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.
Two bills re-introduced in mid-March by U.S. Representatives Morgan Griffith (R-Va.) and Angie Craig (D-Minn.) would exempt CBD from the preclusion provisions. The Hemp and Hemp-Derived CBD Consumer Protection and Market Stabilization Act of 2023 would subject hemp extract products to the regulatory framework for dietary supplements, and the CBD Product Safety and Standardization Act of 2023 would establish regulations for CBD as a food and beverage additive.
Be Careful What You Wish For
FDA’s actions have been predictable, says Chris Fortes, CEO of Trojan Horse Cannabis, which sells infused seltzers that include both CBD and THC. “The FDA doesn’t really want to get involved unless they’re forced explicitly through Congressional action,” he says.
The industry would have been helped if FDA came up with even minor safety guidelines for products, such as child-resistant containers, he adds, but that would mean that the agency also is condoning that the product is acceptable. “They’re not willing to do that, but I’m disappointed that they haven’t put some safety precautions in place for consumers,” he says.
However, he admits that he is “semi-terrified” of asking FDA to regulate CBD-infused products, however, because he doesn’t think the agency understands them well. “You may get what you ask for, but you may not get what you want,” he says. He thinks a new cross-agency framework is a better option, and he would like to have USDA, the U.S. Drug Enforcement Agency, and the Alcohol and Tobacco Tax and Trade Bureau involved alongside FDA. He says the agencies should hold CBD companies to good manufacturing practices and truth-in-labeling standards.
Gabe Parton Lee, general counsel for Wyld, a cannabis edibles company based in Bend, Ore., says he expects a cross-agency framework would include USDA, because all cannabis products come from plants, but he thinks that any ingestible product clearly falls under FDA’s jurisdiction.
With the CBD market regulated at a national scale, he said products could be standardized to make sure they are clearly marked so that consumers know they are not buying an intoxicating product. Wyld also is working with state legislatures to develop standardized programs. “States are the laboratories of democracy,” he says. “There’s a real opportunity to develop regulated programs that the federal government can model after.”
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