WASHINGTON — Scott Gottlieb, M.D., on April 2, in one of his last official acts as commissioner of the Food and Drug Administration, announced new actions to advance the agency’s consideration of a framework for the lawful marketing of cannabis and cannabis-derived products.
“Ultimately, we remain committed to exploring an appropriate, efficient and predictable regulatory framework to allow product developers that meet the requirements under our authorities to lawfully market these types of products,” Dr. Gottlieb said.
He pointed to the rapidly expanding interest in products containing cannabis or cannabis derivatives that are marketed as human drugs, supplements, conventional foods, animal foods and drugs, and cosmetics, among other things.
The Agriculture Improvement Act of 2018 enacted last December created a new category of cannabis classified as “hemp,” and removed hemp from the Controlled Substances Act.
“At the same time, Congress explicitly preserved the F.D.A.’s current authority to regulate products containing cannabis or cannabis-derived compounds,” Dr. Gottlieb said. “This allows the F.D.A. to continue enforcing the law to protect patients and the public while also providing potential regulatory pathways, to the extent permitted by law, for products containing cannabis and cannabis-derived compounds.”
The actions announced April 2 include: a public hearing for stakeholders on May 31 at the F.D.A.’s White Oaks campus in Silver Spring, Md.; the formation of a high-level internal agency working group to explore potential pathways for dietary supplements and/or conventional foods containing cannabis-derived cannabidiol (C.B.D.) to be lawfully marketed; and a more aggressive stance in reining in companies making “egregious and unfounded claims” in marketing C.B.D. products to vulnerable populations.
Dr. Gottlieb said the public hearing will give stakeholders an opportunity to provide the F.D.A. with additional information as it considers how to develop legal pathways to marketing products. The F.D.A. also is seeking information relating to the safety of existing and prospective products.
In the meantime, Dr. Gottlieb said the F.D.A. will continue to treat products containing cannabis or cannabis-derived compounds as it does any other F.D.A. regulated products.
“Among other things, the F.D.A. requires a cannabis product (hemp-derived or otherwise) that’s marketed with a claim of therapeutic benefit to be approved by the F.D.A. for its intended use before it may be introduced into interstate commerce,” Dr. Gottlieb said.
Additionally, he said it remained unlawful to introduce food containing added C.B.D., or the psychoactive compound tetrahydrocannabinol (T.H.C.) into interstate commerce, or to market C.B.D. or T.H.C. products as dietary supplements. The only path that the law allows for such substances to be added to foods or marketed as dietary supplements is if the F.D.A. first issues a regulation, through notice-and-comment rulemaking, allowing such use.
Dr. Gottlieb said he asked Amy Abernethy, M.D., Ph.D., the F.D.A.’s principal deputy commissioner, and Lowell Schiller, principal associate commissioner for policy, to co-chair the internal high-level panel and charged them with considering what options might be appropriate under the F.D.A.’s current authorities.
The working group is scheduled to begin sharing information and/or findings with the public as early as this summer.
The F.D.A. also will continue to use its authority to act against companies illegally selling cannabis-derived products when they are putting consumers at risk.
The F.D.A., in collaboration with the Federal Trade Commission, on April 2 issued warning letters to three companies due to their making unsubstantiated claims related to more than a dozen different products. The companies used online platforms to make “unfounded, egregious claims” about their products’ ability to limit, treat or cure cancer, neurodegenerative conditions, autoimmune diseases, opioid use disorder, and other serious diseases, without sufficient evidence and the legally required F.D.A. approval.
“I believe these are egregious, over-the-line claims, and we won’t tolerate this kind of deceptive marketing to vulnerable patients,” Dr. Gottlieb said.