FDA seeks new pathway to regulate CBD

A new regulatory pathway is needed for oversight of cannabidiol (CBD) products, the US Food and Drug Administration announced Jan. 26. The agency pledged to work with Congress to develop such a pathway, noting that neither food nor dietary supplement regulations are appropriate for CBD.

The FDA denied citizen petitions from the Council for Responsible Nutrition, the Consumer Healthcare Products Association, and the Natural Products Association, all of which urged the FDA to regulate CBD products as dietary supplements.

Concerns about the safety of widespread CBD use led the FDA in 2019 to create an internal working group, which is now chaired by FDA principal deputy commissioner Janet Woodcock.

“The use of CBD raises various safety concerns, especially with long-term use,” Woodcock says in a news release. “Studies have shown the potential for harm to the liver, interactions with certain medications and possible harm to the male reproductive system. CBD exposure is also concerning when it comes to certain vulnerable populations such as children and those who are pregnant.”

CBD began popping up in all sorts of consumer products, including lotions, tinctures, dietary supplements, food and beverages, and pet food, following the legalization of hemp production in the 2018 Farm Bill. The majority of CBD in the US is extracted from hemp.

Woodcock says tools to manage the risks of CBD could include clear labels, prevention of contaminants, CBD content limits, and a minimum purchase age to help prevent ingestion by children.

Groups that petitioned the FDA to regulate CBD as a dietary supplement are disappointed in the agency’s decision. “This is an astonishing dereliction of duty,” Daniel Fabricant, CEO of the Natural Products Association, says in a statement. Fabricant is concerned that giving the FDA discretion to develop new regulatory pathways for ingredients whenever it wants to would set a dangerous precedent for the natural products industry.

“That could include requiring premarket approval, unnecessary testing, or who knows what,” he says.