America’s top public health officials have made clear that natural kratom leaf products are not the real threat.
Now, we must focus on what’s truly hurting our kids and communities: Synthetic 7-OH opioid products.
It’s time to Stop Gas Station Heroin.
See the Concentrated 7-OH Opioid Products Database
By Natalie Neysa Alund – USA Today –
The Food and Drug Administration (FDA) is recommending banning a compound found in unregulated tablets, gummies and drink mixes sold online and at gas stations and convenience stores, the Trump administration announced this week.
The substance, known as 7-OH, will be scheduled as an illicit drug if the Drug Enforcement Administration − a branch of the US Justice Department responsible for classifying drugs as controlled substances − approves the sanction after a review.
“Dark innovations in chemistry have exacerbated the addiction crisis in this country,” US Department of Health and Human Services Deputy Secretary Jim O’Neil told reporters during a Tuesday, July 29, press conference in Washington DC. “Synthetic opioids like carfentanill and the substance we’re here to take action on today: 7-Hydroxymitragynine.”
O’Neil said 7-hydroxymitragynine, 7-OH, is deliberately addictive and a powerful opioid agonist many times more potent than morphine.
Calling it “a recipe for public health disaster,” O’Neill said 7-OH products are often sold without warnings or controls.
“We’ve seen a disturbing rise in reports of overdoses, poisonings and emergency room visits linked to products containing 7-OH,” O’Neil said. “These substances are often sold online or in convenience stores with no quality control, no dosage control and no warnings.”
During the press conference, FDA commissioner Martin Makary spoke alongside US Health and Human Services Secretary Robert F. Kennedy, Jr., as they announced they planned to send warning letters to companies for illegally marketing products containing 7-OH in an effort to combat the country’s opioid addiction problem.
“We have a history in public health of being asleep at the wheel,” Makary said. “Public health is supposed to prevent disasters, not just clean them up after they’ve killed thousands and thousands of people.”
What is 7-OH?
The compound 7-OH is a naturally occurring substance in the kratom plant (Mitragyna speciosa), according to the FDA, but only a minor component comprising less than 2% of the alkaloid content in natural kratom leaves.
“However, 7-OH demonstrates substantially greater mu-opioid receptor potency than kratom’s primary alkaloid constituent mitragynine, as well as other classical opioids such as morphine,” the FDA wrote in its findings.
Mu-opioid receptors, found in the brain and spinal cord, are primarily responsible for pain relief and other opioid effects like euphoria and respiratory depression, according to research published on the National Institutes of Health’s National Library of Medicine.
Last week, the Food and Drug Administration (FDA) took a historic step to protect American communities by recommending that concentrated 7-hydroxymitragynine (7-OH) products be classified as a Schedule I substance under the Controlled Substances Act.
Here’s why that matters.
Natural kratom leaf — harvested from the Southeast Asian Mitragyna speciosa tree — has been used safely for centuries. It contains trace amounts of 7-OH, but nowhere near the levels found in the synthetic, concentrated 7OH opioid products flooding U.S. gas stations, and wellness shops. As warned by FDA Commissioner Dr. Makary, these dangerous 7-OH products are 13 times more potent than morphine, presenting extreme risks of addiction and overdose.
The FDA was clear: It is not targeting natural kratom leaf products, which millions of Americans consume in forms like capsules, teas, liquids, and powders with minimal health concerns. Instead, the warning and scheduling recommendation applies only to the highly concentrated 7-OH opioids being deceptively marketed as “kratom” — products that bear no resemblance to the natural leaf.
Some lobbyists have tried to defend these synthetic opioids. Dr. Michelle Ross, who is an advisor to a 7-OH trade group, even claimed: “I would much rather see someone take 7-OH than a fentanyl tablet.”
Their scheme is clear. The 7-OH lobby is advocating for replacing one highly addictive illegal drug with another — sold in smoke shops and convenience stores for $6 a pill, without restriction. These products are driving a new, fourth wave of the opioid crisis. Unlike the 7‑OH lobby, our coalition doesn’t want to see anyone consuming dangerous, chemically altered substances. We are in full alignment with the FDA that we must act swiftly and decisively to stop the next wave of addiction before it’s too late.
