Will FDA nix CBD in ‘Natural Products?’

February 15 from O’S News Service

An SCC member forwarded this item on Friday with the comment/question: “Thanks, GW?”  The article is by Todd Runestad and ran in newhope360, a site that covers the “Natural Products” industry. Here’s the kernel:

… once a drug has been recognized by the FDA, it can never become a supplement. And it turns out that GW Pharmaceuticals, based in the U.K., gained Investigational New Drug (IND) status and conducted a clinical trial on a CBD product in 2007, which allows a fast track for compounds for rare diseases where patients do not respond to any other conventional medicines. One GW Pharma product, Sativex, is 2.7 mg THC (the cannabinoid that gets you high) and 2.5 mg CBD. Another product, Epidiolex, is all CBD.

“I understand that it was part of the compromise when DSHEA [the Dietary Supplement Health & Safety Act] was enacted,” noted Alice Mead, vice president of U.S. professional relations for GW Pharmaceuticals. “It was between protecting the resources involved in pharmaceutical development and prescription meds and balancing that against legitimate dietary supplements, so if an IND underwent clinicals that were publicized, then dietary supplements couldn’t do an end run around it.”

In the warning letter to Healthy Hemp Oil, the FDA explained that all doors appear to be shut down. “There is an exception,” wrote the FDA, “if the substance was marketed as a dietary supplement or as a conventional food before the new drug investigations were authorized; however, based on available evidence, FDA has concluded that this is not the case for CBD.”

By Monday 2/15, as I write this, GW Pharmaceuticals’ stock on the London exchange had risen more than 6%.  

There’s plenty of relevant background in the new O’Shaughnessy’s.  See our lead story —specifically, the jump to page 31— and the transcript of the Senate Drug Caucus hearing (37-39).