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.

FDA Finds Traces of Melamine in US Infant Formula

The FDA says that these are just trace amounts and that they do not rise to the level of a need for recall. Yet, there's something here that has me wondering about how the melamime entered the manufacturing process and why it was considered acceptable.

The Food and Drug Administration said last month it was unable to identify any melamine exposure level as safe for infants, but a top official said it would be a "dangerous overreaction" for parents to stop feeding infant formula to babies who depend on it.

"The levels that we are detecting are extremely low," said Dr. Stephen Sundlof, director of the FDA's Center for Food Safety and Applied Nutrition. "They should not be changing the diet. If they've been feeding a particular product, they should continue to feed that product. That's in the best interest of the baby."

Melamine is the chemical found in Chinese infant formula — in far larger concentrations — that has been blamed for killing at least three babies and making at least 50,000 others ill.

Previously undisclosed tests, obtained by The Associated Press under the Freedom of Information Act, show that the FDA has detected melamine in a sample of one popular formula and the presence of cyanuric acid, a chemical relative of melamine, in the formula of a second manufacturer.

Separately, a third major formula maker told AP that in-house tests had detected trace levels of melamine in its infant formula.

The three firms — Abbott Laboratories, Nestle and Mead Johnson — manufacture more than 90 percent of all infant formula produced in the United States.

The FDA and other experts said the melamine contamination in U.S.-made formula had occurred during the manufacturing process, rather than intentionally.

The FDA and the manufacturers have a potential mess on their hands, and they need to deal with this judiciously, swiftly, and openly. In sufficient quantities, melamine can kill - toxicity is always in the dosage, and the FDA believes that the trace amounts found in the US infant formula don't pose a hazard.

This is the same chemical that injured thousands of Chinese infants and killed several Chinese children when melamine was purposefully added to baby formula to bolster the protein content. The chemical was also found in milk products and even chocolates that were sold outside China. The Chinese government for its part engaged in a coverup to avoid coverage of the story during the Beijing Olympics.

I think the FDA will need to revisit that position and clarify exactly whether any melamime is acceptable or set limits.

Chocolate Maker Notes Chinese Chocolates Contaminated

The problem of melamine contaminated milk products, including baby formula, is spreading well beyond China and the initial milk products.

Cadbury, the British chocolate manufacturer has found its Chinese made chocolates have been contaminated. So far, the company has pulled 11 types of chocolates from shelves in China, but it appears that other nations and businesses are voluntarily pulling Chinese products with milk ingredients from shelves as a precaution:

The scandal broke this month when authorities said infant formula produced by Sanlu was causing kidney stones in babies and young children. Four infants have died and some 54,000 have become ill after drinking the contaminated baby formula.

Subsequent tests revealed melamine contamination in products ranging from yogurt to candy to pastries.

Authorities believe suppliers added melamine, which is rich in nitrogen, to watered-down milk to deceive quality tests for protein.

Cadbury said the 11 recalled chocolate products were distributed in Taiwan, Hong Kong and Australia.

U.S. companies Kraft Foods Inc. and Mars Inc. said they would adhere to a recall order of Chinese-made Oreos, M&Ms and Snickers in Indonesia, but said they wanted to conduct their own tests with outside experts.

So far only a local agency has checked the products for melamine, but the levels found were considered very high.

"We have asked our trade partners and retailers to suspend the sales of our products in accordance to the agency's order," Mars Indonesia spokesman Bondan Ardi said.

Hong Kong supermarket chain PARKnSHOP also pulled its Chinese-made Oreo, M&M and Snickers products as a precaution, spokeswoman Pinky Chan said.

As for when the scandal broke, the Chinese government hid the details until after the Beijing Olympics were completed because they feared the bad press during their precious games. How many people were injured as a result of eating contaminated products because the Chinese government failed to alert all those who might be consuming milk or milk products laced with melamine?

China Ordered Coverup Of Tainted Milk

Once again, the Chinese government doesn't disappoint. They engaged in a coverup to hide the fact that tens of thousands of Chinese babies were sickened by baby formula and milk that was purposefully contaminated with melamine in order to show that they had a higher protein content. They had also undercounted the numbers of people affected and I doubt we'll ever learn the full extent of the poisonings.

Senior officials gave the order to Sanlu, the company whose poisoned milk powder is said to be responsible for at least four deaths and illnesses in almost 53,000 infants.

