Fix the FDA

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There is no agency that has more effect on our day-to-day safety than the Food and Drug Administration. It is also responsible for maintaining consumer confidence in products that account for one-quarter of our economy. And yet, the Bush Administration has set it adrift. For more than half of the past eight years, it hasn’t even had a permanent commissioner.

Its performance over the past few days underscores why the incoming Obama Administration should make fixing the FDA–quickly–a top priority. At the Environmental Working Group’s Enviroblog, our former TIME colleague Elaine Shannon lays it out:

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 of melamine turning up in exported food or animal feed from China.

Flooded with alarmed calls, FDA officials quickly tried to reassure worried parents that there was no comparison with the Chinese situation. 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. (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. Chinese formula had shown levels of 2500 parts per million.)

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, headlines about U.S. formula supplies prompted FDA 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.

That mark just happens to be 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.

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