Friday is a great day for releasing news that might be controversial. The FDA announced a 1 ppm standard for safe levels of melamine in infant formula – provided cyanuric acid is not also present. By this standard, the amount in the adulterated Chinese infant formula – 2,000 ppm or more – would be deemed demonstrably toxic. The amount in the contaminated U.S. formula – 0.1 to 0.2 ppm – would be considered safe. Of course zero would be better, but that seems hard to achieve in today’s chemically contaminated environment. A 1 ppm standard is tough enough to give the FDA plenty of leeway in banning unsafe products.
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Oh great. So now trace amounts of melamine are turning up in infant formulas made by all the big makers. The amounts – 0.1 to 0.2 ppm or less – are way too low to be harmful, says the FDA. This seems logical, but does this mean that trace amounts of melamine are in everything? And it would be good to know what concentration of melamine mixed with cyanuric acid – or uric acid – is safe. I can understand why the FDA might not want to get into all this but I wish the Associated Press could have gotten this information without having to file a freedom-of-information-act request.
Updates: Here’s the more circumspect account in the New York Times, and a skeptical commentary from LawyersAndSettlements.com. The Washington Post (November 29) reported specific figures: The FDA tested 87 infant formula products and has results for 77. Of these, it found melamine at levels of .137 and .14 parts per million in Nestle Good Start Supreme Infant Formula with Iron in liquid form. It also found cyanuric acid at levels between 0.245 ppm and 0.249 ppm in Enfamil Lipil with Iron (Mead Johnson Nutritionals/Briston-Myers Squibb). These are very low levels.
The British Food Standards Agency has been checking on levels of melamine in sweets imported from China. Some candies contained as much as 152 milligrams melamine per kilogram (mg/kg) or parts per million (ppm). A kg is 2.2 pounds, which would be a lot of candy to eat. Some of the tainted infant formula contained 2,500 mg/kg, but you only use a scoop (10 grams or so) to make up a bottle of infant formula, and that would contain 25 mg.
I realize that I am asking the wrong question – melamine should not be in food at all – but how much is safe to eat? To follow this, you have to pay close attention to the difference between mg/kg melamine in food versus the amount per kg body weight.
The FDA says 2.5 mg/kg in food is unlikely to be harmful in anything other than infant formula. The FDA’s May 2007 melamine risk assessment said 63 mg/kg body weight was safe for adults but it established a Tolerable Daily Intake (TDI) 100 times lower, or 0.63 mg/kg body weight per day. The European TDI is even lower: 0.5 mg/kg body weight per day. Using the European TDI, a person weighing 80 kg (176 pounds) could supposedly safely consume 40 mg melamine from food a day. But a baby weighing 5 kg (12 pounds) drinking infant formula containing 25 mg melamine would be getting 5 mg/kg body weight with every bottle – ten times the European TDI. And babies drink several bottles a day. And if a by-product of melamine, cyanuric acid, is also present, kidney crystals can form at much lower concentrations.
All of this begs the question: how come it is there in the first place and what are the food safety agencies going to do about it? And when? In the meantime, food companies should be testing anything with protein in it for melamine and it’s best to avoid eating foods made in places where they aren’t doing such testing.
In Hong Kong, Cadbury’s is recalling 11 China-made chocolate products found to contain melamine. I hope everyone is testing everything made in China that might have milk or protein in it. Soy anyone?
Update: According to the Wall Street Journal, Indonesia says it found melamine in M&M’s and Snickers bars. Mars says that’s not possible.
I’ve just discovered the Associated Press timeline of the events in this scandal. The timeline starts in December 2007 when the first reports of sick babies came in. It took until June to figure out that melamine was the toxic contaminant, and another three months before anyone did anything about it. I, of course, think that the 2007 pet food recalls should have alerted everyone to look for melamine. Now they are.
It’s not easy to keep up with the widening scandal over melamine-tainted infant formula, although Wikipedia is a big help. The New York Times has a full page on it today. Yesterday, the FDA recalled a bunch of instant coffee and tea drinks because their creamers might be contaminated with melamine. And UNICEF and the World Health Organization issued a joint statement warning mothers not to use Chinese infant formula. Breastfeeding, they point out forcefully, is still the best way to feed infants.
All this reminds me of the unsanitary history of milk adulteration in the United States. By the 1850s, health officials were complaining about the widespread practice of feeding nutritionally deficient swill to cows and watering down milk with magnesia, chalk, plaster of Paris and anything else to make it look creamy, never mind the effects on infants. As a result of efforts by the New York Academy of Medicine, New York passed a state anti-adulteration law in 1862. The 1906 Food and Drug Act laid the groundwork for eliminating most such problems, which is one of the reasons why I think national food safety regulation–with inspection and testing–is so badly needed.
What the Chinese are doing isn’t new. It’s just that in today’s globalized food economy, bad actions do more damage, and worldwide at that.
Postscript: About the recalled White Rabbit candies. Former Premier Zhou Enlai liked them so much that he gave them to President Nixon on his visit to China in 1972.
So much for “just” pet food. Now the Shanghai zoo has baby lions and orangutans with melamine-induced kidney stones. Tainted products have made their way into Japan and Taiwan, and the Europeans are worried that melamine-tainted milk products could be in candies, toffees, and chocolate. They will be testing Chinese products containing at least 15% milk. But what about soy products, I wonder? Those too are supposed to be high in protein and might be good candidates for adulteration.
And just to reiterate: last year’s pet food scandal showed that while it takes lots of melamine to cause kidney crystals, it takes hardly any to form crystals when cyanuric acid (a by-product of melamine) is present. The amount of melamine in food for humans, pets, and zoo animals should be nothing but zero. Food safety officials should test like mad and tighten up policies, and right now! As for China: it had best get its food safety act together and fast.
The European Food Standards Agency has done some calculations. It says the Tolerable Daily Intake (TDI) is 0.5 milligrams per kilogram (mg/kg) body weight. This means that for a young child weighing 10 kilograms (22 pounds), it would only take five of those candies mentioned in the previous post to hit the TDI.
But the Agency also says that Chinese infant formula contained as much as 2500 mg of melamine per kg. Let’s assume that a scoop of formula weighs 10 grams and contains 25 mg melamine. If a child has several feedings a day, this amount of melamine could easily exceed the TDI and, apparently, did. And remember: if cyanuric acid is present, kidney crystals can form at even lower doses.