A new bill introduced by Representative Frank Pallone (D-NJ) and Senator Dick Durbin (D-IL) seeks to amend the Federal Food, Drug and Cosmetic Act. Dubbed, โProhibiting Tianeptine and Other Dangerous Substances Act,โ the bill would give the U.S. Food and Drug Administration (FDA) authority to prohibit certain ingredients that โdonโt meet the definitions of dietary supplements.โ
The bill is designed to halt the sale of tianeptine, also known as gas station heroin, an illegal and potentially deadly opioid-like ingredient. According to Americaโs Poison Control Centers, there were 391 cases of tianeptine poisoning in 2023.
โItโs clear that these harmful tianeptine-containing products pose a serious threat to consumers and are jeopardizing the health of our communities, particularly our kids,โ Pallone said. โThese dangerous products do not belong on store shelves, which is why Iโm introducing a bill today to empower FDA to prohibit the marketing of โgas station heroinโ toprotect consumers.โ
In March, Durbin sent letters to several trade associations, including the Council for Responsible Nutrition (CRN), the Consumer Healthcare Products Association (CHPA), the American Herbal Products Association (AHPA) and the United Natural Products Alliance (UNPA) asking them to โtake action against the inclusion of dangerous or illegal ingredients in products marketed as dietary supplements in the United States.โ
โAmericans 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 illegalโand dangerousโingredients in some of these products, such as tianeptine,โ Durbin said. โAs 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.โ
However, trade associations, and natural product industry legal experts find the new bill concerning. The Natural Products Association (NPA) wrote an opposition letter to Pallone and Durbin.
โAs the NPA has stated time and time again, the FDA has the tools necessary to go after illegal products like tianeptine. Proposals like this make one think that the agency is genetically predisposed against basic law enforcement and would much rather spend taxpayer funded time and resources pursuing overreaching authorities that muddy the waters for legitimate dietary ingredients,โ said Daniel Fabricant, PhD, president and CEO of NPA. โIf tianeptine is such a priority, why hasnโt Congress asked the DEA to schedule the ingredient like other dangerous products? If enacted, the unintended consequences wouldย threaten innovation and worse limit access to safe ingredients spanning probiotics, botanicals, amino acids, vitamins and more.โ
Steve Shapiro, Of Counsel at Rivkin Radler LLP and a contributing writer for VRM Media, said FDA already has the authority to take action against any product including tianeptine, which FDA considers an adulterated ingredient. He questioned why Pallone and Durbin are trying to give FDA more power when its current resources are already adequate.
Shapiro also disagrees with Durbinโs proposal for mandatory product listings (MPLs). He said this could cost several millions of dollars that would be better spent bolstering FDAโs current resources.
โIโm all for aggressive enforcement of the Food and Drug Act, but Iโm concerned as to what the purpose of this bill is and how it would be used,โ Shapiro said.
To read the full text of the bill, visit this link.