Below are the latest safety alerts, product recalls,
public health advisories and other notices

Unauthorized Smoking Cessation Product “Resolve” May Pose Health Risk

Neem Active Toothpaste with Calcium found to contain diethylene glycol

Additional serious harmful bacteria potentially found in counterfeit toothpaste

Counterfeit Toothpaste Falsely Labeled as Colgate Found to Contain Harmful
Bacteria

Chinese toothpaste in Canada found to contain diethylene glycol

FDA Advises Consumers to Avoid Toothpaste from China Containing Harmful
Chemical -FDA Detains One Contaminated Shipment, Issues Import Alert
July 27, 2007
For immediate release
Unauthorized Smoking Cessation Product Resolve May Pose Health Risk
OTTAWA - Health Canada is advising Canadians not to use the unauthorized smoking cessation product
Resolve, because of the potential health risk to consumers.
The product contains an unacceptable amount of an ingredient labelled as "CESTEMENOL-350." Consuming
excessive amounts of this ingredient might result in damage to the kidney, liver or red blood cells.
Resolve is advertised as a natural stop smoking aid and is available in Cool Peppermint and Wild Cherry
flavours. Resolve is distributed by The Winning Combination Inc. These products have been sold in retail stores
across the country and are also available over the Internet.
Resolve is not authorized for sale in Canada and Health Canada has asked the company to recall the products. To
date, the company has not complied with Health Canada's request. Health Canada will take further action to
remove the product from the market.
Health Canada advises retailers to remove the product from their shelves. Consumers should return the product to
the place of purchase.
Drugs and natural health products that are authorized for sale in Canada will have an eight-digit Drug
Identification Number (DIN), a Natural Product Number (NPN) or a Drug Identification Number for
Homeopathic Medicine (DIN-HM) on the label. These numbers indicate that the products have been assessed by
Health Canada for safety, effectiveness and quality.
Consumers requiring more information about this advisory can contact Health Canada's public enquiries line at
(613) 957-2991, or toll free at 1-866-225-0709.
To report a suspected adverse reaction to this product, please contact the Canadian Adverse Drug Reaction
Monitoring Program (CADRMP) of Health Canada by one of the following methods:
Telephone: 1-866-234-2345
back to top
Facsimile: 1-866-678-6789
July 26, 2007
For immediate release
Neem Active Toothpaste with Calcium in Canada found to contain diethylene glycol
OTTAWA - Health Canada is warning Canadians not to use Neem Active Toothpaste with Calcium,
manufactured by Calcutta Chemical Co. Ltd. in India and found on the Canadian market, because it has been
found to contain unacceptable levels of diethylene glycol (DEG).
DEG is a poisonous chemical used in antifreeze and as a solvent. It may cause nausea, abdominal pain, dizziness,
urinary problems, kidney failure, breathing problems, lethargy, convulsions, coma and even death when ingested.
While toothpaste is not meant to be swallowed, it is often swallowed by young children. The potential health
risks from chronic exposure to DEG are a particular concern in specific vulnerable populations such as children
and consumers with kidney or liver disease.
This warning follows previous warnings from Health Canada about Chinese toothpastes with DEG.
Neem Active Toothpaste with Calcium has been found in several stores in Western and Atlantic Canada, but may
also be available in stores across the country. Health Canada is taking steps to ensure that the products are taken
off the market.
Neem Active Toothpaste with Calcium is not approved for sale in Canada. Fluoride-containing toothpastes that
have been approved for sale in Canada will contain either an eight-digit Drug Identification Number (DIN) or a
Natural Product Number (NPN).
Consumers in possession of this toothpaste are advised to discontinue use immediately and ensure that these
products remain out of the reach of children. Consumers should return the product to the store they bought it
from. To date, Health Canada has not received any adverse reaction reports of DEG toxicity related to Neem
Active Toothpaste with Calcium. The product is not authorized for sale by Health Canada. Health Canada is in
the process of testing other unauthorized toothpastes and will update the public as information becomes
available.
Consumers requiring more information about this advisory can contact Health Canada’s public enquiries line at
(613) 957-2991, or toll free at 1-866-225-0709.
To report a suspected adverse reaction to this health product, please contact the Canadian Adverse Drug Reaction
Monitoring Program (CADRMP) of Health Canada by one of the following methods:
Telephone: 1-866-234-2345
Facsimile: 1-866-678-6789
CADRMP
Marketed Health Products Directorate
Ottawa, ON, AL 0701C
Email: cadrmp@hc-sc.gc.ca
The CADRMP adverse reaction reporting form, including a version that can be completed and submitted online,
is located in the MedEffect Canada area of the Health Canada Web site.
