The US Senate bill does not give the FDA new authority to approve dietary supplements

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The US Food and Drug Administration has long played a role in regulating dietary supplements.

But that role doesn’t include approving tens of thousands of vitamins, minerals, herbs, and other products that have multiplied on store shelves in the decades since they began being regulated.

A bipartisan proposal by Sen. Dick Durbin, D-Ill., and Sen. Mike Braun, R-Ind., presented in April aims to give the FDA and consumers more information about these products.

However, some on social media misinterpret the intent of the proposed law, saying it would give the FDA new powers to approve or ban products.

“BREAKING: Senate requires all dietary supplements to be regulated and approved by the FDA,” read an Oct. 25 Instagram post. “Right now herbal medicine is a supplement. They’re trying to ban herbs.”

The Instagram post was flagged as part of Facebook’s efforts to combat hoaxes and misinformation on its news feed. (Read more about our partnership with Meta, owner of Facebook and Instagram.)

The post incorrectly states what the Dietary Supplement Listing Act of 2022 would do if passed.

Under current law, passed in 1994, the FDA has certain regulatory powers over dietary supplements. It can inspect manufacturing facilities, review product labels to ensure they do not contain claims that would make them about drugs, monitor reports of adverse events, and take action to withdraw dangerous products from the market. It does not have the power to approve products before they are placed on the market.

Durbin said of his proposal in a speech before the Senate in April that the 1994 law had some shortcomings.

“Dietary supplement manufacturers … are not required to tell the Food and Drug Administration what products they sell under what name in the United States,” he said. “You don’t have to disclose to the FDA what’s in these products or where they’re made.

“When it comes to dietary supplements,” he said, “the Food and Drug Administration and American consumers are pretty much flying blind.”

The proposed dietary supplement listing bill would require the FDA to create an online tool that consumers could use to search for information about dietary supplements, according to a pamphlet provided by Braun’s office. The tool would “list manufacturer contact information, ingredients, serving sizes, general safety information, health claims, allergens, safety warnings, and precautions for all dietary supplements.”

The bill would require companies that market dietary supplements to register the dietary supplement with the FDA and provide that information, including where the product was manufactured, according to a summary of the legislation.

The law does not grant the FDA power to approve products before they are placed on the market or a new power to withdraw products from the market, according to the memorandum and text of the bill. It is expressly stated that the law should not be construed as an extension of the FDA’s powers.

The Council for Responsible Nutrition, the industry’s largest trade group, hopes the law will pass.

The FDA estimates that there are between 55,000 and 80,000 dietary supplements on the market but can’t give exact numbers because the agency isn’t notified of all new products, said Steve Mister, the council’s president and CEO.

“We’re strong advocates of it. We call it mandatory product listing,” said Mister, who said the transparency enabled by companies providing their labels to the FDA is “incredibly important” to the agency and consumers.

“The FDA does not have premarket approval for dietary supplements. We wouldn’t want them to have pre-market approval for our products,” he said. “But they should know what products are on the market so they can exercise the control that they have.”

A modified version of Durbin and Braun’s bill was originally included in a Senate Health, Education, Labor and Pensions Committee package reauthorizing FDA user fees, but it was later approved by Sen. Richard Burr, RN .C., removed, reported Axios.

The wording added to the amended proposal made it explicit that the plan would not grant the Secretary of Health, who reports to the FDA, “the authority to require a dietary supplement’s approval before it can be placed on the market.”

The proposed bill has been referred to the same Senate committee and it is not clear if it will move forward.

Our verdict

An Instagram post claimed that the proposed Dietary Supplement Listing Act of 2022 would give the FDA new powers to regulate and approve dietary supplements and is an attempt to ban herbal medicines.

The FDA has been the regulator of dietary supplements since 1994, and this bill does not expand its powers. Nor does it give the FDA the authority to approve a product before it hits the market.

The bill would require manufacturers of dietary supplements to register new products with the FDA and provide information about them. The FDA would use this information to create an online database of such products that consumers could also refer to. We rate this as False.

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