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 29, 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: Danone's Nutricia (Netherlands)
Product(s): Pepticate and Pepticate Syneo
Type of Formula: Specialty - Extensively Hydrolyzed Formula
Estimated Quantity:
Pepticate: 50,000 cans (about 44 thousand pounds or over 605,000 full-size, 8-ounce bottles)
Availability: Pepticate Syneo will be shipped in August while Pepticate will be shipped in September
More Information and Where to Find the Products:
Pepticate and Pepticate Syneo will be available through medical and retail channels including national and regional home health care state and government programs such as USDA's Special Supplemental Nutrition Program for Women, Infants and Children (WIC), MMCAP (state GPO, Medi-Cal and Tri-Care as well as several wholesale outlets and pharmacies).
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.
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
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