I am aware that these comments may contain elements that many vapers may find objectionable but that's the way I see it and how I commented as an individual consumer. My comment tracking number code includes the text and photo attachment.
To: Food and Drug Administration
Re: Comments on FDA Docket No. FDA-2014-N-0189
Dear Sirs,
I am a US citizen, a user of e-cigarettes and am not involved in the tobacco or e-cigarette industry. I smoked cigarettes for 35 years at a rate of about 1.5 packs per day. I tried to quit smoking on numerous occasions over the years by quitting cold turkey or using nicotine replacement therapy products including the nicotine patch and nicotine gum. None of those attempts were successful. I was able to quit smoking entirely over two years ago by using an advanced e-cigarette of a type I will describe below. I am a much healthier and happier person thanks to the switch to e-cigarettes. I don’t want the FDA to outlaw the e-cigarette devices I am using.
I agree that the FDA should provide some useful regulation of e-cigarettes.
-FDA should regulate liquids used for production of e-cigarette vapor including accurate measurement of nicotine dosage, purity of base liquids and additional ingredients. FDA should regulate sanitary and safe practices in the e-liquid mixing industry including use of child-resistant packaging and disclosure of ingredients on package labeling.
-FDA should require warnings on e-liquid labeling regarding the addictive nature of nicotine. If these liquids contain flavorings or additives that have not been proven safe for inhalation then this fact must be disclosed on product labeling.
-FDA should limit nicotine strength of nicotine base sold for home liquid mixing to not more than 102 mg/ml nicotine.
-FDA should regulate safe standards for all components of e-cigarette devices that come into direct contact with e-liquid that is vaporized. This includes cartomizers, tanks and atomizers, but not power units.
-FDA should prohibit the purchase of all e-liquids by minors that contain nicotine or flavorings not tested as safe for inhalation.
FDA has missed the mark on proposed regulations of e-cigarettes by restricting the definition of an e-cigarette to fit only the small but expensive to use devices promoted by the big tobacco corporations. Larger, safer, more efficient and less expensive to use e-cigarette devices like the type I use will be outlawed and people like me will be forced to use less effective and more expensive e-cigarettes, relapse to smoking or purchase products on the black market.
Here are the vaping devices I use. These devices are the Chinese-made Sigelei Zmax V3 and V5 variable wattage and variable voltage devices (see attached photo). They use safer chemistry standard IMR 3.7V cylindrical batteries of several different sizes that are safely charged by standardized Li-ion cylindrical battery chargers. These power devices feature several advanced safety circuits and cost about $60.00 each. The atomizer is a Chinese-made cartomizer surrounded by a US-made borosilicate glass tank. I mix my own 12mg/ml nicotine liquid with Glycerin USP distilled water and nicotine base liquid. I use no flavorings of any kind. I vaporize about 2.5ml of liquid per day at a cost of less than $120.00 per year. I previously spent $2,500 per year for cigarettes.
The Sigelei power units and the IBTanked tank shown in the photo will be outlawed by proposed FDA deeming regulations. The power units do not contain or hold nicotine or e-liquid and should not be deemed tobacco products by law as these do not contain nicotine or other tobacco products. The safety of these products should be regulated and should be the responsibility of the Consumer Product Safety Commission, not the FDA. The cartomizer and the glass tank should be regulated by FDA as tobacco products as these are designed to hold and make contact with e-liquids. To the best of my knowledge the cartomizer shown in the photo will be grandfathered into FDA approval as it was available for sale prior to 2009.
E-cigarettes helped me to quit smoking. I ask the FDA to not outlaw effective, safe and economical e-cigarette devices because they are not sold by the big tobacco corporations.
