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FDA News
FOR IMMEDIATE RELEASE
P07-97
June 1, 2007
Media Inquiries:
Kimberly Rawlings, 301-827-6242
Consumer Inquiries:
888-INFO-FDA
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 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" or "diglycol stearate."
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.
http://www.fda.gov/bbs/topics/NEWS/2007/NEW01646.html
MY NOTE: DEG is the main ingredient of antifreeze. It causes permanent blindness!!!
*************************************************
Recalled separately was Ultrabrite Toothpaste
PRODUCT
Ultra Brite Advanced Whitening All in One Clean Mint Toothpaste in a 6.0 oz tube, over-the-counter, Distributed by Colgate-Palmolive Company, New York, NY NDC # 065954-064-60; SKU 0156685, UPC 3500056685, Recall # D-468-2007
CODE
Lots 6293, 6294, 6295, 6296, 6297, 6301, 6302, 6303, 6304 and 6305. All lots expire between 10/08 and 01/09.
RECALLING FIRM/MANUFACTURER
Recalling Firm: Colgate Palmolive Company, Jeffersonville, IN, by letter on January 12, 2007.
Manufacturer: Colgate Palmolive Company, Mission Hills, Mexico. Firm initiated recall is ongoing.
REASON
Misbranded; The label ingredient statement is incorrect. The product contains the following ingredients which are not declared: sodium fluoride, PEG-12 and cocamidopropyl betaine and does not contain the following ingredients which are declared: sodium monophosphate, alumina and glycerin.
VOLUME OF PRODUCT IN COMMERCE
1,441,200 tubes
DISTRIBUTION
Nationwide
http://www.fda.gov/bbs/topics/enforce/2007/ENF00997.html
FOR IMMEDIATE RELEASE
P07-97
June 1, 2007
Media Inquiries:
Kimberly Rawlings, 301-827-6242
Consumer Inquiries:
888-INFO-FDA
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 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" or "diglycol stearate."
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.
http://www.fda.gov/bbs/topics/NEWS/2007/NEW01646.html
MY NOTE: DEG is the main ingredient of antifreeze. It causes permanent blindness!!!
*************************************************
Recalled separately was Ultrabrite Toothpaste
PRODUCT
Ultra Brite Advanced Whitening All in One Clean Mint Toothpaste in a 6.0 oz tube, over-the-counter, Distributed by Colgate-Palmolive Company, New York, NY NDC # 065954-064-60; SKU 0156685, UPC 3500056685, Recall # D-468-2007
CODE
Lots 6293, 6294, 6295, 6296, 6297, 6301, 6302, 6303, 6304 and 6305. All lots expire between 10/08 and 01/09.
RECALLING FIRM/MANUFACTURER
Recalling Firm: Colgate Palmolive Company, Jeffersonville, IN, by letter on January 12, 2007.
Manufacturer: Colgate Palmolive Company, Mission Hills, Mexico. Firm initiated recall is ongoing.
REASON
Misbranded; The label ingredient statement is incorrect. The product contains the following ingredients which are not declared: sodium fluoride, PEG-12 and cocamidopropyl betaine and does not contain the following ingredients which are declared: sodium monophosphate, alumina and glycerin.
VOLUME OF PRODUCT IN COMMERCE
1,441,200 tubes
DISTRIBUTION
Nationwide
http://www.fda.gov/bbs/topics/enforce/2007/ENF00997.html