Senate Democratic Whip Dick Durbin has reintroduced the Dietary Supplement Listing Act, which would require dietary supplement manufacturers to register their products with the U.S. Food and Drug Administration (FDA) prior to market introduction. Versions of the mandatory product listing (MPL) bill were previously introduced by Durbin, most recently in 2024 and 2022, but each failed to pass Congress.

Durbin said in a press statement that in 2023, the FDA received more than 2,000 adverse event reports related to dietary supplements, but estimates that the actual number of adverse events is over 50,000 due to underreporting.

“FDA and consumers should know what dietary supplements are on the market and what ingredients are included in them. This is FDA’s most basic function, and the first step to protecting consumers,” said Durbin. “Americans deserve a transparent supplement market, and it’s past time that we deliver it for them.”

“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 and CEO of Council for Responsible Nutrition (CRN), a trade association that has advocated for MPL for several years. “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 bill would require companies to provide FDA with product names, a list of all ingredients, an electronic copy of the label, allergen statements, health claims, and structure/function claims. The information would be stored in a publicly accessible database.

According to CRN, the legislation preserves the existing framework laid out by the Dietary Supplement Health and Education Act (DSHEA), in that it doesn’t authorize FDA to require premarket approval of supplements. “Creating a federal registry is a transparency tool, not a barrier to innovation,” said Mister. “It aligns squarely with the Administration’s broader transparency goals and strengthens consumer trust without limiting access or disrupting responsible manufacturers.”

NPA: MPL Will Chill Investment in Innovation

According to Daniel Fabricant, PhD, president and CEO of the Natural Products Association (NPA), MPL presents an undue burden on the industry that won’t be an effective tool for safety. “This requires affirmative action from the U.S. Food and Drug Administration, not more paperwork or additional laws on the books,” he said.

The bill would raise administrative costs for supplement companies, thereby raising prices for consumers, he said. FDA will also have an easier time “adversely impact[ing] the availability of legitimate products in the market, based on controversial interpretations of the law and not on safety concerns,” Fabricant said, pointing to the lengthy legal battle over FDA’s declaration that NMN is precluded from supplements.

While proponents maintain that the framework of DSHEA remains unaltered in the bill, Fabricant characterized MPL as “creating a backdoor system that was never authorized. This Trojan Horse will hand bureaucrats new leverage over lawful products, cool innovation, and punish companies investing in new science and better health solutions.”

Fabricant described the notion that FDA can’t already access labels as a “fallacy,” and that the bill perpetuates a misconception that the supplement industry isn’t subject to robust regulations.

“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. NPA remains focused on countering the 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.”

The American Herbal Products Association (AHPA) announced its opposition to the latest iteration of the Dietary Supplement Listing Act, saying advocates for MPL have not sufficiently articulated how this requirement would benefit consumers or meaningfully enhance FDA’s existing authorities to enforce against marketers of drug-spiked products masquerading as dietary supplements. While not opposed to the concept of MPL in principle, AHPA said it does not support legislation that lacks provisions to clearly benefit public health or sufficiently accommodate small businesses.

“AHPA remains committed to protecting public health and fostering a transparent, innovative dietary supplement industry,” said AHPA President & CEO Graham Rigby. “We will continue our direct engagement with FDA and Congress to develop meaningful, common-sense reforms that increase accountability and modernize our regulatory framework to meet the needs of today’s dietary supplement marketplace and consumers.”