FDA issues final rule setting manufacturing standards for infant formula in US
The US Food and Drug Administration (FDA) has announced a final rule setting standards for manufacturers of infant formula which it said will “help ensure that the formulas made for the US market continue to be safe and support healthy growth for infants who consume formula”.
The final rule contains some modifications, clarifications and technical revisions that differ from the interim findings on February 10, 2014.
The FDA said that while breastfeeding was strongly recommended and many mothers hoped to breastfeed their infants, most infants in the US relied on infant formula for some portion of their nutrition. The final rule applies only to infant formulas intended for use by healthy infants without any unusual medical or dietary problems.
The final rule establishes current Good Manufacturing Practices (CGMPs) specifically for infant formula, including required testing for the pathogens Salmonella and Cronobacter. The rule also establishes quality control procedures, requirements about how and when manufacturers must notify the FDA about new formulas, including major changes to formulas, and requirements concerning recordkeeping.
The FDA said companies currently manufacturing infant formula for the US market already voluntarily conduct many of the CGMPs and quality control procedures included in the final rule.
The FDA is also publishing a final guidance document explaining how certain “eligible” infant formula manufacturers can demonstrate that their products meet the quality factor requirements of the final rule. It said this document applied to infant formulas that are the subject of a premarket notification submitted prior to the 8 September 2014 compliance date of the final rule. The guidance 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.
The final rule and final guidance were published officially in the Federal Register on 10 June 2014.