The U.S. Food and Drug Administration said on Thursday it does not intend to make any new guidance on the use of the popular cannabis compound CBD in food and supplements, saying the United States needs to develop a new framework to ensure its safe use.
The health regulator said it would work with Congress to develop a new, cross-agency regulatory framework. The FDA denied three citizen petitions that had requested the agency to provide guidance.
The agency said the current safety standards for dietary supplements or food additives are not appropriate for cannabidiol, based on data and studies it has reviewed and conducted.
“We have not found adequate evidence to determine how much CBD can be consumed, and for how long, before causing harm,” FDA Principal Deputy Commissioner Janet Woodcock said.
Cannabidiol is a non-psychoactive compound derived from cannabis. Long-term use of the compound has raised several safety concerns including potential harm to the liver and to the male reproductive system.
The FDA has generally pursued limited enforcement activity regarding CBD, focusing primarily on food and beverage products that make unsubstantiated health claims.
The FDA said that available data did not show how CBD products could meet the safety standard for substances in animal food, and it did not intend to provide new rules allowing the use of the compound in animal food either.
“A new regulatory pathway for CBD is needed that balances individuals’ desire for access to CBD products with the regulatory oversight needed to manage risks,” the agency said.
Cannabis products, excluding Jazz Pharmaceuticals Plc’s (JAZZ.O) epilepsy drug Epidiolex, are illegal at the federal level in the United States, although some states allow their use.