FDA Issues Guidance for the Labeling of Infant Formula
Monday, September 19, 2016

On the heels of recently released draft guidance concerning substantiation for infant formula structure/function claims, FDA has issued guidance regarding the labeling of infant formula.

  • Infant formula is clearly receiving attention at FDA in 2016.  Just earlier this month, as covered on this blog, FDA released draft guidance concerning appropriate substantiation for structure/function claims made in infant formula labeling.  Earlier this year, FDA issued guidance on production of exempt infant formula.

  • On September 16, 2016, FDA issued guidance entitled, Labeling of Infant Formula.  This guidance, which represents the current Agency thinking on this topic, 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.

  • In issuing this guidance document, FDA noted its concerns regarding the number of infant formula products that bear the same or similar statements of identity but are different in composition or intended use.  The Agency also noted that it has observed an increased use of nutrient content claims that render products misbranded under the Federal Food, Drug, and Cosmetic Act.

  • The issuance of this latest guidance could result in additional scrutiny of infant formula labels.  As such, infant formula manufacturers should be certain to ensure that their products’ are appropriately labeled, and well-positioned to defend them against any potential challenges.


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