I think it was already mentioned earlier in this thread, but any way, main point is "Manufacturers currently marketing their products in the U.S. under enforcement discretion should send a letter to the FDA by Dec. 5, 2022, outlining their intent to pursue completion of all regulatory requirements. Upon receipt, the agency intends to evaluate the request to determine whether to extend the period of enforcement discretion and issue a new letter of enforcement discretion by Jan. 6, 2023. For manufacturers that receive a new letter of enforcement discretion, the FDA does not intend to object to the continued marketing of covered infant formulas in the U.S. through October 2025" https://www.fda.gov/news-events/press-announcements/fda-pathway-supports-long-term-stability-diversity-safe-and-nutritious-infant-formula-supply-us
Guidance on Transition Plan for Covered Exempt Infant Formula Products to ensure they meet regulatory requirements can be found here https://www.fda.gov/media/161904/download
Here is timeline to comply with from that document
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- Ann: FDA approval to supply infant milk formula to United States
Ann: FDA approval to supply infant milk formula to United States, page-56
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