This lawsuit lists 11 plaintiffs (various trade organizations), plus support from SFATA, CASAA, and NBS.
Details here:
E-Vaping Coalition of America Strikes Back Against the FDA | Electronic Vaping Coalition of America
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FDA Another lawsuit filed! E-Vaping Coalition of America
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This lawsuit lists 11 plaintiffs (various trade organizations), plus support from SFATA, CASAA, and NBS.
Details here:
E-Vaping Coalition of America Strikes Back Against the FDA | Electronic Vaping Coalition of America
The Vaper Strikes Back. Wooohooo. I appreciate that this law suit is not only targeting the deemings outcome but also the means to which the FDA came to said outcome.
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Interesting points.... (my emphasis underlined)
47....
Specifically, Congress sought to strike a balance in the TCA between, on the
one hand, prohibiting FDA from effectively banning tobacco products, and instead ensuring that
adults continue to have ready access to such products while, on the other hand, taking steps so
that such products are not accessible to underage consumers. Further, Congress instructed FDA
to regulate tobacco products in a manner that promotes the introduction and sale of safer and less
harmful tobacco products, rather than keeping them off the market.
48. The TCA’s “Purposes” section explicitly provides that FDA must “continue to
permit the sale of tobacco products to adults in conjunction with measures to ensure that they are
not sold or accessible to underage purchasers.”
54. Finally, the TCA’s “Purposes” section provides that the statute is intended to
“strengthen legislation against illicit trade in tobacco products.” Pub. L. No. 111-31, § 3(10),
123 Stat. 1776, 1782 (2009). This indicates that FDA should not regulate deemed products,
including ENDS, in a manner that would foster a black market, such as by banning or severely
restricting the legitimate availability of a product category.
59. In fact, the only PMTAs that have been authorized by FDA to date are for eight
(8) smokeless tobacco (snus) products that have already been subject to extensive clinical and
long-term epidemiological studies.
[this is one reason why I have said that even the tobacco companies PMTA's may not be accepted. And there have been some SE applications accepted but not PMTAs which is what all* ENDS products will require. The FDA has said (as it says in the suit, there 'may be' one ecig grandfathered, where the possibility of SE is available, but that's a stretch, imo.]
I like the fact that the suit brings up one of the most overused lines of ANTZ PR - "there are no long term studies" and uses it against them :- )
FDA Concedes That No Long-Term Clinical Data Exists On ENDS Products
63. Even though FDA is forcing ENDS products manufacturers into a PMTA process
that will require long-term clinical and other similar studies, the Agency concedes that such
information does not presently exist. See, e.g., 81 Fed. Reg. at 28,984 (“there have not yet been
long-term studies conducted”), id. at 29,028 (“long-term studies are not yet available”), 29,031
(“no adequate data on long-term health effects”), id. at 29,041 (“[l]ong-term studies are not
available”); PMTA Draft Guidance at 14 (“Given the relatively new entrance of ENDS on the
U.S. market, FDA understands that limited data may exist from scientific studies and analyses;
id. at 30 (“Due to the emerging nature of ENDS products . . . FDA acknowledges that there may
be limited . . . clinical research”); 79 Fed. Reg. at 23,152, 23,157, 23,166 (FDA noting lack of
sufficient data regarding ENDS products).
So basically, not only is the PMTA process too long and extensive to be done within the time frame, it's also, according to the FDA, impossible!!??
68. At the same time, notwithstanding FDA’s uncertainty, the Agency acknowledges
that additional studies and research may further confirm that ENDS products have a lower risk
profile than traditional tobacco products. See, e.g., 81 Fed. Reg. at 29,030 (“FDA recognizes
that completely switching from combusted cigarettes to ENDS may reduce the risk of tobacco
Case related disease for individuals currently using combusted tobacco products, given the products’
comparative placements on the continuum of nicotine-delivering products”); id. at 29,032 (FDA
“agrees that the exhaled aerosol from ENDS users is potentially less hazardous than secondhand
smoke from combusted cigarettes”); id. at 29,035 (“FDA agrees that use of ENDS is likely less
hazardous for an individual user than continued smoking of traditional cigarettes”); id. at 29,039
(FDA conceding that “ENDS may potentially provide cessation benefits”).
