FDA Publishes Interim Final Rule on Infant Formula

<p>The rule will ensure infant formula contains federal required nutrients, the agency said.</p>

WASHINGTONThe U.S. Food and Drug Administration (FDA) has published an interim final rule that is intended to protect babies who are fed infant formula.

The rule, accompanied by two draft guidance documents, establishes standard for manufacturers to produce safe infant formula, the agency said.

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 childs long-term health and well-being," said Michael R. Taylor, the FDAs deputy commissioner for Foods and Veterinary Medicine, in a statement. "This rule will help to prevent adulteration in infant formula and ensure infant formula supports normal, physical growth."

According to FDA, only 75% of U.S. infants begin their life breastfeeding. By the time they are 3-month-old, infants rely at least partly on formula, the agency said.

The rule will ensure infant formula contains federal required nutrients, the agency said. FDA has established current good manufacturing practices (CGMPs) for infant formula, which includes a requirement that products are tested for microbial contamination. The rule also amends the agency's quality control procedures, notification, and record and reporting requirements.

"The interim final rule also establishes quality factor requirements to support healthy growth," FDA said.

FDA said many companies producing infant formula already voluntarily engage in the CGMPs and quality control procedures that the interim rule requires.

Finally, the agency has issued two draft guidance documents. One of them relates to infant formula products that are made for infants who are suffering from unusual medical or dietary problems. In the other guidance document, FDA explains how manufacturers can demonstrate that their products meet the quality factor requirements.

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