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Durbin Eyes Linking Dietary Supplement Bill to FDA Fee Package

April 26, 2022, 10:24 PM

A top senator is looking to add language requiring dietary supplement reporting to must-pass legislation governing the FDA’s user fees.

The Dietary Supplement Listing Act of 2022, introduced by Senate Majority Whip Dick Durbin (D-Ill.) Tuesday, would boost Food and Drug Administration oversight of dietary supplements to better identify potentially harmful ingredients or health claims. Sen. Mike Braun (R-Ind.) cosponsors the bill.

Durbin’s office said the senator would like to see the legislation added onto the FDA user fee package, which would give the bill a clear path to coverage. The user fee agreements must be reauthorized before the current ones expire Sept. 30.

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“We are working with the Senate HELP committee to add this to the FDA user fee package moving in the next few months,” Durbin’s office said in an email.

The bill would require companies involved in the production of dietary supplements to list their products with the FDA and report to the agency information on ingredients, directions for use, and safety warnings. Any purported health or function claims included in the marketing of their products must also be shared with the FDA under the legislation.

Both the FDA and lawmakers have called for better oversight of the dietary supplement industry, which has expanded up to 20 times in size over the past three decades. According to the Council for Responsible Nutrition’s 2021 Consumer Survey on Dietary Supplements, 80% of Americans report taking dietary supplements. In 2021, FDA said it received 2,719 dietary supplement adverse event reports.

“FDA—and consumers—should know what dietary supplements are on the market and what ingredients are included in them,” Durbin, a member of the Senate Agriculture Committee, said in a statement. “Americans deserve a transparent dietary supplement market, and it’s past time that we deliver it for them.”

The Dietary Supplement Health and Education Act of 1994 gave the FDA authority to regulate dietary supplements, when there were about 4,000 of these products on the market. Manufacturers and distributors aren’t required to register their products and ingredients with the FDA, limiting its ability to track the estimated 50,000 to 80,000 products available in the U.S.

Durbin’s measure follows the FDA’s release of its fiscal 2023 budget request, which included a legislative proposal to require annual listing of individual supplement products. The agency also asked Congress to “clarify FDA’s authorities over products marketed as dietary supplements to facilitate enforcement against unlawfully marketed products.”

Adverse Events

The FDA said that beefing up its authority over dietary supplements will help it be better aware of when new products are added to the market and identify illegal or potentially harmful supplements. The agency could also more quickly take enforcement action against makers of products containing illegal substances or promoting unverified health benefit claims.

Durbin’s office said the bill would boost the FDA’s ability to identify and respond to adverse events associated with certain products.

Durbin’s office said the the FDA estimates that widespread underreporting means the actual number of adverse events from dietary supplements is likely around 50,000, according to Durbin’s office.

“Today, FDA has few tools to spot and address dangerous supplement ingredients, and risky products are often found only after people have been harmed,” said Liz Richardson, director of the Pew Charitable Trusts’ health-care products project. “This bipartisan, pragmatic proposal would bring transparency and stronger safety oversight to the vast dietary supplement marketplace.”

Industry Divided

Dietary supplement trade groups are divided over required reporting on ingredients and other product information to the FDA.

Steve Mister, president and CEO of the Council for Responsible Nutrition, said in a statement that the Washington-based trade association and lobbying group “supports mandatory product listing for supplements.”

“Transparency is the best disinfectant, and a mandatory product listing will give FDA and consumers visibility into the dietary supplement marketplace,” he added.

The leader of the Natural Products Association—which represents more than 10,000 manufacturers and retailers of foods and dietary supplements—said in a March statement that the FDA’s budget request proposal was “a non-starter.”

“Mandatory product listing is pre-market approval disguised as transparency and would only add to the bureaucratic nightmare the industry is experiencing with NAC and CBD,” Daniel Fabricant, NPA’s president and CEO, said. The FDA has determined that NAC (N-acetyl cysteine), which contains antioxidants, and CBD don’t meet the agency’s dietary supplement definition.

To contact the reporter on this story: Celine Castronuovo at ccastronuovo@bloombergindustry.com

To contact the editor responsible for this story: Alexis Kramer at akramer@bloomberglaw.com