The FDA Position

The agency has warned repeatedly: kratom is not safe, not approved, and not a dietary supplement. The industry calls this “bias.” We call it public health.

Read the Truth Evidence Hub

⚠️ Industry spin: They say the FDA is “overreaching.” The FDA says kratom is illegally marketed and unsafe. Return to Evidence →

What the FDA Actually Says

The U.S. Food and Drug Administration has been crystal clear: there are no approved kratom products. No drug applications. No dietary ingredient approvals. Nothing. Yet the industry continues to sell kratom in gas stations and vape shops as if the FDA doesn’t exist.

The industry’s response? Accuse the FDA of “bias” and “lack of evidence.” But the documents below show the FDA has compiled decades of research, adverse event reports, and public health warnings. The industry just doesn’t want you to read them.

⛔ Key FDA Findings the Industry Ignores

No approval, no safety: Kratom products are sold nationwide despite zero FDA-approved applications. The industry calls this a “regulatory gray area.” We call it illegal.
Liver toxicity and seizures: FDA has documented cases of severe liver injury, seizures, and withdrawal — all dismissed by industry as “anecdotal.”
Neonatal withdrawal: Babies exposed to kratom in utero have been born withdrawing. The industry says “more research is needed.” How many newborns is that?
Contamination: Salmonella, heavy metals, and undisclosed adulterants — repeatedly found in “tested” products. Industry “standards” are a joke.
Addiction and dependence: FDA warns that kratom acts on mu-opioid receptors and can cause substance use disorder. The industry still markets it as “herbal wellness.”

⛔ The Industry Spin

They say: “The FDA is biased against natural products.”
The truth: The FDA applies the same science-based standards to kratom as to any other substance. Kratom fails because it’s unsafe.

They say: “The FDA ignores traditional use.”
The truth: Traditional use does not override liver failure, addiction, and death. The FDA follows the data, not marketing.

They say: “Regulation, not prohibition.”
The truth: They’ve had years to produce safety data. They haven’t. “Regulation” is just a delay tactic to keep profits flowing.

Regulatory Status: Illegally Marketed

The FDA has made it plain: kratom is not lawfully marketed in the U.S. as a drug, dietary supplement, or food additive. The agency has issued warning letters, seized products, and collaborated with federal partners to block imports. Yet the industry keeps selling, keeps lobbying, and keeps lying.

Every kratom product on the shelf today is there in defiance of federal law. The only reason they remain is that enforcement has been slow — and industry lobbyists are working overtime to keep it that way.

Read the Original FDA Document

This is the document the industry doesn’t want you to see. It contains the FDA’s full analysis, including references to adverse events, toxicology, and regulatory determinations. No spin. No commentary. Just the evidence they’ve been trying to bury.

OPEN FDA DOCUMENT → BACK TO EVIDENCE