AHPA Sees Pre-Market Approval Behind Legislation Titled ‘Mandatory Listing’ For Supplements In US
“FDA has all the authority it needs to enforce” regulations on supplement manufacturing, marketing and labeling, says AHPA president Michael McGuffin. “We're concerned that this will be a new pre-market registration requirement.”
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Mandatory product listings would help FDA eliminate gap of missing NDI notifications it expects haven't been filed and other information about ingredients but not establish pre-market approval tool.
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.