NDI Or GRAS? Supplement Label But A Drug Claim? Answers Unclear For Some Regulatory Questions
“We try to interpret the language that is given to us and if Congress would make it more clear to us, we would absolutely carry that forward,” ODSP's Cara Welch says about whether FDA regulations require NID notifications or self-GRAS submissions for dietary ingredients yet to be used in supplements.
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Federal judge suggests consumer health and environmental advocacy groups made strong arguments about potential for unsafe ingredients in foods available in the US through the self-GRAS process, but FDA adopted and exercises the rule entirely in line with congressional intent of the authorizing legislation.
FDA’s pause in facility inspections could prompt draft legislation for mandatory supplement product registration. It told industry groups it’s working on language for legislation to give it a better handle on products in the market and facilities with problems, says CRN head Steve Mister.
Experts at a FDLI conference say Food Safety Modernization Act obligations should convince companies to move beyond self-affirming food ingredients as “generally recognized as safe” without notifying FDA. While the GRAS process generally is considered effective, it lacks transparency in some areas.