1 July 2016
TO: Newt Gingrich
FROM:
Mr. Speaker,
First, I’d like to thank you for taking the time to read this letter. Also, I’d like to thank you for your 20+ years of service to The People of the Commonwealth of Pennsylvania, and The American People, writ large, as Speaker of the House of Representatives. While there is no doubt that you have more than paid your dues in service to this country, I sincerely hope that you will again, someday soon, answer the call of The People, and that I have an opportunity to support you with my vote. This nation is clearly in desperate need of strong leaders, and few are as tested and proven as yourself.
I’m writing you today to make you aware, if you are not already, of an egregious overreach of the duties assigned by The People, enumerated in The Constitution, to the executive branch of this government; an overreach that promises to kill thousands, if not millions of Americans, and destroy hundreds of thousands of well-paying jobs. This charge, you’ll see, if you allow the time to read this letter and the others that are surely coming your way, Mr. Speaker, is not an exaggeration.
On 5 May 2016, the FDA announced that it would be deeming all electronic cigarettes, and their constituent components, to be “tobacco products”, granting themselves regulatory control over these products, using the mandate given them by the congress under the FSPTCA (Family Smoking Prevention and Tobacco Control Act) of 2009. During the short news-cycle that this announcement garnered, it was reported that the new “deeming” regulation’s effect would be to enforce child-resistant packaging, and ingredient disclosure requirements, as well as “hold electronic cigarettes to the same standard as combustible tobacco products”.
If this were the sum-total effect of the new regulation, you would not be receiving this letter today. In fact, if it were simply a matter of child-resistant packaging, ingredient disclosures, and age-restrictions, the “vaping” (electronic cigarette using) community would be in near-universal support of these rules. In fact, all three of these requirements were voluntarily instituted by the industry several years ago. Rather, it is the ramifications NOT reported by the mainstream media, a general failure of the American media that I’m sure you’re all too familiar with, that promise to kill thousands to millions of Americans, and destroy hundreds of thousands of jobs.
What was not reported about the new regulation, and is key in the destruction of this industry, is what is required of the manufacturers of these products in order to secure approval to market their products. The FDA requires that the manufacturers complete a PMTA (Pre-Market Tobacco Product Application) for each of their products prior to being authorized to keep their products on the market after August 2018. The PMTA process is estimated, directly by the FDA, to cost anywhere from $300,000 to over $1,000,000 to complete, per product.
This PMTA process is required of every electronic cigarette product manufacturer, nearly all of which are small businesses, for each of their products, which number in the dozens to hundreds for each of these businesses. The net-result being that each of these small businesses will be required to pay anywhere from $3.6 to $100+ million in order to be allowed to stay in business, over the next 2 years. Of course, being an “application” process, there is no guarantee that any of the applications will be approved, with no monies being recovered by the entrepreneurs willing to take the risk required to be allowed to market their products. In fact, accounting for the hundreds of PMTA applications that have been submitted to the FDA since 2009 for safer tobacco products, only ONE application has been granted authorization.
As proof of the coming obliteration of this industry, a $3.7B market comprised of tens of thousands of small businesses employing hundreds of thousands of workers, Mitch Zeller, Director of the FDA’s Center for Tobacco Products and authority over these new regulations, has himself said that these regulations will kill over 99% of this industry, and that he cannot guarantee that ANY of PMTAs submitted by the industry will be approved. Also, the regulatory text does not spell out what the requirements of a successful PMTA entail, or even provide guidance on what might be expected of the applicant, so the industry is left to guess at what the FDA might consider a suitable product, while spending $300k-$1M per attempt at divining it.
While it is being represented as a fair and equal requirement applied to all makers of products deemed as being “tobacco products”, this peril is actually targeted exclusively at the electronic cigarette industry, and other safer alternatives, because of a grandfathering clause in the regulation. The regulation exempts all products marketed prior to 2007, so the actual tobacco products on the market, namely cigarettes and smokeless tobacco, do not have to attempt this expensive, arguably impossible process. Electronic cigarettes have their origin with a Chinese physician in the early 2000s, but the evolution of these products, from a curious novelty into a truly effective, safer alternative to traditional tobacco, has happened here on American soil over the last 4-5 years, through the hard work and ingenuity of American small businesses.
