Senate Majority Leader, Mitch McConnell, has acted to require that the Food and Drug Administration (FDA) provide temporary guidance regarding its enforcement intentions regarding the sale of CBD or products that include CBD.
McConnell’s request for guidance is viewed as a short-term solution, while the FDA implements its long-term CBD policy.
McConnell’s proposed language is to be included in the Senate appropriations bill. It compels the FDA to advise Congress regarding the agency’s progress in drafting its “enforcement discretion” policy regarding CBD.
While CBD was legalized by last December’s Farm Bill, the FDA has thrown a monkey-wrench into America’s fast-growing CBD industry by taking a position that CBD may not be sold as a nutritional supplement, nor as an additive to food or beverage products.
McConnell, a Kentucky Republican, the senior Republican in Congress has been a passionate advocate of the hemp industry, including CBD.
The FDA’s quandary regarding its CBD policy is complicated due to the agency’s approval last summer of the prescription drug, Epidiolex, which is plant-derived CBD. Epidiolex was approved by the FDA for treatment of seizures associated with two rare and severe forms of epilepsy, Lennox-Gastaut syndrome and Dravet syndrome.
While it is clear that the FDA would prefer that CBD not be available as a nutritional supplement or as a food or beverage additive, political pressure and the significant media coverage regarding CBD makes that an impossibility.
There are precedents for drugs to also be allowed as nutritional supplements and food and beverage additives. These include omega-3 fatty acids, vitamin C (ascorbic acid), and fish oil, all of which are approved as drugs and are also available as nutritional supplements. Omega-3 fatty acids and ascorbic acid are also available as food and beverage additives. We believe that the FDA will be forced to adopt a similar policy for CBD.
I also see the likelihood that the FDA will to limit the quantity of CBD in nutritional supplements, and in food and beverages, but view this as problematic for the agency to implement.