Today, the U.S. Food and Drug Administration is providing an update on the steps it has taken, and will continue to take, to ensure that American consumers have access to safe and nutritious infant formula in the coming weeks and months.
“The FDA is working night and day to ensure that parents and caregivers can readily find safe and nutritious formula products for any child who needs it,” said FDA Commissioner Robert M. Califf, M.D. “I have personally spoken with infant formula manufacturers over the past several weeks and all have significantly increased their production efforts, which is resulting in more supply that will be available on stores shelves moving forward.”
FDA Flexibilities Have Resulted in Approximately 365 Million Bottles Worth of Infant Formula
In the past month, the FDA has issued enforcement discretion letters for the importation of the infant formula products from six countries, with a total estimated quantity of 17 million cans, or about 365 million full-size, 8-ounce bottles. These products have already started to hit the U.S. market and more will appear on store shelves over the coming weeks and months.
Consumers should have confidence that the infant formula that is being imported to the U.S. through this process involved a thorough review of the information provided by the companies, including details about the product’s nutritional adequacy and safety, microbiological testing results, labeling information, and importantly, details about the manufacturing facility’s food safety production practices and inspection history.
Agency Continues Regular Inspections of Infant Formula Facilities
The FDA takes its responsibility seriously to ensure the foods we eat are safe and meet our rigorous standards for quality and safety – this is particularly true for infant formula. While the FDA Food Safety Modernization Act (FSMA) requires the agency to inspect domestic food facilities at least once every 3 to 5 years, the FDA has a policy of annually inspecting infant formula manufacturers because the products serve as the sole source of nutrition for some of our most vulnerable consumers.
This goal of annual surveillance inspections of these facilities has consistently been met over the years with the exception of 2020 during the COVID-19 pandemic. However, even throughout the COVID-19 pandemic, the FDA continued to inspect facilities, including infant formula facilities. In fact, we inspected six firms in fiscal year 2020 (Oct. 1, 2019 – Sept. 30, 2020), including several during the height of the pandemic in the summer and fall of 2020. In order to develop a prioritized list of firms to inspect throughout 2021, the FDA evaluated the firms that we did not inspect in 2020 to focus on firms that met certain risk criteria, including a firm’s inspection history, hazard signals such as consumer complaints, and other factors.
While the agency postponed certain food surveillance inspections during the pandemic, the FDA resumed its annual surveillance inspection schedule for infant formula facilities beginning in July 2021. In fiscal year 2021 (Oct. 1, 2020 – Sept. 30, 2021), we prioritized inspections of infant formula firms, conducting 16 domestic inspections throughout the year; including Abbott, Mead Johnson, Gerber, and Nestle. Since the start of fiscal year 2022 (Oct. 1, 2021), we have conducted 10 domestic infant formula inspections and one foreign, including Abbott, Mead Johnson, and Gerber.
Importantly, it is a firm’s responsibility to ensure the consistent quality and safety of the products they produce. In addition to our oversight work, the FDA stresses the importance of a company’s quality systems and culture. Ultimately, when problems are found it is the responsibility of the firm to correct those issues to keep consumers safe.
Latest Update on Certain Specialty, Metabolic Infant Formula Being Released by Abbott on a Case-by-Case Basis
The FDA is continuing to work to ensure infants and individuals with medical conditions who rely on certain specialty, amino acid-based and metabolic infant formula products have access to these life-sustaining products. Some of these products have been available on a case-by-case basis from Abbott Nutrition over the last several months because the risk of not having access to them could significantly worsen underlying medical conditions and in some cases pose life-threatening risks.
If comparable, alternative products are not available or appropriate, parents and caregivers using these products should consider following the FDA and CDC’s most current advice on how to reduce the possibility of a Cronobacter infection. Because powdered formula is not sterile and can also be contaminated in homes, it is advised to wash hands with soap and water, especially before preparing bottles and feeding. Ensuring all surfaces and feeding items are clean when preparing infant formula will also reduce the potential for possible contamination.
- Infant Formula Information and Ongoing FDA Efforts to Increase Supply
- Help Prevent Cronobacter Illness: Prepare and Store Powdered Infant Formula Safely
- Enforcement Discretion to Manufacturers to Increase Infant Formula Supplies
- FDA Investigation of Cronobacter Infections: Powdered Infant Formula (February 2022)
- Powdered Infant Formula Recall: What to Know
- CDC Information on Cronobacter Infection and Infants
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.