On May 24, the FDA issued guidance outlining a process by which the agency would not object to the importation of certain infant formula products intended for a foreign market or distribution in the U.S. of products manufactured in the U.S. for export to foreign countries. This guidance also may provide flexibilities to those who manufacture infant formula products domestically and may be able to increase further the quantity of domestically produced product for the U.S. market.
In accordance with the FDA’s increased flexibilities, the agency is exercising enforcement discretion for the importation of certain Bubs Australia infant formula products, 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.
Bubs Australia plans to provide at least 1.25 million cans of several varieties of its infant formula that will make at least 27.5 million full-size, 8-ounce bottles. Some of this product is currently in stock for transport, and additional product is being produced in the coming weeks and months. The U.S. Department of Health and Human Services is evaluating options for getting the products to the U.S. as quickly as possible.
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Last week, the FDA also informed Kendal Nutricare that it would exercise enforcement discretion for the importation of certain infant formula under the Kendamil External Link Disclaimer brand. The company initially estimates about 2 million cans of infant formula will to land on U.S. store shelves beginning in June. Kendal Nutricare currently has over 40,000 cans in stock for immediate dispatch, and the U.S. Department of Health and Human Services has initiated conversations to evaluate options for getting the products to the U.S. as quickly as possible.
The FDA also has announced it is not objecting to the release of about 300,000 cans of EleCare amino acid-based infant formula previously produced at Abbott Nutrition’s Sturgis, Mich., facility to individuals needing urgent, life-sustaining supplies of this specialty formula on a case-by-case basis. These products will undergo enhanced microbiological testing before release. Although some EleCare product was included in Abbott Nutrition’s infant formula recall, the EleCare products that will be released were in different lots, have never been released, and have been maintained in storage under control by Abbott Nutrition.