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« Melamine in formula: Another round with the FDA | Main | Greening Santa's Workshop: Eco gifts in the blogosphere »
FDA's moving goalposts on melamine in infant formula
Even though the global economic crisis has to be at the top of the incoming administration's agenda, President-elect Obama has signaled he isn't forgetting the other reason so many people voted for change: to do the few essential things we can't do for ourselves. As he put it in a press conference recently, "I think what the American people want more than anything is just common-sense, smart government. They don't want ideology. They don't want bickering. They don't want sniping. They want action and they want effectiveness."
That says it for all of us who believe it's past time to restore credibility to crucial government functions. Obviously, the new White House team must shore up our battered financial security. But close behind is what we at Environmental Working Group call hometown security. We need good policymakers and regulators, acting on the basis of the best science, to assure that we have pure food, clean water, clean air, safe household products, clean, reliable energy and ample jobs devoted to realizing all those basic requirements of a civilized society.
The current bunch of political appointees running the regulatory agencies don't seem to know or care that the taxpayers, not the industries they oversee, have been paying their salaries. Take the leadership at the federal Food and Drug Administration.
Please.
It's been a long time since the FDA front office could make a statement about a food or drug problem without sending our doubletalk detectors (that's the polite term) into red alert.
The latest episode to kick the meter into the red zone started with an Associated Press report last Tuesday that that the FDA had discovered traces of the industrial chemical melamine and a related compound, cyanuric acid, in a few U.S- made infant formula samples. It's hardly surprising that the story, sketchy as it was, made headlines around the globe: everybody who hasn't been living on Mars for the last couple of years knows about the massive melamine tragedy unfolding in China, caused by unscrupulous manufacturers who deliberately spiked baby formula supplies with the chemical to boost their apparent protein levels.
Melamine, a plastics component, is toxic in its own right and when combined with cyanuric acid can cause kidney stones and kidney failure. To date, according to Time Magazine, more than 60,000 Chinese babies have been sickened and at least four have died from drinking tainted formula. The scandal is still spreading as reports surface almost daily that melamine has turned up in Chinese food or animal feed exports.
Flooded with alarmed calls, FDA officials insisted that there was no comparison between the U.S. and the Chinese situations. On Wednesday, the Associated Press reported, Dr. Stephen Sundlof, director of FDA's Center for Food Safety and Applied Nutrition, characterized the levels of melamine found in Nestle's Good Start Supreme Infant Formula with Iron and the cyanuric acid level in Mead Johnson's Enfamil Lipil with Iron as "extremely low" - about l0,000 times less than the levels reported in Chinese infant formula.
But there was nothing reassuring about the agency's bungled handling of the matter.
For one thing, FDA officials didn't make public their own test results in an orderly fashion, with ample information on their website. They ran tests in October, sat on the results for several weeks, then released incomplete and inaccurate data to the AP in response to a Freedom of Information Act request. Corrections issued Wednesday only stoked confusion and doubt.
Even more suspicious was FDA's post-Thanksgiving Friday decision to move the goal posts.
On Oct. 3, in the midst of the Chinese scandal, agency officials posted an advisory on their website asserting that "FDA is currently unable to establish any level of melamine and melamine-related compounds in infant formula that does not raise public health concerns." That seemed to be a bureaucratic way of saying that anything more than zero wasn't safe.
The zero-tolerance position lasted only as long as Chinese products were the issue. When U.S. manufacturers' products came under scrutiny, agency officials scrambled to set out a new position. On Friday, they issued an update on FDA's investigation that declared that formula adulterated with 1 part per million of either melamine or cyanuric acid (but not both) was safe. (Two Nestle's samples tested positive for melamine at 0.137 and 0.14 parts per million, and three Mead Johnson samples tested positive for cyanuric acid at 0.247, 0.245 and 0.249 parts per million. Reports from China said that tainted formula contained as much as 2500 parts per million of melamine)
The one part-per-million mark is well above the adulterant levels found so far in U.S. formula. The FDA advisory declares flatly, "FDA's ongoing investigation continues to show that the domestic supply of infant formula is safe and that consumers can continue using U.S. manufactured infant formulas."
