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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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