FDA Moves to Regulate Potent Kratom Byproduct 7-OH Amid Opioid Crisis Concerns

In a decisive move to curb the growing threat of unregulated synthetic opioids, the U.S. Food and Drug Administration (FDA) has recommended classifying 7-hydroxymitragynine (7-OH)—a powerful, concentrated byproduct of the kratom plant—under the Controlled Substances Act (CSA). This initiative underscores the FDA’s intensified efforts to combat addiction and protect public health, especially among youth.

Importantly, this action does not target natural kratom leaf products. The FDA’s focus is solely on 7-OH, a chemically altered derivative known to strongly bind to opioid receptors, mimicking the effects of traditional opioids and raising significant concerns about abuse potential and safety.

“We’re taking this step to safeguard the health of Americans, particularly our youth, from a potentially dangerous and addictive opioid,” said Health and Human Services Secretary Robert F. Kennedy, Jr. “This is a key part of our broader mission to Make America Healthy Again.”

Why 7-OH Is Under Scrutiny

While kratom leaves have long been used for their stimulant and pain-relieving effects, 7-OH is far more potent—reportedly stronger than morphine in some cases. Its concentrated form is often found in unregulated products like tablets, vapes, gummies, and even desserts marketed toward teens, such as fruit-flavored candies and ice cream cones.

FDA Commissioner Dr. Marty Makary emphasized the urgency of regulation:

“We’ve seen this before with the FYL crisis. Vape shops, gas stations, and online vendors are distributing 7-OH in forms that appeal to youth—without proper labeling or safety warnings. We cannot allow this to become the next wave of the opioid epidemic.”

No Legal Pathway for 7-OH in Foods or Supplements

The FDA reaffirmed that 7-OH is not approved for any medical use. It cannot be lawfully included in dietary supplements or added to food products. In June, the agency issued formal warnings to seven companies found illegally marketing 7-OH-infused products ranging from gummies and drink mixes to energy shots.

Now, alongside its scheduling recommendation, the FDA is distributing educational materials to healthcare providers and the public to raise awareness of 7-OH’s risks, especially when it’s deceptively labeled or disguised as kratom.

What Happens Next?

Under the Controlled Substances Act, substances are categorized into one of five schedules based on their medical value, safety, and potential for abuse. While the FDA provides scientific and medical analysis, the final decision on scheduling lies with the Drug Enforcement Administration (DEA). The DEA must follow a rulemaking process that includes a public comment period before finalizing the classification.

The Bigger Picture

This regulatory push comes at a time when communities across the U.S. are still grappling with the devastating impact of the FYL and XYL crises. As opioids continue to evolve in form and distribution, agencies like the FDA are stepping up to identify emerging threats before they escalate.

With 7-OH increasingly found in products with high abuse potential and marketed in youth-friendly formats, this scheduling recommendation marks a proactive approach to limit exposure, misuse, and addiction.

Final Note

Consumers are urged to stay informed and cautious. Any product claiming to contain kratom or its derivatives—especially from gas stations, vape shops, or online sources—should be scrutinized for possible 7-OH content. When in doubt, consult with a healthcare professional and report suspicious products to the FDA.

Source: FDA