We hope so. But as has been said so many times about so many aspects of the Bush administration's governing style - hope is not a policy. If you don't have anything to hide, why hide? If you know what you're doing, why bungle?
Once the new team takes over FDA, maybe we'll find out why the agency handled the melamine issue this way. And maybe we'll learn a lot more about why FDA has been so determined to resist calls for reducing other contaminants that we know are in food and drink. There will undoubtedly be investigations led by members of Congress like Rep. Rosa DeLauro, D-CT, who told the Washington Post's Lyndsey Layton, "This FDA, this Bush administration instead of protecting the public health, is protecting industry."
But the first priority has to be the health of our children. They can't wait months or years for Congress and the new administration to turn FDA's file cabinets inside out.
That's why EWG president Ken Cook has written the major formula makers, asking them to tell the public exactly what they know about their products and what they are doing to make sure they're pure. As Cook put it, "When FDA claims there isn't any reason to worry, that's exactly what the consumer should do."
So we're looking for change - real change, not the Washington-revolving-door kind - at FDA. And we're keeping our doubletalk detectors tuned up.
Well, now, there seems to be emerging a sense that government cannot be trusted! Amazing grace! A more historical phrasing might go something like, "since when has ANY government been worthy of trust?" Because all forms of government sooner or later prove themselves untrustworthy. Just look at the history of the Catholic (or any other) church. If the heavens cannot hold governments accountable, why are we mortals so cock-sure we can? Geez. Eat some more baby formula.
Three points.
1) The amount of melamine in American baby formula is fine. It's a really, really, low toxicity chemical.
2) The FDA screwed up when it said they haven't determined a safe amount. They should have known that this would be interpreted as "there is no safe amount". This isn't what they meant but let the interpretation go. This was really dumb and likely because they wanted to look tough on imports.
So, to conclude, American babies are safe (from this anyway, other issues like BPA are serious), and the FDA really needs to get some more honest PR people. Every weasily press release bites them in the ass eventually.
Yes,FDA finally (last Friday) published what it says are all its results,and the few that showed some melamine or cyranuric acid showed very low levels. So we're not saying that parents shouldn't give their babies formula based on what we know so far. We ARE saying that FDA should make full disclosure of what it knows about adulterants in baby formula, promptly and fully. Letting partial and inaccurate information trickle out over 4 days isn't good for consumers, industry or the FDA's credibility. Now FDA says it HAS determined a safe amount and that level is higher than anything that has been found in American-made formula. But its credibility is tattered, so many people won't have confidence in that assertion. And, after all, it's still "studying" what to do about BPA in food packaging. After hundreds, perhaps thousands of studies showing trace BPA toxicity, how much more do we need to know to say that we don't need the stuff in food? I, for one, think that while we don't know everything there is to know, we know plenty. More than enough to stay that BPA shouldn't come in contact with food one day longer.
Elaine Shannon
A recent NY Times article spoke of an increasing number of children 5-6 years of age (some younger) getting kidney stones. A writer blamed high levels of salt, not enough water consumption and certain foods containing oxalic acid with no mention of the possibility of milk containing small amounts of melamine being a possible culprit.
For many years children have consumed too much salt and drunk too many sodas but not enough water. But I don't know many kids who consume enough cooked greens or brown sesame seeds to create oxalic acid problem. However, I do know of 60,000 children in China who have consumed milk with melamine that has compromised their kidneys.
Now how can that same melamine be in the American milk supply?
1. American milk suppliers are buying tainted dried milk from China.
While that accounts for a number of products found contaminated, other suppliers say their milk is US produced. I think the following is more likely.
2. Cow feed ingredients that are enhanced with melamine to artificially boost the appearance of higher protein levels are being purchased from China by US animal feed manufacturers. Melamine creates the illusion of high protein because its chemical structure is similar to that of milk. Science has shown that melamine goes right through the cow's system and into the milk.
Why don't the cows die or get stones? Melamine affects the kidneys of babies and children (small creatures) faster than large ones.
Does anyone remember the incident 2 years ago where many dogs died of kidney failure because of Chinese ingredients containing melamine that faked high protein levels being used by many dog food manufacturers?
Hmmmmmmmm. Is there a pattern here?