January 9, 2023To increase the diversity of and support a stable supply of infant formula in the U.S., the FDA is providing a pathway for manufacturers of infant formula products that were imported, sold, and/or distributed under a letter of enforcement discretion received based on factors described in a guidance to industry issued on May 16, 2022 (see “Background” for additional information), to continue marketing their products while they work toward meeting all applicable FDA requirements. The tables below indicate which infant formula companies have expressed interest in taking steps to remain on the U.S. market and the specific formulas they intend to transition to lawful marketing. As described in a September 2022 guidance, FDA intends to continue exercising enforcement discretion beyond Jan. 6, 2023, if the companies demonstrate that they are working to meet all U.S. requirements according to a recommended timetable specified by the FDA. For companies that did not provide a Letter of Intent to FDA by December 5, 2022, enforcement discretion ended on Jan. 6, 2023. The FDA stopped accepting new requests for enforcement discretion on Nov. 14, 2022.
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