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As a result of the decision, the FDA will not be able to rely upon the findings and conclusions of the TPSAC menthol report. In addition, the Court instructed the agency to reconstruct TPSAC by replacing any members who have conflicts of interest. Dr. Samet is the only current TPSAC member who appears to be implicated by this instruction.

The biggest gap between an e-cigarette and a normal cigarette is the fact that a normal cigarette has a distinct burnt tobacco taste and “hit” that smokers associate with the satisfaction of smoking. It is hot, burns the throat, fills the lungs, and feels good upon exhale.

The rest of the story is that if you ask the wrong question, you are going to get the wrong answer. By asking the wrong question about the effectiveness of electronic cigarettes, Dr. Glantz has obtained the wrong answer.

Instead, the law created a huge bureaucracy full of red tape and sluggish approval processes such that there are still close to 3500 substantial equivalence applications stacked up in a pile somewhere, and the FDA is so overburdened that it cannot even issue electronic cigarette regulations in a reasonable amount of time.


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