Archive for the ‘FDA’ Category

Melamine Found in US Baby Formula

November 26, 2008

Traces of melamine are found in American baby formula. The industrial chemical used to make plastics boosts the appearance of protein in food, but if ingested, can cause kidney stones — which are especially dangerous to infants. The FDA says that the amount found in the U.S. formula is too small to pose a health hazard.

“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.

Associated Press

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U.S. says food, drug inspection access in China improving

November 19, 2008

U.S. officials opened the first overseas Food and Drug Administration office in Beijing on Wednesday as they gear up for a long battle to ensure the quality of food, drug and feed imports from China.

The eight FDA workers in Beijing, Shanghai and Guangzhou will set up a process for pre-certifying and inspecting imports from China, which has hundreds of thousands of food processors and drug manufacturers.

A series of food safety scandals in China, where thousands of babies fell ill after melamine was introduced into milk formula to cheat protein tests, has triggered alarm in the United States, which imports about 15 percent of the food it consumes.

By Lucy Hornby, Reuters

A laboratory researcher works at the food safety inspection ...
A laboratory researcher works at the food safety inspection center in Beijing July 18, 2007.(China Daily/Reuters)

Problems with melamine-tainted dairy products from China were so pervasive that the United States issued an import alert, which force importers to certify that the food was problem-free before entering U.S. markets. A similar alert has been in effect on Chinese seafood since last year.

U.S. inspectors have complained in the past of limited access and information when investigating safety disputes with Chinese suppliers and manufacturers, but U.S. Secretary of Health Mike Leavitt said cooperation was improving.

Access was “clearly spelled out” in agreements between U.S. and Chinese authorities, Leavitt told reporters.

“Heparin, for example, was not one of the drugs under the agreement but those protocols were used and there were U.S. inspectors and Chinese inspectors together visiting the points of production,” he said. “Progress is being made.”

Chinese-made heparin, a blood thinner, was blamed for fatalities and adverse reactions in U.S. and German patients, prompting a recall by Baxter International Inc. early this year.

The FDA offices would try to identify and train laboratories that can certify shipments for faster clearance into the United States, with the goal of ultimately accepting inspections by Chinese quarantine and inspection agency AQSIQ.

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The U.S. Food and Drug Administration will open three offices in China this week

November 17, 2008

The U.S. Food and Drug Administration will open three offices in China this week in an unprecedented effort to improve the safety of exports headed to America amid recurring product safety scares.

The new FDA offices, which are the first outside of the United States, will increase effectiveness in protecting for American and Chinese consumers, according to the office of U.S. Health and Human Services Secretary Mike Leavitt.

Leavitt and the agency’s Food and Drug Commissioner Andrew von Eschenbach will open the first office in Beijing on Wednesday, followed by one in Guangzhou and another in Shanghai.

Associated Press

“Establishing a permanent FDA presence in China will greatly enhance the speed and effectiveness of our regulatory cooperation and our efforts to protect consumers in both countries,” Leavitt’s office said in a statement last week.

Safety issues involving the blood thinner heparin, food and other products imported from China has put pressure on the FDA to boost its international presence. In the heparin case, a Chinese-made component contained a contaminant linked to as many as 81 deaths and hundreds of allergic reactions.

In October, cribs made in China were included in a recall of 1.6 million cribs issued by New York-based Delta Enterprises.

Last year, U.S.-based Mattel Inc. recalled more than 21 million Chinese-made toys worldwide. Products including Barbie doll accessories and toy cars were pulled off shelves because of concerns about lead paint or tiny, detachable magnets that might be swallowed.

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Capitalism, fiscal woes; contempt for economic liberty

November 9, 2008

There has always been contempt for economic liberty. Historically, our nation was an important, not complete, exception. It took the calamity of the Great Depression to bring about today’s level of restrictions on economic liberty. Now we have another government-created calamity that has the prospect of moving us even further away from economic liberty with the news media and pundits creating the perception that the current crisis can be blamed on capitalism.

We see comments such as those in the New York Times: “The United States  has a culture that celebrates laissez-faire capitalism as the economic ideal.” Or, “For 30 years, the nation’s political system has been tilted in favor of business deregulation and against new rules.” Another says, “Since 1997, Mr. Brown [the British prime minister] has been a powerful voice behind the Labor Party’s embrace of an American-style economic philosophy that was light on regulation.”

By Walter E. Williams
The Washington Times

First, let’s establish what laissez-faire capitalism is. Broadly defined, it is an economic system based on private ownership and control over of the means of production. Under laissez-faire capitalism, government activity is restricted to the protection of the individual’s rights against fraud, theft and the initiation of physical force.

Professor George Reisman has written a very insightful article on his blog titled “The Myth that Laissez Faire Is Responsible for Our Financial Crisis.” ( nsible.html) You can decide whether we have an unregulated laissez-faire economy. There are 15 Cabinet departments, nine of which control various aspects of the U.S. economy. They are the Departments of: Transportation, Housing and Urban Development, Health and Human Services, Education, Energy, Labor, Agriculture, Commerce and Interior. In addition, there is the alphabet soup cluster of federal agencies such as: the IRS, the FRB and FDIC, the EPA, FDA, SEC, CFTC, NLRB, FTC, FCC, FERC, FEMA, FAA, CAA, INS, OHSA, CPSC, NHTSA, EEOC, BATF, DEA, NIH and NASA.

