“FDA—and consumers—should know what dietary supplements are on the market and what ingredients are included in them,” Senator Durbin shared in a statement issued Jan. 15. “This is FDA’s most basic function, and the first step to protecting consumers. Americans deserve a transparent supplement market, and it’s past time that we deliver it for them.”
He asserts that when Congress passed the Dietary Supplement Health and Education Act (DSHEA) of 1994, the absence of a provision requiring companies to register their products with FDA left the agency without the information needed to properly understand or oversee a market that has grown from 4,000 to an estimated 100,000 products over the last 30 years.
If passed, the act would require companies to provide FDA with product names, a list of all ingredients, an electronic copy of the label, allergen statements and health and structure/function claims made by their products. This information would be made public to Americans through a regularly updated electronic database. Proprietary blend ingredient information would have to be provided to FDA but would be kept confidential. Failure to provide the required information would cause products to be considered misbranded.
Proponents of the 2026 bill listed in Senator Durbin’s press announcement include the Council for Responsible Nutrition (CRN), Consumer Federation of America, United States Pharmacopeia (USP), United States Public Interest Research Group (U.S. PIRG) and supplement company Ritual.
A familiar initiative
Senator Durbin previously pushed for a mandatory product listing (MPL) in 2022 and again in 2024, but both legislative attempts ultimately failed to pass Congress.
In this year’s press statement, he once again highlighted the reports of more than 2,000 adverse events related to dietary supplements in 2023, with the FDA estimating the actual annual number to be closer to 50,000 due to underreporting. This aligns with a 2024 letter addressed to most of the dietary supplement trade associations in which he urged action against the inclusion of dangerous or illegal ingredients in products marketed as dietary supplements in the United States, such as tianeptine. The trade associations replied that their members do not sell tianeptine and that the FDA should act to remove these illegal products from the market.
Shortly thereafter, Sen. Durbin introduced the Prohibiting Tianeptine and Other Dangerous Products Act, which the trade associations warned was being used as a vehicle to reintroduce mandatory product listing and provide the FDA with new overreaching authorities. It remains at the committee stage, pending consideration in Congress.
“This bill, as written, would have the effect of denying access to legitimate dietary supplements to consumers,” Loren Israelsen, founder and president of the United Natural Products Alliance (UNPA), told NutraIngredients at the time. “While we oppose the language of this bill, we fully support FDA efforts to remove tianeptine from the market as an undeclared drug.”
CRN evolves opinion
Soon after the reintroduction of the dietary supplement listing act was announced on Thursday, the Council for Responsible Nutrition (CRN), which opposed the 2024 bill as presented, issued a statement supporting the 2026 legislation as a “CRN-backed product listing proposal.”
“In an era when the Administration has rightly called for more transparency about what we eat and how food is made, it makes sense to apply that same transparency to dietary supplements,” said Steve Mister, president & CEO of CRN. “Consumers deserve to know what products are on the market and what they contain—and FDA needs that same information to do its job effectively.”
The council’s support follows what it calls meaningful improvements that eliminate provisions that it viewed as overly burdensome to industry and beyond FDA’s ability to monitor.
“In particular, the requirement that all marketing claims made on a company’s website—regardless of whether they appear on the product label—be included in the registry was removed,” a spokesperson for CRN told NutraIngredients. “In addition, the legislation now includes explicit protections to ensure that any non-public information submitted to FDA would remain confidential and not be subject to public disclosure, including through FOIA.”
CRN also noted that, importantly, the legislation preserves the existing Dietary Supplement Health and Education Act (DSHEA) framework and does not authorize FDA to require premarket approval of supplements.
NPA maintains opposition to ‘Trojan Horse’
The Natural Products Association continues to oppose the Dietary Supplement Listing Act, stating that Americans do not need Washington micromanaging their dietary supplement cabinets but rather enforcement action from FDA to remove bad actors and unlawful products from market.
“Congress already established a comprehensive, risk-based framework for dietary supplements under DSHEA, and this proposal blows right past it by creating a backdoor system that was never authorized,” Dan Fabricant, president & CEO of NPA, told NutraIngredients. “This Trojan Horse will hand bureaucrats new leverage over lawful products, cool innovation and punish companies investing in new science and better health solutions.”
NPA also believes the proposal perpetuates the mistaken notion that FDA does not already have ready access to product labels, as well as the misconception that dietary supplements in the U.S. are not subject to FDA oversight. It highlights the existence of a robust regulatory framework that includes current good manufacturing practices (cGMPs), labeling requirements, adverse event reporting and safety-related notifications governing new dietary ingredients.
“Finally, NPA is perplexed that industry advocates would make mandatory product listing a priority, amid the most pressing opportunities and challenges facing ingredient suppliers, manufacturers of finished products and retailers,” Dr. Fabricant added.
“NPA remains focused on countering growing threats from state legislatures to restrict and regulate legitimate supplements, addressing the ‘drug preclusion’ clause in DSHEA, expanding consumer access to science-based products that promote health and wellness, and ensuring that FDA moves expeditiously against bad actors. Mandatory product listing will not achieve—and in some cases, will even undermine—those objectives.”
Prospects in Congress
In a memo sent to its members Wednesday evening, the United Natural Products Alliance (UNPA) noted that the bill does not currently have any Republican cosponsors and would have to gain substantial bipartisan support to have even a modest chance of passage in a highly partisan Congress.
Sen. Durbin, who is retiring at the end of this Congress, is expected to push for adoption of the legislation as part of his legacy.
While UNPA previously indicated that it would be generally supportive of a reasonably designed product listing requirement, it confirmed that it did not support the previous bill and does not support the new iteration.
This is a developing story and will be updated as more information becomes available.
