FDA Infant Formula Update: June 17, 2022

For immediate release:

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 U.S. under recent increased flexibilities. agency.

Company (origin of product): Danone (Ireland)

Some products): Aptamil First Infant Milk Stage 1 (This infant formula is suitable for most infants and meets US nutritional requirements, but may not be suitable for infants born prematurely or with low birth weight, infants who had low iron at birth or in infants Parents and caregivers of infants born prematurely or with low birth weight, infants with low iron at birth, or infants at risk of iron deficiency due to illness should check with their child’s health care provider to determine if this formula is appropriate for their child. An iron supplement may be needed in these cases.)

Type of formula: General

Estimated Quantity: Approximately 750,000 cans (about 1.3 million pounds or nearly 19 million full-size 8-ounce bottles)

Availablity: Expected in July – the US Department of Health and Human Services is evaluating options to get the products to the US as quickly as possible.

More information and where to find the products: Should be sold at major retailers. In July, consumers can learn more about Aptamil in the United States at us.aptamil.com.

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 that there is adequate infant formula available where and when parents and caregivers need it.

The FDA issued guidelines on May 16 outlining a process by which the agency would not object to the importation of certain infant formulas intended for a foreign market or the distribution in the United States of products manufactured here to be exported 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 manufactured 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 is taking, and the resumption of production at Abbott Nutrition’s factory in Sturgis, Michigan, to mean that 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 on HHS.gov/formulaincluding 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.

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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.


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