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The Food and Drug Administration has determined a new safety standard for melamine residue in baby formula.
 Melamine is a resin used in making hard plastics, floor tiles, kitchenware, commercial filters, pesticides, and fire retardant fabrics, but is mostly used in industry. It has been blamed for the deaths of at least 3 infants — some report as many as 14 — with over 50,000 sickened, in China very recently.
Chinese manufacturers dumped melamine in baby formula in order to show higher protein levels on quality tests. The concentrations of melamine were as much as 2,500 to 10,000 parts per million. That level of concentration can easily cause kidney stones and kidney failure, and ultimately death.
Melamine is often accompanied by the compound cyanuric acid which, in conjunction with melamine, can intensify the negative effects. So it’s interesting to note that the new standard by the FDA sets the safety level for 1 part per million for either melamine or cyanuric acid, but not in tandem.
The Associated Press, through the Freedom of Information Act, was able to obtain documents that showed the federal government had begun secretly testing domestic baby formula in September.
According to FDA data, trace concentrations of melamine were detected in Mead Johnson’s Infant Formula Powder and Enfamil LIPIL with Iron, with readings of 0.137 and 0.14 parts per million. Three tests of Nestle’s Good Start Supreme Infant formula with Iron detected 0.247 parts per million of cyanuric acid. Abbot Laboratories’ Similac was found to be free of melamine by the FDA, but the company’s own tests did find the chemical; they will not identify the product or the level of contamination.
About 90 percent of all infant formula in the United States is made by the above mentioned manufacturers.
Nestle’s Peptamen Junior and Nestle’s Nutren Junior-Fiber — nutritional supplements for sick children who have trouble digesting food — also showed between 0.201 and 0.206 parts per million and 0.16 and 0.184 parts per million, respectively.
On October 3, the FDA issued a statement in response to the Chinese problem saying, “FDA is currently unable to establish any level of melamine and melamine-related compounds in infant formula that does not raise public health concerns.” This makes this November ruling seem like a rush to judgment, giving rise to speculation that the speed with which the new ruling was reached, and the fact that the 1 ppm is just above the levels found in the domestic formulas, might have been influenced by the manufacturers in order to avert a shift, shall we say, in consumer habits. After all, the conclusion was based on a paltry 74 samples.
According to doctors, the 1 part per million level established by the FDA should be safe. According to Dr. Daniel Rauch, a pediatrician at New York University's Langone Medical Center, "That's a very, very small amount. We think it's safe... But the bottom line is that we don't really know, and zero would be best."
Dr. Jerome Paulson, Associate Professor of Pediatrics at Children’s National Medical Center in Washington D.C., thinks the FDA should research the impact of long-term, low-dose exposure to melamine and cyanuric acid, and not just “assume it’s safe, and then 15 years from now find out that it’s not.”
Scientist Urvashi Rangan from the Consumers Union in New York views the FDA’s decision with much criticism: “This is a slippery slope of rationalization by FDA. 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.”
The government of Hong Kong also set a new melamine standard at the same level as the U.S. this week, 1 part per million, but this is twenty times above that of Taiwan’s safety level.
Most appalling is the trust the American people put in a government agency such as the FDA — if the government says it’s safe, then it’s safe, right? So who wants to line up an eat some melamine?
In a typically convoluted manner the FDA wants to govern and limit what vitamins and supplements are available, but when faced with the life-threatening facts of a deadly toxin like melamine, they are only too eager to dismiss any real safety concerns.
Rep. Rosa DeLauro, (D-Conn.) says the FDA should insist on a zero-tolerance policy when it comes to melamine, and that the agency is taking a “marketplace first, science last,” approach. She believes that conclusions should be based on sound independent science.
The lesson here is caveat emptor. Place no trust in a government “we here to help you” mentality and use common sense judgment instead.
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