The FDA continues to argue that e-cigarettes are a drug product, despite Federal judge's preliminary ruling to the contrary.

By: National Vapers Club

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-- A press release issued by the U.S. Food and Drug Administration on Thursday, states that the FDA intends to regulate e-cigarettes as “drug products”. The press release notes “5 warning letters” were sent to 5 different e-cigarette companies. This press release comes in the wake of the appeal of a legal case in which the FDA was brought to trial for holding e-cigarette shipments based upon their insistence that e-cigarettes are an “unapproved drug delivery device”.In that case, Federal Judge Richard Leon concluded that “[t]his case appears to be yet another example of FDA's aggressive efforts to regulate recreational tobacco products as drugs or devices under the FDCA.” He also stated that the FDA had demonstrated “its tenacious drive to maximize its regulatory power”. This current press release from the FDA comes just two weeks before the appeals court decides the fate of importation of e-cigarette products for the company involved in this lawsuit.In the letters issued in the current press release, the FDA suggests that posting the abstract of a published, peer reviewed journal article on e-cigarettes on the company’s website is a “health claim” made by the company. Janet Andersen of National Vapers Club, an advocacy group for e-cigarette consumers says, “It is absurd that the companies may not educate their customers by letting them access studies on the product they intend to purchase. They should not be penalized for educating people and letting them make their own choices”.“The mom and pop companies who have invested so much into their companies in a poor economy in order to keep their children fed are being harassed illegitimately while we are trying to cooperate” says Josh Gregory, owner of E-Liquid Planet. “We welcome FDA regulation as a tobacco product. We are just trying to provide people with an alternative choice to smoking tobacco cigarettes.”A petition submitted to the FDA by Dr. Joel Nitzkin, on behalf of American Association of Public Health Physicians, cites evidence of the efficacy of e-cigarettes for smoking cessation. However, unless an e-cigarette manufacturer or company is making the claim that the product helps you quit smoking, it is not required to submit evidence to the FDA and so most companies have not. In the warning letters, the FDA cites customer testimonials as marketing for smoking cessation, but in the history of the law, claims made by consumers do not constitute intended use.In the absence of guidance from the Electronic Cigarette Association in the past months, National Vapers Club has provided to e-cigarette industry retailers and wholesalers a list of suggested regulations. Many companies have made a serious effort to self-regulate until such time as the FDA sets standards to regulate the product. The suggested regulations will also be sent to the FDA in a letter asking the FDA, again, to regulate these devices as tobacco products. The regulations can be found at National Vapers Club website at http://www.vapersclub.com/ guidelines.php The FDA has made claims that one company is selling e-cigarettes which contain pharmaceuticals. E-cigarette proponents disapprove of this company’s actions. “That company exercised poor judgment by including pharmaceuticals in their e-cigarettes and they are not reflective of the rest of the hundreds of e-cigarette vendors in the industry,” says National Vapers Club president Spike Babaian, “but we would not condemn all people selling bottled water just because one irresponsible person tried to sell bottled water with Cialis in it.”“Congress has now taken the unprecedented step of granting FDA jurisdiction over [tobacco] products” says Judge Leon, yet the FDA refuses to regulate e-cigarettes as such. The FDA insists the product is a drug delivery device even when it is marketed as a smokeless alternative to tobacco cigarettes. Regulating them as tobacco products would allow the federal government to put an age restriction on purchase to make sure that the product is not purchased by children and would insure that marketing and content of the product is regulated.Dr. Michael Siegel, a public health professor at Boston University, states that "(The FDA) should be regulating it in a way that really allows the potential of the product to be realized rather than a way that just takes it off the market completely and puts an end to the possibility of what really could be a lifesaving product for many smokers”.# # #About National Vapers Club: National Vapers Club (NVC) is a consumer-based organization run and sponsored by e-cigarette users, also known as vapers. The organization is not funded by e-cigarette manufacturers or suppliers and none of NVC’s board members receives income from the e-cigarette industry. NVC encourages responsible self-regulation by e-cigarette retailers until the federal government develops regulatory standards for this consumer product.. The board works with renowned public health professionals to dispel the myths and falsehoods disseminated by misinformed groups and encourages smokers to switch to electronic cigarettes if they are unable or unwilling to stop smoking using FDA approved methods.