Safety Alerts & Recalls

What does this mean?

At this time, consumers who use electronic cigarettes currently have no way of knowing 1) whether e-cigarettes are safe for their intended use, or 2) what nicotine dose or other chemicals they are inhaling when they use these products. Electronic cigarette products should be avoided until manufacturers address the FDA's concerns about safety, effectiveness, and manufacturing standards.

There are a number of FDA-approved smoking cessation aids, including nicotine gum, nicotine skin patches, nicotine lozenges, nicotine oral inhaled products, and nicotine nasal spray that are available for smokers to use to reduce their dependence on nicotine. Free help is available to all smokers who want to quit at 1-800-QUIT-NOW or by visiting www.smokefree.gov.

FDA Sends Warning Letters to Makers of Electronic Cigarettes

The FDA has issued warning letters to five manufacturer's of electronic cigarettes: E-Cigarette Direct LLC, Ruyan America Inc., Gamucci America (Smokey Bayou Inc.), E-Cig Technology Inc., and Johnson's Creek Enterprises LLC. Electronic cigarettes (also known as e-cigarettes) are battery-operated devices designed to look like and to be used in the same manner as conventional cigarettes. The e-cigarette violations included unsupported claims and poor manufacturing practices. The FDA is concerned because e-cigarettes have not been evaluated for safety or effectiveness. In a review of the manufacturing plants, the FDA also found serious quality issues that indicate that quality control processes used to manufacture these products are below standard or do not exist.

The FDA plans to regulate electronic cigarettes and related products in a manner consistent with regulation of other nicotine products. The FDA has invited electronic cigarette firms to work in cooperation with the agency toward the goal of assuring that electronic cigarettes sold in the United States are safe, effective, and lawfully marketed.

The FDA has answered several common questions about the e-cigarette issue. To view the FDA's "E-Cigarettes: Questions and Answers", please visit: more information here

For more information from the FDA, please visit: more information here

Source: FDA
Publication Date: 2010-09-11
Last Updated: 2010-09-14
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