FDA: Congress, not rule-making, likely route for CBD availability
Published: 21 April 2023
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.
Janet Woodcock, MD, principal deputy commissioner in the FDA Office of the Commissioner, said the Food and Drug Administration looks forward to working with Congress to develop a cross-agency strategy for the regulation of cannabidiol products to protect the public’s health and safety.
“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.
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