| FDA Flexibilities to Yield Millions of Cans of Additional Infant Formula in Coming Months to Increase Supply Available to U.S. Consumers May 25, 2022 Dear International Colleague, Today, the U.S. Food and Drug Administration is providing an update on steps it has taken that will lead to millions of cans of additional infant and specialty formula being available to U.S. consumers. "We continue to do everything in our power as part of the all-of-government efforts to ensure there's adequate infant formula available wherever and whenever parents and caregivers need it," said FDA Commissioner Robert M. Califf, M.D. "Our recent steps will help further bolster supply of infant formula, including through the import of safe and nutritious products from overseas based on our increased flexibilities announced last week. Importantly, we anticipate additional infant formula products may be safely and quickly imported into the U.S. in the near-term based on ongoing discussions with manufacturers and suppliers worldwide." Key Activities U.K.'s Kendal Nutricare Will Send About 2 Million Cans to U.S. The FDA has informed Kendal Nutricare that the agency is exercising enforcement discretion for the importation of certain infant formula under the Kendamil brand. Under the agency's recent increased flexibilities regarding importation of certain infant formula products, the company initially estimates that about 2 million cans of infant formula are expected 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. Kendamil has set up a website for consumers to receive updates and locate product once it arrives in the U.S. The agency 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. 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. Today's announcement follows guidance issued last week that outlined a process by which the FDA 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 here 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. The agency remains in further discussions with manufacturers and suppliers regarding additional supply and intends to prioritize submissions for products that can demonstrate safety and nutritional adequacy and have the largest volume of product available and/or those who can get product onto U.S. shelves the quickest. The FDA has posted a webpage that will be updated with information about additional products headed to the U.S. Abbott Will Release About 300,000 Cans of EleCare Specialty Formula on Case-By Case Basis The FDA is announcing that 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, Michigan, 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, these 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. These EleCare product lots were not part of the recall but have been on hold due to concerns that they were produced under insanitary conditions observed at Abbott Nutrition's Sturgis, Michigan, facility. As noted above, these products will undergo enhanced microbiological testing prior to their release. Given the critical need of this product for some individuals, the FDA encourages parents and caregivers to consult with their healthcare providers to weigh the potential risk of bacterial infection with this product. The FDA will continue to work closely with healthcare provider organizations and stakeholders to understand the potential risks and benefits of using this product. Parents and caregivers seeking access to these products should contact Abbott directly to request that a product be made available to them by calling 1-800-881-0876. Parents and caregivers should continue to work with their medical provider to consider whether comparable alternative products may be appropriate. The FDA is also announcing that in response to the agency's concerns, Abbott has confirmed to the agency that EleCare will be the first formula produced at the Sturgis facility when it restarts production, and other specialty metabolic formulas will closely follow. Additionally, under the consent decree with the FDA, Abbott is required to retain an independent expert to review the Sturgis facility's operations to ensure compliance with the law. Additional Ongoing Efforts to Increase Supply of Infant Formula On Friday, the agency held a webinar with more than 700 attendees to review the recent guidance for the infant formula industry, particularly those manufacturers and processors not currently manufacturing infant formula products for the U.S. market. The FDA's around-the-clock work as part of the all-of-government efforts has already begun to improve supply and availability. The agency expects that the measures and steps it is taking, and the potential for Abbott Nutrition's Sturgis, Michigan, facility to safely resume production in the near-term, will mean more and more supply is on the way or on store shelves moving forward. As more formula becomes available to the general population of infants, the agency understands that availability of specialty products -- such as amino acid-based specialty formulas and metabolic products -- continues to be of concern. The FDA has already taken steps with Abbott Nutrition to make product available to those with life-threatening conditions on a case-by-case basis and will continue its efforts to make these products even more readily available as the agency works with the company to implement provisions of a consent decree. In addition, these products have been an area of focus for discussions with other manufacturers that make comparable products. As a result of the recall and work with the FDA, other manufacturers have increased production of comparable product lines and in some cases expedited the importation of these products where available. The FDA continues to advise against making infant formulas at home or diluting formula. Caregivers are encouraged to work with their child's health care provider for recommendations on changing feeding practices, if needed. The U.S. Department of Health and Human Services has also released a fact sheet with information to help families find infant formula. The agency also monitors online marketplaces for fraudulent products and works with major online retailers to remove violative and harmful products offered for sale on their sites. Additionally, since many of these fraudulent products originate overseas, the agency targets and examines these products at ports of entry. The FDA also monitors and follows up on various external signals such as consumer complaints about potential counterfeit and fraudulent products. The FDA will continue to dedicate all available resources to help ensure that infant formula products remain available for use in the U.S. and will keep the public informed of progress updates. Additional Information: | 
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