On May 31, 2019, the U.S. Food and Drug Administration (FDA) held a widely anticipated public hearing with stakeholders on cannabis and cannabis-derived compounds to gain insights on product safety and a potential regulatory framework for products containing such substances. The hearing focused on cannabidiol (CBD)—a popular but controversial compound that has been added to products ranging from tinctures and lotions to sodas and ice cream. Interest in the product was spurred by the passage of the 2018 Farm Bill, which removed hemp (cannabis plants with less than 0.3% THC content) from the Controlled Substances Act. The Farm Bill also complicated FDA’s role in regulating CBD because although the substance was de-scheduled by Congress, the Agency still regulates it as a drug—meaning that any consumer product with CBD is technically a misbranded drug in violation of FDA rules. While the Agency has taken limited actions against companies using CBD as an additive, FDA has reiterated its authority to do so if and until regulatory changes are made.

At the hearing, CBD proponents claimed the compound has beneficial and even therapeutic properties, including relieving pain, reducing anxiety and aiding sleep. But others suggested that the industry is rife with fraudulent marketing and potentially dangerous products contaminated with excessive levels of CBD, THC and even dextromethorphan, an active ingredient in cough syrup. Most participants agreed that FDA should step in to set a regulatory framework for the industry but differed on how this should be achieved. FDA officials posed follow-up questions to presenters that highlighted the Agency’s pressing concerns, including the safety data available to address dosing, drug interactions, side effects and use in special populations. While the Agency is clearly taking a hard look at changing the rules for CBD, FDA did not signal if or when any regulatory changes would be implemented—which, if done under the typical time frame for FDA rulemaking, could take several years.

Reporting provided by Shook Associate Margaret Horn.

About The Author

Avatar

For decades, manufacturers, distributors and retailers at every link in the food chain have come to Shook, Hardy & Bacon to partner with a legal team that understands the issues they face in today's evolving food production industry. Shook attorneys work with some of the world's largest food, beverage and agribusiness companies to establish preventative measures, conduct internal audits, develop public relations strategies, and advance tort reform initiatives.

Close