FDA Change could potentially delay guidance on CBD rules - but not for long

With Scott Gottlieb stepping down as FDA chief, uncertainty surrounds the fate of guidelines for the usage of CBD in food or beverages. In December, the Farm Bill legalized hemp and opened the door for the industry to explode. However, the FDA regulates the ingredients within products that are sold here in the U.S., and has said in a December 2018 statement -

“Additionally, it’s unlawful under the FD&C Act to introduce food containing added CBD or THC into interstate commerce, or to market CBD or THC products as, or in, dietary supplements, regardless of whether the substances are hemp-derived. This is because both CBD and THC are active ingredients in FDA-approved drugs and were the subject of substantial clinical investigations before they were marketed as foods or dietary supplements. Under the FD&C Act, it’s illegal to introduce drug ingredients like these into the food supply, or to market them as dietary supplements. This is a requirement that we apply across the board to food products that contain substances that are active ingredients in any drug.”

The FDA has committed to reviewing this policy and clarifying language regarding CBD’s use as a dietary supplement. The scheduled hearings were for April. But with the unexpected departure of Gottlieb, these decisions could be put on hold. Ned Sharpless has been named as Gottlieb’s replacement. Sharpless seems to hold the same views in regards to Gottlieb’s mission to lower nicotine levels in cigarettes and curb teen vaping, so he may be open to follow the scheduled hearings on CBD usage guidelines.

I think the monumental shift in policy by legalizing hemp puts incredible pressure on the FDA to solidify rules as quickly as possible. Federal legalization has been a tremendous hurdle for companies interested in pursuing products based from hemp and cannabis. For hemp products, this hurdle is now removed, and there will likely be a mad race to launch products and build brands. Industry giant, Coco-cola, denied rumors that they were exploring a CBD-infused beverage in October 2018. At that point however, CBD derived from hemp was illegal - but now it is not. Given public interest, I would be shocked if major food and beverage manufacturers were NOT investigating hemp-based CBD products. So I’m sure the FDA is feeling pressure to clarify the rules.

Therefore, while there could be a short delay given a transition period for leadership at the FDA, I think the new guidelines regarding hemp based CBD as a dietary supplement and isolate will be established within 2019.

NewsCharles Freeman