FDA Finalizes Manufacturing Practices for Infant Formula

The U.S. Food and Drug Administration (FDA) has announced a final rule setting standards for manufacturers of infant formula. With a compliance date of September 8, 2014, the final rule includes (i) “current good manufacturing practices specifically designed for infant formula, including required testing for the harmful pathogens (disease-causing bacteria) Salmonella and Cronobacter”; (ii) “a requirement that manufacturers demonstrate that the infant formulas they produce support normal physical growth”; and (iii) “a requirement that infant formulas be tested for nutrient content in the final product stage, before entering the market, and at the end of the products’ shelf life.”

Although many companies have already adopted these standards on a voluntary basis, the final rule creates federally enforceable requirements for powdered, liquid concentrate and ready-to-feed formulas. “FDA does not approve infant formulas before they can be marketed,” notes the agency in a June 9, 2014, press release. “However, all formulas marketed in the United States must meet federal nutrient requirements, which are not changed by the new rule. Infant formula manufacturers are required to register with FDA and provide the agency with notification prior to marketing a new formula.”

Issue 526