“FDA—and consumers—should know what dietary supplements are on the market and what ingredients are included in them,” Sen. Durbin shared in a statement issued July 29. “This is FDA’s most basic function, and the first step to protecting consumers.”
He and other proponents of the listing, including FDA, assert 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 billion to more than $50 billion in sales over the last 30 years.
“There are more than one hundred thousand products on the market, but we don’t know critical information about most of them,” Sen. Durbin added. “Americans deserve a transparent supplement market, and it’s past time that we deliver it for them.”
The senator previously pushed for a mandatory product listing (MPL) in 2022, but legislative attempts ultimately failed to pass Congress.
What’s in the legislation
If passed this time around, the act would require companies 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 other information about their products. This information would be made public to Americans through an electronic database.
The statement from Sen. Durbin’s office highlighted that FDA received more than 2,000 adverse event reports related to dietary supplements in 2023 but that the agency estimated the actual annual number to be closer to 50,000 due to underreporting.
In a letter addressed to most of the dietary supplement trade associations in March, Sen. Durbin urged action against the inclusion of dangerous or illegal ingredients in products marketed as dietary supplements in the United States, such as tianeptine. He also previewed the reintroduction of his dietary supplement listing act. 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.
At the time, the Natural Products Association (NPA) responded with its own letter to Sen. Durbin, reiterating its continued objection to the legislation and noting that without additional considerations, reintroducing the previous legislation would continue to meet with opposition from NPA membership.
“NPA opposed this bill when you introduced it in 2022 as did the House and Senate committees of jurisdiction when they rejected it during consideration of the FDA user fee reauthorization bills,” wrote Daniel Fabricant, PhD, NPA president and CEO. “The narrative that the industry isn’t adequately regulated is false and should no longer be advanced as the basis for adding unnecessary regulations.”
In April, 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.
“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), previously told NutraIngredients. “While we oppose the language of this bill, we fully support FDA efforts to remove tianeptine from the market as an undeclared drug.”
A call for clear benefits and good faith
Soon after the reintroduction of the dietary supplement listing act, the trade associations began issuing their statements of opposition.
The American Herbal Products Association (AHPA) communicated that without demonstration of clear benefits, it still cannot support but does not oppose the concept of MPL requirements as long as legislation does not impose unnecessary, significant and redundant burdens on the industry.
“We have yet to be convinced that the potential benefits of MPL requirements would justify their costs—both to industry and FDA—as well as the potential unintended consequences that would result from the establishment of such a system,” said Robert Marriott, AHPA director of regulatory affairs. “Even so, AHPA supports more narrowly tailored and effective legal reforms that will reflect the needs of an evolving marketplace.”
The Consumer Healthcare Products Association (CHPA), which has supported MPL as a good first step but not as stand-alone measure, expressed its disappointment with the limited scope of the legislative proposal.
“Under this bill as currently written, FDA would still lack the resources and authority needed to quickly and efficiently remove illegal products like tianeptine from the market, and because it fails to present a comprehensive framework, it would do nothing to prevent criminals from simply removing the term ‘dietary supplement’ from their label to avoid the MPL requirement,” said Scott Melville, CHPA president and CEO.
Reacting to the news, NPA shared that Sen. Durbin introduced the legislation a week after he and his staff were scheduled to visit one of the association’s member companies for a facility tour and discussion.
“We were looking forward to a productive exchange of views, but unfortunately the Senator’s team canceled the night before the scheduled visit,” Dr. Fabricant said. “Our position has been unwavering on this—legislative proposals of this ilk that are developed in bad faith and designed solely to damage the industry’s reputation aren’t to be negotiated and to be improved upon, they’re to be laid to rest.”
Opposition to ‘fishing expeditions’ and ‘poison pills’
The Council for Responsible Nutrition (CRN) responded with a letter to Sen. Durbin thanking him for his continued leadership, supporting the creation of an official registry of dietary supplements and acknowledging the inclusion of provisions clarifying that the program would not create a pre-market approval process by FDA.
“While we appreciate your willingness to engage in constructive dialogue and the spirit of collaboration on the bill to date, unfortunately, CRN cannot endorse it in its current form,” wrote Steve Mister, CRN president and CEO.
Specifically, the Council highlighted the requirement that manufacturers provide FDA with a list of all website claims for a new product—beyond the label and package insert information—as burdensome on industry.
“This requirement exceeds the goal of giving FDA visibility into the array of dietary supplements in the U.S. market and could encourage FDA to conduct ‘fishing expeditions’ for marketing activities beyond the scope of [its] authority,” Mister added.
In a memo sent to its members Tuesday morning, UNPA confirmed that it does not support the legislation as is and said that it does expect any action on the bill this year.
“In April, UNPA had indicated to Senator Durbin’s staff that our members could be generally supportive of a reasonably designed product listing requirement but that we could not support inclusion of the two ‘poison pill’ amendments the HELP Committee had included when it considered similar legislation in 2022 (a new prohibited act and requirement for FDA to finalize their NDI guidance),” wrote UNPA senior political advisors Patricia Knight and Peter Reinecke. These “poison pills” refer to the provision on website claims and questions about the protection of proprietary blends from public disclosure.
UNPA has also consistently maintained the position that advancement of an MPL bill must be contingent on FDA actually receiving the resources needed to implement the program without taking away from existing enforcement against bad actors.
All trades have expressed their commitment to working towards effective, common-sense proposals that would promote consumer safety and enhance public health.
link