When addressing the Food and Drug Administration’s (FDA) reluctancy to develop new regulations for cannabidiol (CBD), FDA Commissioner Robert Califf testified before a House Appropriations subcommittee, on May 19, 2022, stating, “I don’t think the current authority [FDA] ha[s], on the food side and the drug side, necessarily gives us what we need to have to get the right pathway to move us forward.”
Califf’s testimony follows previous agency statements suggesting that FDA would take action to regulate CBD. In April 2019, former FDA Commissioner Scott Gottlieb announced “a number of important new steps and actions to advance [the FDA’s]consideration of a framework for the lawful marketing of appropriate cannabis and cannabis-derived products under our existing authorities.” Contrary to previous indications, Califf’s May 2022 testimony suggests the agency is not going to take action to regulate the marketing of products containing cannabinoids without an expanded congressional authorization.
In December 2018, Congress passed the Agriculture Improvement Act of 2018 (Farm Bill). The Farm Bill removed hemp, which is cannabis with extremely low (0.3 percent or less) concentrations of delta-9-tetrahydrocannabinol (THC)1, from Schedule I of the Controlled Substances Act. The Farm Bill allowed the marketing of hemp and derivatives. But pursuant to the Food, Drug & Cosmetics Act (FDCA), it is currently illegal to introduce or market food or supplements containing CBD, regardless of whether the substances are hemp derived. The FDA-approved prescription medication Epidiolex is the only legal CBD product in the U.S. Nonetheless, many CBD products are marketed, including many with medical claims. Consequently, consumer confusion surrounding the legality and safety of CBD products has increased.2
Given the FDA’s apparent unwillingness to regulate consumer cannabinoid products without new authority, it is necessary for Congress to specify in law how it intends for the FDA to regulate cannabinoid products that are not FDA-approved medications. More information on cannabinoids, their legal status, and potential health effects, is set forth in Aimed Alliance’s Cannabinoids: A Fact Sheet for Consumers.
- 7 US Code Section 1639o https://www.law.cornell.edu/uscode/text/7/1639o
- New York Times, https://www.nytimes.com/2019/05/06/us/cbd-cannabis-marijuana-hemp.html
Last Updated on October 4, 2022 by Aimed Alliance
