Denver, CO (PRWEB) September 13, 2010
An electronic cigarette expert in the blogosphere reacted critically to FDA warning letters sent to 5 electronic cigarette vendors Sept. 8th 2010 for violations of the Food, Drug and Cosmetic Act (FDCA).
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.
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 FDCA compliance which requires FDA approval.
An e cigarette expert that started The Electronic Cigarette Review http://www.talkreviews.com/freeecigarettestarterkits.com ) 2 years ago and goes by the alias “Sparky” published a detailed analysis of the FDA’s actions. His analysis begins by criticizing the FDA’s choice to warn only 5 e cigarette companies with possible legal action claiming there are other large e cigarette distributors with similar product labeling and marketing left alone to conduct business as usual.
The companies receiving warning letters are: Ruyan America Inc., E-CigaretteDirect LLC, Gamucci America, E-Cig Technology Inc. and Johnson Creek Enterprises LLC. The FDA also sent a non-threatening letter to the Electronic Cigarette Association (ECA) to inform the association of the FDA’s intention to begin regulation of electronic cigarettes.
Michael Levy works for the FDA’s Center for Drug Evaluation and Research (CDER) and delivered a media briefing Thursday regarding the warning letters answering questions from the media at the end.
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.”
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 say that he thinks an FDA approved e cig is unlikely in the near future and cautioned people relying on FDA approval saying:
“People need to think for themselves and make good choices. The FDA’s idea of effective is just better than placebo. And, what’s even worse is their idea of safe in some cases. The FDA approves drugs like Viox that ultimately lead to 20,000 fatal heart attacks according to their own data. Also, the FDA approved Chantix for smoking cessation. Since then it (Chantix) 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.