The Food and Drug Administration published the Guidance for Industry: Labeling of Infant Formula. This guidance does not provide an exhaustive list of all regulations covering the labeling of infant formula. FDA’s guidance documents, including this guidance, do not establish legally enforceable responsibilities. Instead, guidances describe FDA’s current thinking on a topic and should be viewed only as recommendations, unless specific regulatory or statutory requirements are cited. The use of the word should in FDA guidances means that something is suggested or recommended, but not required.
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