Is Mitch Zeller Struggling to Make the Right Decision?

Vaper’s Vortex

June 9, 2015

“We need a national debate on nicotine. The issue isn’t e-cigarettes, it’s nicotine.”


In light of the amount of controversy and the very high stakes, it is not difficult to imagine that FDA is struggling with finalizing their proposal. Mitch Zeller and other key players in FDA and HHS are likely weighing “pros” and “cons” at considerable length.

The final deeming regulations must be submitted to the Office of Management and Budget (OMB) prior to their publication in the Federal Register.

OMB review typically takes three to six months. Given the political pressure surrounding the e-cigarette debate, OMB may expedite their review. But FDA has not yet submitted their proposal to OMB. When they do, the submission (but not the content) will be public record. It’s possible we may not see the finalized regs until late summer.

Zeller has consistently shown not only his willingness but his commitment to considering the potential of vaping in the context of what he has labelled the “continuum of risk”. In a May interview with NY Times columnist Joe Nocera, Zeller is quoted as saying “I am fond of quoting Michael Russell” – the man many consider the father of “harm reduction”. It was Russell who first said “People smoke for the nicotine but die from the tar.”

In that same interview, Zeller is quoted:

“When nicotine is attached to smoke particles, it will kill. But if you take that same drug and put it in a patch, it is such a safe medicine that it doesn’t even require a doctor’s prescription.”

The following are some representative samples of the positions taken by various organizations and individuals who have weighed in on the debate. The considerable scientific research that has been published is not included. This is not intended as an editorial supporting one side or the other.

Zeller sees the potential benefit of a nicotine alternative. The question is how to reconcile that with the politics of public health. The answer will shape the future of vaping.


CON’S

Centers for Disease Control

“Use of e-cigarettes in youth doubled just in the past year, and many kids are starting out with e-cigarettes and then going on to smoke conventional cigarettes.”

“…condemning many kids to struggling with a lifelong addiction to nicotine.”

“…significant likelihood that a proportion of those who are using e-cigarettes will go on to use combustible cigarettes.”

“That this is happening, is alarming.”

“This is a really bad thing. This is another generation being hooked by the tobacco industry. It makes me angry.”

“Use of e-cigarettes in youth doubled just in the past year, and many kids are starting out with e-cigarettes and then going on to smoke conventional cigarettes.”

“…deeply alarming.”

University of California, San Francisco

“I frankly think the fault line will be gone in another year. The evidence will show their true colors.”

“While I suppose that he [Mitch Zeller] is doing this [keynote speaker at SFATA conference] as part of the FDA’s policy of “engaging stakeholders,” he and the FDA should reconsider his participation, since SFATA is actively trying to undermine the CDC’s Tips for Former Smokers campaign by posting an ad, which looks exactly like the Tips ads, except that it endorses e-cigarettes as a cessation device.”

“…contrary to glib assertions e-cigarette enthusiasts make that “it is the tar not the nicotine in cigarettes that kills people” they add to case that nicotine, while not the only dangerous thing in cigarettes, is nonetheless dangerous.”

“There’s no question that e-cigarettes are a gateway to smoking.”

Campaign for Tobacco Free Kids

“The news that cigarette smoking is at an all-time low is colored by the fact that we have seen the greatest explosion in the use of e-cigarettes that one could imagine.”

“How many more kids have to be addicted or poisoned by e-cigarettes before our government acts?”

American Lung Association

In 2009, the FDA conducted lab tests and found detectable levels of toxic cancer-causing chemicals, including an ingredient used in antifreeze, in two leading brands of e-cigarettes and 18 various cartridges. A 2014 study found that e-cigarettes with a higher voltage level have higher amounts of formaldehyde, a carcinogen. It is urgent for FDA to begin its regulatory oversight of e-cigarettes, which would require ingredient disclosure to FDA, warning labels and youth access restrictions.”

“We don’t know what’s in it. People are inhaling some vaporized compound into their lungs without really knowing what’s in it.”

“There’s no information about whether they’re safe or not and that’s part of the problem.”

“They are nicotine delivery devices intended to be used like a cigarette. What happens to someone who stops inhaling the tars of cigarettes and inhales only nicotine? We don’t know. There is at least the potential for harm.”

