Often sold as a dietary supplement and promoted by retailers as a mood booster and focus aid, tianeptine is among a growing, unregulated class of potentially addictive products available in gas stations, convenience stores and smoke shops and across the internet. They typically include synthetic pharmaceuticals and plant-derived substances.

Some, such as kratom and phenibut, can be addictive and, in rare cases, fatal. They often originate in other countries, including Indonesia and Russia, where they are commonly used, even prescribed, for mood management. But the Food and Drug Administration has not approved them as medicines in the United States.

“Tianeptine is an emerging threat,” said Kaitlyn Brown, clinical managing director of America’s Poison Centers, which represents and collects data from 55 centers nationwide. “We have people who are able to get a substance that’s not well regulated, that has abuse potential and that, in high doses, can cause similar effects to opioids, leading to really harmful outcomes.”

At least nine states have banned or severely restricted tianeptine, including Florida, Michigan and Ohio. In late November, the FDA issued a nationwide alert about Neptune’s Fix specifically and tianeptine in general, telling people not to take it and warning that it had been associated with overdoses and deaths.

Tianeptine, which also appears as a concentrated powder or an ingredient in products such as Tianaa, Zaza and Pegasus, “is illegally sold with claims to improve brain function and treat anxiety, depression, pain, opioid use disorder and other conditions,” the agency’s warning said.

There are now at least a dozen different products that are foreign drugs being openly marketed as dietary supplements right under the FDA’s eyes, without them being able to stop the sales.”
– Dr. Pieter Cohen, associate professor
at Harvard Medical School

The FDA loosely oversees dietary supplements, an expanding universe of some 50,000 products that includes minerals, vitamins and compounds like melatonin. But the agency does not evaluate supplements for safety or effectiveness; it can only forbid manufacturers to market them as medical treatments. It requires product labels making health claims to list ingredients and include boilerplate disclaimers, such as noting that the product has not been reviewed by the FDA. The agency does not review those labels before a product is released.

Because the FDA’s enforcement powers are limited by law, many products with tianeptine have long skirted labeling requirements. Although the FDA has explicitly said, for example, that tianeptine does not qualify as a dietary supplement, the labels of some brands, like Tianaa, still make that claim.

“There are now at least a dozen different products that are foreign drugs being openly marketed as dietary supplements right under the FDA’s eyes, without them being able to stop the sales,” said Dr. Pieter Cohen, an associate professor at Harvard Medical School who studies the regulation of supplements.

Tianeptine is a drug developed by French researchers in the 1960s as an antidepressant. It is approved in low doses for that use in many European, Asian and Latin American countries.

But at higher doses, it also works much as an opioid does, delivering short-lived euphoria. In the United States, many people take tianeptine under the widespread, mistaken belief that it is a safe alternative to street opioids like fentanyl or heroin, or even a way to taper off using them. On social media sites such as Reddit, its merits are hotly debated, with more than 5,000 people subscribing to a “Quitting Tianeptine” forum.

“People develop a tolerance very quickly, and so they rapidly start advancing the dosing,” said Dawn Sollee, a clinical toxicologist and director of the Poison Control Center in Jacksonville, Florida. “They will set alarms to wake themselves every two hours to take tianeptine pills so they do not go into withdrawal. And then they have to keep taking more and more just to stay functional.”

Expenses can mount swiftly, along with dangers. At a convenience store in Montclair, New Jersey, recently, 15 capsules of Tianaa Red cost $34. A bottle of Neptune’s Fix, which comes in lemon, tropical, cherry or chocolate-vanilla flavor, runs about $16. A salesperson at a roadside smoke shop farther west said customers typically purchased 12-bottle boxes. A salesperson at another roadside shop said that one customer bought 10 boxes each week — whether for resale or personal use, he did not know.

Determining the number of cases of tianeptine abuse is challenging, because hospitals do not test for it. Reports to poison-control centers are voluntary, typically made by a worried relative, so officials say the numbers represent a drastic undercount.

But case reports are increasing. In 2013, only four cases of tianeptine exposure were reported nationwide. In 2023, 391 cases were reported, according to America’s Poison Centers. New Jersey, which typically has one report a year, received 27 in 2023, with patients ranging in age from 20 to 69.

“Some people apparently think it can help with chronic pain instead of having to use an opioid, which might explain the older demographic,” said Dr. Diane Calello, medical director of the New Jersey Poison Control Center.

Similarly to many illicit drugs, tianeptine is often sloppily mixed with unlabeled ingredients, such as potent synthetic cannabis compounds. That is one reason overdose symptoms appear to range widely, poison-control medical directors said, including clamminess, nausea, low blood pressure and unconsciousness as well as seizures and severe stomach cramps.

Sometimes naloxone, a drug that reverses opioid overdoses, can be effective in reviving patients, they said — and sometimes not. At least four deaths have been associated with tianeptine.

The FDA sent warnings in 2021 and 2022 to two companies that it said were “illegally marketing tianeptine products as dietary supplements and unapproved drugs.”

But enforcement requires huge resources, in part because manufacturers and purveyors can be difficult to track down. An inquiry from The New York Times to the makers of Neptune’s Fix submitted through its website received no response. The Sheridan, Wyoming, location listed on the company’s bottles is an address for a registration agent for numerous companies.

Regulatory experts disagree about how the FDA should grapple effectively with tianeptine and other supplements. Some say the agency should establish a strict registry of approved supplements.

In interviews, some poison-center directors did not endorse a full ban of tianeptine, saying that could lead to dangerous underground trafficking. Educating emergency responders and consumers about inherent risks in such products would be a more effective course, they said.

Getting tianeptine off store shelves, they added, would be not only a staggering task but also of limited utility because customers could simply buy it from the most convenient store of all — the internet.

While Eric was recovering from tianeptine poisoning, Anne stormed over to the local smoke shop where he had bought it.

“My husband’s in the hospital because of this product and you’re still going to keep it on the shelves?” she yelled.

“Yes,” she said the owner replied, “because people want it, and we need to make money.” ‘Gas-station heroin’ sold as dietary supplement.

This story was originally published at nytimes.com. Read it here.

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