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  1. CFSAN Constituent Updates

FDA Issues Guidance for the Labeling of Infant Formula

Constituent Update

September 16, 2016

The U.S. Food and Drug Administration has issued guidance for industry to help infant formula manufacturers and distributors comply with certain labeling requirements for infant formula products, including requirements relating to the appropriate statement of identity and to certain claims made on the labeling of infant formula products.

Infant formulas are intended for a vulnerable population and may serve as a sole or primary source of nutrition for some infants during a critical period of growth and development. Caregivers of babies fed infant formula products must be able to trust that the information on the label is truthful, not misleading, and scientifically supported.

In this guidance, “Labeling of Infant Formula,” the FDA clarifies requirements pertaining to the following infant formula labeling elements:

  • Statements of identity;
  • “Exempt” infant formula;
  • Nutrient content claims;
  • Health claims and qualified health claims;
  • Additional infant formula labeling requirements, including directions for preparation and use, pictograms, use-by dates, water statement and symbol, warning statements, and physician’s recommendation; and
  • General labeling requirements, including intervening material, foreign language and religious symbols, statements intended for specific religious needs, and allergen statements. 

For more information:

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