Updated FDA requirements for infant formula will maintain high-quality standards and help ensure healthy growth of infants

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Interim final rule establishes current good manufacturing practices for continued safe infant formula production

Today, 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sets standards for manufacturers to produce safe infant formula that supports healthy growth, is accompanied by two draft guidance documents for industry.

“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.” 

While breastfeeding is strongly recommended and many mothers hope to breastfeed, only 75 percent of infants in the United States start out being breastfed.  By age three 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. 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 two draft guidance documents published today 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.

The FDA is accepting comments from the public on the interim final rule for 45 days at www.regulations.gov (Docket Number FDA-1995-N-0036).

For more information:
Interim final rule and guidance documents

The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation's food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.

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