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Durbin, Braun Introduce Legislation to Mandate Product Listings for Dietary Supplements

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U.S. Senate Majority Whip Dick Durbin (D-IL) and U.S. Senator Mike Braun (R-IN) introduced the Dietary Supplement Listing Dietary SupplementsAct of 2022bipartisan legislation to require dietary supplement manufacturers to list their products with the U.S. Food and Drug Administration (FDA).

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.

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.

“FDA—and consumers—should know what dietary supplements are on the market and what ingredients are included in them,” said Sen. 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 Sen. 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 Sen. 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.”

The legislation is endorsed by the Council for Responsible Nutrition (CRN), Pew Charitable Trusts, the American Medical Association and U.S. Pharmacopeia.

“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 of CRN. “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 Natural Products Association (NPA), however, disagrees and has sent letters to Sens. Durbin and Braun, as well as the U.S. Department of Homeland Security (DHS), the U.S. Department of Health & Human Services (HHS) and the U.S. Department of Justice (DOJ), opposing it.

In the letter to Sens. Durbin and Braun, NPA’s President and CEO Daniel Fabricant stated “NPA has significant concerns with the Dietary Supplement Listing Act of 2022. Responsible natural product retailers and manufacturers go to great lengths to ensure consumers access safe products. FDA has a robust regulatory framework to understand what dietary supplements are being sold and who is selling them. The FDA has several tools with associated penalties for failure to comply. Retailers and manufacturers also have strong market incentives to make safe products. We have built a strong reputation and brand loyalty with the millions of American consumers who use these products every day.”

In the letter to DHS, HHS and DOJ, Fabricant wrote “The bill would create a new Section 403D of the Federal Food, Drug and Cosmetic Act that would require a so-called ‘mandatory product listing’ of all dietary supplements. The bill would require FDA to ‘maintain an electronic database’ that is ‘publicly accessible,’ ‘is populated with information that is provided’ under the bill, and ‘enables the public to search the database’ … This is precisely the type of information that bioterrorists would need to introduce contaminants or poisons into the food supply, and it would all be available to them in a publicly accessible database maintained by the federal government at taxpayer expense.”

For more information, visit www.crnusa.org or www.npanational.org.

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