FDA Moves to Restrict 7-OH Opioid Products That Threaten American Consumers

The U.S. Food and Drug Administration (FDA) announced several months ago that it is recommending a formal scheduling action under the Controlled Substances Act (CSA) for certain products containing 7-hydroxymitragynine, commonly called “7-OH.” These concentrated 7-OH products pose serious public health risks.

Importantly, the FDA clarified that this action does not target natural plant-based products made from the leaves of Mitragyna speciosa (often called kratom). Rather, the agency is concerned about manufactured products that contain concentrated 7-OH, which has opioid-like effects because it can bind strongly to opioid receptors.

There are currently no FDA-approved drugs that use 7-OH. It is not lawful to include 7-OH in dietary supplements or conventional foods.

The FDA’s move follows studies and analysis showing that 7-OH can be more potent than certain opioids, and it may pose a high risk of abuse and dependence. As a result, the FDA is issuing warnings to both consumers and healthcare professionals to raise awareness of these risks.

In June 2025, the FDA issued warning letters to seven firms that were illegally distributing 7-OH products in forms such as tablets, gummies, drink mixes, and shots. The agency also published educational materials to help consumers and health care providers recognize and avoid these potentially dangerous products.

Now that the FDA has submitted a recommendation under the CSA, the Drug Enforcement Administration (DEA) must review the proposal and may proceed to formally schedule 7-OH. This step would significantly limit its legal availability.

Dangers of Kratom

• Addiction and dependence. Kratom acts on opioid receptors, and regular use can lead to dependence. Some users experience withdrawal symptoms similar to mild opioid withdrawal, such as irritability, muscle aches, insomnia, and cravings.
• High-dose side effects. Larger doses can cause extreme drowsiness, slowed breathing, confusion, tremors, or loss of coordination. These effects can make driving or operating machinery dangerous.
• Liver toxicity. There have been reported cases of acute liver injury linked to kratom use. Signs may include jaundice, dark urine, itching, or fatigue.
• Cardiovascular effects. Some users experience increased heart rate, high blood pressure, or arrhythmias. In rare cases, kratom has been linked to heart-related complications.
• Dangerous interactions. Kratom can interact with prescription medications, especially antidepressants, benzodiazepines, alcohol, and opioids. These combinations increase the risk of respiratory depression, seizures, or sudden collapse. Deaths related to kratom use have been documented, but the vast majority of these deaths involve the co-use of other substances.
• Seizure risk. Kratom has been associated with seizures, particularly when taken in large amounts or with other substances.

Contact Us Today

Kratom use has been on the rise in recent years, but its use can be harmful. It can cause adverse side effects even in healthy people.

Product manufacturers, designers, and sellers have a duty to provide consumers with safe and effective products. If you or a loved one became injured or ill due to someone else’s negligence, contact a Mt. Juliet product liability lawyer from The Law Offices of Christopher Eads, PLLC. Schedule a consultation by filling out the online form or calling (615) 622-6060.

Source:

fda.gov/news-events/press-announcements/fda-takes-steps-restrict-7-oh-opioid-products-threatening-american-consumers