21 CFR Part 107: Infant Formula
Part 107 of title 21 runs to 16 sections across 5 subparts, and sits in subchapter B, Food for Human Consumption. Every section is reproduced in full and is current to 2026-09-10.

- Sections
- 16
- Subparts
- 5
- Words of regulation
- 4,946
- Current to
- 2026-09-10
Subpart A: General Provisions
Subpart B: Labeling
Subpart C: Exempt Infant Formulas
Subpart D: Nutrient Requirements
Subpart E: Infant Formula Recalls
- 107.200 Food and Drug Administration-required recall1
- 107.210 Firm-initiated product removals2
- 107.220 Scope and effect of infant formula recalls7
- 107.230 Elements of an infant formula recall6
- 107.240 Notification requirements8
- 107.250 Termination of an infant formula recall3
- 107.260 Revision of an infant formula recall4
- 107.270 Compliance with this subpart1
- 107.280 Records retention1
Read 21 CFR part 107 at the eCFR · All of 21 CFR for food safety
Questions
- What does 21 CFR part 107 cover?
- 21 CFR part 107 is Infant Formula. It runs to 16 sections across 5 subparts and sits in subchapter B of chapter I, Food for Human Consumption.
Every section of part 107 is a clause somebody has to produce evidence for at their next audit. Krolda maps supplier documents to the clause they satisfy in FSSC 22000, IFS Food and 21 CFR 117, and routes the corrective action when the evidence is missing.
Early accessRecall records come from the openFDA food enforcement API, published by the U.S. Food and Drug Administration in the public domain. Krolda adds the hazard classification and the clause mapping; neither is an FDA determination. Always check the FDA notice before acting on a recall.