US FDA’s NDI Notification Costs Estimate Doesn’t Add Up For Supplement Industry
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.
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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.
Stacy Cline Amin expects publication in “near future” of draft guidance on FDA’s NDI notification requirement, a document the agency says it expects to provide within a year. Amin, now with Morrison & Foerster as partner in Washington, also acknowledged FDA’s predicament with regulating products containing cannabinoids.
FDA again sets expected costs at level supplement industry repeatedly has said drastically underestimates spending on preparing and submitting NDI notifications. But FDA says developing scientific evidence to support a notification is separate from submitting the information to the agency.