AHPA reports that the figure is an early estimate that reflects only the costs of product data entry for initial compliance. AHPA is continuing to gather data from members of industry to refine this projection, and suggests that the figure could rise, as the estimate does not include associated training costs or other year-over-year costs for continuing compliance.
“We are conducting this study because the fundamental question of cost has been missing from the mandatory product listing conversation to date,” said Robert Marriott, Director of Regulatory Affairs, in a press release. “This information is essential for all stakeholders to weigh the supposed benefits of MPL against its costs to industry.”
Related: Dietary Supplement Listing Act of 2022 Introduced; Industry DividedAsWholeFoodshaspreviously reported, the industry is divided in its position on the Dietary Supplement Listing Act. AHPA has expressed its opposition, noting that, to date, "neither the FDA nor other advocates for MPL have clearly articulated the need for this premarket product listing requirement. In addition, the legislation introduced by Senators Durbin and Braun would create unnecessary, significant, and redundant burdens on industry. AHPA added its position that the current federal regulatory framework for dietary supplements supports the industry and consumers and provides FDA with all of the authority needed to properly regulate dietary supplements, rendering MPL requirement unnecessary."
TheNatural Products Association(NPA) is also opposed. “NPA is deeply concerned with the Dietary Supplement Listing Act of 2022, which would establish premarket approval for dietary supplements. The FDA has several tools at its disposal, including mandatory facility registration, with associated penalties for failure to comply,” said Dr. Daniel Fabricant, NPA President, and CEO. “The FDA already has access to information regarding who is making dietary supplements, what products are made at which facilities, when new ingredients are introduced into commerce, and whether any products are associated with serious adverse events. The Durbin-Braun approach will hurt consumers and needlessly damage the industry. It mirrors over-the-counter premarket drug regulations and is more stringent than current regulations, including the NDI provision, a notification rather than a pre-market approval. The Dietary Supplement Listing Act is entirely at odds with the current regime, which has delivered world-class consumer safety and broad access to important nutritional supplements for over a generation.”
In support of the legislation: The Council for Responsible Nutrition (CRN). “Transparency is the best disinfectant, and a mandatory product listing will give FDA and consumers visibility into the dietary supplement marketplace,” said Steve Mister, President & CEO Council for Responsible Nutrition, in apress releasefrom the Office of the U.S. Senate. “CRN member companies produce a large portion of the dietary supplements marketed in the United States, so we know responsible industry supports mandatory product listing for supplements. We appreciate the opportunity to work with Sens. Durbin and Braun on this critical legislation.”
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