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FDA VS CHINA ON CHINESE TOOTHPASTE

China rejects US FDA’s warning on Chinese toothpaste

BY OUR PHARMA CORRESPONDENT


June 5, 2007:

The General Administration of Quality Supervision, Inspection and Quarantine (AQSIQ), China’s top quality watchdog, has strongly disagreed with a warning by the United Sates Food and Drug Administration (FDA) over the safety of Chinese toothpaste.

The AQSIQ termed the FDA warning as “unscientific, irresponsible, and contradictory.”

Responding to the FDA notice saying that toothpaste made in China may contains a poisonous chemical, the AQSIQ said in a statement, published in China Daily, that it is safe to consume the chemical in question in small quantities.

The AQSIQ insisted that research conducted by it shows that toothpaste containing up to 15.6% diethylene glycol, the chemical that the United States is concerned about, is “safe, even after prolonged use.”

The United States started checking imports of Chinese toothpaste on May 23, 2007, following media reports that the products may contain diethylene glycol, a solvent sometimes used as a substitute for glycerin, a sweetener used in drugs.

After finding that toothpaste made in China contains 3-4% diethylene glycol, the FDA issued on June 1, 2007, a warning over Chinese toothpaste.

However, experts from the Chinese Health Ministry say that diethylene glycol is a “low-level” poison that does not accumulate in the body and that there is no evidence that this chemical can cause cancer or deformities.

The AQSIQ also said that a list of the ingredients in the toothpaste exported to the United States had been offered to the FDA. The list included diethylene glycol. Also, the toothpaste’s labeling had already been registered with the FDA, meaning it could be sold in the US, the AQSIQ added.

Joseph Famulare, an official with the FDA’s Center for Drug Evaluation and Research, who was in Beijing attending a workshop this weekend, told China Daily that the US laws ban diethylene glycol as an ingredient in toothpaste. The recent scandals over safety, Famulare said, highlighted the importance of being aware of all the ingredients and intermediates in products.

Joseph Famulare told China Daily that, in order to improve the quality of management and the regulatory framework for drug manufacturing, the FDA and Peking University have jointly launched a new graduate programme on pharmaceutical engineering management.

 

BY OUR PHARMA CORRESPONDENT

 

 

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Archive: 7 Jan 2007

Archive: 14 Sep, 2005

 

 

 

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