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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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.
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.
“We would certainly want to have some enforcement and be able to utilize that enforcement,” says ODSP acting director Cara Welch. Stakeholders opposed to the change should “get comfortable with the idea of opening up DSHEA and should most certainly be part of the discussion.”