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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The Dietary Supplement Market US FDA Is Regulating Isn’t Your 1994 DSHEA Version
“In the last 30 years, we've seen this sort of explosion, and it's not just more products and more sales. We're talking about more complex products,” says Cara Welch, FDA Office of Dietary Supplement Programs director. “Today's products are not the products from 1994.”
US Dietary Supplement Industry In 2023: Little New Expected In NDI Notification Enforcement
Chief executives of OTC drug and supplement industry trade groups discussed potential market and regulatory developments affecting their members’ businesses. HBW Insight concludes series here reporting on supplement sector’s outlook for FDA potentially resolving its protracted struggle with NDI notification requirement.
FDA Expects Closing Gap On NDI Notifications To Open Window Wider On Supplements Sold In US
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.