As President Donald Trump signs a sweeping bill that provides billions of dollars in aid to the nation's farmers, the new law has also offered the U.S. Food and Drug Administration a chance to legalize interstate sales of certain cannabis products in food and beverages.
FDA Commissioner Scott Gottlieb said in a Dec. 20 statement that the agency is rethinking its regulation of the interstate trade of products that contain cannabidiol and tetrahydrocannabinol, or THC, both active ingredients in marijuana.
Pharmaceutical companies can already submit drugs containing these ingredients for review as a traditional medication, similar to the recent approval of GW Pharmaceuticals PLC's epilepsy medication Epidiolex. But Gottlieb hinted in the new statement that the agency will now consider legalizing the use of cannabidiol and THC in food or dietary supplements.
"Although such products are generally prohibited to be introduced in interstate commerce, the FDA has authority to issue a regulation allowing the use of a pharmaceutical ingredient in a food or dietary supplement," Gottlieb said.
Consumer companies are already teaming up with cannabis producers to develop new products following the legalization of marijuana for recreational use in Canada in October. Earlier in the week of Dec. 17, Anheuser-Busch Inbev SA/NV said it is partnering with cannabis company Tilray Inc. to research cannabis-based beverages.
The farm bill, officially called the Agriculture Improvement Act of 2018, legalized hemp and cannabidiol that has extremely low levels of THC. The FDA also in its announcement clarified the law as it currently stands, asserting its role as the regulatory authority on products that contain cannabis or cannabis-derived compounds under the Federal Food, Drug and Cosmetic Act.
That act prohibits the interstate commerce of cannabidiol and THC products regardless of whether the products are derived from hemp. The agency noted instances of deceptive marketing of cannabis products that claim to provide a cure or treatment for diseases such as cancer, Alzheimer’s disease, psychiatric disorders and diabetes. Selling such products for therapeutic uses without the approval of the FDA is illegal, the agency said.
But the agency was able to officially say that with the farm bill passed, products containing hulled hemp seeds, hemp seed protein and hemp seed oil are safe and free to be sold.
"These products can be legally marketed in human foods for these uses without food additive approval, provided they comply with all other requirements and do not make disease treatment claims," Gottlieb said.
The FDA plans to hold at least one public meeting to hear feedback on how interstate cannabis laws should be changed.
"At the same time, we recognize the potential opportunities that cannabis or cannabis-derived compounds could offer and acknowledge the significant interest in these possibilities," Gottlieb said.
"We're committed to pursuing an efficient regulatory framework for allowing product developers that meet the requirements under our authorities to lawfully market these types of products."