SAMPLE LETTERS - For Congress, State, Commissioners

[Tommy-Chi]

I'm kicking off the form letters thread.

I have written a few letters and I'll be posting them below.

NOTE: Why support HR 2058. Why support Cole Bishop Amendment. Explained here.


Admin note - No chit chat in the thread. Form letters only.

 

[Tommy-Chi]

IN SUPPORT OF HR 2058. This letter is from CASAA


Representative [NAME HERE]
Washington, D.C.

Dear Representative,

I am writing to express support for the FDA Deeming Authority Clarification Act of 2015 (H.R. 2058), which would protect my access to the variety of quality vapor products (otherwise known as e-cigarettes) currently on the market and help a million plus Americans continue to live smoke-free. Moreover, H.R. 2058 is a boon to the millions of current smokers who are seeking an effective means to help them transition away from deadly combustible cigarettes.

As written, the Food and Drug Administration’s (FDA) proposed regulations would effectively remove 99% of vapor products from the market by subjecting manufacturers to a costly premarket approval application process that only a few large companies might hope to navigate. Consumers would be left to choose from a very limited number of products that were on the market prior to the February 2007 grandfather date -- products that are remarkably less effective and, by some accounts, less safe. As a result, not only would a large number of us return to smoking, but millions of current smokers would be encouraged to continue smoking.

For decades, smokers have been told to just use mediocre smoking cessation aids that are barely helpful, if that; mostly they just triggered cessation by those who were happy to simply quit unaided. Although smoking rates have declined substantially since people first learned about the hazards, they are now only slowly creeping down, and mostly because older smokers are dying, not quitting. For the vast majority of smokers who are not willing and able to just quit, electronic cigarettes offer them a satisfying, low-risk substitute, often the only path away from smoking other than dying.

I and my fellow members of the Consumer Advocates for Smoke-free Alternatives Association (CASAA) thank you for considering my comments and look forward to your continued support of tobacco Harm Reduction policies. We are truly grateful for your introduction of H.R. 2058 and would like to offer any assistance we can to advance this bill.


Sincerely,

 

[Tommy-Chi]

IN SUPPORT OF COLE-BISHOP AMENDMENT


Representative [NAME HERE]
Washington, D.C.

Dear Representative,

Please support the Cole-Bishop amendment to the 2017 Agricultural Appropriations bill. This will change the grandfather date for deemed products from Feb. 15, 2007 to the effective date of the Deeming Regulation, which will be some time in 2016.

This amendment would grandfather qualified products using the Tobacco Control Act, and avoid a lengthy and expensive PMTA process that relatively few manufacturers of vaping products can afford. Grandfathered products will be able to serve as predicate products for future SE Reports for new products that are to be marketed after the new grandfather date.

Sincerely,

 

[mattiem]

This is my follow up letter----

I am writing to you again today to urge you to consider just what will happen if the FDA deeming proposal is passed as written.

This one product that helped me break a 45 year habit will no longer be there for me or for those that have not yet found it. I have now been smoke free for 4 1/2 years.

This one product has the potential to totally eradicate tobacco cigarette use and health issues caused by them. I believe that this can happen in my lifetime.

I am asking you and your friends in Congress to consider this statement:

If you, the members of Congress truly do care about the health of your supporters and if you do not act to change the grandfather date established by the Tobacco Control Act, the wide variety of vapor products that adult smokers have come to rely on to live smoke-free will be swept off the market and thousands of Americans will lose their jobs.

Thank you for your consideration and positive action on this very important issue when it comes up for a vote. Vaping truly does save lives. Please support and keep the specific language of the Cole-Bishop Amendment in the Appropriations Bill, as it is, as it passes through for the Presidents signature.

 

[YoursTruli]

This One Letter Can Save Our Entire Industry

 

[ZeroedIn]

Good afternoon, Honorable Representative/Senator <NAME GOES HERE> and Staff:

I write today to ask for your support of HR-2058, The Food and Drug Administration's (FDA) Deeming Authority Clarification Act of 2015, sponsored by your colleague Rep. Tom Cole (R-OK), and the Cole/Bishop Amendment to the 2017 Agriculture Appropriations bill, as well as any other similar legislation which may come before the House/Senate.

Please indulge a few minutes of your precious time while I explain why I ask for your support of this important legislation.

The Federal Drug Administration (FDA), as you likely know, on May 5th, 2016, released their Final Rule regarding the Deeming of certain products in the marketplace as "Tobacco Products." The 499 pages of this regulatory document includes items such as batteries, wires, electronic circuits, software, even cotton and similar textiles, and surreptitiously classifies them as a "tobacco product." These items, which are clearly not tobacco products, are "deemed" and classified as such by the FDA, because they are components of Electronic Nicotine Delivery Systems (ENDS), as the FDA would call them.

