Will FDA Assert Jurisdiction Over CBD Products?

Scott Gottlieb says the FDA has a responsibility to weigh in on cannabis medical benefits

CBD molecule on a medical tablet

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.”

Jim McDonald

I spend most of my time studying the regulatory, legislative and scientific challenges to vaping, advocating for our right to exist, and talking with others who do the same. Consider me a source for information, and feel free to agree or disagree with anything I say. I love good coffee and sweet Michigan cherries. My childhood hero was Gordie Howe.

  • Tony

    This is a great topic Jim. Nice work. I wonder if these “regulators” you mentioned are discussing that there is a vast distinction between Industrial Hemp and Cannabis. After all, most CBD products being sold nationwide are derived from hemp, rather than Cannabis. Not to mention, The Federal Legislation known as the Farm bill, basically allows the cultivation of Industrial Hemp once again in U.S. and of course Cannabis is legalized at the state level where in most cases, these laws were approved by the voting residents of those states. This would be one huge mess. Oklahoma, Nebraska and some other shit-kickin state tried to sue Colorado when we first legalized recreational use – their claims were that now there was more trafficking of marijuana across state lines into their state – well, long story short, the Supreme Court tossed their case. So, I’d be very interested to see anyone try to go after something that has been generating billions in tax revenue for Colorado, which is a state with a population smaller than the Top 10 cities in America. Henceforth, this money-maker for private business and government (who collects double the taxes in CASH), it seems highly doubtful anyone will even be allowed to rattle this cash flow. Then again, we’ve seen crazier things happen.