January 9, 2023
Today the U.S. Food and Drug Administration (FDA) is announcing that the agency has sent letters of acknowledgement to all manufacturers of infant formula that previously received letters of enforcement discretion for specific infant formula products and have expressed interest in taking steps to remain on the U.S. market. To increase the diversity of those supplying infant formula and support a stable supply of infant formula in the U.S., the FDA is providing a pathway for manufacturers of these infant formula products to continue marketing their products while they work toward meeting all FDA requirements. The agency has updated its web page on enforcement discretion to manufacturers to indicate the 11 companies that have expressed interest in taking these steps.
Under guidance issued in September 2022, infant formula manufacturers currently marketing their products in the U.S. under enforcement discretion were advised to send to the FDA by Dec. 5, 2022, a letter of intent identifying specific infant formula products for which the manufacturer intended to pursue compliance with all regulatory requirements. The FDA has reviewed the letters of intent and has communicated directly with manufacturers with a letter stating that FDA intends to continue exercising enforcement discretion relating to the importation, sale, and distribution of specific products provided the firm adheres to criteria previously communicated in a letter of enforcement discretion (such as continued testing for nutrient content and certain pathogens), and the firm continues to make meaningful progress as described in the September 2022 guidance toward compliance with applicable regulatory requirements for these products. The guidance provides a timetable for the actions manufacturers will be taking to comply with all applicable requirements.
The FDA hosted four industry webinars to provide an overview and answer questions on the recently released guidance to infant formula manufacturers as well as requirements and recommendations for achieving compliance with all U.S. requirements that apply to their products.
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