---
kind: "section"
citation: "21 C.F.R. § 107.220"
title: "21"
number: "107.220"
heading: "Scope and effect of infant formula recalls."
url: "https://uscodex.org/cfr/21/107.220"
---

# §107.220. Scope and effect of infant formula recalls.

- (a) **The requirements of this subpart apply—**
  - (1) When the Food and Drug Administration has determined that it is necessary to remove from the market a distributed infant formula that is in violation of the laws and regulations administered by the Food and Drug Administration and that poses a risk to human health; or
  - (2) When a manufacturer has determined that it is necessary to remove from the market a distributed infant formula that:
    - (i) Is no longer subject to the manufacturer's control;
    - (ii) Is in violation of the laws and regulations administered by the Food and Drug Administration and against which the agency could initiate legal or regulatory action; and
    - (iii) **Does not present a human risk.**
- (b) The Food and Drug Administration will monitor continually the recall action and will take appropriate actions to ensure that the violative infant formula is removed from the market.

## Notes

### Source

Source: 54 FR 4008, Jan. 27, 1989, unless otherwise noted.

### Authority

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

### Source

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