Washington, DC—U.S. Senate Majority Whip Dick Durbin (D-IL) has introduced the Dietary Supplement Listing Act of 2024, which would require dietary supplement manufacturers to list their products with the Food and Drug Administration (FDA). If the legislation passes, companies would have 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 available to the public through an electronic database.
“FDA—and consumers—should know what dietary supplements are on the market and what ingredients are included in them," Sen. Durbin said in a press release. "This is FDA’s most basic function, and the first step to protecting consumers. 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.”
Sen. Durbin's announcement acknowledged that the 1994 Dietary Supplement Health and Education Act (DSHEA) provided FDA with authorities to regulate dietary supplements, but, according to the press release, the agency does not have "the much-needed information to properly understand or oversee the market" that has grown from 4,000 dietary supplements marketed in the U.S. in 1994 (with annual sales of $4 billion) to estimates of more than 100,000 products on the market today (with annual sales of $50 billion) and more than 75% of American adults now using a dietary supplement. Making the case for MPL, Sen. Durbin's release reported that in 2023, FDA received more than 2,000 adverse event reports related to dietary supplements. "However, due to significant underreporting, FDA has estimated the actual annual number of adverse events is more than 50,000."
As WholeFoods Magazine has reported, modernization of the DSHEA and mandatory product listing (MPL) for all dietary supplements marketed in the U.S. has been a hot topic in the natural products industry for years, with a previous push for MPL led by Sen. Durbin (D-IL) faltering in 2022.
Background: Dietary Supplement Listing Act of 2022 Introduced; Industry Divided
Concerns Over Tianeptine Cited as Reason for MPL
Earlier in 2024, Sen. Durbin informed industry trade associations of his plans to introduce the Dietary Supplement Listing Act in 2024. In a letter shared by the Consumer Healthcare Products Association (CHPA), sent on March 18, Sen. Durbin pointed to tianeptine as a reason for MPL. Sen. Durbin's actions followed the death of an Ohio man who ingested tianeptine. Legislation (HR 8123) introduced by Representative Frank Pallone (D-NJ) and Sen. Durbin, aiming to amend the Federal Food, Drug, and Cosmetic Act to establish new prohibited acts relating to dietary supplements. The bill would grant FDA broad authority to prohibit certain ingredients in dietary supplements without a rendering on an ingredient’s safety, according to the Natural Products Association (NPA), which is opposed to the bill. Daniel Fabricant, Ph.D., NPA President and CEO, raised several points about the Durbin-Pallone bill and the illegal substance. “Tianeptine is already illegal, and as it has been referred to as contributing to the opioid epidemic by the Department of Justice, why is it not being scheduled to appropriately stop it and protect public health?" Dr. Fabricant questioned. "Why is there not outrage from the bill’s sponsors, Congressman Pallone and Senator Durbin, on the inaction from those charged with the safety of America’s food and drug when tianeptine was first publicly identified as a problem by FDA in 2018? What’s in this proposal is a re-use of a part of the failed mandatory product listing (MPL) from last Congress, and doesn’t specifically address tianeptine, as the goal of this only appears to be restriction of legitimate and safe ingredients like, NAC, NMN, CBD and many other ingredients without any scientific basis.”
Dr. Fabricant also noted: "As the NPA has stated time and time again, the FDA has the tools necessary to go after illegal products like tianeptine. Proposals like this make one think that the agency is genetically predisposed against basic law enforcement and would much rather spend taxpayer funded time and resources pursuing overreaching authorities that muddy the waters for legitimate dietary ingredients. If tianeptine is such a priority, why hasn’t Congress asked the DEA to schedule the ingredient like other dangerous products? If enacted, the unintended consequences would threaten innovation and worse limit access to safe ingredients spanning probiotics, botanicals, amino acids, vitamins and more.” NPA launched a grassroots campaign to oppose the Durbin-Pallone bill; industry members are encouraged to take action here.
Natural Products Industry Responds to Dietary Supplement Listing Act of 2024
Council for Responsible Nutrition (CRN): CRN shared a letter sent to Sen. Durbin by CRN President & CEO Steve Mister, in which Mister explained that CRN "wholeheartedly supports the creation of an official registry of dietary supplements sold in the U.S.," which this legislation would accomplish. But, Mister added, "CRN cannot endorse it in its current form. As you know, it contains the expanded requirement that manufacturers provide FDA with a list of all their website claims for a new product—beyond the label and package insert information. This additional requirement is burdensome on industry and exceeds the original objective of the registry to provide FDA with a current snapshot of products on the market. 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 a website. But demanding companies submit that information (and keep it up-to-date as websites change) encumbers them with an ongoing administrative burden. 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 their authority. We also note that requiring companies to submit copies of their website claims does little to address your concerns over tianeptine, which we understand is one of the reasons you are reintroducing the legislation at this time."
American Herbal Products Association (AHPA): AHPA announced its opposition to the proposed legislation, explaining that neither FDA nor any other proponent of MPL legislation "has convincingly demonstrated the necessity of this premarket product listing requirement. Due to this lack of clear benefits, AHPA has for several years taken the position that it cannot support – but does not oppose – the concept of MPL requirements for dietary supplements. The latest version of this legislation from Senator Durbin does not alter this position. However, this particular MPL bill would impose unnecessary, significant, and redundant burdens on the industry." In regard to addressing unlawful drug products masquerading as dietary supplements such as tianeptine, AHPA said it "will continue to engage with FDA, Congressional offices, industry colleagues, and advocacy groups to develop alternative modernizing reforms to dietary supplement laws."
Robert Marriott, AHPA Director of Regulatory Affairs, said, “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. Even so, AHPA supports more narrowly tailored and effective legal reforms that will reflect the needs of an evolving marketplace. We will continue our work across the herbal products community, in cooperation with federal decisionmakers, to advance public health and ensure broad access to safe and well-regulated dietary supplement products.”
Consumer Healthcare Products Association (CHPA): President & CEO Scott Melville issued the following statement: “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.
“While we agree that Mandatory Product Listing (MPL) is a good first step, it is simply not enough as a stand-alone measure. 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.
“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. 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.”
Natural Products Association (NPA): Read: NPA "Deeply Concerned" About Proposed Mandatory Product Listing for Dietary Supplements
