Estimated reading time: 4 minutes
Key Takeaways
- The FDA has issued a crackdown on products containing 7-Hydroxymitragynine (7-OH), a highly potent and unsafe opioid derived from kratom.
- 7-OH binds strongly to opioid receptors, causing effects similar to opioids, with a high risk of abuse, addiction, and serious health issues.
- Recent actions include warning letters to seven companies marketing illegal 7-OH products and pushing for federal scheduling of the substance.
- Consumers should avoid products containing 7-OH to prevent potential health risks such as liver toxicity, seizures, respiratory depression, and death.
- The crackdown emphasizes the importance of regulatory oversight and consumer awareness in addressing emerging synthetic opioids.
Table of Contents
What is 7-OH and Why Is It Dangerous?
FDA Warns of the Dangers of 7-Hydroxymitragynine (7-OH) — The New Potent Opioid on the Market
The U.S. Food and Drug Administration (FDA) has issued a sweeping crackdown on products containing 7-Hydroxymitragynine (7-OH), a highly potent opioid compound derived from the kratom plant. This action comes amid rising concerns over the availability of illegal 7-OH products sold as supplements, foods, and even over-the-counter items at gas stations and smoke shops across the country.
What is 7-OH and Why Is It Dangerous?
7-OH is a concentrated byproduct of the kratom plant native to Southeast Asia. While kratom leaf itself has been controversial, regulators are now focused on 7-OH because it binds strongly to opioid receptors, producing effects similar to opioids that carry a high potential for abuse, addiction, and serious health risks.
The FDA stresses that 7-OH has no FDA-approved medical uses, and its presence in dietary supplements, foods, or any consumer products is illegal and unsafe. Adverse health impacts linked to kratom and 7-OH consumption include liver and cardiovascular toxicity, seizures, respiratory depression, addiction, withdrawal symptoms, and even death.
Recent FDA Actions
- On July 15, 2025, the FDA sent warning letters to seven companies illegally marketing products containing 7-OH, including drink mixes and gummies enhanced with this potent opioid.
- The agency is pushing for federal scheduling of 7-OH under the Controlled Substances Act to classify and control its distribution urgently.
- Public education initiatives are underway to inform consumers about the risks and to clarify that this crackdown targets 7-OH specifically — not the natural kratom leaf itself.
Why Is This Important Now?
The popularity of kratom-derived products surged as people search for alternatives to traditional opioids. However, the rise in 7-OH concentrations in products sold at easily accessible retail outlets poses a new public health emergency, as these products increase the risks associated with opioid overdose and addiction.
What Should Consumers Do?
Consumers are strongly advised to avoid any products containing 7-OH, including those marketed as dietary supplements, foods, or treatments for various ailments. Because 7-OH is illegal and unsafe, buying or using these products can lead to serious health consequences.
Looking Ahead
The FDA’s decisive actions against 7-OH mark a critical step in combating the opioid crisis by addressing emerging synthetic or concentrated opioid analogs masquerading as safe supplements. This reinforces the importance of rigorous regulatory oversight and consumer education to prevent harm from unapproved and dangerous substances in the marketplace.
Stay informed, stay safe, and always verify product legitimacy, especially in the rapidly evolving landscape of opioid alternatives and supplements.
FAQ
Is 7-OH legal?
No, 7-OH is illegal to produce, sell, or possess in many jurisdictions because of its high potency and health risks. The FDA has issued warnings and taken enforcement actions against illegal marketing and distribution.
What are the health risks associated with 7-OH?
The health risks include liver toxicity, cardiovascular issues, seizures, respiratory depression, addiction, withdrawal symptoms, and potentially death. There is no safe level of 7-OH consumption.