Understanding 7-OH Legality


⚖️ Statement on 7-OH Federal Legality

Issued by Frost Brown Todd LLP
August 6, 2025

✅ Federally Legal Status

7-Hydroxymitragynine (“7-OH”) dietary supplements may be lawfully marketed in the United States under federal law.

  • 7-OH supplements fully comply with the Federal Food, Drug, and Cosmetic Act (FDCA).

  • FDA “Warning Letters” about 7-OH are not legally binding and do not make the product illegal.

  • 7-OH remains federally legal unless and until the DEA formally takes action—something the record shows is highly unlikely.

🔎 Why 7-OH Is Lawful

  • Natural Constituent of Kratom (Mitragyna speciosa):
    Used safely for centuries in Southeast Asia and marketed in the U.S. since at least the 1980s.

  • Not a New Dietary Ingredient (NDI):
    Kratom was sold in the U.S. before October 15, 1994, so it is excluded from “new dietary ingredient” status.¹

  • Meets FDCA Definition of a Dietary Ingredient:
    Includes “a concentrate, metabolite, constituent, or extract” of a botanical.²

  • Not Adulterated Under Federal Law:
    Even if FDA claimed otherwise, the law requires the FDA to prove adulteration, and the facts don’t support their position.³ ⁴

🚫 Why DEA Scheduling Will Fail

The DEA can only schedule substances that pose an “imminent hazard to public safety” under the Controlled Substances Act. Evidence shows:

  • Zero confirmed single-substance fatalities (per FDA’s FAERS database).

  • Only 53 poison center calls nationwide over three months.

  • No seizures, trafficking intelligence, or organized crime links.

  • In contrast, past DEA scheduling actions involved dozens to thousands of deaths and nationwide emergency surges—none of which apply to 7-OH.

If DEA attempts emergency scheduling:

  • They are likely to withdraw after public comment (as with kratom in 2016).

  • Courts could overturn any temporary order for lack of evidence.

  • Under normal scheduling, DEA would need a full 8-factor safety analysis and public review, which the data does not support.

📌 Conclusion

The evidence clearly shows:

  • 7-OH dietary supplements are federally legal.

  • FDA’s warning letters have no binding effect.

  • DEA has no valid basis to schedule 7-OH.

Ongoing scientific review and industry transparency—combined with the lack of demonstrated harm—support that 7-OH should not and will not be scheduled.

Sincerely,
(Signed)
Jonathan Miller
Frost Brown Todd LLP

References

  1. FDCA §413(a)

  2. FDCA §201(ff)(1)

  3. FDCA §413(a)(1)

  4. FDCA §402(f)(1)