Kimzy Nanney

FDA Update Offers No New Guidelines for CBD

Three weeks after its first public hearing on cannabidiol, the FDA says it will apply a “rigorous and science-based approach” to devising CBD regulations; however, despite the quickly growing marketplace, the agency has not yet set any official guidelines.

Full story after the jump.

In a lengthy news release, the Food and Drug Administration said they would apply a “rigorous and science-based approach” in devising regulations for CBD. The update comes three weeks after the agency held its first public hearing on the cannabinoid.

The release, authored by Dr. Amy Abernethy, principal deputy commissioner, and Lowell Schiller, principal associate commissioner for policy, indicates that while the agency recognizes the “significant public interest” in CBD products, “there are many unanswered questions about the science, safety, and quality of many of these products.”

“The FDA’s approach to cannabis and cannabis-derived compounds has been consistent. We treat substances derived from cannabis just like we do any other substances, and they are subject to the same authorities as any other substance. That said, some other relevant laws have changed, and so has the market.” – FDA officials, in a press release

The authors note that the agency has approved the cannabis-derived CBD pharmaceutical drug Epidilox and, since the drug was under clinical trial prior to CBD being added to foods and dietary supplements, using CBD is such a manner is prohibited. The agency suggests they could issue a regulation to create an exception to allow CBD products in foods and dietary supplements; however, the authors stopped short of saying whether or not they would consider making that exception.

They also cite research by Greenwich Biosciences that alleges that CBD is potentially toxic to the liver – a finding that has been disputed by the CED Foundation, who note that the mice in the study were given the human equivalent of 42,050 milligrams of CBD, which they called “an unreasonable amount.”

“In the days where many people are taking 10mg pills of CBD per day, the amounts of CBD that were force-fed to these animals in this study, if translated to humans, would be 4,305mg, 12,915mg, and 43,050mg over 10 days, or 17,220mg, 51,660mg, and 172,200mg in one-shot doses.),” the foundation wrote in a June 20 rebuttal to a Forbes article by Mike Adams. “For reference, these days, most dispensaries sell CBD in doses of 10mg, 20mg, up to 2-300mg.)”

In their update, the FDA stopped short of offering any guidance for the CBD industry but, in an apparent nod to drugmakers, expressed concern that “widespread availability in products like foods or dietary supplements could reduce commercial incentives to study CBD for potential drug uses.”

The agency is still accepting public comments on CBD until July 16.

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