FDA Bans Toothpaste From China

ByABC News

Mar. 23 -- FRIDAY, June 1 (HealthDay News) -- U.S. health officials warned consumers Friday not to use toothpaste made in China because it may be contaminated with a poisonous chemical used in antifreeze and as a solvent.

"The U.S. Food and Drug Administration (FDA) has placed an import ban on all toothpaste from China," Deborah M. Autor, director of the FDA's Office of Compliance, Center for Drug Evaluation and Research, told reporters at an afternoon briefing.

"The companies will have to prove that their products don't contain harmful levels of DEG (diethylene glycol) before it is allowed into the United States," she added.

There have been no reports of poisoning from DEG in toothpaste, Autor said. "However, the agency is concerned about chronic exposure to DEG and exposure in children and individuals with kidney or liver disease," she added.

The agency began its investigation after it discovered DEG-contaminated toothpaste from China had been sold in Panama. In addition, DEG in cold medicine killed at least 51 people and sickened 68 others in Panama last year.

"DEG is used in antifreeze and as a solvent and it is used as a low substitute for glycerin and as a thickener," Autor said. "It does not belong in toothpaste even in a small concentration."

Autor said consumers should throw out any toothpaste they have that is made in China. But, she added, "no major toothpaste brands are involved in this matter."

Chinese toothpaste makes up about $3.3 million of the $2 billion U.S. toothpaste market, she said.

The FDA identified the following brands of toothpaste from China that contain DEG and are included in the import alert: 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; and ShiR Fresh Mint Fluoride Paste.

The manufacturers of these products are Goldcredit International Enterprises Limited; Goldcredit International Trading Company Limited; and Suzhou City Jinmao Daily Chemicals Company Limited, DentaPro, DentaKleen and DentaKleen Junior, Autor said.

These brands are usually sold in discount stores, Autor said.

The FDA has seized tainted toothpaste at a DollarPlus store in Miami, Fla., and from a Todo, a store in Puerto Rico.

"In addition, FDA inspectors identified and detained one shipment of toothpaste at the U.S. border that contained about 3 percent DEG and FDA inspectors also found product at a distribution center," Autor said.

"FDA continues to investigate this problem," Autor said. "If FDA identifies other brands of toothpaste products containing DEG, FDA will take appropriate actions, including adding products and their manufacturers to the import alert to prevent them from entering the United States."

More information

For more information on the toothpaste ban, visit the U.S. Food and Drug Administration.

SOURCE: June 1, 2007, teleconference with Deborah M. Autor, Edq., director of the Office of Compliance, Center for Drug Evaluation and Research, U.S. Food and Drug Administration

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