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June 9, 2014

FDA finalizes new safety regulations for baby formula

The Food and Drug Administration on Tuesday will finalize new safety standards for manufacturers of infant formula.

The Food and Drug Administration on Tuesday will finalize new safety standards for manufacturers of infant formula.

The standards establish guidelines for how and when manufacturers must notify FDA about new formulas and changes to formulas, in addition to proper record-keeping practices. They require companies to test formula for harmful bacteria such as Salmonella and Cronobacter, and to demonstrate that their formulas promote “normal physical growth” in babies.

Formula now also will have to be tested for nutrient content before going on the market as well as at the end of its shelf life.

Many formula manufacturers in the U.S. already meet these standards voluntarily as part of companies’ quality control procedures, but the FDA’s new rule will make the safety and quality of formula federally enforceable, the agency said.

The standards apply only to formulas marketed to healthy babies, and not babies with medical or dietary problems.

Manufacturers have until September 2014 to comply with the new rules.

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