Durbin, Blumenthal Introduce Bill to Prohibit Sale of Tianeptine

WASHINGTON – U.S. Senate Majority Whip Dick Durbin (D-IL) and U.S. Senator Richard Blumenthal (D-CT) today introduced the Prohibiting Tianeptine and Other Dangerous Products Act, legislation that would prohibit tianeptine from being marketed to consumers.  Tianeptine is an unapproved drug that is marketed as a purported dietary supplement and sold under labels such as “Neptune’s Fix.” Ingestion of the drug has led to an increase in calls to poison control centers and severe adverse effects requiring visits to emergency rooms nationwide.  According to America’s Poison Control Centers, 391 tianeptine cases were reported nationwide last year.  Energy and Commerce Committee Ranking Member Frank Pallone, Jr. (D-NJ) introduced companion legislation in the House last week.

The legislation would give the Food and Drug Administration (FDA) the authority to prohibit the marketing of products, such as tianeptine, as dietary supplements.

“Americans put their trust and faith in a dietary supplement to improve their health and well-being.  But some unscrupulous companies have abused that trust and marketed illegal—and dangerous—ingredients in some of these products, such as tianeptine,” said Durbin.  “As a result, some consumers have been sickened, and even died. Consumers deserve to know that these products are safe. In the face of this mounting public health threat, we must pass legislation to provide FDA with the authorities it needs to rid the market of tianeptine and other dangerous ingredients.  I’m grateful to Senator Blumenthal and Congressman Pallone for working with me on this important legislation.”

“Stopping ‘gas station heroin’ requires stronger FDA oversight to protect consumers. Harmful and potentially addictive substances, including gas station heroin, are being marketed to Americans as dietary supplements—posing a serious and even life-threatening risk to consumers. The Prohibiting Tianeptine and Other Dangerous Products Act will protect consumers from the side effects of ‘Neptune’s Fix’ and other deadly so-called dietary supplements by strengthening the authority of the FDA to remove these hazardous products from shelves across the country,” said Blumenthal.

“It’s clear that these harmful tianeptine-containing products pose a serious threat to consumers and are jeopardizing the health of our communities, particularly our kids. These dangerous products do not belong on store shelves, which is why I’m introducing a bill today to empower FDA to prohibit the marketing of ‘gas station heroin’ to protect consumers,” Pallone said. “I look forward to working with my colleagues to get this bill across the finish line and put a stop to the marketing of ‘gas station heroin’ products.”  

According to FDA, tianeptine is a “potentially dangerous substance that is not FDA-approved for any medical use but is illegally sold with claims to improve brain function and treat anxiety, depression, pain, opioid use disorder and other conditions.”  Tianeptine mimics the sedative effects of opioids.

Last month, Durbin urged the Council for Responsible Nutrition, the Consumer Healthcare Products Association, the American Herbal Products Association, and the United Natural Products Alliance to act against the inclusion of dangerous or illegal ingredients in products marketed as dietary supplements in the United States, such as tianeptine.  In the letters, Durbin cites an investigative piece by ABC7 Chicago which found that Chris Haggarty, a 37-year-old man from Lorain County, Ohio, died after taking a supplement that included tianeptine last November. 

Further, Durbin’s Dietary Supplement Listing Act of 2022 would require dietary supplement manufacturers to list their products with FDA.  In 1994, Congress passed the Dietary Supplement Health and Education Act (DSHEA), which provided FDA with authorities to regulate dietary supplements.  However, DSHEA did not require dietary supplement companies to register their products with FDA—leaving the agency without the much-needed authority or information to properly understand or oversee the market.  Durbin plans to reintroduce the Dietary Supplement Listing Actthis Congress.