FDASLA would establish a mandatory product listing requirement for dietary supplements.
The Natural Products Association (NPA; Washington, D.C.) has sent a letter to the Senate Committee on Health, Education, Labor, and Pension (HELP) urging the removal of the dietary supplement provision from the FDA Safety and Landmark Advancement Act (FDASLA). FDASLA would establish a mandatory product listing requirement for dietary supplements.
In the letter addressed to Committee Chair Patty Murray, and Ranking Member Richard Burr, Fabricant questions the logic of including a dietary supplement provision in FDA user fee reauthorization and giving FDA new regulatory authorities and resources upon failing to effectively utilize the resources currently at its disposal.
“In the history of the user-fee reauthorization, dietary supplements have never been included, and rightfully so. Dietary supplements are not prescription drugs, generic drugs, biosimilars, or medical devices, which the reauthorization has always been intended to cover. Additionally, our industry has never paid user fees,” wrote Fabricant. “I can tell you during my time as the chief regulator for dietary supplements, when we had some of the most impactful enforcement actions in the program’s history, we had more than adequate tools to find a specific problem with a product or ingredient; this is why NPA has opposed the Dietary Supplement Listing Act of 2022 and the provisions in the FDASLA.”
“The NPA strongly urges the committee to drop this section and re-direct the authorized spending to higher priority challenges faced by CFSAN. The FDASLA provides the FDA with an excessive administrative burden that exceeds the current scientific safety evaluation for FDA when companies wish to introduce a new supplement into the market. Providing the FDA with authority to decide administratively what is to be listed will only be abused, causing extreme economic harm,” Fabricant continues. “Additionally, as administrative disagreements do arise (i.e. CBD, NAC etc.) between the industry and the FDA on the ingredient’s status rather than a scientific rendering, should this become law, it will eliminate a product from a listing and the marketplace purely on their biases and do so administratively, without any due process.”
NPA’s letter can be read in full here.