We have written about the industrial chemical melamine in previous issues. You will recall federal food regulators announced that they were unable to set a safety threshold for the melamine in baby formula. But now the FDA has set a standard that allows for higher levels than those found in U.S.-made batches of the product. FDA officials have set a threshold of 1 part per million of melamine in formula, provided a related chemical isn’t present. They still insist, however, that the formulas are safe.

The setting of the standard came 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 manufacturer. The contaminated samples measured at levels below the new standard. Interestingly, there have been no new scientific studies since October that would give regulators more safety data. I have to wonder what has happened in the interim and why the level wasn’t set earlier.

It is the standard as the one public health officials have set in Canada and China where in September the problem of melamine in infant formula first surfaced. But it is 20 times higher than the most stringent level in Taiwan. The FDA now says the lack of dual contamination was key in its decision because “studies so far show dangerous health effects only when both chemicals are present.” Apparently, neither of the two tainted samples had both contaminants. The agency still has not set a safety level for melamine if cyanuric acid is also present.

Reacting to news of the contaminated formulas, members of Congress, a national consumer group and the Illinois Attorney General have demanded a national recall. But the FDA says that made no sense because it had no evidence suggesting that the formula would be dangerous for babies at the levels of contamination found. Consumers Union believes that the FDA advice is of small comfort to parents and caregivers. Jean Halloran, the group’s director of Food Policy Initiatives, observed:

It is very disturbing to us that no recall has been requested. The FDA originally said there was no safe level for these contaminants in infant formula. So this formula is contaminated.

Ms. Halloran has urged the FDA “to immediately make public all of the results of its tests for melamine contamination in food,” even those with levels below what would trigger agency action. As you know, Melamine is the chemical found in Chinese infant formula ‘ in far larger concentrations ‘ that has been blamed for killing at least four babies and making at least 50,000 others ill. The FDA said in October that the toxicity of cyanuric acid was under study, but that it was “prudent” to assume that the potency of cyanuric acid is equal to that of melamine. Rep. Rosa DeLauro, who heads a panel that oversees the FDA budget, said the agency was taking a “marketplace first, science last” approach. The Connecticut lawmaker had this to say:

The FDA should be insisting on a zero-tolerance policy for melamine in domestic infant formula until it is able to determine conclusively based on sound independent science that the trace levels would not pose a health risk to infants.

Hopefully, the Obama Administration and the new Congress will revamp the FDA, give the agency the tools and authority necessary to do its job and then make sure that the job is being done.

Source: Associated Press

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