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By Nancy Thorner – 

Vaping: How Government Regulation Can Kill Innovation was the topic of The Heartland Institute’s continuing series of Wednesday evening events that are available free to the public. Featured speakers were Dr. Brad Rodu of the University of Louisville and Pamela Gorman of Smoke-Free Alternative Trade Association (SFATA). They discussed vaping from a scientific and industry perspective. 

Dr. Rodu is a professor of medicine at the University of Louisville, where he is a member of the James Graham Brown Cancer Center and holds an endowed chair in tobacco harm reduction research.  He is also a senior fellow at The Heartland Institute.  For the past two decades Dr. Rodu has been in the forefront of research and policy development regarding tobacco harm reduction.

Pamela Gorman is executive director of SFATA, the largest trade group representing and protecting the interests of the vapor industry. She has worked in the vaping and tobacco industries for nearly a dozen years. As an elected official in Arizona, Ms. Gorman served terms in both the state House and Senate.

What are E-cigarettes?

E-cigarettes are becoming an increasingly popular alternative to traditional combustible cigarettes.  Many countries around the world (such as England) are recommending these vapor products as a tobacco harm reduction solution, while the United States government and local authorities have been trying to regulate these products out of existence. 

Health professionals have long known that the smoke created by combustible cigarettes, rather that the nicotine, is what makes smoking harmful.  Smokeless tobacco and e-cigarettes provide a much safer and healthier alternative delivery system for nicotine.  

Dr. Brad Rodu introduced by Jim Lakely, Director of Communication at The Heartland Institute

A slide presentation was used to address the following issues:

1.  Poison reports by the American Association of Poison control Centers in 2015, showed that out of 547,286 reported exposures submitted, E-cigarettes came in very last at 0.5%.  At the high end were Cosmetics and personal care products (26%) and Household cleaners (21%).  

2.  Claims about E-cigarettes are exaggerated, such as, they are not loaded with toxins; they are not poisoning our children; they are not a gateway to teen smoking; they do help smokers quit; and indooteens.

  • Important to promote use as widely as possible as a substitute for smoking.
  • Passive exposure:  no evidence of signifir bans are not necessary. 

    3.  E-cigarette vapor contain nicotine, at various levels or none; water; propylene glycol and /or vegetable glycerin (both are in many consumer products and are FDA approved).  Propylene glycol is used to create artificial fog in theaters, concerts.

    4.  Nicotine and Caffeine are both addictive, but they can be used safely.  Both enhance concentration, performance levels, provide a sense of well-being and elevate mood.  Neither cause intoxication, nor are they not linked to any major disease.  We consume caffeine in coffee, tea and cola drinks.  Nicotine is delivered through smoking cigarettes and E-cigarettes, but it is the smoke created by combustible cigarettes smoking, not the nicotine that is dangerous.

    5. Medication to rid addition to combustible cigarettes provides only a temporary bridge to abstinence; it’s expensive; the very low dose of the medication is unsatisfying for smokers; there is only a 5% success.

    6.  The British are more informed than Americans about the use of E-cigarettes, which has led to a differing treatment of E-Cigarettes in the US.   The FDA, CDC, and the NIH all claim:

  • No evidence that e-cigs help smokers quit.
  • No evidence that e-cigs are less hazardous than cigarettes.
  • E-cigs might renormalize smoking and make it e a gateway to smoking among teens.
  • Only safe, effective methods should be used or quitting smoking.
  • E-cigs to be regulated exactly as cigarettes.

7.  The Royal College of Physicians & Public Health in England in 2015 found the following: 

  • Effective as aid to quit smoking.
  • E-cigs are not renormalizing smoking or serving as a gateway to smoking among
  • cant harm to bystanders. 

Pamela Gorman kicked the smoking habit with E-cigs

Once a smoker herself, Ms. Gorman’s used E-cigarettes to quit smoking.  She is now fighting for the free market principles in the vaping industry.  Like Pamela Gorman, nine million individuals have chosen to put down combustible cigarettes and instead use E-cigarettes.  Gorman put aside cigarettes in 2013, never picked one up again, and would find turning back distasteful.  

It was on June 22, 2009 when the Family Smoking Prevention and Tobacco Control Act (Tobacco Control Act) was signed into law.  It granted the FDA authority to regulate the manufacture, distribution, and marketing of tobacco products, as a way to protect the public and create a healthier future for all Americans. 

Restrictions created by the Tobacco Control Act:

The Tobacco Control Act does not:

The law makes clear that FDA’s role is to regulate and protect the public health, but it places a few restrictions on FDA’s powers. FDA cannot:

  • Require prescriptions to purchase tobacco products.
  • Require the reduction of nicotine yields to zero.
  • Ban face-to-face sales in a particular category of retail outlets.
  • Ban certain classes of tobacco products.

