Deeming Regulations have been released!!!!
- Thread starter Oliver
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I just thought.... would 100mg nicotine solution be truly be regulated under the deeming? In 2 years, would WL still be able to sell it? If so, what would the requirements be? PMTA only? I'm not aware whether the dots have been connected on this yet?
That's because people don't understand that a single shot of espresso is roughly equivalent to a 6oz cup of regular coffee.
I Posted this in a DIY Regs Thread....
I think People could be getting a False Sense of Security putting faith in Nothing will happen for the Next 90 Days + 2 Years thing.
YESSSS!!!!!
Could we see the letter that prompted this response? I want to send it to my reps. Thanks!
ETA: Never mind... Still back reading...
To take that further, Zeller was noted as saying that until ecigs were under their control, they can't do anything about the liquids. After it is deemed, then they will discuss what to do then.
Be afraid, be very afraid.
I am not for a ban on anything. With that said a petition with as many signatures as we have had on pro vaping a petition for a total ban on cigarettes would have the same effect on the fda...... NOTHING.....
That tells you everything you need to know about the fda.
That tells you everything you need to know about the fda.
Sorry, long post:
I'm sending an email to my legislators everyday. Here is today's message, it's a mixture of the message sent by @mikepetro and info from Dr. Siegel. Feel free to use any of it you like.
I am a 57-year-old middle class constituent, who has voted in every election since I was 18. I am also an ex-smoker. Almost 4 years ago I quit a 40-year smoking habit by using electronic cigarettes.
I strongly urge you to support the amended Agriculture Appropriations Bill for 2017 and to co-sponsor the FDA Deeming Authority Clarification Act of 2015 (H.R. 2058) that would amend the Food, Drug, and Cosmetics Act to change the predicate date for newly deemed tobacco products to the date when the deeming regulation is finalized.
A predicate date of February 15, 2007 doesn’t benefit public health, it benefits Big Tobacco companies, as the tobacco cigarettes on the market today are “Substantially Equivalent” to those sold in 2007 and will be “grandfathered” in. The e-cigarettes and e-liquids currently on the market are not Substantially Equivalent to what was available in 2007. Accordingly, every product is considered new and will require a pre-market tobacco application (PMTA).
E-cigarette products are being held to a much higher standard than tobacco cigarettes. Manufacturers of e-cigarettes and related products must, among other things: quantify the likelihood that nonsmokers will start using the product; the likelihood that former smokers will relapse back to nicotine use by using the product; the likelihood that nonsmokers who do start using the product will progress to cigarette smoking; the likelihood that former smokers who relapse back to nicotine use will then progress to smoking; the likelihood that consumers will use the product in conjunction with other tobacco products; and the likelihood that smokers who start using the product would otherwise have quit smoking.
The FDA requires a separate PMTA for every product. Thus, if an e-cigarette manufacturer produces four types of starter kits, four types of cartomizers, five types of mods, and 40 e-liquid flavors, each coming in three nicotine strengths, then that manufacturer will have to submit 133 PMTAs! This is a conservative estimate, as there are many companies that sell more than 100 flavors of e-liquids. These companies are being required to submit approximately 300 different product applications.
To submit a PMTA will require a huge research undertaking lasting several years and costing millions of dollars. I don't even think that existing NIH research - in its totality – would be able to provide all of the necessary data by the regulations deadline. Small businesses will not be able to comply.
And even if a company came up with the funds to submit a PMTA, there is no guarantee it will be approved. As Mitch Zeller, director of the FDA's Center for Tobacco Products, told U.S. News, it's impossible to say if any e-cigarette product will be approved.
A 2007 predicate date does nothing to serve the public; it does the opposite. By making legal tobacco harm reduction products unobtainable, vapers like myself will be forced to buy from the black market or go back to smoking cigarettes.
Please support the amended Agriculture Appropriations Bill for 2017 and to co-sponsor the FDA Deeming Authority Clarification Act of 2015 (H.R. 2058) and allow me the legal means to stay off of tobacco.
I vote, and I will support politicians who support my right to harm reduction, even if it means I will have to vote Republican for the first time in 39 years.
Sincerely,
I'm sending an email to my legislators everyday. Here is today's message, it's a mixture of the message sent by @mikepetro and info from Dr. Siegel. Feel free to use any of it you like.
