According to a recent article in The Hill, federal lawmakers are growing increasingly impatient with the FDA’s lack of progress in promulgating CBD rules. While Congress may not take any formal action until this Fall, pressure on the FDA over this issue is already ramping up.
Congress legalized hemp and hemp-derived CBD products in the 2018 Farm Bill. Shortly thereafter, the FDA issued a statement reaffirming its regulatory authority over cannabis products under the Food, Drug, and Cosmetic Act and Section 351 of the Public Health Service Act. According to the FDA, any cannabis product, including hemp-derived CBD, that is marketed with a claim of therapeutic benefit requires FDA approval before it can be introduced into interstate commerce. The FDA also emphasized that adding CBD to food products and dietary supplements is unlawful.
The FDA received some blowback from a Congress and CBD industry eager for a more robust and accessible market. In response, the FDA held a public hearing on May 31, 2019 regarding CBD and solicited public comments that are due by July 16, 2019. But the FDA did not provide a timeline for its next steps. Prior to stepping down this past April, then-FDA Commissioner Dr. Scott Gottleib indicated that conventional products can take two or three years for the FDA to properly regulate. He said it could take even longer than that with CBD.
According to The Hill’s sources, the FDA does not have nearly that much time. Senator Mitch McConnell (R-KY) issued a statement after a recent meeting with current FDA Commissioner Dr. Ned Sharpless that read “Congress’s intent was clear from the passage of the Farm Bill that these products should be legal, and our farmers, producers and manufacturers need clarity as well as a workable pathway forward regarding the agency’s enforcement.” McConnell added that “[l]ike my constituents, I am anxious to know the FDA’s plans to ensure public access to safe CBD products.” Senator Ron Wyden (D-OR) also sent a letter to the FDA requesting an interim policy by August 1, 2019 that would allow for the sale and consumption of hemp-derived CBD.
Should the FDA fail to act by this Fall, we will see how serious Congress is about moving forward on CBD. We will provide any relevant updates on the blog as they occur.