As the U.S. Food and Drug Administration wrestles with the best way to regulate a legal but deadly product – cigarettes – it turns to scientists with expertise in tobacco control to determine the most effective steps it can take.
The work of MUSC Hollings Cancer Center researcher Tracy Smith, Ph.D., will be instrumental to some of the decisions the FDA faces.
The FDA's Center for Tobacco Products awarded Smith two grants this month to study the likely effects of allowing flavored e-cigarettes and a ban on menthol.
"There's a lot that the FDA has the authority to do that could go a long way toward improving public health and toward reducing preventable illness from cigarette smoking," Smith said. She hopes her research will help to guide those decisions, ultimately resulting in more people either quitting smoking or at least moving to less dangerous products.
Smith partnered with Theodore Wagener, Ph.D., director of the Center for Tobacco Research at The Ohio State University Comprehensive Cancer Center, to develop the trial for a $3.9 million grant to study flavored e-cigarettes.
Youth advocates have strenuously objected to flavored e-cigarettes, arguing that with flavors like cinnamon bun, cotton candy, bubble gum, mango strawberry or chocolate, e-cigarettes are enticing young people to take up an addictive and harmful habit. On the other hand, those flavors might also be more appealing to adults who smoke cigarettes and have been unable to quit. Switching to e-cigarettes, while not a completely healthy choice, is better than continuing to smoke, a concept that public health scientists refer to as "harm reduction."
"The FDA is currently making regulatory decisions about e-cigarette flavors with incomplete scientific data. ...Our study will be the first to provide the FDA with definitive information as to the benefit, if any, of e-cigarette flavors to adult smokers."Theodore Wagener, Ph.D.
The Ohio State University Comprehensive Cancer Center
The FDA must decide how to balance its goals of protecting young people and offering harm reduction options to adults; Smith and Wagener will generate data to inform those decisions.
"The FDA is currently making regulatory decisions about e-cigarette flavors with incomplete scientific data. Smokers also prefer flavored e-cigarettes, and while there are a few survey studies suggesting that flavored e-cigarettes may be more helpful for switching to vaping, these studies are not rigorous enough for the FDA to base its regulatory decisions on. Our study will be the first to provide the FDA with definitive information as to the benefit, if any, of e-cigarette flavors to adult smokers," Wagener said.
They'll be recruiting 1,500 cigarette users from across the nation. Some will get a sample pack of different flavors of e-cigarettes, while others will receive only tobacco-flavored e-cigarettes, and a control group will get nicotine replacement therapy instead of e-cigarettes.
"The goal here is really to ask, 'Does the flavor group switch to e-cigarettes more successfully than the tobacco-flavored group?'" Smith said.
"I'm excited about both of the grants, but I do think that the flavors grant can go a long way. It's the question that everybody feels like we should know by now, whether or not flavors help you better switch, and yet somehow we don't have any randomized trials on that," she said.
Smith's second study, funded by a $3.6 million grant from the FDA, will attempt to measure whether banning menthol in cigarettes and e-cigarettes increases the number of people who quit smoking or switch to e-cigarettes.
There are several factors associated with menthol that make advocates want to ban it. First, much like the fruit and dessert flavors of e-cigarettes, menthol could entice teens and young people to begin smoking. Menthol cigarettes are also heavily marketed in Black communities and disproportionately used in vulnerable populations, Smith said, including people at lower socioeconomic levels, people with mental illness and people struggling with substance use disorder.
It's also harder to quit using menthol cigarettes, Smith said. "We know that menthol smokers are less likely to successfully quit, even though they try to quit at about the same level as non-menthol cigarette users," she explained.
Canada banned menthol cigarettes between 2015 and 2018, and that nation's experience indicates that banning menthol could lead to more people quitting. However, Canada and the U.S. have different cigarette advertising policies and different demographics, which could mean that a ban would have different effects here. Menthol cigarettes also make up a larger share of the market in the U.S. than they did in Canada.
To test how a ban might work here, Smith will recruit South Carolinians who smoke menthol cigarettes and assign them to one of four groups:
- One group will have access to menthol cigarettes as well as menthol e-cigarettes. This group mimics existing regulatory conditions.
- One group will have access to non-menthol cigarettes and menthol e-cigarettes. This mimics what might happen if the FDA bans menthol in cigarettes but allows it to be used as a flavor for e-cigarettes.
- One group will have access to menthol cigarettes and tobacco-flavored e-cigarettes. This mimics a ban on flavors for e-cigarettes but no menthol ban for cigarettes.
- One group will have access to non-menthol cigarettes and tobacco-flavored e-cigarettes. This mimics a complete ban on menthol flavors across products.
"We know that people who smoke menthol cigarettes have a harder time quitting, but that's a long way from saying that removing menthol would make it easier to quit, which we don't really know."Tracy Smith, Ph.D.
MUSC Hollings Cancer Center
The participants will be asked to use only their assigned products for six weeks then try to quit smoking cigarettes altogether for one week. The goal is to see whether those living with the simulated menthol ban will have an easier time quitting.
"We know that people who smoke menthol cigarettes have a harder time quitting, but that's a long way from saying that removing menthol would make it easier to quit, which we don't really know," Smith said.
If a menthol ban does make quitting easier, that information could have significant implications.
"Because a menthol ban hasn't been implemented in a country like the United States where it's so prominent, it has the potential to have a huge public health impact if it helps people switch to e-cigarettes, which are less harmful or, ideally, if it helps people to quit," she said.
Any decisions the FDA might make based on this research will likely take years to implement, as most tobacco regulatory decisions end up in litigation. Still, Smith is excited to contribute to the scientific knowledge on this topic. She hopes that her work can contribute to legal changes that, in turn, help people to lead healthier lives.
"My excitement in my research has been about reducing the appeal and the addictiveness of these combustible products and in understanding how we could regulate tobacco to move people away from those," she explained. "Ideally, that's through quitting because we've reduced the addictiveness of tobacco, and now people who want to quit actually can quit."