I am a 57-year-old middle class constituent, who has voted in every election since I was 18. I am also an ex-smoker. Almost 4 years ago I quit a 40-year smoking habit by using electronic cigarettes.
I strongly urge you to support the amended Agriculture Appropriations Bill for 2017 and to co-sponsor the FDA Deeming Authority Clarification Act of 2015 (H.R. 2058) that would amend the Food, Drug, and Cosmetics Act to change the predicate date for newly deemed tobacco products to the date when the deeming regulation is finalized.
A predicate date of February 15, 2007 doesn’t benefit public health, it benefits Big Tobacco companies, as the tobacco cigarettes on the market today are “Substantially Equivalent” to those sold in 2007 and will be “grandfathered” in. The e-cigarettes and e-liquids currently on the market are not Substantially Equivalent to what was available in 2007. Accordingly, every product is considered new and will require a pre-market tobacco application (PMTA).
E-cigarette products are being held to a much higher standard than tobacco cigarettes. Manufacturers of e-cigarettes and related products must, among other things: quantify the likelihood that nonsmokers will start using the product; the likelihood that former smokers will relapse back to nicotine use by using the product; the likelihood that nonsmokers who do start using the product will progress to cigarette smoking; the likelihood that former smokers who relapse back to nicotine use will then progress to smoking; the likelihood that consumers will use the product in conjunction with other tobacco products; and the likelihood that smokers who start using the product would otherwise have quit smoking.
The FDA requires a separate PMTA for every product. Thus, if an e-cigarette manufacturer produces four types of starter kits, four types of cartomizers, five types of mods, and 40 e-liquid flavors, each coming in three nicotine strengths, then that manufacturer will have to submit 133 PMTAs! This is a conservative estimate, as there are many companies that sell more than 100 flavors of e-liquids. These companies are being required to submit approximately 300 different product applications.
To submit a PMTA will require a huge research undertaking lasting several years and costing millions of dollars. I don't even think that existing NIH research - in its totality – would be able to provide all of the necessary data by the regulations deadline. Small businesses will not be able to comply.
And even if a company came up with the funds to submit a PMTA, there is no guarantee it will be approved. As Mitch Zeller, director of the FDA's Center for Tobacco Products, told U.S. News, it's impossible to say if any e-cigarette product will be approved.
A 2007 predicate date does nothing to serve the public; it does the opposite. By making legal tobacco harm reduction products unobtainable, vapers like myself will be forced to buy from the black market or go back to smoking cigarettes.
Please support the amended Agriculture Appropriations Bill for 2017 and to co-sponsor the FDA Deeming Authority Clarification Act of 2015 (H.R. 2058) and allow me the legal means to stay off of tobacco.
I vote, and I will support politicians who support my right to harm reduction, even if it means I will have to vote Republican for the first time in 39 years.
Sincerely,
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What are the CC companies scared of ...guilty by association?
"What people do not understand about nicotine dependency is once you do become
dependent, maintaining nicotine is not about getting a buzz because you are no longer
getting a buzz and getting a buzz has long been dropped as for your reason to smoke.
You remain smoking so as not to experience the withdrawal symptoms."
Sounds like h.
I don't see e-cigs mentioned on this site, although I may not have looked hard enough: USA Liquid Nicotine
I may be wrong ... however, once they submit their PMTA along with fees ... if they get approved, they will now be able to sell to manufacturers who have also paid into and passed the PMTA process.
I am guessing their customer base is going to shrink by @ 99%
Indeed, Robino and Zoidman... something that hasn't been heavily discussed.
I fully believe a flavor ban will be first on the agenda, with the exception of tobacco and menthol. Flavors are already banned in all tobacco products under FDA regulatory control, I see no reason why they wouldn't extend this to e-cigarettes and newly deemed cigars/cigarillos (bye bye, Swisher Sweets).
Some time ago the FDA banned clove cigarettes (which, frankly, got me smoking as a teenager in the mid 1980s when they became popular... and to this day LOVE the smell). However, they are still available, as I occasionally (gleefully!) smell people smoking them. So obviously the FDA hasn't been able to completely abolish them.
They were re-formulated as mini cigars. Cigarellos.
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