FDA Holds First Public Hearing on Cannabidiol

Billions are at stake in how the FDA decides to regulate the compound…

With thousands of unproven products flooding the market, the Food and Drug Administration is convening its first public hearing Friday to wrestle with how to regulate cannabidiol (CBD), a cannabis extract already being sold in pills, tinctures, skin lotions, sodas and dog food.

The CBD industry has exploded in recent years as companies have trumpeted the compound’s alleged health benefits — claiming it can reduce anxiety, pain and insomnia and treat conditions from Parkinson’s disease to cancer. But almost all such claims lack rigorous scientific proof, prompting concern among health officials and scientists about safety and deceptive marketing.

“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.”

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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.”

Billions are at stake in how the FDA decides to regulate the compound, with business analysts projecting the industry could grow to be worth as much as $22 billion in the next five years.

Market research firm New Frontier Data estimated that sales of CBD products in the United States more than tripled between 2014 and 2017, to $367 million.

Retailers like CVS and Walgreens have announced plans to sell CBD lotions and creams. Food and beverage companies have eagerly jumped in, too, with burger chain Carl’s Jr. selling CBD-infused burgers. Full story at Washington Post

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