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The FDA’s War on E-cigarettes (cont.)

BY LAURA CONZO BRADY
Editor, eCigs HQ

The FDA's War on E-cigarettes, FDA Commissioner Margaret Hamburg illustration.

March of the Wooden Soldiers or The Nutcracker ? Who’s really calling the shots
on e-cigarettes? FDA Commissioner,
Margaret Hamburg.

Continued from previous page.

In the US

When e-cigarettes first became widely available in the US, they quickly caught the public’s imagination. With an ever-growing litany of diseases and conditions being blamed on conventional tobacco use, fewer and fewer venues permitting smoking and a growing public distaste for smoking, any workable alternative was likely to be well-received.

Just like their inventor, many US consumers see e-cigarettes as a means to wean themselves off their tobacco addiction. Nicotine gums and patches, once touted as the ideal solution for those looking to stop smoking, have proven largely ineffective, partly because they don’t offer a replacement for the physical act of smoking. 7 Nicotine inhalers (essentially a mouthpiece that attaches to a plastic nicotine cartridge) have produced a success rate of only 11-13% at 12 months compared to 5–10% for placebo test subjects. 8 While inhalers may be helpful in reducing nicotine withdrawal symptoms, they do not create a convincing “smoking” experience, and are therefore of little assistance in overcoming the psychological aspects of tobacco addiction.

For these and other reasons, e-cigarettes, while not commanding the same kind of market share as conventional tobacco products, have enjoyed increasing popularity with more than 1 million current users. 9

Controversy

In July 2009, the US Food and Drug Administration held a press conference to address the growing use of e-cigarettes. The agency made much of “carcinogens” and “toxins” claimed to have been found in the liquid used to create the vapor; and that cartridges advertised as nicotine-free have been found to contain nicotine in some cases. 10 The FDA also emphasized the untested nature of the new devices and complained that e-cigarettes constitute a “nicotine delivery system.” Based on such criticisms, the FDA sought to restrict the import and sale of e-cigarettes from China, where most are manufactured.

These moves met with resistance from both e-cigarette users and those who saw the FDA’s stance as being at odds with good science. While traces of some toxic materials have indeed been found in some cartridges, it is pointed out that levels have been low. The issue could be resolved by the introduction and enforcement of smoke cartridge regulations. 11

Many of the FDA’s criticisms have related to the use of propylene glycol for the “smoke juice.” Although propylene glycol can, under certain circumstances and in certain dosages, exhibit carcinogenic properties, it’s not at all clear that the amounts inhaled by an e-cigarette user would be great enough to pose any serious cancer risk. Furthermore, propylene glycol is a very widely used chemical that is employed in many day-to-day products, from cosmetics and toiletries to paints and detergents. 12

E-cigarettes, having been introduced relatively recently, can be described as an untested product. One can’t prove a negative; therefore it would be counter-rational to completely discount the possibility of negative health effects relating to e-cigarette use appearing sometime in the future. That said, the alternative to e-cigarettes for many people isn’t nothing — it’s conventional cigarettes, one of the single most dangerous products one can buy. Compared to the very real dangers associated with tobacco use, the far more nebulous and unproven risks that theoretically might arise from e-cigarette use seem negligible.

The FDA blocked the importation of e-cigarettes in 2009. Two manufacturers then brought a successful lawsuit against the agency. In 2010, the resulting judgment ordered the FDA to lift its ban until it produces more convincing evidence that e-cigarettes are harmful. 13

Studies

…however, evidence is mounting to support the use of e-cigarettes, while evidence against their use remains in short supply…”

Laura Conzo Brady
eCigs HQ Editor

One major criticism raised by proponents of e-cigarettes is that the study relied upon by the FDA as their evidence for the dangers of the new devices is limited and flawed. The study, conducted in 2009, involved the analysis of only 19 types of cartridges and just two e-cigarette brands. Additionally, the FDA study did not examine the effects of e-cigarettes on human subjects 14 but was limited to a chemical analysis of the “smoke juice” used in them.

While a single cartridge was found to contain traces of the toxin diethlyene glycol, it is not clear that this represented a widespread hazard. The trace presence of nitrosamines (cancer-causing substances found in tobacco) is likewise not necessarily an indicator of a dangerous product. 15

Later and more wide-ranging studies have appeared to contradict the FDA’s position, finding no more than trace amounts of toxins (comparable to amounts found in FDA-approved nicotine patches and inhalers), or no toxins whatsoever.16, 17, 18, 19 While some negative impact on lung function has been demonstrated in the 10 minutes following the use of an e-cigarette, it’s not clear that how long these effects last or whether there is cause for concern in the long-term. Notably, COPD and asthma sufferers showed no reduction in lung function from using e-cigarettes. 20 Other studies have shown no impact on heart health, 21 and have even demonstrated the benefits of nicotine-infused “smoke juice” which included enhanced concentration abilities and improved memory function. 22 Further, concerns over “secondary smoke” effects related to e-cigarettes vapor have proven groundless. 23

It is also clear from studies into smokers’ behavior that switching from conventional cigarettes to e-cigarettes is a viable tactic for many. Even heavy smokers can successfully transition from one to the other, potentially reducing the harm they experience from their tobacco addiction while they work on cutting down for good. 24

In making its distorted, incomplete and misleading statement, FDA was violating its long-cherished tradition of sticking to sound science as the basis for its policies. And in doing so, it is putting the lives and health of millions of Americans at risk. 25

Dr. Elizabeth Whelan

President
The American Council on Science and Health

Conclusion

The electronic cigarette debate is far from over; however, evidence is mounting to support the use of e-cigarettes,26, 27 while evidence against their use remains in short supply. 28 It may only be a matter of time before the FDA is forced to embrace e-cigarettes as a healthier alternative to tobacco products and a crucial part of tobacco-harm-reduction strategies that hold the potential to save millions of lives.

