There has not been much change in the dietary supplements world since Congress passed and President Bill Clinton signed the Dietary Supplement Health and Education Act of 1994 (“DSHEA”). That 1994 statute defines and sets the regulator bounds for dietary supplements,
The 1994 law exempts dietary and herbal supplements from most FDA drug regulations, allowing them to be sold and marketed without scientific backing for any health or medical claims.
But now, U.S. Senate Majority Whip Dick Durbin, D-IL, has stepped forward to introduce the Dietary Supplement Listing Act of 2024, legislation to require dietary supplement manufacturers to list their products with the FDA.
The DSHEA, In 1994, provided FDA with some authority 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 understand or oversee the market properly.
In 1994, 4,000 dietary supplements were marketed in the United States. Today, the FDA estimates that more than 100,000 people use them.
“FDA — and consumers — should know what dietary supplements are on the market and what ingredients are included. This is FDA’s basic function and the first step to protecting consumers,” said Durbin, “There are more than one hundred thousand products on the market, but we don’t know critical information about most of them. Americans deserve a transparent supplement market, and it’s past time that we deliver it for them.”
The Dietary Supplement Listing Act of 2024 would require companies to provide the FDA with critical 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 through an electronic database.
More than 75 percent of American adults use dietary supplements. However, Durbin says no product is without risk. In 2023, the FDA received more than 20,400 adverse event reports related to dietary supplements. However, due to significant underreporting, the FDA has estimated the actual annual number of adverse events is more than 50,000. Over 30 years, annual dietary supplement sales increased from $4 billion to more than $50 billion.
Durbin’s introduction of the Dietary Supplement Listing Act of 2024 follows his April introduction of the Prohibiting Tianeptine and Other Dangerous Products Act, which would prohibit illegal or otherwise dangerous ingredients, such as tianeptine, from being included in products marketed as dietary supplements.
Tianeptine is an unapproved drug that is marketed as a purported dietary supplement and sold under labels such as “Neptune’s Fix.” Ingestion of the drug has led to an increase in calls to poison control centers and severe adverse effects requiring visits to emergency rooms nationwide. According to America’s Poison Control Centers, 391 tianeptine cases were reported nationwide last year. House Energy and Commerce Committee Ranking Member Frank Pallone Jr., D-NJ, introduced companion legislation in the House.
In April, the FDA announced the availability of a draft guidance for the industry titled “New Dietary Ingredient Notification Master Files for Dietary Supplements.” This draft guidance responds to the dietary supplement industry’s requests for specific guidance on recommendations about Master Files for new dietary ingredient notifications (NDINs).
NDIN Master Files are not required by statute or regulation but, as explained in the draft guidance, can facilitate the submission of NDI-related identity, manufacturing, and/or safety information to the FDA for use in evaluating a potential future NDIN. The intent of the guidance, once finalized, will be to help the industry comply more easily with the NDIN requirement by providing recommendations on the content, submission, and use of Master Files
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