| The FDA issued a press release of interest to the CFSAN Constituent Update, Importer News, and Retail Food Protection subscribers. FDA Infant Formula Update: July 6, 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): Vitaflo USA LLC (The Netherlands) Product(s): PKU Start Type of Formula: Specialty/metabolic formula for infants with phenylketonuria (PKU), a rare genetic disorder in which the amino acid phenylalanine builds up in the body. Estimated Quantity: 3,192 cans (about 2,815 pounds or about 39,844 full-size, 8-ounce bottles) Availability: Product will be available within two weeks through direct purchase from Vitaflo and medical distribution channels, with a second round of product expected to be available in September. More Information and Where to Find the Products: PKU Start must be used under medical supervision and is available directly from Vitaflo with a medical prescription. It will be distributed through medical distribution channels such as pharmacies, durable medical equipment providers, Special Supplemental Nutrition Program for Women, Infants, and Children (WIC) and home care providers. These designated providers can place an order on behalf of patients by calling Vitaflo at 888-848-2356. 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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