New rules would ensure safety of infant formula

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WASHINGTON (AP) — 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.
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Follow Mary Clare Jalonick on Twitter: http://twitter.com/mcjalonick
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