Document ID: FDA-2014-N-0189-4819
Agency: fda
Document Type: Supporting & Related Material
Title: 
Posted Date: 2014-06-16T04:00Z

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

General Comment:Dear Mr. Zeller and the FDA,

I write today 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 and others affected, I humbly request 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 numerous question that which I believe myself capable and willing to respond to. While I would like to provide my insight and experience, I am a High School Teacher, and my time is limited. I have already devoted a considerable amount of time to the research and study of these topics. The FDA was granted and spent a more-than-adequate amount of time to write and propose these regulations; I ask only for a small extension.

Electronic cigarettes, or personal vaporizers (a more fitting name), are the only viable solution to a countless people like me. While outsiders may simply say "it's as easy as just quitting," former smokers like myself know that is not the case. I switched to a vaporizer 6 months ago, after smoking for 7 years, and have never looked back. I feel better, I breathe better, and I smell better. I have reduced my nicotine concentration to a quarter of what it once was. While one person's anecdotal evidence is proof of nothing, it is at least worth allowing myself and fellow vapers more time to compose informed responses to the Proposed Rule.

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.

Thank you for reading, and I welcome your contact if you wish to discuss these issues further.

Sincerely,
Marc