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Consumer Update |
On June 1, 2007, FDA warned consumers to avoid using tubes of toothpaste labeled as made in China because of concerns that the toothpaste may contain the poisonous chemical diethylene glycol (DEG). Also known as "diglycol," DEG is used in antifreeze and as a solvent. The agency also issued an import alert to prevent toothpaste containing DEG from entering the United States.
Out of an abundance of caution, FDA suggests that consumers throw away toothpaste labeled as made in China. Although FDA is not aware of any U.S. reports of poisonings from toothpaste containing DEG, the agency is concerned about potential risks from chronic exposure to DEG and exposure to DEG in certain populations, such as children and people with kidney or liver disease.
FDA has identified the following brands of toothpaste from China that contain DEG and are included in the import alert:
These products are made by Goldcredit International Enterprises Limited; Goldcredit International Trading Company Limited; and Suzhou City Jinmao Daily Chemicals Company Limited. They are typically sold at low-cost, "bargain" retail outlets.
Reports that contaminated toothpaste from China had been found in several countries, including Panama, spurred FDA to increase its scrutiny and begin sampling toothpaste and other dental products manufactured in China and imported into the United States.
FDA inspectors identified and detained one toothpaste shipment at the U.S. border that contained about 3 percent DEG by weight. FDA inspectors also found and tested toothpaste products from China located at a distribution center and a retail store. The highest level found was between 3 percent and 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. FDA 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, and will take appropriate actions if it identifies other brands of toothpaste products containing DEG. Consumers can report adverse reactions or quality problems experienced with the use of these products to FDA's MedWatch Adverse Event Reporting program at www.fda.gov/medwatch/report.htm or by phone (800) 332-1088.
For more information, including a list of recalled products, visit FDA's Web page on DEG in Toothpaste from China at www.fda.gov/oc/opacom/hottopics/toothpaste.html
Date Posted: June 1, 2007
Updated: June 4, 2007
