Regulators are testing whether baby formula made by Mead Johnson Nutrition Co. caused the death of a newborn after Kroger Co., Walgreen Co. and other retailers removed the product from stores.
Officials screening samples of the formula and water used to prepare it said results may not come until next week. A second child infected with the same bacteria in Missouri, who survived, also was given formula, though officials today said the baby ingested other types of products as well.
Both babies tested positive for Cronobacter, an environmental bacteria that can be fatal. The possible link to formula is prompting concern from parents, who said they were throwing the product away, and health officials outside of Missouri, who were reviewing infant deaths. If bacteria are conclusively found in unopened formula, a formal recall could follow, the U.S. Food and Drug Administration said.
“Every mom and dad who sees symptoms are going to think they’ve got it,” said Dave Theno, chief executive officer of Gray Dog Partners Inc., a food safety consultant in Del Mar, California, in an interview. “If an infant is using this formula and your child is exhibiting any of the symptoms, get them seen right away and make sure they test for this.”
Mead Johnson, based in Glenview, Illinois, fell 5.1 percent to $65.29 at the close of New York trading, after plunging 10 percent yesterday when Wal-Mart Stores Inc. pulled its Enfamil Newborn formula from shelves. SuperValu Inc. and Safeway Inc. also withdrew the formula from stores.
‘Shoot First, Ask Later’
“This is a shoot-first, ask questions later moment for the stock,” Robert Moskow, an analyst at Credit Suisse in New York, wrote in a Dec. 22 note to investors. “The headline is scary enough to cause consumers to change their purchase patterns in the near-term, and no one knows how long that will last even if it is unjustified.”
The surviving baby, who fell sick in Missouri during a trip from its Illinois home, had been given a number of different products, and 17 samples were taken for tests, the FDA said today. Samples in the case of the newborn who died include an open formula container and a mixture of formula and water.
In both cases, “we are trying to figure out whether it came from the food,” said Siobhan DeLancey, an FDA spokeswoman, by telephone. “We take these into local labs and test them. We expect first results back next week.”
U.S. health officials probe about four to six such cases a year, DeLancey said.
Parents are concerned. Shreyash Maheshware, 30, a software engineer in Feasterville, Pennsylvania, is debating whether to continue using Enfamil Infant for his 3-month-old girl, he said in a telephone interview today.
“You can’t take any risk and you have to think twice,” Maheshware said. “I think I’m going to throw out everything.”
At Internet sites such as Cafemom, which carried news of the Missouri infant death, more than 60 parents have posted comments about Enfamil or formula. “Very scary,” read one post. “I just tossed the only can of formula I had out,” read another. “This terrifies me,” said another.
Roger Smith, chief deputy coroner with the Madison County coroner’s office in Edwardsville, Illinois, said his office was reviewing the case of a 25-day-old infant who died in that state on Dec. 21 is looking into the formula as a cause.
‘Getting in Front’
“It’s just being looked at because of the timing with her death” said Smith in an interview. “Her formula is different, but we wanted to get in front of it”
Neither Wal-Mart nor Mead Johnson provided the number of cans removed from shelves. The number is in the thousands, and about half of Wal-Mart’s stores carry the formula, said Chris Perille, a spokesman for Mead Johnson. Customers can return the withdrawn formula for a refund or exchange, said Dianna Gee, a spokeswoman for Wal-Mart, the world’s biggest retailer.
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. About 12 percent of Mead Johnson’s sales come from Wal-Mart, according to data compiled by Bloomberg.
A widespread recall may strip as much as 15 percent from Mead Johnson’s sales next year, wrote Amit Sharma, an analyst with BMO Capital Markets Corp. in New York, in a Dec. 22 note to investors. The U.S. accounts for about 30 percent of the company’s total sales, he said. A recall probably would also reverse Mead Johnson’s market share gains for the past two years, he said.
Kroger has pulled about 1,400 cans of the Mead Johnson formula that went to about 220 stores, said Keith Dailey, a spokesman for the Cincinnati-based retailer.
Walgreen withdrew the formula while “awaiting further clarity from the manufacturer and FDA,” said Robert Elfinger, a spokesman for the Deerfield, Illinois company, in an e-mail.
SuperValu, owner of 2,500 retail stores under names including Acme, Jewel-Osco and Shaw’s, pulled the formula yesterday “out of an abundance of caution,” said Mike Siemienas, a spokesman.
Several hundred markets across the company are affected, Siemienas said. The company will keep the Enfamil off shelves until the Eden Prairie, Minnesota-based grocer hears it is safe from health officials or Mead Johnson, he said.
The Missouri Department of Public Health and Senior Services on Dec. 19 issued a health alert on two babies infected with the bacteria within the last month, according to the agency’s website. The department didn’t say if the second infant used the Mead Johnson product.
‘Big, Fat Unknown’
That question is “a big, fat unknown,” the FDA’s DeLancey said.
Mead Johnson hasn’t received any complaint or requests for samples related to the child who survived the infection, Perille, the company spokesman, said.
“As far as we know, there is no connection between Enfamil Newborn and this second case,” Perille said. “Clearly if this other case was connected to Enfamil Newborn, we would have received case information and been contacted for samples.”
Cronobacter is part of a family of microorganisms called Enterobacter sakazakii that has a fatality rate of 40 percent to 80 percent in infants, according to Marler Clark, a Seattle-based law firm that focuses on foodborne illness litigation.
Finding a common source may be daunting, in part because memories of what was purchased can be faulty, said Bill Marler, a food-safety lawyer in Seattle. “They’re trying to ask people who are going through a trauma what they bought,” he said.
While it’s premature for parents to change what they feed their infants, it’s important to remind them to prepare formula properly, said Lorry Rubin, chief of pediatric infectious diseases at Cohen Children’s Medical Center of New York.
Glassware and bottles should be cleaned and sterilized, and the water should be boiled and cooled before it is added to powered formula, Rubin said. Any extra prepared formula should be immediately refrigerated and used within 24 hours, he said.
Bacteria from the Cronobacter family are known in the past to have contaminated infant formula, he said in a telephone interview. The strains are similar to the bacteria humans carry in their gut and typically don’t cause significant concern, Rubin said.
Last year, Abbott Laboratories recalled Similac-brand powder infant formulas distributed in the U.S., Puerto Rico, Guam and some Caribbean nations because of possible insect contamination.
Abbott hasn’t been contacted by public health authorities and there are no cases related to Similac or any of its infant formula products that the company knows about, said Jennifer Smoter, a company spokeswoman.
Typically the company would have been contacted by investigators from the hospital, the FDA or Centers for Disease Control and Prevention if there was any chance the illness was tied to the formula given to the newborn, Smoter said.
Nestle SA, maker of Gerber infant formula, hasn’t been contacted by regulators and has had no reports of any infants falling sick after receiving Gerber Good Start, said David Mortazavi, a company spokesman, in a statement.
Jennifer Kokell, a spokeswoman for Pfizer Inc.’s infant formula brands including SMA and Promil, had no immediate comment.