FDA 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.

In this guidance, “Labeling of Infant Formula,” 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: Guidance for Industry: Labeling of Infant Formula.