FDA Warns E-Cigarette Makers, Moves To Regulate Products

In National News on September 10, 2010 at 10:18 am

Yesterday, the FDA sent warning letters to five electronic cigarette distributors for various violations of the FDCA, including unsubstantiated health claims and poor manufacturing practices.  The FDA also stated that it has determined that electronic cigarette products are subject to FDA regulation as drugs, which means they would have to comply with the FDA’s drug approval process and meet the same safety, efficacy and manufacturing standards as other drugs.

Here is a statement that was released by the Campaign for Tobacco-Free Kids.

FDA Takes Appropriate Action to Regulate Electronic Cigarettes And Protect Public Health

WASHINGTON, DC (September 9, 2010) – We applaud the U.S. Food and Drug Administration for taking appropriate enforcement action today against five distributors of electronic cigarettes for various violations of the Federal Food, Drug and Cosmetic Act (FDCA), including unsubstantiated claims and poor manufacturing practices.

The FDA appropriately has asserted authority under the FDCA to regulate electronic cigarettes, which deliver the powerfully addictive drug nicotine and have been marketed with unsubstantiated claims that they can help smokers quit or are less harmful than regular cigarettes. The FDA also issued warnings about shoddy and dangerous manufacturing practices and the use of electronic cigarettes as delivery devices for an erectile dysfunction drug and a weight loss drug that has not been approved for use in the United States.

As the FDA noted today, for a drug product to gain FDA approval, a company must demonstrate to the agency that the product is safe and effective for its intended use and adheres to good manufacturing practices. To protect public health, the FDA must hold electronic cigarettes to the same safety, efficacy and manufacturing standards as other drugs, including nicotine replacement products.

No one is suggesting that these products should never be allowed on the market if they meet appropriate safety and efficacy standards. Rather, like other drugs and delivery devices, electronic cigarettes should be regulated to protect public health before they are permitted to be sold to consumers.

More information on the FDA’s enforcement action can be found at:


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