Description
This guidance document describes the type and quality of evidence that the Food and Drug Administration (FDA or we) recommends infant formula manufacturers and distributors have to substantiate claims about effects on the structure or function of the body (“structure/function claims”) made on the label and in other labeling of nonexempt and exempt infant formulas.
Scope & Applicability
Product Classes
3The 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
Products containing dietary ingredients intended to supplement the diet; The final product category for which the NDI is intended.
Stakeholders
5Entity responsible for submitting NDINs
Entities involved in the supply chain of APIs.
entities responsible for reviewing evidence and substantiating claims
Entity responsible for submitting NDINs
Responsible for reviewing case report forms
Regulatory Context
Attributes
2adequate statistical power and accounting for planned analyses
the substantiation standard required for structure/function claims
Related CFR Sections (4)
- 21CFR10.115§ 10.115 Good guidance practices.
(a) What are good guidance practices? Good guidance practices (GGP's) are FDA's policies and procedures for developing, issuing, and using guidance documents.Read full regulation →
- 21CFR106.3§ 106.3 Definitions.
The definitions in this section and the definitions contained in section 201 of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 321 ) shall apply to infant formula requirements in 21 CFR parts 106 and 107 of this chapter.Read full regulation →
- 21CFR101.14§ 101.14 Health claims: general requirements.
(a) Definitions. For purposes of this section, the following definitions apply:Read full regulation →
- 21CFR101.13§ 101.13 Nutrient content claims—general principles.
(a) This section and the regulations in subpart D of this part apply to foods that are intended for human consumption and that are offered for sale, including conventional foods and dietary supplements.Read full regulation →
Related Warning Letters (10)
- 2025-09-09
Clinical Investigator
Shirish M. Gadgeel, M.D.
- 2025-07-15
Clinical Investigator
Mark J. Savant, M.D
- 2025-06-03
Low Acid Canned Food Regulation/Adulterated
United King Foods Private Limited
- 2025-05-21
Low Acid Canned Food Regulation/Adulterated
Baldwin Richardson Foods Pennsauken, LLC
- 2025-05-20
Low Acid Canned Food Regulation/Adulterated
Chongqing Tianrun Food Development Co., Ltd
- 2025-05-20
Bioresearch Monitoring Program/Institutional Review Board (IRB)
United Health Products, Inc.
- 2025-03-25
Clinical Investigator
Americo F. Padilla, M.D.
- 2024-11-26
Low Acid Canned Food Regulation/Adulterated
Advance Nature Sdn Bhd
- 2024-11-12
Seafood HACCP/CGMP for Foods/Adulterated/Insanitary Conditions
Rongcheng Jiayuan Food Co., Ltd
- 2024-11-05
Institutional Review Board (IRB)
Armstrong County Memorial Hospital
See Also (8)
- Draft Guidance for Industry: New Dietary Ingredient Notification Master Files for Dietary Supplements (Status: Draft)
- Questions and Answers Regarding Mandatory Cosmetics Recalls: Guidance for Industry : Draft Guidance for Industry (Status: Draft)
- CPG Sec. 460.300 Return of Unused Prescription Drugs to Pharmacy Stock (Status: Final)
- CPG Sec. 444.100 Recovery of Investigational New Drugs from Clinical Investigators (Status: Final)
- CPG Sec. 400.900 Class I Recalls of Prescription Drugs (Status: Final)
- CPG Sec. 454.100 OTC Ear Drop Preparations (Status: Final)
- CPG Sec. 430.300 Labeling Shipping Containers of Drugs (Status: Final)
- CPG Sec. 455.100 Inert Glandular Preparations *(OTC)*, Inadequate Full Disclosure and Claims (Status: Final)