July 6, 2007
For immediate release
back to top
Additional serious harmful bacteria potentially found in counterfeit toothpaste
OTTAWA - Further to a warning issued on June 29, Health Canada is warning Canadians not to use a
counterfeit product falsely labelled as Colgate Fluoride Toothpaste Maximum Cavity Protection. Ongoing testing
has resulted in preliminary evidence of a further, potentially harmful bacterial contamination. If confirmed, the
presence of this bacterium could pose a serious health risk.
Health Canada will notify Canadians if it is determined that there is a health risk once final testing is completed.
Consumers who have this counterfeit product are advised to discontinue use immediately and not to use their
toothbrush. The product should be kept out of the reach of children. Consumers should seal the tube and put the
tube in a sealed bag. They should also wash their hands after handling the tube. Health Canada will provide
additional instructions on the proper disposal of the product if needed.
Consumers who have this product should contact Health Canada's Health Products and Food Branch Inspectorate
at 1-800-267-9675.
The counterfeit product falsely labelled as Colgate Fluoride Toothpaste Maximum Cavity Protection is marked
as 100 ml, and is labelled as "Manufactured in South Africa." It contains misspellings including "isclinically"
"SOUTH AFRLCA" and "South African Dental Assoxiation."
This counterfeit toothpaste product was found in the discount chain "Everything for a Dollar Store." Canadian
distributors are cooperating in the investigation and have removed the product from their shelves.
Genuine Colgate toothpaste approved for sale in Canada is safe and is labelled in English and French.
Additionally, fluoride-containing toothpaste that has been approved for sale in Canada will contain either an
eight-digit Drug Identification Number (DIN) or a Natural Product Number (NPN).
Canadian consumers with questions on how to identify genuine Colgate toothpaste can contact Colgate Canada's
consumer line at (1-800-268-6757) or visit
www.colgate.ca.
Consumers are also advised to monitor the Health Canada Web site for additional updates regarding this issue.
2007-79
June 29, 2007
For immediate release
back to top
Counterfeit Toothpaste Falsely Labelled as Colgate Found to Contain Harmful Bacteria
OTTAWA - Health Canada is warning Canadians that counterfeit toothpaste products, falsely labelled as
Colgate Fluoride Toothpaste Herbal and Colgate Fluoride Toothpaste Maximum Cavity Protection, have been
found to contain high levels of harmful bacteria. These products have been found on the Canadian market and
pose a significant risk to health, especially to children and individuals with compromised immune systems.
Health Canada is assisting in the criminal investigation that is being conducted by the Royal Canadian Mounted
Police.
Potential adverse effects of ingesting products that contain unacceptable amounts of aerobic bacteria include
fever, and gastrointestinal symptoms such as vomiting, diarrhea and abdominal pain. Infants and children are
more sensitive to these effects and severe vomiting and diarrhea could lead to potentially life-threatening
dehydration. While toothpaste is not intended to be swallowed, it is often swallowed by young children.
These counterfeit products were also found to contain a type of bacteria from the Enterobacteriaceae family,
which is of particular concern in vulnerable populations such as patients hospitalized for severe underlying
diseases or with compromised immune systems. In addition to gastrointestinal illnesses, infections can occur in
the lungs and urinary tract, and can cause blood poisoning.
Consumers who have purchased one of these counterfeit toothpaste products are advised to discontinue use
immediately. Consumers who have experienced any symptoms after using one of these products, or are
concerned about their health, are advised to consult their physician immediately.
The counterfeit products are falsely labelled as Colgate Fluoride Toothpaste Herbal and Colgate Fluoride
Toothpaste Maximum Cavity Protection marked as 100 ml. The Colgate Fluoride Toothpaste Maximum Cavity
Protection is labelled as “Manufactured in South Africa” and contains misspellings including “isclinically”
“SOUTH AFRLCA” and “South African Dental Assoxiation”. A third toothpaste, also falsely labelled as
Colgate, Fluoride Toothpaste Gel, was confirmed to be counterfeit.
Genuine Colgate toothpaste approved for sale in Canada is safe and is labelled in English and French.
Additionally, fluoride-containing toothpaste that has been approved for sale in Canada will contain either an
eight-digit Drug Identification Number (DIN) or a Natural Product Number (NPN). None of the three counterfeit
brands of toothpaste have a DIN or NPN or have bilingual packaging.
These counterfeit toothpaste products have been found in the discount chain “Everything for a Dollar Store.”
Canadian distributors are cooperating in the investigation and have removed the product from their shelves.
Consumers who find a health product they believe to be counterfeit for sale in Canada should contact Health
