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WASHINGTON — The U.S. Food and Drug Administration heard Friday from more than 100 people representing marijuana businesses, lawyers, state agencies and patient groups as it considers whether, or how, to regulate hemp-derived cannabidiol, better known as CBD.
The day-long hearing came at a time when manufacturers are adding CBD to numerous consumer products and some are making unsubstantiated health claims about the ingredient. The agency also is accepting written comments through July 2.
“Finally, the federal government is taking meaningful steps to get a grasp on the industry,” said Mike McQueeny, who co-chairs Genova Burns’ cannabis law practice group. “Regulation takes time and in the interim there is a huge flood of products in the marketplace.”
While hemp, the non-psychoactive cousin of marijuana, was legalized in the 2018 farm bill, the FDA said the bill specifically preserved its authority to regulate all products containing cannabis or cannabis-derived compounds.
A lot is riding on the FDA’s decision. The National Cannabis Industry Association estimated that the CBD industry could grow to $16 billion in five years, directly or indirectly supporting as many as 278,000 jobs.
“Hemp-derived CBD products are in very high consumer demand and the industry is eagerly awaiting FDA’s regulatory framework for these products,” said Andrew Kline, the NCIA’s policy director. „We strongly recommend that FDA act quickly to clarify the regulatory environment because there is significant confusion in the market.”
The FDA already has approved hulled hemp seeds, hemp seed protein and hemp seed oil in products such as soups, dips, baked goods, snacks and nutrition bars.
But companies can’t tout the unproven health benefits of CBD, and the FDA said in announcing the hearing that it had taken action against companies selling products that claimed to prevent or treat diseases or were marketed as dietary supplements.
“Selling unapproved drug products with unsubstantiated therapeutic claims is not only a violation of the law, but also can put patients at risk as the marketing of unproven treatments raises significant public health concerns,” the FDA said.
McQueeny and Charles Messina, the other Genova Burns co-chair, said there are many other issues for the FDA to address, such as setting standard doses of CBD, looking at whether warnings need to be placed on labels, establishing expiration dates for products, and ensuring that manufacturing processes for cannabidiol products do not contain THC, the psychoactive compound in marijuana.
The FDA isn’t the only agency involved. The U.S. Agriculture Department said it will regulate hemp production and Congress could decide to act as well.
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