References

 1. Gilbert Ross, M.D. “The Deadly Crusade Against E-cigarettes,” The American (American.com, 11/15/2012).
 2. Joshua Holland. “E-cigarettes: Holy Grail for Addicted Smokers?,” The State Journal, Frankfort, Kentucky (State-Journal.com, 1/7/2011).
 3. Michael Siegel. “Smoke Screen” The Baltimore Sun (BaltimoreSun.com, 6/9/2009).
 4. Health New Zealand. The Ruyan e-cigarette Health New Zealand Ltd Information Sheet (HealthNZ.co.nz, 2007).
 5. Wiki Patents. A Non-Smokable Electronic Spray Cigarette (WikiPatents.com, 2007).
 6. Dr. Elizabeth Whelan, M.D. “FDA smoke screen on e-cigarettes” The Washington Times (WashingtonTimes.com, 8/6/2009).
 7. Gilbert Ross, M.D. “The Deadly Crusade Against E-cigarettes,” The American (American.com, 11/15/2012).
 8. Pfizer. Nicotrol® Inhaler (LAB-0345-3.0) (Pfizer.com, 12/2008).
 9. Dr. Elizabeth Whelan, M.D. “FDA smoke screen on e-cigarettes” The Washington Times (WashingtonTimes.com, 8/6/2009).
10. Melissa Vonder Harr. “Irresponsible E-Cigarette Advice From The Department Of Health?” (CSPNet.com, 11/20/2012).
11. Brad Rodu. “The scientific foundation for tobacco harm reduction, 2006-2011” Harm Reduction Journal (HarmReductionJournal.com, 8/19/2011).
12. PO/PG sector group of Cefic, Brussels. What is propylene glycol? (propylene-glycol.com, last accessed 11/22/2012).
13. Duff Wilson. “Judge Orders FDA to Stop Blocking Imports of E-Cigarettes From China” The New York Times (NYTimes.com, 1/14/2010).
14. U.S. Food and Drug Administration. E-Cigarettes: Questions and Answers (FDA.gov, 9/9/2010).
15. Katie Zezima. “Analysis Finds Toxic Substances in Electronic Cigarettes” The New York Times (NYTimes.com, 7/22/2009).
16. McCauley TR et al, US National Library of Medicine, National Institutes of Health. Comparison of the effects of e-cigarette vapor and cigarette smoke on indoor air quality (NCBI.NLM.NIH.gov, 10/24/2012).
17. Murray Laugesen, MBChB FNZCPHM, Health New Zealand Ltd. and Society for Research on Nicotine and Tobacco, Dublin Ruyan E-cigarette Bench-top tests (HealthNZ.co.nz, 4/3/2009).
18. Zachary Cahn and Michael Siegel. “Electronic cigarettes as a harm reduction strategy for tobacco control: A step forward or a repeat of past mistakes?” Journal of Public Health Policy (Palgrave-Journals.com, 12/10/2010).
19. Chris Bullen et al., The University of Auckland, Faculty of Medical and Health Sciences. Effect of an E-Cigarette on Cravings and Withdrawal, Acceptability and Nicotine Delivery: Randomised Cross-Over Trial (HealthNZ.co.nz, 4/9/2009).
20. Science Daily. “E-Cigarettes Can Damage the Lungs, Experts Warn” (ScienceDaily.com, 9/2/2012).
21. Science Daily. “Electronic Cigarettes Do Not Damage the Heart, Study Suggests” (ScienceDaily.com, 8/25/2012).
22. Science Daily. “Electronic Cigarettes May Help Smokers’ Memory While They Kick the Habit” (ScienceDaily.com, 4/16/2012).
23. McCauley TR et al, US National Library of Medicine, National Institutes of Health. Comparison of the effects of e-cigarette vapor and cigarette smoke on indoor air quality (NCBI.NLM.NIH.gov, 10/24/2012).
24. Michael B. Siegel, MD, MPH, Kerry L. Tanwar, BA and Kathleen S. Wood, MPH. “Electronic Cigarettes As a Smoking-Cessation Tool,” American Journal of Preventive Medicine (AJPMOnline.org, April 2011).
25. Dr. Elizabeth Whelan, M.D. “FDA smoke screen on e-cigarettes” The Washington Times (WashingtonTimes.com, 8/6/2009).
26. Science Daily. “Some Smokers Successfully Switch to Electronic Cigarettes” (ScienceDaily.com, 9/15/2012).
27. J. Foulds, S. Veldheer, and A. Berg. “Electronic cigarettes (e-cigs): views of aficionados and clinical/public health perspectives” The International Journal of Clinical Practice (Wiley.com, 8/1/2011).
28. B.J. Westenberger, Deputy Director, CDER/OPS/OTR, Division of Pharmaceutical Analysis. “Evaluation of e-cigarettes” (FDA.gov, 5/9/2009).


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