Source: United States Senator for Illinois Dick Durbin
HELP Committee’s draft FDA User Fee Package includes a modified version of the Durbin-Braun dietary supplement bill; legislation will improve safety and ensure transparency of dietary supplement industry
WASHINGTON – U.S. Senate Majority Whip Dick Durbin (D-IL) applauded the inclusion of a modified version of his Dietary Supplement Listing Act of 2022 in the Senate Health, Education, Labor and Pension (HELP) Committee’s recently-released draft Food and Drug Administration (FDA) User Fee package. The Dietary Supplement Listing Act of 2022 requires dietary supplement manufacturers to list their products with 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, “With tens of thousands of products on the market, this bipartisan legislation will ensure transparency in the dietary supplements that Americans take every day. I’m pleased that a modified version of our bill was included in the HELP Committee’s draft user fee package and I look forward to working with my colleagues to get this done.”
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 HELP Committee’s FDA User Fee package would reauthorize vital FDA programs that collect “user fees” from certain regulated industries—prescription drug companies, medical device companies, generic drug companies, etc.—to conduct specific oversight activities, such as reviewing and approving drug and biological products. Congress must reauthorize the User Fee Act Amendments (UFAs) each five years. Approximately 45 percent of FDA’s budget come from user fees.
The Durbin–Braun bill is endorsed by the Council for Responsible Nutrition, Pew Charitable Trusts, Environment America and U.S. PIRG, and the American Medical Association, and U.S. Pharmacopeia.
-30-