The FDA’s action marks a critical turning point in stopping the Gas Station Heroin crisis. We’ll be watching closely as the DEA considers this recommendation and urging swift adoption to keep American families safe.
By Dan Flynn – Food Safety News –
“Gas station heroin” took another hit on Wednesday as HHS Secretary Robert F. Kennedy Jr’s FDA recommended a scheduling action to control certain 7-hydroxymitragynine (also known as 7-OH ) products under the Controlled Substances Act (CSA).
The FDA is specifically targeting 7-OH, a concentrated byproduct of the kratom plant; it is not focused on natural kratom leaf products. Users often boil the leaves into a tea to consume. Some of the popular 7-OH products are marked as gummies, other candies and drink mixes.
7-OH is increasingly recognized as having potential for abuse because of its ability to bind to opioid receptors. The FDA has released a new report to educate the public about the health concerns of 7-OH and its distinction from the kratom plant leaf.
Kratom is a tropical tree (Mitragyna speciosa) that is native to Southeast Asia. Kratom is not lawfully marketed as a drug product, a dietary supplement, or a food additive in conventional food in the United States. Although seven states ban kratom entirely, it is widely available in gas stations and convenience stores that sell vapor and tobacco products in the 43 other states.
The U.S. Drug Enforcement Administration (DEA) tried in 2016 to classify kratom as a dangerous Schedule 1 drug, but backed off when there was a public backlash.
Schedule I drugs, substances, or chemicals are defined as drugs with no currently accepted medical use and a high potential for abuse and include heroin, lysergic acid diethylamide (LSD), marijuana (cannabis), 3,4-methylenedioxymethamphetamine (ecstasy), methaqualone, and peyote.
“Today, we’re taking action on 7-OH as a critical step in the fight against opioid addiction,” said Secretary Kennedy, “We will protect the health of our nation’s youth as we advance our mission to Make America Healthy Again.”
There are no FDA-approved 7-OH drugs, 7-OH is not lawful in dietary supplements, and 7-OH cannot be lawfully added to conventional foods.
“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,” said FDA Commissioner Marty Makary, M.D., M.P.H. “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.”
The widespread availability of 7-OH products is a significant concern for the FDA.
The particular concern is with the growing market of 7-OH products that may be especially appealing to children and teenagers, such as fruit-flavored gummies and ice cream cones. These products may not be clearly or accurately labeled as to their 7-OH content and are sometimes disguised or marketed as kratom.
The FDA has also published educational materials to inform consumers about these harmful products. In June, the FDA issued warning letters to seven companies for illegally distributing products containing 7-OH, including tablets, gummies, drink mixes, and shots. On Wednesday, the FDA also issued a letter to healthcare professionals and warned consumers about the risks associated with 7-OH products.
Under the Controlled Substances Act, drugs, substances, and certain chemicals are placed into one of five schedules based upon their medical use, potential for abuse, and safety or dependence liability. The Drug Enforcement Agency is reviewing the FDA’s recommendation. It has the final authority on scheduling, which requires a rulemaking process that includes a period for the public to provide comments before any scheduling action is finalized.
Lab-Made Drugs are Hurting Kids and Fueling For-Profit Addiction in American Communities
WASHINGTON, D.C. — The Stop Gas Station Heroin coalition today applauded the U.S. Food and Drug Administration (FDA) for recommending a scheduling action to control certain 7-OH (7-hydroxymitragynine) opioid products under the Controlled Substances Act (CSA).
7-OH is a chemical compound that occurs naturally in only trace amounts in the kratom leaf. Yet, the 7-OH products being sold in gas stations, smoke shops, and convenience stores across the country are not natural. Instead, they are the result of bad actors isolating that trace compound from the leaf and supercharging it into an addictive drug up to 30 times more potent than morphine.
