At the end of the year I wrote my US Senator, Claire McCaskill, and urged her to monitor the FDA's deeming regulation of E-Cigs. Below is the body of my letter and her response. Take what you will from it. There's no real commitment in her response, and I think she felt she was throwing me a bone in noting that the FDA can't ban tobacco products, but at least she read my letter and responded. While it may not mean much individually, I feel that the more of these that our reps and senators receive, the better. They will at least be aware that there are constituents who are affected by the FDA regulations and they may view the proposed regulations with that in mind.
LETTER
Dear Senator,
I am writing to ask you to look closely at any proposed restrictions on E-Cigarettes and "juices" that are used in them that will be in the Deeming Regulation that will be proposed in the next month or so from the FDA.
I ask that you do so with an eye toward reducing or eliminating any over regulation that would give an advantage to large pharmaceutical and tobacco interests. By placing E-Cigs in regulatory framework of the Family Smoking Prevention and Tobacco Control Act, the agencies put in place to safeguard our health may wind up jeopardizing it.
This would occur if heavy handed regulation would make it significantly more expensive to reduce tobacco harm by using e-cigs, and reducing the options now available to do so. This would also give the large tobacco and pharmaceutical interests a leg up in meeting any excessive regulatory standards as they have the finances and physical facilities to do so.
E-Cigarettes are harm reduction plain and simple. Democrats have previously supported other forms of harm reduction. I see no reason they cant do so here. I also think this is one of those rare times when you can join with those across the aisle who are opposed to any regulation and work for a compromise and the good of your constituents who have been able to quit smoking using e-cigarettes. I ask this of you as a lifelong Democrat (I canvassed for you prior to the last election.) and a 30 year smoker who in those thirty years tried everything to quit and found that as soon as I tried E-Cigarettes I put the cigarettes away and have been smoke free for a month and a half.
As there is no provision for attachments in your contact page, I have included a link to a letter from leading e-cigarette researchers to Dr. Hamburg urging the FDA to go lightly in any e-cigarette regulation. If the link does not bring you the letter, please e-mail me and I will be glad to send you a copy.
Thank you for your time.
RESPONSE
January 19, 2014
Dear Mr. -----,
Thank you for contacting me regarding the regulation of electronic cigarettes. I appreciate hearing from you and welcome the opportunity to respond.
As you may know, the Family Smoking Prevention and Tobacco Control Act of 2009 (TCA, Public Law 111-31) gave the Food and Drug Administration (FDA) the authority to regulate tobacco products. Under the TCA, tobacco products are subject to a number of controls, including registration, product and ingredient listing, good manufacturing practice requirements, and adulteration and misbranding provisions, among others. The TCA immediately placed cigarettes, roll-your-own tobacco, and smokeless tobacco under these requirements. The law also allows the FDA to extend these controls to other categories of tobacco products in future rulemaking.
While the FDA originally regulated electronic cigarettes as drug/device combination products, in 2010 the U.S. Court of Appeals for the D.C. Circuit ruled that, unless they were marketed for therapeutic purposes, the FDA could only regulate electronic cigarettes as tobacco products. In the FDA's most recent regulatory agenda, it announced that it would be issuing proposed regulations regarding tobacco products subject to regulation under the TCA. While it is possible that the FDA may address the regulation of electronic cigarettes at that time, you may be interested to know that the TCA explicitly prohibits the FDA from banning certain tobacco products or requiring the elimination of nicotine in tobacco products.
Please know that I will keep your views in mind should legislation regarding electronic cigarettes come before the full Senate for a vote.
Again, thank you for contacting me. Please do not hesitate to contact me in the future if I can be of further assistance to you on this or any other issue.
Sincerely,
Claire McCaskill
United States Senator
LETTER
Dear Senator,
I am writing to ask you to look closely at any proposed restrictions on E-Cigarettes and "juices" that are used in them that will be in the Deeming Regulation that will be proposed in the next month or so from the FDA.
I ask that you do so with an eye toward reducing or eliminating any over regulation that would give an advantage to large pharmaceutical and tobacco interests. By placing E-Cigs in regulatory framework of the Family Smoking Prevention and Tobacco Control Act, the agencies put in place to safeguard our health may wind up jeopardizing it.
This would occur if heavy handed regulation would make it significantly more expensive to reduce tobacco harm by using e-cigs, and reducing the options now available to do so. This would also give the large tobacco and pharmaceutical interests a leg up in meeting any excessive regulatory standards as they have the finances and physical facilities to do so.
E-Cigarettes are harm reduction plain and simple. Democrats have previously supported other forms of harm reduction. I see no reason they cant do so here. I also think this is one of those rare times when you can join with those across the aisle who are opposed to any regulation and work for a compromise and the good of your constituents who have been able to quit smoking using e-cigarettes. I ask this of you as a lifelong Democrat (I canvassed for you prior to the last election.) and a 30 year smoker who in those thirty years tried everything to quit and found that as soon as I tried E-Cigarettes I put the cigarettes away and have been smoke free for a month and a half.
As there is no provision for attachments in your contact page, I have included a link to a letter from leading e-cigarette researchers to Dr. Hamburg urging the FDA to go lightly in any e-cigarette regulation. If the link does not bring you the letter, please e-mail me and I will be glad to send you a copy.
Thank you for your time.
RESPONSE
January 19, 2014
Dear Mr. -----,
Thank you for contacting me regarding the regulation of electronic cigarettes. I appreciate hearing from you and welcome the opportunity to respond.
As you may know, the Family Smoking Prevention and Tobacco Control Act of 2009 (TCA, Public Law 111-31) gave the Food and Drug Administration (FDA) the authority to regulate tobacco products. Under the TCA, tobacco products are subject to a number of controls, including registration, product and ingredient listing, good manufacturing practice requirements, and adulteration and misbranding provisions, among others. The TCA immediately placed cigarettes, roll-your-own tobacco, and smokeless tobacco under these requirements. The law also allows the FDA to extend these controls to other categories of tobacco products in future rulemaking.
While the FDA originally regulated electronic cigarettes as drug/device combination products, in 2010 the U.S. Court of Appeals for the D.C. Circuit ruled that, unless they were marketed for therapeutic purposes, the FDA could only regulate electronic cigarettes as tobacco products. In the FDA's most recent regulatory agenda, it announced that it would be issuing proposed regulations regarding tobacco products subject to regulation under the TCA. While it is possible that the FDA may address the regulation of electronic cigarettes at that time, you may be interested to know that the TCA explicitly prohibits the FDA from banning certain tobacco products or requiring the elimination of nicotine in tobacco products.
Please know that I will keep your views in mind should legislation regarding electronic cigarettes come before the full Senate for a vote.
Again, thank you for contacting me. Please do not hesitate to contact me in the future if I can be of further assistance to you on this or any other issue.
Sincerely,
Claire McCaskill
United States Senator
