Recognizing Potentially Unsafe Imported Toothpastes

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

FDA has found that some imported toothpastes do not contain DEG, but that 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. Consumers should examine imported toothpaste packages carefully before purchasing them.

To find out if a toothpaste is imported:

• Look on the label for the manufacturer's or distributor's name, followed by the city and state.
• If the above information is not there, or the label states another country name, it's most likely imported.

Diethylene Glycol (DEG) in Toothpaste

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.

Advice:

• Look on the toothpaste label at the list of ingredients. If diethylene glycol or diglycol are listed, do not use it.
• Avoid using toothpaste labeled as made in China.

Counterfeit and "Gray Market" Products

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 cannot assure the safety or effectiveness of counterfeit toothpastes or gray market toothpastes.

Do not use:

• counterfeit toothpastes, which may sometimes be identified by spelling mistakes and uneven spacing between letters and words on the product label.
• 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.

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.

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 listed under the headings, and in this order:
  • Active ingredient(s)
  • Use
  • Warnings
  • Directions
  • Other information
  • Inactive ingredients
  • Questions

Do not use:

• a drug toothpaste that does not show the "Drug Facts" information above
• any toothpaste that does not list ingredients on the label

• any toothpaste that does not have information on the label in English (Toothpaste can include required information in a foreign language if it also provides this information in English.

  This article appears on FDA's Consumer Updates page, which features the latest on all FDA-regulated products.

  Date Posted: October 15, 2007