FDA Holds Hearings on CBD

May 31, 2019

For weeks, the elite of the cannabis trade have been badgering the Food and Drug Administration for a coveted speaking slot on Friday at the agency’s summit on cannabis-derived consumer goods.

 

Blue-chip lawyers were rejected. Scientists were spurned. The agency finally created a complex lottery system to whittle down the list from 400 applicants to just over 120. They were given between two and five minutes to make their case. Only some are permitted slides.

 

The U.S. Hemp Roundtable nabbed a spot, as did purveyors of cannabis-spiked soft drinks, gummy bears, dietary supplements, and something called Hempy Pet CBD Soft Chews, “specially formulated to help canines with pain, inflammation, anxiety and other age-related issues, and also to manage symptoms in dogs with cancer.”

 

 

The F.D.A. has been skeptical of the burgeoning cannabis industry, but it is under increasing pressure from Congress to ease the path to market for cannabis-derived products. These products are different from medical marijuana, which is allowed by a growing number of states to treat severe pain, nausea and other ailments.

 

Today, cannabis companies — many of which are already selling their goods in stores and online — will try to convince the F.D.A. to let them do so legally. Currently, CBD is not allowed in dietary supplements or foods, but the F.D.A. tends to overlook these infractions.The F.D.A. will not decide anything until later, but it could eventually end up ordering some products off the market.

 

“I don’t think that CBD is doing anything approximating what people are purporting is its magic quality,” said Dr. Scott Gottlieb, who stepped down as F.D.A. commissioner in April. “It’s a real safety issue here. There are risks of accumulated effects. It’s not a completely benign compound.”

 

“There’s a very limited understanding of what would be considered a safe amount of CBD to be consumed outside of a physician’s care,” said Justin Gover, chief executive of GW Pharmaceuticals, the parent company of Greenwich Biosciences, whose cannabis-based drug, Epidiolex, was approved last year to treat seizures associated with two rare forms of epilepsy. “There should be in our view a clear differentiation between FDA-approved medicines derived from cannabis, like Epidiolex and any form of CBD taken without a physician’s supervision,” he added in a clearly self-serving comment.

 

“It’s a wild West kind of environment right now,” said Yasmin Hurd, a psychiatry professor at the Icahn School of Medicine at Mount Sinai in New York City, who has researched CBD for almost 10 years. “I’m inundated every day with patients wanting to know how much CBD they should take, which ones to buy. But we don’t know what’s in the stuff now being sold. . . . We’ve had this explosion without guidance to the public or regulation.”

 

More than 120 people were scheduled to speak at the FDA’s packed, all-day hearing Friday, including manufacturers, academic researchers, consumer advocates and legal experts. The shape that new regulations may take and how long the FDA will need to figure that out, however, remain unclear — to the frustration of almost everyone with a stake, including companies, consumer advocates, researchers and patients.

 

CBD can be derived from the marijuana plant or hemp. Congress in December legalized hemp as part of the Farm Bill, clearing the way for industrial production of the nonintoxicating compound from that plant.

 

But CBD continues to be illegal in many of the products now being sold under the Federal Food, Drug and Cosmetic Act, which bars sale of an active ingredient in already approved drugs, in dietary supplements or foods across state lines.

 

After Congress legalized hemp, the FDA quickly made it clear to companies that CBD remained under government regulation. In recent months, the agency sent warning letters to some companies that it said were “illegally selling CBD products that claimed to prevent, diagnose, treat, or cure serious diseases, such as cancer.”

 

“For years now, the agency’s position has been just to throw up their hands and say it’s a confusing issue,” said Daniel Fabricant, a former FDA official overseeing dietary supplements, who is now chief executive of the Natural Products Association representing the supplement industry.

 

In addition to Friday’s hearing, the FDA has set a deadline of July 2 for written comments on the issue. It also convened a working group led by Deputy Commissioner Amy Abernethy to explore ways CBD products might be sold legally, the impact of such products on public health, and whether new FDA rules or congressional legislation may be needed.

 

 

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