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FDA Sets Manufacturing Standards for Infant Formula

Wednesday, June 11, 2014
Sandler, Travis & Rosenberg Trade Report

The Food and Drug Administration has issued a final rule setting standards for manufacturers of infant formula. This rule, which contains some modifications, clarifications and technical revisions from the February 2014 interim final rule, applies only to infant formulas intended for use by healthy infants without any unusual medical or dietary problems. Compliance with this rule will be required as of Sept. 8, 2014, for certain requirements and Nov. 12, 2015, for others.

The final rule establishes current good manufacturing practices specifically for infant formula, including required testing for the pathogens Salmonella and Cronobacter. The rule also establishes quality control procedures (e.g., a requirement that infant formulas be tested for nutrient content in the final product stage, before entering the market, and at the end of their shelf life), requirements on how and when manufacturers must notify the FDA about new formulas (including major changes to formulas), and requirements concerning recordkeeping. The agency notes that companies currently manufacturing infant formula for the U.S. market already voluntarily conduct many of the CGMPs and quality control procedures included in this rule.

The FDA has also published a final guidance document explaining how manufacturers of infant formulas that are the subject of a premarket notification submitted prior to Sept. 8 can demonstrate that their products meet the quality factor requirements of the final rule. This document answers questions about what evidence is needed to show that these products fulfill the quality factor requirements (i.e., sufficient biological quality of protein contained in the product and normal physical growth of infants consuming the formula), related record requirements, and the process for the voluntary submission of a citizen petition to demonstrate that the eligible infant formula products meet the quality factor requirements.

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