New Baby Formula Standards Require More Safety Testing

The FDA announced the finalization this week of new rules designed to make baby formula safer, requiring that manufacturers demonstrate the formula supports a baby’s normal physical growth and that the formula is properly tested.

The new FDA infant formula rules provide safety standards for manufacturers and encourage practices that may prevent harm for babies.

Among the new rules are requirements that manufacturers conduct testing to ensure disease-causing bacteria, such as Salmonella and Cronobacter, are kept of out baby formula.

Manufactures will also be required to demonstrate that the formula supports normal physical growth, and test for nutrient content in the final product stage, before the formula is allowed on the market, and again at the end of a product’s shelf life.

“This rule will set in place federally enforceable requirements for the safety and quality of infant formula,” said Stephan Ostroff, FDA’s acting chief scientist, in the FDA news brief.

The rules will only apply to infant formulas used by healthy babies without unusual medical or dietary problems. The FDA reported many infant formula manufacturers in the U.S. have already voluntarily applied many of the current good manufacturing practices and quality control procedures outlined in the final rule.

The rules were initially published as interim rules on February 10. After receiving feedback during the open comment period, the FDA made adjustments before releasing the details of the final rules. Manufacturers will be required to comply by the new rules set forth by September 8, 2014.

The FDA does not approve infant formula before it goes to market, however, all formulas marketed in the U.S. must meet federal nutrient requirements, which were not changed by the rule. The FDA does hold other regulatory authority over formula manufacturers to help ensure the formula manufactured is safe for consumption.

Manufacturers are required to register with the FDA and provide the agency with notification before marketing a new formula. In addition, the FDA conducts a yearly inspection of facilities that manufacture infant formula.

The FDA also collects and analyzes samples from the facilities to ensure product safety, and inspects new facilities.

If the FDA deems an infant formula is a risk to infants, the manufacturer is required to issue a product recall.

Experts recommend that infants be breastfed to receive optimal nutrition, yet many infants still rely on formula for a some or all of their nutrition. One million infants are fed formula at birth in the U.S., by three months of age more than 2.7 million babies are fed formula.

Infant formulas are sold in powder, liquid concentrate and ready to feed liquid forms. The FDA sets specifications for nutrient content for infant formula, yet many manufacturers set levels above what the FDA dictates.

Recent Infant Formula Problems

The new rules come following several high-profile recalls issued in recent years involving infant formula.

Abbott Laboratories recalled more than 5 million containers of Similac products in 2010, due to reports of contamination by insect parts. Concern was raised due to the likelihood of a child ingesting the small beetles and having difficulty feeding, breathing or other gastrointestinal problems.

A class action lawsuit was filed alleging the company deceptively promoted the formula as safe and did not put adequate quality control measures in place to make sure the formula was free of beetles.

In 2011, Mead Johnson Nutrition Co. recalled powdered versions of Enfamil products after the death of a Missouri baby was linked to contaminated infant formula. The baby was 10 days old and died from a Cronobacter sakazaki infection, a rare bacterium linked to contaminated baby formula. Wal-Mart initially pulled the formula from the shelves, prompting a larger recall by the FDA.