Friday, January 09, 2009

One More Reason Why I Don’t Rely on the FDA: Melamine in US Infant Formula

I don’t consider myself a conspiracy theorist, but I admit I don’t trust a lot of the information our government offers on matters of health and safety. Of course I’m not suggesting the FDA and the CDC are out to get us, but the evidence of industry’s significant influence over such agencies is disconcerting, to say the least. I’ll save my favorite example - the story of the conflicts of interest discovered in FDA and CDC vaccine advisory committees for its own post on another day; suffice it to say, my inquiry into the risks and benefits of anything I'm considering for my daughter NEVER ends with "according to the FDA . . ."

So when I heard yesterday that the FDA says the amount of the toxic chemical melamine detected in U.S. baby formula is safe, I wasn’t entirely convinced. Last summer, more than 50,000 Chinese babies were sickened after drinking formula contaminated with melamine. Shortly thereafter, the FDA stated that it wasn’t able to establish ANY level of melamine and melamine-related compounds in infant formula that did not raise public health concerns. The agency also assured the American public that there was no known threat of contamination of formula manufactured by companies approved to sell formula in the U.S. That was the last anyone heard from the FDA on the subject until the Associated Press filed a Freedom of Information Act request requiring the FDA to disclose that it had found trace amounts of melamine in formula and nutritional supplements sold in the U.S. Consumer groups have questioned whether the information would ever have been released absent the FOIA request.

The FDA’s reticence on the issue hardly inspires confidence. Many Americans rely on government agencies like the FDA to protect them from harmful products, assuming that if it’s on the shelf it’s been approved by the FDA and so must be safe. Instead, the FDA seems to be sitting on information that may affect the most vulnerable among us. And the agency’s concurrent statement that the amounts detected in the U.S. formula were “trace amounts” which it considered to be “perfectly fine” for infants? Quite a departure from the agency’s original position that it could not identify any amount of melamine as safe for infant consumption. Color me skeptical.

Now that the word is out, the FDA appears to have been more forthcoming on the subject. Earlier this week, it revealed that melamine and byproduct cyanuric acid have now been detected in more containers of infant formula - twice as many as were reported in November. (Results of FDA testing for melamine in formula can be viewed here. Additionally, formula manufacturer Abbott Laboratories (makers of Similac) has also said that it detected trace levels of melamine in its formula. Whether the trace amounts of melamine discovered in any of these samples of formula would be harmful to a baby and how is uncertain, but I’m certainly not taking the FDA’s declaration that it is as the last word.

Melamine isn’t something I’d want to mess around with. A chemical commonly used in plastics and adhesives, it has been found in food products, usually added to increase nitrogen content which makes the protein content appear higher. For example, in the Chinese formula that made such news last summer, water was added to raw milk to increase volume, and melamine added to mask the lower protein content of the end product formula. Melamine can also get into food products through packaging or from a cleaning solution used on some food processing equipment. While no studies have been conducted on human subjects, animal tests demonstrate adverse health effects such as bladder stones and kidney stones which can lead to kidney failure and even death. Melamine has also been shown to have a carcinogenic effect on animals.

The levels of melamine in the Chinese formula that harmed so many children there were higher than those in the U.S. formula tested by the FDA (which the FDA believes was contaminated in the manufacturing process, rather than added intentionally), but it’s not clear to me how the FDA arrived at the conclusion that the levels in U.S. formula are safe for consumption by little bitty babies, especially with respect to long term effects. Hopefully more information will become available now that melamine is on the public’s radar. As to how reliable that information might be . . . I’ll be considering the source.

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