Here’s my question to you: Can one be sane and at the same time hold that ours is an unregulated laissez-faire economy? Better yet, tell me what a businessman, or for that matter you, can do that does not involve some kind of government regulation.

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US says contaminated blood-thinner came from China

March 7, 2008

WASHINGTON (AFP) – Batches of the recalled blood thinner heparin, which contained an unidentified contaminant and has been linked to 19 deaths, have ingredients that came from China, the US government said Thursday.

The federal Food and Drug Administration (FDA), which added that Germany has announced its own recall of heparin due to allergic reactions, has yet to prove that the contaminant was the cause of the deaths as well as other adverse health effects.

But the FDA said that all the US batches of heparin linked to health problems and deaths were made with ingredients that came from China.

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China: Tainted Drugs Remain Threat to Life

January 31, 2008
January 31, 2008
BEIJING — A huge state-owned Chinese pharmaceutical company that exports to dozens of countries, including the United States, is at the center of a nationwide drug scandal after nearly 200 Chinese cancer patients were paralyzed or otherwise harmed last summer by contaminated leukemia drugs.
Chinese drug regulators have accused the manufacturer of the tainted drugs of a cover-up and have closed the factory that produced them. In December, China’s Food and Drug Administration said that the Shanghai police had begun a criminal investigation and that two officials, including the head of the plant, had been detained.Read the rest: 

Beijing Has No Control Over Food Safety

October 12, 2007

By John E. Carey
Peace and Freedom
October 12, 2007

“There is simple no way the Chinese government can have control” of food and product safety, the Food and Drug Administration told a congressional subcommittee yesterday.

David Nelson, one of the FDA investigators who just returned from China, described to the House Energy and Commerce Oversight Subcommittee “hundreds of millions of farmers” in China producing food on tiny plots, some no bigger than a basketball court.

A long series of product safety scandals rocked both China the producer and almost all other nations, China’s customers, since last December. The lesson for the West certainly is, “Trust, But Verify.”

We consulted with a manufacturing process and quality specialist with experience in China who told us: “I found it impossible to get companies in China to acknowledge that foreign customers needed to exert some control over the process and thus the product. The Chinese just would not listen. Now they are reaping the result.”

The process engineer finished with this: “It is quite impossible for any Chinese official to guarantee anything in China because of the lack of control that the government has and the lack of standards we take for granted in the West.”

We have commented on this in The Washington Times and elsewhere several times since the food and product safety crisis from China erupted on the scene last December.

Not only does Beijing lack the ability to fully and properly regulate the countryside in its sprawling land mass, the problem is compounded by a culture of corruption.

Local party bosses won’t enforce the rules if a small bribe suddenly becomes available.

China’s central government, unable to enforce the rules, frequently lies to the international media to cover up their problems.

On June 12, 2007, with the food safety scandal roiling, China’s Vice Minister for the State Administration for Industry and Commerce in China said, “We can guarantee food safety.”

He knew that was simply not the case because on August 4, 2007, the official China news agency Xinhua quoted the deputy head of the State Food and Drug Administration, Hui Lusheng, as saying “Dealing with and preventing food safety risks is a long-term, arduous and complicated project.”

The bottom line is this: with China, it is buyer beware.

Japanese food makers shun China for Thailand

China: ‘Trust but verify’ needed

Bacteria Filled Chopsticks Found in New China Scare

If China Has Nothing to Hide, Why Do They Hide So Much So Often?

China turns safety drive to dirty restaurants

China: You Won’t Get The Truth

China: So Big, So Powerful, So Disorganized, So Corrupt

China: At Long Last Admits Food Safety Clean Up Will Be “Arduous,” Long Term

Lawmakers seek tougher food-safety rules

October 12, 2007

By Missy Ryan 
October 12, 2007

WASHINGTON (Reuters) – House lawmakers hurled tough questions at U.S. regulators on Thursday as they pressed the Bush administration, after a year marred by public health scares, to come up with more aggressive defenses against dangerous food.

Bart Stupak, the Michigan Democrat who chairs the House Energy and Commerce Oversight Subcommittee, and other lawmakers were visibly exasperated as they questioned the Bush administration’s food czar and others in a hearing targeted at U.S. screening of domestic and imported food.

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More Fallout from the Chinese Food Scandals: Heavy Metals in Our Food?

October 8, 2007

By Barry Brownstein
Professor of economics and leadership at the University of Baltimore. He can be reached at:

 The Chinese food scandal continues to multiply. There is now little doubt that Chinese food imports have entered the United States food supply in widespread and unexpected ways.

For instance, a former FDA official, William Hubbard, was quoted in the New York Times as saying that most of the candy in supermarket aisles is “likely made with at least one ingredient that originated” in China.

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Puffer fish sold as salmon kills 15

August 23, 2007

BANGKOK, Thailand (AP)- Unscrupulous vendors in Thailand have been selling meat of the deadly puffer fish disguised as salmon, causing the deaths of more than 15 people over the past three years, a doctor said Thursday.

Although banned since 2002, puffer fish continues to be sold in large quantities at local markets and restaurants, said Narin Hiransuthikul of Bangkok‘s Chulalonkorn University Hospital.

“Some sellers dye the meat of puffer fish and make it look like salmon which is very dangerous,” Narin said.

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End Note:
In Asia it is not uncommon for vendors to add dye or anti-bacterial medications to seafood to “lengthen freshness.”  According to the U.S. Food and Drug Administration, this is one U.S. concern with imported Chinese seafood.