US Rule For Mandatory Supplement Registration Would Likely Give FDA Authority For Fines
ODSP Head Advises Stakeholders To Expect Congress To Open DSHEA
“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.”
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“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.”
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.
Already differing on supporting FDA suggestion for mandatory annual registration of each VMS product sold in US, consumer health industry stakeholders’ schism now extends to agency suggestion that Congress clarify its regulatory authority over supplement manufacturing and marketing.