FDA Sends Warning Letters to Companies Selling Illegal Opioid Compound

Follow Drugslib on

By Stephanie Brown HealthDay Reporter

Medically reviewed by Drugs.com

via HealthDay

TUESDAY, July 15, 2025 -- The U.S Food and Drug Administration has issued seven warning letters to companies illegally marketing products containing 7-hydroxymitragynine (7-OH), which is found in trace amounts in kratom.

The agency issued the letters to companies selling concentrated 7-OH products (e.g., tablets, gummies, drink mixes, shots) online and in retail outlets such as smoke shops, gas stations, and corner stores. 7-OH is not permitted in dietary supplements or conventional foods, and there are no FDA-approved drugs containing 7-OH. Furthermore, the marketing of drugs that contain 7-OH is illegal.

The letters instruct the companies to cease the illegal marketing of products containing added 7-OH or that have elevated levels of 7-OH. These products include adulterated conventional foods and dietary supplements, for which 7-OH does not meet safety standards, as well as unapproved new drugs for pain relief and anxiety management, which are being marketed with unsubstantiated claims.

The FDA warns that people using these products "are exposing themselves to products that have not been proven safe or effective for any use."

Warning letters were sent to the following companies: Shaman Botanicals LLC; My Smoke Wholesale; Relax Relief Rejuvenate Trading LLC dba RRR Trading or EDP Kratom; Thang Botanicals Inc. dba 7ΩHMZ, 7-OHMZ, or 7OHMZ; Royal Diamond Imports Inc. dba Roxytabs.com; Hydroxie LLC; and 7Tabz Retail LLC.

The recipients were asked to respond to the letters within 15 business days.

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 : 2025-07-16 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