Myself, along with millions of other Americans who are now, or becoming ex-smokers, have taken up "vaping;" the use of ENDS, or Advanced Personal Vaporizers (APVs) as we "vapers" would call them, as a safer alternative to smoking conventional, analog tobacco cigarettes. These devices provide users an OPTIONAL dose of nicotine by heating a solution to an aerosol which is then inhaled. It does not burn or combust whatsoever, and produces no smoke. The exhaled emission is basically a water vapor, not much different in composition than the "fog" produced by "fog" machines used for decades in movies, theater productions, and other similar events. In fact, APVs should be classified as recreational technology products, not tobacco products, as there is absolutely no tobacco in them whatsoever.

The ingredients in the solution (e-liquid) include the following; 1) propylene glycol (PG), which is a substance that is Generally Recognized as Safe (GRAS) for human consumption by the FDA, 2) vegetable glycerine (VG), which is also a substance that is GRAS by the FDA, 3) food-grade flavoring compounds, usually in a PG solution, or a PG and ethyl alcohol solution and 4) an OPTIONAL nicotine extract additive. That's all, only four ingredients in most e-liquid currently on the market. The ingredients of cigarette smoke however, are well known to be harmful to public health and contain hundreds if not thousands of harmful substances. In fact, PG is commonly used as a vehicle for delivering other substances via inhalation, such as bronchodilators in asthma inhalers and carriers for certain vaccines/innoculations; while VG is a common, non-toxic component of soaps, cosmetics, suppositories, and other items.

While the vaping community is not opposed to SENSIBLE regulation, such as codifying age restrictions for the purchase of these products, the sweeping regulations and onerous as well as prohibitively expensive Pre-Market Tobacco Application (PMTA) process as outlined in these regulations, will ostensibly create a de-facto ban on all such products currently in the marketplace, stifle innovation in the creation of new and improved products, and kill a burgeoning $3.4B+/year industry which has created tens of thousands of jobs over the past several years.

While the economic impact due to the loss of local businesses and jobs will be significant, the more important issue is that public health will be greatly harmed by the inability of the vaping community to obtain goods and services to assist them with their continued journey of staying quit from tobacco cigarettes; not to mention those smokers who have not yet discovered vaping as a safer alternative to smoking who will be deprived of the latest generation of devices which have already helped millions of people world-wide.

I invite you to review research on vaping presented by Dr. Konstantinos Farsalinos, a cardiac surgeon in Greece (E-cigarette Research), as well as the recent report from Public Health England (https://www.gov.uk/government/uploa...mmissioned_by_Public_Health_England_FINAL.pdf). After reviewing the material above from the medical community, I also invite you to visit the testimonials page at CASAA.org (Testimonials | CASAA Testimonials), where you can view thousands of stories from real people, like myself, speaking about how the use of Advanced Personal Vaporizers (APVs) has helped or is helping them "kick the habit," and its overall positive impact on their health and well-being.

I also request that Congress undertake a Congressional Review of these new regulations, due to the economic impact of so many lost jobs because of the thousands of small businesses which will surely have to close their doors due to the excessive financial burdens of filing PMTAs to keep their product(s) on the market.

Thank you for taking the time to read this letter, and I pray that you will make the correct and honorable decision regarding this important issue.

Sincerely,
Your constituent

 

[rwoodin]

Sent to Senator Ron Johnson (R-Wis) regarding his inquiry to the head of FDA on deeming regulations.

Dear Sirs,


I would like to personally thank you for the inquiry sent to FDA Commissioner Robert M. Califf, MD regarding FDA Deeming ecigarette regulations.


My parents both died early from complications of smoking. I myself smoked from the age of 13 to the age of 50. I never imagined I would be able to quit and had long resigned myself to likely getting sick and dying from smoking. No one was more amazed than me, when trying ecigarettes in 2009 and successfully quitting smoking altogether a short time later. It was literally, an unexpected new lease on life. Both my wife and I have not had any regular cigarettes since October of 2009. My lungs cleared up and my sense of smell returned over a period of a few months while using ecigarettes. I became very enthused about ecigarettes at the time because I realized what a huge, positive difference they could make in my life and literally millions of other smokers lives.


Then I started noticing that the FDA, other departments of the government and medical organizations all started targeting ecigarettes as a dangerous product to be avoided at all costs. Throughout 2010, I watched as the FDA tried unsuccessfully to ban ecigarettes in the USA by declaring them a 'combination drug, delivery device'. I read about the countless confiscations and raids of ecigarette products by US Customs dept., even though this was a perfectly legal product. I became very active in explaining to however many people I could, online and in person, how the information portrayed about ecigarettes in the mainstream media was just plain wrong. At this time, I must say, my eyes were opened for the first time, to witness the US Government working hand in hand with large, powerful medical organizations and corporations to eliminate ecigarette use entirely, even though the early facts showed that this product could save tens of millions of lives.

