Document ID: FDA-2014-N-0189-7078
Agency: fda
Document Type: Supporting & Related Material
Title: 
Posted Date: 2014-06-17T04:00Z

Comment Info: =================

General Comment:Dear Mr. Zeller:

I am writing as an individual consumer to request an extension of the comment period for the Food and Drug Administration's ("FDA") Proposed Rule Deeming Tobacco Products to be Subject to the Federal Food, Drug, and Cosmetic Act, as amended by the Family Smoking and Prevention and Tobacco Control Act (the "Proposed Rule") published at 79 Fed. Reg. 23,142 and Federal Register No. 2014-09491. On behalf of myself, I am requesting that the comment period for the Proposed Rule be extended by the FDA for an additional 105 days, from its current 75-day period, to 180 days.

The Proposed Rule raises a number of significant issues and questions that are important and relevant to me, as a consumer of products that are proposed for regulation under the Proposed Rule. The Proposed Rule asks about a hundred different questions I might want to respond to. I want to provide my thoughts and comments on many of these issues, but my time to devote to researching and providing thoughtful comments on these important questions is limited. I have already spent many hours researching and dissecting these issues, but they take time. I know that the FDA took many years to even come up with the Proposed Rule, so I do not think it is at all unreasonable to allow the public a mere six months to comment on it. This is our only opportunity, as consumers, to provide our feedback. 

I feel very strongly about e-cigarettes as an alternative to combustible cigarettes. Quite simply, I firmly believe that they saved my life. I wish to provide you with my personal story, as well as science- and evidence-based responses to your questions so that you can take my comment into account. I don't feel the media and government are explaining to people the huge amount of research and science that shows all the benefits of electronic cigarettes and vaporizers. The information seems to be cherry picked to serve the purpose of making ecigs and vaporizers look harmful or mysterious. There have been over 155 clinical studies done by doctors and researchers that have shown how safe and effective they are and a safer alternative to smoking. People need to know the good and ecigs and vaporizers need to be available to all consumers the same way that coffee makers are available. There seems to be a scare tactic about "Think of the children". We are thinking of the children. We don't want children to have to watch their friends and family die of cancer from smoking cigarettes. There is no evidence anywhere that vaping is a gate way to smoking. There is no evidence. This is just a concept someone came up with based on no facts. The myths about eliquid poisoning children is also being blown far out of proportion. The calls of children being poisoned by eliquid have rose to one a month. Well, honestly why are we  not reporting stories of how over 3,000 children are poisoned a year by energy drinks from caffeine? Or how 4,000 children a year are poisoned by laundry detergent packets? We are hearing reports that use of ecigs has risen in teens… but we aren't hearing the evidence being promoted that this past year, for the first time in decades, the percentage of teens smoking cigarettes has gone down. It's the first time that figure has gone down. I don't believe that ecigs should be available to anyone under 18 years of age and I do think they need child proof caps and ingredients listed, however a lot of the fine print in these documents regarding ecigs will put thousands of people out of jobs and many eliquid companies and device manufactures out of business because they won't be able to afford all the expensive fees to have products reviewed (and without promise of being accepted). These regulations are forcing ecigs into a tobacco shaped drawer and hurting lives and jobs. Vaporizers are no different than the coffee industry. Vape Shops are the new coffee shops. There are lots of flavors in coffee shops that appeal to children. Chocolate and whipped cream and caramel. We don't fear that children are being lured to start drinking coffee. Caffeine and Nicotine area almost the same molecularly. Both are natural chemicals plants make to ward off insects. Coffee shops and coffee culture have a variety of low to high end devices and endless amounts of accessories. From Mr. Coffee to Kcups to expensive italian espresso machines… there is a wide market and interest in coffee as a hobby as well as a thing to consume and enjoy. Vaping is the exact same way. These regulations could stop innovation and americans the financial means to start companies. 

I realize that the FDA has the authority under 21 CFR 10.40 to extend this time frame and that the FDA has exercised this authority on numerous occasions in the past. I would therefore ask that you do so here, so that all stakeholders have the opportunity to provide their comments on this proposed regulation.

I appreciate your consideration of my request and am happy to discuss this issue with you further.