The Deeming Rule 

A big blow came to the vaping industry when almost overnight action taken by the Food and Drug Administration on 04/25/2014, to be made effective August 8, 2016, classified E-cigarettes in the same category as cigarettes (a combustible product) to be regulated like a tobacco product.  Called the Deeming Rule”, overnight E-cigarettes became tobacco rolled in paper.  The Facts on the FDA’s New Tobacco Rule.

According to Ms. Gorman, the vaping industry has a lease on life until August 8, 2018, when the FDA will prohibit 99.9%+ of vapor products on the market,” then all will go dark unless something is done. The new regulations are of concern for the e-cigarette industry, as approval of products offered will cost small companies millions of dollars that they cannot afford. 

If the FDA’s current approach is implemented, producers would be required to remove every single product from the market and submit expensive and burdensome applications for the chance to allow their products to stay on the market after the August 8, 2018 date.  There are 3,200 separate products and each one must go through separate testing that could cost $300,000 per application.  Then too, some of the studies required could take as long as 8 years. The Smoke-Free Alternatives Trade Association says the average vape shop makes $26,000 in monthly sales, which doesn’t leave a lot of room for new costs to be incurred.

As to the effectiveness of E-cigarettes, a report published on the National Center for Biotechnology Information’s website showed that vaping has helped decreased the smoking rates among 21 to 35 year-olds. 

Help solicited from public

Federal level: A new bill (HR 1136) has been introduced by Reps. Tom Cole (R-OK) and Sanford Bishop (D-GA) that would change the predicate date in the FDA’s deeming regulations. The legislation is called the FDA Deeming Authority Clarification Act of 2017.  Changing the predicate date will not prevent the FDA from having approval authority over products introduced after the new predicate date, but it allows all current products to remain on the market without applying for marketing approval. Existing products will still have to meet safety and marketing standards imposed by the agency.  Co-sponsors are needed

Join  CASAA.org (Consumer Advocates for Smokefree Alternatives Association).

Heartland publicationVaping, E-Cigarettes, and Public Policy Toward Alternatives to Smoking by Brad Rodu, DDS; Matthew Glans, and Lindsey Stroud.  Pdf download available. 

The Smoking Status quo is unacceptable.  Although the American anti-smoking campaign is 51 years old, according to the CDC there are 39 million smokers in the U.S., with 480,000 deaths every year in the U.S.

If the status quo continues, in the next 20 years 9.6 million Americans will die from smoking.  All will be adults over 35 years of age.  None of them are now children. 

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Friday, April 29, 2016

Thorner: Heartland Institute Panel: Vaping as a Public Policy ‘War’ – Part 2

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By Nancy Thorner –  

Public Health England last in August of 2015 became the first national government agency to endorse e-cigarettes as safer options for current smokers. Its report also dispelled several bogus anti-tobacco claims.  Why is it that e-Cigarettes are seen as life-savers by the UK Government, but condemned by the US?  Find out why by checking this recent article of Wednesday, April 13, 2016.

Brian Foitik, guest speaker at The Heartland Institute’s event about “The Vaping War” on Wednesday, April 20 (see Part 1), linked the “war” on vaping to a happening 52 years ago when the Surgeon General recognized tobacco as a health issue, where upon tobacco was taxed at all levels of government.  It was easy to levy a tax on tobacco because of the limited of individuals who smoked at the time.  Nevertheless, even after a 52-year campaign of educating the public about smoking and related health issues through word-of-mouth, negative advertising, and marketing restrictions, there are still 40+ million smokers in this nation.  450,000 will die every years from tobacco-related illnesses.  Although 70% of smokers want to quit; a majority have tried to quit but weren’t successful.

Even though many e-cigarette smokers begin vaping to wean themselves off tobacco products, why do e-cigarette smokers reap the same hatred from the non-smoking public as those who smoke tobacco cigarettes?   Might it be because people are taught not only to hate cigarettes, but also to hate the one who smokes them?  For these individuals a cigarette is a cigarette.  It matters not that one is a tobacco product and the other a vapor product that is not comparable to the thousands of toxic agents formed when tobacco is burned.

Vaping as a Consumer-Driven Business

As more and more individuals desire a product that is a safe and effective smoking cessation aid, the number of consumer driven vapor shops are growing proportionally.  There are 15,000 vapor shops.  All are new businesses; people are employed and property taxes are paid.  When there are people who want something, products are offered as a solution to the problem.  This is the free market at work.  Regulations and taxes only inhibit innovation in a free market system.

