NJOY refutes FDA's claim about E-cigarettes

William Atkins
Saturday, 25 July 2009 18:40

Science - Health

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."

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