A bill called the “Dietary Supplement Listing Act of 2022” was introduced Tuesday in the U.S. Senate.
Backed by Sens. Dick Durbin (D-Ill.) and Mike Braun (R-Ind.), S.4090 would require manufacturers of dietary supplements list their products with FDA.
Some of the required disclosures to FDA would include:
- the proprietary name of the product and a statement of identity;
- electronic copies of dietary supplement product labels; and
- a list of the ingredients in the dietary supplement required to appear on the label under federal regulations, including, for example, the amount per serving of each listed ingredient, conditions of use, warnings and precautions, and statements concerning major food allergens.
FDA, which has supported mandatory product listing in previous budget requests to Congress, has said the U.S. market contains as many as 80,000 dietary supplement products. Mandatory listing, an FDA spokesperson said Tuesday, “would allow the FDA to know when new products are introduced, quickly identify illegal products, improve transparency and promote risk-based regulation.”
The bill also imposes obligations on FDA, which would be directed to maintain an electronic database populated with product-specific information within two years of creating “a unique dietary supplement identifier system” for use by manufacturers. The public could search the database, based on the dietary supplement’s specific identifier or other information.
The bill would earmark $4 million for FY22 and $1 million in each of fiscal years 2023 through 2026 for FDA to maintain the database.
The listing requirements would not take effect immediately. Rather, within 18 months following the bill’s enactment into law, manufacturers selling products in interstate commerce would have 60 days to list information with FDA. After the 18-month period, manufacturers would need to submit information to FDA before introducing any new dietary supplement products into the U.S. market.
Manufacturers also would need to list reformulated products with FDA, based on the criteria specified in the bill, notify the agency within 90 days of discontinuing marketing of a dietary supplement product and keep certain records.
Failure to list a product with FDA, if required, would render the dietary supplement “misbranded” under federal law.
“Responsible dietary supplement manufacturers should welcome this because the people who are abusing the market and endangering consumers are giving them a bad name,” Durbin said Tuesday in a speech commenting on his bill.
He described his bill as a “common-sense, bipartisan compromise that will protect consumers’ health and save lives.”
“As long as that dietary supplement is not dangerous to you or to Americans, as long as we know that it’s for sale, who made it, what’s in it, I think that basic information is what the government should gather,” Durbin said. “The vast majority of these supplements will not harm people, and the dietary supplement manufacturers know that, and that’s why they’re supporting our effort.”
As expected, industry trade associations had mixed reactions to the Dietary Supplement Listing Act of 2022.
Steve Mister, president and CEO of the Council for Responsible Nutrition (CRN), expressed his support for the bill in an April 26 letter to Durbin and Braun.
“This legislation will provide FDA and consumers a more complete understanding of the marketplace and the range of products and ingredients currently marketed as dietary supplements,” Mister wrote. “In addition, this new registry should assist FDA in taking enforcement actions against irresponsible companies marketing products as dietary supplements inappropriately.”
On the other hand, the American Herbal Products Association (AHPA) criticized the bill. Neither FDA nor others who support mandatory product listing “have clearly articulated the need for this premarket product listing requirement,” AHPA President Michael McGuffin said in a statement. “In addition, the legislation introduced by Senators Durbin and Braun would create unnecessary, significant and redundant burdens on industry.”