FDA Flexibilities, Collaboration to Yield Millions of Bottles of Specialized Medical Infant Formula in Coming Months to Increase U.S. Supply

SILVER SPRING, Md., May 26, 2022 /PRNewswire/ -- Today, the U.S. Food and Drug Administration is providing an update on steps it has taken that will lead to millions of bottles of specialized medical infant formula to help address immediate needs for infants with certain allergies or critical health conditions. This type of specialized medical infant formula is currently in short supply in the U.S.

"We have made tremendous progress, including notable steps in just the past week, which will allow us to immediately begin bringing specialty and infant formula products into the U.S. as quickly as possible," said FDA Commissioner Robert M. Califf, M.D. "We continue to work closely with our U.S. government partners and domestic and international manufacturers to identify additional formula product that will be available to parents and caregivers in the weeks and months ahead. It is our goal to ensure that hospitals, specialty pharmacies, and retail store shelves will begin seeing adequate supplies again in the coming weeks."

About 500,000 additional cans of specialized medical formula manufactured by Danone's Nutricia business will be headed to the U.S. These Neocate amino acid-based formula products -- some of which are already manufactured for the U.S. market and are made at facilities in Europe -- amounts to more than 5 million full-size, 8-ounce bottles. 

The U.S. Department of Health and Human Services and Danone continue to partner to evaluate options for getting the products to the U.S. as quickly as possible. The specialized medical formula is expected to be distributed through direct ordering, hospitals, health care professionals, pharmacies, healthcare product distributors and Special Supplemental Nutrition Program for Women, Infants, and Children (WIC) local access points to ensure they get to the infants who rely on these products.

The FDA has been working with Danone's Nutricia business over the past several months to boost production of these products at its facilities and to identify additional supply of other infant formula products moving forward.

The agency is leveraging a number of flexibilities to bolster the supply of products that serve as the sole source of nutrition for many infants while ensuring the infant formula can be used safely and provides adequate nutrition. The FDA remains in further discussions with manufacturers and suppliers regarding additional supply to ensure there's adequate infant formula available wherever and whenever parents and caregivers need it.

On Tuesday, the FDA announced that it 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 (over 50 million full-size, 8-ounce bottles) are expected to land on U.S. store shelves beginning in June. Kendal Nutricare also currently has over 40,000 cans in stock for immediate dispatch. The FDA also announced 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.

Last week, the FDA issued guidance 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 FDA has posted a webpage that will be updated with information about additional products headed to the U.S.

The agency'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. HHS 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:

• Enforcement Discretion to Manufacturers to Increase Infant Formula Supplies
• FDA Flexibilities to Yield Millions of Cans of Additional Infant Formula in Coming Months to Increase Supply Available to U.S. Consumers
• FDA Encourages Importation of Safe Infant Formula and Other Flexibilities to Further Increase Availability
• FDA Takes Important Steps to Improve Supply of Infant and Specialty Formula Products
• HHS Fact Sheet: Helping Families Find Formula During the Infant Formula Shortage
• FDA Investigation of Cronobacter Infections: Powdered Infant Formula (February 2022)
• Powdered Infant Formula Recall: What to Know
• CDC Information on Cronobacter Infection and Infants

Media Contact: FDA Office of Media Affairs, 301-796-4540 
Consumer Inquiries: 888-723-3366 

The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation's food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products. 

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SOURCE U.S. Food and Drug Administration