FDA Approves First Infant Formula for Import Under New Enforcement Discretion Policy
FDA recently approved the first foreign infant formulas allowed for import into the U.S. under its new enforcement discretion policy announced earlier this month to address the infant formula shortage, it said May 24. The U.K.’s Kendal Nutricare will send the over 40,000 cans it has in stock of three types of Kendamil infant formula, and the company has estimated it will eventually send about 2 million cans total.
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FDA “reviewed applicable information relating to certain Kendamil products and, based on the information provided, does not have concerns that the products can be used safely and that they provide adequate nutrition,” the agency said. “In reaching this decision, the FDA evaluated information pertaining to nutritional adequacy and safety, including microbiological testing, labeling, and additional information about facility production and inspection history.”
The approval is the first since FDA announced its policy of enforcement discretion May 16. The policy allows for imports of infant formulas that don’t meet all U.S. regulatory requirements but are otherwise deemed safe and sufficiently nutritious by the agency. FDA has created a webpage listing companies approved for the enforcement discretion policy. As of press time May 26, it listed only the three Kendamil formulas from Kendal Nutricare.