As we previously have reported, in May FDA announced an enforcement discretion policy which would allow certain non-compliant infant formula to be marketed in the U.S. The policy, which will remain in effect until November 14, 2022, was intended to address the infant formula shortage that resulted from the temporary shutdown of Abbot’s facility in Sturgis, Michigan due to positive test results in the facility for Cronobacter sakazakki and an outbreak of food-borne illness among infants who had been exposed to infant formula produced at the facility.

Last week FDA announced steps to facilitate the continued use of infant formula marketed under the enforcement discretion policy past its November 14, 2022 expiration date. Specifically, FDA announced that it would:

• Provide a single technical assistance contact at FDA for companies aiming to enter the U.S. infant formula market.

• Host meetings this summer with companies that import, sell, and/or distribute infant formula under the enforcement discretion policy to determine what additional steps would need to be taken to allow them to market infant formula in the U.S. long-term.

• Issue guidance in September on the topic of how companies that are marketing infant formula under the enforcement discretion policy can continue to supply infant formula.

Although FDA emphasized that it would continue to apply “rigorous” standards to ensure that infant formula is safe and nutritious, FDA’s actions have been subject to scrutiny. Last month Congresswomen Rosa DeLauro sent a letter to the Department of Health and Human Services which requested a review of the enforcement discretion policy and voiced concern that the enforcement discretion was being provided too rapidly to ensure that the infant formula was safe and nutritious and that the decision-making process was opaque. We also note that the Abbot plant in Sturgis has only just restarted production. While it had initially restarted production in June after meeting the initial requirements mandated by the consent decree, it was forced to shut down later that month following storms and flooding.