FDA publishes interim final rule regarding cGMPs for infant formula

SILVER SPRING, Md. — The Food and Drug Administration last week 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sets standards for manufacturers to produce safe infant formula that supports healthy growth, is accompanied by two draft guidance documents for industry.

“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,” stated Michael 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.” 

While breastfeeding is strongly recommended and many mothers hope to breastfeed, only 75% of infants in the United States start out being breastfed. By age 3 months, two-thirds, or 2.7 million U.S. infants, rely on infant formula for some portion of their nutrition. The interim final rule applies only to infant formulas represented for use by healthy infants without unusual medical or dietary problems. 

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 from cronobacter or 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The two draft guidance documents published last week provide industry with additional information related to the interim final rule. One draft guidance document addresses the manufacture of infant formula products made for infants with unusual medical or dietary problems. For example, these infant formulas might be made for infants who are born extremely premature and have special dietary needs. This type of formula is not the subject of this interim final rule. The draft guidance provides information about the manufacture of such formulas in relation to the requirements for current good manufacturing practices, quality control procedures, the conduct of audits, and records and reports that apply to the infant formulas covered by the interim final rule. 

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.

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