Dollar-store toothpaste can kill you

NEWS RELEASES

HEALTH CANADA

************************* OTTAWA, ON (June 29, 2007) - 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 (www.healthcanada.gc.ca) 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.

************************* Chinese toothpaste in Canada found to contain diethylene glycol

OTTAWA, ON (June 29, 2007) - 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.

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.

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.

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: [email protected]

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.

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