Controversial Durbin-Braun Proposal for Dietary Supplements Makes Its Way into PDUFA

Controversial Durbin-Braun Proposal for Dietary Supplements Makes Its Way into PDUFA

WASHINGTON – Today, the United States Senate Health, Education, Labor, and Pensions Committee (HELP) released a discussion draft of its legislation to reauthorize FDA user fees for drugs, biologics, and medical devices package, which includes the controversial and divisive Durbin-Braun premarket approval concept and more that would be damaging to the industry.

“The NPA is significantly concerned with Chair Murray and Republican Leader Burr who failed to reject the radical and dangerous legislation from Senators Durbin and Braun that would require premarket approval for dietary supplements and weaken key privacy protections of the Bioterrorism Act, which protects the dietary supplement supply chain,” said Daniel Fabricant, Ph.D. president and CEO of the Natural Products Association.

“Last time I checked, dietary supplements are not drugs, biologics, or medical devices, so why is Congress or anyone supporting nongermane legislation that will only add costs to consumers who are doing all they can to stay healthy is extremely troubling. Groups who have supported this legislation, have stated there are protections for technical disagreements with the FDA like those with hemp, CBD, NAC, and several other products. However if this legislation were to pass, it is abundantly clear these products would be eliminated from the market.

“The war is far from over. We need America’s health and wellness advocates to continue writing their members of Congress through the NPA Action Center, here. Grassroots involvement over the coming weeks is absolutely critical to defeating this radical and dangerous proposal.