FDA discovers trace amounts of melamine in infant formula.

The FDA's discovery of trace amounts of melamine in infant formula attracted significant attention in major US newspapers and on cable TV. The New York Times (11/26, A19, Martin) reports the discovery raises "the possibility that the problem was more extensive in the United States than previously thought." Although "few details were available late Tuesday, agency officials said they had discovered melamine at trace levels in a single sample of infant formula. It was also discovered in several samples of dietary supplements that are made by some of the same manufacturers who make formula." FDA spokeswoman Judy Leon said, "There's no cause for concern or no risk from these levels." She "said the contamination was most likely the result of food contact with something like a can liner, or from some other manufacturing problems, but not from deliberate adulteration."
The Los Angeles Times /Bloomberg (11/26) reports, "Of 77 samples tested, only one was found to have melamine, said Leon, who declined to identify the product." The contamination was discovered "as part of an FDA testing program begun after the chemical was found in Chinese products. The amount of melamine in the US sample was 'well below' 250 parts per billion, Leon said." Leon said, "That is what is considered trace amounts. ... It has nothing to do with adulteration."
The Washington Post (11/26, Shin) in its "Check Out" blog cites the Bloomberg News story and points out, "Not sure how this jibes with the Food and Drug Administration's recent risk assessment which said it was 'unable to establish any level of melamine and melamine-related compounds in infant formula that does not raise public health concerns' but you be the judge!"
In an article published on the web sites of over 150 US media outlets the AP (11/26, Mendoza, Pritchard) reports FDA Center for Food Safety and Applied Nutrition director Dr. Stephen Sundlof said, "The levels that we are detecting are extremely low. ... They should not be changing the diet." He "told the AP the positive test results 'so far are in the trace range, and from a public health or infant health perspective, we consider those to be perfectly fine.'" The AP notes, "That's different from the impression of zero tolerance the agency left on Oct. 3."
The Wall Street Journal (11/26, Zhang, Wang) reports, "Dr. Sundlof said the agency didn't find the combination of melamine and cyanuric acid in any infant formula sample. Together, the two substances cause kidney stones, among other illnesses, and sickened the Chinese infants." Despite the assurance of FDA officials "the findings are likely to upset parents who feed formula to their babies. But just how much is at stake for the manufacturers isn't certain." CNN (11/26) also reports the story.

Formula For Tragedy: Milk-Based Powdered Formula

The Chicago press has picked up on the E. Sak dilemma. Hopefully, this will lead to more coverage.

