There’s bad news for cannabidiol fans.
“It’s not apparent how it would be safe to put in food and supplements,” an FDA spokesman said. “The safety standards for food and supplements are very protective, by law. We don’t see how CBD can meet those safety standards.”
The use of CBD raises various safety concerns, especially with long-term use, according to the agency statement. It cited studies that show potential harm to the liver and the male reproductive system as well as risky interactions with some medications. CBD exposure may also hold risks for certain vulnerable populations such as children and those who are pregnant.
The 2018 Farm Bill legalized hemp, but the legal status of hemp-derived cannabidiol remained in limbo. This is largely because CBD can be derived from hemp or cannabis, but if a hemp plant contains more than 0.3 percent THC (the active “high” ingredient in marijuana), it is technically a marijuana plant under the Farm Bill. Amid these confusing classifications, experts at the time said drafting and implementing regulations could take years.
In short, the federal government never concluded that CBD is “generally recognized as safe” for use in human or animal food. And the Federal Food, Drug and Cosmetic Act prohibits adding even approved drugs to human or animal food in interstate commerce — which has meant that CBD in food and drink has remained illegal.
Despite the lack of a green light, CBD products have proliferated in the marketplace, from energy drinks and bubbly water to ointments and tinctures — and even pet foods. Industry studies had predicted the global CBD market would grow to $1.25 billion by 2024, with thousands of CBD-infused products now available online.
That all may have to take a pause.
Advocacy groups and food industry experts criticized the FDA decision.
“When it comes to the safety of CBD, the FDA gets it wrong,” Jonathan Miller, general counsel of the U.S. Hemp Roundtable, said in a statement. He called the agency’s intent to tighten regulations “unprecedented and unnecessary” but said he endorsed a legislative solution to allow marketing of CBD in dietary supplements and foods.
Alex Buscher, a Colorado-based lawyer who advises hemp companies, said that CBD doesn’t seem to be riskier than other dietary supplements on the market that have the potential for side effects if taken at higher-than-recommended doses.
“The FDA is kicking the decision back to a divided Congress, which will take time to create a new regulatory framework,” he said. “We need actual regulation from the FDA.”
Food safety experts have said that the FDA has been in an impossible situation as states have decriminalized marijuana — which remains illegal under federal law — and related products have gained popularity. According to the National Conference of State Legislatures, as of this past February, 37 states (plus D.C., Puerto Rico, Guam and the U.S. Virgin Islands) have legalized medical use. As of Nov. 9, 21 states (plus D.C., Guam and the Northern Mariana Islands) have decriminalized recreational use — a strong indication that public sentiment has shifted.
“I’m sure the FDA probably concluded that no matter which way they went, it would involve trying to fit a very big genie back into a very small bottle, and create a political firestorm,” said Brian Ronholm, director of food policy for Consumer Reports. “It’s not surprising that they would want to seek some cover from Congress.”
Peter Lurie, executive director of the Center for Science in the Public Interest, described the appeal to Congress as “kicking the can up the Hill.” But he also said that because there is a legal CBD-based drug, Epidiolex, prescribed for a severe form of epilepsy, the FDA has limited ability to expand access to the substance. A federal law says active compounds in prescription drugs can’t be used as food additives.
Aaron Smith, chief executive of the National Cannabis Industry Association, said Thursday’s announcement underscores the need for Congress to provide clear direction on products available from the cannabis plant, many of which are legal in individual states.
“We’re seeing support for the regulation of marijuana growing to the point where I just can’t imagine Congress continuing to ignore this issue,” he said.