The Food and Drug Administration on Thursday announced that CBD products, increasingly popular but largely unregulated, will soon join the ranks of other more mainstream, regulated products.

But rather than regulate the product as a dietary supplement or food, the agency announced it will work with Congress to create a new regulatory pathway for CBD products.

The announcement came as the agency has faced some pressure to regulate CBD products as dietary supplements. As part of the announcement, the agency said it was denying three citizen petitions that had asked for FDA rule-making to allow the marketing of CBD products as dietary supplements — an idea that had gained some traction on Capitol Hill.

In 2021, Oregon Rep. Kurt Schrader and 45 other Democrats introduced a bill to regulate CBD as a dietary substance.

While many American city corner stores are stocked with CBD products that claim to do everything from relieve pain to help people sleep, the products were not legalized until 2018, when Congress passed legislation to remove hemp from the Controlled Substances Act. CBD is also found in cannabis. 

Still, a few states have not removed hemp from their controlled substances list, meaning there’s still a patchwork approach to CBD legalization.

The FDA in 2018 also approved Epidolex, a drug derived from CBD, to treat rare seizure disorders. But most other marketed products that contain CBD are not FDA-approved.

The agency warns that while CBD is popular across the United States, there are still many unknowns about the substance and how it impacts the body, and there are some safety concerns with long-term use. Some preliminary studies show the potential for adverse interactions with other medications, harm to the liver and harm to the male reproductive system. The agency is also concerned about the impact of CBD use in pregnant women and in children.

CBD, formally called cannabidiol, is one of the 113 identified cannabinoids in cannabis and accounts for 40 percent of the plant’s extract. CBD does not contain THC, is not impairing and does not cause a high but is used in many products to alleviate pain.

Oversight and regulation of the product would allow the FDA to further investigate potential harms and give Americans information before consumption. 

Next steps

A new regulatory path for CBD would mandate specific safeguards and oversight specifically targeted to CBD products. Some tools could include clear labels, prevention of contaminants, CBD content limits and measures such as minimum purchase age, the FDA said. 

A new pathway could also provide oversight for CBD products intended for animals, such as CBD canine gummies meant to alleviate joint pain or calm down an anxious dog.

Under current law, any substance, including CBD, has to meet specific requirements to be marketed as a dietary supplement or food additive. CBD products often don’t meet these requirements, so the agency does not intend to pursue rule-making allowing the use of CBD 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,” FDA Principal Deputy Commissioner Janet Woodcock said.