The agency has issued a guidance document to help increase the supply of infant formula in the U.S.  The FDA intends to temporarily exercise enforcement discretion with respect to certain requirements for infant formulas that may not comply with certain statutory and regulatory requirements and is seeking information from manufacturers regarding the safety and nutritional adequacy of their products. This guidance document is intended to:

  • Explain factors that FDA intends to consider in making case-by-case determinations about whether to exercise enforcement discretion to allow the introduction into interstate commerce (including importation) of infant formula that is safe and nutritionally adequate, but that may not comply with all statutory and regulatory requirements; and
  • Advise infant formula manufacturers about the type of information to provide to the FDA, if they would like the FDA to consider whether to exercise enforcement discretion with regard to particular products.

The FDA reports that this guidance document will remain in effect until November 14, 2022, and then they will evaluate whether an extension is necessary. The FDA says they will give public notice when the period of enforcement discretion ends.

The contents of this document do not have the force and effect of law and are not meant to bind the public in any way, unless specifically incorporated into a contract. It is intended only to provide clarity to the public regarding existing requirements under the law.

This guidance is being implemented without prior public comment because the FDA has determined that prior public participation for this guidance is not feasible or appropriate (see section 701(h)(1)(C) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 371(h)(1)(C)) and 21 CFR 10.115(g)(2). This guidance remains subject to comment in accordance with the agency’s good guidance practices.