Document ID: FDA-2014-N-0189-42657
Agency: fda
Document Type: Supporting & Related Material
Title: 
Posted Date: 2014-07-14T04:00Z

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

General Comment:Dear Mr. Zeller,

I am writing as an individual consumer to request an extension of the public comment period for the Food and Drug Administration’s Proposed Rule Deeming Tobacco Products to be Subject to the Federal Food, Drug, and Cosmetics 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 comment 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 some of the 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 be able to give my thoughts and comments on many of the issues raised, but my time to devote to researching and providing thoughtful comments on these questions is limited.  I have already spent time 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 to be unreasonable to allow the public six months to comment on it.  As a consumer, this is the only opportunity that we have to provide our feedback on the Proposed Rule. 

I feel very strongly about e-cigarrettes as an alternative to combustible, traditional cigarettes.  I was 28 years old whenever I took up “vaping.” I wish to provide you with my personal experiences as well as provide any science and evidence-based responses to your questions so that you can take my comment on the Rule into account.  I would ask that you use the authority under 21 C.F.R. §10.40 to extend this time-frame, as the FDA has done so on numerous occasions in the past.  By extending the period for comment, all stakeholders will have the opportunity to provide their comments on this proposed regulation. 

My understanding of the industry is that e-cigarettes have been around since before 2007, consisting of a cartomizer and a small battery.  Most of these e-cigarettes were produced by tobacco giants such as R.J. Reynolds and other producers of the traditional combustible cigarettes.  Today, while the original e-cigarettes are still available at smoke-shops and drug stores throughout, the varieties of devices and products available have vastly increased, with personal vaporizers, mods, gourmet e-liquids, etc. being available to the consuming public.  

Of particular concern is the effect of the Proposed Rule on the small and medium sized producers of the “e-liquid,” which would be crippled by the costs of complying with the Proposed Rule requiring that all producers of such liquids receive approval through the FDA.  My understanding of the process, like other regulatory processes, is that approval would result in prohibitive expenditures of funds that many producers do not have and thousands of hours for each application, which would be required for all of its products.  I feel that this requirement is unnecessary for providing the consuming public the necessary information about the products and to ensure that the products that they are consuming are relatively safe.

The shops that I have frequented, all of which produce the liquids in-house, have been forthcoming to me about the contents of the liquids that they sell to the public, and I have been able to ask them about what ingredients are being used and have been able to do my own research about their relative safety of each of the liquid blends. I have no problem with requiring that “e-juice” producers provide a list of ingredients that are used in the liquids, as such information is necessary for consumers to make informed purchases, and most retailers are compliant with my requests for such information.   

I appreciate your consideration of my request and would be happy to further comment and discuss this issue with you further.  You or your staff may contact me about this matter, wherein I can discuss specific questions that you might have by email.  My personal email is ocrsracer77j@gmail.com.  

Sincerely, 

Tyler C. Johnson