Thursday, June 30, 2022

FDA Infant Formula Update: June 30, 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 30, 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): Danone (New Zealand) 

Product(s): Aptamil Gold Plus

Type of Formula: General

Estimated Quantity: 555,000 cans (about 1.1 million pounds or about 16.5 million full-size, 8-ounce bottles)

Availability: Likely to start in August. 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: Expected to be available across several retail channels in the US.

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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