WASHINGTON -- There has been quite a bit of speculation as electronic cigarette companies, retailers and lawmakers alike wait for the U.S. Food and Drug Administration (FDA) to issue electronic cigarette deeming regulations. Will the FDA's Center for Tobacco Products (CTP) hold e-cigarettes to the same strict regulations as tobacco cigarettes, effectively banning all flavors and severely limiting advertising and product innovations? Or will the agency recognize the segment's potential to improve public health by offering a nicotine delivery system that closely mirrors the smoking experience in a non-combustible form?
The only clue given by CTP director Mitch Zeller is that any tobacco regulations proposed on his watch must be supported by science and benefit public health.
"In an effort to create lasting regulations, FDA decisions must be based on the strongest possible science," Zeller said in a July telebriefing. "In doing so, our policies will strengthen the legal precedent and change the tobacco marketplace as we know it."
This emphasis on science seemingly stands to benefit the electronic cigarette industry. While there's more work to be done on the lasting effects of e-cig vapor, early studies have repeatedly shown electronic cigarettes as less harmful than combustible tobacco. The science has garnered support from a variety of somewhat unexpected players, including a former surgeon general and one-time anti-tobacco advocates who view the segment as a lifesaving development.
Some more notable supporters include:
Dr. Richard Carmona: As the U.S. Surgeon General under President George W. Bush, Carmona notably supported a ban on all tobacco products. Yet, in March, Carmona accepted a seat on NJOY's board of directors to chair the Scottsdale, Ariz.-based company's scientific advisory committee. It's a natural fit, given NJOY's stated mission to make cigarettes obsolete.
"We see that there are still more than 40 million committed adult smokers, who face well-established risks of death and disease if they continue to smoke," Carmona told CSP. "Electronic cigarettes have the extraordinary potential to appeal to and satisfy the adult smoker, moving them away from tobacco cigarettes with their established harm profile."
Charles D. Connor: Connor spent years working with the American Lung Association, first as executive vice president and COO, then as president and CEO. Yet, after realizing the electronic cigarettes "might be that alternative that persuades the smoker to stop smoking tobacco," Connor signed on as a consultant for the Electronic Cigarette Industry Group Inc. (ECIG). While anti-smoking groups have been leery of electronic cigarettes, Connor told CSP he hopes to serve as a liaison between the public health community and the electronic cigarette industry.
"I don't think much communication has happened so far," he said. "I believe opening up a dialog between those organizations who are quite correctly concerned about America's public health and an industry that wants to market safe products can be productive."
Dr. Michael Siegel: Dr. Michael Siegel has spent most of his career fighting for stricter tobacco regulations, including two years at the CDC's Office on Smoking and Health and later testifying in the Engle v. Liggett lawsuit. Yet, as a professor at Boston University's School of Public Health and author of the Tobacco Analyses blog, Siegel now finds himself in the unlikely role of advocating against taxes or regulations.
"Electronic cigarettes are the first smoking cessation product that addresses both the pharmacologic and behavioral aspects of the smoking addiction," Siegel said. "Not only do they provide nicotine, but they simulate cigarette smoking. Thus, unlike nicotine patches or nicotine gum or other drugs, they address all of the behavioral, physical, and even social aspects of the smoking addiction."
With the Office of Management and Budget (OMB) currently reviewing the FDA's proposed deeming regulations, only time will tell if--like Carmona, Connor and Siegel--Zeller recognizes the potential of electronic cigarettes.