By Requiring Pre-Market Listing, US FDA Could ‘Just Say No’ To Some Dietary Supplements – NPA
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.
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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.
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.
“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.”