 2018 Farm Bill, however, cannabis containing less than 0.3 percent THC can be used for clinical research.
- Quality Considerations. New drug sponsors must be able to demonstrate they can consistently manufacture a quality product. At each research stage, sponsors must “submit sufficient information to ensure the identify, quality, purity, and potency or strength of the investigational drug.” The guidance further addresses some of the specific information sponsors should submit to demonstrate the quality of the products. In addition, the guidance sets forth a list of documents and principles sponsors should consider to ensure product integrity.
- Percent THC Calculation. The guidance states sponsors should first consult with the DEA to ensure compliance with the Controlled Substance Act and DEA requirements related to THC content levels of cannabis materials. The guidance further states sponsors should work with reliable laboratories to test THC levels.