FDA Warns of Chinese-Made Toothpaste

Agency Says Some Brands May Contain Poisonous Chemical

Medically Reviewed by Louise Chang, MD on June 01, 2007
From the WebMD Archives

June 1, 2007 -- The FDA warned consumers Friday not to use toothpaste made in China after regulators found some brands contained a poisonous ingredient also found in antifreeze.

Officials say they have identified at least 16 brands of imported toothpaste potentially containing diethylene glycol, a chemical that can be used as a sweetener and thickening agent but that is toxic to humans.

None of the brands is widely distributed in the U.S.; regulators say they are sold primarily at discount stores. Officials say they have not received reports of any U.S. consumers injured by the contaminated toothpaste.

'Abundance of Caution'

Debora Autor, the FDA's director of compliance, urges consumers to check the labels of toothpaste in their medicine cabinets to see if it indicates Chinese origin.

"Out of an abundance of caution, FDA recommends consumers should throw away toothpaste with that labeling," Autor says.

Some of the contaminated brands include the chemical in their labels under the names "diethylene glycol," "diglycol," or "diglycol stearate." But others have no mention of the chemical on their packaging, the agency says.

Autor says contaminated toothpaste has been recovered from a Dollar Plus store in Miami as well as from an outlet called Todo a Peso in Puerto Rico.

Similar reports of contaminated toothpaste from China emerged from Panama last month. An FDA news release says the agency "increased its scrutiny and began sampling toothpaste and other dental products manufactured in China that were imported into the United States."

Officials say they issued the alert after detaining a shipment of toothpaste from China that contained 3% diethylene glycol. Autor speculates that the chemical was used as a less costly alternative to glycerin, which is used as a sweetener in some products.

"It's less expensive, but unfortunately, it's not safe for humans," she says.

Diethylene glycol poisoning can cause abdominal pain, vomiting, diarrhea, altered mental state, and kidney failure in severe cases.

Low Poisoning Risk

Officials say they considered the products to carry a low risk of acute poisoning. Toothpaste is not typically swallowed during regular use, and several ounces would have to be ingested to deliver a poisonous dose.

But chronic exposure could carry some risks, and little scientific data point to the consequences of long-term, low-level poisoning, they say.

Autor says the agency has not yet determined how many American consumers may have purchased potentially contaminated toothpaste.

Chinese toothpaste accounts for an estimated $3.3 million out of the overall $2 billion U.S. toothpaste market, she says.

The FDA's alert identified three companies as the sources of suspect brands: Goldcredit International Enterprises Limited, Goldcredit International Trading Company Limited, and Suzhou City Jinmao Daily Chemicals Company Limited.

It also included the following brands: 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; DentaKleen Junior; and BrightMax.

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SOURCES: FDA import alert #66-74. Deborah Autor, director for compliance, Center for Drug Evaluation and Research, FDA. News release, FDA.

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