FDA Threatens Some E-Cigarette Vendors, Ignores Others

Sept. 22, 2010 - PRLog -- The FDA sent warning letters to 5 electronic cigarette vendors for violations of the Food, Drug and Cosmetic Act (FDCA) according to a media briefing the FDA held Thursday.

The FDA says that the products sold by the e cigarette companies receiving warnings are labeled and promoted as smoking cessation aids which makes them drugs or drug delivery devices in the eyes of the FDA.  Drugs and drug delivery devices are subject to the FDCA and require FDA approval.  The warning letters threaten the 5 e cigarette companies with possible legal action for failure to promptly correct these violations while the majority of other e cigarette distributors are left to conduct business as usual.  

Electronic cigarettes, also known as e cigarettes or simply e cigs, are battery operated devices that can resemble real cigarettes and vaporize a flavored liquid nicotine solution that gets inhaled into a smoker’s lungs as a mist.  

Michael Levy works for the FDA’s Center for Drug Evaluation and Research (CDER) and delivered the media briefing Thursday answering questions from the media at the end.  In addition to the warning letters Levy also stated that a letter was sent to the Electronic Cigarette Association (ECA) http://www.ecassoc.org/ headed by former congressman Matt Salmon, to inform the association of the FDA’s intention to begin regulation of electronic cigarettes.

When asked by the media at the briefing if other e cigarette companies could expect similar warnings Levy replied that the FDA will examine each company and their products on a case by case basis.  He clarified by saying, “This action only concerns the 5 companies that got warning letters,” and later went on to say, “We have not made a decision to remove all e-cigarettes from the market.”

The blogosphere was swift with a response to the FDA’s actions.  Many e cig related blogs provided detailed analyses of the FDA’s actions regarding e cigarettes in the past 2 years and made very strong arguments for the future of e cigarettes.

One blogger in particular that goes by the alias “Sparky” at The Electronic Cigarette Review http://www.electroniccigarettereview.com wrote an extremely detailed and thorough analysis of the FDA’s actions.

When asked to comment on the FDA’s actions Sparky said he is, “optimistic,” though he doesn’t believe that any of the companies receiving warning letters will submit new drug applications (NDA) for their products as suggested by the FDA.  He believes they will instead opt to change their labeling and marketing so their e cigs will be classified as tobacco products instead of drugs avoiding FDCA compliance altogether.  

Sparky went on to caution people about FDA approval saying, “people need to think for themselves and make good choices.   The FDA’s criteria for effective is just better than placebo.  These e-cigarettes may be a better alternative for smokers than quitting smoking with drugs like Chantix for which have been approved by the FDA.  Since the FDA approved Chantix it has been shown to cause suicidal tendencies.  The FDA updated the label acknowledging the problem, but the drug remains approved.”

The e cigarette vendors receiving warning letters have 15 days to respond to the FDA in writing with steps they have taken or will take to correct the violations.

The audio from the FDA’s media briefing and Sparky’s detailed analysis of the FDA’s actions can be accessed at The Electronic Cigarette Review at the following link:

http://www.electroniccigarettereview.com/fda-warning-lett...