Despite saying just over a month ago that it couldn’t set a safe level for melamine in infant formula, US Food and Drug Administration (FDA) has changed its mind.  And it seems like a rush to judgment.  I’m not trying to scare any parents – the melamine levels found in US infant formula are very, very low.  But, I’m concerned by an agency that doesn’t seem to use science for decision making (bisphenol A anyone?), although I’m hoping that this will soon change come January.

So why am I critical of the FDA’s decision?  In the FDA’s October 3, 2008 statement, the FDA stated that “the US FDA cannot establish a level of melamine and its analogues in [infant formula] that does not raise public health concerns.”  Yes, despite no new studies since its statement on October 3, 2008, the FDA has now issued a safe level for melamine in infant formula.  The FDA said it couldn’t establish a safe melamine level because of “several significant gaps” in its scientific knowlege about melamine, including the impact of the presence of more than one melamine analogue, the consequences of continuous use of infant formulas as the sole source of nutrition and the possibility that infant formulas can be the sole source of nutrition for premature infants with immature kidney function.

No new research studies have addressed these concerns.  But, suddenly, the FDA has figured it all out and set a safe level.  Why was the FDA compelled to do this?  What’s changed?  Well, the FDA has found low levels of melamine and cyanuric acid in some US infant formulas.  And it hasn’t completed its testing.  It has only tested 74 samples, yet the FDA is ready to assure us that the US infant formula supply is safe.  If you want to read the test results so far, check out the list.  The FDA has found, so far, melamine present at 0.137 ppm and 0.140 ppm in Good Start Supreme Infant Formula with Iron from Nestle and cyanuric acid present in Mead Johnson’s Infant Formula Powder, Enfamil Lipil with Iron, in the 12.9 oz can at 0.247, 0.245 and 0.249 ppm.  None of the 74 samples tested so far have both melamine and cyanuric acid present, which is when you get problems.  But, as Urvashi Rangan, a senior scientist with the Consumers Union in New York says, the FDA “just haven’t tested enough to know [the scope of the problem] yet.”

Also, the third major formula maker, Abbott Laboratories, announced that it found traces of melamine in its infant formulas, which include the Similac brand.

Now, these levels are not from melamine being added to the formula to fool quality control checks.  The melamine found in China milk products was intentionally added because, like protein, is rich in nitrogen.  So, if inspectors are checking to see if dilution has occurred, they will measure nitrogen content.  Adding melamine will fool this test.  That’s the basis of the problem in China, and the levels in the US are well below the levels found in Chinese milk products that sickened so many babies and killed at least 4.

With the US infant formula, the presence of melamine appears to be a result contact during processing, not intentional addition, which is prohibited in the US.  Melamine is used in the  manufacturing of dishes, plastic resins, flame-retardant fibers, components of paper and paperboard and industrial compounds.  So, melamine may come from rubbing off from these surfaces.  Also, trichloromelamine is approved as a sanitizer for food processing equipment and utensils, except for milk containers and equipment.  Trichloromelamine easily breaks down into melamine when it is used as a sanitizer.  This could also be a source.

Of course, needing to reassure us of the safety of the food supply, the FDA set a supposedly “safe” level of melamine in infant formulas.  FDA has concluded that melamine alone or cyanuric acid alone at or below 1 part per million (ppm) is safe.  The levels found in the US infant formula are below this safe level.  According to Dr. Stephen Sundlof, FDA’s Director of Food Safety, dangerous health effects occur only if both melamine and cyanuric acid are present. 

Taking a look at how the FDA established this new standard, it hasn’t addressed the questions that it raised.  Instead, it has applied some safety factors to derive the standard, using a 6.6 pound infant that eats 0.3 pounds infant formula per day.  The safety factor is suppose to take into account differences, but the analysis doesn’t really evaluate premature infants with immature kidney function.  It also doesn’t take into account other potential melamine exposure situations.  So, it seems just a bit odd that the FDA decided now to set a standard.  And Dr. Sundlof has no explanation for why the standard wasn’t set earlier.

John Dyer, FDA’s Deputy Commissioner for Operations and Chief Operating Officer believes that “FDA has worked hard to ensrue the safety of [our] food this Thanksgiving.”  I’m not sure I agree Mr. Dyer.  I’m not impressed by the FDA’s actions with respect to bisphenol A or melamine, because, well, it seems that the FDA doesn’t always follow the science.

But, again, for those parents using formula, the levels found in US formula so far are WELL BELOW those levels found in Chinese infant formula.  I’m not saying that there is a problem – there isn’t enough evidence as yet.  What I am critical of is FDA’s decision making that isn’t based on science, and its quick change from its October position of accepting no melamine in infant formula without new scientific support.