SafeGuardS baby with milk bottle

On September 16, 2016 the US Food and Drug Administration (US FDA) issued guidance [1] to industry concerning the labeling of infant formula in order to provide to the manufacturers of these items the tools to comply with the requirements, especially those that concern the appropriate statement of identity and those related to claims made on these labels.

What Information Does This Guidance Contain?

  • Statements of Identity

  • “Exempt” infant formula

  • Nutrient content claims

  • Health claims and qualified health claims

  • Additional requirements for infant formula labeling:

    • Direction for preparation and use

    • Pictograms

    • Use-by dates

    • Water statement and symbol

    • Warning statement

    • Physician recommendations

  • General labeling requirements:

    • Intervening material

    • Foreign language and religious symbols

    • Statements intended for specific religious needs

    • Allergen warnings

Statement of Identity

The general labeling requirements, as noted in 21 Code of Federal Regulations (CFR) 103, indicates that the common and usual name of the product (infant formula), with any specific forms (powder, liquid concentrate, etc.), must be placed on the principal display panel, in bold type, in lines generally parallel to the base and related in size to the largest type on the principal display panel (PDP), which is usually the brand name.  

21 CFR 102.5 requires the common and usual name of non-standardized food to include its characterizing properties or ingredients (milk-based, soy-based).

21 CFR 107.10, the requirements for certain nutrient information to be included on infant formulas, requires that when the regulatory level of iron is added the label lists “Infant Formula with Iron”, or when iron is not added at the regulatory required amount “Additional Iron May be Necessary”. While these statements are required to be on the PDP, they are not legally required to be part of the statement of identity, but the US FDA does require these statements to be as close as possible to the statement of identity.

Nutrient Content Claims, Health Claims and Qualified Health Claims

The following nutrient content claims are allowed for products used for infants

  • A statement that describes the percentages of a vitamin or mineral in the formula, in relationship to a reference daily intake defined in 21 CFR 101.9, unless this claim is prohibited by law or regulation

  • A factual statement that a food is unsweetened or contains no added sweeteners

  • Certain sugar content claims, such as sugar free or no sugar added, on dietary supplements

  • A factual statement that a food is unsalted, if such statement refers to the taste of the food and is not false and misleading

  • US FDA does permit the qualified health claim regarding the consumption between 100% Whey-Protein partially Hydrolyzed infant formula and the reduced risk of atopic dermatitis, providing that the product and label meet the requirements set forth by the US FDA for this claim. [2]

What Does This Mean For The Food Industry?

The US FDA is providing this tool in order to help the industry assure that their products are labeled in accordance with the law, so as to assure consumers that the products they are purchasing are truthful and not misleading.

SGS is committed to keeping you informed of regulatory news and developments. Leveraging our global network of laboratories and food experts, SGS provides a comprehensive range of food safety and quality solutions, including analytical testing, audits, certifications, inspections and technical support. We continually invest in our world class testing capabilities and state-of-the-art technology to help you reduce risks, and improve food safety and quality. For further information please visit our website.

For enquiries, please contact:

James Cook
Food Scientific and Regulatory Affairs Manager

t: +01 973 461 1493

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