Q&A: Effective interventions and policies to reduce tobacco-caused harm

HERSHEY, Pa. — Earlier this year, the U.S. Food and Drug Administration (FDA) proposed a new rule to limit nicotine in cigarettes and certain other tobacco products, like cigars and pipe tobacco, bringing nicotine down to minimal or nonaddictive levels. If finalized, this change would be a major step in addressing the public health concerns of smoking and tobacco use in the United States.

“It could be the end of smoking-caused diseases such as lung cancer and chronic obstructive pulmonary disease as we know it, at least in the future,” said Jonathan Foulds, professor of public health sciences and of psychiatry and behavioral health at the Penn State College of Medicine.

Cigarette smoking is the leading cause of preventable disease, death and disability in the United States, according to the Centers for Disease Control and Prevention. More than 16 million American live with a smoking-related disease and smoking is estimated to cause nearly half a million deaths a year.

Foulds has studied tobacco use for 35 years. He and others from Penn State played a role in conducting research supporting the proposed FDA rule change. He also has a new book available, “Treating Addiction to Tobacco and Nicotine Products,” to help practitioners better assess and treat tobacco use disorder.

In the following Q&A, Foulds discussed the role of research in public policymaking and what the science says about the benefits of lowering nicotine levels in tobacco products.

Q: What drew you to studying tobacco and smoking?

Foulds: I was trained as a clinical psychologist and got a job with the smoking research team at the Institute of Psychiatry, Psychology and Neuroscience at King’s College London. I didn't really have a personal interest in smoking, and I wasn't a smoker.

But I liked the idea that with smoking, there's just one behavior you have to change. I liked the simplicity of it. If we can help people to not put a cigarette in their mouth every day, you can add 10 healthy years to their life. It's a big impact from a very specific change in behavior.

Q: What does the FDA’s newly proposed rule mean in practice?

Foulds: The proposed rule would decrease the amount of nicotine — the addictive substance in tobacco — in cigarettes and other combusted tobacco products to minimal or nonaddictive levels. They would contain roughly 95% less nicotine. The rule wouldn’t ban cigarettes or other tobacco products.

In practice, this would mean that young people would be less likely to become addicted to cigarettes. It would also mean that current smokers may find it easier to quit or switch to an alternative product that’s less harmful. The FDA projects that within the first year of implementation of the new rule, 12.9 million people would quit smoking cigarettes and that by 2060, there would be 1.8 million tobacco-related deaths averted.

Q: What’s the relationship between research and a policy change such as this? How did research from Penn State contribute?

Foulds: In 2009, the government passed a law that gave the FDA the right to regulate tobacco products, and the FDA needed research to give them information and science to guide their regulatory policy. In 2013, they awarded the first round of grants, designating research centers as Tobacco Centers for Regulatory Science (TCORS) and Penn State was designated a TCORS site.

This designation means that our research might make a difference. There aren’t many ways to directly guide a government agency on how to regulate something that causes a large portion of illness and disease in the country.

Research from Penn State and other research centers has directly informed the proposed nicotine rule change. For example, one of our randomized controlled clinical trials found that those who used very low-nicotine cigarettes were more than four times as likely to quit smoking as those who smoked normal nicotine cigarettes 

Last year, we received a new TCORS grant, with Josh Muscat and I as co-principal investigators again, to investigate the effects of alternative tobacco products like nicotine pouches and e-cigarettes. The funding from the National Institutes of Health and FDA originates from users-fees that cigarette manufacturers pay to the FDA as required by the Tobacco Control Act passed in 2009. We expect our results from these studies to influence the way the FDA views these products.

Q: What sets Penn State apart in this area of research?

Foulds: At the Penn State Center for Research on Tobacco and Health, we have a multidisciplinary team of experts — basic scientists, public health research and medical professionals. We investigate both the chemical toxicity of tobacco and nicotine products — what causes harm to the body — and the addictiveness of these products. We need to study both to understand overall health effects and to estimate the relative harmfulness of the products.

Biochemists, like Zach Bitzer, Neil Trushin and Dongxiao Sun at the Penn State College of Medicine, help us measure toxicant exposure and how much is absorbed by the body by analyzing biomarkers in the blood and urine. There aren’t that many places that can do this work. For example, our group was the first to determine the blood nicotine levels from smoking very low nicotine cigarettes. 

While tobacco products can have immediate effects on the body, most don’t cause disease in a week, a month or a year. With cigarettes, for example, it takes decades of use for lung cancer and chronic obstructive pulmonary disease to materialize. By measuring addictiveness, you can predict how long someone will use a product and by extension, their exposure to toxicants.

Q: What’s the public health impact of research like yours? What has your research shown?

Foulds: The findings from our scientific studies inform the FDA so that they can better regulate products in the best interest of the public’s health. But they also help the public make more informed choices, too, by clarifying the relative harmfulness and benefits of new tobacco products on the market.

Having less harmful nicotine products on the market that are not smoked and that smokers are willing to switch to is a necessary requirement for the reduced nicotine rule to be a success. Our research suggests that the combination of lower nicotine smoked products plus the availability of regulated alternative nicotine products, like e-cigarettes and nicotine pouches, could have a tremendous impact.

We conducted a trial with cigarette smokers who were willing to reduce their smoking and use an e-cigarette but didn’t want to quit smoking. We found that people who used the high-nicotine e-cigarette were more likely to quit cigarette smoking, even though they didn’t have plans to do so.

We’re now doing a similar study, replacing cigarettes with nicotine pouches, which are like little tea bags filled with nicotine powder. We believe the pouches are less addictive because they don’t deliver the nicotine as quickly as cigarettes, but we still have to measure that. What we find might help determine the relative risks and benefits of switching to some of these products.

We’ve also done other studies with e-cigarettes and have found evidence of less harm compared to cigarettes because they deliver lower levels of toxicant exposure.

Q: What are the next steps with the FDA’s proposed new rule to limit nicotine levels in cigarettes and other combustible products?

Foulds: Rule approval is a multi-step process and with the announcement of the proposed new rule, we’re about halfway there. Now there’s a period of public comment until September, when people — industry, scientists, the public — can provide input. Then, the FDA and the government considers the feedback and decides whether to move forward.

Research reported in this publication was supported by the National Institute On Drug Abuse of the National Institutes of Health under award number U54DA05827.