I learned firsthand, about government policy, about government over reach, about a government agency dedicated to improving the health of Americans, staunchly opposing a product that could do just that, all because that product was beyond their system of control and that product disrupted the current business model surrounding tobacco use, the illnesses caused by tobacco use and the vested interests that profit into the billions of dollars from the continuation of the status quo. I have not looked at my government the same way, ever since then.

I became less active in advocating ecigarettes and was happily comfortable using them over the ensuing years. The products provided by the ecigarette market improved dramatically from the early, crude and expensive models. I had mostly forgotten about the struggle with the FDA, over Americans continued access to this incredible product. Then in 2016, I was jolted by the news of the FDA passing regulations that will in fact and without question decimate the entire ecigarette industry, by removing 99.99 percent of the products on the shelves today due to FDA choice to use Feb, 2007 as the deeming date of the regulations. This is nothing short of prohibition and no one involved believes the FDA does not know exactly what it is doing. FDA has, through regulatory power, destroyed an entire industry, one that was created for the sole purpose of people being able to use nicotine in a product similar to cigarettes, that did not carry the health risks of cigarettes. The final and most perversely cruel result of this FDA prohibition is to hand 100% of the market share of the multibillion dollar ecigarette industry to the very companies that ecigarettes were meant to provide an alternative to, the tobacco companies. They are the only stakeholders with the resources to conduct business with ecigarettes under the current FDA regulations. Any suggestion that these simple facts are not true is merely subterfuge, meant to distract people from the truth.

None of the esmokers or the manufacturers and retailers of ecigarettes would oppose any sensible regulations. We all want a safe, high quality alternative to smoking tobacco. It is my sincerest hope that it is not too late to arrive at sensible regulations for ecigarette products. Many lives depend upon it, many jobs depend upon it and the trust, of average Americans, just like myself, depend upon it. I know I am not alone when I applaud your communications to the FDA and strongly encourage your effort to help us all, in settling on some commonsense regulations for the revolutionary ecigarette industry.

Thank You Kindly,


Ralph Woodin

 

[The Ocelot]

I sent an email May 22nd to Sen. Ron Johnson thanking him for his letter to the FDA. I also submitted the following message to the U.S. Senate Committee on Homeland Security & Governmental Affairs. (I purposely focused on the job angle.)

Dear Senators,

I applaud Sen. Johnson's letter to the FDA regarding the deeming regulations of tobacco products and urge all of you to question if the FDA's egregious overstep is really in the public's best interest.

When congress gave the FDA authority to regulate tobacco I'm sure they did not envision that authority would extend to creating a Catch-22 PMTA system that would shut down thousands of small businesses and put hundreds of thousands of citizens out of jobs. Under the regulations anything even remotely connected to vaping can be deemed a "tobacco product," even if it contains no tobacco, or, in fact, any organic material. It's like deeming a glass an alcohol product because there is wine in it.

America needs jobs. America needs to support small businesses in their efforts to innovate. An application system so expensive and so complex that only Big Tobacco companies have the funds to try to be approved ("try" as in there is no guarantee even they will be successful) is detrimental to our economy.

I know you are all busy and it may be too much to ask, but I beg at least one of you to watch this video about ProVape, the largest US manufacturer of vaping hardware devices. That's right, "Hardware." They make steel battery tubes and boxes, that contain no plant matter whatsoever. Despite that, according to the regulations they are a tobacco product manufacturer. ProVape has worked very hard to become the type of small business America should be proud of, but now they can't afford to stay in business:



I'm a 57-year-old constituent who has voted in every election since I was 18. I am also an ex-smoker. After 40 years of smoking, I have been tobacco free for almost 4 years by vaping. I will vote for candidates who support tobacco harm reduction, not for those who would block a path to health for millions of people in a misguided attempt to "Protect the Children."

Thank you in advance for having common sense.

 

[The Ocelot]

June 1, 2016 I just sent another email to the Homeland Security and Governmental Affairs Committee.

Dear Senators,

Yesterday you should have received a response from the FDA to Sen. Ron Johnson’s letter regarding the burdensome e-cigarette regulations. I urge you to review the material very carefully. I suspect much of the response will be based on Final Regulatory Impact Analysis (Docket No. FDA-2014-N-0189).

I am a member of the Electronic Cigarette Forum, a web forum with over 244,000 members. Many of us have been analyzing the Final RIA line-by-line (as we have, and continue to do, with any relevant documents we find) and, honestly, the report is more complex, confusing and contradictory than the Final Deeming regulations.

Here is a short list (I realize it’s actually long, but there are a lot of troubling statements in the document):

1) It is clear the FDA has little information on how many businesses the regulations impact. They seem pretty arrogant about it as well.

