Sen. Durbin reintroduces Dietary Supplement Listing Act

U.S. Senate Majority Whip Dick Durbin (D-Ill.) on Monday reintroduced a bill that would require manufacturers of dietary supplements to list their products with the U.S. Food and Drug Administration.

Durbin, FDA and other proponents of mandatory product listing argue that FDA cannot effectively regulate or police the market if it is not aware of all the dietary supplements sold in the U.S.

According to FDA estimates, the market contains as many as 100,000 different products.

“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 in a July 29 news release. “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.”

Under the Dietary Supplement Listing Act of 2024, companies would be required to provide FDA with product names, a list of all ingredients and an electronic copy of the label, Durbin's office said. Among other things, additional mandated disclosures to FDA would include allergen statements and the health and structure/function claims being made.

Related:Trade groups oppose Durbin’s Dietary Supplement Listing Act

Durbin's office said the dietary supplement information would be made available to Americans through an electronic database.

More than 75% of American adults use a dietary supplement, and annual sales over the last 30 years have grown from $4 billion to more than $50 billion, Durbin's office said in the news release.

According to the release, FDA in 2023 received more than 20,400 adverse event reports related to supplements, yet the agency estimates the actual figure — due to underreporting — tops 50,000.

Durbin and Sen. Richard Blumenthal (D-Conn.) in April introduced a bill aimed to stop the sale of tianeptine products, which have been marketed as dietary supplements, raised concerns among U.S. regulators and earned the nickname “gas station heroin.” When announcing the bill, the lawmakers cited data from America’s Poison Control Centers (based on a New York Times story) that 391 tianeptine cases were reported nationwide last year. 

But in separate letters to Durbin, trade associations underscored their members do not sell tianeptine, the substance does not belong in dietary supplements and the Food and Drug Administration should use its authorities to remove these products from the market. 

For several years, FDA has been a strong supporter of mandatory product listing, while some industry trade associations have remained divided over the issue.

"Under our current authorities, FDA has no systematic way of knowing what dietary supplements are on the market, when new products are introduced, or what they contain," Cara Welch, Ph.D., director of FDA's Office of Dietary Supplement Programs, wrote in a 2023 column published by Natural Products Insider. "When dealing with a marketplace that has grown more than 20 times since 1994, this puts FDA at a distinct disadvantage."