Document ID: FDA-2014-N-0189-8035
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 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. Being from a country where the minimum age of tobacco sales is often ignored by vendors, I have been been smoking since about twelve years of age. Despite various and numerous attempts to quit cigarettes and cigars, it was to no avail. I always ended up smoking again. Several months ago, I heard about e-cigarettes and their use, commonly known as vaping. I did a bit of digging around the internet, using plethora of positive and negative sources, I learned that the main ingredients of e-cigarette liquids are nicotine, which is completely optional as I learned from my local vape store, propylene glycol and vegetable glycerin. The nicotine is an optional ingredient. The dosage of nicotine can be adjusted to fit the user's desired strength or removed entirely. Propylene glycol research yielded, in short, that the FDA as well as the the World Health Organization also considers it as safe for use in its medical grade form for medicine and food use, such as inhaler medication, desert foods and cosmetics. I do recognize as a studying automotive technician that propylene glycol has other, more harmful effect in industrial grade strength in products such as brake fluid, hydraulic fluid and anti-freeze. However this is NOT the grade used in e-liquids. Again, medical grade propylene glycol is generally recognized as safe and the amount in e-cigarette fluids is well within normal. Vegetable glycerin, a common byproduct of vegetable oil productions, such as soaps and biodiesel, is very commonly used in foods as a substitute sweetener, cosmetics and a range of medicines. With the science out of the way, feeling pretty confident about the safety of the product, I made a purchase of an electronic cigarette. At first, I was using it along side regular cigarettes, rationing the remaining cigarettes to a stop. With my last cigarette two weeks ago, with the use of the e-cigarette, I have not had almost any cravings, and generally I am feeling better, more energized and breathing easier. I can now safely, in regards to accidental burns and fire, enjoy my old habits indoors and in many places I normally wouldn't be allowed to smoke. I enjoy that I no longer smell like an ashtray, and the freedom of being able to not be tied down to a schedule of when to smoke. There is joyous feeling that I no longer have to panic if I don't have a cigarette to smoke and no longer have to rush to the store in the sight of the last cigarette in the pack. A 12ml bottle of liquid lasts almost two weeks making it also cheaper as well. I realize and recognize that it's not a perfect solution to the problem of smoking and it may not be 100% safe but it sure beats smelling like smoke, generally feeling unwell and the much more potent health risks of burning cigarettes. Another research I conducted even unveiled that nicotine may have positive effects on mental activity such as depression.

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.