"In comments, the CEO of Vape World is cited as saying there are more than 3,500 independent vape shops in the U.S. Comments cited industry analysts estimating that there are 5,000 to 10,000 vape shops in the U.S. In comments, an individual from a trade association is said to estimate that there are 14,000 to 16,000 brick and mortar vape shops in the U.S. The Tobacco Vapor Electronic Cigarette Association estimates that brick and mortar stores will sell more than $1 billion in vaping equipment and products in 2014."

FDA response:

"As the comments describe, the industry is in a state of flux; during the time that the proposed rule was in review, and since the proposed rule was published, the ENDS industry has grown and additional vape shops have opened. The comments on the number of ENDS manufacturers did not provide concrete data sources, but rather industry estimates for which the bases were not given."

"In the RIA for this final rule, based on logo counts from trade association websites and FDA listening sessions, we estimate that there are 168 to 204 manufacturers of ENDS products, other than retailers who mix their own e-liquids, selling goods in the US market. We also estimate that there are 14 importers of ENDS products."

I don't see how "logo counts from trade association websites and FDA listening sessions" are more concrete data sources than industry estimates. All they have identified are manufacturers with logos who are members of trade associations.

2) The word “consolidation” appears 37 times in the report. According to my interpretation, it suggests Big Tobacco companies that can afford to comply with the regulations will buy-out smaller companies they forecast to be profitable. As for the rest, all they have to do is wait for the competition to exit the market.

The word “exit” appears 147 times.

“…consolidation and exit would be expected to occur under the baseline as successful firms represent an increasing share of market sales, market leaders perhaps absorb smaller firms and products, and smaller firms merge into larger entities or exit from the market). We expect a much larger share of ENDS products to exit rather than submit a premarket application.”

“We continue to assume a substantial amount of product consolidation and exit will occur as a result of regulation, as described in the final RIA.”

“[The] FDA acknowledged in the PRIA that premarket submission requirements could lead to significant product exit and reduced entry.”

“To the extent that smaller firms or firms in particular segments of the industry have relatively low sales volume per product, they will be disproportionately burdened…”

“…the growth we have seen in the ENDS market, we now forecast that a larger number of requests for marketing authorization will be submitted for e-liquids and ENDS delivery systems…”

“We also assume 54 percent of delivery systems and somewhere between 50 and 87.5 percent of e-liquids will not submit a marketing application and will exit the market after the initial compliance period for the submission and FDA receipt of PMTAs ends. The e-liquid share is particularly difficult to predict in view of uncertainties about the number of distinct products currently available on the market.”

3) The high estimate of smaller companies exiting the market isn't surprising when one considers:

“…at the low end of the average cost spectrum would be product lines of cartridge- or disposable e-cigarettes which have an identical underlying delivery system, flavor variants likely to share basic ingredients, and similar ingredients and constituents for which existing information can be used to support a PMTA. This case is assumed to have total costs of $285,656.”

“…at the high average cost end is a single open-system device requiring considerable original research and testing amounting to $2.6 million.”

It is clear these estimates give an unfair advantage to the makers of cartridge or disposable e-cigarettes, which are what Big Tobacco companies currently have on the market.

I also have yet to find a specific definition of a “single open-system device.” Does that refer to the battery tube/box? The tank? The drip tip? The device I am using this very moment is made up of components from 5 separate companies. Does that really mean it would take 13 million dollars to bring the same configuration to market?

By using what I think is an “open system,” I was able to quit cigarettes 4 years ago after smoking for 40 years. I’m very worried about this situation as a consumer, a supporter of small businesses, and as person who wants other smokers to have the same options to stop using combustible tobacco I had.

Thank you in advance for having common sense.

Sincerely,

 

[The Ocelot]

I sent this to my legislators via the CASAA webpage form.

I am a 57-year-old middle class constituent, who has voted in every election since I was 18. I am also an ex-smoker. Almost 4 years ago I quit a 40-year smoking habit by using electronic cigarettes.

I strongly urge you to support the amended Agriculture Appropriations Bill for 2017 and to co-sponsor the FDA Deeming Authority Clarification Act of 2015 (H.R. 2058) that would amend the Food, Drug, and Cosmetics Act to change the predicate date for newly deemed tobacco products to the date when the deeming regulation is finalized.

A predicate date of February 15, 2007 doesn’t benefit public health, it benefits Big Tobacco companies, as the tobacco cigarettes on the market today are “Substantially Equivalent” to those sold in 2007 and will be “grandfathered” in. The e-cigarettes and e-liquids currently on the market are not Substantially Equivalent to what was available in 2007. Accordingly, every product is considered new and will require a pre-market tobacco application (PMTA).

E-cigarette products are being held to a much higher standard than tobacco cigarettes. Manufacturers of e-cigarettes and related products must, among other things: quantify the likelihood that nonsmokers will start using the product; the likelihood that former smokers will relapse back to nicotine use by using the product; the likelihood that nonsmokers who do start using the product will progress to cigarette smoking; the likelihood that former smokers who relapse back to nicotine use will then progress to smoking; the likelihood that consumers will use the product in conjunction with other tobacco products; and the likelihood that smokers who start using the product would otherwise have quit smoking.

