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Powdered infant formula

FDA, AAP offer resources to help families using imported infant formula

July 14, 2022

The Food and Drug Administration (FDA) is stressing that the imported infant formulas it has approved for use in the U.S. are safe and nutritious.

Parents and caregivers can learn about where to find comparable products, how to read the labels and how to prepare these formulas through new FDA tip sheets and videos as well as answers to frequently asked questions on the AAP’s website.

The FAQ has additional information on understanding imported formula labels, using goat’s milk formula, the dangers of families importing their own formula and eligibility with Special Supplemental Nutrition Program for Women, Infants, and Children (WIC) benefits.

“Consumers should have confidence that the infant formula being imported to the U.S. through FDA’s flexibilities involved a thorough review of the information provided by the company, including details about the products’ nutritional adequacy and safety, microbiological testing results, labeling information and importantly details about the manufacturing facilities’ foods safety production practices and inspection history,” said Susan T. Mayne, Ph.D., director of the FDA’s Center for Food Safety and Applied Nutrition.

Formulas for more than 524 million 8-ounce bottles are being imported from nine countries and include brands that may be unfamiliar to U.S. consumers such as Bubs Australia and Kendamil.

Because some labels have metric measurements, the FDA has created a tip sheet showing conversions from milliliters to fluid ounces and Celsius to Fahrenheit. It also has videos answering parents’ questions and pictures of imported labels parents and caregivers may see on store shelves.

Dr. Mayne encouraged families to try different brands if they can’t find their usual formula but also recommended talking to their pediatrician about feeding changes, especially if their baby has a medical condition. Pediatricians also can help families request specialty formula from Abbott Nutrition.

The infant formula shortage has been ongoing for months due to supply chain issues and the shutdown of an Abbott Nutrition plant following complaints of bacterial infections among several infants who had consumed the formula. Dr. Mayne said U.S. manufacturers have been ramping up production to make up for the shortage. The FDA also is making plans to allow expanded access to formula to avoid future shortages.




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