As part of its ongoing battle against tobacco addiction, the Food and Drug Administration is toying with a plan to reduce nicotine levels in cigarettes.

In June, the agency announced that it is developing a proposal to slash nicotine in cigarettes by 95%. The effort’s twin goals are making smokers less dependent on the drug and decreasing the volume of health issues associated with smoking.

While it could take years for such a proposal to be turned into law, experts believe it represents a step in the right direction.

“In America, we’ve seen a lot of concern expressed about the opioid overdose crisis killing over 100,000 people in the last year or so,” noted Warren Bickel, professor of psychology at Virginia Tech and director of the Addiction Recovery Research Center at the Fralin Biomedical Research Institute. “But we don’t talk as much about the nearly half-million Americans who die every year from the consequences of smoking tobacco.”

Owing to their combination of nicotine and toxic chemicals, cigarettes are both addictive and deadly, said Eric Donny, a professor of physiology and pharmacology at the Wake Forest University School of Medicine. In his mind, the FDA effort should address that particular mix.

“The idea is relatively simple: To break the connection between harm and addiction,” he explained.

The notion of low-nicotine cigarettes isn’t new; it’s been bandied about for nearly 30 years. But the FDA hasn’t implemented rules about nicotine levels since the link between smoking and addiction became obvious during the 1960s. That’s partly because the agency didn’t have power over regulating tobacco products until 2009, the year the Family Smoking Prevention and Tobacco Control Act became law.

Even with that regulatory power in hand, however, several scientific questions remained. For instance, would low-nicotine cigarettes help effect smoking cessation, or would they cause more harm by spurring people to smoke more to compensate for the lower nicotine levels?

Meanwhile, before it could pass any such regulation, the FDA needed solid scientific evidence. Tobacco companies, as you might have heard, tend not to accept regulation without a fight.

“The tobacco industry is very rich and good at lobbying, so there would probably be some pushback,” Bicket explained. “If the FDA puts down any rules, they would have to be pretty ironclad because they’ll certainly be taken to court by the industry. So the agency has been trying to move forward, but very prudently.”

Donny’s research on the effects of low-nicotine cigarettes was funded by the FDA. In 2015, one of his studies found that, after six weeks, the average number of cigarettes smoked per day was lower among people using low-nicotine cigarettes. Various studies since then have arrived at the same conclusion: That low-nicotine cigarettes are effective in helping people quit smoking, or at least in de-incentivizing them to smoke the high amounts they did previously.

Low-nicotine cigarettes ultimately prove less satisfying to smokers, prompting them to smoke less, Donny added.

“We’ve run a number of very large clinical trials now and what we find across studies is that if you reduce nicotine to somewhere around 95% less nicotine than in typical cigarettes, people smoke fewer cigarettes a day,” he said. “They report fewer symptoms of dependence, are more likely to make a quit attempt and are more likely to report days where they don’t smoke at all.”

Recent years have also seen the emergence of a wider variety of nicotine replacement options, such as oral nicotine pouches. In theory, this would widen the “safety net” for smokers if the FDA were to cut nicotine levels.

But there would need to be plenty of support in place for the proposal to evolve into policy. It would likely mean increasing access to nicotine replacement therapy and drugs like bupropion, which alleviate symptoms of nicotine withdrawal. There would also be a need for mental health services to help individuals going through nicotine withdrawal.

In addition, the real-life effects of low-nicotine cigarettes may be a bit more complex than how they’ve played out in clinical studies.

“We do have to recognize that different people want different things,” Donny explained. “Some people are going to want medicinal nicotine — the patch, the lozenge, the gum — while others aren’t. Some people may, in the short-term, experience changes in anxiety and depression. And I would absolutely expect that the demand for non-medicinal nicotine products would go up.”

So if the FDA follows through on its proposal, communications around it will be critical. One note that must be sounded, according to Donny, is that low-nicotine cigarettes aren’t safer. Given the chemicals in tobacco, they remain deadly products.

“We have to get across the message that it’s not reducing nicotine that makes the product safer — but rather that it may make you more likely to quit smoking, and that will improve your health,” he explained. “That message of harm reduction related to smoking is going to be important.”

For an April 2024 article featuring Qnovia’s CEO weighing in on the Take Down Tobacco National Day of Action, click here.

From the September 01, 2022 Issue of MM+M - Medical Marketing and Media