The FDA requires a separate PMTA for every product. Thus, if an e-cigarette manufacturer produces four types of starter kits, four types of cartomizers, five types of mods, and 40 e-liquid flavors, each coming in three nicotine strengths, then that manufacturer will have to submit 133 PMTAs! This is a conservative estimate, as there are many companies that sell more than 100 flavors of e-liquids. These companies are being required to submit approximately 300 different product applications.

To submit a PMTA will require a huge research undertaking lasting several years and costing millions of dollars. I don't even think that existing NIH research - in its totality – would be able to provide all of the necessary data by the regulations deadline. Small businesses will not be able to comply.

And even if a company came up with the funds to submit a PMTA, there is no guarantee it will be approved. As Mitch Zeller, director of the FDA's Center for Tobacco Products, told U.S. News, it's impossible to say if any e-cigarette product will be approved.

A 2007 predicate date does nothing to serve the public; it does the opposite. By making legal tobacco harm reduction products unobtainable, vapers like myself will be forced to buy from the black market or go back to smoking cigarettes.

Please support the amended Agriculture Appropriations Bill for 2017 and to co-sponsor the FDA Deeming Authority Clarification Act of 2015 (H.R. 2058) and allow me the legal means to stay off of tobacco.

I vote, and I will support politicians who support my right to "harm reduction,” even if it means I will have to vote Republican for the first time in 39 years.

Sincerely,

 

[mattiem]

This is my note to Sen. Johnson @Homeland Security

I just wanted to take a moment to say Thank you for what you are doing.

I smoked for 45 years. I smoked up to 2 packs a day. I bought my first personal vaporizer November 13th, 2011. I have been smoke free since that very day. It was a tiny cig-a-like. I knew that if I got a better device I would never smoke a traditional cigarette again and I haven't.

When I first started on this journey I needed 24mg/ml nicotine. Within a month I was down to 18 and as my vaping devices improved (got more efficient) my nicotine strength has gone down. I am now down to 6mg/ml in some of my e-liquids and up to 12 in others. I need a variety of flavors to keep me interested.

I tried to quit numerous times over the years. Once with patches and they were a total fail. One time I quit cold turkey for 6 months. I craved a cigarette every moment of every day during that time. I finally decided that I would not spend the rest of my life feeling like that so went back to smoking. I also gained a LOT of extra weight during that 6 months. There were a few other times that I tried cold turkey but could never go over a few weeks.

With my personal vaporizer I have not had a single craving for a cigarette and I have actually lost weight with this method of smoking cessation.

This miracle device has the potential to do what it seems some want to happen (total eradication of traditional cigarettes). I can see that happening but only if they are not regulated out of existence by those that are losing money from loss of tobacco tax. Regulated out of existence by a regulatory committee that claims they just don't know enough about the long term effects. Read our stories---read and accept all of the research that has been done and you will see what we see.

This is a life saver for me and for hundreds of thousands of others and the ones that want to roll it all back to 2007 and call it a tobacco product so that they can control/basically ban it are, in my opinion murderers.

Thank you for taking the time to read my story,

 

[rwoodin]

OK, letter #2 sent to Senator Johnson regarding his second letter to FDA.


