# 21 CFR § 107.1: Status and applicability of the regulations in part 107

> Federal · Regulations · In force

URL: https://www.frixlaw.com/law-library/statutes/ecfr-21-107.1

## Section

- **Citation:** 21 CFR § 107.1
- **Heading:** Status and applicability of the regulations in part 107
- **Jurisdiction:** Federal
- **Kind:** Regulations
- **Status:** In force
- **Text as of:** September 22, 2026
- **Source:** Publisher's official text
- **Location:** Title 21—Food and Drugs > CHAPTER I—FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES > SUBCHAPTER B—FOOD FOR HUMAN CONSUMPTION > PART 107—INFANT FORMULA > Subpart A—General Provisions

## Text

(a) The criteria in subpart B of this part describe the labeling requirements applicable to infant formula under section 403 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C 343). Failure to comply with any regulation in subpart B of this part will render an infant formula misbranded under section 403 of the Federal Food, Drug, and Cosmetic Act.
(b) The criteria in subpart C of this part describe the terms and conditions for the exemption of an infant formula from the requirements of section 412(a), (b), and (c) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 350a(a), (b), and (c)). Failure to comply with any regulations in subpart C of this part will result in withdrawal of the exemption given under section 412(h)(1) of the Federal Food, Drug, and Cosmetic Act.
(c) Subpart D of this part contains the nutrient requirements for infant formula under section 412(i) of the Federal Food, Drug, and Cosmetic Act. Failure to comply with any regulation in subpart D of this part will render an infant formula adulterated under section 412(a)(1) of the Federal Food, Drug, and Cosmetic Act.
(d) An exempt infant formula is subject to the provisions of § 107.50 and other applicable Food and Drug Administration food regulations.
[79 FR 8074, Feb. 10, 2014]

## Nearby sections

- [21 CFR § 107.1 § 107.1 Status and applicability of the regulations in part 107.](https://www.frixlaw.com/law-library/statutes/ecfr-21-107.1.md)
- [21 CFR § 107.3 § 107.3 Definitions.](https://www.frixlaw.com/law-library/statutes/ecfr-21-107.3.md)
- [21 CFR § 107.10 § 107.10 Nutrient information.](https://www.frixlaw.com/law-library/statutes/ecfr-21-107.10.md)
- [21 CFR § 107.20 § 107.20 Directions for use.](https://www.frixlaw.com/law-library/statutes/ecfr-21-107.20.md)
- [21 CFR § 107.30 § 107.30 Exemptions.](https://www.frixlaw.com/law-library/statutes/ecfr-21-107.30.md)
- [21 CFR § 107.50 § 107.50 Terms and conditions.](https://www.frixlaw.com/law-library/statutes/ecfr-21-107.50.md)
- [21 CFR § 107.100 § 107.100 Nutrient specifications.](https://www.frixlaw.com/law-library/statutes/ecfr-21-107.100.md)
- [21 CFR § 107.200 § 107.200 Food and Drug Administration-required recall.](https://www.frixlaw.com/law-library/statutes/ecfr-21-107.200.md)
- [21 CFR § 107.210 § 107.210 Firm-initiated product removals.](https://www.frixlaw.com/law-library/statutes/ecfr-21-107.210.md)
- [21 CFR § 107.220 § 107.220 Scope and effect of infant formula recalls.](https://www.frixlaw.com/law-library/statutes/ecfr-21-107.220.md)
- [21 CFR § 107.230 § 107.230 Elements of an infant formula recall.](https://www.frixlaw.com/law-library/statutes/ecfr-21-107.230.md)
- [21 CFR § 107.240 § 107.240 Notification requirements.](https://www.frixlaw.com/law-library/statutes/ecfr-21-107.240.md)
- [21 CFR § 107.250 § 107.250 Termination of an infant formula recall.](https://www.frixlaw.com/law-library/statutes/ecfr-21-107.250.md)
- [21 CFR § 107.260 § 107.260 Revision of an infant formula recall.](https://www.frixlaw.com/law-library/statutes/ecfr-21-107.260.md)

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Source: Frix Law Library, https://www.frixlaw.com/law-library/statutes/ecfr-21-107.1. Check the current official text before relying on it. Not legal advice.