Michigan Lawmakers Deserve the Whole Record on HB 4969

On October 30, 2025, the Michigan House Committee on Regulatory Reform received testimony in support of HB 4969. The presentation was polished, citation-heavy, and framed as science-driven.

But when you slow it down and compare it to the underlying federal record, the picture becomes more complicated.

What Michigan Was Told

• The FDA has “shifted.”
• Natural leaf is distinct from 7-hydroxymitragynine.
• A small human study showed tolerability.
• Millions use kratom safely.
• Federal posture supports incremental regulation.

Those claims sound reassuring. The federal record is narrower.

FDA Position: No Approval, No Safety Determination

• No FDA-approved drug products containing kratom.
• FDA has not declared kratom safe.
• No formal safety determination under the FD&C Act.
• FDA continues to warn of liver toxicity, seizures, and substance use disorder.

The Human Study Cited

Michigan legislators were told a small FDA study showed kratom was “well tolerated.”

• Phase I, single-dose study.
• 40 participants.
• Conducted by Altasciences (industry CRO).
• Short-term adverse events only (Day 1–7).
• No chronic dosing.
• No long-term follow-up.
• No sustained dependence or withdrawal measurement.

The 7-Hydroxymitragynine Distinction

• Mitragynine is metabolized in humans into 7-hydroxymitragynine.
• 7-OH is the more potent mu-opioid receptor agonist.

Federal Court Framing

The referenced federal case involved falsified shipping manifests.

• Not a safety trial.
• Not a rulemaking.
• Not a judicial determination that kratom is safe.

Sentencing hearings do not establish toxicology standards.

“Lawfully Marketed as Food”

• FDA has concluded kratom is not appropriate as a dietary supplement.
• FDA has determined kratom added to food is an unsafe food additive.
• FDA states there are no lawfully marketed drug, supplement, or food products containing kratom.

Lack of preapproval does not equal legality.

“Millions Use It Safely”

Prevalence is not proof of safety.

Widespread access measures availability — not toxicology.

Three Questions Michigan Should Ask

1. Has FDA declared kratom safe?
   No.
2. Has dependency risk been ruled out?
   No.
3. Does short-term tolerability equal long-term safety?
   No.

The Bottom Line

• Acts on opioid receptors.
• Produces a more potent opioid metabolite in the human body.
• No FDA-approved medical use.
• Abuse potential still under federal study.