Not sure if this has been posted but wanted to share a recent article about e-cigs.
E-cigs debate takes turn: Expert says they may pose less risk than cigarettes
Richard Craver/Winston-Salem Journal
The debate about the potential societal benefit of electronic cigarettes has taken an interesting turn with a former Food and Drug Administration advisor saying they “likely pose” a reduced-risk option to traditional cigarettes.
Dr. Neal Benowitz, who served on the FDA’s Tobacco Products Scientific advisory committee, co-authored a July 15 report on e-cigs posted on the Journal of the American Medical Association’s website.
E-cigs are battery-powered devices that heat a liquid nicotine solution in a disposable cartridge and create a vapor that is inhaled.
Bonnie Herzog, an analyst with Wells Fargo Securities, projected $2 billion in retail sales for e-cigs this year and to exceed $10 billion in annual sales by 2017.
Benowitz said e-cigs “likely pose less direct hazard to the individual smoker than tobacco cigarettes and might help smokers quit smoking or reduce harm by smoking fewer tobacco cigarettes.”
“On the other hand, there are potential harms, including promoting continued smoking of cigarettes and renormalizing cigarette smoking behaviors.”
Benowitz’s acknowledgement of the potential public-health benefit of e-cigs is noteworthy considering he is serving on a Pfizer smoking cessation medication advisory board, and has been a consultant to two other pharmaceutical companies. Analysts have said e-cigs, particularly those made by large tobacco manufacturers, could prove stiff competition for the pharmaceutical nicotine-replacement therapy products if given FDA approval.
The FDA was given oversight of the tobacco industry by Congress in 2009, but it cannot ban nicotine or tobacco. It said in 2011 it would determine whether to regulate e-cigs as a tobacco product.
The FDA’s Center for Tobacco Products is charged with evaluating applications for new “modified risk” tobacco products. Products that could fit in that category include R.J. Reynolds Tobacco Co.’s Camel dissolvable orbs, film strips and sticks, the Zonnic nicotine-replacement therapy (NRT) product and the Vuse vapor cigarette.
A company that wants to market a lower-risk tobacco product in the United States must offer scientific proof to the FDA that the marketing of the product will not only reduce harm to individual users, but also benefit the health of the population as a whole.
In April, the FDA said it is no longer putting limits on how long someone trying to quit smoking can use a nicotine-replacement therapy product, such as gum or a patch. The agency said it is removing warnings, as well as limitations in directions, to allow flexibility in how the products are used and for how long.
“Currently available NRT products are not as satisfying and are less acceptable to smokers compared with inhaling and absorbing nicotine from cigarette smoke,” Benowitz said. “The possibility of an inhaled clean-nicotine device has been discussed by health researchers for many years as a potentially more effective way to promote smoking cessation.
“Although not yet proven safe or effective for smoking cessation, the e-cigarette has been positioned as such an inhaled nicotine delivery device and has gained popularity through this perception.”
Benowitz said there are more than 250 e-cig brands in the marketplace.
“Different e-cigarette brands are engineered differently, affecting the character and potential toxicity of the vapor,” he said. “Thus, it is difficult to generalize about e-cigarettes as a single device.”
A regulatory challenge, in the United States and in Europe, has been how to regulate e-cigs – as a medication or a tobacco product. If the FDA determines e-cigs can be helpful in smoking cessation, they could be regulated both ways.
Benowitz said dual regulation for e-cigs makes little practical sense. “A comprehensive regulatory approach to nicotine-containing products is needed,” he said.
The reaction to Benowitz’ report was mixed, with many analysts saying he either went too far or not far enough in evaluating the potential public-health aspects of e-cigs.
“It is good to see Benowitz join the growing number of academicians and scientists who acknowledge the obvious harm-reduction benefits of e-cigarettes and recognize that pharmaceutical-style regulation would stifle critical innovation,” said Carl Phillips, scientific director of the Consumer Advocates for Smoke-free Alternatives Association.
“Unfortunately, they stop short of acknowledging that the innovation matters because people like using e-cigarettes, and innovation contributes to this benefit in addition to improving the safety of the product.”
John Spangler, a professor of family and community medicine at Wake Forest School of Medicine, supports developing and marketing products that lessen exposure to tobacco, including e-cigs if they can be proven scientifically to play that role.
However, he said he is concerned about how e-cigs are being advertised.
“E-cigs might normalize or glamorize smoking because e-cigs look like regular cigarettes, and people will see others/celebrities ‘smoking’ them,” Spangler said.
“It might increase nicotine addiction and decrease cessation – act as a bridge product until a smoker can get to a place where combustible smoking is allowed.”
Brad Rodu, a professor of medicine at the University of Louisville and a smokeless-tobacco advocate, said it is important to note Benowitz said the levels of toxicants in e-cigs “are orders of magnitude lower than those found in cigarette smoke.”
Still, he said hyping the potential risk of e-cigs as a gateway to traditional cigarettes and other tobacco products, as well as dual use of e-cigs and cigarettes, is “unsubstantiated and hypothetical.”
“They represent a distortion of the precautionary principle: e-cigarettes must be heavily regulated by the FDA because they are not proven to be safe and effective. Meanwhile, cigarettes are killing 1,205 Americans. Every. Single. Day.”
Scott Ballin, past chairman of the Coalition on Smoking or Health, said the monitoring and surveillance of new tobacco products should be done jointly by the FDA, manufacturers, the research community and others.
“We should be encouraging innovation and the development of new low-risk products, not suppressing them,” Ballin said.
“The public needs and deserves access to these products. Not making these products available under a regulated system could be a public health disservice.”
rcraver@wsjournal.com
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