US: FDA finalising new infant formula regulations
US stepping up regulation of formula manufacture
The US Food and Drug Administration is finalising new standards for infant formula manufacture.
Under the new regulation, infant formula manufacturers distributing products for sale in the US will be required to test for pathogens including salmonella and cronobacter.
Formula firms will also have to test the nutrient content of formula products in the final product stage - before entering the market - as well as at the end of the product's shelf life. Manufacturers will be required to demonstrate that their products "support normal physical growth", the regulator said.
"FDA sets high quality standards for the safety and nutritional quality of infant formulas during this critical time of development," said Stephen Ostroff, the FDA's acting chief scientist.
The FDA recognised that "many" companies manufacturing infant formula for the US market have "voluntarily applied many of the current good manufacturing practices and quality control procedures". However, the regulator added: "This rule will set in place federally enforceable requirements for the safety and quality of infant formula."
All formulas marketed in the US must meet federal nutrient requirements, which are not changed by the new rule.
Infant formula makers are required to register with the FDA and the agency carries out yearly inspections of all facilities where infant formula is made.
Manufacturers must be compliant with regulations by 8 September, the FDA said.
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