FDA Warns e-Cigarette Makers

October 12th, 2010 | Sources: Wall Street Journal

Subjects:

The Food and Drug Administration has sent letters to 5 electronic cigarette makers warning them that they are violating federal law.

e-Cigarettes vaporize liquid nicotine. The addictive chemical is then inhaled by users. Tobacco is not contained in these products.

In its warning letter, the FDA stated that e-cigarettes require FDA approval before they can be marketed, just like nicotine-laced gums, patches and lozenges.

Regulatory approval would depend on the results of clinical trials designed to assure the safety and effectiveness of e-cigarettes.

The companies in receipt of the letters were Ruyan America,  E-CigaretteDirect , E-Cig Technology, Gamucci America and Johnson’s Creek Enterprises. They have 15 days to respond.

More than 300 firms are believed to be involved in the production and distribution of e-cigarettes.

In response to the FDA’s warning, Ruyan America told the Wall Street Journal that it hasn’t distributed e-cigarettes since 2009, but that it would respond nevertheless. E-CigaretteDirect told the Journal it didn’t promote e-cigarettes for use in smoking cessation.

The other companies either didn’t respond or couldn’t be reached.

The FDA also cited E-Cig Technology for adding the erectile dysfunction drug tadalafil, and a non-FDA approved weight loss drug known as rimonabant in some of its products.

Michael Levy, a director in the FDA’s drug division, told the Journal his agency planned to review the companies’ responses before deciding what to do next. Regardless, the FDA will likely move to ban those tadalafil- and rimonabant-containing products from the market.

When it sent the letters, the FDA was actually opening a second theater in its battle with e-cigarette makers. Two years ago, the agency began detaining shipments of the products from China on grounds that they had not been approved by the agency as drug devices.


 

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