US Senate bill doesn’t give FDA new power to approve dietary supplements

The U.S. Food and Drug Administration has long had a role in regulating dietary supplements.

But that role does not include approving the tens of thousands of vitamins, minerals, herbs and other products that have multiplied on store shelves in the decades since their regulatory oversight began.

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

Some on social media, however, are misinterpreting the proposed law’s intent, saying it would give the FDA new power to approve or ban products.

"BREAKING: Senate is requiring all dietary supplements to be regulated and approved by the FDA," read an Oct. 25 Instagram post. "As of right now herbal medicine is a supplement. They are trying to ban herbs."

The Instagram post was flagged as part of Facebook’s efforts to combat false news and misinformation on its News Feed. (Read more about our partnership with Meta, which owns Facebook and Instagram.)

The post misstates what the Dietary Supplement Listing Act of 2022 would do if it is 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 don’t include claims that would render them drugs, monitor adverse event reports and act to remove dangerous products from the market. It does not have authority to approve products before they go to market.

Durbin, in an April Senate floor speech about his proposal, said the 1994 law has some flaws.

"Manufacturers of dietary supplements … are not required to tell the Food and Drug Administration what products they’re selling in the United States under what names," he said. "They’re not required to disclose to the FDA what is in those products, or where they are manufactured.

"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 Act, according to a fact sheet provided by Braun’s office, would require the FDA to create an online tool that consumers can use to search for information about supplements. 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 introducing dietary supplements to the market to register the supplement with the FDA and provide that information, including where the product is manufactured, according to a summary of the legislation. 

The law does not grant the FDA authority to approve any products before they go to market or any new authority to remove products from the marketplace, according to the fact sheet and the text of the bill. It explicitly states that the law should not be construed as expanding FDA authority.

The Council for Responsible Nutrition, the largest trade group in the industry, hopes to see the legislation passed.

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The FDA estimates there are between 55,000 and 80,000 dietary supplement products on the market, but can't provide exact figures because the agency isn’t made aware of all new products, said Steve Mister, president and CEO of the council.

"We are strong supporters of this. We call it mandatory product listing," said Mister, who said the transparency made possible by companies providing the FDA with their labels is "incredibly important" for the agency and consumers. 

"FDA does not have premarket approval over dietary supplements. We would not want them to have premarket approval over our products," he said. "But they should know what products are in the marketplace, so that they can exercise the oversight that they do have."

A modified version of Durbin and Braun’s bill was initially included in a Senate Health, Education, Labor and Pension Committee’s package reauthorizing FDA user fees, but it was later stripped out by Sen. Richard Burr, R-N.C., Axios reported.

Language added to the modified proposal explicitly made clear that the plan would not grant the "authority to require approval of a dietary supplement prior to marketing" to the secretary of Health and Human Services, to whom the FDA reports.

The proposed bill has been referred to the same Senate committee, and it’s not clear whether it will advance.

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

The FDA has had regulatory authority over dietary supplements since 1994, and this bill does not expand its powers. Nor does it grant the FDA the power to approve a product before it goes to market.

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