Canada’s Health Products and Food Branch Inspectorate at 1-800-267-9675.
Canadian consumers with questions on how to identify genuine Colgate toothpaste can contact Colgate Canada’s
consumer line at (1-800-268-6757) or visit
www.colgate.ca.
Consumers are also advised to monitor the Health Canada website for additional updates regarding this issue.
To date, no adverse reactions suspected to be associated with the use of these counterfeit toothpaste products
have been reported in Canada. To report a suspected adverse reaction to toothpaste products, please contact the
Canadian Adverse Drug Reaction Monitoring Program (CADRMP) of Health Canada by one of the following
methods:
Telephone: 1-866-234-2345
Facsimile: 1-866-678-6789
CADRMP
Marketed Health Products Directorate
Ottawa, Ontario, AL 0701C
K1A 0K9
Email: cadrmp@hc-sc.gc.ca
The CADRMP adverse reaction reporting form, including a version that can be completed and submitted online,
is located in the MedEffect Canada area of the Health Canada Web site.
2007-80
June 29, 2007
For immediate release
back to top
Chinese toothpaste in Canada found to contain diethylene glycol
OTTAWA - Health Canada is warning Canadians not to use Chinese toothpaste found on the Canadian market
because 21 products to date have been found to contain unacceptable levels of diethylene glycol (DEG). DEG is
a poisonous chemical used in antifreeze and as a solvent that may cause nausea, abdominal pain, dizziness,
urinary problems, kidney failure, breathing problems, lethargy, convulsions, coma and even death when ingested.
While toothpaste is not meant to be swallowed, it is often swallowed by young children. The potential health
risks from chronic exposure to DEG are a particular concern in specific vulnerable populations such as children
and consumers with kidney or liver disease.
UPDATE -- July 5, 2007: Health Canada updates list of toothpastes from China found to contain diethylene
glycol
A second toothpaste-related Warning was issued today by Health Canada on counterfeit Colgate products with
high bacteria levels, which is unrelated to this Warning.
The DEG-containing toothpastes identified to date are labelled primarily in Chinese and were found in Chinese
markets and dollar stores across the country. None of the products are approved for sale by Health Canada.
Health Canada is requesting retailers to remove all Chinese toothpaste from their shelves and the Department
will be communicating further with Chinese merchant associations across the country about this warning. Health
Canada will also verify that the products have been taken off the market.
A customs alert was issued June 5, 2007 to the Canada Border Services Agency to stop shipments of toothpaste
originating from China. Intercepted shipments will not be allowed into Canada until the importer can
demonstrate that it complies with the Food and Drugs Act and Regulations.
There are no fluoride-containing toothpastes approved for sale in Canada that are manufactured in China.
Fluoride-containing toothpastes that have been approved for sale in Canada will contain either an eight-digit
Drug Identification Number (DIN) or a Natural Product Number (NPN).
As of June 29, 2007, 21 Chinese toothpastes tested by Health Canada had been found to contain DEG levels up
to 13.7 per cent. Further testing is being done, and Health Canada will update the list of products as required.
Photos of the DEG-containing products are attached to this release, and can also be found on the Health Canada
Web site.
Consumers in possession of any of these toothpastes are advised to discontinue use immediately and ensure that
these products remain out of the reach of children. Consumers should return the product to the store they bought
it from. Retailers of these Chinese toothpastes are to return the products to the importer. To date, Health Canada
has not received any adverse reaction reports of DEG toxicity related to a toothpaste product.
Additional DEG-containing toothpastes have recently been identified in the United States. More information on
these products is available at
http://www.fda.gov/oc/opacom/hottopics/toothpaste.html
Consumers requiring more information about this advisory can contact Health Canada’s public enquiries line at
(613) 957-2991, or toll free at 1-866-225-0709.
To report a suspected adverse reaction to this health product, please contact the Canadian Adverse Drug Reaction
Monitoring Program (CADRMP) of Health Canada by one of the following methods:
Telephone: 1-866-234-2345
Facsimile: 1-866-678-6789
CADRMP
Marketed Health Products Directorate
Tunney's Pasture, AL 0701C
Email: cadrmp@hc-sc.gc.ca
The CADRMP adverse reaction reporting form, including a version that can be completed and submitted online,
is located in the MedEffect Canada area of the Health Canada Web site.
FOR IMMEDIATE RELEASE
P07-97
June 1, 2007
Media Inquiries:
Kimberly Rawlings, 301827-6242
Consumer Inquiries:
888-INFO-FDA
301-827-4570
FDA Advises Consumers to Avoid Toothpaste From China Containing
Harmful Chemical
FDA Detains One Contaminated Shipment, Issues Import Alert
back to top
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.
back to top