Smoking has declined in the U.S., but 49.2 millions Americans, about 20 percent, still use tobacco products. And the tobacco wars rage on, with rates rising globally even as they’re falling in many developed countries. Tobacco companies have created new active compounds to replace cooling menthol and mimic addicting nicotine in an end run around state laws seeking to reduce the harm tobacco products do. Those steps forced California in September to pass legislation closing loopholes in laws banning menthol and regulating nicotine. The Gazette spoke with Vaughan Rees, director of the Center for Global Tobacco Control at the Harvard T.H. Chan School of Public Health, about the increasing sophistication of the tobacco battlefield. This interview has been edited for length and clarity.

Tobacco companies have developed new formulations of nicotine and menthol, sparking an argument as to whether the new compounds can be regulated by current laws. How big a loophole is this?

It could be an enormous loophole, and tobacco manufacturers have exploited it in some states. For example, in Massachusetts, when a ban on the use of methylation went into effect, tobacco manufacturers came up with an analog product that functions like menthol, that imparts a cooling sensation, and that was not technically banned under the Massachusetts law. So tobacco manufacturers continued to sell products that looked, tasted, and functioned almost exactly like mentholated cigarettes.

That subverted the intention of the law, which was to prevent consumers from being misled about the health risks of smoking and to prevent young people from starting smoking, in part because of menthol’s cooling sensation.

How big a problem is the substitution of ingredients to circumvent restrictions? Is this a blip and once lawmakers understand the strategy, they can get ahead of it? Or is this potentially opening a new front in the tobacco wars?

Relatively few jurisdictions in the United States have put product standards like this in place. Massachusetts and California are leaders in that area with bans on methylation, and a ban on the use of synthetic nicotine compounds is about to go into effect in California. So tobacco manufacturers haven’t really had to do much, in a wider way, in terms of subverting those laws.

If a federal ban did go into effect, tobacco manufacturers would very likely seek to introduce menthol or nicotine analogs. Better-crafted regulations should eliminate the opportunity for tobacco manufacturers to substitute analog chemicals for menthol or nicotine. But it’s been a long-term theme of tobacco manufacturers to subvert the intention of laws put in place to protect the health of the public.

Another example was the adoption of clean indoor air laws. There was a lot of pushback from tobacco manufacturers or allies of tobacco manufacturers. The owners of hospitality venues argued that they could create smoking sections in pubs or restaurants, for example, that would  meet the needs of all of their customers. But the science doesn’t support that. When people are smoking in one part of a room or building, the smoke infiltrates other areas, exposing nonsmokers and workers to secondhand smoke.

In the end, public health and science prevailed, but it took some effort to ensure that public venues were 100 percent smoke-free. Tobacco manufacturers have prevailed in other parts of the world, though. In other countries, laws have been put in place that allowed smoking if portions of the building are open-air.

1% Or less of Massachusetts high school students smoke cigarettes

Are there other significant developments on the tobacco-control scene?

Nicotine is the constituent that causes or promotes addiction, so there’s a rationale for thinking about reducing the nicotine in tobacco products below the level at which those products can be considered addictive. That is something that the FDA has proposed as a potential strategy to reduce harm associated with tobacco products.

The idea is that tobacco manufacturers might one day be required to sell cigarettes and other tobacco products that have such low levels of nicotine that people would never become addicted to them. Those products would still produce smoke that contains carcinogens and other dangerous constituents, but consumers wouldn’t be addicted, and the product couldn’t satisfy anybody’s nicotine dependence.

How far along are plans for this new, low-nicotine cigarette?

The FDA issued a proposed federal rule in 2018. The FDA has regulatory authority for tobacco products and can issue regulations around the way products are designed, formulated, sold, and marketed.

A few years ago, the FDA issued what is called “an advanced notice of proposed rulemaking” to seek public comment and input from stakeholders — which includes public health agencies and tobacco manufacturers — to guide a proposed final rule.

We haven’t seen any further action on that from the FDA, so this is something that could be taken up by states such as California, who have the prerogative to advance those kinds of rules themselves. Regulating product standards is an important strategy, but we have seen less come to fruition in that area.

“Among the lowest-income populations in the United States, we’ve seen little decline in the rate of smoking over the past 30 years.”

Where we’re seeing a lot of impact is around the accessibility of tobacco products: Four years ago, the legal age to purchase tobacco products went from 18 to 21.

Another thing that shouldn’t be overlooked is a dramatic decrease in the use of traditional combusted cigarettes, particularly among youth. Kids who might have smoked 15 or 20 years ago now are vaping instead. That’s not a perfect outcome but presents a lower health risk for those individuals than might have been the case. So we’ve seen a dramatic change in the tobacco landscape with regard to the products used and preferred by young people.

Does that mean the tobacco companies are still making profits with e-cigarettes?

Yes and no. Not all cigarette manufacturers have found a way to pivot to the sale of e-cigarettes — at least in the United States. But the bigger companies, Philip Morris and RJ Reynolds, for example, seem to be increasingly attracted to the idea that nicotine vaping products are the way forward, at least in countries like the United States. In low- and middle-income countries, there’s relatively little interest in moving in that direction. The evidence suggests they’re selling more cigarettes in those countries than they’ve ever sold in the past.

What is the broad trend right now? My understanding is that smoking is down in the U.S.

In the United States and many developed countries, we’re seeing year-over-year declines in the prevalence of smoking, most particularly among younger populations. In Massachusetts, 1 percent or less of high school students smoke cigarettes — that doesn’t include those vaping.

But among the lowest-income populations in the United States, we’ve seen little decline in the rate of smoking over the past 30 years. People who live in federally subsidized housing, for example, smoke at perhaps four times the rate of the general public. People with substance use disorders and mental health disorders smoke at a vastly greater prevalence than the general population. People who’ve been historically oppressed — for example, people of gender and sexual minority — smoke at much greater rates than the general population.

In other parts of the world, it’s very different. We haven’t seen the same impact from tobacco control interventions. There are higher rates of smoking among men in some countries, among both men and women in others.

Optimistically, we may see improvements in many global regions in the near future, as tobacco control initiatives are put in place, as high excise taxes are implemented, as clean indoor air laws are implemented, as restrictions on marketing and advertising go into effect. These all reduce demand for tobacco. So regulations really do matter. These battles need to be fought until the public is no longer being harmed by these products.