SILVER SPRING, Md. — By 10:30 a.m., a panel of the Food and Drug Administration’s top regulators had already heard from more than 50 different people, all eager to squeeze their hopes or concerns about CBD, the booming marijuana-adjacent compound companies are suddenly adding to everything from dog food to dietary supplements, into the short speaking time they were granted.

There were mothers claiming marijuana drove their children to suicide, millennial entrepreneurs who struggled for a good answer when regulators asked what effect CBD has in cosmetics, and high-paid industry lawyers pitching well-vetted regulatory frameworks. More than 60 more people were still scheduled to speak.

The wide range of participants, from former FDA officials to CBD retailers, didn’t seem to agree on much, except for one point: The status quo wasn’t working, and the FDA had to act fast.

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Friday’s meeting, the agency’s first-ever public hearing on the regulation of cannabis-derived products, is the public kickoff of the FDA’s quest to sketch a clear framework to regulate CBD products.

The FDA’s existing rules make that task perplexingly difficult. CBD dietary supplements, a broad category that includes many of the most popular CBD products, like capsules and oils, are currently illegal under the FDA’s rules. But the FDA has pledged to explore how those products could legally come to market, and Friday’s meeting was the first step in that endeavor.

Former FDA Commissioner Scott Gottlieb has said previously said it would take years for the agency to figure out exactly how it will regulate CBD. And while Acting FDA Commissioner Ned Sharpless made no promises in remarks Friday about when the agency might have an answer to that question, he made clear he thinks the FDA is entering uncharted territory.

“While we have seen an explosion of interest in products containing CBD, there is still much that we don’t know,” Sharpless said.

That didn’t stop speakers on all sides of the CBD debate from urging the FDA to hurry up.

Dietary supplement lobby groups groused that FDA was allowing an underregulated shadow market of CBD makers to unfairly compete with their more closely regulated products.

“FDA does not have the luxury of time,” Megan Olsen, assistant general counsel of the dietary supplement lobby the Council For Responsible Nutrition said. “They must act quickly to address the market that is out of control.”

CBD advocates, too, called for clearer rules. “There is an urgent need for an efficient regulatory framework,” Jonathan Miller, general counsel of the U.S. Hemp Roundtable said, who said his association, which represents many of the top CBD producers, is willing to work with the FDA “to help the agency establish measures of quality safety and transparency for the entire industry.”

Among the concerns raised both by FDA officials and industry speakers: Whether allowing CBD products to be regulated under the FDA’s lax dietary supplement rules would disincentivize the more rigorous research required before an FDA-approved drug can be put on the market.

Perhaps no company made this point more strongly than Greenwich Biosciences, the company behind Epidiolex, the first FDA-approved CBD-based drug.

“The FDA approval process is the only way to answer important questions about a drug, about the disease it seeks to treat, and safety considerations that are unique to the patient who will take the drug,” said Alice Mead, the company’s vice president of U.S. professional relations. “For example, no one knew CBD was potentially toxic to the liver until we conducted clinical and preclinical studies. To answer such questions, we’ve spent the past 20 years researching this plant.”

FDA officials were clear what they wanted from the public: more data. Speaker after speaker was asked to submit the sorts of well-controlled studies FDA regulators have come to expect when dealing with the more established pharmaceutical and medical device industries.

But CBD makers, it seemed, were new at this. Seemingly basic questions from FDA regulators, like: What exactly is a “full spectrum” hemp oil? How young is too young for exposing consumers to CBD? And is CBD psychoactive? all went largely unanswered from speakers.

Perhaps nowhere was that more apparent than when the co-chair of FDA’s CBD working group, Lowell Schiller, pressed James Shults, who was speaking on behalf of a CBD cosmetic company, Wildflower Brands, for a clearer definition of what it meant for a CBD cosmetic to be “more effective” as a beauty product.

Shults demurred, claiming that the product promotes “a higher sense of personal attraction,” which he admitted was not a “clinical definition.”

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    • sorry, what?
      1. you realize that opioids predate the FDA by thousands of years, right?
      2. what does a non-psychoactive component of marijuana have to do with opioids?
      3. should CBD remain unregulated or should FDA step up and follow its mandate?

  • If the FDA only seeks scientific data, the many benefits of CBDs (single or as CBD blend) will remain in the in-accessible dark (or the undergroud market) for more decennia = far too long for many who should be legally allowed to benefit NOW. The CBD group is a thus far black-balled power-house that ought to be in a new Category, off of Schedule 1, on its own, for which Epidiolex-type research should not apply or be required. The plant has been used for milennia, tauted for its countless benefits, and the fact that users have better lives with less (chronic) pain / fewer epileptic attacks / greater attention spans / better sleeps / calmer guts / etc, and livers that are still just fine, is not just in the users imagination, and SHOULD speak for itself. Not every merit needs to be exactly quantified by super-defined CBD content – as the current FDA system requires. The FDA should be more creative (= less archaic), with cannabis decriminalized, and in a category on its own, with a different approach to acceptance and use – like with acupuncture, physiotherapy, chiropractic – all hyper beneficial yet not 100% scientifically explained.
    As a pharmacy student in The Netherlands I studied this plant, 40 years ago. The FDA has to catch up hard and fast, and not stick to antiquated questioning or systems. The meeting was a first eye-opening step to the realization that this institution must treat the cannabis plant and its merits differently.

  • I’ve been a systems analyst consultant for Group Health HMO and Insurance models. As both a systems analyst and a patient and a mostly retired old guy with managed pain I am most interested in something I can afford AND is effective AND not damaging. I would be very interested in something that can relieve the pain of CRPS (RSD). And there is the rub. To do me any good I need it soon, before I die from something or another. I can’t wait 20 more years. Part of the problems is that for tracking results one it is necessary to know what you are tracking, especially if there are multiple possible definitions. If there are arbitrarily, 20 different cannabinoids that might be included in various percentages, we need to need to be able to specify each specific item as part of a mix, and with the right data and logic design, the differences will be seen in the wash, or not, which is also important, as well as all the secondary symptoms that appear. Then considering the data as a Monte Carlo simulation some tendencies can be seen. If it irritates the skin that would show up, or maybe who gets irritated skin because they have “pattern X” whereas pattern “Y” gets clear skin. However we figure out if it is any good or not is a different problem than defining the differences between “types” of mixes or something. We data analysts need defined substances even if they are just numbered like CBD1 to CBD20. We are another interested party since Everybody wants to know the results of this brand new methodology that needs to be created for this.

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