Washington, DC—Legislation (HR 8123) introduced by Representative Frank Pallone (D-NJ) and Senator Dick Durbin (D-IL) aims to amend the Federal Food, Drug, and Cosmetic Act to establish new prohibited acts relating to dietary supplements. The bill would grant the Food and Drug Administration (FDA) broad authority to prohibit certain ingredients in dietary supplements without a rendering on an ingredient’s safety, according to the Natural Products Association (NPA), which is opposed to the bill.

As WholeFoods Magazine has reported, Sen. Durbin has called for the modernization of DSHEA and also let industry trade associations know the he will be reintroducing the Dietary Supplement Listing Act in 2024. In a letter shared by the Consumer Healthcare Products Association (CHPA), sent on March 18, Sen. Durbin pointed to tianeptine as a reason for mandatory product listing (MPL). CHPA explained that Sen. Durbin's letter comes following the death of an Ohio man who ingested tianeptine. CHPA clarified that tianeptine "is not an over-the-counter (OTC) medicine nor a dietary supplement, but an adulterant used by bad actors falsely marketing products as dietary supplements."

Regarding HR 8123, Daniel Fabricant, NPA President and CEO, raised several points about the Durbin-Pallone bill and the illegal substance. “Tianeptine is already illegal, and as it has been referred to as contributing to the opioid epidemic by the Department of Justice, why is it not being scheduled to appropriately stop it and protect public health?" he questioned. "Why is there not outrage from the bill’s sponsors, Congressman Pallone and Senator Durbin, on the inaction from those charged with the safety of America’s food and drug when tianeptine was first publicly identified as a problem by FDA in 2018? What’s in this proposal is a re-use of a part of the failed mandatory product listing (MPL) from last Congress, and doesn’t specifically address tianeptine, as the goal of this only appears to be restriction of legitimate and safe ingredients like, NAC, NMN, CBD and many other ingredients without any scientific basis.” 

Dr. Fabricant also noted: "As 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. If tianeptine is such a priority, why hasn’t Congress asked the DEA to schedule the ingredient like other dangerous products? If enacted, the unintended consequences would  threaten innovation and worse limit access to safe ingredients spanning probiotics, botanicals, amino acids, vitamins and more.”

Call to Action for Natural Products Industry

NPA has launched a grassroots campaign to oppose the Durbin-Pallone bill granting FDA new powers. Industry members are encourage to take action here.

Related: Industry Groups Respond to Durbin Letter Calling for DSHEA Modernization

CRN Issues Warning on Tianeptine-Containing Fake Supplement Products