The company, based in Shijiazhuang, met city officials three times to explain the extent of the crisis. Present were local representatives of the General Administration of Quality Supervision, Inspection and Quarantine, China's national product safety watchdog.

AQSIQ had already carried complaints on its Web site from a doctor concerned about the numbers of children fed with Sanlu milk who were suffering from kidney stones.

Yet despite Sanlu's warnings that its baby formula was contaminated with the chemical melamine, no recall notice was issued to consumers.

The central government had issued orders to suppress "bad news" during the period of the Olympic Games, which were starting that week.

The Chinese purposefully suppressed this news because it coincided with the Olympic games. So much for the openness that the Games was to have provided.

The Communist government did what it always does - look after its own interests rather than the well being of millions of Chinese people who didn't know that they might be poisoning their children by providing them baby formula or milk from these suppliers. They were worried that people might demonstrate against the government if news of the tainted milk and baby formula made headlines.

China's Tainted Milk and Baby Formula Sickens Nearly 13,000

The number of people affected by tainted milk and baby formula continues to grow. Nearly 13,000 people have been affected by the tainted milk.

More than 80 percent of the 12,892 children hospitalized in recent weeks were 2 years old or younger, the Health Ministry said in a statement posted on its Web site late Sunday. Four children have died.

The ministry said most of the children sickened consumed infant formula from one company, the Shijiazhuang Sanlu Group Co. The dairy is at the center of one of China's worst food safety scandals in years.

Over the weekend, the Chinese territory of Hong Kong reported the first known illness outside mainland China — a 3-year-old girl who developed kidney stones after drinking Chinese dairy products. She was discharged from the hospital, the Hong Kong government said.

In the two weeks since the government first acknowledged the contamination, it has issued recalls for dairy products from 22 companies after tests turned up traces of melamine. The Health Ministry said that most of the hospitalized were sickened by powdered milk and formula.

"The hospitalized children basically consumed Sanlu brand infant milk powder. No cases have been found from ingesting liquid milk," said the statement.

Melamine is used in making plastics and is high in nitrogen, which registers as protein in tests of milk. Though health experts believe ingesting minute amounts poses no danger, melamine can cause kidney stones, which can lead to kidney failure. Infants are particularly vulnerable.

Some of the farmers who sell milk to Chinese food companies are thought to have used melamine to disguise watered-down milk and fatten profit margins hurt by rising costs for feed, fuel and labor.

UPDATE 9/22/2008:
Make that 50,000 sickened infants and children.

Tainted Baby Formula In China Kills Three; 6300 Sickened

This is yet another sad story from China, where this kind of thing continues to happen despite government crackdowns.

More than 6,200 babies have been sickened by tainted milk formula and dozens of infants are suffering from acute kidney failure, China's health minister said Wednesday as the death toll rose to three children.

Health Minister Chen Zhu said he expected the numbers of affected babies to increase as "more and more parents take kids to the hospital."

Meanwhile, the head of China's quality control watchdog agency, Li Changjiang, said that 5,000 inspectors will be dispatched nationwide to monitor companies after government testing showed that 20 percent of the companies producing milk powder had dairy products with melamine.

Also Wednesday, the country's two largest dairy companies, Mengniu Dairy Co. and Yili Industrial Group Co., were among the companies forced to recall baby formula. In addition, Guangdong-based Yashili and Qingdao-based Suncare recalled their tainted milk powder, which is exported to five countries in Africa and Asia: Bangladesh, Yemen, Gabon, Burundi and Myanmar.

How did the baby formula or milk get contaminated?

It was done on purpose.

Someone added the chemical melamine to the formula or milk in order to increase the protein content in watered down milk for purposes of testing, and the chemical causes kidney failure or death.

Several people have already been arrested, but that will be of little comfort to those families who are watching their children suffer horribly from these dastardly act.

The concern is that some of this formula has ended up in markets outside China, including the US.

China is saying that they will begin testing milk and formula for melamine. It's about time, given that this issue has appeared before.

China Must Come Clean

The Chinese government must do a far better job of providing key information relating to health and environmental crises after a spate of recent health crises that appear to have originated in their country.

There was contaminated pet food that sickened and killed thousands of pets because the food was tainted with a chemical that appears to have been traced back to Chinese companies cutting corners.

Then, there's the bogus medication imported from China that used toxic chemicals that have killed dozens in Panama:

The Food and Drug Administration (FDA) in the United States has issued a warning to drug manufacturers, suppliers and health professionals that counterfeit drug additives have been using diethyline glycol, or DEG as a substitute for glycerin in cough medicine, fever medication and injectable drugs.

