Kudos to the FDA: E-Cigarettes Are Tobacco Products

On April 25, the FDA abandoned its claim that e-cigarettes are drug delivery devices. In an open letter published on the agency’s website (here), Tobacco Center Director Lawrence Deyton and Drug Center Director Janet Woodcock acknowledged that e-cigarettes are tobacco products and would be subject to regulations under the 2009 Tobacco Act. This is consistent with the January 2010 decision by federal judge Richard Leon (discussed here).

This is a victory on several counts for smokers and for our nation’s public health. First, the FDA decision guarantees that e-cigarettes, which have helped many smokers quit, will remain on the market.

Second, as the Deyton-Woodcock letter indicates, FDA regulation of e-cigarettes will subject them “to general controls, such as registration, product listing, ingredient listing, good manufacturing practice requirements, user fees for certain products, and the adulteration and misbranding provisions, as well as to the premarket review requirements for ‘new tobacco products’ and ‘modified risk tobacco products.’” These requirements will promote the marketing of safe and quality-controlled products.

Finally, this decision could allow pharmaceutical companies to reposition nicotine medicines as recreational alternatives to cigarettes. Today, these products are sold with a therapeutic claim for smoking cessation, but they are expensive, unsatisfying and FDA-approved only for temporary use (10-12 weeks). That accounts for their dismal success rate of only seven percent among smokers (evidence here). I believe pharmaceutical companies should enter the recreational nicotine market with products that satisfy smokers indefinitely and are cheap enough to compete directly with cigarettes. Clearly, the tobacco industry is poised to compete in this new market -- Reynolds American owns Niconovum (here) and British American Tobacco recently formed Nicoventures (here).

In my 1995 book “For Smokers Only” (description here), I shared my perspective on recreational nicotine for smokers:

“Smokers derive a lot of pleasure from smoking tobacco. You may be reading this book because you or your loved one actually enjoys lighting up a cigarette and taking several deep puffs. A smoke may be especially welcome when you are in a stressful situation or when you need to relax. Or you may enjoy smoking when you need to concentrate on a difficult problem at work or at home. Cigarette smoking can activate that mental pressure-relief valve, which is followed by the feeling that the problem can be solved, the crisis will pass. These feelings are real, and not just a figment of your imagination.

“Many tobacco opponents claim that these sensations are not truly pleasurable, but are merely the satisfying of induced cravings and avoidance of withdrawal symptoms. One of the big advantages of the smokeless tobacco solution is that it addresses either view of smoking equally well. That is, it doesn't matter if you are a smoker who is unwilling to quit because you enjoy tobacco, or if you are unable to quit because of nicotine craving and withdrawal. Because in either case you recognize the potential life-shortening effects of this nicotine delivery system. In either case the smokeless tobacco solution can work for you.”

Smoking has been the problem; smoke-free tobacco and nicotine can be the solution. In making the right call on e-cigarettes, the FDA has facilitated that solution.

Clinical Trial Evidence: Snus Is Superior Cigarette Substitute

New Zealand Researchers have published clinical trial results demonstrating that snus is a better cigarette substitute than nicotine gum. The study appears in the online edition of Nicotine and Tobacco Research.

The authors are Brent Caldwell, Carl Burgess and Julian Crane from the Department of Medicine at the University of Otago in Wellington, New Zealand. After observing smoking patterns and consumption for one (lead-in) week, Caldwell’s group gave 63 smokers three different cigarette substitutes, each for two weeks. The substitutes were Swedish snus (4-gram pouches in three flavors), Habitrol nicotine gum (containing 4 milligrams of nicotine) and a new product called Zonnic (a peppermint pouch containing 4 milligrams of nicotine embedded in microcrystalline beads). The latter product is a new medication developed by a Swedish company called Niconovum, which was purchased by R.J. Reynolds in December.

The researchers collected information from the participants about the “acceptability and the willingness of smokers to use” the substitutes. They asked five questions gauging satisfaction, and they reported that “subjects scored Zonnic and snus more highly than gum for four out of the five…” All three products significantly reduced craving for cigarettes, and all three “…enabled subjects to reduce their smoking significantly compared with the lead-in week.”

Participants ranked Zonnic and snus higher than nicotine gum for both quitting and reducing smoking. “At the conclusion of the study, subjects were asked to rank the three products in order of overall preference. For their first choice, an equal number (40%) chose snus or Zonnic, while 20% chose gum” This is great news, because prohibitionists have argued that snus will never be accepted outside Sweden as a cigarette substitute.

Caldwell’s study was funded by the Asthma & Respiratory Foundation of New Zealand. It is refreshing to learn of a health organization that places a higher priority on finding solutions to smoking than on tormenting tobacco companies and users.

The FDA will soon be in a position to approve safer cigarette substitutes. This is the kind of evidence that the agency cannot ignore.