Why The FDA Is Cracking Down On CBD

From the proliferation of CBD stores and CBD-infused products, you’d think CBD is legal, either approved by the FDA or having found a happy little loophole in which the agency can’t touch it. But that’s not true, and the FDA sent a bunch of warning letters today to companies selling CBD products.

First, CBD can’t legally be in food, including pet food or animal feed, because it isn’t “generally recognised as safe” (GRAS). The FDA says, arguably correctly, that scientists don’t agree on whether it’s safe to use as a food additive. So, companies that make food with added CBD are liable to receive warning letters from the government telling them to stop.

Second, CBD is only an approved drug if we’re talking about Epidiolex, one specific CBD formulation that’s approved for treating certain kinds of epilepsy. Any other way it’s marketed as a drug, it’s an unapproved drug and, likewise, sellers can get in trouble.

And finally, the supplement loophole doesn’t work either. You can package up all kinds of herbs and vitamins as supplements, which are neither drugs nor foods but occupy a legal area in between. But CBD doesn’t fit the definition of a supplement because it contains the same ingredients as an approved drug. So this isn’t cool with the FDA either.

Tracking down all the CBD stores in the country isn’t really possible on the agency’s budget, so they’ve sent warning letters to fifteen companies that violate one or more of the rules above, and that market their products across state lines. The FDA keeps saying they want to create ways for people to legally sell and buy CBD, but regulations on that could be years in the making. They have a fact sheet about their concerns and the legal status of CBD, if you’d like to learn more, and they said they in the announcement about the warning letters today:

Today’s actions come as the FDA continues to explore potential pathways for various types of CBD products to be lawfully marketed. This includes ongoing work to obtain and evaluate information to address outstanding questions related to the safety of CBD products, while maintaining the agency’s rigorous public health standards. The FDA plans to provide an update on its progress regarding the agency’s approach to these products in the coming weeks.