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FDA Drafts Guidance Concerning Infant Formula Labels and Labeling

October 13, 2016

The US Food and Drug Administration (FDA) has drafted a guidance concerning the type and quality of scientific evidence for the structure/function claims made in infant formula labels and labeling.

The guidance aims to describe the type and quality of evidence that the FDA is recommending on infant formula manufacturers and distributors to have substantiate claims about effects on the structure or function of the body (“structure/function claims”) made on the label and in other labeling of nonexempt and exempt infant formulas.

The guidance is open for consultation until November 8, 2016.

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