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FDA Sets Safety Standards for Infant Formula

Friday, February 07, 2014
Sandler, Travis & Rosenberg Trade Report

The Food and Drug Administration has issued an interim final rule that, effective July 10, will set standards designed to prevent the manufacture of adulterated infant formula and ensure that the nutrients in the infant formula are present in a form that is bioavailable and safe. This rule applies only to infant formulas represented for use by healthy infants without unusual medical or dietary problems. Comments on issues or information not previously considered will be accepted through March 24.

According to an agency press release, the interim final rule amends FDA’s quality control procedures, requirements about how and when manufacturers must notify the agency about new formulas and changes to formulas, and requirements concerning what manufacturing and related records and reports must be established and maintained. It also establishes current good manufacturing practices specifically designed for infant formula, including required testing for contamination from harmful bacteria such as Salmonella. In addition, the rule will help ensure that infant formula contains all federally required nutrients, such as protein, fat, and certain vitamins and minerals, and supports healthy growth.

FDA notes that companies currently manufacturing infant formula in the U.S. have been producing safe infant formula in compliance with requirements of the Infant Formula Act and voluntarily conduct many of the current good manufacturing practices and quality control procedures included in the interim final rule.

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