Congratulations and kudos to everybody who submitted comments to the FDA! And happy “Close-of-Comments Day” to each and every one. Y'all rock, dudes!
Wanna see what the big guys said to the FDA? Here's the stuff – read it 'n' weep, Stanton!
Of course it's no mystery to Mitch Zeller what the Hellenic Hombre, Konstantinos Farsalinos, and his stethoscope totin' sidekick, Ricardo Polosa, think about vaping, but it's nice to see it in print – They say it so well!
First, e-cigs deliver aerosols with or without nicotine, but without combustion. Like 'duh'! We're with ya, docs! And…?
Second, although some lab-dish tests can produce cancer-type effects from nicotine, nobody's shown these effects at levels remotely close to human use, and it's not officially listed as a carcinogen.
Third, ya wanna get your tobacco-specific nitrosamines and carbonyls fix, you'll just have to go back to smokin' coffin-nails, dudes, because their levels in e-cigs are “orders of magnitude” lower.
Fourth: Particles – Shmarticles! It's not size that matters, it's composition! All this yammering about nano-particles is based on zilch evidence that they are comparable with particles from combustion or even “to environmental pollution particulate matter” – as in the air you breathe, Bubba! “Based on their composition, they confer minimum (if any) risk.” Just what I was thinking!
Five: E-cig aerosol has no cytotoxicity effects on cultured cells, not to mention boorish ones. None! Nada! Zip! Rien! Nichts! Ništica! Numero zero!
Six: Second hand nicotine exposure is non-carcinogenic, and 10 times lower anyway. Told ya so!
Seven: If you've been worrying about spirometry measurements, you can put that one away. “No study has found worsening,” while a comparison of active vs passive use has “found adverse effects only after smoking.” And asthmatics who switch to vaping show improvement. Ha ha ha ha ha!
“Current evidence overwhelmingly supports that electronic cigarettes are by a large margin less harmful compared to tobacco cigarettes,” the good doctors conclude. Couldn't have said it better myself! Like really couldn't have!
And furthermore, the magnitude of reduced risk should be evaluated after marketing “as is the case for every other consumer product and even for medications.”
That's tellin' 'em!
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