WASHINGTON – U.S. Senate Democratic Whip Dick Durbin (D-IL) today reintroduced the Dietary Supplement Listing Act, legislation to require dietary supplement manufacturers to register their products with the Food and Drug Administration (FDA).
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In 1994, Congress passed the Dietary Supplement Health and Education Act (DSHEA), which provided FDA with authorities to regulate dietary supplements. However, DSHEA did not require dietary supplement companies to register their products with FDA, leaving the agency without the much-needed information to properly understand or oversee the market.
In 1994, there were 4,000 dietary supplements marketed in the United States. Today, FDA estimates there are more than 100,000 on the market.
“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, “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 Council for Responsible Nutrition. “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.”
The Dietary Supplement Listing Act 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 and structure/function claims. This information would be made public to Americans through an electronic database.
More than 75 percent of American adults use a dietary supplement. However, no product is without risk. 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. Over the last 30 years, annual dietary supplement sales increased from $4 billion to more than $50 billion.
This legislation has earned endorsements from the Council for Responsible Nutrition (CRN), Consumer Federation of America, United States Pharmacopeia (USP), United States Public Interest Research Group (U.S. PIRG), and Ritual.
