Only one drug containing cannabidiol (CBD) has been approved by the FDA — for treatment of rare and severe forms of epilepsy — and the agency is worried by the tide of products that tout CBD as a tonic. The FDA warned against use of unapproved products at the same time it said on Tuesday that it was exploring ways for CBD products to be marketed lawfully.
“The FDA is working quickly to further clarify our regulatory approach for products containing cannabis and cannabis-derived compounds like CBD while using all available resources to monitor the marketplace and protect public health by taking action as needed against companies,” said the agency’s principal deputy commissioner, Dr Amy Abernethy. “We recognize that there is significant public interest in cannabis and cannabis-derived compounds; however, we must work together to fill in the knowledge gaps about the science, safety and quality of many of these products.”
The 2018 farm bill legalized cultivation of industrial hemp and the USDA aims to release regulations in time for the 2020 growing season. At present, CBD is driving the market for hemp. The FDA said last month that it was expediting its work on CBD regulation.
On Tuesday, the FDA and the Federal Trade Commission posted a joint warning letter to a Florida company that said, without proof, its CBD products treated diseases and conditions such as ear aches, autism and Alzhiemer’s disease. It was the latest in “numerous warning letters,” said the FDA, against products which were not evaluated for effectiveness, proper dosage or possible side effect with medications.