Since the passage of the 2018 Farm Bill, which legalized hemp after an eighty year ban, a cloud of uncertainty has been hovering over hemp’s most notorious substance, CBD. On December 20, 2018, FDA Commissioner Scott Gottlieb published a statement effectively banning CBD from being included in food or supplement products:
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.
Initially, the industry was up in arms, naturally. Since then, some have become more optimistic due to Commissioner Gottlieb’s recent testimony indicating a new pathway for the safe sale of CBD products.
We now know that Congressional hearings on this new pathway will be held sometime in April:
The commissioner said that the FDA would hold public hearings including public comment from stakeholders sometime in April. Gottlieb added that he would soon be appointing “a high-level working group that’s going to report to me on this, with some senior officials in the agency who are going to be chairing that.”
It remains to be seen who will make-up the workgroup, what power this group will yield, and what timeline they may act on. Nonetheless, a pathway to legalization is in sight and this is good news for industry players.