The U.S. Food and Drug Administration published an interim final rule to further safeguard the health of infants fed infant formula in the United States. The rule, which sets standards for manufacturers to produce safe infant formula that supports healthy growth, is accompanied by two draft guidance documents for industry.
The interim final rule amends the FDA’s quality control procedures, notification, and record and reporting requirements for manufacturers of applicable infant formula products. The rule, in part, will ensure that infant formula contains all federally required nutrients. The interim final rule also establishes current good manufacturing practices 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 infant formula products contaminated with the pathogens Cronobacter and Salmonella. The interim final rule also establishes quality factor requirements to support healthy growth.
Companies currently manufacturing infant formula in the United States already voluntarily conduct many of the current good manufacturing practices and quality control procedures included in the interim final rule. Following publication of the rule, the FDA will be accepting and reviewing comments on issues or information not previously considered.
The FDA is accepting comments from the public on the interim final rule for 45 days at http://www.regulations.gov (Docket Number FDA-1995-N-0036).
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