US FDA Allows Supplement Firms More Time To Submit NDI Notifications, And For It To Respond
More time for notifications than current deadline of at least 75 days before NDI-containing product is offered for sale in US doesn’t solve problems with FDA’s management of NDI regulation, say trade groups.
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FDA regulatory framework for VMS product manufacturing and marketing provides little pre-market transparency into what’s available in US, but it’s clear from post-market monitoring by the Office of Dietary Supplement Programs that compliance with the NDI notification requirement is lax.
Under Senate legislation proposing mandatory listing with FDA for all supplements sold in US, a product labeled in compliance with all other agency regulations would be deemed misbranded if not registered for proposed list.
Mandatory product listings would help FDA eliminate gap of missing NDI notifications it expects haven't been filed and other information about ingredients but not establish pre-market approval tool.