These are confusing times as we enter new territory regarding businesses in the marijuana and CBD industry. Many are left with questions, so the Food and Drug Administration (FDA) has issued frequently asked questions with responses related to marijuana and CBD, as they are attempting to clarify their role and guidance in the ever-changing industry. The FDA is only one agency with regulatory requirements. It also is advised to refer to other federal and state agency laws, regulations, and guidance for their marijuana and CBD requirements to remain in compliance.
Based on the FDA guidance, a few items to highlight include:
- As of April 2, 2019, the FDA had not approved a marketing application for cannabis for the treatment of any disease or condition; they have approved one cannabis-derived (Epidiolex) and three cannabis-related (Marinol, Syndros, and Cesamet) drug products
- The FDA states that products containing the active ingredients of THC or CBD cannot be sold as dietary supplements or added to food (in most cases)
- They have sent warning letters to some companies “illegally selling CBD products that claimed to prevent, diagnose, treat, or cure serious diseases;” these warning letters can be found at https://www.fda.gov/news-events/public-health-focus/warning-letters-and-test-results-cannabidiol-related-products and illustrate the FDA’s position on marketing of CBD products out of compliance with the Federal Food, Drug, and Cosmetic Act; They can possibly serve as examples on what is not allowed when evaluating companies who market CBD products
- A December 20, 2018 statement from the FDA commissioner announced that “the agency has completed our evaluation of three Generally Recognized as Safe notices related to hulled hemp seeds, hemp seed protein, and hemp seed oil and that the agency had no questions regarding the company’s conclusion that the use of such products as described in the notices is safe. Therefore, these products can be legally marketed in human foods for these uses without food additive approval, provided they comply with all other requirements and do not make disease treatment claims.”
The December 2018 statement and FDA frequently asked questions – FDA Regulation of Cannabis and Cannabis-Derived Products: Questions and Answers could be useful as your institution investigates and implements policies and processes for banking customers that participate in the marijuana and CBD industry. Contact Richard Dugas at KPM with additional questions.