'Gas station heroin’: Bill introduced to prohibit sale of tianeptine, but also much more

The Bill has been introduced in the House of Representatives by Rep. Pallone and seeks to give the Food and Drug Administration (FDA) the authority to prohibit the marketing of products, such as tianeptine, as dietary supplements.

However, the language in the ‘Prohibiting Tianeptine and Other Dangerous Products Act’ would also open the door to using this potential prohibition power against other ingredients in the marketplace.

According to the bill’s text, the act would amend the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 331) to prohibit the “introduction or delivery for introduction into interstate commerce of any product marketed as a dietary supplement that does not meet the definition of a dietary supplement.

Also prohibited would be: “The introduction or delivery for introduction into interstate commerce of a dietary supplement that has been prepared, packed, or held using the assistance of, or at the direction of, a person debarred under section 306.”

Sen.Durbin is slated to introduce companion legislation in the Senate, according to a release from Rep. Pallone’s staff.

Tianeptine​

The bill is anchored against tianeptine, an unapproved drug that is illegally marketed as a dietary supplement. The ingredient has been in the headlines recently when it was implicated in the death of a 37-year-old Ohio man​ who reportedly purchased a tianeptine-containing product marketed as a dietary supplement from a gas station.

According to America’s Poison Control Centers, 391 tianeptine cases were reported nationwide last year​.

Sen. Durbin employed tianeptine to call for Mandatory product listing (MPL)​ for all dietary supplements earlier this year.

Commenting on the new legislation, Sen. Durbin stated: “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. 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 Congressman Pallone for working with me on this important legislation.”

Rep. Pallone added: “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.”

The text for the proposed bill is available HERE​.

Opposition… ​

Commenting on the new bill, Loren Israelsen, founder and president of the United Natural Products Alliance (UNPA), told us: “This bill, as written, would have the effect of denying access to legitimate dietary supplements to consumers. While we oppose the language of this bill, we fully support FDA efforts to remove tianeptine from the market as an undeclared drug.”

Daniel Fabricant, PhD, president and CEO of the Natural Products Association (NPA), told NutraIngredients-USA: “This is not a tianeptine bill. Sen. Durbin is using tianeptine as a vehicle to reintroduce bits of his ill-fated MPL bill that he wants.

“This broad language would give FDA the authority to prohibit the marketing of 'dangerous' products as dietary supplements. This is a huge red flag where the FDA would be given new overreaching authorities to essentially ban the very 'dangerous' NAC, CBD, NMN and many, many more without any scientific basis. All they would have to do is have an opinion that something doesn’t meet the definition of a supplement,” Dr. Fabricant added.

“We will be pushing back hard on this.”