DEG is an industrial solvent commonly used in antifreeze and in recent years has caused deaths in Panama and Haiti when it was used as a substitute for glycerin, a more expensive sweet syrup, in cough medicine.

The FDA says some Chinese suppliers are using the poisonous DEG instead of glycerin and is warning manufacturers and suppliers of the importance of testing glycerin for DEG.

The FDA says although they have had no reported contamination cases as yet in the U.S. regarding DEG the most recent incident in Panama in September 2006 involved DEG-contaminated glycerin used in cough syrup and resulted in dozens of hospitalizations for serious injury and more than 40 deaths.

DEG is a chemical cousin of antifreeze that can cause kidney and neurological damage if ingested and though the source was eventually traced back by investigators in four countries to the Taixing Glycerine Factory factory in China, no one in China has ever been charged with causing the Panamanian deaths.

Now comes word that there is a animal epidemic in China that is killing pigs in large numbers. There's no word as to the source of the illness or what the Chinese are doing to prevent its spread. The government is mum over the story, and that means health officials around the world are in the dark about a possible emerging illness.

Hong Kong television broadcasts and newspapers were full of lurid accounts today of pigs staggering around with blood pouring from their bodies in Gaoyao and neighboring Yunfu, both in Guangdong Province. The Apple Daily newspaper said that as many as 80 percent of the pigs in the area had died, that panicky farmers were selling ailing animals at deep discounts and that pig carcasses were floating in a river.

The reports in Hong Kong said the disease began killing pigs after the Chinese New Year celebrations in February, and is now spreading. But state-controlled news outlets in China have reported almost nothing about the pig deaths, and very little about the wheat gluten problem.

A man answering the phone at the city government offices in Gaoyao, 140 miles northwest of Hong Kong, confirmed late this afternoon that pigs were dying there. He declined to give his name.

Instapundit is concerned about the silence of the Chinese government over the incident. He's right to be concerned.

I'm also concerned about the immediate health policy implications for the Chinese downriver of where reports claimed that there were pig carcasses floating in a river. That means that whatever killed the pigs may have entered the river as well - potentially contaminating and infecting other animals - and even humans - who use that water for drinking or other purposes. What are the Chinese doing about that? If their experience with the Songhua disaster is any indication, the answer is not much and not until the problem is spiralling out of control.

The problem is that with Chinese products bought and sold globally, the lax oversight and quality control problems, not to mention fraud and dangerous products can affect not just Chinese users, but consumers around the world. The silence and inaction of the Chinese government puts lives at risk.

UPDATE:
The pet food recall may be expanded even further as authorities in the US and China are looking at yet another chemical contaminant:

A second industrial chemical that American regulators have identified as a pet food contaminant may have been intentionally added to animal feed by producers seeking larger profits, according to interviews Tuesday with chemical industry officials.

Three chemical makers said Chinese animal feed producers often came to purchase cyanuric acid to blend into their feed because it was cheaper and helped increase protein content. In the United States, cyanuric acid is often used as a chemical stabilizer in swimming pools, though it is not thought to be highly toxic on its own.

Up until now, American regulators had focused on a chemical called melamine. Animal feed producers here have acknowledged recently that for years they added melamine to animal feed to gain bigger profit margins.

But American regulators and scientists have also been aware for several weeks that cyanuric acid may have played a role in causing sickness or death in pets.

China said on Tuesday that it had found two companies guilty of intentionally exporting pet food ingredients containing melamine to the United States.

It would appear that the latest contamination issues may have entered the human food supply as farm raised fish may have been given tainted feed. Researchers believe that the combination of cyanuric acid and melamine may have combined to form a toxic brew sufficient to kill and injure thousands of pets in the US and spurred a massive pet food recall.

Tainted Pet Food Affected Thousands Pets

Scientists have extrapolated that 39,000 cats and dogs may have been affected by the tainted pet food, based on data received by 615 hospitals. The scientists believe that three out of every 10,000 cats and dogs was affected by the tainted pet food. Cats seem to have been more affected by the tainted food than dogs.

Banfield, The Pet Hospital, said an analysis of its database, compiled from records collected by its more than 615 veterinary hospitals, suggests that three out of every 10,000 cats and dogs that ate the pet food contaminated with melamine developed kidney failure. There are an estimated 60 million dogs and 70 million cats in the United States, according to the American Veterinary Medical Association.