Formula For Tragedy: Milk-Based Powdered Formula
Powdered Baby Formula Could Be Dangerous For Some Infants
CHICAGO (CBS News) ― Connor McGray and his twin brother, Logan, were born prematurely on Nov. 16, 2007 at an Illinois hospital. Connor appeared to be the healthier of the two. It wasn't until their parents, Amanda Carlin and Tim McGray of Somonauk, Ill., received a call from a doctor at the hospital a week later saying the infant was lethargic and refusing to eat. Doctors discovered Connor had meningitis and "they basically told us, all we could do was pray," their parents recall. On May 3, 2008, their baby died at home. "He knows there's something missing," Amanda Carlin says of their surviving child, Logan, who turned 1 last week.Officials listed the cause of death as hydrocephalus and bacterial meningitis. The bacterial infection, according to a memo from the Illinois Department of Public Health, "may be associated with the consumption of a powdered breast milk fortifier." The Enfamil brand powdered formula was fed to the Connor during his time in the the Neo-Natal Intensive Care Unit at Rush-Copley Medical Center. In a statement released on Nov. 13, 2008, Rush-Copley said: "We have the utmost compassion for the baby and his family." Hospital officials noted 4,000 babies are born at the facility each year and "the procedures followed here are consistent with the standards of care provided to prematurely born infants in the U.S." "There was nothing I could do. I felt helpless and part of me was gone forever," Carlin said. During an investigation by the CBS station in Chicago, research found Connor's death was not the only associated with the tainted baby formula claim. The Centers for Disease Control and Prevention says the danger with powdered formula is that -- unlike the liquid kind -- it cannot be sterilized, which makes it vulnerable to bacteria growing in it, CBS station KTVT-TV reported.The most severe cases involve babies exposed to a bacteria called Enterobacter sakazakii, or E-sak. The CDC notes e-sak can lead to raging infections, severe brain damage and ultimately death, as in Connor McGray's case. The baby suffered from seizures and brain abscess. According to official health records, his blood and cerebral spinal fluid tested positive for the organism. Premature Infants or those with weak immune systems are at greatest risk of getting infections, the U.S. Department of Health and Human Services reports. There is even a warning on powdered formula containers. One brand warns: "... powdered infant formulas are not sterile and should not be fed to premature infants or infants who might have immune problems unless directed and supervised by your baby's doctor." During the week before Connor's illness, a health department memo notes he was fed ready-to-feed liquid formula, as well as, breast milk with powdered infant fortifier. Hospital records show the powdered formula the hospital used was Enfamil by Mead Johnson. From Nov. 20 to Nov. 24, Connor was fed the product orally and through a nasogastric tube. The same health department report noted the product was prepared at the hospital in a prep area/station, not a dedicated formula preparation room. On Dec. 3, 2007, Connor was transferred from Rush-Copley to the University of Chicago because, Tim McGray said, the family wanted the twin boys together. Logan was being treated at the University of Chicago for an intestinal condition. His mother said the hospital did not tell her about the risks of powdered formula. She said she also didn't learn about her son being given the powder, until she hired The Collins Law firm in Naperville. "We didn't find out until afterward, when we got a hold of whatever medical records we could get," McGray adds. "That's the only way we knew." The CBS2 investigation also uncovered other cases in which powdered formula was blamed for causing brain damage or death in infants. There have been at least two Illinois cases and cases in at least 17 other states, including Texas. Ed Manzke, one of the attorneys hired in Connor McGray's case said it's not an isolated problem. "There have been deaths all across the country related to powder infant formulas. And what is so shocking about it, is hardly anyone knows it. It's like leaving a loaded gun in a nursery." A 2001 E-Sak outbreak in Tennessee led to a 2002 U.S. Food and Drug Administration warning to health professionals. In a letter the FDA wrote: "FDA recommends that powdered infant formulas not be used in neonatal intensive care settings unless there is no alternative available." FDA officials also said there are sterilized liquid fortifiers on the market that can be used as an alternative. The FDA stopped short of issuing a complete ban on the powder, but said it may be used in the NICU when no appropriate liquid product is available. Despite the warning, five years later Connor McGray was given the powdered formula. His family says he was getting stronger and doing well until he got the powder. Daniel Korte also was fed powdered infant formula and was struck with the same infection and meningitis. His parents said the contaminated formula was fed to him at Mercy Medical Center in Des Moines, Iowa. Daniel survived, but is living in a nursing facility on a ventilator. "It basically turned his brain to mush," said Michelle Korte, Daniel's mother. "He is ventilated and his upper brain is destroyed." Korte said the hospital in this case also never warned her about the risk associated with the formula. An attorney she hired, Andy Weisbecker, said powdered formula manufacturers need to do a better job of informing doctors and parents about the danger. "More needs to be done to increase the level of knowledge about this deadly bug," Weisbecker said. "Who knows how many parents are out there with affected children who may still not be aware of a possible connection between these illnesses and contaminated formula." Federal regulators believe the number of cases are underreported. There may be other infants diagnosed with meningitis that have not been checked for E-sak. "They pretty much just want to sweep it under the rug and it's not an issue you can just sweep under the rug. I mean it took a baby's life," Copley stresses. Babies are not just being sickened by formula in hospitals, however. Parents unknowingly are buying the powdered formula for at-risk babies. Stephen Meyer, an attorney at the Law Office of Nick Stein in Indiana, has spent nine years working on E-sak cases. He said the FDA's warning should have gone to consumers. "Most moms would think 'If it's marketed to me, it's safe' … especially if it comes in a hospital gift bag." Mead Johnson officials said its products are safe as long as they are used according to label directions. The company said it has "taken the position that powdered infant formula should not be used in neonatal intensive care settings unless no alternative is available." Tracey Noe, a spokesman for Abbott, which manufactures formula including Similac, said it uses rigorous testing procedures, including bacterial testing, on its powdered formulas. "Abbott agrees with the U.S. Food and Drug Administration/Centers for Disease Control and Prevention joint recommendation that powdered formula should not be used in hospital neonatal intensive care units — unless no nutritionally suitable alternative is available," Noe responded. Both manufacturers have been sued by families who say they were affected by the tainted formula. The parents of Connor McGray and Daniel Korte also are planning to file lawsuits. In the meantime, they are talking about what happened in hopes of warning — and educating — doctors, hospital staff and other parents about the potential danger of powdered formula. "I want other people to be aware of it so they don't have to go through what I did," Amanda Carlin said.

