 June 1st - 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."
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.
Frequently Asked Questions (updated June 8, 2007)
This has been a press release from the FDA
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