WASHINGTON, June 9 U.S. health officials on
Monday finalized manufacturing guidelines for infant formula
makers that aim to ensure products sold for babies meet certain
quality controls to keep them safe.
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 Administration said.
The move follows several, high-profile nationwide recalls of
various formula products in the past several years that have hit
the multi-billion 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 not needed.
While public health officials generally say breast milk is
best for babies, they acknowledge that many infants get some or
part of their nutrition through formula. The new rule, FDA said,
is aimed at establishing so-called "good manufacturing
practices" that many companies have already adopted voluntarily.
It also only applies to formula marketed for "for use by
healthy infants without unusual medical or dietary problems,"
FDA said in a statement.
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, 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, under the rule companies must also test
their products' nutrient content and show that their formulas
can "support normal physical growth," the agency said.
Representatives for the International Association of Infant
Food Manufacturers, the Switzerland-based group that represents
the industry, could not be immediately reached for comment.
Representatives for the International Formula Council, another
industry group, also could not be immediately reached.
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)