FDA Cracks Down on 7-Hydroxymitragynine: A Warning for All
In a sweeping enforcement action, the U.S. Food and Drug Administration (FDA) has issued seven warning letters to companies illegally marketing products containing 7-hydroxymitragynine (7-OH)—a potent compound derived from kratom, a Southeast Asian plant increasingly linked to youth substance experimentation and serious health risks.
What Is 7-Hydroxymitragynine and Where Is It Found?
7-OH is a powerful alkaloid found in trace amounts in kratom leaves. While kratom itself has a long-standing traditional use for pain relief and stimulation, 7-OH is far more potent, acting on the brain’s opioid receptors with strength comparable to morphine.
In recent years, manufacturers have begun concentrating and adding 7-OH into a growing list of products, including:
Gummies
Tablets
Drink mixes
Shots
Supplements — often falsely marketed as “natural” or “herbal” remedies
These products are sold online and in gas stations, smoke shops, corner stores, and even some wellness retailers, often with flavored packaging that appeals to youth.
What the FDA Warning Covers
The FDA’s letters target companies selling concentrated 7-OH products that:
Are illegally marketed as dietary supplements or foods
Make unsubstantiated medical claims (e.g., pain relief, anxiety reduction)
Contain unsafe levels of 7-OH, far exceeding what occurs naturally in kratom
The FDA emphasized:
“There are no FDA-approved drugs containing 7-OH, and it is illegal to market any drugs containing 7-OH. Consumers who use these products are exposing themselves to substances that have not been proven safe or effective for any use.”
Companies have 15 days to respond, or they may face further regulatory and legal action.
Is 7-OH Banned?
While 7-OH is not currently a federally scheduled substance, it is not lawful in:
Dietary supplements
Conventional foods
Over-the-counter drugs
This means any product containing added or concentrated 7-OH is illegal to market or sell in the U.S. The FDA has not approved it for any medical use or therapeutic claim.
Risk to Youth: What Families Need to Know
These products are often packaged like candy, flavored with mango, cherry, or citrus, and sold in places frequented by teens. The risk to youth is especially alarming because:
7-OH is highly addictive, with rapid tolerance and withdrawal symptoms similar to opioids
It can cause sedation, nausea, dizziness, constipation, and respiratory depression
Overdose risk increases when combined with alcohol or other depressants
Brain development may be impacted, especially in adolescents
Former CDC Commissioner Dr. Robert Redfield warned:
“This is not botanical kratom—this is pharmaceutical-grade opioid chemistry operating without oversight.”
What Parents and Counselors Should Do
Monitor purchases from gas stations, vape shops, and online retailers
Talk openly with youth about kratom and 7-OH—many don’t realize it’s addictive
Watch for signs of sedation, mood swings, or withdrawal
Report suspicious products to the FDA or local health departments
Final Thoughts
The FDA’s crackdown is a wake-up call. 7-hydroxymitragynine is not a harmless herbal supplement—it’s a potent, opioid-like compound being sold in youth-friendly packaging with little oversight. As prevention advocates, educators, and parents, we must stay vigilant and informed.
For more information, help, and resources, please visit www.steeredstraight.org or call (856) 691-6676
Our mission is to steer youth straight toward making sound, rational decisions through a learning experience that provides a message of reality to help them make positive, informed choices.
