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FDA to Tighten Baby Formula Standards

The U.S. Food and Drug Administration (FDA) today announced new rules surrounding the manufacture of infant formula. The rules are meant to raise standards for formula manufacturing and ensure all for...
FDA to Tighten Baby Formula Standards
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  • The U.S. Food and Drug Administration (FDA) today announced new rules surrounding the manufacture of infant formula. The rules are meant to raise standards for formula manufacturing and ensure all formula is safe and nutritious.

    The new rule would improve quality control, notification, and record-keeping for manufacturers of infant formula. Microbial contamination testing will now also be required for infant forumla products. New quality factor requirements that will “support healthy growth” are also established by the rule, as are requirements that all infant formula contain federally-required nutrients.

    “Many families rely on infant formula as either the sole source of nutrition or an integral part of an infant’s diet through 12 months of age,” said Michael Taylor, deputy commissioner for Foods and Veterinary Medicine at the FDA. “The FDA sets high quality standards for infant formulas because nutritional deficiencies during this critical time of development can have a significant impact on a child’s long-term health and well-being. This rule will help to prevent adulteration in infant formula and ensure infant formula supports normal, physical growth.”

    According to the FDA, only 75% of U.S. infants are breast-fed from birth. Three months on from birth around two-thirds of all U.S. infants are estimated to rely on infant formula for at least part of their food intake.

    The new rule (technically an interim rule) will be available for public comment for 45 days. In the meantime, the FDA has stated that many of the rule’s provisions are already followed by infant formula manufacturers in the U.S.

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