A public hearing for stakeholders will take place May 31.
The Food and Drug Administration (FDA) announced it will hold a public hearing on regulating cannabinoid (CBD) on May 31.
The 2018 Farm Bill federally legalized hemp-derived CBD, but the FDA said companies still can’t add CBD to food or sell it as a dietary supplement.
“The public hearing will give stakeholders an opportunity to provide the FDA with additional input relevant to the agency’s regulatory strategy related to existing products, as well as the lawful pathways by which appropriate products containing cannabis or cannabis-derived compounds can be marketed, and how we can make these legal pathways more predictable and efficient,” said Gottlieb. “We hope to gain additional information and data for the FDA to consider with respect to products containing cannabis and cannabis-derived compounds, including CBD.”
In March, Gottlieb said it could take years for the agency to create rules around CBD in food products without Congressional action.
The process can take two to three years for typical products. Because of CBD’s association with marijuana, and because it was already approved by the FDA as a drug to treat epilepsy, it could take much longer.
“CBD didn’t previously exist in the food supply, and it exists as a drug under the statute,” said Gottlieb.
The FDA said it will continue to take action against companies illegally selling these products and said it has issued warning letters, in collaboration with the Federal Trade Commission, to three companies — Advanced Spine and Pain’s Relievus, Nutra Pure LLC and PotNetwork Holdings Inc. — in response to their claims online.
“The companies used these 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 FDA approval,” said Gottlieb.
Requests to make oral presentations and comments at the public hearing must be submitted by May 10. Electronic or written comments will be accepted until July 2.
