To: Amanda Bryan
MHRA
Room 14-212, Market Towers
1 Nine Elms Lane
LONDON SW8 5NQ
From:
[My name & Address]
CONSULTATION LETTER MLX 364: THE REGULATION OF NICOTINE CONTAINING PRODUCTS
MY STORY: I am 64 years old. I smoked for 45 of those years. Products and methods that I used over the years in unsuccessful quitting attempts include FDA-approved nicotine patches, gum, lozenges, and nasal inhaler; Bupropion; American Lung Association smoking cessation class; Nicotine Anonymous; and hypnosis. The problem underlying these multiple failures is the fact that nicotine abstinence triggers memory, attention, and mood impairments that persist until I resume taking in adequate amounts of nicotine. Obviously, medicinal nicotine provides inadequate amounts.
I used to lie in bed at night, being kept awake by my wheezing and pray that God would send me something that would allow me to stop smoking without forcing me to sacrifice my cognitive and emotional health. E-cigarettes were the answer to that prayer.
On March 27, 2009 I began using an electronic cigarette and stopped inhaling the thousands of toxins and carcinogens in tobacco smoke. The wheezing is gone. I no longer cough up a nasty chunk of phlegm in the morning. I can laugh out loud without triggering a coughing jag. My BP is down and so is my cholesterol.
Tell me please, why do you want to “fix” this situation for me? Why do you want to “protect” e-cigarette users by forcing them to resume tobacco smoking? Why do you want to “protect” continuing smokers from the most effective quitting method the world has ever seen?
My comments on the proposals in MLX 364 are below.
GIGO (GARBAGE IN = GARBAGE OUT): Annex A uses the least accurate and least reliable sources of information on e-cigarette safety and efficacy. As a result, the Conclusions reached are dangerously erroneous.
TOXICOLOGY: A toxicology report that fails to include a quantitative analysis (i.e., FDA’s report) is unforgivably unprofessional. You can find a collection of toxicology reports on several different brands of e-cigarettes and e-cigarette liquid here: http://www.casaa.org/resources/lab.asp
All of these reports, conducted by professional laboratories, specify the
quantities of substances identified. One report compares the quantity of TSNAs in the e-cigarette liquid (8 ng/g) to the quantity in approved nicotine replacement products (8 ng/g).
http://www.healthnz.co.nz/RuyanCartridgeReport30-Oct-08.pdf
Note that later reports reveal that very little of the barely-detectable amounts of toxins found in the liquid form make it into the vapor. So much for the terrible danger that e-cigarette users face from being poisoned.
Now, MHRA needs to go one step farther: Compare these substances and quantities with the substances and quantities delivered by the smoke from a pack of tobacco cigarettes.
SAFETY: In July, the FDA invited the public to submit reports on adverse events due to using electronic cigarettes to the MedWatch program. Given the fact that no reports have been presented as evidence in the ongoing court case, we must conclude that there have been no serious problems experienced by e-cigarette users in the U.S. How many reports of serious problems have been reported to authorities over the three years that e-cigarettes have been used in the UK?
HEALTH EFFECTS: Users of e-cigarettes are reporting increased lung capacity, less need for asthma medications, disappearance of wheezing and coughing, improved energy, improved sense of smell, lower blood pressure and cholesterol numbers. Read the comments in these two examples of testimonials:
·
Over 13,000 people signed: http://www.thepetitionsite.com/1/keep-life-saving-electronic-cigarettes-available
·
User Success Stories: http://www.e-cigarette-forum.com/forum/e-cigarette-success-stories/
EFFECTIVE AS SMOKING REPLACEMENT: Surveys and polls of actual consumers consistently show that approximately 80% of regular users of e-cigarette have successfully substituted the e-cigarette for all of their tobacco cigarettes. Here are two examples:
·
University of Alberta survey: http://www.tobaccoharmreduction.org/wpapers/011v1.pdf
·
E-Cigarette Success Poll: http://www.e-cigarette-forum.com/forum/polls/6470-e-cig-success-rate.html
Thousands and thousands of people who switched from tobacco cigarettes to inhaling vaporized nicotine from an electronic cigarette report that they tried and failed to quit with approved medicinal products. Not surprising, when you know that the quitting rate with medicinal nicotine is only about 10%. Approving medicinal nicotine for longer term use is not enough. The dosage is too low for most users to achieve initial cessation, much less maintain long-term cessation.
ERRONEOUS CONCLUSION: The conjecture that users of e-cigarettes might fail to quit due to getting sub-therapeutic doses of nicotine is laughable. The strength of the e-cigarette product is that, similar to smoking tobacco cigarettes, it allows the users to control their own nicotine intake. The greatest weakness of medicinal products is that the dosage is too low.
DO THE RIGHT THING: If you don’t believe any of the above resources, conduct your own research. Hire a lab you trust and conduct toxicology tests. Ask e-cigarette vendors to supply you with contact information for their customers. Ask consumers how using an e-cigarette has affected their smoking. Ask them about the effects on their health.
