FDA Warns of Growing Threat From ‘Gas Station Heroin' Sold as Supplements

Epoch Times

08-05-2025

Federal health officials are warning about a surge in reports of serious health issues tied to tianeptine, a drug being sold as a supplement despite not being approved for any medical use in the United States.
Commonly referred to as 'gas station heroin' due to its availability at convenience stores, gas stations, and online retailers, tianeptine has been associated with overdoses, withdrawal symptoms, and at least one cluster of deaths. The Food and Drug Administration (FDA) issued a renewed alert this week, urging the public and health care providers to avoid products that contain the substance.
'I am writing to draw your attention to a dangerous and growing health trend facing our nation and particularly young people—the increasing number of adverse events involving products containing tianeptine, which can lead to serious harm, including death,' FDA Commissioner Dr. Martin Makary said in a May 8
The FDA stressed that many consumers mistakenly
The drug is prescribed as an antidepressant in some countries, though it is not approved in the United States and is not scheduled under the Controlled Substances Act. The FDA notes that it is being illegally sold as a dietary supplement or 'nootropic,' with product names that include Tianaa, Zaza, Neptune's Fix, Pegasus, and TD Red.
Some vendors are also making unproven and illegal claims that tianeptine can improve brain function or treat anxiety, depression, pain, and opioid use disorder, according to the agency.
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Ingesting tianeptine can lead to severe health effects, including respiratory depression, coma, and death. Withdrawal symptoms similar to those caused by opioids have also been reported. Medical literature cites instances of users taking doses of up to 10,000 milligrams per day—hundreds of times greater than the level it is prescribed at in other countries.
The FDA noted that individuals with a history of opioid dependence may be particularly vulnerable to abusing tianeptine, sometimes using it as an opioid substitute or for self-treatment of mental health conditions.
A 2024 outbreak in New Jersey linked to a product called 'Neptune's Fix' highlighted the drug's dangers. The product was found to contain both tianeptine and synthetic cannabinoid receptor agonists, the agency said. Reported side effects included seizures, cardiac irregularities, and fatalities.
'Historically, there has been a delayed recognition of fast-growing trends, such as opioid abuse and vaping addiction in youth,' Makary said in the statement. 'Let's be proactive in understanding and addressing the use of tianeptine products, which are available even to our nation's youth.'
The FDA has taken some enforcement actions, including issuing warning letters and placing imports of tianeptine-containing products on alert to prevent them from entering the country. Still, the agency noted that the products continue to be sold without regulation.
The agency also classified tianeptine as an unsafe food additive and stated it does not meet the legal definition of a dietary ingredient, underscoring that such products cannot be lawfully marketed as supplements.
Health care professionals are being advised to counsel patients on avoiding tianeptine and to consider alternative, evidence-based treatments for conditions such as depression, anxiety, or opioid use disorder. In cases of suspected tianeptine poisoning, medical professionals should contact the Poison Help Line and report incidents to the FDA's MedWatch portal.
The FDA emphasized that routine drug screening panels may not detect tianeptine, complicating diagnosis in emergency settings.
Consumers and medical professionals can report adverse effects or suspicious products through the FDA's website or by calling 1-888-INFO-FDA. Individuals struggling with substance use or addiction can call 1-800-662-HELP or visit FindTreatment.gov for support and treatment resources.