- Media outlets are reporting that a Farm Bill provision removing industrial hemp (Cannabis sativa L.) from Schedule I of the Controlled Substances Act will change the FDA status of cannabidiol (CBD) in foods. However, the relevant provisions under Subtitle G (“Hemp Production”) affect only the Drug Enforcement Administration’s (DEA’s) authority over hemp farming and allow states to exercise authority over industrial hemp production.
- The 2018 Farm Bill, which passed the Senate on December 11 and the House on December 12, does not affect FDA’s authority to regulate CBD or other hemp products, or change the regulatory requirements for such materials in FDA-regulated products like food, dietary supplements, cosmetics, or drugs. In fact, Section 297D, paragraph (c)(1) (“Regulations and Guidelines; Effect on Other Law”) states “nothing in this subtitle shall affect or modify the Federal Food, Drug, and Cosmetic Act.”
- FDA has stated on its “FDA and Marijuana: Questions and Answers” website that CBD is not permitted in food (including dietary supplements) and has sent warning letters to companies marketing CBD products for food uses. Thus, companies that wish to market CBD-containing foods, dietary supplements, or cosmetics are still at risk of FDA enforcement action unless they can develop an appropriate regulatory status for CBD in those products. Through its regulatory procedures, in June 2018, FDA approved Epidiolex, a drug product containing CBD as the active ingredient, as a treatment certain forms of epilepsy.