FDA Chief Says CBD Is Not NBD, Urges Congressional Action

Supporters of hemp-derived cannabidiol (CBD) who hoped the Food and Drug Administration would adopt a more progressive view of CBD were disappointed when FDA Chief Robert Califf recently testified that FDA does not consider hemp-derived CBD safe enough to be sold lawfully as a dietary supplement, and urged Congress to create a new pathway to regulate CBD.  Specifically, Califf stated that “CBD doesn’t fall under any particular regulatory scheme that we have” and that “[FDA] very much would like Congress to establish a regulatory pathway for CBD.”

The statements are important perhaps most for their timing. Congress is currently working on a new Farm Bill to replace the 2018 Farm Bill, a piece of legislation that legalized hemp as distinct from marijuana. Since 2018, the hemp market – and CBD in particular – has seen explosive growth.  With that growth, however, have come questions about the safety and efficacy of CBD.

During his testimony:

Califf said multiple times that the specific health concern raised by research into CBD use was the elevation of liver enzymes in regular users, which he said could cause liver damage over time. While CBD is unsafe as a dietary supplement, Califf said, it could hypothetically be “regulated in another way and made available” if Congress directed the agency to do so.

Put simply, the current FDA is not going to regulate CBD unless and until it receives clearer guidance from Congress. That raises the stakes for the upcoming Farm Bill, which as we have written has the potential to cause extraordinary harm or allow for extraordinary growth to the hemp industry.

In my opinion, FDA could do at least a little better here. Hemp-derived CBD has been federally legal for more than five years. FDA has the authority under the 2018 Farm Bill to regulate hemp. If FDA simply needs more time to study the safety and efficacy of hemp, that is one thing (although it seems like five years is enough compared to the usual FDA approval process). If FDA would rather pass the buck to someone else to make the call… well, maybe it would do what it’s doing now. If the latter is right, I get it. FDA has the responsibility to ensure the safety of ingredients that go into the human body, and it should exercise caution and restraint when making such determinations. That said, it’s past time for someone to take a position and give the hemp industry a reliable indication of the federal government’s position on hemp-derived products.