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Despite being a challenging year, the U.S. Food and Drug Administration’s Foods Program has taken important strides in 2022 to protect the safety of human foods and expand access to safe and nutritious foods for all consumers last year.
We know the infant formula issue created hardships for far too many families across the country, so first we’d like to take a moment to highlight our work to address the Cronobacter sakazakii related illnesses in infants and the ensuing infant formula shortage, one of the toughest challenges the FDA has faced since the passage of the Food Safety and Modernization Act. This situation reinforced our public health mission.
As the infant formula incident unfolded, we worked around-the-clock with infant formula manufacturers to increase production and used data tools to monitor industry-provided production volumes for infant formula and assist with tracking and addressing infant formula supply shortages throughout the country.
Additionally, we have expanded access to infant formula by exercising enforcement discretion for 12 firms to temporarily import their foreign-produced infant formula products into the U.S. market. The agency has provided a pathway for those manufacturers to bring their products into full compliance with U.S. requirements and be able to sell in the U.S. permanently. Importantly, we also worked with manufacturers to increase their production capacity by exercising flexibility on ingredient and packaging supply chain issues and by working with other government partners activated the Defense Production Act to ensure availability of critical ingredients.
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