This recommendation marks a major milestone in the federal government’s effort to curb the rise of Gas Station Heroin — an umbrella term for harmful substances that include high dose mitragynine isolates, 7-hydroxymitragynine isolates, tianeptine, nitrous oxide, and intoxicating hemp compounds — and prevent the next wave of the opioid epidemic.
“This FDA action is a tremendous step toward ending the Gas Station Heroin crisis that is robbing everyday Americans of their health,” said Dr. Nicole Avena, a Stop Gas Station Heroin Board Member and Associate Professor of Neuroscience, Mount Sinai School of Medicine. “By moving to schedule 7-OH, the FDA has taken bold action to protect consumers from dangerous synthetic opioids.”
The FDA made it clear to distinguish that its action is targeted at concentrated 7-OH products and not at the natural kratom leaf, which has been used safely for centuries and remains outside the scope of this recommendation.
“This is a huge win for science, common sense, and consumers,” said Dr. Avena. “The FDA has drawn a clear line: 7-OH is an unapproved, dangerous opioid — not a dietary supplement. We now urge the DEA to act quickly to adopt the FDA’s recommendation and ensure 7-OH is scheduled without delay.”
As the Drug Enforcement Administration (DEA) reviews the FDA’s recommendation, the coalition urges swift scheduling of 7-OH to protect families and communities across the country. Only then can we finally end the scourge of Gas Station Heroin in American communities.
By Krys’tal Griffin – Delaware Online –
A popular harmful substance can be found on many store shelves, but that soon won’t be true in Delaware because it’s now illegal to sell in the First State.
Here’s what you need to know.
What is House Bill 21?
House Bill 21 was introduced on Dec. 19 by Rep. Kimberly Williams, D-Stanton, and seeks to ban the sale of tianeptine in Delaware by identifying it as a Schedule I controlled substance.
Tianeptine, known as “gas station heroin” for its easy accessibility at local gas stations, is marketed as Coaxil or Stablon and is prescribed in some Latin American, Asian and European countries to treat depression and anxiety, according to the U.S. Food and Drug Administration.
In the United States, tianeptine is not approved for medical use. The FDA classifies the drug as a substance that does not meet the statutory definition of a dietary ingredient and brands it as an unsafe food additive.
Tianeptine is also known as:
Tianeptine sulfate
Tianeptine sodium powder
Tianaa
Tianna Green
Tianna Red
Tianna white
ZaZa
Neptune’s Fix
Pegasus
Neptune’s Elixir
The FDA reports that tianeptine has been sold in-store and online, typically in tablet or powder form.
Is tianeptine safe to use?
The FDA does not approve Tianeptine for any medical use. It is linked to serious health risks and even death, despite being illegally sold with the claim that it will treat mental illnesses and opioid use disorder, improve brain function, ease pain, or help other conditions.
While some countries have approved tianeptine use, others have restricted how it is dispensed and prescribed or revised product labels to warn of the possible side effects and addiction risk.
The FDA reports that unwanted effects of and bad reactions to tianeptine are increasing, noting that poison control center cases involving tianeptine exposure have increased nationwide. The number of total cases jumped from 11 cases between 2000 and 2013 to 151 cases in 2020.
“People seeking to treat their ailments sometimes mistake products as being safe because it’s easily available, whether online or even at gas stations,” the FDA said. “But availability is no indication of effectiveness or safety.”
From 2000 to 2017, 217 tianeptine exposures were documented, with 75 reported in the South, 54 in the West, 47 in the Midwest and 41 in the Northeast, according to the Centers for Disease Control and Prevention.
The demographic most impacted by tianeptine exposure was 21- to 41-year-olds, followed by those between the ages of 41 and 60, those under 20 years old and those above 61 years old.
The CDC reports that clinical effects of tianeptine abuse and withdrawal can mimic opioid toxicity and withdrawal, with neurologic, cardiovascular and gastrointestinal signs and symptoms possible.
