FDA Infant Formula Update: June 28, 2022

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SILVER SPRING, MD., June 28, 2022 /PRNewswire/ — Today, the U.S. Food and Drug Administration provides an update on additional steps it has taken that will lead to more infant formula available in the United States under recent increased agency flexibilities.

Company (origin of product): Abbott Nutrition (Ireland)

Some products): Similac Advance 2′-FL Stage 1

Type of formula: General

Estimated quantity: 18,677 cans (about 35,000 pounds or about 535,000 full-size 8-ounce bottles)

Availablity: Mid-July. The US Department of Health and Human Services is evaluating options to get the product to the United States as soon as possible.

More information and where to find the products: Abbott Nutrition will set aside a portion of inventory to provide critical needs products free of charge to special Women, Infants and Children’s Supplementary Nutrition (WIC) program agencies. Abbott will also use online outlets (Similac.com, Abbottstore.com, Amazon.com, Walmart.com, Target.com and others to maximize nationwide availability for the remainder of the product.

The FDA exercises its discretion to import the infant formulas listed above after reviewing the information provided regarding nutritional adequacy and safety, including microbiological testing, labeling, and additional information on the production of the infant formula. establishment and inspection history.

The agency is leveraging a number of flexibilities to strengthen product offerings that are the only source of nutrition for many infants while ensuring infant formula is safe to use and provides adequate nutrition. The FDA is continuing discussions with manufacturers and suppliers regarding additional supply to ensure there is enough infant formula available when and where parents and caregivers need it.

The FDA has issued guidance on May 16 which outlined a process by which the agency would not object to the importation of certain infant formula intended for a foreign market or the distribution in the United States of products manufactured here for export to foreign countries. This guidance may also provide flexibilities to those manufacturing infant formula domestically and may be able to further increase the amount of domestically produced product for the US market. The agency has released a webpage that will be updated with information on additional products destined for the United States.

Ongoing FDA Actions to Increase Availability of Safe and Nutritious Infant Formula

The agency’s round-the-clock work as part of government-wide efforts has already begun to improve supply and availability. The agency expects the actions and measures it takes, and the resumption of production at Abbott Nutrition Sturgis, Mich.installation, will mean more and more supplies are on the way or on store shelves in the future.

The FDA continues to advise against making infant formula at home or diluting formula. Parents and caregivers are encouraged to work with their child’s health care provider for recommendations on modifying feeding practices, if needed. The US Department of Health and Human Services also has additional information available at HHS.gov/formula, including information to help families find infant formula.

The agency also monitors online marketplaces for fraudulent products and works with major online retailers to remove non-compliant 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 tracks various external signals such as consumer complaints about potentially counterfeit and fraudulent products.

The FDA will continue to dedicate all available resources to help ensure that safe and nutritious infant formulas remain available in the United States and will keep the public informed of progress updates.

Further information:

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

The FDA, an agency of the United States Department of Health and Human Services, protects public health by ensuring the safety, efficacy, and safety of drugs, vaccines, and other biological products for human use, and medical devices. The agency is also responsible for the safety and security of the food supply, cosmetics, dietary supplements, electronic radiation emitting products and the regulation of tobacco products.

SOURCE US Food and Drug Administration

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