The US natural products industry has been pushing the Food and Drug Administration for clarity on the legal status of hemp-derived CBD following the legalization of hemp by Congress in Devember 2018.
While the passing of the Farm Bill meant that a federal ban on hemp was lifted, FDA rules continue to prohibit the use of hemp and hemp-derived CBD in food and drink products – although this hasn’t stopped hundreds of CBD products coming to market over the last few months (and the FDA admitting that in the majority of cases no action has been taken against brand-owners).
Amidst continuing regulatory uncertainty some US states and city authorities – New York City, Ohio and Maine – have asked retail outlets to stop selling CBD food and drinks on the basis that the FDA does not consider them safe.
But last week, the FDA’s outgoing Commissioner Scott Gottlieb gave an indication that will apply a flexible approach, in recognition of the change in federal law on hemp. Ahead of internal discussion on future FDA rule-making on the category, Gottlieb told a US Senate Committee on Appropriations that the agency would use “enforcement discretion” on CBD products.
“I will take enforcement action against CBD products that are on the market if manufacturers are making what I consider ‘over the line’ claims’.”
Gottlieb said that the force of enforcement action would be directed at companies making illegal health claims for products, suggesting that a ‘light touch’ approach elsewhere. He told the Committee: “I will take enforcement action against CBD products that are on the market if manufacturers are making what I consider ‘over the line’ claims’.”
The Commissioner also suggested that new FDA laws on the category could be some years coming because of “the highly novel rule-making to do a concept like this”.
Photo: FDA commissioner Scott Gottlieb. Andrew Propp for the FDA