FDA’s interim final rule amends the FDA’s quality control procedures, notification, and record and reporting requirements for manufacturers of infant formula products. The rule, in part, will ensure that infant formula contains all federally required nutrients. It also establishes cGMPs specifically designed for infant formula, including required testing for microbial contamination. This microbial testing includes testing representative samples of finished products to prevent the distribution of products contaminated with the pathogens Cronobacter and Salmonella. The rule also establishes quality factor requirements to support healthy growth. Applying only to formulas for healthy infants, the rule is accompanied by two draft guidance documents for industry, including one document that addresses the manufacture of formula products made for infants with unusual medical or dietary problems, such as infants who are born extremely premature.
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