Supplemental Information on Dietary Supplements: Federal Proposal Aims to Establish Mandatory Dietary Supplement Database
In an aim to increase transparency in the U.S. dietary supplement industry, Senators Dick Durbin (D-IL) and Mike Braun (R-IN) recently introduced the Dietary Supplement Listing Act of 2022—a bill that would require manufacturers, packers, and/or distributors of dietary supplements to submit key product information to FDA for inclusion in a public database.
Under the proposal, dietary supplement companies would have to provide the following information to FDA for each supplement they bring to market: the product’s brand name and statement of identity; company contact information; an electronic copy of the product label; an ingredient list; the number of servings per container; the conditions of use; warnings and precautions; allergen statements; the dosage form (e.g., pill, capsule, liquid, or powder); any health and/or structure/function claims made on the product; and the product’s unique dietary supplement identifier (a number to be generated by FDA and assigned to registered dietary supplement products). This information would be made available to the public via a searchable database administered by FDA.
Any company that fails to submit this product information could be subject to FDA enforcement for misbranding under the Federal Food, Drug and Cosmetic Act. The proposal would apply both to new supplements and those that are currently on the market.
The DSLA is currently a stand-alone bill, but its sponsors are seeking to add it to the annual FDA user fee package—a must-pass piece of legislation with a Sept. 30, 2022 deadline. As currently drafted, the bill would provide a grace period of at least 18 months before the onset of FDA enforcement.