FDA Cautions Against DEG-containing Toothpaste from China

The US Food and Drug Administration (FDA) warned consumers on June 1, 2007, 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), also known as diglycol or diglycol stearate, from entering the United States.

According to the FDA, DEG is used in antifreeze and as a solvent. Consumers are urged to examine toothpaste products for "Made in China" on the label and, as a precautionary measure, to throw away toothpaste with such labeling. The FDA reported it is not aware of any US 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, claims the FDA. 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, says the FDA. Based on reports of contaminated toothpaste from China found in several countries, including Panama, the FDA increased its scrutiny and began sampling toothpaste and other dental products manufactured in China that were imported into the United States. FDA inspectors reportedly identified and detained one shipment of toothpaste at the US border containing about 3%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%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, reports the FDA. 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. Thus, the FDA recently issued a guidance document to urge US 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.

The FDA continues to investigate this problem and if other brands of toothpaste products containing DEG are identified, the agency states it will take appropriate actions, including adding products and their manufacturers to the import alert to prevent them from entering the United States.