The industry went from fearing nicotine replacements to selling them.
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Nicotine replacement therapy is a proven tool to help smokers quit—but only if they're careful about tapering it off, and get regular counseling to keep them on track. According to a new study in the American Journal of Public Health, internal research conducted years ago by tobacco companies had already indicated that most smokers don't keep to the strict regimen—and end up staying hooked on their product.
Researchers at the University of California San Francisco searched through 50 years of internal tobacco industry research and memoranda that are now publicly available on the Truth Tobacco Industry Document Archive. They looked for any mentions of nicotine replacement therapy (NRT) and discovered how the industry's attitudes toward the quitting aids shifted from fear to nonchalance to embracing it over that time period.
"When nicotine replacement first came out, they were pretty panicked by it," says study author Stanton Glantz, director of the UCSF Center for Tobacco Control Research and Education. But recently tobacco companies have started selling their own nicotine replacement products. Zonnic, an over-the-counter nicotine gum and lozenge, is marketed by a Swedish subsidiary of Reynolds American, Inc. called Niconovum. The nicotine chewable Verve (currently only available in Virginia), is made by the US Smokeless Tobacco company, which also makes dipping tobacco including Copenhagen and Skoal, and is owned by Altria, the parent company of Philip Morris USA.
As early as 1959, with the public increasingly aware of the health dangers from smoking, tobacco execs discussed developing nicotine gum that would serve as an alternative vehicle for the addictive compound. Over the next decade, executives also considered putting nicotine in beverages, edibles, a skin lotion, and even inhalers that were similar in concept to the e-cigarettes that would come to market decades later.
In one 1970 internal study from the R.J. Reynolds Tobacco Company (which makes Camel and Pall Mall cigarettes, among others), these products were envisioned for "former smokers and those where were inclined to, but didn't start smoking (probably because of the health controversy)." They decided not to pull the trigger, however, because the company worried that selling nicotine delivery directly would draw the scrutiny of the Food and Drug Administration.
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Nicotine gum was eventually developed instead at a Swedish university with the goal of helping people to break their smoking habit. In the clinical trials, the therapy included careful dosing, monitoring, and behavioral counseling. With all those steps working together, nicotine replacement proved to be an effective way to help smokers quit, and it was approved by the FDA in 1984—but only with a doctor's prescription. The nicotine patch was released in the late 1980s.
Despite the effectiveness shown in clinical trials, Philip Morris had determined by 1992 that nicotine replacement therapy didn't seem to be making a dent in their cigarette business. One reason, according to one memo, was that many doctors felt like their job helping smokers stopped once they wrote the prescription. "While doctors seem to readily encourage patch usage, few get any more involved—offering advice, discussing side effects suggesting behavior modification," the memo states. And while over-the-counter sales initially seemed like a smart move to improve access to helpful nicotine replacement, in fact it may be making this problem worse.
It would be a few years more before scientists came to the same realization. "The tobacco companies are generally 20 or 30 years ahead of the public health community in their thinking about their issues," Glantz says. "They have much more resources than the health community does to study their products."
One 2002 study in the Journal of the American Medical Association compared how successful smokers were in quitting both before and after over-the-counter nicotine replacement therapy became widely available in 1996. They found that most people only stuck with the program for about 14 days, far less than the recommended six weeks. And less than half of the people in the study could last more than one day without smoking again once they stopped the nicotine replacement. "Since becoming available over the counter, NRT appears no longer effective in increasing long-term successful cessation," the study authors concluded.
Once the FDA finally began to regulate the tobacco industry in 2009, that removed the only hurdle for the tobacco companies to get into the nicotine replacement business, the study authors say. Reynolds American acquired Niconovum in 2009, but David Howard, a spokesperson for Reynolds American Services Company, said the timing of that purchase was not related to FDA regulation. "Federal regulation had been a topic for decades, long before 2009," he says.
"It is in line with our strategy that has been in place for several years now, and that is to lead the transformation of the tobacco industry," Howard says. "There is a total tobacco portfolio that we believe has positioned us well, and it is providing tobacco consumers a range of products to consider." Howard also pointed out that Zonnic is, strictly speaking, a nicotine replacement therapy and not a tobacco product, and is regulated by the Food and Drug Administration as such. Representatives at Philip Morris parent company Altria did not immediately respond to requests for comment.
Zonnic is marketed as a product to help stop smoking, and its FDA-regulated packaging (like any drug) includes detailed directions on how to use the product over 12 weeks and taper off nicotine consumption. Verve, the mint-flavored chewable, makes no mention of smoking cessation on their website, and instead is described as a "tobacco-derived nicotine product."
"NRT, done right, works," Glantz says. But since people are often less likely to accomplish their goal of quitting while trying to use a nicotine patch on their own, Glantz believes it should only be available if the smoker commits to regular counseling to use it properly—he cites California's 1-800-NO-BUTTS help line as a positive example—or barring that, should revert to prescription-only. "I think the FDA is falling into the tobacco industry's trap," he says.
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