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Updated June 8, 2007
Q: Why are consumers being warned about toothpaste?
FDA is strongly warning consumers to avoid using any toothpaste labeled as made in China because we have found levels as high as 3-4% of a poisonous chemical, diethylene glycol (DEG), in Chinese toothpaste.
Q: What is diethylene glycol, or DEG?
Diethylene glycol (DEG), also known as "diglycol" is a poisonous chemical used in antifreeze and as a solvent. It does not belong in toothpaste even at small concentrations.
Q: What brands of toothpaste contain DEG?
FDA has identified the following brands of toothpaste from China that contain DEG:
Q: Who makes the toothpaste with DEG?
To date the following manufacturers of toothpaste known to contain DEG are:
Q: How do I know if my toothpaste may be contaminated? If it is, what should I do with it?
Consumers should examine toothpaste products for labeling that says the product is made in China. FDA suggests that consumers throw away toothpaste with that labeling. We are concerned that these products may contain "diethylene glycol," also known as "diglycol." Please note that no major brands of toothpaste have been involved in this matter.
Q: I don't eat or swallow toothpaste. Should I be concerned if I use it and just spit it out?
Toothpaste is not intended to be swallowed, but FDA is concerned about unintentional swallowing or ingestion of toothpaste containing DEG, especially among children.
Q: What is FDA doing about the contaminated toothpaste?
Besides warning consumers, FDA has issued an import alert to prevent Chinese toothpaste containing DEG from being sold in the United States. The import alert stops all brands of toothpaste from the three companies in China that make the brands found to contain DEG. The companies will have to prove that their toothpaste is free from harmful levels of DEG before it is allowed into the United States.
In addition, FDA will also continue to stop all other brands of Chinese toothpaste from other manufacturers for testing, as we have been doing since May 23, 2007.
Q: How did FDA find out about the contaminated toothpaste?
Reports of contaminated Chinese toothpaste found in several countries, including Panama, led FDA to begin testing Chinese toothpaste and dental products that were imported into the United States.
As a result, 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 Chinese toothpaste products located at a distribution center and a retail store. The highest level found was between 3% and 4% by weight. The product at the retail store was not labeled as containing DEG but was found to contain the substance.
Q: Have there been any illnesses or deaths in the United States because of the contaminated toothpaste?
FDA is not aware of any U.S. reports of poisonings from toothpaste containing DEG; however, DEG in toothpaste has a low but meaningful risk of toxicity and injury to these populations. The agency is concerned about chronic exposure to DEG and exposure to DEG in certain populations, such as children and individuals with kidney or liver disease.
Q: What happens if other brands of toothpaste are found to contain 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 being sold in the United States.
Q: Has DEG been found in other products besides toothpaste?
Yes. FDA 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 address this important public safety issue. The guidance urges 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 guidance states that the relevant safety limit for DEG is 0.1%, as recognized by the US Pharmacopeia monograph for glycerin. This amount is for the raw ingredient glycerin, which would lead to amounts in finished products of far less than 0.1%.