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 indoor 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 teens.
- Important to promote use as widely as possible as a substitute for smoking.
- Passive exposure: no evidence of significant 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:
- Restricts Tobacco Marketing and Sales to Youth
- Requires Smokeless Tobacco Product Warning Labels
- Ensures “Modified Risk” Claims are Supported by Scientific Evidence
- Requires Disclosure of Ingredients in Tobacco Products
- Preserves State, Local, and Tribal Authority
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 publication: Vaping, 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.
