21 CFR 107.220
§ 107.220 Scope and effect of infant formula recalls.
United States · 21 CFR — Food and Drugs · Status: effective
Cite this
- Citation
- 21 CFR 107.220, § 107.220 Scope and effect of infant formula recalls, United States, version 1 as recorded 2026-07-09, yourstate.us, https://yourstate.us/provision/84072
- Permanent ID
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Full text
(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.
Legislative history
This is a federal regulation, adopted through agency rulemaking under the Administrative Procedure Act — not enacted by a recorded vote of Congress.