Wednesday, June 15, 2022

FDA Infant Formula Update: June 15, 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 15, 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.

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): Mead Johnson Nutrition/Reckitt (Singapore)
Product(s): Base powder to manufacture Enfamil Stage 1
Type of Formula: Finished product will be general infant formula
Estimated Quantity: 4.5 million pounds of base powder that will be used to produce about 5.7 million cans (more than 66 million full-size, 8-ounce bottles).
Availability: Base powder will begin shipping in June to a Minnesota facility for conversion to final product that will be made available in the coming weeks. Monthly follow-on shipments will continue through November. 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: The finished product would be used to meet contractual obligations under the 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


This email was sent to ooseims.archieves@blogger.com using GovDelivery Communications Cloud on behalf of: U.S. Food and Drug Administration · 
10903 New Hampshire Ave · Silver Spring, MD ·  20993-0002 ·  1-888-INFO-FDA
GovDelivery logo

No comments:

Post a Comment