FDA is no longer accepting requests for enforcement discretion for certain requirements that apply to infant formula, the agency announced in November, based on its temporary guidance released in May 2022 and in effect through earlier this week. Now, FDA has said it will provide a pathway for formula manufacturers to continue marketing these products while they work toward fully meeting FDA requirements. “Under the new guidance, the period of enforcement discretion for these products is being extended until January 6, 2023, with further extensions possible for firms that express interest in and take steps toward remaining on the U.S. market,” FDA said in a statement.
For background, in May 2022, FDA issued new guidance to manufacturers of infant formula as a way to temporarily exercise enforcement discretion on certain requirements that applied to infant formula, an action the agency hoped would help increase the supply of infant formula in the United States. The need for increased supply of formula became even more pressing after two major occurrences—a February 2022 voluntary recall by Abbott Nutrition due to formula contaminated with Cronobacter sakazakii at the company’s Sturgis, Michigan, facility, and increased strains on supply chains experienced during the COVID-19 pandemic.
Additionally, on November 15, FDA announced plans to create a dedicated team of investigators for infant formula production as part of its ongoing strategy to prevent contamination of any product. Part of the agency’s plan would be to realign staff across the Center for Food Safety and Applied Nutrition and the Office of Regulatory Affairs in hopes of better supporting the regulatory oversight of infant formula.
FDA has also released a proposed rule that Cronobacter infections be added to CDC’s list of national notifiable diseases, an action that would require physicians to report cases of infection to public health officials.
Other actions FDA is considering include reevaluating testing requirements to enhance safety of finished infant formula products; developing and improving consumer education on how to safely prepare and store infant formula; and providing added training for staff who inspect infant formula production facilities.