Infant formula enforcement discretion policy
USA
Oct 05, 2022
Infant formula enforcement discretion policy
The Food and Drug Administration (FDA) is announcing the availability of a guidance document to help increase the supply of infant formula in the United States. 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 FDA, if they would like FDA to consider whether to exercise enforcement discretion with regard to particular products.
For further information (in English), click on the Link
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