The hospital chain saw 1 million dogs and cats during the three months when the more than 100 brands of now-recalled contaminated pet food were sold. It saw 284 extra cases of kidney failure among cats during that period, or a roughly 30 percent increase, when compared with background rates.

"It has meaning, when you see a peak like that. We see so many pets here, and it coincided with the recall period," said veterinarian Hugh Lewis, who oversees the mining of Banfield's database to do clinical studies. The chain continues to share its data with the Food and Drug Administration.

FDA officials previously have said the database compiled by the huge veterinary practice would probably provide the most authoritative picture of the harm done by the tainted cat and dog food.

From its findings, Banfield officials calculated an incidence rate of .03 percent for pets, although there was no discernible uptick among dogs. That suggests the contamination was overwhelming toxic to cats, Lewis said. That is in line with what other experts have said previously.

Yet More Pet Food Recalled

Menu Foods continues to add to the items already being recalled. The problem is that the recall now extends to products sold even earlier than first acknowledged.

A recall of pet food tainted with melamine, a chemical used to make plastic products, has been widened to include 22 types of dog biscuits, the Food and Drug Administration said yesterday.

The biscuits, made by Sunshine Mills Inc., contain wheat gluten imported from China that contained melamine, said Stephen F. Sundlof, director of the Center for Veterinary Medicine at the F.D.A.

Sunshine Mills, of Red Bay, Ala., manufactures branded and private label dry pet food and biscuits. The recalled biscuits include Nurture Chicken and Rice Biscuit, Ol’ Roy Peanut Butter Biscuit and Pet Life Large Biscuit.

Conrad Pitts, a lawyer for Sunshine Mills, said 80 percent of the tainted biscuits were sold by Wal-Mart, under the Ol’ Roy brand. Mr. Pitts said that the company had produced about 24 truckloads of biscuits with the contaminated gluten, and that the majority of the product was large biscuits. He said wheat gluten accounted for less than 1 percent of the total weight of the biscuits.

Until last week, when moist cat treats, dog jerky and a type of dry cat food were added to the recall, it had been limited to wet pet food sold under a variety of brand names.

Menu Foods, which last month recalled more than 90 brands of its “cuts and gravy” pet food, said yesterday that it had extended the period of time covered by its recall to include food made after Nov. 8, 2006. The company, based in Ontario, initially recalled only food made from Dec. 3, 2006, to March 6, 2007.

The ongoing and growing list of recalls means that you almost have to check back hourly or daily to see whether the recalls have affecting the pet food you may have bought. The FDA has compiled the list and provides additional information.

UPDATE:
The Chinese companies implicated in the tainted pet food are hemming and hawing over their role.

The Chinese agency that monitors food exports says China has never exported wheat or wheat gluten to the U.S.

The accused company, Xuzhou Anying Biologic Technology Development, at first said the U.S. was its main overseas customer for wheat gluten. But then the company said it had never shipped gluten directly to the U.S.

A company official was later quoted as saying it sold the suspect gluten to another Chinese food processor, and that company "probably" shipped it to the States.

This is the latest in a series of food scares in China in recent years.

Considering that the Chinese government has been notorious in its coverup of environmental disasters and poisonings, I would be reluctant to trust the Chinese government when it issues definitive statements denying a role in the pet food poisonings.

Chinese Wheat Gluten Implicated in Pet Deaths Banned

The U.S. is blocking imports of wheat gluten from a company in China, acting after an investigation implicated the contaminated ingredient in the recent pet-food deaths of cats and dogs.

The Food and Drug Administration took action against wheat gluten from Xuzhou Anying Biologic Technology Development Co. in Wangdien, China, after the U.S. recall of nearly 100 brands of pet food made with the chemically contaminated ingredient. The pet food, tainted with the chemical melamine, apparently has resulted in kidney failure in an unknown number of animals.

Wheat gluten from China has been suspected in the outbreak since the first of multiple recalls was announced in mid-March. Even more pet food could be recalled in the next few days, though there probably has been no contamination of human food, FDA officials said Monday.

The FDA reported last week that it had found melamine in samples of the vegetable protein source used in the recalled wet and dry pet foods and treats, as well as in cats that died after eating contaminated food.

"The wheat gluten that is positive for melamine all has come from this manufacturer," Neal Bataller, director of the division of compliance with the FDA's veterinary medicine office, told reporters. Melamine is used in plastics, countertops, glue, fire retardants and other products. Its toxicity to dogs and cats is unknown, but it is not allowed in food in any quantity.

