Cannabis stocks were mostly higher on Monday, after the U.S. Food and Drug Administration said it is expediting its effort to create a regulatory framework for CBD with plans to publish a report on its progress by early fall.
Amy Abernathy, acting chief information officer, said in a series of tweets sent on Friday that the agency is “expediting its work to address the many questions about cannabidiol. This is an important national issue with public health impact, and an important topic for American hemp farmers and many other stakeholders.”
The FDA is still working its way through the public comments posted after more than 100 speakers presented at a May 31 public hearing on the subject, she said, urging anyone who still plans to submit information to do so by Tuesday.
CBD, a non-psychoactive ingredient in cannabis, is widely held to have wellness properties and to help treat a range of complaints, from pain management to inflammation to anxiety. But the FDA cannot allow companies to add it to food and beverages, because it’s the main ingredient in the only FDA-approved cannabis-based drug, GW Pharmaceuticals PLC’s GWPH, -0.33% Epidiolex, a treatment for severe childhood epilepsy. That makes it a drug in the FDA’s eyes, and means it would require research and trials to determine its efficacy and safety.
But with many companies anxious to launch products containing CBD, the FDA has come under pressure to devise rules sooner, rather than later. Clinical trials typically take several years to complete. Former FDA Commissioner Scott Gottlieb proposed congressional action to speed things up, based on using very low doses of the substance.
Companies are selling topicals and oils containing CBD, which the FDA is tolerating, as long as they don’t make exaggerated health claims.
The company surprised with a loss and revenue miss, which it said was related to how Ontario, Canada’s most populous province orders pot and the dearth of retail stores there, as MarketWatch’s Max A. Cherney reported.
Organigram Chief Executive said on the earnings call that the increased costs were due to an ultimately unsuccessful experiment it conducted with how it planted new harvests.