Buzz
With CBD stores and CBD-infused products popping up everywhere, it might seem like CBD is fully legal, either FDA-approved or operating in a regulatory gray area. However, this isn't the case, as the FDA recently issued numerous warning letters to businesses selling CBD products.
To start, CBD is not permitted in food items, including pet food or animal feed, as it lacks the designation of being 'generally recognized as safe' (GRAS). The FDA argues, with some validity, that there's no scientific consensus on its safety as a food additive. As a result, companies incorporating CBD into food products risk receiving government warnings to cease their activities.
Additionally, CBD is only officially approved as a drug in the form of Epidiolex, a specific CBD formulation used to treat certain types of epilepsy. Any other marketing of CBD as a drug is considered unapproved, and sellers could face legal consequences.
Lastly, the supplement loophole doesn’t apply here. While herbs and vitamins can be marketed as supplements, existing in a legal gray area between drugs and food, CBD doesn’t qualify. Since it shares ingredients with an approved drug, the FDA doesn’t consider it a supplement, making this approach non-compliant.
Given budget constraints, the FDA can’t monitor every CBD store nationwide. Instead, they’ve issued warning letters to fifteen companies that breach the aforementioned rules and market their products across state lines. While the FDA expresses interest in establishing legal pathways for CBD sales, such regulations may take years to finalize. For more details, the agency has published a fact sheet outlining their concerns and CBD’s legal status. In their recent announcement, they stated:
Today’s actions reflect the FDA’s ongoing efforts to identify lawful pathways for marketing various CBD products. This includes gathering and analyzing data to address unresolved safety concerns while upholding the agency’s strict public health standards. The FDA intends to provide an update on their progress and approach to these products in the coming weeks.
