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Monday, June 3, 2019

FDA hearing on CBD finds conflicting views

Cannabis stocks were mostly lower Monday, as investors digested the first reports from Friday’s regulatory hearing on cannabis and its ingredients and the news that Illinois is legalizing weed for adult recreational use.
The U.S. Food and Drug Administration conducted its first-ever hearing on cannabis and its nonintoxicating ingredient CBD all day Friday 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 GWPH, +2.05%  Epidiolex, a treatment for severe forms of childhood epilepsy.
The FDA has warned companies that because it views CBD as a drug, it cannot be added to food or beverages or marketed as a dietary supplement in interstate commerce. But it has also said that given the strong public interest in CBD as a wellness aid, it will 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.

The discussion was “at times quite absurd with outlandish claims, inconsistent messages and an undercurrent of potential safety concerns,” said the analyst. It was however quite favorable for GW Pharma, as the FDA made clear that it wants to ensure the substance continues to be subjected to clinical research, he wrote. GW Pharma shares offered a rare glimpse of green in the cannabis sector Monday, gaining 1.1%.

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