Saturday, November 29, 2008

Melamine oh my!

Yesterday, November 28, 2008, the FDA issued an update on a synthetic plastic called melamine on their food safety website entitled, Update Interim Safety and Risk Assessment of Melamine and its Analogues in Food for Humans. The article provides the FDA’s maximum acceptable concentration of melamine (1 part per million) for baby formula manufactured in the US . In addition, the FDA confirms that US domestic sources of infant formula are safe. The alert comes after the tragic illnesses and four (4) deaths in China of babies exposed to melamine-contaminated powdered infant formula that was manufactured in China. It also comes over a year after the illnesses and deaths of pets in the US and subsequent FDA recalls of human and pet food products in the US that had contained wheat gluten from China that had been contaminated with melamine. The US FDA prohibits any melamine directly added to any US food products that are consumed by humans or by animals.

Melamine-contaminated food products on the FDA’s September 2008 recalls list for humans included: milk and milk-derived products that came from China and which contained melamine.

The FDA Human Food Recalls list included: White Rabbit Candy, the chinese candy with the white rabbit logo on the front which I relished a few years back; the fresh and crispy Jacobina biscuits, the philippino biscuits with many layers in them; and the Koala's March creme filled cookies, the cute japanese cookies shaped like a koala. For animal lovers who also love eating desserts, this has been a blow to their enjoyment of two loves packed into one dessert. The cartoon character and small size of these desserts hold great appeal to both children and adults. For a more comprehensive list of human foods with melamine (cute or not cute looking, such as Mr. Brown coffee), see: FDA Nov 28 update. All kidding aside, the melamine outbreak is actually quite serious and extended to even greater populations.

Pet Owners, do you remember the Pet food scare? Over a year ago (March 15, 2007), the public scare about melamine occurred in the US over a completely different and separate incident, when pets were getting sick or dying. It was determined in all cases that the pets ate pet food whose normal vegetable protein ingredient had melamine mixed in it. Pet food companies reported to the FDA about many kidney failures and deaths of dogs and cats that their customers relayed; the common thread among all the pets was they ate the same types of pet food. Not all pet foods on the US market had problems. On May 4, 2007, the LA Times reported that the FDA received 17,000 calls from people. The FDA reported in January 3, 2008 that 1950 deaths of cats and 2200 deaths of dogs were reported from these calls. This number does not include the number of reported deaths provided by pet food companies.
The American Veterinarian Medical Association issued a press release in May 2007 over the incident, and was collecting data via online surveys.

Among the melamine-contaminated pet foods, all contained wheat gluten imported from China that contained melamine and all had melamine in the food. In addition, some fish and farm animals used for the human food supply chain were given animal feed that was contaminated with melamine; these animals were later processed to make human food. The FDA then authorized a national recall for destruction of all pet foods, animal feed, fish feed, and vegetable proteins that contained melamine. On April 28, 2007, the FDA announced that hog meat and other meat were still safe to eat by humans; there would be no recalls on these processed animal meats[Source: FDA April2007] Between May 1, 2007 and June 2007, the FDA launched some protein surveillance audits across the US , to ensure that the US food and feed were safe from melamine contamination. [Source: Groter FDA 2007 report] Justice arrived for the unnecessary animal losses on February 8, 2008, when the FDA indicted one (1) Chinese company, its two (2) Chinese nationals owners, one (1) US company, and the owners (2 people) for importing products into the US that were contaminated with melamine when they were sold purely as "wheat gluten," which is made of many different ingredients, none which include melamine. [Source: FDA pet food site and Source 2: FDA indictment Feb 2008]

At that point, there were no questions, or questions were skirted about possible high melamine contamination in the human food supply and their effects.