Other effects of tianeptine exposure include:
High blood pressure
Drowsiness
Confusion
Coma
Cellulitis
Fever
Miosis
Urinary retention
Kidney failure
Acidosis
Muscle weakness
Rigidity
Delusions
People with a history of opioid use disorder or dependence may be at an increased risk of abusing tianeptine, especially if used with other drugs like antidepressants and anti-anxiety medicines, the FDA said.
According to the FDA, tianeptine is not generally recognized as safe, does not qualify as a dietary ingredient, and is not an approved food additive; therefore, it is considered adulterated under the Federal Food, Drug, and Cosmetic Act.
The FDA previously stated that it issued warning letters to companies illegally marketing tianeptine products as dietary supplements and unapproved drugs and issued import alerts to stop tianeptine shipments at U.S. borders.
Several U.S. states have taken action against the drug through executive orders. Tianeptine is banned in Alabama, Florida, Georgia, Indiana, Kentucky, Michigan, Mississippi, Ohio and Tennessee.
Delaware just joined that list.
Delaware’s ban on tianeptine is official
HB 21 passed in the House on March 20 and in the Senate on June 30, the last day of the legislative session.
Gov. Matt Meyer signed the bill into law on the afternoon of July 21 at the Carvel Government Building in Wilmington, along with several other bills related to healthcare and public health.
The bill is effective immediately and makes tianeptine illegal to sell, possess or distribute in Delaware. Senate Amendment 1, which was introduced and passed by the Senate on June 30, was added to the bill to “ensure that no civil or criminal penalties are imposed” on someone for possessing a small quantity of tianeptine. HB 21’s goal is to remove the harmful substance from shelves, not to punish individuals for purchasing it.
Sen. Stephanie Hansen, a Democrat in the 10th district, is another sponsor of the bill and stated at the bill signing that she wanted to support HB 187 due to its already visible impact in Delaware and Pennsylvania.
Although she didn’t catch tianeptine products in her district when she visited a handful of stores, she said “it just means that we were able to get some of it off the shelves preemptively.”
When asked how the tianeptine ban and removal of current stock from local shelves would be enforced, Hansen said the plan is still being developed.
“Delaware Department of Health and Social Services is actually the entity that will be in charge of enforcing. We’re gonna find out with the new director if this is something that they would be interested in checking,” she said. “Other than that, I could see it being complaint-driven, unless we have some sense as to where it is here in Delaware.” Meyer added that residents can help by checking for tianeptine products when they visit stores and reporting any they spot.
By Currie Myers – Police 1 –
Throughout my more than four decades in law enforcement — from street patrols to federal investigations — I’ve confronted every threat to public safety you can name: armed gangs, illicit narcotics, transnational cartels. Yet the stealth and reach of today’s illicit vape trade is just as concerning. These devices masquerade as innocent consumer products, slipping past regulators and landing in the hands of our children.
That’s why I applaud the National Sheriffs’ Association for taking a stand. Their recent resolution condemning the trafficking and sale of illicit vape products sends a powerful message: America’s sheriffs are not only aware of this threat but united in their readiness to dismantle it.
Make no mistake, this isn’t a debate over an adult’s right to choose a legal tobacco alternative. We’re witnessing a rapidly expanding black market — overwhelmingly fueled by overseas manufacturers, particularly in China — pushing unregulated, chemically altered vape devices into our neighborhoods, schools and playgrounds.
And now, Mexican drug cartels have seized on this trend, employing their established smuggling routes and money-laundering networks to move these products into the United States. Groups like the Sinaloa Cartel and the Jalisco New Generation Cartel are taking advantage of less-scrutinized cargo lanes, blending illicit vape shipments with their traditional drug loads to diversify revenue while evading law enforcement scrutiny.
Cartels push illicit vapes into the U.S.
