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Jonathan Foulds: Nicotine reduction could prevent millions of deaths

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The cigarette is the only legal consumer product that — when used as intended — causes the premature death of half of long-term users.

To address this long-standing health threat, the Biden administration recently announced plans to develop a new standard for combustible tobacco products, making them vastly less addictive.

A similar nicotine-reduction strategy has also recently been announced by the government of New Zealand. It is the key component in a new smoke-free plan.

The Biden plan is patterned on one developed during the Trump presidency. Mitch Zeller, former director of the Food and Drug Administration’s Center for Tobacco Products, said the move “could have the greatest impact on public health in the history of public health.”

So what does the proposal mean in practice?

When implemented — likely not for at least another three years — it would cut cigarette and cigar nicotine levels about 95%. As nicotine is the addictive substance in tobacco, it would render these products virtually non-addictive.

The aim is two-fold: to prevent young people from becoming addicted and help current smokers find it easier to quit.

As a researcher focusing on smoking cessation for more than 30 years, I’m impressed by any intervention that increases the quit rate among smokers. In one of our recent randomized clinical trials of very low-nicotine cigarettes, my research team at Penn State, along with colleagues at Harvard, found those switching to them were more than four times as likely to quit.

That suggests the public health benefits of a successfully implemented reduced nicotine standard for cigarettes could be enormous.

A 2018 Food and Drug Administration study projected that by the year 2060, a reduced nicotine standard for cigarettes could reduce the smoking rate dramatically from around 13% now to below 2%, preventing 16 million people from becoming regular smokers and preventing more than 2.8 million tobacco-caused deaths.

Smoking can cause infertility, erectile dysfunction, cataracts, premature aging, hair loss and tooth loss. It stands with heart disease, stroke and cancer as a leading killer.

The proposed standard would not simply result in something akin to a “light” cigarette.

Light cigarettes, which have been marketed for decades, contain about the same amount of nicotine as regular cigarettes — typically 10 to 15 milligrams. To comply with the new standard, a cigarette will likely be required to contain less than 0.5 milligram.

So-called “light” or “low-tar” cigarettes have tiny holes in the filter that allow air flow into the filter to dilute the smoke.

When smoked by a machine, light cigarettes deliver lower levels of tar and nicotine per puff. However, when held by a human, the holes are often blocked by the fingers, and smokers can easily puff a bit harder to inhale the same amount of nicotine and tar.

Some skeptics of the proposed nicotine reduction has raised the concern that smokers might just smoke reduced-nicotine-content cigarettes more intensely, as they do with “light” cigarettes.

However, dozens of research studies have shown that with very low-nicotine-content cigarettes, smokers do not increase their smoke intake. Instead, over a short period of time, they learn the new version is not very satisfying, and begin gradually reducing their usage.

In randomized trials, those using very low-nicotine-content cigarettes are also more likely to quit.

When nicotine reduction in cigarettes was initially proposed under the Trump administration, Zeller and former FDA director Scott Gottlieb recognized that one of the main challenges to the success of this plan was the possibility that the regulation might give rise to an illicit market for high-nicotine cigarettes. Zeller and Gottlieb understood that one critical way to keep that from happening is to allow non-smoked nicotine products — notably electronic cigarettes — to remain on the market.

E-cigarettes deliver a satisfying amount of nicotine for smokers while exposing the user to significantly lower amounts of toxic substances than regular cigarettes. As a result, e-cigarettes are likely to be significantly less harmful.

New research by our team, along with colleagues at Virginia Commonwealth University, recently found that when smokers switch to electronic cigarettes with cigarette-like nicotine delivery, a greater proportion end up quitting.

The potential for e-cigarettes to help replace smoking explains why it came as a surprise to many when — just two days after the Biden proposal to drastically reduce the permissible nicotine content in cigarettes — the FDA announced that it was effectively banning all sales of JUUL, the biggest selling e-cigarette brand over the past five years. When JUUL appealed the decision, the FDA suspended the denial order until an additional review is completed, which is expected to take months.

And JUUL is not the only e-cigarette to be threatened with a ban. Of the millions of e-cigarette applications submitted to the FDA by the deadline in September 2020, more than 99% have been denied.

The e-cigarette ban is puzzling and counterintuitive in the context of the FDA’s plan to drastically cut nicotine content in cigarettes and cigars. Leading researchers agree that having a variety of legal, regulated high-nicotine e-cigarettes on the market is a critical element in reducing consumer demand for illegal high-nicotine smoked products.

Health authorities in other parts of the world, including the United Kingdom and New Zealand, have also recognized the important role that e-cigarettes can play in reducing cigarette smoking. As a result, New Zealand’s nicotine-reduction plan explicitly includes providing access to alternative nicotine products like e-cigarettes.

Research shows that e-cigarettes are much less harmful than cigarettes, and they are proved to help smokers transition from highly toxic cigarettes. It is therefore highly likely to be appropriate for the protection of public health to keep a variety of e-cigarette brands on the market until after the nicotine reduction plan for cigarettes has been successfully implemented.

In my view, implementation of a reduced-nicotine standard for combustible tobacco represents the possibility of finally bringing an end to cigarette addiction within our lifetimes.

From The Conversation, an online repository of lay versions of academic research findings found at https://theconversation.com/us. Used with permission.

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