Court Suggests Critics Ask Congress To Change FDA's GRAS Rule – Same For NDI Notifications?
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.
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FDA's evaluation of NDI notifications for cannabinoids currently is pointless, say industry stakeholders asking for a rule exempting hemp-derived cannabinoids from the agency’s prohibition against using in dietary supplements any ingredient studied or approved for use as a drug.
“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.
FDA estimate “simply perpetuates the agency’s previous misunderstanding of the burden that NDI notifications impose,” says CRN CEO Steve Mister. FDA says its estimate is for costs of submitting information, not for studies to generate the information.