For the first time, on May 31, 2019, the U.S. Food & Drug Administration (FDA) held a public hearing to inform its regulatory approach on cannabidiol (CBD). More than 400 groups and individuals applied to speak before the agency panel and more than 100 speakers testified during the 10-hour long hearing.
The hearing served primarily as a listening exercise for the agency and did not result in any substantive consensus surrounding CBD regulations. However, it marked an important step toward providing some much-needed legal clarity in the U.S. CBD market. A diverse stakeholder group was in attendance which included hemp farmers, manufacturers, veterinarians, grocers, patient advocates, dermatologists, concerned citizens, and researchers.
During the panel, FDA regulators made a clear distinction between the legality of hemp farming, authorized by the 2018 Farm Bill, and the developing regulatory framework surrounding CBD extracts and their sales, noting that it would convene a working group to develop key strategies for legally bringing CBD to the market and understanding potential public health impacts.
As things stand today, the FDA prohibits the sale of CBD-infused food and dietary supplements in the U.S., despite the cannabinoid’s growing popularity and demand across the nation. Regulations surrounding topical, pet-specific and inhalable products continue to be unclear as they were left out of the FDA’s press release and subsequent communications, though cosmetics and ingestibles do fall under the agency’s purview. Though doctor-prescribed childhood epilepsy medication Epidiolex is the only CBD product explicitly federally authorized to be sold to patients, all of the products listed above continue to be sold across the country, especially in more CBD- and canna-friendly territories where state legislatures have specifically authorized their sale (with varying regulatory and safety standards), making the establishment of a clear national regulatory framework all the more pressing.
While the agency appears to recognize the importance of making progress on this framework, during the hearing it repeatedly cited concerns with the lack of data and research about CBD and its effects. Stakeholders, too, listed a range of concerns (and many offered suggestions) with regard to the need for quality standards, labeling laws, dosing limits, understanding the effects of long-term use, and the difficulty of verifying content and guaranteeing results. Advocates urged the FDA to build on the expertise gained by states and localities that have already begun working to establish quality standards and policies for CBD testing, as opposed to reinventing the wheel.
While much debate remains as to how the regulations will ultimately be written, there was clear consensus that the need for regulations exists. A recurring theme of the hearing was that there are many products on today’s market that are not being reviewed for consumer safety, a concern that could jeopardize the health of consumers as well as the success of the industry.
What remains to be seen is how the FDA will process the information gleaned thus far, and within what timeframe – two questions whose results will have tremendous implications for CBD businesses across the country, as well as the industry’s mainstream growth prospects.
