Kratom and the FDA: Current Status Explained

“Is kratom FDA approved?” is one of the most common questions we get. The short answer is no — and here’s what that actually means for you.

The FDA’s position

The FDA has not approved kratom as a drug, food or dietary supplement, and it has issued import alerts and warnings. It has not, however, scheduled kratom under the Controlled Substances Act — scheduling decisions belong to the DEA.

What “not approved” means for buyers

It means no vendor may legally claim kratom diagnoses, treats, cures or prevents any disease. Honest vendors — like the Official MIT45 Shop — carry a clear FDA disclaimer and make no medical claims. If a seller promises medical results, that’s a red flag.

Our approach

We sell kratom as a botanical product for adults, publish lab results, and direct anyone with health questions to a professional. Read our health disclaimer.