WHO

“The argument for e-cigarettes is that they don’t contain the toxic byproducts found in cigarettes, such as tar, and don’t produce smoke. But the fact is that there is very little research on ENDS and no convincing evidence that they are effective as a ‘quit smoking device.”

“It contains cancer-causing agents, such as formaldehyde, which in some brands reach concentrations close to that of some conventional cigarettes. They deliver nicotine, which we know is a potent vasoconstrictor that may contribute to cardiovascular disease.”

“While some evidence does show that e-cigarettes are likely to be less toxic than conventional cigarettes, it is not known how much less toxic they are. Until we have sufficient evidence to determine the extent of their health impacts, the industry must be regulated.”

American Cancer Society

There are questions about how safe it is to inhale some substances in the e-cigarette vapor into the lungs. And e-cigarettes are not labeled with their ingredients, so the user doesn’t know what’s in them.”

“Until electronic cigarettes are scientifically proven to be safe and effective, ACS will support the regulation of e-cigarettes and laws that treat them like all other tobacco products.”

“What they’re trying to do is carve out a new definition that will muddy the waters for many other tobacco products now, and new and emerging products that we don’t know about yet.”


PRO’S

Joe Nocera

“In fact, to take it a step further, it seems pretty obvious that the decline in cigarette smoking has largely been caused by the rising popularity of e-cigarettes.”

“In a conference call with reporters, Tom Frieden, the director of the C.D.C., couldn’t stop talking about how awful this was.”

“Yes, teens are better off if they never inhale nicotine. But equating smoking cigarettes with inhaling e-cigarettes, as the C.D.C. is doing in its messaging around teen tobacco use, is a huge disservice to public health.”

David Sweanor

Discussing the unprecedented drop in smoking rates – “What other huge interventions have there been? It’s not like there has been a big new cigarette tax, or tough new package warnings. The only thing that is new is the introduction of e-cigarettes.”

Michael Siegel

“How can the CDC possibly claim that a youth smoker switching completely to e-cigarette use is not a good thing?”

The CDC “is misleading the public not only through its outright lies, dishonesty, and deception about e-cigarettes, but also by its failure to ask the right questions to actually test its pre-determined conclusions.”

“If we make it too hard for this experiment to continue, we’ve wasted an opportunity that could eventually save millions of lives.”

“These products are not acting as a gateway to smoking among youth, they are not particularly addictive among youth, and they may even be serving as a deterrent to youth who might otherwise become addicted to cigarette smoking.”

Jacob Sullum

“Although tobacco companies have begun to enter the e-cigarette business in recent years, the two industries are hardly synonymous. Leaving aside the question of ownership, e-cigarettes do not burn and contain no tobacco, which is why they are so much safer than traditional cigarettes. It is more than a little misleading to classify them as tobacco products.”

“That makes as much sense as counting nicotine gum or patches (which also contain nicotine derived from tobacco) as tobacco products.”

“Rather than admit they were wrong to claim that e-cigarettes are a “gateway” to the conventional kind, opponents of vaping have escalated their prevarications by implying, in defiance of all scientific evidence, that there is no important difference between the two kinds of nicotine delivery devices.”

Clive Bates

Prior to the emergence of e-cigarettes, the alternatives were broadly cast as ‘quit or die’ – this new value proposition fits between the two. It is likely to be successful, because it requires less effort to reduce the harm – i.e. it does not require complete nicotine cessation. Expert views suggest a health risk of at least 95% or 20 times lower than smoking.”

If vaping came close to overtaking cigarette use, it would be one of the most remarkable disruptive public health technologies of modern times.”

However, vaping does not need to be harmless or completely safe to make deep inroads into the risks of disease if people switch from smoking.”

“The aim should be to achieve a ‘sweet spot’ of regulatory intervention that builds confidence among consumers and removes cowboys and rogue products from the market, but does not impose costs, burdens and restrictions that crush the smaller players, radically change the products available and obstruct innovation.

“The optimum regulatory regime would strike a subtle balance between protecting users, non-users, bystanders and limiting the risks of harmful unintended consequences.”


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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 dave@diyels.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.

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