Myth #10: All CBD Products Are FDA-Approved and Regulated

Quick Fact

Is CBD regulated by the FDA? Not in the way most people assume. The vast majority of CBD products on the market are not FDA-approved. The only FDA-approved cannabidiol medication is Epidiolex, a prescription drug for epilepsy. Over-the-counter CBD supplements exist in a largely unregulated space, which makes it critical to choose products that have already been third-party tested.

The Full Story

Many consumers assume that because cannabidiol (CBD) products are sold openly in stores and online, the FDA has reviewed and approved them. This is not the case.

The FDA regulates CBD as it would other dietary supplements. Companies cannot make specific health claims, and products do not require FDA approval before going to market. The agency has the authority to act against companies that make illegal claims or sell unsafe products. But it does not proactively review individual products before they reach shelves.

Is CBD Regulated Enough to Protect Consumers?

This gap has real consequences. A Penn Medicine study found that approximately 70% of CBD products sold online were mislabeled. They contained either more or less cannabidiol than stated. In some cases, detectable levels of tetrahydrocannabinol (THC) were not disclosed.

For the consumer, the solution is to choose products that provide a Certificate of Analysis (COA) from an independent third-party laboratory. A COA confirms the actual cannabinoid content and verifies the product is free from pesticides, heavy metals, and other contaminants.

A legitimate COA will show the actual cannabinoid content. For instance, how much CBD is present, whether any THC is present, and at what levels. It will also show results for contaminants like pesticides and heavy metals. The lab that produced it should be independent — not owned or operated by the company selling the product. If a company does not publish its COAs openly on its website, that is a red flag.

For more on label accuracy, see our Myth #11 on whether product labels can be trusted.