Now in 2008, we are seeing the effects of melamine on the human food supply. It was not until September 11, 2008 that the FDA heard that melamine might have been found in powder baby infant formula manufactured in China . This sparked an international controversy in the press. Even more chilling, what did not get leaked to the press so quickly was the September 21, 2008 safety alert that the FDA learned, that as of that date, China had 52,857 reported cases of nephrolithiasis (and, in some instances, renal failure) "linked to consumption of this contaminated powdered formula" [Source: FDA website, October 3, 2008 alert] Nephrolithiasis is a medical term for kidney stones (renal calculi). It is rare for humans to develop kidney stones at such an early age. Renal failure means that the kidneys no longer worked, and they could not perform their basic bodily functions as natural and unnatural toxins build up in the blood as a consequence in either a chronic or even worse acute renal failure. What is most disturbing is that all the cases occurred in infants, who are still undergoing stages of development in their body systems, such as their renal systems. In addition, the powdered baby formula might have been the primary source of food for these infants, thereby exposing a vulnerable system to increasingly high concentrations of melamine in a body that does not yet have the full capability of removing the substance in the first place.

This essentially means that levels of melamine in a baby internally experiences levels that are potentially toxic, even potentially lethal. In fact, the FDA website noted "13,000 hospitalizations" in China from melamine contamination. One Chinese hospital reported 16 infants between the ages of 5 months to 11 months who had kidney stones, and some of these infants developed renal insufficiency. "3 deaths" of infants were reported in China from melamine exposure as of October 3, 2008. Have there been any more reported deaths since then? Not sure, but the World Health Organization has reported a 4th death in China on its website, and the WHO will discuss the melamine contamination worldwide in an international conference on December 4, 2008. The FDA's data feature prominently on the website. The Netherlands has also found melamine in the Koala brand cookies imported from China. Korea has located melamine in their Nabisco Ritz cracker cheese sandwiches that came from China. Other countries are checking their food supplies, see USA Today.

In case you were dozing off, here are the numbers again from the FDA and from China:

Animal cases in US:
-17,000 phone complaints to FDA
-1950 deaths of cats reported from phone complaints to FDA
-2200 deaths of dogs

Human cases in China:
-52,857 reported cases of nephrolithiasis (and, in some instances, renal failure) "linked to consumption of this contaminated powdered formula"
-13,000 hospitalizations
-4 deaths
[Source: FDA website, October 3, 2008 announcement and WHO website]

Is melamine or some related contaminant with melamine the cause of this toxicity? Or is something reacting with the melamine to cause the reaction? The FDA is still investigating this question but has noted that melamine is inert on its own. Melamine and its derivative cyanuric acid combine together to form crystals. When the crystals block the flow of urine and other substances that naturally flow through kidney tubes, kidney damage and kidney failure result.

Definitely, these chemical interactions indicate that high levels of exposure (as found in a contamination) to melamine, combined with high levels of cyanuric acid, over a continuous, long period can lead to potential nephrolithiasis, kidney problems, kidney failure, and potential deaths. [Source: WHO website] The WHO even posted a website on clinical detection, diagnosis, and treatment of melamine contamination. Both melamine and cyanuric acid have been detected in the pet food from China . Only melamine has been detected, and there is still no information about cyanuric acid levels in the September baby formula scare in China. [Source: WHO website] So far, no human adult problems have been reported from exposure to melamine anywhere worldwide. [Source: WHO link2].
Just because human adult problems have not been reported does not mean they can't exist, making the numbers a potential departure from reality. It is easy to imagine being an adult who does not live in the US, and who loves constantly eating Nabisco Ritz cheese crackers, Pocky Men's chocolate cigarette biscuits, Cadbury chocolate, non-dairy creamer, M&Ms, KitKat, Snickers bars, and munches on rice crackers. While that is one unhealthy person who loves snacks, that is a potentially realistic scenario. No one can resist that snack attack. Now people around the world will have to hold back on that snack attack.
Ordinarily, melamine is used industrially in cleaning products, resins, foams, and pesticides. So, why would people illegally add melamine to wheat gluten, milk and milk-derived products? What value does adding melamine have? According to the WHO and European Union, melamine (chemical formula C3H6N6) has nitrogen content in it that can be utilized deceptively. Protein has nitrogen, and food testers use methods to measure the amount of protein in a food product. If a food product is originally made with less protein content than it is supposed to have, melamine can be added to inflate the amount of supposed protein in a food product and fool the measures used during the testing process. [Source: WHO link and EU link].

