(a) The requirements of this subpart apply:

1. (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. (2) When a manufacturer has determined that it is necessary to remove from the market a distributed infant formula that:

   1. (i) Is no longer subject to the manufacturer's control;
   2. (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
   3. (iii) Does not present a human risk.