Tuesday, June 28, 2022

FDA Infant Formula Update: June 28, 2022

US Food and Drug Administration

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 28, 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 Nutrition (Ireland)

Product(s): Similac Advance 2'-FL Stage 1

Type of Formula: General

Estimated Quantity: 18,677 cans (about 35,000 pounds or about 535,000 full-size, 8-ounce bottles)

Availability: Mid-July. The U.S. Department of Health and Human Services is evaluating options for getting the product to the U.S. as quickly as possible.

More Information and Where to Find the Products: Abbott Nutrition will reserve a portion of the inventory to provide free of charge product for critical needs to Special Supplemental Nutrition Program for Women, Infants, and Children (WIC) agencies. Abbott will also use online outlets (Similac.com, Abbottstore.com, Amazon.com, Walmart.com, Target.com, and others to maximize availability nationwide for the balance of the product. 

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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