FDA has issued another warning about tianeptine products, and announced a prison sentence that was handed down to a seller of the banned product. The news comes amid more tianeptine cases at poison control centers and a move by North Carolina lawmakers to take their own action against the illegal antidepressant drug.

Hank Schultz, Senior Editor

February 20, 2024

3 Min Read

At a Glance

  • FDA has issued another warning about products containing tianeptine that are labeled as Neptune's Fix.
  • A seller of the banned products was sentenced to two years in federal penitentiary.
  • North Carolina is considering its own laws to restrict access to the illegal drug.

The rising wave of tianeptine exposures has prompted the Food and Drug Administration to issue another warning about the substance described as “gas station heroin,” as well as publicize a jail term handed down to a seller of the illegal drug.

Last week, FDA issued a warning about products sold by Super Chill Products under the brand name Neptune’s Fix. The agency had previously warned about products sold under this name and said this new set of products might have slightly different branding than those it has cited in the past.

According to the warning, FDA said it “continues to receive severe adverse event reports after use of Neptune’s Fix products, including seizures, loss of consciousness and death.”

“These products may also interact, in life-threatening ways, with other medications a consumer may be taking. The agency is actively investigating adverse event reports in conjunction with local and state health departments,” FDA added.

Jail sentence handed down in tianeptine case

In addition to the warning, the agency announced a sentencing in a successful prosecution over sale of the banned ingredient. 

Ryan M. Stabile, 37, of Pasadena, Calif., was sentenced by a U.S. District Court judge in Boston to two years in prison as well as three years of probation. He also was ordered to pay a forfeiture of $1.8 million. Stabile had pleaded guilty in September 2023 to one count of conspiracy and two counts of introduction of misbranded drugs with intent to defraud and mislead.

Related:Tianeptine, aka ‘gas station heroin,’ leads to congressional letter to FDA

“Mr. Stabile knew how addicting and dangerous tianeptine was and yet it did not stop him from smuggling the illegal drug into the United States and selling it under false pretenses,” said Acting United States Attorney Joshua S. Levy. “He continued to profit off the addiction of others even after he was indicted.”

Stabile’s lawyers argued he had proactively addressed his drug addiction during the 11 months he had already served before his sentencing trial. They requested he be sentenced to time served, along with three years of probation. The prosecutors had asked the judge to impose a sentence of four years in prison, followed by probation.

Stabile’s lawyers did not immediately respond to a request for additional comment.

Stabile marketed his products via his business named Supplements for Work. Despite the name, Stabile marketed the products using the catchphrase “for research purposes only,” which is an increasingly common dodge used by marketers of banned ingredients or novel substances that have not gone through the new dietary ingredient notification process required under the Dietary Supplement Health and Education Act of 1994 (DSHEA).

Related:Bad company: How the industry can save itself – and consumers – from fake supplements

Stabile marketed tianeptine as a mood enhancer and claimed it could improve cognitive functioning.

North Carolina considers tianeptine restrictions

Action on the federal level has spurred some state lawmakers to act, too. On Sunday, Feb. 19, it was reported by the site North Carolina Health News that lawmakers in that state are considering ways to more tightly regulate the product.

During a hearing of the state’s House Select Committee on Drug Abuse, Penny Shelton, head of the N.C. Association of Pharmacists, testified, “When tianeptine is taken at high doses, it produces euphoria.”

“Tianeptine in high doses is like any other substance with the potential for misuse and dependence, in that it does far more than create euphoria — or a high. It actually changes neuronal pathways in the brain,” she added. “This is particularly problematic for teens and young adults.”

Tianeptine is sold as an antidepressant drug in some countries, where a typical dose is 12.5 milligrams (mg) a day. Products available on the internet in the U.S. can contain 100 mg per capsule or more.

Poison center data shows increasing exposures

Related:Tianeptine sales besmirch supplement industry’s reputation, but who is really at fault?

According to Dr. Kait Brown, PharmD, the clinical managing director of America’s Poison Centers, tianeptine exposures have shown an alarming trend.

The organization’s data from its 55 poison control centers shows that 105 cases involving tianeptine were documented in 2019. That number had risen to 391 in 2023.

“Most cases of tianeptine exposures reported to U.S. Poison Centers involved adults intentionally using the substance to get high. Symptoms reported range from agitation, increased heart rate and confusion to more severe symptoms similar to opioid toxicity including sedation, respiratory depression and slowed heart rate,” Brown said.

About the Author(s)

Hank Schultz

Senior Editor, Informa

Hank Schultz has been the senior editor of Natural Products Insider since early 2023. He can be reached at [email protected]

Prior to joining the Informa team, he was an editor at NutraIngredients-USA, a William Reed Business Media publication.

His approach to industry journalism was formed via a long career in the daily newspaper field. After graduating from the University of Wisconsin with degrees in journalism and German, Hank was an editor at the Tempe Daily News in Arizona. He followed that with a long stint working at the Rocky Mountain News, a now defunct daily newspaper in Denver, where he rose to be one of the city editors. The newspaper won two Pulitzer Prizes during his time there.

The changing landscape of the newspaper industry led him to explore other career paths. He began his career in the natural products industry more than a decade ago at New Hope Natural Media, which was then part of Penton and now is an Informa brand. Hank formed friendships and partnerships within the industry that still inform his work to this day, which helps him to bring an insider’s perspective, tempered with an objective journalist’s sensibility, to his in-depth reporting.

Harkening back to his newspaper days, Hank considers the readers to be the primary stakeholders whose needs must be met. Report the news quickly, comprehensively and above all, fairly, and readership and sponsorships will follow.

In 2015, Hank was recognized by the American Herbal Products Association with a Special Award for Journalistic Excellence.

When he’s not reporting on the supplement industry, Hank enjoys many outside pursuits. Those include long distance bicycle touring, mountain climbing, sailing, kayaking and fishing. Less strenuous pastimes include travel, reading (novels and nonfiction), studying German, noodling on a harmonica, sketching and a daily dose of word puzzles in The New York Times.

Last but far from least, Hank is a lifelong fan and part owner of the Green Bay Packers.

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