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Infant formula guidance

This article was originally published in The Tan Sheet

Executive Summary

A "major change" in an infant formula includes "a change in either the formulation or processing of an infant formula that could result in a possible significant adverse impact on levels of nutrients or availability of nutrients," such as a new manufacturing plant, addition of new ingredients or employment of a new technology, according to an FDA guidance for industry issued March 1. "Frequently Asked Questions about FDA's Regulation of Infant Formula" is intended to "centralize" all available information on the topic, which was previously dispersed throughout the CFSAN website, FDA says. Other questions addressed in the document include what substances may be used in formula, the steps manufacturers must take before marketing a new product and how the Bioterrorism Act of 2002 affects regulation...
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