WASHINGTON — After nearly two decades of study, the Food and Drug Administration announced rules Thursday designed to make sure that infant formula is safe and nutritious.
Most formula makers already abide by the practices, but the FDA now will have rules on the books that ensure formula manufacturers test their products for salmonella and other pathogens before distribution. The rules also require formula companies to prove to the FDA that they are including specific nutrients — proteins, carbohydrates, fats, vitamins and minerals — in their products.
It is already law that formula must include those nutrients, which help babies stay healthy. But the new rules will help the FDA keep tabs on companies to make sure they are following the law. The rule would require manufacturers to provide data to the FDA proving that their formulas support normal physical growth and that ingredients are of sufficient quality.
“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,” Michael Taylor, the FDA's deputy commissioner for foods, said.
The rules also are aimed at new companies that come into the market. In recent years, grocery store aisles have become even more crowded with new kinds of formula, some capitalizing on natural or organic food trends.
The agency said breastfeeding is strongly recommended for newborns but that 25 percent of infants start out using formula. By three months, two-thirds of infants rely on formula for all or part of their nutrition.
The FDA doesn't approve formulas before they are marketed but formula manufacturers must register with the agency. The FDA also conducts annual inspections of facilities that manufacture infant formula — far more often than the agency does inspections of other food facilities.
Dr. Stephen Ostroff, chief medical officer of the FDA's Office of Foods and Veterinary Medicine, says the rules will help the agency enforce the law if it inspects a facility or looks at a company's records and find problems. He said the rules were stalled for so many years — they were first proposed in 1996 — as the agency was keeping up with science that became available on food safety and other related issues.
Congress passed the Infant Formula Act in 1980 after a major manufacturer reformulated some of its formula products and omitted salt. A year later, infants who had eaten the formula were diagnosed with a chloride deficiency. The act required formula makers to use specific nutrients.
Over the years, infants occasionally have been diagnosed with cronobacter, one of the pathogens formula makers will now be required to test for and that is linked to infant formula. Found in the environment, hospitals and homes, cronobacter can multiply when formula sits out between feedings. It has only been found once in an unopened powdered formula, in 2002.
In 2011, the FDA and the federal Centers for Disease Control and Prevention tested infant formulas for cronobacter after four infants were infected with the pathogen in four states, and two of those infants died. They found no cronobacter in unopened cans of formula and were unable to link the cases to each other.