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.
