NOTICE TO RETAILERS: Sale of Infant Formula Past the "Use By" Date

This letter is to advise you of the Food and Drug Administration's (FDA) concern about the retail sale of infant formula that is past the "use by" date printed on the product container.

Regulations administered by the FDA require that a "use by" date be declared on each container of infant formula. The purpose of this "use by" date is to inform retailers and consumers that the infant formula, until that declared date, will contain the quantity of each nutrient as specified on the label and that the formula is otherwise of an acceptable quality. An infant formula that has passed its "use by" date may not provide the nutrient levels required under the Federal Food, Drug, and Cosmetic Act (the act). A formula that does not provide the nutrient levels required under the act would be adulterated and subject to seizure by the FDA. Therefore, a retailer should not offer for sale any infant formula that has passed its "use by" date. Such formula should be pulled off of the retail shelf.

We understand that infant formula manufacturers have established marketing programs designed to prevent the potential sale of outdated formula by encouraging retailers to return, to the manufacturer, product not sold before the "use by" date. Retailers should discuss such marketing programs with the manufacturer and use such programs, as necessary, to keep outdated formula off of the retail shelf.

We are asking retailers to critically evaluate training and management practices to ensure that store managers and employees take steps to prevent the sale of outdated infant formula.

Thank you for your cooperation, and please contact my office if we can be of assistance to you.

cc: Food Marketing Institute
International Formula Council
Ross Labs
Nestle USA, Inc.
Mead Johnson
Wyeth Ayerst Labs