FDA Infant Formula Update: June 3, 2022
June 3, 2022
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 available in the U.S. under the agency’s recent increased flexibilities.
Company (Product Origin): Nestlé (Mexico)
Product(s): Gerber Good Start Gentle
Type of Formula: General
Estimated Quantity: About 1.3 million cans (about 2.2 million pounds or nearly 33 million full-size, 8-ounce bottles)
Availability: Expected beginning in July through October – 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 FDA is exercising enforcement discretion for the importation of the infant formula products listed above 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.
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 16 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 flexibility to those who manufacture infant formula products domestically and may be able to increase further the quantity of domestically produced products 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.
Ongoing FDA Steps to Increase Availability of Safe, Nutritious Infant Formula
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. Parents and caregivers are encouraged to work with their child’s health care provider for recommendations on changing feeding practices if needed. The U.S. 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 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 safe and nutritious infant formula products remain available for use in the U.S. and will keep the public informed of progress updates.