Consider Louisiana’s recent Operation Vape Out. Over four weeks, the Office of Alcohol and Tobacco Control, State Police, Homeland Security Investigations and local partners executed coordinated raids. The haul was staggering: ten arrests, more than $1 million in counterfeit products, and tens of thousands of dangerous items seized. Among them were 34,000 unregulated vape pens and pods, 16,000 CBD edibles and pre-rolled cigarettes, 6,500 canisters of nitrous oxide, and over 1,800 doses of Schedule I narcotics — including psilocybin and tianeptine, often sold as “gas station heroin.”
Even more alarming, these goods were being peddled in smoke shops only blocks from schools, wrapped in candy-flavored packaging designed to entice young buyers.
Louisiana is far from alone. From coast to coast, illicit vape shipments — carefully concealed in legitimate cargo — evade detection at our ports and highways. Some devices are so cleverly designed they resemble ordinary office supplies or children’s toys, making them all but invisible until it’s too late. Mexican cartels exploit every weakness in our border security, routing pallets of e-liquids and vaping devices through remote crossings and using bribery or intimidation to slip shipments past customs officers.
Sheriffs call for federal action on vape threat
This is not a random assortment of bad actors; it’s a sophisticated supply chain engineered to exploit every gap in our enforcement. If we hope to protect our communities, our response must be equally strategic and comprehensive.
First, we must strengthen collaboration across all levels of government. Local sheriffs and police cannot shoulder this burden alone. Customs and Border Protection must intensify inspections of inbound shipments, deploying advanced screening technology at both major and secondary ports of entry. The Food and Drug Administration and the Department of Homeland Security must prioritize illicit vape interdiction, sharing intelligence and resources with state and local partners. And Congress must allocate sustained funding for operations like Vape Out, transforming them from sporadic successes into the new baseline.
Second, we must recognize this as a national security concern. When foreign manufacturers and Mexican cartels flood our markets with addictive, unregulated substances — substances landing kids in emergency rooms and financing violent criminal networks — we are not merely confronting a public health issue; we are defending the very safety of our streets.
History offers a roadmap. We’ve faced synthetic drug surges before — from crack cocaine in the 1980s to meth in the 1990s and, more recently, fentanyl — and we’ve proven capable of decimating those pipelines. A decisive, unified federal response shut down those threats; it can do so again.
We cannot allow another generation of Americans to fall prey to this insidious market. The enemy’s supply lines do not run through distant deserts or jungle trails — they flow in shipping containers from overseas, through cartel-controlled corridors, and end up on store shelves disguised as innocuous vape products.
It’s time for a coordinated crackdown: tougher inspections at the ports, enhanced interagency enforcement, and accountability for every actor in this illicit network. Only then will we close the loopholes that enable this crisis and safeguard our communities from the next wave of deception.
Enough talk. It’s time to act.
By Fiona Rutherford – Bloomberg –
The Food and Drug Administration is taking a closer look at kratom extracts and preparing to ask Congress for expanded authority to shut down illegal vaping imports, according to the agency’s head.
A new public health threat is gripping America, and it’s being called the fourth wave of the opioid epidemic. What’s driving this crisis? It’s not prescriptions, heroin, or fentanyl — it’s foreign lab-made drugs. And you would be shocked to find out how easy it is to get your hands on this stuff.
In a recent interview on Newsmax, David White, Professor and Head of the Department of Pharmacy Practice at the University of Connecticut, and Matthew Lowe, Executive Director of Stop Gas Station Heroin, share with the American people how these synthetic substances are illegally imported, illegally marketed, and illegally sold across the United States.
While Gas Station Heroin products are disguised as copycat snacks, knockoff prescription opioids, all-natural supplements, and other novelty items, make no mistake: They are not safe. Dangerous, unapproved drugs are taking over America — available at gas stations, convenience stores, and smoke shops near you.
Watch to this segment and JOIN our fight to STOP GAS STATION HEROIN.
The total value of the Gas Station Heroin market exceeds $26 billion. The market involves international manufacturing in Chinese and Indian labs, with substances distributed through unregulated convenience stores and smoke shops across the U.S. Using false labeling as “supplements” and “incense,” traffickers evade law enforcement and oversight.