FDA Infant Formula Update: November 14, 2022

SILVER SPRING, Md., Nov. 14, 2022 /PRNewswire/ -- 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 increased flexibilities.

Company (Product Origin): Danone (The Netherlands)

Product(s): Nutricia UCD Anamix Infant Formula

Type of Formula: Specialty – Metabolic formula for infants with urea cycle disorders

Availability: The product will be available through home health care and durable medical equipment (DME) distributors, state and other government programs, and hospitals. The distribution of this formula will be targeted to metabolic clinics and patients and not available on retail shelves. 

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. 

Ongoing FDA Steps to Increase Availability of Safe, Nutritious Infant Formula

The FDA has been 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 agency continues to dedicate all available resources to help ensure that safe and nutritious infant formula products remain available for use in the U.S. Important progress has been made toward improving the infant formula supply in the U.S. and paving the way for a more robust and diverse marketplace for the future.

The FDA issued guidance in May 2022 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 flexibilities to those who manufacture infant formula products domestically and may be able to further increase the quantity of domestically-produced product for the U.S. market.

Additionally, in September 2022, the FDA announced new guidance that will help provide a pathway for infant formulas operating under enforcement discretion in the U.S. to remain on the market. This will help ensure the U.S. continues diversifying its infant formula market, and make families less susceptible to shocks in the infant formula market.

The agency 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 FDA 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.

Additional Information:

• Infant Formula Information and Ongoing FDA Efforts to Increase Supply
• Enforcement Discretion to Manufacturers to Increase Infant Formula Supplies
• HHS.gov/formula
• HHS.gov/news
• FDA Investigation of Cronobacter Infections: Powdered Infant Formula (February 2022) 
• Powdered Infant Formula Recall: What to Know 
• CDC Information on Cronobacter Infection and Infants 

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

The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation's food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products. 

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SOURCE U.S. Food and Drug Administration