FDA Guidance on Infant Formula Labeling

  • By: Staff Editor
  • Date: February 08, 2017
  • Source:
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FDA Guidance on Infant Formula Labeling

The US FDA oversees manufacturers and distributors of infant formulas and helps ensure that these products are safe for infants who consume them. In line with this mission, FDA has released its final guidance on labeling requirements for infant formula products.

The guidance aids manufacturers and distributors of infant formula products to comply with labeling requirements including requirements related to the statements of identity, exempt infant formula and nutrient content claims.

Related Training:

Food Allergen Labeling - Complying with FALCPA and FSMA

Overview of Labeling Requirements

The regulatory document further clarifies the requirements pertaining to the following labeling elements:

  • Health claims and qualified health claims
  • Directions for preparation and use
  • Pictogram presenting the major steps for formulating the infant formula
  • Use by date indicating the month and year
  • Water statement and symbol
  • Warning statement
  • Physician’s recommendation

The document also includes general labeling requirements such as intervening material, statements intended for specific religious needs, foreign language and religious symbols, allergen statements, and much more.

Click here to download the file
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