Section 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.