As promised a few months ago, U.S. Senator Dick Durbin (D-IL) has introduced another bill seeking to require mandatory product listing (MPL) for all dietary supplement products with the U.S. Food and Drug Administration.

The new effort comes after a 2022 bid for MPL failed when it was stripped from the FDA User Fee Reauthorization, an omnibus spending package.

“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,” Durbin said. “There are more than one hundred thousand products on the market, but we don’t know critical information about most of them. Americans deserve a transparent supplement market, and it’s past time that we deliver it for them.”

The ‘Dietary Supplement Listing Act of 2024’ would require the manufacturers of dietary supplements to provide FDA with product names, a list of all ingredients, an electronic copy of the label, allergen statements, health and structure/function claims, and more. This information would be made public through an electronic database.

In his statement announcing the introduction of the present MPL bill, Durbin noted that in 2023, there were more than 20,400 adverse event reports related to dietary supplements received by FDA. But the agency estimates that, due to underreporting, the actual annual number of adverse events is closer to 50,000.

The ‘Dietary Supplements Listing Act of 2024’ comes on the heels of another bill introduced by Durbin, as a companion piece to a bill introduced by Rep. Frank Pallone, Jr. (D-NJ) in the House, called the ‘Prohibiting Tianeptine and Other Dangerous Substances Act,’ which seeks to grant FDA with additional enforcement powers and seizure authority against products that fail to meet the regulatory definition of a dietary supplement.

The Consumer Healthcare Products Association (CHPA) said that the bill doesn’t afford FDA with enough clarity to actually target products containing substances like Tianeptine, if those products are not labeled as dietary supplements.

“CHPA is disappointed with the limited scope of this legislative proposal. Having worked closely with federal lawmakers to underscore the critical need for dietary supplement regulatory reform, CHPA remains hopeful a more comprehensive approach that cracks down on illegal activity and better protects consumers is achievable in this or the next Congress. Unfortunately, this bill would not have that effect. This is especially disappointing considering the Senator’s recent attention to resolve issues such as tianeptine, which this bill would not address,” said Scott Melville, president and CEO of CHPA.

He described MPL as a “good first step,” but that, alone, it would do nothing to prevent criminals from simply removing the term ‘dietary supplement’ from their label to avoid the MPL requirement.

“We appreciate the senator’s initial willingness to come to the table on this issue but cannot support a proposal that fails to achieve these critical priorities and burdens responsible industry,” said Melville. “As we approach 30 years of DSHEA, the time is ripe for a more comprehensive approach to regulatory modernization, and CHPA is committed to working with Congress on effective proposals that will promote consumer safety and enhance public health.”

In a letter to Durbin, Steve Mister, president and CEO of the Council for Responsible Nutrition (CRN) said that CRN “wholeheartedly” supports the creation of an official dietary supplement registry for all products in the U.S., and is encouraged by provisions explicitly stating that MPL wouldn’t serve as a form of pre-market approval. However, the association can’t endorse the bill in its current form, as the requirement that companies share all website claims with FDA is too burdensome.

“This additional requirement is too burdensome on industry and exceeds the original objective of the registry to provide FDA with a current snapshot of products on the market,” said Mister. “Indeed, once FDA is aware of the presence of a dietary supplement ingredient from the submission of the label information, it could easily perform internet searches for any particular product to examine additional marketing claims on its website. But demanding companies submit that information (and keep it up-to-date as websites change) encumbers them with an ongoing administrative burden … and could encourage FDA to conduct ‘fishing expeditions’ for marketing activities beyond the scope of their authority.”

CRN remains hopeful that further discussions will lead to a compromise which addresses these concerns, Mister wrote. “We remain committed to transparency through a listing program, as well as other common-sense reforms that address our shared goals of creating an even safer dietary supplement marketplace, fostering innovation and scientific research for these products, and assuring consumers of the quality and benefits of dietary supplements.”