Thank You Senator Senator Ron Johnson for being a voice of level headed reason and sanity, amidst the mob mentality displayed by the FDA in instituting regulations that result in an effective Government Prohibition against small businesses and former smokers that stopped smoking with e-cigarettes. I'm one of those former smokers who, after 37 years smoking, had long given up on thinking I'd ever be able to shake the smoking habit. The remarkable fortuity of having electronic cigarettes appear on the consumer market, at a time when smoking was taking more and more of a toll on my health, was, in my opinion, nothing less than a lifesaving event. In October of 2009, at 50 years old, after smoking for 37 years and countless failed quit attempts via 'approved' methods, I was able to give up smoking once and for all by transitioning to e-cigarettes I have been aware over the ensuing years that literally millions of smokers have quit smoking using e-cigarettes. I have also witnessed a government organization, the FDA, whose stated mission is to improve the health and safety of all Americans, relentlessly attempt to wipe e-cigarettes off the face of the earth, entirely, by whatever means possible. FDA tried banning e-cigarettes as a drug back in 2010. They went to court and lost 3 separate times before giving up using those means to achieve their end goal of eliminating e-cigarettes. Now it appears that years later, with the passage of time, documented scientific evidence and millions of accumulated case histories that e-cigarettes are roughly 95% less harmful than regular cigarettes. In regard to these facts, FDA appears to lack the ability to consider or admit, that a largely unregulated product, developed by private industry, that has seen explosive growth due to real world, consumer demand, has accomplished in less than 10 years, exactly what decades of 'traditional' anti-smoking measures have sought, but have not and will not be able to achieve. Instead of showing any humility in the face of this tremendous success, instead of embracing and assisting businesses to accelerate development of a product that really can put an end to smoking, the FDA has chosen to exert massive regulatory power over this market, to the extent that most, if not all small businesses will be shuttered, due to the enormous expense of having e-cigarette products go through FDA premarket approval. Many, maybe many millions of former smokers that have been able to quit by using e-cigarettes as a means to end their smoking habits, will return to smoking as a direct result of FDA regulations as now published, being so restrictive as to form an effective Government Prohibition of e-cigarettes. The groups that will benefit from having the FDA bring a $4 Billion dollar a year e-cigarette private market to an abrupt end are the large tobacco companies, which are losing billions of dollars in revenue to small businesses that manufacture and distribute e-cigarette products. Also, those that stand to gain from e-cigarette prohibition are pharmaceutical companies that make what have been to date, largely ineffective stop smoking aids. With e-cigarettes being a competing product that is quickly and completely removed from the market, pharma company sales of NRT’s will rebound. The government also will receive an increase in tax revenue on traditional cigarettes that, before the FDA e-cigarette ban, were quickly declining. Organized crime will quickly capitalize on the huge black market opportunities created by this, or any, prohibition. Those are the winners. The losers in the FDA e-cigarette prohibition are the former smokers who now use e-cigarettes. As many return to tobacco use, they will spend much more to purchase highly taxed Marlboro’s and Newport’s than they now spend on vapor products, which are considerably cheaper than regular cigarettes. These people will also reverse the health gains they have made from quitting smoking. More innocent people, including children, will again be subjected to second hand smoke from those once again, ‘lighting up’. The health care system will again be strained more so as to meet the demands of more smokers becoming ill and slowly dying from cigarettes. The $4 Billion dollar market, which sustains as many as 70,000 workers and thousands of small business owners, will vanish under FDA prohibition. All the jobs, the retailers, the business owners, the economic value of the entire electronic cigarette industry will vanish in the USA. The jobs that were in the USA will move to other countries in order to meet the market demands. Meanwhile, traditional tobacco cigarettes, known to kill millions, will be untouched by these regulations and will be available as always at the corner store in Anywhere, USA.

This is the current state of affairs as dictated by the FDA. There is no doubt of their intention for the e-cigarette market in the USA. One can simply read the regulations, or a summary of the regulation’s FDA published to see it is all fact. The reason for all of this is of course, money. But in addition to money, there is also the factor of mentality. Tobacco and tobacco smoking even now kills about 500,000 Americans a year. The figure used to be much higher. Tobacco has been the deadliest single product marketed in the history of the country. There is good reason for the negative mentality towards tobacco from health organizations and regulatory agencies alike. This visceral, public revulsion at all things derived from tobacco finds its roots in the many decades spent trying to reduce the harm caused by this deadly product. The leap required to see that ‘people smoke for the nicotine, but die from the tar’ does not apply, at all, to e-cigarettes as it does to tobacco, is just too far for most that have witnessed the consequences of tobacco use. That is the conscious and sub conscious driver behind the mainstream medical industry belief that ‘all things tobacco must be stamped out, at all costs’. It is extremely counter-intuitive to understand that nicotine, by itself, in small quantities, is not inherently harmful to humans. It is the tar, the toxic gases and the carcinogenic chemicals that are all created by the burning of tobacco, in cigarettes, that is the cause of the health consequences associated with smoking cigarettes. When nicotine is heated and vaporized, but not burned and it is delivered to the lungs via the vapor form of a carrier solution known to not cause harm to humans, such as is the nicotine, vegetable glycerin, propylene glycol and generally, the flavorings that make up an ‘electronic cigarette’, it is far less harmful than normal tobacco cigarettes. The risk associated with e-cigarettes is much as an order of magnitude less than traditional tobacco cigarettes. This is what the scientific evidence has shown and continues to show, the more that e-cigarettes are objectively analyzed. So finally, the FDA regulations have been written and adopted based on the combined ‘feelings’ and ‘fears’ of health care professionals and organizations. The regulations are not based on the scientific, public health and economic facts that have emerged when the technology of e-cigarettes is looked at and studied objectively. Hopefully for the citizens of this country, the continued focus on the facts, the scientific investigation of the differences between e-cigarettes vs tobacco cigarettes and the effort of yours and other legislative members of the government will produce the collective clarity of vision to move forward in policies that truly help the public health and safety rather than keep us collectively trapped in the past based on the feelings and fears that ‘all things tobacco are evil and must be destroyed’. The abundance of evidence shows that this is just not the case. Thank You once again in your sincere effort to elicit transparency from the FDA on its reasoning for placing restrictive regulations on a product that shows no significant evidence of harming people.

