Americans are consuming the cannabis derivative cannabidiol (CBD) in food, beverages, and supplements, and dosing their pets with it as well, but “there is still much that we do not know about … potential risks,” said FDA commissioner Stephen Hahn on Thursday. The agency may adopt a risk-based enforcement policy aimed at misleading claims and unlawful CBD products that pose a health risk to consumers.
“Any enforcement policy would need to further the goals of protecting the public and providing more clarity to industry and the public regarding the FDA’s enforcement priorities while we take potential steps to establish a clear regulatory pathway,” said Hahn. So far, only two epilepsy drugs containing CBD have won FDA approval. Hundreds or thousands of CBD products are sold in a regulatory gray market.
Farmer interest in hemp has been amplified by reports of high revenue from sales to CBD processors. Hemp also can be used in apparel, biocomposites, food, and livestock feed, although at lower farm-gate prices.
By legalizing industrial hemp, the 2018 farm law created the opportunity for research and the development of new public information about low-THC cannabis and derivatives such as CBD, said Hahn. “To this end, in the coming days, we are reopening the public docket we established for our May 2019 public hearing. The docket provides a valuable conduit for submission of scientific data on CBD to the agency.” The 2019 hearing covered medical marijuana and hemp-derived extracts such as CBD.
The FDA has periodically warned vendors against making unsubstantiated claims about CBD, including that it will cure serious diseases, such as cancer.