On September 8, 2016, FDA issued draft guidance "Substantiation for Structure/Function Claims in Infant Formula Labels and Labeling." The guidance describes the type and quality of evidence that is appropriate to substantiate claims about effects on the structure or function of the body (i.e., supports digestion) made on the label and in other labeling of nonexempt and exempt infant formulas, which are defined as "a food which purports to be or is represented for special dietary use solely as a food for infants [a person not more than 12 months old] by reason of its simulation of human milk or its suitability as a complete or partial substitute for human milk." FDA does not preapprove structure/function claims in the labeling of infant formulas. However, FDA stated these claims need to be substantiated by "competent and reliable scientific evidence" as "this vulnerable population is entirely dependent upon caregivers who must be able to trust that the information on the label is truthful and scientifically supported."
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