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FDA updates safety standards for infant formula

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The FDA has published an interim final rule to maintain high quality-standards for manufacturing the safest possible infant formula to support babies’ health in the United States.

“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 R. Taylor, the FDA’s deputy commissioner for Foods and Veterinary Medicine. “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.”

Although nursing is the perferred method of feeding infants, not all women are able to, or even want to breastfeed for both medical as ell as personal reasons. In fact, the FDA reports that 75% of infants in the US are breastfed from birth.

“By age three months, nearly 2.7 million U.S. infants rely on infant formula for some portion of their nutrition. The interim final rule applies only to infant formulas represented for use by healthy infants without unusual medical or dietary problems,” continued Taylor.

While most companies currently manufacturing infant formula here already voluntarily conduct many of the current good manufacturing practices and quality control procedures included in the FDA’s interim final rule, the agency is seeking to amends its quality control procedures, notification, and record and reporting requirements for manufacturers of applicable infant formula products in order to ensure that all brands of infant formula “contains all federally required nutrients.” It also establishes improved manufacturing practices requiring testing for microbial contamination and sampling of finished products to prevent the spread of salmonella and cronobater.

Those interested in expressing their own opinions regarding the interim final rule are invited to submit their comments for 45 days at (Docket Number FDA-1995-N-0036).



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