FDA News
June 1, 2007
FDA Advises Consumers to Avoid Toothpaste From China Containing Harmful
Chemical FDA Detains One Contaminated Shipment, Issues Import Alert
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
<
http://www.fda.gov/ora/fiars/ora_import_ia6674.html>; 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."
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 hasa 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
theseproducts 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 <
http://www.fda.gov/cder/guidance/7654fnl.htm>; 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.
