FDA Efforts to Result in Millions of Additional Bottles of Infant Formula to Further Increase U.S. Supply

SILVER SPRING, Md., May 27, 2022 /PRNewswire/ -- Today, the U.S. Food and Drug Administration is providing an update on additional steps it has taken that will lead to more infant formula on U.S. store shelves in the coming weeks and months.

"We continue to work around the clock with our government partners and industry to ensure there's adequate infant formula available wherever and whenever parents and caregivers need it," said FDA Commissioner Robert M. Califf, M.D. "Steps like the one the agency is taking today means more infant formula will be available to parents and caregivers in the weeks and months ahead. We will not rest until our shelves are replete with safe and nutritious infant formula."

Under the agency's recent increased flexibilities, Bubs Australia plans to provide at least 1.25 million cans of several varieties of its infant formula such as stage 1 and 2 cans of Bubs Organic Grass Fed, Bubs Supreme A2 Beta-Casein Protein and Bubs Easy-digest Goat Milk, 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. The company has information about the products and where to find product once in the U.S. on the Aussie Bubs website.

The FDA notified Bubs Australia that the agency is exercising enforcement discretion for the importation of certain 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. 

On Tuesday and Thursday, the FDA also announced steps that will lead to tens of millions of additional bottles of infant formula, including specialty infant formula that is in short supply for infants with certain allergies or critical health conditions.

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.

The FDA issued guidance on May 24 that outlined 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 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 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.

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

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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. 

SOURCE U.S. Food and Drug Administration