Last month, the FDA published an interim final rule to further safeguard infant formula in the U.S. 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sets standards for manufacturers to produce safe infant formula that supports healthy growth, is accompanied by two draft guidance documents for industry.
“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, the FDA’s deputy commissioner for Foods and Veterinary Medicine. “The FDA sets high quality standards for infant formulas because nutritional deficiencies during this critical time of development can have a significant impact on a child’s long-term health and well-being. This rule will help to prevent adulteration in infant formula and ensure infant formula supports normal, physical growth.”
The rule amends the FDA’s quality control procedures, notification, and record and reporting requirements for manufacturers. It 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 pathogens like Salmonella. The rule also establishes quality factor requirements to support healthy growth.
Companies currently manufacturing infant formula in the U.S. already voluntarily conduct many of the current good manufacturing practices and quality control procedures included in the interim final rule, which only applies to infant formulas for use by healthy infants without unusual medical or dietary problems.
There are two draft guidance documents providing industry with additional information. One document addresses the manufacture of infant formula products made for infants with unusual medical or dietary problems, such as infants who are born extremely premature and have special dietary needs. The other draft guidance document explains how manufacturers of currently and previously marketed infant formulas can demonstrate that their products meet the quality factor requirements of the interim final rule.
FDA Draft Guidance for Industry:
- Exempt Infant Formula Production: Current Good Manufacturing Practices, Quality Control Procedures, Conduct of Audits, and Records and Reports
- Demonstration of the Quality Factor Requirements Under 21 CFR 106.96(i) for “Eligible” Infant Formulas
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