FDA comment, links & attachments
by, 08-08-2014 at 09:32 PM (228 Views)
Here's what I submitted to the FDA comments on the proposed deeming regulations:
From: Scott D. Casey
To: FDA Center for Tobacco Products
RE: FDA, Docket No. FDA-2014-N-0189, Regulatory Information Number (RIN) 0910- AG38
As a person who started smoking at the age of 13, and suffered the addiction for 43 years and polluting my body & personal space with 40 cigarettes each day, I found my way to QUIT SMOKING with e-cigarettes / vaping!!
Solely because of e-cigarettes & vaping, I have been SMOKE-FREE for 250 days and AVOIDED SMOKING more than 7,530 cigarettes!
Quitting smoking is not a process that 1 way works for everyone.
Quite the opposite: each individual needs to find the effective combination of factors that will be "JUST-RIGHT" for them that will allow them to break free from SMOKING.
That is why NRT products FAIL 92% of the time! They rely on 1 way/method of dealing with what that SMOKER needs to quit, and as common sense dictates: FAILS 92% of the time.
Vaping provides the VARIETY of FLAVORS, nicotine strengths, and diversity of HARDWARE that allows the smokers to find that JUST-RIGHT combination to help them greatly reduce, or completely QUIT SMOKING.
The ability to have 100's of CHOICES of FLAVORS & nicotine content is a critical-success factor me, and the vast majority of people who have QUIT SMOKING.
NOTE: NRT products are now all FDA approved for FLAVORS and LIFETIME USAGE
Being forced to continue to endure that 'tobacco taste' is inhumane, will greatly REDUCE SUCCESS IN QUITTING, and is based on theoretical / hysterical claims of POTENTIAL harm, and JUVENILE REASONING.
Restricting FLAVORS will directly lead to fewer successful QUITS, and more smoking related DEATHS
For the millions of people world-wide that have been using e-cigarettes / vaping as a means to quit SMOKING, NOT ONE DEATH HAS BEEN DOCUMENTED. NOT ONE DEATH FROM POISONING, NOT ONE DOCUMENTED PATTERN OF HARM FROM USAGE!!
Those who conspire to restrict and eliminate e-cigarettes / vaping rally around THEORETICAL HARM, while happily IGNORING THE TANGIBLE HARM REDUCTION, the documented SUCCESSES, the all-time LOW TEENAGE SMOKING RATES, the ACCELERATED CIGARETTE SALES DECLINES, the SCIENTIFIC & FACTUAL ANALYSIS that provides EVIDENCE of <1% the risk of harm as compared to SMOKING, and ZERO RISK OF HARM TO NON-USERS.
Unfair and illegal restrictions that will dissuade and reduce the OPPORTUNITY and ACCESS to a GREATLY REDUCED HARM OPTION and CHOICE - THAT IS VAPING / E-CIGARETTES - WILL COST MILLIONS OF LIVES. SMOKERS who will continue to expose themselves and their loved ones to the proven harms of SMOKING, and will be denied access to, or hysterically scared away from tools and resources and products that millions have had to successfully QUIT SMOKING,
E-cigarettes & vaping are NOT TOBACCO PRODUCTS - Any more than a car that has soy bean by-products in them would be considered a grocery item, or should be subject to FDA COSMETIC regulatory over-sight.
These 'deeming regulations' are the most inappropriate 'tool' to bring mild over-sight to the e-cigarette / vaping industry.
Please DO NOT use these "deeming regulations" to PROTECT SMOKING.
DO NOT PROTECT the big tobacco companies that would be the only likely entities that could meet the useless, destructive regulatory requirements
DO NOT PROTECT the sales of the pharmaceutical companies that profits from the smoking related diseases that ravage the human body.
If my choices and options are restricted, and or completely eliminated, I will be forced to the UNREGULATED BLACK MARKET for my needs. The BLACK MARKET where the FDA has NO role to play, no government taxes are paid, and product SAFETY is NOT subject to even the basest of oversight.
REDUCED HARM: Analysis of what is in the vapor: http://www.biomedcentral.com/1471-2458/14/18/abstract
Thoughtful & REALISTIC approach to legislative over-sight: http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3926346/ AND http://www.rstreet.org/policy-study/...cal-lawmakers/
First-hand accounts of VICTORY OVER SMOKING - A NEW LIFE BEGINS: http://www.e-cigarette-forum.com/for...tend-quit.html
A proud member of CASAA!
NOTE: here are additional links to files I was able to attach to the comment:
E-cigarette primer for state and local lawmakers | R Street Institute | Free Markets. Real Solutions.
Achieving appropriate regulations for electronic cigarettes
"Tobacco Harm Reduction: opportunity and opposition" by Phillips & Rodu: https://docs.google.com/file/d/0B3FU...1vMGF4b0k/edit