FDA Draft Substantiation for StructureFunction Claims Made in Infant Formula Labels and Labeling

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Draft Substantiation for StructureFunction Claims Made in Infant Formula Labels and Labeling[附网盘链接]是于不久之前发布的FDA标准，适用于美国。

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标准文档类型为Draft Substantiation for StructureFunction Claims Made in Infant Formula Labels and Labeling[附网盘链接]高清PDF版本（文字版），标准文档内可进行搜索，可以复制原文，可粘贴。

标准部分原文

Draft-Not for Implementation Substantiation for Structure/Function Claims Made in Infant Formula Labels and Labeling 1

Guidance for Industry This draft guidance, when finalized, will represent the current thinking of the Food and Drug Administration (FDA or we) on this topic. It does not establish any rights for any person and is not binding on FDA or the public. You can use an alternative approach if it satisfies the requirements of the applicable statutes and regulations. To discuss an alternative approach, contact the FDA staff responsible for this guidance as listed on the title page. I. Introduction This guidance document describes the type and quality of evidence that the Food and Drug Administration (FDA or we) recommends infant formula manufacturers and distributors have to substantiate claims about effects on the structure or function of the body (“structure/function 2

claims”) made on the label and in other labeling of nonexempt and exempt infant formulas. The purpose of this guidance document is to help infant formula manufacturers and distributors making structure/function claims to comply with the statutory requirement that all claims in food labeling must be truthful and not misleading under section 403(a)(1) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 343(a)(1)). FDA regulates infant formula under the FD&C Act. Section 201(z) of the FD&C Act (21 U.S.C. 321(z)) defines “infant formula” as “a food which purports to be or is represented for special dietary use solely as a food for infants by reason of its simulation of human milk or its suitability as a complete or partial substitute for human milk.” FDA regulations in Title 21 of the Code of Federal Regulations (21 CFR) define the term “infant” as “a person not more than 12 months old” (21 CFR 106.3). Although human milk is the recommended source of nutrition for infants (Ref. 1), infant formula nonetheless provides the sole source of nutrition for many infants during a vulnerable period of life when diet plays a critical role in affecting long-term growth and development. 1

This guidance has been prepared by the Office of Nutrition and Food Labeling in the Center for Food Safety and Applied Nutrition at the U.S. Food and Drug Administration. 2

Nonexempt infant formulas are represented and labeled for use by healthy, full-term infants. Such formulas are subject to the requirements set forth in section 412(a), (b), and (c) of the FD&C Act (21 U.S.C. 350a(a), (b), and (c)). Exempt infant formulas are represented and labeled for use by infants who have an inborn error of metabolism or low birth weight or who otherwise have an unusual medical or dietary problem. Under section 412(h) of the FD&C Act (21 U.S.C. 350a(h)), these infant formulas are exempt from the requirements of section 412(a), (b), and (c) of the FD&C Act; exempt infant formulas are, however, subject to the requirements of 21 CFR part 107, subpart C, Exempt Infant Formulas. 3

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