Former FDA Commissioner Dr. Scott Gottlieb recently penned an op-ed in the Washington Post titled “The CBD craze is getting out of hand. The FDA needs to act.” In the piece, Dr. Gottlieb proposed an expedited process to permit cannabidiol (CBD) to be added to foods and drinks and marketed as a supplement.
Since the passage of the Farm Bill in December of 2018 that legalized hemp and hemp-derived CBD, there has been a spike in interest in CBD products. The FDA, however, must approve products containing CBD (at least those for human consumption that are intended for interstate commerce) because CBD is an active ingredient in an FDA-approved drug. While the FDA has been actively investigating a more-permissive approach to CBD, as Dr. Gottlieb noted, the traditional path for FDA approval is a multiyear process. Dr. Gottlieb expressed concern (as we did here) that the market cannot wait years for approval, and that the FDA is at risk of being rendered irrelevant as consumers clamor for CBD products and the market responds.
Dr. Gottlieb suggested a hybrid approach that, from his perspective, would reasonably open the CBD market, while still allowing the FDA to continue to reasonably evaluate the safety of CBD products. Under this approach, manufacturers would be able to immediately petition the FDA for permission to include CBD in their products, with such petitions providing evidence for the safety of the product. The FDA, in turn, would use its enforcement power liberally but with discretion, focusing (as it largely is now) on those making unsubstantiated health claims regarding CBD products. In other words, the FDA would crack down hard on claims that CBD is a treatment for cancer, while approving (or not cracking down on) manufacturers making reputable products and claims about the effects of CBD.
Dr. Gottlieb’s proposal needs some fleshing out, as it is not clear why any entity would go to the trouble and expense of petitioning for permission from the FDA if it knows the FDA is only going to be cracking down on seriously misleading health claims. A petition process would seem to only work if it is combined with a robust enforcement approach, and there does not appear to be the political willpower or resources for such a crackdown. The import of the op-ed is thus more symbolic than substantive. Dr. Gottlieb is no longer making policy for the FDA, but by publicly pushing for a more-permissive and speedier approach, he is certainly sending a pro-CBD signal to the FDA and CBD manufacturers. We continue to believe that the FDA is going to propose a plan for legalizing CBD for human consumption sooner rather than later.