This would be a good place for Zeller's famed comment:
"If we could get all of those people [who can't or wont quit smoking conventional cigarettes] to completely switch all of their cigarettes to the non-combustible products that would be good for public health."
Although he 'revises' it in the next passage....
"But our job as the regulator is to figure out what is going on at the population level and it includes the much larger group of smokers not like the first group I defined, a much larger group of smokers who are concerned about their health and who are interested in quitting and what happens instead of those people completely substituting with a non-combustible product, they start using both, and then along the way they wind up becoming less interested in quitting. So then we would say that might not be good for public health, and our job is to figure out what is the net of all of those possible behaviors including any initiation which would not be good for public health and then try to make public policy on top of that."
[from an earlier post]
And the true fallacy of the idea that dual use will lead back to smoking is shown in his own understanding of the people in the 'larger group': those "who are concerned about their health and who are interested in quitting." But those who are 'concerned about their health' would be those who already know that they should be concerned, and about what they are concerned. IE. that smoking combustible tobacco can lead to illness and early death. If they've found their way to ecigarettes and choose that as an alternative, they do that for the very reason why they are 'concerned about their health!' and have likely done a bit of research on it.
But Zeller ignores the obviousness of the above and of the implications of what he says. He invalidates his own premise: of 'those who are concerned' and concludes by saying they will go back to smoking and what? forget about what they were concerned about?
The "syllogism" would look something like this:
A large group is very concerned about their health.
Quitting smoking would eliminate that concern.
Therefore: The will continue to smoke.
edit:
Also meant to include this - the source of the term "deeming" no doubt... from the Tobacco Control Act....
31. FDA was initially charged under the TCA with regulating “all cigarettes, cigarette
tobacco, roll-your-own tobacco, and smokeless tobacco.” In addition, it was given authority to regulate in the future “any other tobacco products that [the Agency] by regulation deems to be subject to this chapter.” 21 U.S.C. § 387a(b). The Deeming Rule subjects a wide range of ENDS products to the TCA’s requirements. 81 Fed. Reg. at 28,975.
47....
Specifically, Congress sought to strike a balance in the TCA between, on the
one hand, prohibiting FDA from effectively banning tobacco products, and instead ensuring that
adults continue to have ready access to such products while, on the other hand, taking steps so
that such products are not accessible to underage consumers. Further, Congress instructed FDA
to regulate tobacco products in a manner that promotes the introduction and sale of safer and less
harmful tobacco products, rather than keeping them off the market.
48. The TCA’s “Purposes” section explicitly provides that FDA must “continue to
permit the sale of tobacco products to adults in conjunction with measures to ensure that they are
not sold or accessible to underage purchasers.”
54. Finally, the TCA’s “Purposes” section provides that the statute is intended to
“strengthen legislation against illicit trade in tobacco products.” Pub. L. No. 111-31, § 3(10),
123 Stat. 1776, 1782 (2009). This indicates that FDA should not regulate deemed products,
including ENDS, in a manner that would foster a black market, such as by banning or severely
restricting the legitimate availability of a product category.
59. In fact, the only PMTAs that have been authorized by FDA to date are for eight
(8) smokeless tobacco (snus) products that have already been subject to extensive clinical and
long-term epidemiological studies.
[this is one reason why I have said that even the tobacco companies PMTA's may not be accepted. And there have been some SE applications accepted but not PMTAs which is what all* ENDS products will require. The FDA has said (as it says in the suit, there 'may be' one ecig grandfathered, where the possibility of SE is available, but that's a stretch, imo.]
I like the fact that the suit brings up one of the most overused lines of ANTZ PR - "there are no long term studies" and uses it against them :- )
FDA Concedes That No Long-Term Clinical Data Exists On ENDS Products
63. Even though FDA is forcing ENDS products manufacturers into a PMTA process
that will require long-term clinical and other similar studies, the Agency concedes that such
information does not presently exist. See, e.g., 81 Fed. Reg. at 28,984 (“there have not yet been
long-term studies conducted”), id. at 29,028 (“long-term studies are not yet available”), 29,031
(“no adequate data on long-term health effects”), id. at 29,041 (“[l]ong-term studies are not
available”); PMTA Draft Guidance at 14 (“Given the relatively new entrance of ENDS on the
U.S. market, FDA understands that limited data may exist from scientific studies and analyses;
id. at 30 (“Due to the emerging nature of ENDS products . . . FDA acknowledges that there may
be limited . . . clinical research”); 79 Fed. Reg. at 23,152, 23,157, 23,166 (FDA noting lack of
sufficient data regarding ENDS products).
