4. Labeling Requirements

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Infant Formula
USA

This section provides information on labeling requirements and the label approval process.

4.1 Mandatory Labeling Parameters

The document "Labeling of Infant Formula Guidance" provides instructions to develop a compliant label, including principal display panels, claims, nutrient content tables, use of Kosher symbols, etc. Part 107 of the Code of Federal Regulations also outlines requirements for label requirements unique to infant formula.

Mandatory labeling requirements:

Statement of identity on the principal display panel
§101.2 Information panel of package form food.
§101.4 Food; designation of ingredients.
§101.5 Food; name and place of business of manufacturer, packer, or distributor.
Religious Symbols/ Statements
Allergen Statement
Directions for Preparation and Use
Pictogram
Use By Date
Water Statement and Symbols
Warning Statement
Physician's Recommendation
Nutrient Information

[1,2]

4.2 Languages

American English plus infographic requirements are used for product labeling. In regions of the US, such as Puerto Rico where Spanish is the predominant language, Spanish is also required. [2]

4.3 Mandatory Information on Stickers

A sticker is acceptable if the final label is correct and complies with all regulations at the time of retail sale. The stickers should not cover other mandatory labeling and should adhere tightly to the packaging. [2]

4.4 Product Legal Name

Infant Formula

Where a food is marketed in various optional forms (wholes, sliced ....), the particular form shall be considered to be a necessary part of the statement of identity and shall be declared in letters of a type size bearing a reasonable relation to the size of the letters forming the other components of the statement of identity. In the case of infant formula it is usually on the form of powder, liquid concentrated or liquid ready-to drink.

4.5 Product-specific Labeling Statements

The Code of Federal Regulations, Part 107 Sub-part B Labeling, outlines special labeling requirements specific to infant formula. [1]

Please refer to the mandatory labeling requirements in section 4.1 above.

4.6 Authority Approval

Label review would be required only for new products as part of the notification requirements. Under section 412 of the FFDCA (21 USC 350a), a manufacturer who intends to market a new infant formula in the United States must register with, must notify, and must submit written verification to the FDA (the authority providing approval). Such registration, notification, and verification are to be sent to ONPLDS. [3,4,5]

Estimated cost and duration for the product label approval process:

No separate product label approval is required. Labels would be reviewed as part of the registration process.

The US FDA does not charge a fee for the registration process for new infant formula, including label review. The process is not really an "approval" process, but rather one of "no objection'. Brand owners who are confident that their products fully meet US requirements can simply register and then notify the FDA 90 days in advance of introducing the new formula into US commerce.

While not required, the US FDA strongly encourages infant formula manufacturers to contact ONPLDS with questions about their infant formula, including questions on whether a substance has previously been used in infant formula in the United States prior to registration, notification, and verification. In the aftermath of the infant formula shortage of 2022, delays can be expected for this kind of advisory meeting. Unless consultants are hired, there would be no costs associated with the meeting other than the usual travel costs for the company. The reason why the FDA encourages a voluntary pre-market advisory meeting is to ensure all requirements are met as failing to do so could result in the risk that if the US FDA determines the product does not meet requirements it could be deemed adulterated and subject to recall. [3,5]

4.7 Additional Notes on Labeling

The Center for Food Safety and Applied Nutrition is responsible for regulation of infant formula. The Office of Nutritional Products, Labeling, and Dietary Supplements (ONPLDS) has program responsibility for infant formula. The Office of Food Additive Safety (OFAS) has program responsibility for food ingredients and packaging.

ONPLDS evaluates whether the infant formula manufacturer has met the requirements under section 412 of the FFDCA. ONPLDS consults with OFAS regarding the safety of ingredients in infant formula and of packaging materials for infant formula. Under sections 201(s) and 409 of the FFDCA, OFAS evaluates the safety of substances intended for use in or in contact with infant formula. [5]