The rule, to be officially released on Tuesday, includes requiring
companies to test for salmonella and cronobacter, two bacteria that
can cause particularly severe illness in babies, the Food and Drug
The move follows several, high-profile nationwide recalls of various
formula products in the past several years that have hit the
multi-billion-dollar industry, which has increasingly sought to
expand by selling formulas aimed at older infants and toddlers.
In 2010, Abbott Laboratories recalled 5 million containers of its
Similac products because of possible contamination from insect
parts. Mead Johnson Nutrition Co in 2011 saw its shares fall when
stores pulled some powdered versions of its Enfamil product over
concerns about infection, although the FDA later said a recall was
While public health officials generally say breast milk is best for
babies, they acknowledge that many infants get all or part of their
nutrition through formula. The new rule, the FDA said, is aimed at
establishing "good manufacturing practices" that many companies have
already adopted voluntarily.
It only applies to formula marketed for "for use by healthy infants
without unusual medical or dietary problems," the FDA said in a
Under the regulation, companies must screen formula for salmonella,
which can cause diarrhea and fever resulting in particularly severe
problems for babies. They must also check for cronobacter, which is
known to live in dry conditions such as powdered formula and cause
swelling of the brain known as meningitis in infants.
While the FDA does not approve infant formula products before they
can be sold, companies under the rule must also test their products'
nutrient content and show that their formulas can "support normal
physical growth," the agency said. The International Formula Council
said it strongly supported finalization of the regulation.
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“As an industry, we are proud of our record and support any effort
that further advances infant formula safety and quality,” Mardi
Mountford, executive vice president of the industry group, said in a
The American Academy of Pediatrics, which represents physicians who
treat babies and children, also welcomed the regulation.Other infant
formula manufacturers include Nestle SA, which makes Gerber brand
formula, and Hain Celestial Group Inc, maker of Earth's Best.
Perrigo Co manufactures many store-brand formulas.
(Reporting by Susan Heavey; Editing by Andrew Hay, Peter Cooney and
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