So basically, not only is the PMTA process too long and extensive to be done within the time frame, it's also, according to the FDA, impossible!!??
68. At the same time, notwithstanding FDA’s uncertainty, the Agency acknowledges
that additional studies and research may further confirm that ENDS products have a lower risk
profile than traditional tobacco products. See, e.g., 81 Fed. Reg. at 29,030 (“FDA recognizes
that completely switching from combusted cigarettes to ENDS may reduce the risk of tobacco
Case related disease for individuals currently using combusted tobacco products, given the products’
comparative placements on the continuum of nicotine-delivering products”); id. at 29,032 (FDA
“agrees that the exhaled aerosol from ENDS users is potentially less hazardous than secondhand
smoke from combusted cigarettes”); id. at 29,035 (“FDA agrees that use of ENDS is likely less
hazardous for an individual user than continued smoking of traditional cigarettes”); id. at 29,039
(FDA conceding that “ENDS may potentially provide cessation benefits”).
This would be a good place for Zeller's famed comment:
"If we could get all of those people [who can't or wont quit smoking conventional cigarettes] to completely switch all of their cigarettes to the non-combustible products that would be good for public health."
Although he 'revises' it in the next passage....
"But our job as the regulator is to figure out what is going on at the population level and it includes the much larger group of smokers not like the first group I defined, a much larger group of smokers who are concerned about their health and who are interested in quitting and what happens instead of those people completely substituting with a non-combustible product, they start using both, and then along the way they wind up becoming less interested in quitting. So then we would say that might not be good for public health, and our job is to figure out what is the net of all of those possible behaviors including any initiation which would not be good for public health and then try to make public policy on top of that."
[from an earlier post]
And the true fallacy of the idea that dual use will lead back to smoking is shown in his own understanding of the people in the 'larger group': those "who are concerned about their health and who are interested in quitting." But those who are 'concerned about their health' would be those who already know that they should be concerned, and about what they are concerned. IE. that smoking combustible tobacco can lead to illness and early death. If they've found their way to ecigarettes and choose that as an alternative, they do that for the very reason why they are 'concerned about their health!' and have likely done a bit of research on it.
But Zeller ignores the obviousness of the above and of the implications of what he says. He invalidates his own premise: of 'those who are concerned' and concludes by saying they will go back to smoking and what? forget about what they were concerned about?
The "syllogism" would look something like this:
A large group is very concerned about their health.
Quitting smoking would eliminate that concern.
Therefore: The will continue to smoke.
edit:
Also meant to include this - the source of the term "deeming" no doubt... from the Tobacco Control Act....
31. FDA was initially charged under the TCA with regulating “all cigarettes, cigarette
tobacco, roll-your-own tobacco, and smokeless tobacco.” In addition, it was given authority to regulate in the future “any other tobacco products that [the Agency] by regulation deems to be subject to this chapter.” 21 U.S.C. § 387a(b). The Deeming Rule subjects a wide range of ENDS products to the TCA’s requirements. 81 Fed. Reg. at 28,975.
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Here is an interview conducted a few days ago with Azim Chowdhury, lead attorney for the Plaintiffs involved in the suit.
- Apr 2, 2009
- 5,171
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- 66
I could find the lawsuit on the website
E-Vaping Coalition of America Strikes Back Against the FDA | Electronic Vaping Coalition of America
Please post the weblink for the lawsuit.
E-Vaping Coalition of America Strikes Back Against the FDA | Electronic Vaping Coalition of America
Please post the weblink for the lawsuit.
Thanks Kent C- your such a good researcher. I read every word. I'm not particularly religious but I'm going to say a little prayer. Okay a BIG prayer. So we have our answer from CASAA and all the rest. A BIG Thank You to the coalition for all the hard work. I would love to show up in that courtroom.
