FDA Report: Synthetic 7-OH Products Pose Severe Opioid Risks

Agency Finds 7-OH Products Lack Safety Data, Carry High Abuse Potential, and Risk Respiratory Failure

WASHINGTON, D.C. — The Stop Gas Station Heroin coalition today applauded the U.S. Food and Drug Administration’s release of a new report, 7-Hydroxymitragynine (7-OH): An Assessment of the Scientific Data and Toxicological Concerns Around an Emerging Opioid Threat. 

Its findings confirm what public health experts have long warned: Concentrated 7-OH opioid products are not natural kratom, but highly addictive synthetic opioids that put American consumers at serious risk.

The FDA’s Center for Drug Evaluation and Research (CDER) found that:

• Concentrated 7-OH is not natural kratom, but a chemically concentrated derivative far removed from the traditional leaf.

• No human clinical trials exist to show safe use, with no reliable data on blood concentrations, side effects, or benefits.

• Addiction potential is high, matching that of traditional opioids.

• Respiratory depression risk is severe, raising the danger of overdose deaths.

• Adverse event data is unreliable due to underreporting and mislabeling, masking the true scope of harm.

“7-OH isn’t a wellness product, it’s a synthetic opioid,” said Dr. Nicole Avena, research neuroscientist and expert in addiction. “The FDA’s findings reinforce what we’ve seen clinically — these products carry real risks of dependency, overdose, and long-term harm. Selling them as dietary supplements is misleading and dangerous.”

The FDA report also notes that results across multiple independent studies align: Preclinical addiction models show the high-risk profile of concentrated 7-OH, making it clear that these substances should not be marketed directly to consumers.

Despite being packaged as “natural” remedies, concentrated 7-OH products are chemically manufactured drugs that are illegally sold without FDA approval. Some are branded as pain relievers or treatments for opioid withdrawal despite lacking any clinical proof of safety or effectiveness.

“Objective science has spoken,” Avena said. “Concentrated 7-OH opioid products are illegal, unapproved new drugs. Until companies produce peer-reviewed clinical research and secure FDA new drug approval, these products must be kept off the market to protect American families.”