FDA: Congress, not rule-making, likely route for CBD availability

Cannabidiol products for humans and veterinary patients may require a new regulatory pathway, according to a recent announcement from the Food and Drug Administration.

With the cannabidiol products market continuing to grow and after reviewing published scientific literature and information submitted to a public docket, an internal working group of the FDA concluded that a new regulatory pathway for cannabidiol is needed. It wasn’t clear how CBD products could meet safety standards to be lawfully marketed as dietary supplements or food additives for humans, so rather than conduct rule-making to allow the marketing of CBD products under those authorities, the agency said in a Jan. 26 statement that it will work with Congress to develop a cross-agency strategy for the regulation of these products.

“A new regulatory pathway would benefit consumers by providing safeguards and oversight to manage and minimize risks related to CBD products,” said Janet Woodcock, MD, principal deputy commissioner in the FDA Office of the Commissioner, in the statement. Safety concerns include potential for harm to the liver, interactions with certain medications, and possible reproductive harms.

Some risk management tools could include clear labels, prevention of contaminants, CBD content limits, and minimum purchase age.

Dr. Woodcock noted, however, that CBD also poses risks to animals and that people could be unknowingly exposed to CBD through meat, milk, and eggs from animals fed CBD.

“Because it is not apparent how CBD products could meet the safety standard for substances in animal food, we also do not intend to pursue rulemaking allowing the use of CBD in animal food,” she said in the statement. “A new regulatory pathway could provide access and oversight for certain CBD-containing products for animals.”

Although cannabis containing 0.3% or less THC is no longer scheduled under the federal Controlled Substances Act, its products do fall under the Federal Food, Drug, and Cosmetic Act if they are used therapeutically or included in animal food. One CBD-based drug, Epidiolex, has been approved. The FDA considers other such products intended for therapeutic use to be unapproved new drugs.

The FDA said it will continue to take action against CBD and other cannabis-derived products to protect the public, in coordination with state regulatory partners, when appropriate.

“We will remain diligent in monitoring the marketplace, identifying products that pose risks and acting within our authorities,” Dr. Woodcock said. “The FDA looks forward to working with Congress to develop a cross-agency strategy for the regulation of these products to protect the public’s health and safety.”