 

[drum747]

Sent this to my Senator


Dear ..............
I am writing to express my deepest disappointment in your support for the FDA's so called "Deeming regulations" with regard to the life saving technology of vaping products.
I smoked for 30 years and tried everything on the market in order to quit and failed until September 11th 2010, my daughters 2nd birthday.
Feeling the devastating effects of smoking for 30 years, more and more each day, I knew I had to quit for my daughters sake as well as mine but nothing had worked (patches, gum, wellbuterin, etc.) I discovered vaping, still in its infancy mind you, not the great devices on the market today which will essentially be banned due to the PMTA costs under the "Deeming". I quit that day and have been vaping for almost 6 years now and all my smoking related symptoms went away, I can breath again! Vaping literally saved my life.
I am not suggesting reasonable labeling and laws prohibiting sales to minors not be implemented, all vapers that I know (helped 5 other people quit tobacco myself) seem to support that idea but this is essentially a de-facto prohibition and cannot be allowed to stand,

I have to say I do find it ironic that this is being pushed at a time when tobacco use has fallen dramatically in this country, make no mistake, thats because of vaping. I suspect that is why this is happening now as the big tobacco and big pharma companies see the writing on the wall and lack of profits will not be allowed to go unchallenged,

Are you aware of the Royal College of Physicians statement on vaping that just came out?
Nicotine without smoke: Tobacco harm reduction

Here are some highlights:

- Vaping holds less than a 5% risk to the vaper

- NO harm to bystanders.

- More than 95% safer compared to smoking cigarettes,

- Is not a gateway to smoking but rather a gateway from smoking,

- Does not renormalize smoking but helps reduce allure of smoking,

- Electronic nicotine delivery systems (ENDS) should be encouraged for smokers to help quit

This video might help:
It’s Just the Science – Royal College of Physicians’ John Britton Talks e-Cigarette Benefits & Regulation (RegWatch Exclusive)

This is the oldest institution of physicians in the world and the first to link cigarettes with cancer in 1962.

In addition, I really find the "save the children" angle frankly ridiculous, perhaps "save big tobacco" or "save big pharma" might be a more honest approach since they will be the only ones who can afford the $500K plus fee for each item through the PMTA process. These "regulations" are a gift to big tobacco and big pharma and nothing more.

In closing, you must know that supporting this massive overreach is absurd and a detriment to public health, so at a minimum I would expect you to support HR2058 and/or the Cole-Bishop Amendment to reduce the negative impact on availability of products and ultimately peoples health, including mine.



Sincerely,

 

[rwoodin]

My latest letter. This one went straight to The Donald!


Mr. Trump,

I would first like to thank you for running for President and for the countless hours you have spent speaking common sense to the people of this country.

I know you are a business man so I will cut right to the chase. I'm writing about a huge government bureaucracy that has far exceeded its original purpose. The FDA and specifically its tobacco regulation arm, has implemented what amounts to a total ban on electronic cigarettes.

Electronic cigarettes were invented by a Chinese pharmacist to allow for the inhaling of nicotine, without smoke and thereby, to reduced harm to people. I and millions of other tax paying; voting, middle class Americans have successfully used electronic cigarettes to quit smoking tobacco entirely. I myself smoked for 37 years and quit in October of 2009 by using electronic cigarettes. I have been smoke free ever since. My health has visibly and markedly improved.

The FDA in its misguided ‘regulate everything’ logic has mistaken electronic cigarettes as being just like regular cigarettes. Nothing could be further from the truth. Yet the FDA, with billions of dollars and enormous scientific resources at its disposal, has chosen to regulate electronic cigarettes even more so than regular cigarettes. This comes almost entirely from ‘guilt by association’ where the FDA simply decided that electronic cigarettes seem similar to real cigarettes, without any formal scientific investigation into the detailed differences between the two products and more importantly; the far less harmful physical aspects that electronic cigarettes possess relative to traditional, tobacco burning cigarettes .

It is estimated that along with saving my own life, electronic cigarettes could save approximately 1 billion lives of those smokers who will otherwise die from smoking related disease over the next 20 years. Instead of embracing and encouraging a new technology that has created a revolutionary change that almost completely removes all the toxins from a nicotine containing product and allows consumers to actually enjoy the product, much like a cup of coffee, the FDA has imposed mandatory regulations that are so onerous, so costly and so ridiculously out of sync with the electronic cigarette business model and consumer market, that they (FDA) have created what amounts to a total government prohibition of electronic cigarettes.

The FDA user fees (approx. $500K per product) for premarket tobacco product application and the clinical data (phase 3 trials spanning years and costing hundreds of millions of dollars) requirements set by FDA will not be able to be met by 99% of the current businesses that produce and market electronic cigarettes. The electronic cigarette business model is extremely decentralized as compared to the large cigarette manufactures. Tens of thousands of small businesses that provide hundreds of thousands of jobs to Americans, here in America have, starting today 8/8/2016, been completely destroyed, eliminated, abolished through the unelected bureaucrats FDA decree. The destruction of this industry will be complete within 2 to 3 years from now, as the regulatory burden on small businesses increases beyond what they can financially bear.

