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Saturday, 25 July 2009 18:40

NJOY refutes FDA's claim about E-cigarettes

The Njoy company has issued a news release stating that the U.S. Food and Drug Administration's analysis concerning its E-cigarette contains "omissions" and "scientific inconsistencies." Njoy is having an independent third party analysis performed on the FDA study.

The U.S. Food and Drug Administration (FDA) report on E-cigarettes was detailed in the July 24, 2009 iTWire article “FDA calls E-cigarettes 'Illegal'.”

The article refers to a statement made by Michael Levy, the director of the FDA’s Office of Compliance (Division of Drug Evaluation and Research). Levy stated, “The products [Smoking Everywhere and Njoy E-cigarettes] we reviewed so far we found to be illegal."

The chief executive officer of NJOY, Jack Leadbeater, one of the manufacturers of the electronic cigarette (E-cigarette) issued a statement on Friday, July 24, 2009.

It said that the FDA study has “omissions and scientific inconsistencies.”

The press release stated, “We at NJOY are having independent third party analytical and toxicology experts conduct a scientific analysis [of] the FDA’s “Evaluation of e'Cigarettes.” The preliminary results of this analysis indicate that the study itself does not confirm a risk to health from using NJOY's products, and identify very low levels of constituents that are found in FDA approved products themselves.”

The statement adds, “In addition, there are omissions with respect to the FDA's study design and scientific inconsistencies and potentially misleading omissions with regards to FDA's qualitative (rather than quantitative) presentation of the study results. We are continuing to work with the experts to finalize the review and expect to have more information available on Wednesday, July 29."

Page two continues.

The press release by Njoy emphasizes that its CEO believes two critical points should be addressed when evaluating the FDA study  These two key points are: “levels less than the limit of quantification” and “present but at less than that of the Nicotrol (test component FDA used) specification.”

NJOY states that these quotes can be found on page 4 of the FDA study.

The FDA report along with articles on E-cigarettes can be found at: “FDA E-cigarettes"

In addition, in a July 24, 2009 email sent out by NJOY, it quotes Michael Siegel with a subject heading, “Subject: Disingenuousness of the FDA's Press Conference is Concerning; FDA and Anti-Smoking Groups are Committing Medical Malpractice on a Massive Scale.”

Siegel states, “This is one of the most important commentaries I have written in several years, because I think it gets to the absolute heart of the question of what are the goals of public health and tobacco control. It asks the question of whether our goal is utilitarian - trying to maximize the health and welfare of the human population, or whether there are non-teleological concerns that are subconsciously (or maybe not so subconsciously) guiding our actions. Are our actions guided by a pure concern for the maximum benefit to the public's health, or is there an ideology that we are blindly following to the detriment of the public welfare?”

Siegel begins his blog, “To me, the most alarming concern regarding the FDA's press conference on electronic cigarettes was how unscientific and disingenuous the Agency was in its presentation of laboratory findings on electronic cigarettes. The Agency struck an alarmist tone, acting as if its finding of detectable levels of tobacco-specific nitrosamines in electronic cigarettes demonstrated that these products are toxic and unsuitable for use. The clear message to e-cigarette users was that they should stop using these toxic products and go back to regular cigarettes.”

The commentary by Michael Siegel, in its entirety, appears on his tobacco policy blog, at: The Rest of the Story: Tobacco News Analysis and Commentary.

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