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

The United States 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 mushroomed 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, aims to give the FDA and consumers more information about these products.

Some on social media, however, misinterpret the bill’s intent, saying it would give the FDA new power to approve or ban products.

“BREAKING: Senate demands that all dietary supplements be regulated and FDA approved,” read an Instagram from October 25. Publish. “For now, herbal medicine is a supplement. They are trying to ban the herbs.”

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

The message distorts what the Dietary Supplements List Act 2022 would do if adopted.

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

Durbin, in a speech to the Senate in April on his proposal, said the 1994 law had some flaws.

“Dietary supplement manufacturers … are not required to tell the Food and Drug Administration what products they sell in the United States under what names,” he said. “They are not required to disclose to the FDA what is in these products or where they are made.

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

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

According to fact sheet and the invoice text. It explicitly states that the law should not be interpreted as expanding the authority of the FDA.

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

The FDA estimates there are between 55,000 and 80,000 dietary supplement products on the market, but cannot provide exact numbers because the agency is not aware of all new products, Steve Mister said. , Chairman and CEO of the Board.

“We’re strong supporters of that. We call it a 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 doesn’t have premarket approval for dietary supplements. We wouldn’t want them to have premarket approval for our products,” he said. “But they should know what products are on the market, so they can exercise the oversight they have.”

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

Wording added to the amended proposal explicitly stated that the plan would not grant the “power to require approval of a dietary supplement before 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 is unclear whether it will move forward.

Our decision

An Instagram post claimed that the Dietary Supplements List Bill 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 authority. It also does not grant the FDA the authority to approve a product before it is marketed.

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

Norman D. Briggs