U.S. Senator Democratic Whip Dick Durbin (D-IL) has announced the reintroduction of the Dietary Supplement Listing Act, which would require supplement manufacturers to register their products with the U.S. Food and Drug Administration. The legislation was originally introduced in 2022. Since the passage of the Dietary Supplement Health and Education Act in 1994, the number of dietary supplements on the market went from 4000 to over 100,000, according to estimates made by FDA. Because these products are not subject to premarket approval, FDA does not maintain a database of dietary supplements, creating the rationale for the bill. The legislation would require supplement companies to provide FDA with critical product information that includes: product names, a list of all ingredients, an electronic copy of the label, allergen statements, and health and structure/function claims. This information would 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, in a press release. “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 & CEO of the Council for Responsible Nutrition (CRN; Washington, D.C.). “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.”
CRN has been advocating for a registry for over a decade, and states in a release that the reintroduction, “reflects that sustained engagement and growing bipartisan recognition that transparency is essential for a modern, trusted supplement marketplace.” It also maintains its own voluntary registry that serves as a proof of concept, called the Supplement OWL (Online Wellness Library).
“Creating a federal registry is a transparency tool — not a barrier to innovation,” Mister added. “It aligns squarely with the Administration’s broader transparency goals and strengthens consumer trust without limiting access or disrupting responsible manufacturers.”
Industry is divided on the subject of mandatory product listings or registries. The Natural Products Association (NPA; Washington, D.C.), for example, is opposed to a mandatory registry. “A mandatory product listing will not only unduly burden the industry with a mountain of administrative paperwork, but it will raise costs for everyday health products,” Daniel Fabricant, PhD, president and CEO of NPA in a statement. “The Senator’s proposal also will chill investments in new dietary ingredients and make it easier for FDA to adversely impact the availability of legitimate products in the market, based on controversial interpretations of the law and not on safety concerns. NMN is the most recent case in point, culminating in NPA actions in the executive and judicial branches.”
NPA argues that FDA has ample resource and access to product labels to enforce regulations, and notes that dietary supplements are already subject to robust regulations that include cGMPs, labeling requirements, adverse event reporting, and safety-related notifications for new dietary ingredients. “NPA remains focused on countering 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.”
