From foodconsumer.org : China says US warning on toothpaste unjustified By David Liu
Jun 3, 2007 - 11:09:32 AM
China is rejecting the warning issued Friday by the U.S. government against use of toothpaste made in China that contains diethylene glycol or DEG, a potentially poisonous chemical commonly used in antifreeze. China says that the amount of diethylene glycol in toothpaste made in China is safe and demands the U.S. government to show scientific evidence to justify its warning.
On June 1, the FDA warned consumers not to use toothpaste made in China because its inspectors have detected as high as 4 percent of diethylene glycol in at least one shipment detained at the U.S. border. Contamination of DEG was also found at least in samples collected from two bargain stores, a Dollar Plus in Miami and a Todo A Peso in Puerto Rico.
The warning affects 13 Chinese brands of toothpaste including Cooldent Fluoride, Cooldent Spearmint, Cooldent ICE, Dr. Cool, Everfresh Toothpaste, Superdent Toothpaste, Clean Rite Toothpaste, Oralmax Extreme, Oral Bright Fresh Spearmint Flavor, Bright Max Peppermint Flavor, ShiR Fresh Mint Fluoride Paste, DentaPro; DentaKleen and DentaKleen Junior.
These toothpaste products were made by three manufacturers in China, namely, International Enterprises Limited; Goldcredit International Trading Company Limited; and Suzhou City Jinmao Daily Chemicals Company Limited.
China's General Administration of Quality Supervision, Inspection and Quarantine on June 2 issued a statement on its website saying the advisory from the U.S. Food and Drug Administration is unscientific, irresponsible and contradictory.
Li Yuanpin, Director of Food Safety Administration is cited as saying by a Chinese newspaper that these toothpaste products are custom-made for the US importers. Use of diethylene glycol is actually allowed by the FDA. Prior to the sales of these products, the FDA is notified of the formulations which list diethylene glycol as an ingredient and the FDA grants permission for the sales.
To get future permission for sales, manufacturers that made brands of toothpaste found with DEG will have to demonstrate that their products are free of the chemical; the FDA was cited as saying by the Associated Press. The FDA also has issued an import alert to block entrance of Chinese-made toothpaste to the US and all products will be tested for diethylene glycol.
China says experts commissioned by the China’s Department of Health have conducted a toxicity assessment and concluded diethylene glycol in toothpaste will not pose any risk to consumers. Diethylene glycol belongs to the class of chemicals that are minimally toxic, the Chinese quality regulator says, citing the assessment results, and it does not cause any genetic mutation, cancer or deformations of fetuses when the chemical is present at a low level.
China claims that according to the European Commission of Food Science, daily ingestion of no more than 0.5 mg per kg of body weight is safe. Citing a 2000 epidemiologic study of 1865 Chinese men and women, it also says that long-term use of toothpaste containing no more than 15.6 percent diethylene glycol will not cause any negative impact on health.
The U.S. Food and Drug Administration acknowledges that there is no reporting of poisonings from Made in China toothpaste and believes normal use of the affected toothpaste will not lead to any health consequences. But the U.S. food regulator is concerned that toothpaste may cause a problem in children and those who have liver and or kidney diseases.
China says that the US warning contradicts Code of Federal Regulations 21CFR172.820, which allows diethylene glycol present in polyethylene glycol indicated for use in food. The law does not say, however, diethylene glycol can be used as an ingredient in food or toothpaste, a scientist affiliated with foodconsumer.org points out. The law permits 0.2 percent of DEG and ethylene present as an impurity.
According to news media reports, the affected toothpaste products account for about $3 million in sales, only a tiny fraction of $2 billion in total sales on the US market. But the Chinese chemical companies are concerned that this type of warning may affect their trade with US importers in other chemical products, considering early reports on the mislabeling of glycerin as diethylene glycol, which resulted in many deaths in Panama although China has said that the fault is not on their side.
