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Dairy Facts 2016

FDA Issues Final Rule Setting Manufacturing Standards for Infant Formula

Jun 11, 2014

The Food and Drug Administration this week announced a final rule setting standards for makers of infant formula to help ensure that products made for the U.S. market continue to be safe and support healthy infant growth. The final rule, which will be effective July 10, 2014, includes modifications, clarifications and technical revisions to the interim final rule issued in February.

The rule will affect all infant formula manufacturers as well as companies that supply ingredients for infant formulas.

It establishes current Good Manufacturing Practices (CGMPs) for infant formula, which include required testing for the pathogens Salmonella and Cronobacter sakazakii. [NOTE: FDA currently is conducting a sampling assignment of spray drying facilities, and not only those producing for infant formula, to determine a baseline prevalence level of Salmonella and Cronobacter sakazakii in those environments. FDA has not been clear about what action they will take regarding positive test results.]

The rule also establishes quality control procedures, requirements about how and when manufacturers must notify FDA about new formulas or major changes to formulas, and recordkeeping requirements. According to FDA, companies that make infant formula for the U.S. market already voluntarily conduct many of the CGMPs and quality control procedures included in the rule.

FDA also released a new final guidance document to explain how manufacturers can demonstrate that their products meet the rule’s quality factor requirements. These requirements cover the biological quality of protein in the product and the normal physical growth of infants consuming the formula.

The final rule and final guidance were published Tuesday.

For more information, contact John Allan, IDFA vice president of regulatory affairs and international standards, at

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