Guidance for the Labeling of Infant Formula

The Labeling of Infant Formula guide for industry from the U.S. FDA helps infant formula manufacturers and distributors comply with certain labeling requirements. In this guidance, the FDA clarifies requirements pertaining to the following labeling elements: statements of identity, “exempt” infant formula, nutrient content claims, and health claims and qualified health claims. Additional infant formula labeling requirements include directions for preparation and use, pictograms, use-by dates, water statement and symbol, warning statements, and physician’s recommendation. It also includes general labeling requirements, such as intervening material, foreign language and religious symbols, statements intended for specific religious needs, and allergen statements.