FDA Warns of Dangerous Drug Sold in Stores Nationwide
Sold openly in vape shops and gas stations, this compound binds to your brain like morphine - and federal investigators say we may be repeating history.
STORY AT-A-GLANCE
The FDA has issued a nationwide warning about 7-hydroxymitragynine (7-OH), an opioid substance found in some products available in gas stations and convenience stores across the U.S.
7-OH binds strongly to opioid receptors and has been shown to be more potent than morphine, yet it is unregulated, lacks approved medical use, and is often sold without proper safety labeling
Many 7-OH products are disguised as energy shots or wellness aids, often with bright packaging that looks like candy or juice. This makes them easy to grab, especially for young consumers, and they’re frequently marketed with false claims for pain, anxiety, or mood support
Most 7-OH products sold in the U.S. are lab-altered or highly processed, delivering doses far beyond what’s found in natural kratom leaves and carrying a much greater risk of dependence and harm
If you’ve used 7-OH products, tapering gradually, supporting your body with movement, nutrition, and professional guidance helps reduce withdrawal symptoms and support a safe recovery process
You have probably seen them lined up by the cash register at a gas station or tucked onto the shelves of a corner store — small bottles of energy shots, brightly colored gummies, and novelty products that promise relaxation, focus, or a quick burst of energy. Their packaging is eye-catching and designed to feel as approachable as candy or soda, making them easy to grab without much second thought.
Behind those labels, however, many of these products contain a little-known ingredient called 7-hydroxymitragynine (7-OH), a byproduct of the plant kratom. The U.S. Food and Drug Administration (FDA) has issued an urgent nationwide warning against this substance, emphasizing that it carries serious health risks despite being sold openly as a “natural” product.1
The FDA’s announcement has drawn national attention and sparked urgent calls for action as 7-OH products continue to appear on store shelves without proper oversight. For you and anyone you care about, the warning serves as a reminder to look more closely at what’s being marketed as safe, because the stakes for your health could be greater than you realize.
FDA Cracks Down on 7-OH — A Potent Opioid Sold in Plain Sight
On July 29, 2025, the FDA took its first formal step toward restricting 7-OH, a potent opioid compound being sold in vape shops and convenience stores. The move follows growing concern that 7-OH is fueling patterns of misuse and addiction reminiscent of the early days of the opioid epidemic.2
The FDA recommends scheduling 7-OH under federal law — The agency announced that 7-OH should be placed under the Controlled Substances Act, a decision that would classify it alongside other regulated opioids. U.S. Health and Human Services (HHS) Secretary Robert F. Kennedy Jr. framed the action as essential to protecting public health, stating:
“Today, we’re taking action on 7-OH as a critical step in the fight against opioid addiction. We will protect the health of our nation’s youth as we advance our mission to Make America Healthy Again.”3
Potent opioid activity with no legal medical use — Regulators confirmed that 7-OH is a highly potent compound that acts on the same brain receptors targeted by opioids. Under the proposed scheduling, 7-OH would be designated as a Schedule I substance, the most restricted category reserved for drugs with high potential for abuse, no accepted medical use, and no established safety profile.
FDA targets illegal sales and false claims — As a result, the FDA emphasized that it cannot be legally sold as a dietary supplement, food ingredient, or over-the-counter product. In June 2025, the FDA sent warning letters to seven companies marketing 7-OH in various formulations. These products made unauthorized claims for conditions such as anxiety, pain, opioid withdrawal, or mood disorders.
Scientific review shows high risk of addiction and abuse — The scheduling recommendation was based on a full medical and scientific review, which concluded that 7-OH carries significant risks. FDA Commissioner Dr. Marty Makary warned that its spread could mirror the beginnings of the opioid crisis, when the dangers of prescription opioids were underestimated.
