The FDA issued a press release of interest to the CFSAN Constituent Update, Importer News, and Retail Food Protection subscribers. FDA Infant Formula Update: June 10, 2022 Today, the U.S. Food and Drug Administration is providing an update on additional steps it has taken that will lead to more infant formula available in the U.S. under the agency's recent increased flexibilities. Company (Product Origin): Abbott (Spain) Product(s): Similac Total Comfort Stage 1 (0-12 months), Similac Total Comfort (up to 24 months), Similac NeoSure Type of Formula: Similac Total Comfort Stage 1 (0-12 months), Similac Total Comfort (up to 24 months)- General; NeoSure is for premature and low birth weight infants Estimated Quantity: 686,530 cans (about 1.1 million pounds or more than 16.5 million full-size, 8-ounce bottles) Availability: Beginning in June; the U.S. Department of Health and Human Services is evaluating options for getting the products to the U.S. as quickly as possible. More Information and Where to Find the Products: Abbott will sell some on Similac.com as well as other online retailers and will provide some as emergency samples to critical areas of low supply for Special Supplemental Nutrition Program for Women, Infants, and Children (WIC) program. The FDA is exercising enforcement discretion for the importation of the infant formula products listed above following the review of information provided pertaining to nutritional adequacy and safety, including microbiological testing, labeling, and additional information about facility production and inspection history. Read the full press release Learn more about Enforcement Discretion to Manufacturers to Increase Infant Formula Supplies |
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