21 CFR 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
(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.