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"The FDA proposalwouldsignificantly delay the implementation of premarket review for newly covered products. Most egregiously, the proposal creates a twenty-four month provisional period for the submission of tobacco product marketing applications. Applicationsreceived during the provisional period enable thecontinued marketing of the productuntil the FDA acts on the application which may be wellbeyond the twenty-fourmonth period. A similar loophole was established during the passage of the Act to apply to cigarettes and smokeless products. The FDA received 3,517 applications but three years later has only issued an order removing four products from the market. After the withdrawal of 117 applications, the tobacco companies are still able to market the unapproved products represented by the 3,396 outstanding applications."

In order to draw the conclusion that Dr. Glantz drew in his comment, one would have to completely ignore this study. Obviously, Dr. Glantz has done exactly that. He has based his comment on one narrow study and ignored the rest of the literature.

This respiratory therapist misleadingly reports that: "emergency rooms across the United States have been reporting visits from patients that use e-cigarettes, with a variety of complaints, includingblood clots, difficulty breathing, coughing, headaches and chest pain." But he fails to also mention that emergency rooms across the nation have also been reporting visits from patients who use NRT, with a variety of complaints that include blood clots, difficulty breathing, coughing, headaches and chest pain.

"And most importantly, you are not just anecdotes. Each one of you is a real, courageous person who has accomplished one of the most difficult personal struggles that a person can face in terms of health behavior: quitting smoking, one of the strongest and most powerful addictions. Congratulations!"


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