The FDA published an interim final rule Thursday, with guidelines to continue the safe manufacturing of infant formulas.
“Many families rely on infant formula as either the sole source of nutrition or an integral part of an infant’s diet through 12 months of age,” said Michael R. Taylor, FDA's deputy commissioner for foods, in a statement. “The FDA sets high quality standards … because nutritional deficiencies during this critical time of development can have a significant impact on a child’s long-term health and well-being.”
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The rule ensures that infant formulas contain all federally required nutrients and requires testing for microbactieral contamination to prevent the distribution of infant formula products contaminated with Cronobacter and Salmonella. It also establishes quality factor requirements to support healthy growth.
This rule applies only to infant formulas for use by healthy babies without unusual medical or dietary problems.
Companies manufacturing infant formula in the U.S. already voluntarily conduct many of the manufacturing practices and quality control included in the FDA rule. The public has 45 days to comment on the rule.
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