The U.S. Food & Drug Administration (FDA) is under increasing pressure to provide regulatory guidance for using hemp-derived cannabidiol (CBD) in food. Currently, there is no clear route forward, and the FDA rulemaking process will take years. While the recent FDA leadership change will likely complicate the process, FDA is taking the first steps to enact the necessary rules.
On December 20, 2018 the Agriculture Improvement Act of 2018, commonly known as the Farm Bill, was signed into law. Among other things, the Farm Bill made changes relating to the production and marketing of hemp and derivatives of cannabis with low (not more than 0.3 %) concentrations of the psychoactive compound delta-9-tetrahydrocannabinol (THC). These changes included legalizing hemp (and CBD derived from hemp) by removing it from Schedule I of the Controlled Substances Act.
While the Farm Bill removed hemp from the DEA’s purview, it preserved FDA’s authority to regulate it. The very day the Farm Bill became law, then Commissioner Gottleib made FDA’s position clear by issuing a statement that it is “unlawful under the FD&C Act to introduce food containing added CBD … into interstate commerce, or to market CBD … products as, or in, dietary supplements, regardless of whether the substances are hemp-derived.” This prohibition stems from the fact that CBD is an active ingredient in an FDA-approved drug (Epidiolex, approved for the treatment of epilepsy). However, in his statement, Gottlieb also acknowledged public and Congressional interest in the topic and noted that FDA intended to hold a public meeting “in the near future” concerning hemp products.
In recent interviews, Gottlieb indicated that the regulatory framework will be highly novel and could result in an extended approval process. Rule-making can take two to three years for conventional products – which cannabis-derived products are not. Gottlieb stated that the added complexities for CBD, due to its association with marijuana, its drug status and the fact that it has not previously been in the food supply, mean that it could take significantly longer to develop appropriate regulations. Gottlieb noted that the most efficient way forward is likely through CBD-specific legislation.
FDA has formed an internal working group to look into potential legislative pathways for CBD in food. The group will be co-chaired by Dr. Amy Abernethy (FDA’s Principal Deputy Commissioner) and Lowell Shiller (FDA’s Acting Associate Commissioner for Policy). Gottlieb stated he expected the working group to start releasing recommendations by the summer of 2019.
The start of 2019 saw a number of city and state bans and enforcement actions regarding CBD-containing foods. In response to the marketplace confusion caused by that activity, twelve members of Congress co-signed a letter to FDA in February 2019. The letter called for guidance on lawful pathways for food products containing CBD and pressed FDA to indicate when a public meeting on the topic would take place.
In March, regulatory uncertainty spiked when Commissioner Gottlieb unexpectedly announced his resignation. Before his departure, Gottlieb announced that the public hearing had been scheduled for May 31 and that FDA is taking a risk-based approach to enforcement of violative CBD-containing products.
Gottlieb officially stepped down on April 5, handing the reigns to Dr. Norman “Ned” Sharpless (previously the director of the National Cancer Institute) as interim Commissioner. Gottlieb’s departure may slow the CBD rule-making process, but momentum from Congress, consumers, and industry continues to grow. The question remains, how long will it take to define the path forward?