Description
The Food and Drug Administration (“FDA” or “we”) is publishing this reminder to infant formula manufacturers and distributors (“you”) about certain labeling requirements for infant formula products. While this guidance provides information about the labeling requirements for infant formula products generally, we are concerned particularly about the number of infant formula products that bear the same or similar statements of identity but are different in composition or intended use. We have also noticed an increased use of nutrient content claims that render products misbranded under the Federal Food, Drug, and Cosmetic Act (FD&C Act). This guidance provides information that can help you understand and comply with relevant labeling requirements.
Scope & Applicability
Product Classes
2The primary product category covered by the guidance; Essential food product that is the sole source of nutrition for many infants.
Infant formulas for infants with inborn errors of metabolism or low birth weight
Stakeholders
1Entity responsible for submitting NDINs
Regulatory Context
Attributes
2must accurately identify or describe the basic nature of the food
Required date on label indicating product quality and nutrient quantity
Identified Hazards
Hazards
1Specific foods or ingredients containing protein derived from them that elicit allergic reactions.
Related CFR Sections (9)
- 21CFR101.3§ 101.3 Identity labeling of food in packaged form.
(a) The principal display panel of a food in package form shall bear as one of its principal features a statement of the identity of the commodity.Read full regulation →
- 21CFR101.1§ 101.1 Principal display panel of package form food.
The term principal display panel as it applies to food in package form and as used in this part, means the part of a label that is most likely to be displayed, presented, shown, or examined under customary conditions of display for retail sale. The principal display panel shall be large enough to acRead full regulation →
- 21CFR102.5§ 102.5 General principles.
(a) The common or usual name of a food, which may be a coined term, shall accurately identify or describe, in as simple and direct terms as possible, the basic nature of the food or its characterizing properties or ingredients. The name shall be uniform among all identical or similar products and maRead full regulation →
- 21CFR107.10§ 107.10 Nutrient information.
(a) The labeling of infant formulas, as defined in section 201(z) of the Federal Food, Drug, and Cosmetic Act, shall bear in the order given, in the units specified, and in tabular format, the following information regarding the product as prepared in accordance with label directions for infant consRead full regulation →
- 21CFR107.100§ 107.100 Nutrient specifications.
(a) An infant formula shall contain the following nutrients at a level not less than the minimum level specified and not more than the maximum level specified for each 100 kilocalories of the infant formula in the form prepared for consumption as directed on the container: [TABLE] Nutrients | Unit oRead full regulation →
- 21CFR107.3§ 107.3 Definitions.
The following definitions shall apply, in addition to the definitions contained in section 201 of the Federal Food, Drug, and Cosmetic Act (the act):Read full regulation →
- 21CFR107.50§ 107.50 Terms and conditions.
(a) Terms and conditions. Section 412(f)(1) of the act exempts from the requirements of section 412(a), (b), and (c)(1)(A) of the act infant formulas that are represented and labeled for use by an infant who has an inborn error of metabolism or low birth weight or who otherwise has an unusual medicaRead full regulation →
- 21CFR107.20§ 107.20 Directions for use.
In addition to the applicable labeling requirements in parts 101 and 105 of this chapter , the product label shall bear:Read full regulation →
- 21CFR101.15§ 101.15 Food; prominence of required statements.
(a) A word, statement, or other information required by or under authority of the act to appear on the label may lack that prominence and conspicuousness required by section 403(f) of the act by reason (among other reasons) of:Read full regulation →
Related Warning Letters (4)
- 2025-09-30
CGMP/Dietary Supplement/Adulterated/Misbranded
Time Challenger Labs International, Inc.
- 2022-09-13
Seafood HACCP/CGMP for Foods/Adulterated/Insanitary Conditions
CR Grupo Comercial Alvacora S.A.
- 2022-07-19
Unapproved and Misbranded Products Related to Coronavirus Disease 2019 (COVID-19)
H2 Beverages, Inc.
- 2021-07-28
Unapproved New Drugs/Misbranded
Nutrishus Brands, Inc.
See Also (8)
- Guidance for Industry: Food Labeling Guide (Status: Final)
- CPG Sec 540.700 Labeling of Processed and Blended Seafood Products Made Primarily with Fish Protein (Status: Final)
- Guidance for Industry: Questions and Answers on FDA’s Fortification Policy (Status: Final)
- Guidance for Industry: Proper Labeling of Honey and Honey Products (Status: Final)
- Draft Guidance for Industry: Voluntary Labeling Indicating Whether Food Has or Has Not Been Derived From Genetically Engineered Atlantic Salmon (Status: Draft)
- Guidance for Industry: Voluntary Labeling Indicating Whether Foods Have or Have Not Been Derived from Genetically Engineered Plants (Status: Final)
- CPG Sec 540.750 - Use of The Seafood List to Determine Acceptable Seafood Names (Status: Final)
- Guidance for Industry: Frequently Asked Questions About Medical Foods - Third Edition (Status: Final)