Soundly and repeatedly lambasting the FDA's lack of credibility in its scientific claims in the deeming:
Regulations.gov
Regulations.gov
FDA National Hookah Alliance's comment to FDA
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Thanks for posting.
And they cite:
"FDA’s failure to do so thus far would
run afoul of the Administrative Procedures Act (“APA”)."
Another act that will be ignored...
And familiar themes:
"if the FDA takes the step of issuing a regulation that could eliminate a significant portion of one
subsector of the tobacco industry, thereby steering consumers toward other forms of tobacco..."
“[o]nly about 14% of the 12th -grade students in 2013 indicated use on more than two
occasions during the past 12 months, which suggests that a considerable amount of hookah
use is light or experimental.”
"As can be seen, for a hookah tobacco company with earnings of $5 million or less, the
estimated costs of complying with the Proposed Regulation will be sufficiently prohibitive as to
drive the company out of business."
"The CDC’s epidemiological evidence for long-term health effects of waterpipe smoking was
based on fact sheets, review articles, a study whose results did not reach statistical significance,
and a case series; this epidemiological evidence is of low quality. The CDC fact sheet does not
mention the risk of waterpipe smokers becoming cigarette smokers or dual users, and as such
does not provide adequate evidence to support the statement in the proposed rule regarding
these risks."
And hookahs are something that hits a personal note for Zeller as mentioned in the Legacy seminar where he went to visit his daughter on a gap trip in Israel and was confronted with a "virtual museum" of hookahs at the place she was staying. I asked in one comment to the FDA 'if they ended up banning ecigs, if Zeller would ask his daughter what hookah she'd recommend?' leaving my email address for a reply....
And they cite:
"FDA’s failure to do so thus far would
run afoul of the Administrative Procedures Act (“APA”)."
Another act that will be ignored...
And familiar themes:
"if the FDA takes the step of issuing a regulation that could eliminate a significant portion of one
subsector of the tobacco industry, thereby steering consumers toward other forms of tobacco..."
“[o]nly about 14% of the 12th -grade students in 2013 indicated use on more than two
occasions during the past 12 months, which suggests that a considerable amount of hookah
use is light or experimental.”
"As can be seen, for a hookah tobacco company with earnings of $5 million or less, the
estimated costs of complying with the Proposed Regulation will be sufficiently prohibitive as to
drive the company out of business."
"The CDC’s epidemiological evidence for long-term health effects of waterpipe smoking was
based on fact sheets, review articles, a study whose results did not reach statistical significance,
and a case series; this epidemiological evidence is of low quality. The CDC fact sheet does not
mention the risk of waterpipe smokers becoming cigarette smokers or dual users, and as such
does not provide adequate evidence to support the statement in the proposed rule regarding
these risks."
And hookahs are something that hits a personal note for Zeller as mentioned in the Legacy seminar where he went to visit his daughter on a gap trip in Israel and was confronted with a "virtual museum" of hookahs at the place she was staying. I asked in one comment to the FDA 'if they ended up banning ecigs, if Zeller would ask his daughter what hookah she'd recommend?' leaving my email address for a reply....
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