And, electronic cigarettes are truly that: an effective and safer alternative to traditional, combustible tobacco products. While there have been numerous studies that claim effects from electronic cigarettes that are equal to traditional cigarettes, in each case, these studies have been found to be intentionally biased, relying on improper, often destructive use of the products, in ways that no user would actually ever do. These studies were found to have financial backing from the big tobacco and big pharmaceutical companies who have a vested interest in crushing their electronic, vapor-based competitors.
The first independent, unbiased comprehensive study of these products was completed earlier this year by the UK’s Royal College of Physicians, titled Nicotine Without Smoke: Tobacco Harm Reduction. I highly recommend that you read as much of this study as your time will allow, to see for yourself what the the unbiased findings of electronic cigarette use are, but, to distill the study into as few words as possible; the RCP found that electronic cigarettes are at least 95% less harmful than traditional cigarettes, and the UK government’s voice of medicine and health-care actually recommends that physicians educate their patients who smoke about the harm-reduction offered by electronic cigarettes. The UK government has found that many, many lives can be saved by the promotion of electronic cigarette use over traditional cigarettes, yet our own government, promised to be of, for, and by The People, has somehow seen fit to destroy this effective harm-reduction by using the executive branch’s authority as a weapon to be wielded against The People, to the benefit of deep-pocketed lobbyists and big-government cronies.
We, the beneficiaries of electronic cigarettes’ harm-reduction potential, know well the good that they are capable of offering otherwise hopeless tobacco users. The countless stories of long-term smokers being finally able to quit smoking, after dozens of failed attempts using the FDA’s approved and favored cessation methods, namely ineffective patches, gums and lozenges, are easy to find with only minimal research, so I will not bore you with mine, or any of the thousands of other successful quitting testimonials that are out there to read.
I will, however, point out one rather high-profile case that I’m sure you have heard, even if you are not aware of it. Without a doubt, you have heard Rush Limbaugh refer to a news piece that he is “holding in (his) formerly nicotine-stained fingers”. Several years ago, Mr. Limbaugh successfully quit smoking though the use of an electronic cigarette product made by the small Hawaiian business “Volcano e-Cigs”. Seeing how quick and effective their product was as a cessation tool, he raved about the company’s wares for a year or more, everyday on his show. Now, years later, Mr. Limbaugh will still occasionally refer to a piece of paper he is holding in his “formerly nicotine-stained fingers” as a tribute to what Volcano e-Cigs was able to do to help him improve his health and quality of life.
There are millions of us now, Mr. Speaker, who are reaping the benefits offered by these innovative products; living better, and hopefully longer lives because of them. There are, however, tens of millions more who will never get to benefit from them, if this administration’s FDA is allowed to be wielded as a weapon to destroy this industry. These tens of millions, perhaps hundreds of millions or more, will live shorter, less healthy lives, because the most effective smoking cessation tool ever devised is being regulated out of existence in the interest of big tobacco, big pharmaceutical, and big government cronies.
We are in desperate need of a champion with a mature, intelligent, and respected voice to help us make the American People aware of the corrupt acts being perpetrated by this administration’s FDA, since our journalist corps has proven themselves not up to the task and uninterested in the truth. With an important election just months away, there are millions of voters who are watching their right to harm-reduction and a path away from smoking being destroyed, and they are unsure of who they can vote for that will help them defeat this peril. While a great many of us were disappointed to not see your name on this year’s ballot, we know that you project an influential voice of wisdom to those who are running to be one of the People’s representatives.
If you look closely, hidden among the din and flash of the season’s political messaging, you will see the phrases “A Billion Lives”, and “I Vape. I Vote.” plastered here and there. These are the voice of one of the millions of disenfranchised voters who realize that their right to a healthier life is threatened, and are intending to express their power through their vote. Unfortunately, as of yet, they have no champion to cast their vote for. I hope you can thoughtfully consider this issue, research it to your satisfaction, and help urge your party to become a force to save these lives.
Respectfully,
