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How to Recognize Potentially Unsafe Imported Toothpastes

On June 1, 2007, FDA warned consumers to avoid using tubes of toothpaste labeled as made in China because of concerns that the toothpaste may contain the poisonous chemical diethylene glycol (DEG), an ingredient used in antifreeze. FDA has also identified toothpaste products from South Africa that contain DEG. FDA is working to stop the import of toothpaste containing DEG. The agency issued an import alert to prevent toothpaste containing DEG from entering the United States from any country.

FDA's scrutiny of toothpastes has uncovered other problems. Some imported toothpastes do not contain DEG, but they do not meet the requirements of FDA regulations for other reasons. These toothpastes, typically sold at low-cost, "bargain" retail outlets, may not be safe.

FDA advises consumers to examine imported toothpaste packages carefully before purchasing them, using the information below to help identify unacceptable imported toothpastes. To find out if a toothpaste is imported, look at the label for the manufacturer's or distributor's name, followed by the city and state. If this information is not there, or the label states another country name, it's most likely imported.

Diethylene Glycol (DEG) in Toothpaste

DEG is not allowed in any toothpaste marketed in the United States. Some of the toothpastes FDA has found to contain DEG have labels that identify the ingredient either as diethylene glycol or diglycol. FDA has also found DEG in imported toothpastes that did not declare the ingredient on the label. FDA is taking steps to identify toothpastes that may contain undeclared DEG in order to prevent their distribution and sale in the United States.

Although FDA is not aware of any U.S. reports of poisonings from toothpaste containing DEG, the agency is concerned about potential risks from chronic exposure to DEG and exposure to DEG in certain populations, such as children and people with kidney or liver disease.

On July 11, 2007, China's government banned the export of DEG-containing toothpaste products. FDA commends this action, but continues to advise consumers to avoid using toothpaste from China at this time. Toothpaste currently on store shelves may have arrived in the United States prior to the ban and may contain DEG. In addition, some manufacturers in China may not yet have reformulated their toothpastes to comply with the ban. FDA will continue to monitor toothpaste from China and update its advice if appropriate.

Advice to consumers:

• Look at the list of ingredients on the toothpaste label. If diethylene glycol or diglycol are listed, do not use it. Throw it away or return it to the store where you bought it.
• Avoid using toothpaste labeled as made in China.

Counterfeit and "Gray Market" Products

Even with the precautions taken by FDA, illegal toothpaste products may still reach consumers, particularly through discount stores and flea markets. Some of these toothpaste products are considered "counterfeit" or "gray market" goods.

Counterfeit toothpaste is marketed under a product name without the permission of the company that has the legal right to use that name. These products are not legally marketed in the United States and they may not have the same ingredients, or the same quality of ingredients, as the original products.

Imported "gray market" toothpastes are products that are authorized for production and marketing in other countries. These products are not intended for the U.S. market, but are sold in the United States through unauthorized channels.

FDA specifically prohibits the marketing of counterfeit drugs. Gray market drugs do not usually meet FDA requirements, particularly with respect to labeling and fluoride content. FDA cannot assure the safety or effectiveness of counterfeit toothpastes, gray market toothpastes, and toothpastes that do not otherwise meet FDA regulatory requirements.

Advice to consumers:

• Do not use counterfeit toothpastes, which may sometimes be identified by spelling mistakes and uneven spacing between letters and words on the product label.
• Do not use gray market toothpastes, which may sometimes be identified by foreign language labeling and, for toothpastes that are drugs, by labeling that is not consistent with the "Drug Facts" format described below.

Regulated as Drugs or Cosmetics

FDA regulates toothpastes as drugs or cosmetics, depending on their ingredients and purpose. Toothpastes are drugs if they contain fluoride, are intended to prevent or lessen diseases like tooth decay, or affect the structure of the body or how it functions. Toothpastes that do not contain fluoride and that claim only to cleanse teeth are considered cosmetics and are not regulated as drugs.

Understanding the requirements for drug and cosmetic toothpaste labeling may help consumers identify potentially unsafe toothpastes.

Drug Toothpaste Labeling

Over-the-counter toothpaste that is not sold as a cosmetic must be labeled in "Drug Facts" format, which means a standard "box" format on the side or back panels of the outer carton or on the tube of toothpaste if there is no outer carton. This format is easy to recognize:

• The panels are labeled with the heading "Drug Facts."
• Information in the panel is printed in a single color against a white or contrasting background.
• Information in the box is separated by horizontal lines.
• Information is under the headings "Active ingredient(s)," "Use," "Warnings," "Directions," "Other information," "Inactive ingredients," and "Questions" in that order.

Advice to consumers:

• If a drug toothpaste does not show the "Drug Facts" information above, do not use it. It is not legally marketed in the United States.
• If any toothpaste does not list ingredients on the label, do not use it. Cosmetic toothpastes are not required to have all the drug labeling information, but must still list all ingredients on the label.
• If any toothpaste does not have information on the label in English, do not use it. Both cosmetic and drug toothpastes must have information on the label in English to meet U.S. standards. The toothpaste can also include required information in a foreign language if it also provides this information in English.

Additional Information

For more information on unacceptable toothpastes, including a list of recalled products, visit Imported Toothpaste.

For more information on labeling of over-the-counter drug products, including drug toothpastes, visit OTC drug labeling.

To report any problems with toothpaste, call the Consumer Complaint Coordinator for your geographic region.

Imported Toothpaste Home Page

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