Will FDA assert jurisdiction over CBD products?

The Food and Drug Administration (FDA) will soon address claims that marijuana has medical benefits. Many users of cannabis insist that cannabinoids in the plant — like cannabidiol (CBD) and THC — have therapeutic benefits.

FDA Commissioner Scott Gottlieb spoke on the issue at an unrelated Congressional hearing earlier this month.

“I see people who are developing products who are making claims that marijuana has antitumor effects in the setting of cancer,” Gottlieb told the House panel, according to Bloomberg. “And I think reasonable people can ask reasonable questions about whether marijuana is a chemotherapeutic agent.”

“It’s a much broader question about where our responsibility is to step into this and start to ask questions about the claims that are being made,” the commissioner added. “We’ll have some answers to this question very soon, because I think we do bear responsibility to start to address these questions.”

“As a result, all state-legal medical cannabis businesses should be aware that FDA intervention may be imminent.”

While 29 states and the District of Columbia have legalized cannabis in some form, it remains illegal federally. And the Drug Enforcement Administration, which enforces drug laws, even views non-psychoactive CBD as a Schedule 1 drug — the category that is supposed to represent the most dangerous and least beneficial drugs.

According to an attorney who specializes in marijuana law, a review of cannabis medical benefits by the FDA could shut down the CBD business quickly by requiring makers to submit products to clinical trials, which can cost millions or even billions of dollars.

“And what would likely go down in the event your medical cannabis products are ever viewed as drugs by the FDA?” asks Hilary Bricken of Los Angeles law firm Harris Bricken. “The FDA’s efforts to pursue and shut down interstate CBD sellers tells us that it would likely be a short and swift ending for most state-legal medical cannabis businesses unless they have buckets of cash and time to get through formal, comprehensive drug trials.”

“As of now,” Bricken added, “the FDA has kept its nose out of state-legal medical cannabis and it remains a sleeping giant, but change may be on the horizon given the FDA’s recent spike in feeling a ‘responsibility’ to answer whether cannabis has medical benefits in certain contexts. As a result, all state-legal medical cannabis businesses should be aware that FDA intervention may be imminent.”