FDA Declines to Regulate Edible CBD Products

In January 2023, FDA announced that it would not regulate cannabidiol (CBD) edible products under the existing regulatory frameworks for dietary supplements, citing health concerns and a lack of safety data for the substance.

The agency said it had not found adequate evidence to determine how much CBD can be consumed and for how long before causing harm, so it would not pursue rulemaking for the substance in dietary supplements or conventional foods. “Given the available evidence, it is not apparent how CBD products could meet safety standards for dietary supplements or food additives,” Janet Woodcock, MD, Principal Deputy Commissioner at FDA, said in the statement.

Consumers eat food for reasons other than to take CBD, and they may end up taking more CBD than they meant to, according to an FDA spokesperson. They might also confuse eating CBD-infused food with non-CBD food, which the agency says is especially concerning for children when CBD takes the form of a candy or snack.

FDA did state that it is prepared to work with Congress to develop a new cross-agency regulatory framework to oversee these products. Until then, regulation in the U.S. is in the hands of each state. Seventeen states plus the District of Columbia have fully legalized CBD products, with the remainder offering varying degrees of conditional approval (see “The State of CBD Legalization in the U.S.,” below).

The FDA news was disappointing to many in the CBD industry, but not entirely unexpected. Industry experts say they were waiting for FDA to proceed with federal oversight following the 2018 Farm Bill, which legalized hemp-based CBD. “The FDA has been dragging its feet for four years now,” says Jonathan Miller, general counsel for the U.S. Hemp Roundtable in Washington, D.C. “This was just another way to kick the can down the road.”

He agrees that Congress needs to step in to implement a regulatory plan, but he doesn’t want to wait years for that to happen. He would like to see CBD regulated in the same way FDA regulates other dietary supplements, with strict good manufacturing practices and labeling requirements. Miller adds that FDA’s inaction continues to be damaging for everyone—from the farmers planning their crops to the companies that sell products.

What Should Regulations Cover?

CBD products should be screened for any impurities or contaminants, says David Vaillencourt, CEO of The GMP Collective, a Denver-based organization that works with cannabis and hemp businesses. He adds that these products should also be screened for microbials and toxins produced by microbials, and labels should give an accurate and full disclosure of what is in the product and in what quantity. He says that there should also be a standard for the laboratory certificate of analysis, and that, ultimately, the products should be reasonably expected to be safe. “Consumers should go to reputable stores like Whole Foods or major retailers rather than gas stations or convenience stores, which could be risky,” he says. “Otherwise, they take a risk every time they buy a product.”

Right now, the lack of federal oversight leaves the CBD-infused food and beverage market as a “wild west” of food safety. States have moved to their own regulatory patchwork, making it difficult for companies to develop a national brand, says Steve Mister, president and CEO of Washington, D.C.-based Council for Responsible Nutrition, which represents the dietary supplement industry. “The FDA decision has stifled a market that was supposed to take off after 2018,” Mister adds.

Drug Preclusion Provisions

Other than safety concerns related to the lack of research data on CBD, there are drug preclusion provisions in the federal Food, Drug and Cosmetic Act that say if a drug company gets an ingredient to the market first, it has a monopoly over that ingredient. The drug Epidiolex, which contains CBD, is an FDA-approved treatment for epilepsy care that is on the market.