Pharmaceutical companies are able to come up with new products to help people stop smoking, but each new product must receive FDA approval, which requires an expensive and lengthy process to be able to market and sell a new product. Pharmaceutical companies do get a break from taxes.  As a result of ill-conceived tax breaks, the pharmaceutical industry pays just 5.6 percent of its profits in taxes.  After one product doesn’t work, repeat customers can be drawn back when a new cessation of smoking product is developed.  In contrast, the vaping community could ill afford, with its limited resources, to have each vaping product approved by the FDA.  Even a different vaping flavor would require new FDA approval at a great cost and with considerable approval time.

The vaping industry enjoyed a bit of a victory in a report dated April 14, 2016, when the House appropriations committee voted to approve an amendment to the FY 2017 Agricultural Appropriations bill that would change the predicate date for newly deemed tobacco products. Products on the market since 2007 would not have to retroactively go through the PMTA process.  As such vaping products would not be considered tobacco products. The bipartisan amendment by Rep. Tom Cole (R – OK) and Rep. Sanford Bishop (D – GA) passed by a 31-19 vote.

Victoria Vasconcello, former long-time smoker and owner of Cignot Inc.

As already noted in Part 1, Ms. Vasconcello, as a former long-time smoker, has been in the vaping business since 2009.  She considers vaping as a consumer-driven solution to a problem; however, government is seeking to balance budgets by putting lives in jeopardy.  Victoria Vasconcello graciously relinquished most of her allotted speaking time, noting that Brian Fojtik had covered the vaping topic so thoroughly in his prior comments, likewise expressing that she wanted there to be ample time for a productive Question and Answer session.

In response to one of the question from the audience (questions were also submitted by those watching the live on-stream presentation) “What can the little guy do to have a presence in CASAA (Consumer Advocates for Smoke-free Alternates)?” Ms. Vasconcello suggested joining the 135,000 member CASAA group and meeting with local legislators.  The science is out there to support the use of e-cigarettes.  Help legislators know what the science is.  Genuine fear develops from not knowing the truth.  Finally long time smokers have found something that helps them, and they are standing up and fighting with truth on their side.  Consumers do have power!

Concluding Thoughts

Support for the vaping community can be broadened by minimizing the arguments of center left groups.  Unfortunately, PR hasn’t been on the side of e-cigarettes to enable them to become mainstream, unlike in England where the government backs e-cigarettes for smokers.  There is limited money in the vaping community to get out the truth. This results in most of the studies being done by those who hold a con e-cigarette agenda.  The minds of the American people must be changed.  A New Poll Finds Americans’ Risk Perception of Vaping is All Wrong.  The vaping community just wants to compete!

As government is addicted to the money it receives from tobacco products, and this money is decreasing as smoking decreases, there are attempts being made to tax e-cigarettes to keep coffers filled. The good news is that there have been 500 pieces of legislation enacted which attempt to tax and restrict e-cigarette use, but only a few of them have passed.  It is ironic, however, that the Omnibus Bill Will Protect Cigarette Markets & Harm Public Health.  Letters to the Editor are a good way to educate the public about e-cigarettes.

Below are three articles that show how Chicago is dealing with e-cigarettes.  The e-cigarette tax referred to in the first article went into effect on January 1, 2016.

Chicago’s Deadly E-Cigarette Tax Takes Effect Tomorrow

Chicago Vaping Tax is About Cigarette Tax Dollars, Not Health

Rahm Emanuel’s E-Cig Tax Will Kill Smokers & Small Businesses

Following are additional note-worthy e-cigarette articles:

1.  Articles by Brad Radu, Heartland’s Senior Fellow who holds the Endowed Chair in Tobacco Harm Reduction Research at the University of Louisville.

2.  “Wall Street Journal” article published Monday, April 11, 2016.

In the article “Are E-Cigarettes a Healthy Way to Quit Smoking?”, both the pro and the con sides were presented.  Even though e-cigarette sales have been growing, they remain dwarfed by the $100 billion tobacco market. 

Jim Lakely, Communications Director at The Heartland Institute, served as moderator, describing The Heartland Institute as a free market think tank that fights for policies that increase freedom and liberty and promotes the free market.  Covering only domestic policies, Heartland is one of few think tanks that stands up for the rights of the smoker.

An announcement was made by Jim Lakely to join Heartland for the Grand Opening of the largest freedom library in Chicagoland. The Michael Parry Mazur Library, named after an economist who passed away in 1987 by his family in Mazur’s honor, is a rapidly growing research library containing an excellent collection of works on economics, history, political science, public policy, and related topics. The public is invited to attend on Wednesday, May 4, from 4:00 pm to 6:00 p.m. at Heartland headquarters, 3939 N. Wilke Road, Arlington Heights, Illinois 60004. Registration is free. See map: Google Maps.  Check this link for free registration for the event. 


 

Thursday, April 28, 2016