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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The Congressional Research Service published a dietary supplements report on 20 September that provides an overview of the industry and current regulatory issues, including ‘limitations’ in the US FDA’s authority over supplements and, in particular, the absence of mandatory product listing.
"We haven't utilized the ingredient advisory list quite as much as I'd like to see. But it's something we'll be working on this year,” says Cara Welch, acting director of FDA’s Office of Dietary Supplement Programs.
Why stakeholders have many questions and why so many ingredients that weren’t cleared by FDA are rampant in the US are questions at the heart of resolving disagreement between the industry and the agency over regulation both sides acknowledge is biggest impediment to market growth.