The Food and Drug Administration is looking to better regulate companies that manufacture infant formulas in an effort to protect babies from foodborne illnesses and promote healthy growth.
That rule would establish new safety standards for the manufacture of infant formulas, including quality control procedures, notification, and record and reporting requirements. It will also ensure that infant formula contains federally required nutrients, such as protein, carbohydrates, fat, vitamins and minerals.
These measures are intended to protect newborns who, the agency says, are more vulnerable to contracting diseases from contaminated food than older children and adults.
“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,” Michael Taylor, deputy commissioner for foods and veterinary medicine at the FDA, said in a statement. “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.”
The FDA noted that 75 percent of infants start out with breastfeeding. But by the time they reach three months, as many as 2.7 million infants rely on infant formula.
The rule would set in place good manufacturing practices and quality control procedures that many companies already follow voluntarily, the agency noted. This is intended to prevent companies from manufacturing an "adulterated" infant formula that is contaminated with pathogens such as salmonella and Cronobacter.
It would establish manufacturing controls for workers, facilities, equipment, ingredients and containers to protect the formula during the production, packaging and labeling processes.
The rule would also require testing for final product powdered infant formula before it has been distributed to make sure it has not been contaminated during the production process.
The current rules are based on a 1986 infant formula law. The FDA will accept comments on the interim final rule for 45 days.
The new rules do not apply to infant formulas manufactured for infants with special dietary needs and unusual medical conditions, such as for babies who are born prematurely.