“Vape stores are popping up in every neighborhood in America, and many are selling addictive products like concentrated 7-OH. After the last wave of the opioid epidemic, we cannot get caught flat-footed again,” Makary stated. “7-OH is an opioid that can be more potent than morphine. We need regulation and public education to prevent another wave of the opioid epidemic.”4
Public education campaign launched — The agency has released educational materials for public distribution, including a dedicated report for health providers and a consumer bulletin titled “Hiding in Plain Sight,” which highlights how these products are often disguised as kratom and sold without adequate warning.5
Reports of severe health effects are mounting — Adverse event reports submitted to the FDA describe troubling outcomes linked to 7-OH use, including seizures, gastrointestinal distress, liver injury, depression, anxiety, insomnia, and withdrawal symptoms such as cold sweats, irritability, body aches, and restlessness. Given the severity of these, the agency urged consumers to avoid all products containing 7-OH.6
The FDA’s recommendation now moves to the Drug Enforcement Administration (DEA), which will decide whether to officially schedule 7-OH as a controlled substance. That process includes a public comment period before becoming law. Until then, the compound remains widely available in retail outlets, leaving the public exposed to unregulated products with opioid effects and real risks.
What Exactly Is 7-OH and How Is It Related to Kratom?
Kratom (Mitragyna speciosa) is a tropical evergreen tree native to Southeast Asia, where it’s long been used as a traditional remedy for fatigue, pain, and mood and anxiety disorders. The leaves contain dozens of alkaloids, but the one most abundant and pharmacologically significant is mitragynine, the compound from which 7-OH is formed in the liver.7
Mitragynine is kratom’s primary alkaloid — Making up about 60% of the leaf’s alkaloid content, mitragynine acts as a partial agonist at the μ-opioid receptor. It produces stimulant and analgesic effects without fully activating the receptor in the way that drugs like morphine do.8
7-OH is rare in the plant but extremely potent when isolated — In natural kratom leaves, 7-OH typically makes up less than 0.05% of total alkaloid mass. Only a small fraction of mitragynine is metabolized into 7-OH inside the body. Commercial products on store shelves often bypass this slow conversion process, delivering synthesized or extracted 7-OH directly at concentrations far higher than anything the plant itself provides.
Pharmacology reveals potency and risk similar to opioid — Unlike mitragynine’s weaker receptor activity, 7-OH engages the μ-opioid receptor far more strongly. In animal models, it produces rapid pain relief at lower doses than morphine, with sedation and reinforcement that point to clear opioid-class effects.
Researchers describe both mitragynine and 7-OH as “atypical opioids” because they bias signaling toward pain-relief pathways, but this does not eliminate the risks of dependence, overdose, or other harm.
Addiction potential is clear in experimental models — In laboratory studies, animals repeatedly dosed with 7-OH displayed opioid-like patterns of self-administration, withdrawal, and drug-seeking behavior. These findings align with user reports describing powerful sedation, rapid onset, and a strong compulsion to redose throughout the day — all markers of high abuse potential.
Understanding how 7-OH differs from the natural chemistry of kratom is key. In the plant, it exists only in trace amounts. When isolated and concentrated, however, it becomes a pharmacologically powerful drug with little research to guide safe use. That leap from trace metabolite to high-dose product is what transforms 7-OH into such a hazardous and unpredictable substance.
What About Fresh Kratom Leaves?
When headlines link 7-OH to kratom, it’s important to clarify that the plant and the compound are not the same. According to Christopher McCurdy, Ph.D., professor of medicinal chemistry and former National Institutes of Health (NIH) opioid chemistry fellow, fresh kratom and post-processed products differ significantly in chemical composition and potency.9
Post-harvest processing shapes alkaloid content — According to McCurdy’s team, 7-OH appears to form during post-harvest changes, particularly drying and oxidation. The longer and harsher the processing, the more 7-OH is likely to develop. By contrast, lab tests on fresh leaf preparations from native Malaysian kratom trees showed no detectable 7-OH.
Marketing doesn’t match chemistry — In the U.S., kratom is often sold under names like “red vein,” “green vein,” or “Maeng Da.” These labels suggest chemical consistency, but in reality, factors like soil quality, sunlight, harvest timing, and drying methods drive far more variation. McCurdy’s analyses found that even supposedly “strong” strains sometimes had low alkaloid levels, while cheaper or generically labeled samples tested stronger.
