On Sept. 19, scientists at Yale received a federal grant from the Food and Drug Administration and the National Institute of Health to study the effects of flavored tobacco products and electronic cigarettes. The five-year, $20 million allocation will go towards the creation of the Yale Tobacco Center of Regulatory Science, one of 14 similar centers across the country.
Tobacco addiction remains the most common preventable cause of death in the United States today, a startling statistic that helped spur this new effort to provide the investigation necessary for future regulation. The various grants funding the program are part of a larger effort on the part of the FDA to better regulate various tobacco products. The FDA’s effort is concentrated on seven research goals, some of which include looking into the diversity of tobacco products, reduction of addiction, reduction of toxicity and carcinogenicity, and adverse health effects. Marina Picciotto, professor of psychiatry and one of the core members of Yale’s research team, explained that new nicotine products required the FDA to update its research. “The FDA has new regulatory oversight over tobacco products, and they need to get the science that is appropriate so that they can regulate these products rationally,” she said.
The introduction of new nicotine delivery systems such as E-Cigarettes has left a gap in the necessary research required for federal regulation. Electronic cigarette tech involves heating a nicotine-infused liquid until it evaporates, creating nicotine water vapor that can then be drawn into the lungs. Other ingredients in this mixture often include vegetable glycerine, artificial flavoring, and propylene glycol, a common ingredient in asthma inhalers.
“They are looking for strong scientific support for regulatory decisions they are trying to make,” said Suchitra Krishnan-Sarin, associate professor of psychiatry and co-director of the project. One such decision involves the legality of smoking electronic cigarettes indoors. Nicholas was speaking to me from the Baltimore/Washington International Airport, and if he had lit up an electronic cigarette while we were on the phone he would have been breaking Maryland state law. Had he been talking to me from Minneapolis-St. Paul International Airport in Missouri, however, smoking his FIN brand electronic cigarette would have been perfectly legal. In fact, one Blu E-cig advertisement features the actor Stephen Dorff saying to the camera, “With Blu, you can smoke at a basketball game if you want to, and how about not having to go outside every ten minutes when you’re in a bar with your friends?”
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The research effort at Yale will be multidisciplinary, combining programs from the perspective of different departments, including psychiatry and the school of public health. “Each level of investigation will interact closely with the others, so that we can use the science at each level to determine what we will study next,” Picciotto said. The center also features a program that addresses FDA’s changing interests over the five-year period. Benjamin Toll, associate professor of psychiatry and program director of the Smoking Cessation Service at Smilow Cancer Hospital, will head this effort: “We will begin with five pilot programs that will change on a yearly basis,” he said.
The pilot project programs are intended to give Yale’s researchers the capacity to alter the focus of their investigations based on the fluctuating needs of the FDA. As the results begin to flow in, it is expected that the necessary areas of research required for the FDA’s intended regulations will shift based on the findings.
The main focus of Yale’s research will be on what Toll calls “modified risk products,” such as E-Cigarettes and flavored tobacco products, including sugar additives and menthols, an additive that triggers cold-sensitive nerves. The center will seek to explain how these products affect the brain in both adults and adolescents. “There is very little research on the effects of menthol on consumers,” Sven-Eric Jordt, associate professor of psychology, said. “Data shows that sales of menthol products have increased over the years, which is not necessarily true in other countries.”
E-Cigarettes in particular remain somewhat of a mystery to the scientific community, given that limited research has been done on these relatively new products. Though they are sometimes marketed as an alternative option for smoking or even as a method for eventual quitting, there is little scientific evidence to back up this claim, according to the World Health Organization. Because the nicotine is delivered using vapor instead of carcinogens, E-Cigarettes are widely considered to be healthier, though no formal research has been conducted to support these claims.
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Although it remains to be seen what the center’s research will reveal over the next five years, the investigators have several working hypotheses about the outcome of their efforts. The researchers expect to find that flavored tobacco works to intensify the effect of nicotine on the brain: “We think that when sugars or other flavors are combined with nicotine, there is an additive or synergistic effect to increase the addiction,” Picciotto said. The concern is that smokers are experiencing an entirely different biological effect when using these products, an effect that has not been studied and therefore has unknown effects on humans. “We can’t really say what we will find, but there is the hypothesis that in these new products, added flavors can change consumer behavior,” Jordt added. “Certain consumers may favor certain flavors over others and they might also work pharmacologically to drive consumption.” The FDA can’t address any additional risks potentially associated with these unknown effects until more data has been collected.
If this is indeed the case, it certainly would not be the first time that tobacco companies manipulated various nicotine products to increase the possibility of addiction and thereby increase profits. In 2007, Harvard researchers released a study that showed that tobacco companies knowingly increased the nicotine content in their products steadily over a seven-year period between 1997 and 2005 and the increase in nicotine led to skyrocketing levels of cigarette addiction.
Another critical aspect of the research, headed by Krishnan-Sarin, who co-directs the larger initiative, is the study of the effects of these products on younger populations. “We are developing a bio-behavioral understanding of the effects of tobacco on adolescents,” Krishnan-Sarin said. “Flavors can be very attractive forms of initiation of smoking in children and adolescents, and can actually enhance how much adolescents like these products and increase the likelihood of initiation and addiction.”
The regulation of tobacco products has always been largely focused on adolescents. This is in large part due to the interest in tobacco companies of gaining long-term users at a young age, which they achieve by targeting adolescents through marketing and advertising. Yale’s research may provide scientific evidence that flavored tobacco products serve as another means to this end.
Through this interdisciplinary approach, Yale researchers seek to present the federal government with the necessary tools for better regulation of these presently mysterious products. E-Cigarettes, now comprising 10-15 percent of overall cigarette sales, is a massive two billion dollar industry that is only growing. In the past year, the number of middle and high school students who tried alternative nicotine products doubled to 1.8 million. One fifth of those adolescents had never smoked before, reinforcing Krishnan-Sarin’s hypothesis that these products serve as methods of initiation.
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A recent FIN E-Cigarette advertisement featured young men and women in bars and restaurants dressed in 1950s clothing, coolly smoking their E-Cigarettes. The narrator recalled a golden age of smoking, when no one concerned themselves with the health consequences, but did it only for the social appeal. He announces that e-cigarettes promise to return smokers to this age of nonchalance. The ad embodies the efforts of E-Cigarettes to reverse the toxic stigma surrounding smoking that has been built up over the last four decades and return smoking to its former ubiquity.
And the efforts of Yale researchers hope to combat this campaign with hard science.