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China Faults U.S. FDA In Toothpaste Flap

Consumers Should Discard All Toothpaste from China, Feds Warn

By Joseph S. Enoch
ConsumerAffairs.com

June 4, 2007

Toothpaste • 'Whiter Smile' Ads Can Leave Consumers Frowning • Toothpaste Importers Face Charges In California • Gilchrist & Soames Recalls Toothpaste • Toothpaste Scare Spreads to Hospitals, Prisons • China Pledges to Improve Food Safety • Another Importer Recalls Chinese Toothpaste • Colgate Warns of Counterfeit Toothpaste • Importer Recalls Toothpaste After FDA Warning • China Faults U.S. FDA In Toothpaste Flap • FDA Warns Chinese Toothpaste May Be Contaminated • Chinese Toothpaste Scare Spreads to Canada • FDA Bans Toothpaste from China after 51 Deaths in Panama • Foreign Toothpaste Illegally Imported, Sold in U.S. --- Complaints • Colgate • Crest • Ultrabrite

China is in a public dispute with the U.S. Food and Drug Administration over that agency’s recent warning about toothpaste made in China. China’s state-run consumer watchdog agency said the FDA’s complaints are a little late and ring a little hollow.

The FDA last week warned consumers to throw out all toothpaste made in China after finding a poison commonly used in anti-freeze in toothpaste it checked in three U.S. cities.

The agency said it had found diethylene glycol (DEG) in toothpaste sold at a Dollar Plus retail store in Miami under the brand name ShiR Fresh. It said nine other brands also contained the sweet, syrupy chemical and warned the products had a “low but meaningful risk of toxicity and injury,” especially when used by children or individuals with kidney or liver disease.

“All the toothpastes were registered with the FDA and approved to be distributed in the United States, so they contradicted themselves by warning consumers to avoid using China-made toothpastes and detaining shipments from China,” said Li Yuanping, director of General Administration of Quality Supervision, Inspection and Quarantine.

The Chinese government says its manufacturers were not trying to deceive anyone, and complied with all U.S. laws. It says U.S. importers submitted the formula used to produce the toothpaste exports to the FDA before the shipment, and that the content level of chemical D-E-G was indicated on the packaging.

FDA said brands of toothpaste from China that contain DEG include: 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.

As ConsumerAffairs.com reported on May 22, tubes of toothpaste from foreign lands are routinely sold in dollar-discount stores and neighborhood bodegas, even though the importation and sale of such products is illegal.

The agency said its inspectors identified and detained one shipment of toothpaste at the U.S. border, containing about 3 percent DEG by weight. In addition, FDA inspectors found and tested toothpaste products from China located at a distribution center and a retail store.

The highest level found was between 3-4 percent by weight. The product at the retail store was not labeled as containing DEG but was found to contain the substance. Contaminated toothpaste was also found in Puerto Rico and the Port of Los Angeles, the FDA said.

DEG killed 51 residents of Panama a year ago after it was found in Chinese-imported cough syrup.

Foreign Toothpaste Widespread

A recent story by ConsumerAffairs.com found illegally imported toothpaste being sold in in discount stores. We found 17 tubes of illegally imported toothpaste being sold in D.C.-area discount stores. The tubes were all manufactured in other countries and are not intended for sale in the U.S. One illegal tube of toothpaste was from China.

Imported toothpaste found in D.C.-area stores

The tubes are illegal because they do not follow the FDA’s over-the-counter drug labeling requirements. Two tubes didn’t even list all the ingredients while many of the others are in foreign languages.

After almost three weeks of ignoring many of our questions, the FDA told ConsumerAffairs.com that companies who manufacture, market and distribute the toothpastes could all face prosecution for selling the illegal products.

“Over-the-counter drug products that do not comply with FDA labeling requirements are misbranded and may also be unapproved new drugs, both of which violate the Food, Drug and Cosmetic Act,” FDA spokeswoman Veronica Castro wrote in an e-mail.

“Enforcement regarding products that violate the FDCA include regulatory correspondence, seizure, injunction, and in some cases criminal prosecution.”

Most of the illegal tubes were common U.S. names designed for foreign use.

Colgate representative Tom Paolella, said regardless of the tube’s origin, all their products are safe.

Crest representatives have not returned two phone calls and two e-mails.

The worst retail offender was discount store chain, National Wholesale Liquidators, which has not returned two e-mails and does not answer the phone.

When shopping at discount stores, consumers should ensure the product has the over-the-counter drug facts labeling that includes: a list of active ingredients, a description of the product’s use, warnings, directions, a list of inactive ingredients and a toll-free phone number.

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