Not much has changed in the world of dietary supplements since Congress passed the Dietary Supplement Health and Education Act (DSHEA) and President Bill Clinton signed it in 1994. The 1994 law defined and established the scope of regulation regarding dietary supplements.
A 1994 law exempted dietary and herbal supplements from most FDA drug regulations, allowing them to be sold and marketed without scientifically backed health or medical claims.
But now, U.S. Senate Majority Whip Dick Durbin (D-Ill.) has moved forward with introducing the Dietary Supplement Listing Act of 2024. A law requiring dietary supplement manufacturers to register their products with the FDA.
The 1994 DSHEA gave the FDA some authority to regulate dietary supplements. But because DSHEA did not require dietary supplement companies to register their products with the FDA, the FDA did not have the information it needed to properly understand or monitor the market.
In 1994, there were 4,000 dietary supplements available in the U.S. Today, the FDA estimates that more than 100,000 people use dietary supplements.
“FDA and consumers should know what dietary supplements are on the market and what ingredients they contain. This is FDA’s fundamental function and the first step in protecting consumers,” Durbin said. “There are over 100,000 products on the market, but we don’t know important information about most of them. Americans need a transparent supplement marketplace, and it’s time for us to provide that to Americans.”
The Dietary Supplement Registration Act of 2024 requires companies to provide the FDA with key information about their products, including the product name, full ingredient list, electronic copy of the label, allergen declarations, and health and structure/function claims. This information will be made available to the American public through an electronic database.
More than 75% of American adults use dietary supplements. But Durbin says no product is without risk. In 2023, the FDA received more than 20,400 reports of adverse events associated with dietary supplements. But because of a significant underreporting, the FDA estimates the actual number of adverse events per year to be more than 50,000. In 30 years, annual sales of dietary supplements have grown from $4 billion to more than $50 billion.
Governor Durbin’s introduction of the Dietary Supplement Listing Act of 2024 follows the introduction in April of the Tianeptine and Other Dangerous Products Ban Act, which would ban illegal or dangerous ingredients such as tianeptine from being included in products sold as dietary supplements.
Tianeptine is an unapproved drug sold as a dietary supplement and under labels such as “Neptune’s Fix.” Ingestion of the drug has led to increased calls to poison control centers nationwide and serious side effects requiring emergency room visits. According to the National Poison Control Center: Last year, 391 cases of tianeptine were reported nationwide.Sen. Frank Pallone Jr. (D-N.J.), chairman of the House Energy and Commerce Committee, has introduced a companion bill in the House of Representatives.
In April, the FDA issued a “New Nutrition Facts Notification Master File for Dietary SupplementsThis draft guidance responds to the dietary supplement industry’s request for specific guidance regarding New Dietary Ingredient Notification (NDIN) master file recommendations.
NDIN Master Files are not required by law or regulation, but as explained in the draft guidance, they can facilitate the submission of NDI-related identification, manufacturing, and/or safety information to FDA for evaluation of future NDINs. Once finalized, the guidance is intended to make it easier for industry to comply with NDIN requirements by providing recommendations on the content, submission, and use of Master Files.
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