06.03.19
If you thought the FDA would have a productive, consequential hearing regarding cannabis and cannabidiol-based products, you must be smoking something. The US Food and Drug Administration's first hearing on cannabis and its nonintoxicating ingredient CBD took place on May 31, with more than 100 speakers offering views, including researchers, health professionals, advocates, manufacturers and opponents. The hearing came after hemp was legalized in the 2018 Farm Bill, leading to a crop of hemp-based products being sold online and in stores, including at mom-and-pop stores. But CBD, which is widely held to have wellness properties, particularly in treating pain, inflammation and anxiety, was not included in the lifting of the federal ban and was instead placed under the regulatory purview of the FDA. That’s because it’s the key ingredient in the only cannabis-based drug to win FDA approval, GW Pharmaceuctical’s PLC’s Epidiolex, a treatment for severe forms of childhood epilepsy.
The FDA has warned companies that because it views CBD as a drug, it can't be added to food or beverages or marketed as dietary supplement in interstate commerce. Yet, FDA said that give the strong public interest in CBD as a wellness aid, it seek to help provide pathways to regulatory approval.
The hearing “highlighted the messy state of the industry, with widespread use of CBD products with minimal standardization, evidence for benefit and understanding of safety profile,” said Evercore ISI analysts led by Josh Schimmer in a note to clients. “Considering the extent to which the CBD cat is out of the bag, it remains to be seen how the FDA will regulate this industry; it might not have adequate resources to fully monitor and police it.”
Like so many other FDA hearings, this one was rife with speakers making outlandish claims about the benefits of CBD. Yet, nearly all of them agreed that there is a need for quality testing and safety standards, as much of the CBD currently available is substandard or mislabeled with incorrect amounts of CBD or even THC, the intoxicating ingredient in cannabis, as well as impurities including pesticides and bacteria. Sounds like a sweet deal for testing companies!
Like so many other FDA hearings, this one was rife with speakers making outlandish claims about the benefits of CBD. Yet, nearly all of them agreed that there is a need for quality testing and safety standards, as much of the CBD currently available is substandard or mislabeled with incorrect amounts of CBD or even THC, the intoxicating ingredient in cannabis, as well as impurities including pesticides and bacteria. Sounds like a sweet deal for testing companies!
