June 16, 2015
“This means that vapor business owners and interested parties still have an opportunity to submit comments in an effort to assist the FDA in understanding the role that e-cigs and vapor products play.”
SFATA made a post on Reddit late yesterday advising everyone that the FDA has extended to July 2, 2015 the comment period for submission of written comments in response to FDA’s Electronic Cigarettes and the Public Health Workshops (Public Docket No. FDA-2014-N-1936).
As of this writing, the FDA site is showing they have received 1,463 comments. I almost did not take the time to post a comment. But the lead quote here taken from SFATA’s post kept going through my mind: “… an effort to assist the FDA in understanding the role that e-cigs and vapor products play.”
Mitch Zeller will not see my comment. Best case scenario, he will see a tally sheet summarizing key points raised in comments along with an indication of how many comments were received for each key point. Still, there is a sense of satisfaction in adding my thoughts and concerns to those of others. This is what I said.
Smoking combustible tobacco products is the number one cause of preventable death and disease in the world. The primary goal of public health should be the reduction of preventable death and disease. The response of public health organizations to electronic cigarettes:
- Ignores science in favor of ideology.
- Fails to offer a single alternative that even remotely approaches the harm reduction potential of electronic cigarettes, for reducing the death of 480,000 Americans every year.
- Has been accurately summarized – “Quit or die.”
Electronic Cigarettes are Not Harmless
“Harmless” is a ridiculous, irrational standard that cannot be met by tens of thousands of consumer products found in households across the nation.
People are dying. Every day. Public health’s message? Nothing can be done. We don’t have a “harmless” alternative. We know millions will die while we pursue “harmless”. Our hands are tied. Safer? Not good enough. Dramatically safer. Not good enough. 95% safer. Not good enough. All or nothing. Quit or die.
I respectfully submit to public health, the FDA and to the American people – this position is irresponsible, unrealistic, unjustified, and inexcusable. This position arbitrarily condemns millions to a premature death. For what?
Electronic Cigarettes are Not a Smoking Cessation Alternative
- 2014 Monitoring the Future Survey – E-cigarette use by youth surpasses cigarette smoking. Smoking drops to the lowest level ever recorded in the forty year history of the MTF survey. Year over year decline in smoking is the largest drop ever recorded in MTF.
- 2014 National Youth Tobacco Survey – E-cigarette use by youth triples in one year. Smoking rates by youth are the lowest ever recorded.
- May 2015 – The U.K. Action on Smoking and Health announces that electronic cigarette smokers increased from 2.1 million in 2013 to 2.6 million in 2014. An increase of 24% in one year. Deborah Arnott, chief executive of ASH: “The number of ex-smokers who are staying off tobacco by using electronic cigarettes is growing, showing just what value they can have.”
- June 2015 – N.Y. Gov. Cuomo announces: “With the lowest smoking rate in recorded history, it’s clear that New York State is becoming healthier than ever.”
- June 2015 – A Reuters/Ipsos poll shows that 10% of U.S. adults now vape. That represents a quadrupling of American vapers in just over a year – from 2.6% in 2013 to 10% today.
Electronic cigarettes are not a smoking cessation alternative. But millions of former smokers all over the world don’t seem to understand that. As vaping goes up, smoking goes not just down, but down to levels with no historical precedence.
Electronic cigarettes are not a smoking cessation alternative because U.S. law would require that they be regulated under the Food, Drug and Cosmetic Act. The FDA estimate of the cost of new product qualification under FDC – 5,000 man hours and $300,000 per individual product.
We Must Protect Our Children
There is absolutely no doubt in anyone’s mind – we must protect our children. We have been attempting to protect our children for years and years. We cannot and we will not ever stop trying to protect our children.
For the first time in decades, a new product, a safer product, has surpassed youth use of combustible tobacco cigarettes. The deadliest consumer product ever created. What possible line of reasoning can conclude that this is anything but a victory for our youth? A victory for our efforts? A victory for public health?
No one is suggesting that we abandon our goal of total abstinence from the use of any nicotine product by youth. Just as no one is suggesting that we have a viable plan for accomplishing that goal. At least not yet.
What we have is a clear alternative. An option for reducing the harm caused by cigarette smoking. A major step in the direction of protecting our youth. How can we possibly ignore that alternative? How will we justify our actions to this generation 20, 30 or 40 years from now? What will we tell them? Electronic cigarettes are not “harmless”? In the interest of public health, quit or die? We meant well?
Harm reduction is not a “theory”. Harm reduction is not even new. Public health experts have accepted the immeasurable value of harm reduction for many things. Needle exchange. Methadone for heroin addicts. Vaccinations. Condoms. Seat belts.
But when it comes to nicotine addiction – “Quit or die.”
Harm reduction is not about money. It’s not about politics. It’s not a crusade. Harm reduction is about science. Electronic cigarettes are an unprecedented opportunity. An opportunity for public health to again demonstrate their understanding of the necessity to weigh potential risks against potential benefits.
I call on the FDA and public health to seize this opportunity. Based on science. In the interest of public health. In the interest of doing the right thing. But most of all, in the interest of saving lives.
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Dave Coggin has a Master’s Degree in business and spent 35 years in corporate America. He is a co-founder and partner in DIYELS. He has spent the last five years actively researching and following the evolution of the e-cigarette industry. He is a strong proponent of e-cigarettes as the most promising option currently known for tobacco harm reduction. He may be contacted directly at email@example.com .
The opinions presented here are exclusively those of the author. Vaper’s Vortex is offered as a service to our customers and followers. Anyone considering e-cigarettes as an alternative to tobacco cigarettes should seek qualified advice from a medical professional.