On July 29, U.S. Senate Majority Whip Dick Durbin (D-IL) introduced the Dietary Supplement Listing Act of 2024, legislation to require dietary supplement manufacturers to list their products with the U.S. Food and Drug Administration (FDA). If passed, the legislation would require companies to provide FDA with critical information about their products, including product names; a list of all ingredients; an electronic copy of the label; allergen statements; health and structure/function claims; and more. The information would then be made public to Americans through an electronic database.
“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. “There are more than 100,000 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.”
Scott Melville, president and CEO of the Consumer Healthcare Products Association (CHPA), expressed the association’s disappointment with the limited scope of this legislative proposal.
“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,” Melville continued. “As we approach 30 years of DSHEA (Dietary Supplement Health and Education Act), 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 while the association appreciates Durbin’s willingness to collaborate with the industry, it would not support the legislation in its current form. “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. 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.”
The American Herbal Product Association (AHPA) also announced its opposition to the legislation. “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. 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.”
For more information, visit www.chpa.org, www.crnusa.org or www.ahpa.org.