In a perverse twist or calculated strategy, the only businesses that will benefit greatly from and be able to easily meet FDA premarket requirements for electronic cigarettes are the few large tobacco companies, Lorillard, RJ Reynolds, and Philip Morris. They are being given 100% market share, for free, of the only product that poses real competition to the deadly cigarettes they produce. That they will be handed this windfall by the very agency tasked with protecting Americans health and safety is the final and complete irony of this situation.

I implore you, as I know firsthand, by being a lifelong smoker, by losing both of my parents to early deaths caused by smoking, to please look at how valuable and incredible electronic cigarette technology is, or could have been for the health of Americans and American Small Business. Can you please set aside your (very public and very correct) view that cigarettes are bad and look a bit deeper to find out how disconnected electronic cigarettes are from old fashioned, cowboy killer, tobacco cigarettes. The electronic cigarette story is one of private business creating a solution to the number one killer in the world – tobacco, the product that causes Ischemic heart disease, stroke, lower respiratory infections and chronic obstructive lung disease, which remain the leading cause of death. Electronic cigarettes, inspired by the idea of helping mankind and driven by swift market innovation, have exploded in popularity, with the vast majority of consumers being ex-smokers.
It is estimated that the global electronic cigarette industry will exhibit a growth of over 22.36% (CAGR) from 2015 to 2025, to reach a total market value of $50 Billion by 2025.

I and the vast majority of people that use, make and distribute electronic cigarettes would like common sense regulation that protects youth from electronic cigarettes. Likewise, both producers and consumers know that common sense regulations are in everyone’s best interest. We all want a safe and reliable product. That’s why we all quit the cancer sticks in the first place! But there are many ways that regulation could be introduced that would help small businesses succeed and help consumers to have safe and reliable access to the product they buy and use. Regulation is not the problem, over regulation is the problem.

The FDA, with its overreaching desire to regulate all consumer products, at the expense of innovation and the public health, cannot be allowed to have the last word and doom electronic cigarettes to extinction through regulation.

I want to vote for you Mr. Trump.

I want you to help me in this matter.

I hope that you can please respond and render some kind of assistance in this truly, life or death struggle.


Thank You

Ralph Woodin

rwoodin3@triad.rr.com

336-202-3137

 

[mattiem]

My letter to President-elect Donald Trump...

Dear Mr. President Donald Trump,

Congratulations on your win. I was one of the millions that helped make that happen.

I wanted to take a moment to bring something that is very important to me to your attention.

I smoked for 45 years. I smoked up to 2 packs a day. I bought my first personal vaporizer November 13th, 2011. I have been smoke free since that very day. It was a tiny cig-a-like. I knew that if I got a better device I would never smoke a traditional cigarette again and I haven't.

When I first started on this journey I needed 24mg/ml nicotine. Within a month I was down to 18 and as my vaping devices improved (got more efficient) my nicotine strength has gone down. I am now down to 6mg/ml in some of my e-liquids and up to 12 in others. I need a variety of flavors to keep me interested.

I tried to quit numerous times over the years. Once with patches and they were a total fail. One time I quit cold turkey for 6 months. I craved a cigarette every moment of every day during that time. I finally decided that I would not spend the rest of my life feeling like that so went back to smoking. I also gained a LOT of extra weight during that 6 months. There were a few other times that I tried cold turkey but could never go over a few weeks.

With my personal vaporizer I have not had a single craving for a cigarette and I have actually lost weight with this method of smoking cessation.

This miracle device has the potential to do what it seems some want to happen (total eradication of traditional cigarettes). I can see that happening but only if they are not regulated out of existence by those that are losing money from loss of tobacco tax and money from traditional THR products that have proven to be ineffective to most of those that have tried to quit.

Regulated out of existence by a regulatory committee that claims they just don't know enough about the long term effects. Read our stories---read and accept all of the research that has been done and you will see what we see. This is a life saver for millions upon millions of people.

This one product that helped me break a 45 year habit will no longer be there for those that have not yet found it. I have now been smoke free for over 5 years.

This one product has the potential to totally eradicate tobacco cigarette use and health issues caused by them. I believe that this can happen in my lifetime.

I am asking you to consider this statement:

If you, truly do care about the health of your supporters and if you do not act to stop the far reaching regulations the FDA has established by using the Tobacco Control Act to eradicate the vaping industry, the wide variety of vapor products that adult smokers have come to rely on to live smoke-free will be swept off the market. On top of that thousands of Americans will lose their jobs as vape shops are forced to close their doors.

Thank you for your consideration and positive action on this very important issue when it comes to your attention. Vaping truly does save lives.......

I hope each and every one of y'all have or will let him know what we are facing. He can't know if we don't let him know since he has a LOT of important things on his plate right now.