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 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,
