CONTAMINATION FROM CHINESE PRODUCTS
FDA has banned all CHINA-made Toothpaste
due to its poisonous chemical Diethylene Glycol (DEG)
U.S. health officials are beginning to check all shipments of toothpaste coming from China, following reports of tainted products in other countries, a government spokesman said.
China - the second-largest exporter of toothpaste to the United States behind Canada, according to the FDA - has been at the forefront of growing concerns about its standards as well as the U.S. government's ability to monitor foods and other products.
The FDA's action comes after the lethal chemical diethylene glycol was found in toothpaste sold in the Dominican Republic and Panama.
It follows a wave of concern over pet food from China containing another toxic chemical, melamine, thought to have sickened thousands of U.S. cats and dogs and made its way into livestock feed. "We are going to be sampling and testing all shipments of toothpaste that come from China," Arbesfeld said. "We're doing this as a precautionary measure. We have no evidence that toothpaste containing diethylene glycol has entered the country."
Diethylene glycol is toxic to humans and animals. Several poisonings have occurred when DEG is substituted for the non-toxic naturally-occurring "triol" glycerine (HOCH2CH(OH)CH2OH, also called glycerol) in foodstuffs and pharmaceuticals. Glycerine, which is higher melting (18 vs. -10.45 °C) and more viscous than DEG, costs about three times the price of DEG.
Because of its toxicity, diethylene glycol is not allowed for food and drugs. The U.S. Code of Federal Regulations allows no more than 0.2% of diethylene glycol in polyethylene glycol when the latter is used as a food additive.
DA has received and continues to receive (most recently in October 2006) reports about fatal DEG poisoning of consumers who ingested medicinal syrups, such as cough syrup or acetaminophen syrup, that were manufactured with DEG-contaminated glycerin. This guidance provides recommendations that will help pharmaceutical manufacturers, repackers, and other suppliers of glycerin, and pharmacists who engage in drug compounding, avoid the use of glycerin that is contaminated with DEG and prevent incidents of DEG poisoning.
All manufacturers take every opportunity to ensure proper testing of glycerin for DEG contamination. All personnel in pharmaceutical manufacturing facilities (especially personnel directly responsible for receipt, testing, and release of glycerin) should be made aware of the importance of proper testing and the potential hazards if the testing is not done.
Diethylene glycol is used in the manufacture of unsaturated polyester resins, polyurethanes and plasticizers. It is a water-soluble liquid; boiling point 245 C; soluble in many organic solvents. It is used as a humectant in the tobacco industry and in the treatment of corks, glue, paper and cellophane. Diethylene glycol (DEG) is derived as a co-product with ethylene glycol and triethylene glycol.
Air conditioning systems use TEG as dehumidifiers and, when volatilized, as an air disinfectant for bacteria and virus control. Glycols, having high boiling point and affinity for water, are employed as liquid desiccant for the dehydration of natural gas.
Repackers, and others who distribute and prepare glycerin for use in drug products, test glycerin that is used, sold for use, or intended for use in drug products. Pharmacies that use glycerin in compounding drug products either test the glycerin for DEG content or ensure that such testing was properly done by a reliable supplier.
Glycol ethers enter your body when they evaporate into the air you breathe, and they are rapidly absorbed into your body if the liquids contact your skin. Cases of poisoning have been reported where skin contact was the main route of exposure, even though there was no effect on the skin itself. The effects of overexposure can include anemia, mild intoxication (somewhat like the effects of drinking alcohol), and irritation of the skin, eyes, nose, and throat.
Highly toxic and may be fatal if swallowed. May cause central nervous system (CNS) depression resulting in dizziness, light-headedness, headache, nausea and loss of coordination. Significant exposure may result in unconsciousness and death. Repeated ingestion in experimental animals and humans caused kidney toxicity, intentional abuse, misuse or other massive exposure may cause multiple organ damage and or death.
Some glycol ethers are hazardous to the male and female reproductive systems. Certain glycol ethers have been found to cause birth defects and damage to the testicles in laboratory animals. These effects occurred at lower exposure levels than other effects did, so there were no obvious symptoms to warn that the animals were being harmed. Recent studies of exposed workers indicate that glycol ethers can reduce sperm counts in men.
