Sen. Durbin to reintroduce Dietary Supplement Listing Act

Amid concerns over an ingredient nicknamed “gas station heroin” that is associated with deaths, a U.S. senator intends to reintroduce a bill this year that would require a listing of dietary supplement products with the Food and Drug Administration. 

In a letter to Scott Melville, the president and CEO of the Consumer Healthcare Products Association (CHPA), Sen. Dick Durbin (D-Ill.) said he would reintroduce the Dietary Supplement Listing Act, which was introduced in the last Congress.

Durbin raised concerns in the letter to Melville about tianeptine, which he said has caused coma, nausea, rapid heartbeat, vomiting and even deaths. The senator sent letters as well to three other industry trade organizations: American Herbal Products Association (AHPA), Council for Responsible Nutrition (CRN) and United Natural Products Alliance (UNPA).

Tianeptine “is not approved for use in the United States, but that has not deterred some unscrupulous companies from including it in their products and marketing them as dietary supplements that can treat substance use disorder,” the senator wrote to Melville. “Such claims and marketing are illegal actions under the Federal Food, Drug and Cosmetic Act. It also is cruel to those Americans who experience substance use disorder and need real support —not a cheap, unsubstantiated ‘fix.’ However, recent reporting indicates that tianeptine is reaching and harming consumers now more than ever before.” 

Related:FDA seeks dietary supplement listing requirement in FY25 budget proposal

Durbin told Melville he introduced the Dietary Supplement Listing Act in the last Congress to help families like the mother of a 37-year-old man from Ohio who recently died after taking a supplement containing tianeptine. FDA has not approved tianeptine for any medical use and does not consider it to meet the statutory definition of a dietary ingredient. 

Durbin pointed out the dietary supplement market has increased in size from 4,000 to more than 95,000 products since the Dietary Supplement Health and Education Act (DSHEA) became law in 1994. 

“But the agency does not know the true number — let alone what ingredients are included in those products,” he wrote. “The Dietary Supplement Listing Act would have given FDA much-needed insight into the market and improved its abilities to initiate enforcement action against the companies that market dangerous or illegal ingredients, such as tianeptine, in their supplement products.” 

Responding to the senator’s letter, CHPA expressed support for a modernized regulatory structure over dietary supplement products.   

Related:Industry survey reveals views on MPL, legislative priorities and FDA – report

“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,” the industry trade group said in a statement. “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.” 

In its recent budget request for FY25, FDA requested legislative authority to require manufacturers list their dietary supplement products with the agency. 

So-called mandatory product listing (MPL) was first proposed by FDA in FY20 under then-President Donald Trump. MPL gained momentum in the summer of 2022 when the Senate Committee on Health, Education, Labor and Pensions passed a bill (FDA Safety and Landmark Advancements Act) that included FDA’s proposal. However, MPL was not included later that year in a continuing resolution to fund the government. 

“In the face of mounting public health threats, I urge the Consumer Healthcare Products Association to help support legislative efforts such as this that would ensure the FDA can protect consumers effectively,” Durbin wrote to Melville. “I also request that the Consumer Healthcare Products Association provide my office with a written plan to work with responsible supplement manufacturers to remove tianeptine and other dangerous or illegal ingredients from the supplement market.” 

The Council for Responsible Nutrition was a strong supporter of the Dietary Supplement Listing Act in 2022 and remains steadfast in its support of MPL. 

“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,” the trade association said in a statement. “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’s legislative proposal for MPL doesn’t have unanimous support from the supplement industry. For example, the Natural Products Association (NPA) has been vehemently opposed, arguing FDA needs to step up its enforcement activities against criminals and that sellers of tianeptine and other illegal ingredients in supplements wouldn’t bother to list their products with FDA. 

A 2023 survey (conducted by Natural Products Insider) of ingredient suppliers, finished goods manufacturers and other businesses, found that slightly more respondents favored mandatory product listing than opposed it, with 21% of survey respondents undecided. The survey revealed that businesses tend to prefer other legislative reforms over MPL as their top priority, such as expanding health savings and flexible spending accounts to include dietary supplements among the list of approved products. 

Steven Shapiro, an experienced attorney in New York who advises supplement companies and opposes Durbin’s legislative proposal, observed that tianeptine is an unlawful unapproved drug.

“These products are put into the stream of commerce by criminals,” he wrote in a LinkedIn post. “The answer to this problem is not more paperwork filings by the legitimate dietary supplement industry.”

The proper government response to this illegal activity should be criminal enforcement rather than paperwork that criminals "will most certainly ignore," he added in an email to Natural Products Insider.