In response to the 2022 infant formula supply crisis and resulting deadly infections, the FDA has updated its infant formula compliance program.
The outbreak of Cronobacter infections in five infants, two of whom died, began in the fall of 2021 and continued into early 2022. Abbott Nutrition began a recall of Similac infant formula and other brands in February 2022. This recall caused a nationwide shortage. And parents ended up driving hours to find formula for their babies.
During its investigation, the Food and Drug Administration discovered Cronobacter contamination at an Abbott manufacturing plant in Sturgis, Michigan. The agency also found that the company tested the product and tested positive for Cronobacter, but Abbott did not report it to the FDA.
In May 2022, after intense Congressional hearings, FDA officials began an internal investigation that included a review of the issues raised by the whistleblower. The new compliance program is in response to that investigation. This program is aimed at FDA investigators, laboratory analysts, and compliance personnel.
” Infant Formula Compliance Program The purpose is to provide a comprehensive overview of the agency’s approach to testing, sample collection, sample analysis, and compliance activities to ensure the safety and nutritional value of infant formula products in the U.S. food supply, according to an FDA statement. It is said that ”
“FDA today announced an updated compliance program that builds on lessons learned over the past several years and details our approach to testing, sampling, laboratory analysis, and imported infant formula products. I am.”
Going forward, to remain compliant, companies will need to follow the latest instructions regarding annual environmental sampling at baby formula manufacturing facilities. These sampling tests should include Cronobacter and Salmonella. If your test finds any pathogens, you must notify the FDA. You must also notify the agency if testing shows nutrients above or below levels required according to FDA infant formula regulations.
The compliance program also includes instructions on how to immediately escalate any positive product or environmental concerns identified during records review to the appropriate subject matter expert within the Food and Drug Administration’s Human Food Program .
Additional background on the risks associated with Salmonella and Cronobacter in infant formula products and conditions that may lead to environmental contamination within manufacturing facilities is included in the updated compliance program.
Additionally, learn more about the new requirements related to infant formula included in the Food and Drug Omnibus Reform Act of 2022.
For all the latest information on FDA oversight of infant formula, FDA Infant Milk Web Page.
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