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  1. I sat down and read the FDA regs the other day and it took quite a bit of reading, a good 3-4 hours. The document is 499 pages, however, the last 50 pages or so are references, definitions and laws that were referred to in the whole document. Around 100 or so of the pages directly refer to e cigs and maybe 50 are related to e cigs as it pertains to nicotine warnings, underage sales and packaging. Some of the regulations I found quite humorous, such as regulating screwdrivers and lanyards because they are considered to be used directly with e cigs and the FDA has found them to be in the class of "tobacco products". So The Home Depot is gonna need FDA approval to sell screwdrivers? And I guess all of my colleagues will need FDA approval for the lanyards with our ID's that we are required to wear while on campus. I was wondering what the sports coaches are going to do about their whistles? I know they are referring to items that come with tanks or kits, but it doesn't really specify that in the document. I agree that a good part of the regs are a bit restrictive, however, so many vaping groups are screaming PROHIBITION when if you read closely, this is regulation. The FDA clearly states in the document they are not looking to ban e cigs: "(Comment 161) Many comments expressed concern that Congress did not wish to effectively ban e-cigarettes (as they claimed would occur as a result of deeming these products), because such a ban violates section 907(d)(3) of the FD&C Act. They stated that if Congress wanted to ban them, they would have done so under their drug authority. (Response) FDA is not banning any category of tobacco product by issuing this final deeming rule." The FDA recognizes that there may be possible health benefits to e cigs: "(Comment 141) Many comments stated, but did not provide supporting data, that ecigarettes: (1) Are approximately 99 percent less hazardous than cigarettes; (2) are only consumed by smokers and former smokers who quit by switching to e-cigarettes; and (3) have not been found to create nicotine dependence in any nonsmoker. They also stated that there is no evidence that ingesting e-liquid leads to fatalities. (Response) As discussed throughout this document, FDA agrees that use of ENDS is likely less hazardous for an individual user than continued smoking of traditional cigarettes." " Until the FDA publishes a final guidance for each product category and to provide ENDS manufacturers a lengthier compliance period based on where they purport to fit within the risk continuum for nicotine-delivering products (e.g., Comment No. FDA-2014-N-0189-81859; Comment No. FDA-2014-N-0189-10852). In response to these comments, we note that nicotine use in any form is of particular concern for youth and pregnant women. On the other hand, some evidence suggests that ENDS may potentially promote transition away from combusted tobacco use among some current users and it is possible that there could be a public health benefit." While it may seem that the FDA is coming down hard on vapers, if you read closely there are comments that suggest they are trying to help product manufacturers by way of offering guidance to get products approved. Instead of trying to address all of the possible passages that are "good news", I've made a list highlighting passages that we vapers can look at and possibly see that these regs aren't as bad as they seem. The FDA even states in a few places that they will take new information into consideration while drafting the "be all-end all" rules that will be in effect once it's all said and done. All of these passages in the attachment are taken directly from the document and while some passages are not "whole", meaning I've taken a lot of the legal speak out to highlight the main point of the passage, they remain in context with the spirit of the passage itself. You can take these for what they are worth. There is no reading between the lines here, nor are there any of my opinions inserted in the passages. They are cut and pasted directly from the document as they appear within. If you believe that the government is out to kill vaping and the vaping industry, so is your right to think so. Personally I don't see any conspiracy or prohibition in this document, such is my opinion. I'm merely trying to point out some of the positive aspects of this document, as restrictive as it may seem, to show that there is a light at the end of the tunnel. And no, it is not a train coming in your direction FDA regs.doc
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