---
kind: "section"
citation: "21 C.F.R. § 107.1"
title: "21"
number: "107.1"
heading: "Status and applicability of the regulations in part 107."
url: "https://uscodex.org/cfr/21/107.1"
---

# §107.1. Status and applicability of the regulations in part 107.

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

## Notes

### Amendments

[79 FR 8074, Feb. 10, 2014]

### Authority

Authority: 21 U.S.C. 321, 343, 350a, 371.

### Source

Source: 50 FR 1840, Jan. 14, 1985, unless otherwise noted.

### Amendments

[79 FR 8074, Feb. 10, 2014]