Safety notice: Hydroxie is a brand name used for products containing 7-hydroxymitragynine (7-OH). FDA sent Hydroxie, LLC a warning letter in 2025, and DEA has announced it intends to place 7-OH above a set threshold in Schedule I. This page gives no dosing guidance.
What Is Hydroxie?
Hydroxie, LLC is one of seven firms FDA named when it announced warning letters to companies marketing products containing 7-hydroxymitragynine on July 15, 2025. 7-OH is a compound found in small amounts in the kratom leaf. Concentrated 7-OH products are a different thing from whole-leaf kratom powder. Source: FDA press release, July 15, 2025.
FDA Position
In that announcement FDA stated that 7-OH is not lawful in dietary supplements and cannot be lawfully added to conventional foods. FDA also said there are no FDA-approved drugs containing 7-OH, and that marketing a drug containing it is illegal.
DEA Status (As Of November 1, 2026)
On October 14, 2026, DEA published a notice of intent to issue a temporary scheduling order (Docket DEA-1570, 91 FR 65370). The notice says the order will be published on or after November 13, 2026, and it had not taken effect as of today. As proposed, the order would cover 7-OH and mitragynine pseudoindoxyl above a threshold: more than 1 mg per gram of solid product or 1 mg per milliliter of liquid, or a mitragynine-to-7-OH mass ratio below 100. The notice does not place whole-leaf kratom or mitragynine in Schedule I. DEA also states that products below the threshold should not be considered safe. Source: Federal Register notice, Oct. 14, 2026. States set their own kratom laws, so check yours before buying anything.
Why We Do Not Give Doses
We found no clinical trial that establishes a safe or effective dose of 7-OH products in people. Product strength varies. Dose tables for 7-OH products would be guesses, so we removed them.
Risks To Know
- Opioid receptor activity. 7-OH acts on opioid receptors. Do not combine it with alcohol, opioids, benzodiazepines or other sedatives.
- Dependence. Regular use of kratom-related products can lead to dependence. If you want to stop and cannot, ask a doctor or call SAMHSA’s helpline at 1-800-662-4357.
- Unregulated quality. These products are not FDA-approved, and label claims about strength or purity are not verified by any regulator.
- Drug testing. Standard panels may not detect kratom, but specialized tests exist.
- Pregnancy, breastfeeding and under 18. No safety data. Avoid.
Safer Reading
If you are looking at whole-leaf kratom instead, read what kratom is and how to screen kratom vendors.
Last reviewed: November 2026. This article is for information only and is not medical advice.