FDA Sets Melamine Levels For Baby Formula

Days after claiming that they were unable to do so, the FDA has announced that they've set levels for melamine.

Food and Drug Administration officials on Friday set a threshold of 1 part per million of melamine in formula, provided a related chemical is not present. They insisted the formulas are safe.

The development comes days after The Associated Press reported that FDA tests found traces of melamine in the infant formula of one major U.S. manufacturer and cyanuric acid, a chemical relative, in the formula of a second major maker. The contaminated samples, which both measured at levels below the new standard, were analyzed several weeks ago.

The FDA had said in early October it was unable to set a safety contamination level for melamine in infant formula.

Dr. Stephen Sundlof, the FDA's director of food safety, said Friday the agency was confident in the 1 part per million level for either of the chemicals alone, even though there have been no new scientific studies since October that would give regulators more safety data. He had no ready explanation for why the level was not set earlier.

The standard is the same as the one public health officials have set in Canada and China, but is 20 times higher than the most stringent level in Taiwan.

It's a chemical that mimics protein and can be toxic and fatal to children in sufficient dosages; it's the chemical responsible for injuring thousands of Chinese children after Chinese manufacturers spiked baby formula and milk products with melamine to increase the protein counts for tests.

What's curious about the level set by the FDA is how it was seemingly set in such an arbitrary manner. It's as though the FDA chose to show action merely by positing a level, and that they'll eventually get around to figuring out what is a reasonable level after additional tests. I'd be interested in knowing how Taiwan set its level, which also could be an arbitrary response to how China flooded the market with melamine-tainted products.

The FDA mandated-level is well below the level of melamine found in the tainted Chinese products.

It doesn't inspire confidence either that the FDA admitted errors in its testing:

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.

Also, what exactly is considered a trace level? That's left unstated by the reports.