Source:http://cbs4.com/health/tainted.baby.formula.2.871279.html

Aussie baby formula contaminated: China

The Australian manufacturers of a baby milk formula and a milk powder rejected by Chinese authorities say their products are safe.
Nine tonnes of Ausnutria products, manufactured by Australian dairy supplier Tatura, have tested positive to a potentially deadly bacterium.
China Inspection and Quarantine (CIQ) claim the products contained Enterobacter sakazakii which can cause fatal infections in infants.
Tatura said they were surprised by CIQ's findings.
"Other products, produced at the same time but sent on different shipments were cleared," Tatura spokesman Tony McKenna said.
Mr McKenna said Tatura would not change its testing standards which it claims are "state of the art".
The northern Victorian company maintains the discrepancy was due to the sensitivity of the tests, as well as the equipment and techniques used.
The Tatura products were rejected in June but only reported in the media this week.
Mr McKenna said the timing was disappointing but "not malicious".
"It's a hot topic and the press got a hold of it," he said.
He said Tatura's product was not linked to the recent scandal in which the industrial chemical melamine was discovered in milk made by 22 Chinese companies and then in eggs.
That tainted milk has killed four infants, while at least 53,000 have fallen ill.
"The fact is, we make different formula," he said.
Tatura said Ausnutria, the company exporting the product, remained confident with their testing standards.
Some 891 tonnes of Tatura products had been exported to China in the past year without incident, the company said.
Mr McKenna welcomed CIQ's decision to issue a public statement, assuring consumers products on the shelves were safe.
But Mr McKenna said the process should be changed to improve transparency.
"We don't get the results. You can't negotiate, you can't fight it, it just gets turned around (at the border)."
Tatura said it would be working with the Australian government to improve transparency in China's border control.
Chinese media has reported that more than 2,700 batches of tainted imported food and cosmetics had been rejected in the first seven months of the year.
Meanwhile, Brisbane-based milk producer Parmalat says it has not been informed by Chinese officials of problems with a batch of its products.
A Chinese government website has listed more than 14 tonnes of Parmalat's Pauls brand milk powder as having failed a bacteria standard in July.
A Parmalat spokesman told AAP it was only aware of the incident through media reports.
"Parmalat has not been informed of any problems with any products from any Chinese authorities," the spokesman said.
"We are keen to assist in any way to clarify the issue but it is unusual that the issue has only just been raised now and only through the media.
"All Parmalat products are subject to stringent quality standards, passing quality inspections in Australia prior to export."

http://au.news.yahoo.com/a/-/latest/5130756/australian-firm-says-baby-formula-safe/

Australian baby formula in China “safe” says company

This is another case of E. Sak contamination that has been linked to the Chinese milk product issues from earlier this year. It is likely that the ramifications from the Chinese failures will be felt worldwide, and for some time. Yet more reason for concern. Below is the story:

The Australian manufacturers of a baby milk formula and a milk powder rejected by Chinese authorities say their products are safe.
Nine tonnes of Ausnutria products, manufactured by Australian dairy supplier Tatura, have tested positive to a potentially deadly bacterium.
China Inspection and Quarantine (CIQ) claim the products contained Enterobacter sakazakii which can cause fatal infections in infants.
Tatura said they were surprised by CIQ’s findings.
“Other products, produced at the same time but sent on different shipments were cleared,” Tatura spokesman Tony McKenna said.
Mr McKenna said Tatura would not change its testing standards which it claims are “state of the art”.
The northern Victorian company maintains the discrepancy was due to the sensitivity of the tests, as well as the equipment and techniques used.
The Tatura products were rejected in June but only reported in the media this week.
Mr McKenna said the timing was disappointing but “not malicious”.
“It’s a hot topic and the press got a hold of it,” he said.
He said Tatura’s product was not linked to the recent scandal in which the industrial chemical melamine was discovered in milk made by 22 Chinese companies and then in eggs.
That tainted milk has killed four infants, while at least 53,000 have fallen ill.
“The fact is, we make different formula,” he said.
Tatura said Ausnutria, the company exporting the product, remained confident with their testing standards.
Some 891 tonnes of Tatura products had been exported to China in the past year without incident, the company said.
Mr McKenna welcomed CIQ’s decision to issue a public statement, assuring consumers products on the shelves were safe.
But Mr McKenna said the process should be changed to improve transparency.
“We don’t get the results. You can’t negotiate, you can’t fight it, it just gets turned around (at the border).”
Tatura said it would be working with the Australian government to improve transparency in China’s border control.
Chinese media has reported that more than 2,700 batches of tainted imported food and cosmetics had been rejected in the first seven months of the year.
Meanwhile, Brisbane-based milk producer Parmalat says it has not been informed by Chinese officials of problems with a batch of its products.
A Chinese government website has listed more than 14 tonnes of Parmalat’s Pauls brand milk powder as having failed a bacteria standard in July.
A Parmalat spokesman told AAP it was only aware of the incident through media reports.
“Parmalat has not been informed of any problems with any products from any Chinese authorities,” the spokesman said.
“We are keen to assist in any way to clarify the issue but it is unusual that the issue has only just been raised now and only through the media.
“All Parmalat products are subject to stringent quality standards, passing quality inspections in Australia prior to export.”

http://www.thewest.com.au/default.aspx?MenuID=2&ContentID=106957