Geng Xiujuan, Xuzhou Anying's sales manager, said the company was aware of the FDA's import alert and was looking into it. However, Geng said the company had not manufactured the wheat gluten but had instead bought it from companies in neighboring provinces.

Investigators are still trying to track down the source of the contamination and how it entered the food stream for pets.

For those who aren't quite sure what products have been recalled thus far, here's what claims to be a comprehensive listing. That list may yet expand further.

There's another recall of pet food that is unrelated to the one that felled so many pets in the past couple of weeks. This recall relates to potential salmonella contamination.

Pet Food Recall Crisis Deepens

This story just keeps getting worse. More brands and food lines are being recalled for fear that they include contaminants that are injuring and killing pets.

Alpo is the latest brand to be affected. Hill's dry pet food is still the only dry food to be recalled.

Nestle Purina PetCare Co. said it was recalling all sizes and varieties of its Alpo Prime Cuts in Gravy wet dog food with specific date codes. Purina said a limited amount of the food contained a contaminated wheat gluten from China.

The same U.S. supplier also provided wheat gluten, a protein source, to a Canadian company, Menu Foods, which this month recalled 60 million containers of wet dog and cat food it produces for sale under nearly 100 brand labels.

Menu Foods and the Food and Drug Administration, which regulates the pet food industry, have refused to identify the company that supplied the contaminated wheat gluten.

Hill's Pet Nutrition said late Friday that its Prescription Diet m/d Feline dry cat food included the tainted wheat gluten. The FDA said the source was the same unidentified company. Hill's, a division of Colgate-Palmolive Co., is so far the only company to recall any dry pet food.

Federal testing of some recalled pet foods and the wheat gluten used in their production turned up the chemical melamine. Melamine is used to make kitchenware and other plastics. It is both a contaminant and byproduct of several pesticides, including cyromazine, according to the Environmental Protection Agency. Melamine is toxic only in very high doses and has been shown in rats to produce bladder tumors, according to the EPA.

The federal pet food testing failed to confirm the presence of aminopterin, a cancer drug also used as rat poison, the FDA said. Cornell University scientists also found melamine in the urine of sick cats, as well as in the kidney of one cat that died after eating some of the recalled food.

Earlier, the New York State Food Laboratory identified aminopterin as the likely culprit in the pet food. But the FDA said it could not confirm that finding, nor have researchers at the University of Medicine and Dentistry of New Jersey when they looked at tissue samples taken from dead cats.

Pets around the country have been affected by the contamination, and the true toll is unknown. Veterinarians have been fielding calls for the past several weeks from pet owners trying to figure out what to do next.

The pet food manufacturers have a crisis on their hands and they've got to get ahead of the problem in a very aggressive manner. They also have to make amends to pet owners whose pets have been injured or killed by the contaminated pet food.

UPDATE:
Forget about trying to sue the manufacturers as an individual. The way that legal experts think this is going to shake out is in the form of class action suits. You get the benefit of shared legal representation, medical and scientific experts, and the weight of hundreds or thousands of participants spreading the risk of the case expenses.

Numerous pet owners around the country have sued or are considering legal action against Menu Foods. Some are seeking class action status.

"I would love to find an attorney to take on this company," said Brenda Hitchcock of Tampa, Fla. Hitchcock said she racked up $4,000 in veterinarian bills trying to save her 5-year-old cat "S.S." to no avail. She said she still has two pouches of the recalled food to prove her case.

Ontario-based Menu Foods has taken a low-key approach to the recall, expressing concern for people who have lost pets and offering to pay veterinary bills if a pet's illness or death can be directly linked to the food, but admitting no wrongdoing.

Jack Hall, a product liability lawyer from Pittsburgh, said the owner of a dog or cat used for breeding or of a specially trained animal could argue for higher compensation on the basis of lost potential earnings.

Hall said pet owners would fare better if they joined in a class action suit.

"I would think this kind of case would allow itself to a class action. That could work for somebody here," he said.

Still, Tobias said even a class-action suit could be tricky.

"The factual variations in the cases will make it very difficult to form a class action," he said. "Will people have the proof they need to trace the harm done to the animal back to Menu Foods?"

Well, one way to trace the harm would include retaining grocery and pet store receipts for the food purchased, along with health records for the pets and any tests done following the pets' illnesses. One has to establish a paper trail to show that their pet consumed the alleged tainted food.

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