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'Various safety concerns': Why the FDA declined to regulate CBD as a food or supplement

The Food and Drug Administration announced last week there’s not enough data addressing the “various safety concerns” of cannabidiol, or CBD, to regulate the marijuana-derived products as foods or supplements.

The agency argued its regulatory framework for food and supplements provides “limited tools” to mitigate risks associated with CBD products and called on Congress to create new rules for the market.

The agency also denied three petitions from advocacy groups that had asked the agency to allow products that contain the hemp ingredient to to be marketed as dietary supplements.

The FDA’s action comes after repeated calls from lawmakers, advocates and consumer groups for CBD to be allowed in foods and supplements. While health experts applaud the agency’s call for more evidence, frustration grew among CBD market leaders.

Pot for pain relief?: What cannabis can (and can’t) do for chronic pain.

What is CBD?

CBD often comes from a cannabis plant known as hemp, which is defined by the U.S. government as having less than 0.3% THC, the compound that causes marijuana’s mind-altering effect. CBD doesn’t cause that high, but fans of the products claim benefits including relief for pain and anxiety.

The marijuana-derived products have become increasingly popular in lotions, tinctures and foods, while their legal status has remained murky in the U.S.

Marijuana Copycat: Meet hemp-derived delta-9 THC.

CBD is the active ingredient in an approved prescription drug, Epidiolex, used to treat two rare seizure disorders. Under FDA regulations, a drug can’t be added to food or sold as a dietary supplement if officials haven’t determined it’s safe or effective for other conditions.

Marijuana itself remains illegal at the federal level in the U.S., although it has been allowed for medical and recreational use in many states, including use in pot-laced food and drinks.

What the FDA says

FDA Deputy Commissioner Dr. Janet Woodcock said studies have shown CBD has the potential to harm the liver, interact with certain medications and harm the male reproductive system.

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She’s also concerned about long-term use, and exposure to children and pregnant people, according to a statement.

“A new regulatory pathway would benefit consumers by providing safeguards and oversight to manage and minimize risks related to CBD products,” she said.

The agency will continue to take action against CBD and other cannabis products to protect the public, Thursday’s statement said. The agency has sent warning letters to some companies making health claims for CBD.

‘The right call’

Health experts applauded the FDA’s call for more safety data and hopes it motivates the CBD industry to comply.

“That’s the right call,” said Dr. Jordan Tishler, an instructor of medicine at Harvard Medical School and president of the Association of Cannabinoid Specialists. “The FDA is doing something that is not going to increase their popularity, but they’re there to guarantee the safety and efficacy of substances for the market.”

Although CBD companies argue there’s sufficient data out there, Tishler suspects it’s not rigorous enough for FDA standards.

Chase Terwilliger, CEO of Balanced Health Botanicals, said not regulating CBD poses bigger threat to consumers than CBD itself.

“The FDA is saying there’s potential safety concerns but they’re not going in and regulating and that can be very frustrating,” he said.

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Contributing: Associated Press. Follow Adrianna Rodriguez on Twitter: @AdriannaUSAT.

Health and patient safety coverage at USA TODAY is made possible in part by a grant from the Masimo Foundation for Ethics, Innovation and Competition in Healthcare. The Masimo Foundation does not provide editorial input.

This article originally appeared on USA TODAY: FDA declines regulating CBD as supplement due to ‘safety concerns’


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