Friends & Families, News, Patient's Own Decision-Maker

FDA Abruptly Reverses Itself on Baby Formula and Melamine
Cheree Cleghorn | November 29, 2008

News/Commentary

Melamine in infant formula has killed at least three babies and affected 50,000 more by causing bladder or kidney stones or kidney failure.

The chemical is used in plastic production.

There have been no reports of illnesses in the United States.

Parents should read the Associated Press story with care. It explains the whole issue as it has unfolded up until two hours ago.

As the story notes, 90% of all baby formula in the U.S. is made by three companies, named below.

No American babies have yet been ill.

The FDA is under fire for many reasons—including from Congress—-so it is not reassuring to read that a significant change in the agency’s recommendation about baby formula came following examination of 74 samples. That sample size is not adequate in relation to the amount of infant formula bought and consumed in this country.

What Can You Do?

  • If you buy infant formula from one of these companies, go to school on what these stories say.
  • Speak with your baby’s doctor about what she or he thinks about the formula issue as it applies to your child.
  • If, and underscore if, you needed or chose to change baby formulas, what would the baby’s doctor recommend and why? Three companies make 90% of all formula and changing a baby’s formula should be done, ideally, gradually. Have a Plan B although you may never need it. It will give you some peace of mind.
  • You may be sure that additional developments about this issue will be headline news. You will not have to go searching for news. Keep watching for updates, however.

U.S.News and World Report

“Reversing a decision made less than two months earlier, the U.S. Food and Drug Administration Friday announced an allowable threshold of 1 part per million of the chemical melamine in baby formula, the Associated Press reports.

“The wire service reports that the FDA’s decision actually allows for more melamine than has been found in U.S.-made baby formula. The one caveat is that this amount is allowable only if other related chemicals aren’t present, the A.P. reports.

“And, as it did Nov. 26, the FDA reiterated that the baby formulas that were tested are absolutely safe.

“Consumers Union, the national consumer advocacy group, and the Illinois attorney general, Lisa Madigan, had demanded that the FDA issue a recall of the products.”

Associated Press

….”A scientist for a national consumer group said it was irresponsible of FDA to assure the public that infant formula is safe based on tests of only 74 samples, especially since cyanuric acid is a byproduct of melamine, making it likely that they will be found together.

“This is a slippery slope of rationalization by FDA,” said Urvashi Rangan, a senior scientist with the Consumers Union in New York. “FDA needs to get a handle on how widespread the problem is and, most important, if both these chemicals are occurring in any products. They just haven’t tested enough to know that yet.”

“Earlier this week, members of Congress and the Illinois attorney general demanded a national recall, something FDA said made no sense because it had no evidence suggesting that the formula would be dangerous for babies at the levels of contamination found.

“After saying it made an error in its data, the FDA on Wednesday produced these results: Nestle’s Good Start Supreme Infant Formula with Iron had two positive tests for melamine on one sample; Mead Johnson’s Infant Formula Powder, Enfamil LIPIL with Iron had three positive tests on one sample for cyanuric acid.

“Separately, a third major formula maker, Abbott Laboratories, told the AP that in-house tests had detected trace levels of melamine in its infant formula.

“Those three formula makers manufacture more than 90 percent of all infant formula produced in the United States.”

Source: U. S. News and World Report, November 29, 2008

Source: Associated Press, November 29, 2008

Topics: Friends & Families, News, Patient's Own Decision-Maker

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