American Herbal Products Association (AHPA) President Michael McGuffin urged the Food and Drug Administration (FDA) to use existing authority to quickly create a lawful pathway -- including considering issuing a interim final rule -- for marketing of cannabidiol (CBD)-containing supplements and foods at a public meeting held by FDA today in Silver Spring, MD.
The meeting, "Scientific Data and Information about Products Containing Cannabis or Cannabis-Derived Compounds," was organized by FDA to gather scientific data and information about the safety, manufacturing, product quality, marketing, labeling, and sale of products containing cannabis or cannabis-derived compounds.
McGuffin stressed that FDA has previously acknowledged its authority to create a lawful pathway for marketing CBD-containing supplements and foods. He urged FDA to promptly use this authority by issuing an interim final rule with an accelerated effective date.
Of significant relevance to McGuffin's recommendation, the U.S. Department of Agriculture (USDA) recently announced an intent to issue an August 2019 interim final rule (IFR) implementing the hemp production provisions of the 2018 Farm Bill, the same law that removed hemp from the Controlled Substances Act.”
McGuffin said that FDA's current stated position that provisions of the Food Drug and Cosmetic Act (FD&C Act) prohibit marketing CBD dietary supplements and adding CBD to conventional foods has resulted in significant marketplace confusion for companies working to meet consumer demand for CBD products.
McGuffin recommended FDA either use its authority under the FD&C Act to issue a regulation permitting CBD as a lawful ingredient in supplements and foods, or issue guidance to state the Agency’s intent to exercise formal enforcement discretion with respect to the provisions of the FD&C Act on which FDA bases its position that CBD-containing supplements and foods are unlawful.
"To fully implement Congress’s intent to allow access to products that contain hemp-derived CBD, and to further AHPA’s and FDA’s shared goal of ensuring safe and well-manufactured supplements and foods, AHPA requests that FDA promptly take one of [these] two ... actions," McGuffin said.