FDA Moves to Restrict Dangerous 7-OH Opioid Products

FDA Moves to Restrict Dangerous 7-OH Opioid Products

Introduction

In a significant move to combat the ongoing opioid crisis, the U.S. Food and Drug Administration (FDA) has recommended a scheduling action under the Controlled Substances Act (CSA) to regulate certain products containing 7-hydroxymitragynine (7-OH1).

This potent substance, a concentrated byproduct of the kratom plant, is increasingly recognized for its potential to cause harm due to its opioid-like effects.

Targeting 7-OH, Not Natural Kratom Leaves

The FDA clarified that this action does not apply to natural kratom leaf products, but specifically targets 7-OH, which is derived during processing. 7-OH binds to the same receptors in the brain as opioids, raising serious concerns about its abuse potential. To further public understanding, the FDA is releasing a new report to highlight the risks associated with 7-OH and explain how it differs from natural kratom.

Health Officials Emphasize Public Safety

“Today, we’re taking action on 7-OH as a critical step in the fight against opioid addiction,” said the Secretary of Health and Human Services. He emphasized the administration’s commitment to protecting young Americans and advancing national health goals. The FDA’s recommendation follows comprehensive scientific and medical evaluation and reflects broader efforts to address the rise in 7-OH product use.

FDA Highlights Dangers of Unregulated 7-OH

FDA Commissioner echoed the urgency of the decision, noting that 7-OH, when concentrated, can be more potent than morphine. “Vape stores are popping up in every neighborhood, selling addictive 7-OH products. After the last opioid epidemic, we must not be unprepared again,” he stated. The agency warns that regulation and education are essential to prevent another wave of opioid-related harm.

Concerns About Youth-Targeted Products

The FDA is especially troubled by the increasing availability of 7-OH in forms attractive to minors, such as fruit-flavored gummies and novelty edibles like ice cream cones. These items are often mislabeled or disguised as natural kratom, putting unsuspecting consumers—especially youth—at risk. Many are sold online or through convenience stores and vape shops.

Enforcement and Outreach Efforts Continue

In June, the FDA sent warning letters to seven companies for illegally marketing 7-OH products, including tablets, drink mixes, and gummies. In conjunction with the scheduling recommendation, the FDA is also issuing a formal letter to healthcare professionals and updating public advisories to highlight the dangers of 7-OH.

Next Steps in the Scheduling Process

Under the CSA, substances are categorized based on their medical use, potential for abuse, and safety profile. While the FDA can make recommendations, the Drug Enforcement Administration (DEA) has the final authority to schedule substances. The DEA will now begin a rulemaking process, which includes a public comment period, before any decision is finalized.