FDA Infant Formula Update: July 29, 2022


SILVER SPRING, Md., July 29, 2022 /PRNewswire/ — Today, the US Food and Drug Administration provides an update on additional steps it has taken that will result in more infant formula being available in the US under the agency’s oversight recently increased flexibilities.

Company: Danone’s Nutricia (Netherlands)

Products): Pepticate and Pepticate Syneo

Type of formula: Specialty – Extensively hydrolyzed formula

Estimated amount:

Pepticate: 50,000 cans (about 44,000 pounds or over 605,000 full-size 8-ounce bottles)

Pepticate Syneo: 24,000 cans (about 24,000 pounds or nearly 327,000 full-size 8-ounce bottles)

Availability: Pepticate Syneo ships in August while Pepticate ships in September

More information and where to find the products:

Pepticate and Pepticate Syneo will be available through medical and retail channels, including national and regional state and federal home health care programs such as the USDA’s Special Supplemental Nutrition Program for Women, Infants and Children (WIC), MMCAP (State GPO, Medi-Cal and Tri-Care, as well as several wholesale markets and pharmacies).

FDA, after reviewing the nutritional adequacy and safety information provided, including microbiological testing, labeling and additional information about the facility’s production and inspection history, will exercise enforcement discretion for the importation of the infant formula products listed above.

The Agency uses a number of flexibilities to improve the supply of products that serve as the sole source of nutrition for many infants, while ensuring that infant formula is safe to use and provides adequate nutrition. The FDA is in further discussions with manufacturers and suppliers about additional supplies to ensure adequate infant formula is available where and when parents and caregivers need it.

The FDA has released guidance on May 16th It described a process whereby the agency would not object to the importation into the United States of certain infant formula products destined for a foreign market or the distribution of locally manufactured products for export abroad. These guidelines may also provide those who manufacture infant formula domestically with flexibility and the ability to further increase the volume of domestically manufactured products for the US market. The agency has posted a website which will be updated with information about additional products shipping to the United States

Ongoing steps by the FDA to increase the availability of safe, nutritious infant formula

The agency’s 24/7 operations have already begun as part of the state-wide effort to improve coverage and availability. The agency expects that Measures and steps it takesand the resumption of production at Abbott Nutrition Sturgis, Mich.Setup, means more and more supplies are on the way or on store shelves.

The FDA continues do not recommend making infant formula at home or diluting infant formula. Parents and caregivers are encouraged to work with their child’s healthcare provider for recommendations on changing feeding practices, if needed. The US Department of Health and Human Services also provides additional information at HHS.gov/formulaincluding information to help families find baby food.

The agency also monitors online marketplaces for fraudulent products and works with major online retailers to remove illegal and harmful products offered for sale on their websites. In addition, since many of these fraudulent products originate from abroad, the agency targets and examines these products at the 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 use all available resources to ensure safe and nutritious infant formula products remain available for use in the United States and will keep the public informed of any progress updates.

Additional information:

Media contact: FDA Office of Media Affairs, 301-796-4540
consumer inquiries: 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 human and veterinary drugs, vaccines, and other biological products intended for human use, and medical devices. The agency is also responsible for the safety of the food supply, cosmetics, dietary supplements, products that emit electronic radiation, and for the regulation of tobacco products in our country.

SOURCE US Food and Drug Administration


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