Date Published: 6 February 2014

Updated FDA rules for infant formula - new regulations to maintain quality standards

The United States Food and Drug Administration (FDA) have just announced updated requirements for infant formula products. Changes to the FDA requirements for these products are intended to maintain high-quality standards and to help ensure the healthy growth of infants whose early nutrition relies on them.

The U.S. FDA has published an interim final rule that sets standards for manufacturers to produce safe infant formula that supports healthy growth. It is accompanied by two draft guidance documents for industry.

This is important because although breastfeeding is strongly recommended and many mothers would like to breastfeed, only 75% of infants in the USA are breastfed from birth. By the age of only three months, around two-thirds (2.7 million) American infants rely on infant formula for at least some part of their nutrition.

The interim final rule applies only to infant formulas for use by healthy infants who do not have known unusual medical or dietary problems. It amends the FDA's quality control procedures, notification, and record and reporting requirements for manufacturers of applicable infant formula products. The rule will, in part, ensure that infant formula contains all federally required nutrients. The interim final rule also establishes good manufacturing practices specifically designed for infant formula, such as the required testing for microbial contamination - which 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The two draft guidance documents provide industry with additional information about the interim final rule. One draft guidance document addresses the manufacture of infant formula products made for infants with unusual medical or dietary problems. The other draft guidance document explains how manufacturers of currently and previously marketed infant formulas can demonstrate that their products meet the quality factor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.

Expert comment:

Michael R. Taylor, the FDA's deputy commissioner for Foods and Veterinary Medicine said:

" 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.
_ 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."

Note: The FDA is an agency within the U.S. Department of Health and Human Services that is responsible for protecting 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. It is also is responsible for the safety and security of the USA's food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products. (This is understood to be correct as of February 2014.)

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