Sen. Durbin Will Introduce US Mandatory Supplement Registration Bill
Sen. Durbin has been a critic of FDA’s regulation of VMS product market regulation, putting him at odds with industry stakeholders. But “Dietary Supplement Listing Act” he and Sen. Braun will introduce later in week has support of CHPA and CRN.
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Some stakeholders have supported mandatory listing but they join opponents questioning legislation also authorizing FDA to prohibit sales of products compliant with manufacturing and labeling regulations but deficient, incomplete or late with registration information required for the agency.
Proposal “seems driven by a desire to allow FDA to ‘bar the door’ from listing anything that they wish to keep out that doesn’t meet their convenience,” NPA CEO Daniel Fabricant tells Senate HELP Committee.
HELP Committee Chairwoman Patty Murray, and ranking member Richard Burr also include supplement registration requirement in discussion draft for reauthorizing FDA’s user fee programs for prescription, generic and biosimilar drugs and medical devices.