FDA: ‘CBD Has the Potential to Harm You’

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The U.S. Food and Drug Administration (FDA) wants cannabidiol (CBD) users to know that the popular additive found in everything from bath salts to beverages could be harmful.

On Monday, the agency sent warning letters to 15 companies that it said were illegally selling products containing CBD, the non-psychoactive cannabinoid that many health and wellness-minded startups have begun marketing as a quasi-panacea for anxiety, insomnia, joint pain and other ailments.

The FDA also published a revised consumer update outlining carious safety concerns, including that CBD can cause liver injury, gastrointestinal distress and even male reproductive toxicity.

“Based on the lack of scientific information supporting the safety of CBD in food, the FDA is also indicating today that it cannot conclude that CBD is generally recognized as safe (GRAS) among qualified experts for its use in human or animal food,” the agency wrote.

Although products containing CBD have exploded in recent years, it is illegal to include the compound in anything other than cosmetics. Under the Federal Food, Drug, and Cosmetic Act (FD&C Act), only cosmetic products and ingredients do not require FDA approval prior to hitting the market.

Nevertheless, hundreds of products containing CBD -- including vaping cartridges, capsules, beverages, gummies and pet food -- have flooded the market and have even made inroads at big box retailers.

Speaking to THCnet, Alva Mather, a partner at McDermott Will & Emery, said companies selling non-cosmetic CBD products across multiple states run the risk of being targeted by the FDA.

“From the FDA’s perspective, they are operating illegally,” she said.

However, she said the FDA is under pressure from Congress after the passage of the Farm Bill, which removed hemp — defined as cannabis and cannabis derivatives containing less than 0.3 percent THC — from the definition of marijuana in the Controlled Substances Act and was at least partially intended to open up the CBD market.

Instead of shutting down companies making claims about the benefits of CBD, The FDA has mostly stuck to issuing warning letters and consumer information bulletins.

“They don’t want a PR nightmare,” Mather suggested.

For her part, FDA principal deputy commissioner Amy Abernethy said the agency is working to “clarify” its “regulatory approach for products containing cannabis and cannabis-derived compounds like CBD,” noting that “a number of questions remain regarding CBD’s safety.”

“We recognize the significant public interest in CBD and we must work together with stakeholders and industry to fill in the knowledge gaps about the science, safety and quality of many of these products,” she said via a press release.

The FDA is worried that many “unapproved” CBD products are being marketing with unproven medical claims and creating consumer confusion.

“Often, people wrongly think that the myriad of CBD products on the market have been evaluated by FDA and determined to be safe, or that trying CBD can’t hurt,” Abernathy said via Twitter. “Aside from one prescription drug, CBD products have not been approved by FDA.”

Last year, the FDA approved Epidiolex, a drug containing CBD, for the treatment of rare forms of epilepsy.

Additional information about the FDA’s stance on CBD can be found via the following links.

FDA Consumer Update

FDA's FAQ on CBD