In October 2006 the CDC and the Ministry of Health of Panama detected toxic levels of diethylene glycol in a sugarless liquid expectorant during an investigation of 46 deaths from a syndrome characterized by gastrointestinal symptoms, renal failure and paralysis. Almost all the victims were hypertension and diabetes patients in their 40s to 80s. Criminal investigations are ongoing. The source of the contamination was found to be the Taixing Glycerine Factory, a Chinese company in Hengxiang, China. Taixing Glycerine sold diethylene glycol falsely labeled as pharmaceutical grade glycerine, through the state-owned Chinese trading company CNSC Fortune Way, based in Beijing. A government agency in Panama purchased the falsely labeled product containing diethylene glycol and incorporated it into 260,000 bottles of cold medicine. The United States Food and Drug Administration issued an Industry Guidance Document highlighting appropriate testing procedures for use of glycerin in response to product contamination and misrepresentation.
Diethylene glycol is toxic to humans and animals. It has been responsible for a number of mass poisonings. The most infamous incident was the 1937 Elixir Sulfanilamide disaster in the USA, in which 107 people died after taking sulfanilamide dissolved in diethylene glycol. This episode was the impetus for the Federal Food, Drug, and Cosmetic Act of 1938.
In recent years, deaths from medicines adulterated with diethylene glycol have been reported from South Africa, India, Nigeria, Argentina, Haiti, and Panama. In Haiti in 1996, 85 children died due to glycerine contaminated with diethylene glycol in a paracetamol syrup produced by Pharval Laboratories, a Haitian company.
In 1990, in Bangladesh, 339 children developed kidney failure, and most of them died, after being given paracetamol (acetaminophen) syrup contaminated with diethylene glycol.
Tests on product pulled from shelves in Panama showed they contained high levels of diethylene glycol, used in engine coolants. Investigators in that country said two toothpaste brands were imported illegally from China through a free-trade zone. Tainted toothpaste has also been reported in Australia, Arbesfeld said.
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.
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.
"The U.S. Food and Drug Administration (FDA) has placed an import ban on all toothpaste from China," Deborah M. Autor, director of the FDA's Office of Compliance, Center for Drug Evaluation and Research, told reporters .
"The companies will have to prove that their products don't contain harmful levels of DEG (diethylene glycol) before it is allowed into the United States," she added.
There have been no reports of poisoning from DEG in toothpaste, Autor said. "However, the agency is concerned about chronic exposure to DEG and exposure in children and individuals with kidney or liver disease," she added.
The agency began its investigation after it discovered DEG-contaminated toothpaste from China had been sold in Panama. In addition, DEG in cold medicine killed at least 51 people and sickened 68 others in Panama last year.
The outbreak in Haiti emphasizes the need for pharmaceutical producers worldwide to be aware of possible contamination of glycerin and other raw materials with DEG and to use appropriate quality-control measures to identify and prevent potential contamination.
***First Aid Measures for diethylene glycol (DEG)
Check for and remove any contact lenses. Immediately flush eyes with running water for at least 15 minutes, keeping eyelids open. Cold water may be used. Do not use an eye ointment. Seek medical attention.
After contact with skin, wash immediately with plenty of water. Gently and thoroughly wash the contaminated skin with running water and non-abrasive soap. Be particularly careful to clean folds, crevices, creases and groin. Cold water may be used. Cover the irritated skin with an emollient. If irritation persists, seek medical attention. Wash contaminated clothing before reusing.
Serious Skin Contact:
Wash with a disinfectant soap and cover the contaminated skin with an anti-bacterial cream. Seek medical attention.
Allow the victim to rest in a well ventilated area. Seek immediate medical attention.
Do not induce vomiting. Loosen tight clothing such as a collar, tie, belt or waistband. If the victim is not breathing, perform mouth-to-mouth resuscitation. Seek immediate medical attention.
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See also Poison found in Chinese Kids' Clothing
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