Traditional teas and acidifiers extract selectively — Southeast Asian users typically brew kratom tea using fresh leaves and may add acidic ingredients like lemon juice to increase alkaloid solubility. This method extracts only a subset of compounds and avoids concentrating them to extreme levels. Alcohol- or solvent-based Western extracts pull out different sets of alkaloids, altering potency and effect, and introducing more 7-OH in the process.
Safety depends on context and use — Compared to opioids or synthetic 7-OH products, fresh kratom appears to carry a more favorable safety profile, but that does not mean it is risk-free. It is a psychoactive substance, and its effects vary widely between individuals and products.
Certain types of kratom are still addictive, so make sure to do your research before trying it. One place to start is the American Kratom Association.10 Check out my interview with McCurdy in “Kratom as an Alternative for Opium Withdrawal” to learn more about this plant.
Until there are more standardized production and clearer research on long-term safety, kratom should be approached with care. For those considering this substance for pain relief, there are other safe and effective options to explore before turning to concentrated kratom products. Get a list of safer solutions for pain relief in “Opioid Deaths Continue to Rise Despite Drop in Prescriptions.”
6 Strategies to Help You Wean Off 7-OH Products
If you or a loved one has been using products that contain 7-OH, a thoughtful tapering plan makes the process safer and more manageable. Here’s how to approach it:11 12 13
Work with a health professional — Find someone familiar with withdrawal from natural substances, whether a physician, integrative practitioner, or other qualified provider who will take your experience seriously. A professional will help you come up with a withdrawal plan, monitor symptoms, and adjust the approach if challenges arise. This is especially important if you’ve been using 7-OH daily or at higher doses.
Reduce gradually, not all at once — Stopping cold turkey often leads to intense withdrawal. Instead, lower your intake step by step by cutting the dose or spacing out the time between doses. For instance, if you consume 7-OH product twice a day, reduce to once daily for a week, then shift to every other day.
Nourish your body properly — Give your system the resources it needs to adapt. Stay hydrated and focus on regular meals built around high-quality protein, healthy fats, and mineral-rich whole foods. Limit processed snacks, alcohol, and sugary drinks, which amplify fatigue, mood swings, and cravings.
Move daily — You don’t need intense exercise. Gentle, consistent activity, such as walking, stretching, or light yoga, helps regulate mood, reduce tension, and promote restorative sleep. Even 10 to 20 minutes a day reinforces progress and builds resilience.
Avoid other stimulants or sedatives — Now isn’t the time to lean on caffeine, alcohol, or other substances to take the edge off. They interfere with your body’s natural reset and make it harder to interpret withdrawal symptoms. Keep your inputs clean so your system resets without additional stressors.
Seek support and connection — Withdrawal has emotional as well as physical dimensions. Share your plan with a trusted friend, family member, therapist, or peer support group. Regular check-ins provide accountability, encouragement, and a reminder that you’re not doing this alone.
Coming off 7-OH may be challenging, but with these strategies, it’s possible to break free safely. Each small step is progress, and consistency is what makes the transition last.
Frequently Asked Questions (FAQs) About 7-Hydroxymitragynine
Q: What is 7-hydroxymitragynine, and why should I be concerned about it?
A: 7-hydroxymitragynine (7-OH) is a lab-synthesized or concentrated compound derived from the kratom plant. It acts like an opioid in your body and has been linked to serious health risks including seizures, withdrawal, liver injury, and addiction. The FDA has formally warned against its use and recommended that it be regulated as a controlled substance.
Q: I’ve seen 7-OH products sold in stores — how is that legal?
A: Right now, 7-OH is not yet classified as a controlled substance, which is why it’s still being sold in gas stations, vape shops, and online. But the FDA has called for it to be scheduled under federal law, and warned that it cannot legally be sold as a dietary supplement, food, or over-the-counter product.
Q: Is 7-OH the same as kratom, or are they different?