... and thanks.
For those interested in contributing...
Right to be Smoke-Free Coalition | Fight For Sensible E-Vapor Laws
Right to be Smoke-Free Coalition | Fight For Sensible E-Vapor Laws
I see the site has other issues they're addressing. Wondering if one can contribute directly to the attorneys handling the 11 member case? khlaw/Azim Chowdhury et al?
I don't see SFATA, CASAA, or NBS listed as plaintiffs on this suit. But,
Maybe they're keeping their powder dry for more lawsuits?
The attorney says it's going to be a hard case to win. May be that's what they all say but may be it's going to be a hard case to win. I can afford to stock up and know what to get and know what to do with it. After that I'll be politically active but it will be for everybody else who isn't so lucky.
Just in case you care, I emailed Azim asking if I could contribute directly to him or khlaw. I'll let you know when or if he replies.....
Apologies for leaving out that little tidbit. I was in a rush before heading off to a meeting at work.
I'll edit that post. 
Interesting points.... (my emphasis underlined)
47....
Specifically, Congress sought to strike a balance in the TCA between, on the
one hand, prohibiting FDA from effectively banning tobacco products, and instead ensuring that
adults continue to have ready access to such products while, on the other hand, taking steps so
that such products are not accessible to underage consumers. Further, Congress instructed FDA
to regulate tobacco products in a manner that promotes the introduction and sale of safer and less
harmful tobacco products, rather than keeping them off the market.
48. The TCA’s “Purposes” section explicitly provides that FDA must “continue to
permit the sale of tobacco products to adults in conjunction with measures to ensure that they are
not sold or accessible to underage purchasers.”
54. Finally, the TCA’s “Purposes” section provides that the statute is intended to
“strengthen legislation against illicit trade in tobacco products.” Pub. L. No. 111-31, § 3(10),
123 Stat. 1776, 1782 (2009). This indicates that FDA should not regulate deemed products,
including ENDS, in a manner that would foster a black market, such as by banning or severely
restricting the legitimate availability of a product category.
59. In fact, the only PMTAs that have been authorized by FDA to date are for eight
(8) smokeless tobacco (snus) products that have already been subject to extensive clinical and
long-term epidemiological studies.
[this is one reason why I have said that even the tobacco companies PMTA's may not be accepted. And there have been some SE applications accepted but not PMTAs which is what all* ENDS products will require. The FDA has said (as it says in the suit, there 'may be' one ecig grandfathered, where the possibility of SE is available, but that's a stretch, imo.]
I like the fact that the suit brings up one of the most overused lines of ANTZ PR - "there are no long term studies" and uses it against them :- )
FDA Concedes That No Long-Term Clinical Data Exists On ENDS Products
63. Even though FDA is forcing ENDS products manufacturers into a PMTA process
that will require long-term clinical and other similar studies, the Agency concedes that such
information does not presently exist. See, e.g., 81 Fed. Reg. at 28,984 (“there have not yet been
long-term studies conducted”), id. at 29,028 (“long-term studies are not yet available”), 29,031
(“no adequate data on long-term health effects”), id. at 29,041 (“[l]ong-term studies are not
available”); PMTA Draft Guidance at 14 (“Given the relatively new entrance of ENDS on the
U.S. market, FDA understands that limited data may exist from scientific studies and analyses;
id. at 30 (“Due to the emerging nature of ENDS products . . . FDA acknowledges that there may
be limited . . . clinical research”); 79 Fed. Reg. at 23,152, 23,157, 23,166 (FDA noting lack of
sufficient data regarding ENDS products).
So basically, not only is the PMTA process too long and extensive to be done within the time frame, it's also, according to the FDA, impossible!!??
68. At the same time, notwithstanding FDA’s uncertainty, the Agency acknowledges
that additional studies and research may further confirm that ENDS products have a lower risk
profile than traditional tobacco products. See, e.g., 81 Fed. Reg. at 29,030 (“FDA recognizes
that completely switching from combusted cigarettes to ENDS may reduce the risk of tobacco
Case related disease for individuals currently using combusted tobacco products, given the products’
comparative placements on the continuum of nicotine-delivering products”); id. at 29,032 (FDA
“agrees that the exhaled aerosol from ENDS users is potentially less hazardous than secondhand
smoke from combusted cigarettes”); id. at 29,035 (“FDA agrees that use of ENDS is likely less
hazardous for an individual user than continued smoking of traditional cigarettes”); id. at 29,039
(FDA conceding that “ENDS may potentially provide cessation benefits”).