Surely a human life, baby or adult, cannot be considered cheap enough to hurt or kill in order for someone else to dodge some protein measuring standard. A pet's life cannot be considered cheap enough either in order to dodge some protein measuring standard.
Which foods utilize ingredients from China that contain melamine, aside from White Rabbit candy, Koala cookies, and Jacobina biscuits, snack items mainly Asians and Asian foodies only know? I just wonder whether the noodles I buy, which contain wheat gluten, as safe. What I wonder about are foods that contain milk-derived ingredients. Milk-derived ingredients are ingredients that include whole milk powder, non-fat milk powder, whey powder, lactose powder, and casein. Hopefully, FDA will continue testing of all kinds of foods. In their June 2008 report, the FDA identified many potential sources food products for humans, like soybeans, pie filling, soy milk, gelatin, whole grain, wheat and rice flour, rice, and corn, to name a few [See Groter on FDA website]. The reason is clear to me, as these are items that someone could easily substitute melamine into ingredients as a way to artificially increase the protein quota during testing.

This has food safety ramifications on vegan fans like myself, who try to eat less snacks and eat more healthy, more "natural" foods. Well, this situation turns the natural into something quite unnatural. Have the FDA and health authorities for other countries considered this consumer population?

As for baby formula produced in the US , while the FDA does not approve baby formula, the companies that manufacture baby formula must register their formula with the FDA, are under FDA's jurisdiction and must follow federal nutrient requirements. [Source: See FDA link].

In its November 28, 2008 report, the FDA announced that while no amount of melamine in baby formula is tolerated (Oct 3 alert "zero tolerance" policy), the scientific measure of 1 part per million (1 ppm) of melamine in baby formula is the maximum concentration that can be considered safe. The European Union and Canadian health authorities have not made such strong statements as the US FDA on what they will not allow. A few weeks ago, the FDA found traces of melamine in infant formula below the 1 part per million standard of one major U.S. manufacturer named Nestle Nutrition and cyanuric acid in the formula of a second major manufacturer named Mead Johnson. The melamine and cyanuric acid ended up in the formula unintentionally during the manufacturing process [Source:
FDA website]. As the samples did not contain both melamine and cyanuric acid, the formulas have also been acceptable and no cause for recall. Is everyone in agreement with this? The jury is still out on this one. Let's see how sales look after a few months for these companies.

So, I guess I'm lucky I'm not a baby and can eat other things.

In its October 3, 2008 report, the FDA noted that "melamine, in its chainlike 'polymerized' form, has been used to manufacture dishes, plastic resins, and components of paper and paperboard that may come in contact with food. Additionally, trichloromelamine is approved for use as a sanitizing agent on food processing equipment and utensils, except for milk containers and equipment, and it readily decomposes to melamine during such uses. FDA estimated that the cumulative dietary concentration from these approved food uses would be less than 15 µg/kg (0.015 ppm). This is an estimate of the average concentration of melamine in food from approved uses; it is not intended as an estimate of the acceptable maximum level of melamine in an individual food. Additionally, individual products may contain more or less melamine than 0.015 ppm of melamine as a result of approved uses. The levels would depend on the type of food and the conditions of the approved uses." [Source:FDA link]. Ever think about that? That your plastic wrap or plate could have substances like melamine that mix in with your food? The governments in other countries have followed in the US' footsteps, providing data from the FDA on their test results on melamine. Canada and the European Union have posted websites about melamine and their countries' standards of melamine exposure on the human population. [Source: Health Canada link and EU link].

It sounds like more melamine testing will continue around the world. This will not be the last word on food products and melamine. The solutions to this international problem rest in the continuing transparency or openness about any cases that arise, whether at the supplier, consumer, or service medical level. While the reports are heartbreaking, transparency and fast reporting are the only ways of identifying sources, thereby providing the necessary corrective actions towards ensuring the safe health and lives of everyone, both man and animal. The melamine outbreak is affecting those populations who cannot really speak for themselves or fully understand what is going on with their health--infant children and animals, those that are pets or food supply chain animals. It is up to those who care for these vulnerable populations to listen, pay attention, and protect their rights, safety, and welfare. It is also up to the governments to hold accountable those people who contaminate food supplies.

-Reported by the Boldly Liberal Intern



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