Document ID: FDA-2014-N-0189-60585
Agency: fda
Document Type: Supporting & Related Material
Title: 
Posted Date: 2014-08-05T04:00Z

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

General Comment:I urge FDA for a second extension for  Federal Register No. 2014-09491,  Proposed Rule Deeming Tobacco Products. I have spent the last few months reading through the rule, and given that FDA took over 2 years to draft this document, I had anticipated that the rule would contain all the information consumers, Doctors, Researchers and Public Health workers et al, would need to be able to write a well-formed comment for FDA's consideration. However, After spending weeks and weeks reading the rule, it is clear that FDA is asking more questions that it is providing information for the public. FDA admits in the rule itself,  that it doesn't understand E-cigarettes very well. Given this admission, it is paramount that FDA gives the public enough time to educate FDA on FDA's significant lack of knowledge on the e-cigarette industry. 

Furthermore, it is necessary for FDA to allow consumers and vested individuals to combat misguided FDA's efforts to inform the public on e-cigarettes given FDA doesn't seem to know much about them. For instance, FDA claims it is not able to discern that nicotine-only products are less harmful than tobacco-smoke products. I am greatly concerned that FDA is not able to apply its own knowledge to 'nicotine-only' NRT products to that of e-cigarettes. For example, in:

Modifications To Labeling of Nicotine Replacement Therapy Products for Over-the-Counter Human Use
https://www.federalregister.gov/articles/2013/04/02/2013-07528/modifications-to-labeling-of-nicotine-replacement-therapy-products-for-over-the-counter-human-use
Agency/Docket Number:
Docket No. FDA-2013-N-0341
Document Number:
2013-07528

FDA seems to be able to use evidence-based science to determine that nicotine-only products such as those sold as flavored-NRT to be safe. In fact, FDA goes so far as to say that nicotine-only products can:

1. Be used concomitantly with tobacco cigarettes (Dual-Use)
2. Be used at higher than advertised dosages
3. Be used indefinitely 

Just this year, FDA demonstrated the ability to use research to re-label Flavored NRT products because:

 "In the years since NRT products became available for OTC use, a number of studies have examined the use of NRT products over periods longer than 12 weeks. We have reviewed the published literature on this longer-term use of NRT products and have not identified any safety risks associated with such use. "

"Upon reviewing the published reports of these and other studies, we have determined that the concomitant use of OTC NRT products with cigarettes or with other nicotine-containing products does not raise significant safety concerns. "

I am concerned that FDA is unable to use its own publications and apply it own research to other nicotine-only products on the market. FDA must, if it plans to write responsible, informed regulation, allow the public to help FDA find the scientific research already published, as well as the research FDA was able to reference just last year, but can no longer find. 

I believe that FDA is very aware that there is a lot of research to cover in regards to e-cigarettes, from its implications of public health, to large economic factors the deeming regulations will have on the 2 billion dollar marketplace, much of which, is located in small mom and pop shops that are providing employment to small local communities. Since FDA has said it needs help in navigating these areas, I believe that FDA must give us an appropriate amount of time to provide the answers FDA is unable to provide for itself.

For this reason, I think an extension is warranted. 

Thank you, 

Jen