This would be a good place for Zeller's famed comment:
"If we could get all of those people [who can't or wont quit smoking conventional cigarettes] to completely switch all of their cigarettes to the non-combustible products that would be good for public health."
Although he 'revises' it in the next passage....
"But our job as the regulator is to figure out what is going on at the population level and it includes the much larger group of smokers not like the first group I defined, a much larger group of smokers who are concerned about their health and who are interested in quitting and what happens instead of those people completely substituting with a non-combustible product, they start using both, and then along the way they wind up becoming less interested in quitting. So then we would say that might not be good for public health, and our job is to figure out what is the net of all of those possible behaviors including any initiation which would not be good for public health and then try to make public policy on top of that."
[from an earlier post]
And the true fallacy of the idea that dual use will lead back to smoking is shown in his own understanding of the people in the 'larger group': those "who are concerned about their health and who are interested in quitting." But those who are 'concerned about their health' would be those who already know that they should be concerned, and about what they are concerned. IE. that smoking combustible tobacco can lead to illness and early death. If they've found their way to ecigarettes and choose that as an alternative, they do that for the very reason why they are 'concerned about their health!' and have likely done a bit of research on it.
But Zeller ignores the obviousness of the above and of the implications of what he says. He invalidates his own premise: of 'those who are concerned' and concludes by saying they will go back to smoking and what? forget about what they were concerned about?
The "syllogism" would look something like this:
A large group is very concerned about their health.
Quitting smoking would eliminate that concern.
Therefore: The will continue to smoke.
edit:
Also meant to include this - the source of the term "deeming" no doubt... from the Tobacco Control Act....
31. FDA was initially charged under the TCA with regulating “all cigarettes, cigarette
tobacco, roll-your-own tobacco, and smokeless tobacco.” In addition, it was given authority to regulate in the future “any other tobacco products that [the Agency] by regulation deems to be subject to this chapter.” 21 U.S.C. § 387a(b). The Deeming Rule subjects a wide range of ENDS products to the TCA’s requirements. 81 Fed. Reg. at 28,975.
Congratulations Kent. Your post is twice as long as the original article.
Do you mind if I provide a shorter version for the audience members with ADD?
1) FDA is WAY out of bounds.
If Congress had wanted the TCA to simply BAN any categories of "Tobacco Product" they'd have done so. (Legislative intent in this case is critical.)
2) FDA is operating (by their own admission) either in the dark, ("Limited data available... ") or in conflict with the evidence that IS available. (PHE, RCP, Zeller's OWN statements...)
Posts like this give me hope that we can overturn or rework the ridiculous regulations
Yes, I do care, so thanks.
And @KODIAK (TM)
Got a reply from Azim today. Thanked me... Basically ...funds received by the Right to be Smoke Free Coalition are being directed toward the FDA lawsuit. Click on "Fight the FDA Deeming Regulations" box. While that coalition has other issues with Indiana specifically, that's a separate deal. Azim also suggests anything 4 figures should be done by check rather than paypal, where they'd have to use some to pay paypal.... but just a suggestion.
And @KODIAK (TM)
Got a reply from Azim today. Thanked me... Basically ...funds received by the Right to be Smoke Free Coalition are being directed toward the FDA lawsuit. Click on "Fight the FDA Deeming Regulations" box. While that coalition has other issues with Indiana specifically, that's a separate deal. Azim also suggests anything 4 figures should be done by check rather than paypal, where they'd have to use some to pay paypal.... but just a suggestion.
Thanks Kent!
Yes, I corresponded with Azim as well. I don't have deep pockets so I wanted to make sure what little I could do went to the right place. (And these folks aren't asking for much I might add).
While every suit is important, I believe this one has the potential to make a very big noise. And it's just so damned heartwarming to see some major players in the industry finally pull together.
Totally agree. I'm impressed with his views from audios/articles. Well worth whatever one can give, imo.
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