Mead Johnson Says FDA Inspects Formula Factory in Probe of Infant Death
U.S. regulators have spent today and yesterday inspecting a Mead Johnson Nutrition Co. (MJN) factory as part of an investigation into whether a Missouri child’s death this month was due to tainted infant formula.
Food and Drug Administration inspectors remain at the plant in Zeeland, Michigan, Susan Ricker, Mead Johnson’s global quality-services director, said today in a telephone interview. The Glenview, Illinois-based company said Dec. 25 that its tests had shown the batch of formula used by the infant was not contaminated with the Cronobacter bacteria blamed for the death.
“They have come in and we’ve been cooperating with them and providing information as they request it,” Ricker said.
U.S. regulators last week identified two other children infected by Cronobacter, a microbe that can lead to permanent neurological damage. Retailers led by Wal-Mart Stores Inc. (WMT) pulled a batch of Mead Johnson’s Enfamil Newborn formula after authorities said the Missouri child had used it. The formula used by the other children hasn’t been identified.
The FDA doesn’t discuss specifics of open investigations, Stephanie Yao, an agency spokeswoman, said today in an e-mail. Testing in the Cronobacter investigation is ongoing and the FDA doesn’t have a timetable for the results, she said.
Mead Johnson fell 1.6 percent to $67.98 at 4 p.m. New York time. The company, the world’s leading seller of child formula, had its biggest one-day gain in five months yesterday, increasing 5.8 percent, after announcing its test results. That followed a fall of 15 percent on Dec. 22 and 23, after retailers pulled the formula.
The first two infections were revealed last week. The U.S. Centers for Disease Control and Prevention said yesterday that a third case had been identified in Oklahoma. That newborn had been hospitalized and was given a different brand of formula than used in the two previously reported cases of the infection, said the CDC’s Chris Braden.
There’s too little evidence yet to say whether the Oklahoma illness is linked to baby formula, Braden said yesterday in a telephone interview. Regulators are testing powdered products in each of the cases, and have said they may have results this week. Wal-Mart said yesterday it will wait for the government results before deciding whether to return Mead Johnson’s formula to its shelves.
The Cronobacter bacteria “can be found in a lot of different places,” said Braden, who heads the Division of Foodborne, Waterborne and Environmental Diseases. “Even if these infants were on powdered infant formula, and even the same powdered infant formula, we still don’t know yet if that’s the source of their infections.”
Braden declined to identify the product being tested in the Oklahoma case. The Atlanta-based CDC is working with state health departments and the FDA to study the infections and doesn’t want to mislead the public, he said.
The CDC is testing for “numerous types of exposures,” Kate Levinson, an agency spokeswoman, wrote in an e-mail.
Mead Johnson said in a Dec. 25 statement that it used formula samples matching those screened by U.S. regulators in the case involving the dead baby, and employed the same methods.
Wal-Mart, Kroger Co. (KR) and Walgreen Co. (WAG) last week pulled a batch of Mead Johnson’s formula after the Missouri baby’s death was disclosed. Chris Perille, a Mead Johnson spokesman, said his company has received no contact from regulators or requests for samples to test in connection with the other two cases.
“There’s no indication of any connection whatsoever to any of our products,” he said.
Wal-Mart will await FDA results before deciding whether to return the product to its shelves, Dianna Gee, a spokeswoman for the Bentonville, Arkansas-based company, said yesterday in a telephone interview. Jim Cohn, a spokesman for Walgreen, in Deerfield, Illinois, said he was gathering information and couldn’t yet comment. Messages weren’t returned by Keith Daley, a spokesman for Cincinnati-based Kroger.
The Enfa brands, which include Enfamil, accounted for 79 percent of Mead Johnson’s $3.14 billion in 2010 revenue and were the world’s lead brand franchise in pediatric nutrition based on retail sales, the company said in a February filing.
The CDC is working with state regulators and the FDA in testing samples in the case of the Missouri baby who died, said Robert Tauxe, deputy director of the foodborne infection division.
The second case involved an Illinois baby who fell sick in Missouri during a trip, officials have said. Public health officials are checking to see if the bacteria in the infections have the same genetic fingerprint, Tauxe said in a Dec. 23 telephone interview. If they do, that may suggest they came from the same source.
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