Document ID: FDA-2014-N-0189-7695
Agency: fda
Document Type: Supporting & Related Material
Title: 
Posted Date: 2014-06-18T04:00Z

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 friends' lives. 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 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.

Several friends of mine have made the switch to e-cigarettes and vaporizers over a year ago. Initially, it was difficult for them to get over the initial addiction of fire-based cigarettes. However, those that dedicated themselves to it, began to notice changed after roughly 2 weeks. The changes could only be attributed to the harmful chemicals in fire-based cigarettes leaving their bodies. During the initial 2 week period, several accounts of nausea and irritability could be accounted for. After the 2 week period, there was virtually no sign of withdrawals from fire-based cigarettes. Not long after that, they noticed a lesser craving for nicotine, and thus, lowered the amount they would intake. This process repeated numerous times the the point where at least one of them used a minuscule amount of nicotine in their vapor cigarette (8mL vs the original 36mL when he started 1 year ago) His breathing has improved, his sense of smell and taste have strengthened, and his ability to exercise for longer periods before needing to catch his breath has increased greatly.

This account serves as a reminder that the chemicals in the fire-based cigarettes are what's really doing the most damage, and causing the addiction. the nicotine levels, over time, have lowered again and again. It seems nicotine is not an addictive drug. It feels more like the chemicals burned in fire-based cigarettes are what's causing the issue.

In terms of children coming into contact with nicotine (liquid or from fire-based cigarettes) is all on whether the individuals consuming the nicotine are responsible enough to keep the substances out of reach. Irresponsible consumers will always be the cause of irresponsible reactions. A responsible parent that smokes fire-based cigarettes would never leave it out where a child could reach them. A responsible parent using an e-cigarette will never leave the product within reach. 

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