FDA Urges Restrictions, Education on Illegal 7-OH Opioid Products

Follow Drugslib on

By Stephanie Brown HealthDay Reporter

Medically reviewed by Drugs.com

via HealthDay

TUESDAY, July 29, 2025 -- The U.S. Food and Drug Administration is recommending that certain products containing 7-hydroxymitragynine (7-OH) -- an illegal opioid easily accessible in high-concentration versions online and at gas stations, corner stores, and vape shops -- be controlled under the Controlled Substances Act.

A concentrated compound derived from the kratom plant, 7-OH has a great potential for abuse. The agency is not focusing on natural kratom leaf products. A new report issued by the FDA aims to inform the public about the health risks of 7-OH and to clarify how it differs from the kratom leaf.

The FDA recommendation follows a detailed scientific review and is part of broader efforts to address concerns about the rise of 7-OH opioid products. Currently, 7-OH has no FDA-approved drug uses and is not legally permitted in dietary supplements or conventional foods.

The FDA has issued educational materials to inform consumers about the dangers of 7-OH products, as well as warning letters to seven companies for illegally selling 7-OH in forms like tablets, gummies, drink mixes, and shots. The FDA is also alerting health care professionals about the risks of these products.

"Vape stores are popping up in every neighborhood in America, and many are selling addictive products like concentrated 7-OH. After the last wave of the opioid epidemic, we cannot get caught flat-footed again," FDA Commissioner Marty Makary, M.D., M.P.H., said in a statement. "7-OH is an opioid that can be more potent than morphine. We need regulation and public education to prevent another wave of the opioid epidemic."

The Drug Enforcement Agency is reviewing the FDA recommendation on 7-OH and holds final authority on drug classification, which involves public input before any decision is finalized.

More Information

Disclaimer: Statistical data in medical articles provide general trends and do not pertain to individuals. Individual factors can vary greatly. Always seek personalized medical advice for individual healthcare decisions.

Source: HealthDay

Posted : 2025-07-30 12:00

Read more

Disclaimer

Every effort has been made to ensure that the information provided by Drugslib.com is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. Drugslib.com information has been compiled for use by healthcare practitioners and consumers in the United States and therefore Drugslib.com does not warrant that uses outside of the United States are appropriate, unless specifically indicated otherwise. Drugslib.com's drug information does not endorse drugs, diagnose patients or recommend therapy. Drugslib.com's drug information is an informational resource designed to assist licensed healthcare practitioners in caring for their patients and/or to serve consumers viewing this service as a supplement to, and not a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners.

The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. Drugslib.com does not assume any responsibility for any aspect of healthcare administered with the aid of information Drugslib.com provides. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.

Popular Keywords