Washington, D.C.—The modernization of the Dietary Supplements Health and Education Act of 1994 (DSHEA) and mandatory product listing (MPL) for all dietary supplements marketed in the United States has been a hot topic in the natural products industry for years. The push for MPL has been led by  by Senator Richard Durbin (D-IL), but as WholeFoods Magazine has reported, in 2022 efforts to move MPL  forward faltered. Industry members had mixed reactions to the news in 2022, with some celebrating the move and others commenting that MPL will become a reality in the future. 

Background: Dietary Supplement Listing Act of 2022 Introduced; Industry Divided

Now, Sen. Durbin is calling for the modernization of DSHEA and has 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 MPL. CHPA explained that Sen. Durbin's letter comes following the recent 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."

About Tianeptine-Containing Fake Supplement Products

As WholeFoods Magazine has reported, on January 23, FDA warned consumers not to purchase or use any tianeptine product due to serious risks. The Council for Responsible Nutrition (CRN) clarified the issue, explaining that some gas stations, convenience stores, and online marketplaces may sell products that are often misleadingly labeled as dietary supplements, health products, or other benign-sounding descriptions, and consumers should be vigilant and avoid any products that list tianeptine as an ingredient or that make unverified health claims. Dietary supplements should be purchased from reputable sources, CRN stressed, and consumers should consult healthcare professionals before starting any new supplement regimen.

Trade Groups Respond to Senator Durbin

CHPA issued a statement in response to Sen. Durbin's March 18 letter. “CHPA commends Senator Durbin for recognizing the need for a modernized regulatory structure for dietary supplements that will further protect public health. Recent reports about the presence of tianeptine in products fraudulently marketed by unscrupulous companies as dietary supplements underscore the need for key regulatory modernizations to protect public health. Priorities such as mandatory product listing, increasing inspection capacity, and clarifying FDA’s authority to better facilitate enforcement against unlawfully marketed products would enhance the Agency's ability to identify and more quickly remove illegitimate products from the market.  

“DSHEA turns 30 in October, and since 1994 when this law was originally enacted, industry has grown from $4 billion to more than $50 billion today. Without modernization, bad actors will continue to prey on the fact that regulations have not kept pace with growth. DSHEA should protect the 21st century consumer who has access to an ever-expanding dietary supplement marketplace, and CHPA looks forward to continuing to work with FDA and Congress on the shared goal of regulatory modernization.”  

CRN also issued a statement: "The Council for Responsible Nutrition (CRN) shares the Senator’s grave concerns that tianeptine is being fraudulently marketed as a dietary supplement when it is an unsafe and illegal substance. CRN’s members, and all responsible supplement marketers, do not sell this ingredient and condemn the sale of it.

"CRN has not only been vocal about the risks associated with products containing tianeptine misrepresented as dietary supplements, but has also shown steadfast support for enhancing FDA’s regulatory oversight through initiatives like a product listing registry for supplements. We offered our strong support for Senator Durbin’s previous bill seeking to make product listing a reality, and we look forward to working with him again if new legislation is introduced.

"CRN urges the FDA to take enforcement action against these illegal, fake supplement products, and encourages consumers to be vigilant, avoid products containing tianeptine, purchase dietary supplements only from reputable sources, and report any adverse events related to tianeptine-containing products to the FDA's MedWatch program. Our support for legislative and regulatory efforts that enhance consumer protection, such as product listing bills, aligns closely with the concerns expressed in Senator Durbin's letter, emphasizing a shared commitment to preventing the distribution of dangerous or illegal ingredients posing as dietary supplements."

FDA & MPL...Plus NPA's Take

In related news from earlier in March, the Food and Drug Administration (FDA) presented its Fiscal Year 2025 Budget Request and shared an FY 2025 FDA Budget Summary Fact Sheet. Regarding supplements, FDA said the budget "would provide FDA with additional authorities to increase oversight of dietary supplements to better protect consumers."

Following FDA's budget request, the Natural Products Association (NPA) issued a statement regarding mandatory product listing: “Year after year, the FDA’s budget proposal includes mandatory product listing. Congress has routinely shut down this proposal, another example of the FDA being distracted from doing the basics,” said Daniel Fabricant, Ph.D., President and CEO of NPA. “While the FDA continues to receive more funding, the previous price tag for mandatory product listing was $34 million and does not include the millions spent for the NIH Dietary Supplement Label Database.” 

Related: Relaunched Dietary Supplement Caucus Supported by Major Trade Groups

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