A: They’re different. While 7-OH is derived from kratom, it’s found in only trace amounts in the natural plant. Most 7-OH sold in stores is either synthesized or concentrated through heavy processing. Fresh kratom used traditionally has a different chemical profile and is far less potent than isolated 7-OH products.
Q: How do I tell if a product contains 7-OH before I buy it?
A: Check the label closely, but be aware — many 7-OH products are disguised under names like “kratom extract,” “enhanced kratom,” or “relaxation shots.” If the product promises intense effects like pain relief, euphoria, or opioid withdrawal support and doesn’t list full ingredients, it’s best to avoid it. The safest move is to steer clear of unregulated products entirely, especially those sold in gas stations or smoke shops.
Q: How do I safely stop taking products that contain 7-OH?
A: To taper off 7-OH safely, reduce your dose gradually instead of quitting suddenly. Work with a health professional who understands withdrawal. Support your body with hydration, nourishing food, regular physical activity, and emotional connection. Avoid stimulants or sedatives that could complicate the process.
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Multiple Fatal Overdoses Tied to Synthetic Kratom Compound in Los Angeles County
The Los Angeles County Department of Public Health is making residents and health care providers aware of the risks of the synthetic kratom compound known as 7-Hydroxymitragynine (7-OH) after the County of Los Angeles Medical Examiner recently identified three fatal overdoses in LA County residents between the ages of 18 to 40 years old. Alcohol was present in all cases. The decedents were otherwise healthy, with no other substances identified as substantively contributing to their deaths.
Kratom and 7-OH products are unregulated and marketed as remedies for pain, anxiety, and depression. They are made from the leaves of a tree (Mitragyna speciosa) native to Southeast Asia that are crushed and then smoked, brewed with tea, or placed into gel capsules.
7-OH, the psychoactive component of kratom leaves, is being synthetically concentrated into various products that are sold in gas stations, smoke shops, and other retail and online venues in LA County. They are often promoted as dietary supplements to address a broad range of issues such as pain, anxiety and mood disorders, opioid withdrawal, or energy/general well-being. These products come in various forms such as tablets, gummies, drink mixes, and concentrated (“enhanced” or “super”) liquid extracts or shots for drinking, which significantly increase its adverse and potentially life-threatening effects.
Products are often labeled with terms such as “plant alkaloids” or “alkaloid”. At low doses, 7-OH can have stimulant-like effects and at higher doses it has opioid-like effects. High doses of 7-OH and/or co-used with alcohol or other sedatives can cause severe respiratory depression and death. Again, they are unregulated and may contain unknown concentrations of 7-OH, increasing the risk of unintentional overdose.
In July 2025, the Federal Drug Administration (FDA) issued warning letters to firms for illegal marketing of concentrated 7-OH products and posted product images, saying, “7-OH is not lawful in dietary supplements and cannot be lawfully added to conventional foods. Additionally, there are no FDA-approved drugs containing 7-OH, and it is illegal to market any drugs containing 7-OH. Consumers who use 7-OH products are exposing themselves to products that have not been proven safe or effective for any use.”
The safest course of action is to avoid using 7-OH or kratom products. To minimize the risk of overdose and overdose-related death for people who are using drugs, Public Health urges residents to:
Never use alone: Using with another person is protective and increases the chances of lifesaving interventions such as the administration of naloxone in instances of an overdose. Naloxone can reverse 7-OH toxicity.
Stagger drug use with others: Making sure at least 1 person in the group can administer naloxone to reverse an overdose can save a life.
Avoid mixing 7-OH with other drugs: The effects of combining substances may be stronger and more unpredictable than using one drug alone and mixing and using multiple drugs increases the risk of an overdose.
Carry naloxone: Naloxone can reverse an opioid overdose and successfully restore breathing to reverse the effects of opioids, including 7-OH. Naloxone can be administered through the nose or as an intramuscular injection to save their life. Both methods are equally effective.
http://publichealth.lacounty.gov/phcommon/public/media/mediapubhpdetail.cfm?prid=5139