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FDA Advisory: Avoid Toothpaste From China

Summary:
Emails and online articles claim that the FDA has warned consumers to avoid using toothpaste made in China because it may contain a dangerous chemical called DEG (Full commentary below).



Status:
True

Example:(Submitted, June 2007)
Subject: Chinese toothpaste...

I just heard that the FDA is warning people about toothpaste made in China. Apparently it contains a poisonous chemical called DEG.

PASS THIS ON




Commentary:
Early in June 2007, warnings about a dangerous chemical in Chinese toothpaste began making their way around the Internet via email, blogs, and online news articles. The warnings are factual. According to America's Food and Drug Administration (FDA), there are concerns that toothpaste made in China may contain a poisonous chemical called diethylene glycol (DEG).

On June 1st, the FDA published the following News Release about the issue:
The U.S. Food and Drug Administration (FDA) today warned consumers to avoid using tubes of toothpaste labeled as made in China, and issued an import alert to prevent toothpaste containing the poisonous chemical diethylene glycol (DEG) from entering the United States.

DEG is used in antifreeze and as a solvent.

Consumers should examine toothpaste products for labeling that says the product is made in China. Out of an abundance of caution, FDA suggests that consumers throw away toothpaste with that labeling. FDA is concerned that these products may contain "diethylene glycol," also known as "diglycol" or "diglycol stearate."

FDA is not aware of any U.S. reports of poisonings from toothpaste containing DEG. However, the agency is concerned about potential risks from chronic exposure to DEG and exposure to DEG in certain populations, such as children and individuals with kidney or liver disease. DEG in toothpaste has a low but meaningful risk of toxicity and injury to these populations. Toothpaste is not intended to be swallowed, but FDA is concerned about unintentional swallowing or ingestion of toothpaste containing DEG.

FDA has 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; ShiR Fresh Mint Fluoride Paste; DentaPro; DentaKleen; and DentaKleen Junior. Manufacturers of these products are: Goldcredit International Enterprises Limited; Goldcredit International Trading Company Limited; and Suzhou City Jinmao Daily Chemicals Company Limited. The products typically are sold at low-cost, “bargain” retail outlets.

Based on reports of contaminated toothpaste from China found in several countries, including Panama, FDA increased its scrutiny and began sampling toothpaste and other dental products manufactured in China that were imported into the United States.

FDA 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.

DEG poisoning is an important public safety issue. The agency is aware of reports of patient deaths and injuries in other countries over the past several years from ingesting DEG-contaminated pharmaceutical preparations, such as cough syrups and acetaminophen syrup. FDA recently issued a guidance document to urge U.S. pharmaceutical manufacturers to be vigilant in assuring that glycerin, a sweetener commonly used worldwide in liquid over-the-counter and prescription drug products, is not contaminated with DEG.

FDA continues to investigate this problem. 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.

Consumers can report adverse reactions or quality problems experienced with the use of these products to FDA's MedWatch Adverse Event Reporting program:
www.fda.gov/medwatch/report.htm
(800) 332-1088
It should be stressed that, at the time of writing, there had been no reports of actually poisonings from DEG contaminated toothpaste in the United States. Moreover, the Chinese government has rejected the FDA's warning and claims that the low levels of DEG included in Chinese toothpaste are unlikely to be harmful. However, as the FDA news release points out, there have been reports of fatal DEG poisonings from pharmaceutical products containing the chemical, so caution is certainly warranted.

The FDA notes that toothpaste containing DEG has been typically sold at "low-cost, 'bargain' retail outlets". The bargain store reference is reminiscent of email warnings about foreign toothpaste from "dollar" stores that have been circulating for several years. However, the messages, like the example included below, were about excessive fluoride levels rather than DEG levels.
A news investigation on dollar stores (including Dollar Tree and others):

They discovered the Crest, Colgate and other brand name toothpastes weren't the same as from drug, and grocery stores, etc. The toothpastes were manufactured in many other countries and are not approved by the American Dental Association ( ADA ). There was even some from South Africa and the fluoride is ten times stronger than what we're allowed in the U.S. (prescription strength)

In 2004, an NBC 5 investigation found that some imported toothpastes sold in discount stores were several times higher than that of toothpaste normally sold in the US.

References:
FDA Advises Consumers to Avoid Toothpaste From China Containing Harmful Chemical
China Rejects U.S. Warning on Toothpaste
Fatalities Associated with Ingestion of Diethylene Glycol
Some Dollar-Store Bargains Could Prove Costly

Last updated: 4th June 07
First published: 4th June 2007

Write-up by Brett M.Christensen

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