The Natural Products Association (NPA; Washington, DC) sent a letter to the Senate Committee on Health, Education, Labor and Pensions (HELP) requesting 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 to Committee Chair Patty Murray and Ranking Member Richard Burr, the manufacturer questions the logic of including a dietary supplement provision in the FDA user fee reauthorization and giving the FDA new regulatory authorities and new resources if the effective use of the resources currently available to it fails. .
“In the history of user fee reauthorization, dietary supplements have never been included, and rightly so. Dietary supplements are not prescription drugs, generic drugs, biosimilars, or medical devices. , which the reauthorization was always intended to cover. Also, our industry has never paid user fees,” wrote Manufacturer. “I can tell you that when I was the chief regulator of dietary supplements, when we had some of the most effective enforcement action in the history of the program, we had more than enough tools to find a specific problem with a product or ingredient, which is why the NPA objected to the Dietary Supplements List Act of 2022 and FDASLA provisions.
“The NPA strongly urges the committee to abandon this section and redirect authorized spending to higher priority challenges facing CFSAN. The FDASLA imposes an excessive administrative burden on the FDA that exceeds the FDA’s current scientific safety assessment when companies want to introduce a new supplement to the market. Giving the FDA the power to administratively decide what should be listed will only be abusive, causing extreme economic harm,” continues Manufacturer. “Additionally, as administrative disagreements arise (i.e. CBD, NAC, etc.) between industry and the FDA over the status of the ingredient rather than a scientific rendering, should this become law, it would remove a product from a list and market solely on their biases and do it administratively, without any due process.
The NPA letter can be read in full here.
Comments are closed.