FDA Infant Formula Update: June 30, 2022

SILVER SPRING, MD., June 30, 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 the of the agency recent increased flexibilities.

Company (origin of product): Danon (New Zealand)

Some products): Aptamil Gold Plus

Type of formula: General

Estimated quantity: 555,000 cans (about 1.1 million pounds or about 16.5 million full-size 8-ounce bottles)

Availablity: Probable start in August. 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: Expected to be available on multiple US retail channels.

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 has released tips 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 manufactured product for the US market. The agency has published a webpage which 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 the measures and measures he takesand 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 infant 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.

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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