United States Senator Dick Durbin (D-IL) introduced the Dietary Supplement Listing Act of 2024, which requires dietary supplement manufacturers to list their products with the U.S. Food and Drug Administration (FDA).
In 1994, Congress passed the Dietary Supplement Health and Education Act (DSHEA), which provided FDA authority to regulate dietary supplements. However, DSHEA does not require supplement companies to register their products with FDA, according to Durbin.
At the time of DSHEA, there were 4,000 dietary supplements marketed in the United States. Today, FDA estimates that number has risen to more than 100,000.
Durbin’s 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 and health, structure and function claims.
“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 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.”
Marc Ullman, of Counsel at Rivkin Radler LLP and a VRM Media contributor, said Durbin’s bill is “more of the same nonsense.” He emphasized FDA already has the resources it needs to regulate dietary supplements.
“It’s almost like he was trying to see how much worse he could make it for an already compliant industry,” Ullman said.
Robert Marriott, director of regulatory affairs at American Herbal Products Association (AHPA), added, “We have yet to be convinced that the potential benefits of [mandatory product listing] 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.”
Steve Mister, president and CEO of the Council for Responsible Nutrition (CRN) sent a letter to Durbin’s office. Mister said he appreciates Durbin’s willingness to engage in constructive dialogue, but the association cannot endorse the bill.
In his letter, Mister criticized the expanded requirements saying they are “burdensome” on the industry “exceed the goal of giving FDA visibility” into the supplements market and opens the door for “fishing expeditions” on marketing activities.
“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 introducing the legislation at this time,” Mister wrote.
