Document ID: FDA-2014-N-0189-42324
Agency: fda
Document Type: Supporting & Related Material
Title: 
Posted Date: 2014-07-11T04:00Z

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

General Comment:Dear Mr. Zeller,

I am writing this letter 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.

180 days would be a more realistic time to gather the information needed in order to craft sensible guidelines for this important product.

Electronic cigarettes saved my life. I am a Physician Assistant specializing in Interventional Cardiology who smoked for 30 years. The shame in that alone was a weight on my practice, I felt like nothing but a hypocrite yet I was unable to free myself from smoking for a large portion of my life. The first time I puffed on an electronic cigarette was the last moment I felt like smoking a real cigarette. It has now been 7 months and my health has improved dramatically.

This product frees people from a life of smoking, which causes untold death and formidable expense. It is not a product that deserves banishment but study. We who use this product want a safe product, we understand that some standards for all products in this category are fine. What we do not want is for this product to undergo the stigma that is rightly attached to cigarettes. 

We need the FDA to be sensible here, to be a voice of reason so that local and state governments do not force us to stand with smokers outside in the cold. We need the FDA to note that the health benefits far outweigh any potential risk they may or may not incur. In short, we need the FDA to treat this product like a nicotine replacement product, and taxed accordingly. Which is to say, at no punitive level.

I find it odd that some argument is made that this product doesn't stop all smoking from happening once a user tries it. NRT has been on the shelves for years and its efficacy has always been rather weak. Why are we holding E-Cigs to a higher standard? 

Do we need to know more? Yes. Lets fund a study and get to the bottom of it. Lets make standards that companies have to meet, I have no problem with that. But lets not make the requirements so onerous that it forces everyone making these devices and liquids go out of business. Every ingredient currently used meets existing standards individually, if by coupling the ingredients no risk is ascertained then a simple statement of that fact is what we need to see.

I would be delighted to provide any additional information or testimonials you may need. I understand there are folks on both sides of the issue that are more militant than I am. I am simply a consumer of a product that saved my life, and I am concerned that knee jerk responses of the militant anti-smoking crowd will flock to this device and attempt to destroy it. For what reason I have no idea.

Thanks for your time,

James Torey PA-C
Physician Assistant Certified
Detroit, Michigan