Durbin, Braun Introduce Legislation To Improve Safety And Ensure Transparency Of Dietary Supplement Industry
9 out of 10 American adults support listing requirements for dietary supplements
WASHINGTON – U.S. Senate Majority Whip Dick Durbin (D-IL) and U.S. Senator Mike Braun (R-IN) introduced the Dietary Supplement Listing Act of 2022, bipartisan legislation to require dietary supplement manufacturers to list their products with the Food and Drug Administration (FDA). 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 authority or information to properly understand or oversee the market. In 1994, there were 4,000 dietary supplements marketed in the United States. Today, there are anywhere between 50,000 and 80,000.
“FDA—and consumers—should know what dietary supplements are on the market and what ingredients are included in them,” said Durbin, “There are tens of thousands of products on the market and we don’t know about many of them. Americans deserve a transparent dietary supplement market, and it’s past time that we deliver it for them. I’m grateful to Senator Braun for working with me on this important legislation.”
“A large majority of Americans take dietary supplements daily, yet there is little transparency into this industry to allow patients and providers access to information needed to make decisions around dietary supplement consumption,” said Braun. “I am proud to introduce this legislation to improve visibility into the dietary supplement industry because American consumers deserve to know what they’re taking. Having this information will enhance Americans’ health care options.”
“Today, FDA has few tools to spot and address dangerous supplement ingredients, and risky products are often found only after people have been harmed,” said Liz Richardson, director of The Pew Charitable Trusts’ health care products project. “This bipartisan, pragmatic proposal would bring transparency and stronger safety oversight to the vast dietary supplement marketplace. Nine in 10 adults support requiring manufacturers to inform the agency of all supplements they make and their ingredients. This bill would answer that call, and Congress should pass it without delay to ensure that FDA knows which products are being sold—and what’s in them.”
“Transparency is the best disinfectant, and a mandatory product listing will give FDA and consumers visibility into the dietary supplement marketplace,” said Steve Mister, President & CEO Council for Responsible Nutrition. “CRN member companies produce a large portion of the dietary supplements marketed in the United States, so we know responsible industry supports mandatory product listing for supplements. We appreciate the opportunity to work with Sens. Durbin and Braun on this critical legislation.”
"The dietary supplement marketplace is an uncertain place for consumers -- so little transparency, so much confusion. The American Medical Association appreciates the bipartisan effort of Sens. Richard Durbin (D-IL) and Mike Braun (R-IN) to introduce some clarity to this situation. The Dietary Supplement Listing Act would create a much-needed electronic database so consumers can access vital product information. We urge Congress to be on the side of consumers and pass this legislation," said AMA President Gerald E. Harmon, M.D.
The Dietary Supplement Listing Act of 2022 would require companies to provide FDA with vital 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. This information would be made public to Americans.
More than 75 percent of American adults use a dietary supplement. No product is without risk, which is why greater oversight is needed. In 2021, FDA received more than 2,400 adverse event reports related to dietary supplements. However, due to significant underreporting, FDA estimates the actual annual number of adverse events is 50,000. Over the last 27 years, annual dietary supplement sales increased from $4 billion to more than $50 billion.
The legislation is endorsed by the Council for Responsible Nutrition, Pew Charitable Trusts, the American Medical Association, and U.S. Pharmacopeia.
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