Our smoking cessation expert answers questions on e-cigarettes and the FDA's push to limit nicotine

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E-cigs, apps and the FDA’s push to limit nicotine

Smoking cessation expert Dr. Jonathan Bricker weighs in on new studies and a federal effort to regulate an ‘astonishingly addictive’ drug

Aug. 1, 2017
cigarettes

FDA Commissioner Dr. Scott Gottlieb announced Friday that the agency plans to cut back on the level of nicotine in cigarettes. "We must do more to help Americans and their families lead healthier lives, and to avoid or break free from harmful cigarette addiction," he said. "The key lies in taking a new and comprehensive approach to the regulation of nicotine."

AFP file via Getty Images

Smoking is in the news again with a new study touting the usefulness of e-cigarettes as a smoking cessation tool and an announcement from the Food and Drug Administration regarding their plans to cut back on nicotine, an “astonishingly addictive” drug that keeps people hooked, usually from a young age.

The FDA’s move was announced Friday by its new commissioner Dr. Scott Gottlieb, who referred to nicotine and the smoke particles it attaches itself to as an “addictive chemical mix of disease and death.”

“We need to envision a world where cigarettes lose their addictive potential through reduced nicotine levels,” Gottlieb said of the FDA’s proposed plan. “Cigarettes will likely remain incredibly toxic, what with the presence of over 7,000 chemicals in cigarette smoke. But with a balanced regulatory approach, we may be able to reach a day when the most harmful products are no longer capable of addicting our kids.”

What does all this mean and what’s the science behind it? We turned to Dr. Jonathan Bricker, a psychologist and smoking cessation expert with Fred Hutchinson Cancer Research Center’s Public Health Sciences Division for answers. Bricker and his team have created a handful of tools, some of which rely on acceptance and commitment therapy, or ACT, to help smokers acknowledge, and eventually overcome, their cravings. Most recently, he’s teamed up with CVS Health Foundation to support cancer patients who want to kick their nicotine addiction.

Dr. Jonathan Bricker

Fred Hutch public health researcher Dr. Jonathan Bricker

Photo by Robert Hood / Fred Hutch News Service

First, let’s talk about the idea of reducing the amount of nicotine in cigarettes. Can the FDA do that? And would that also include limiting nicotine in e-cigs?

Yes, it is within the authority of the FDA to do this, through something known as the Family Smoking Prevention and Tobacco Control Act, which was passed in 2009. That act allows the FDA to set standards for how much nicotine is in a cigarette.

The FDA is regulating the manufacture of e-cigarettes and vaping devices, as well, and regulating the nicotine content in those devices. That's separate from what they're doing with combustible cigarettes — there's a phase-in period of several years. But they are going to regulate the manufacture of e-cigarettes, which includes the nicotine content, the method of extracting the nicotine and they're also going to limit the marketing of flavors that we know appeal to children. 

Going after the chemical that hooks people seems pretty logical. What do you think of the idea?

It’s a smart strategy. On a population level, a policy like this would serve two functions: It would help adult smokers quit because they’d be reducing their addiction level over time and it would keep young people from smoking and becoming addicted. It would prevent progression of smoking in youth and help reduce smoking addiction in adults. Those are very good things.

And it’s actually an old idea, proposed by some colleagues of mine back in 1994, that’s finally getting some traction. The FDA will seek input from scientists, from the public and from industry to determine how to shape the policy and ensure that it’s being properly implemented by the manufacturers. We won’t see it take shape for maybe three years.

Nonetheless, it’s a big deal that they’re reviewing it and taking this part of tobacco control science seriously enough to entertain and pursue it. It’s good news from that perspective.

It seems like good news. Why has it taken 23 years to get to this point?

The main reason we’ve had to wait is because of the tobacco industry. They have a lot of lobbyists and they have a lot of say and control, and there’s been industry resistance to this idea. As soon as the news came out that the FDA intended to seek input for a policy change, the stocks for tobacco products dropped. There’s a huge financial reason for Big Tobacco to resist this type of policy.

Is that the only reason?

No, the other reason is you have to figure out what level to reduce the amount of nicotine to and that’s an experimental question, a laboratory question. And the devil is in the details.

There’s not a consensus among the scientific community as to what the level should be. What it takes for one person to become addicted may be more nicotine than for another person. There are individual differences in our biology. If we’re going to do a massive change at a population level, we have to figure out what the level should be.

There have been some studies that suggest reducing it to about half a milligram provides less pleasure for smokers. But getting the number right is important.

Why not just take nicotine out of cigarettes completely?  

You could, in concept, but the FDA does not have the authority to remove all nicotine from cigarettes. It’s a part of the law and the way it’s written. They cannot remove it completely. But the FDA does have the authority to lower the amount of nicotine in cigarettes. That’s where we are.

So how do they do it? Through genetic engineering? Or is it more like decaffeinating coffee?

You can genetically engineer the tobacco plants or chemically extract nicotine levels after the fact, just like they do with caffeine and coffee beans.

There are about 10 to 15 milligrams of nicotine in one cigarette. But the amount of nicotine that a smoker takes in when he or she smokes is about 1 to 2 milligrams per cigarette. If you can lower the content so that you get about a half milligram, then you can reduce the reinforcing qualities of nicotine, the level of pleasure you get from smoking that cigarette. It becomes less enjoyable and therefore less addicting.

They’re sort of putting a lock on the cigarette, limiting how much nicotine is in the cigarette to begin with.

But nicotine isn’t the only harmful thing in cigarettes? It's just the most addictive thing, correct?

Yes, they actually add other chemicals to make cigarettes more addictive. They add benzene and fluorine and chlorine and ammonia. When they are combined and they bind to the nicotine, cigarettes become much more addictive.

Big Tobacco’s goal is to get the nicotine to cross the blood-brain barrier more quickly. The quicker you cross this barrier, the more addictive the substance will be. Cigarette manufacturing is really a chemistry question: How do we manipulate this substance so it will cross the blood-brain barrier faster so people will use this product more than that product? It’s what differentiates the product — the flavor and how fast it crosses the blood-brain barrier.

Could those other chemicals still be added even if the nicotine levels are lowered?

Yes, they could. There’s a whole area of National Institutes of Health-funded research called tobacco regulatory science, and the purpose is to do these types of studies to help inform policy for questions just like this.

Should we also regulate how much ammonia is in cigarettes? I hope so. But it’s a chemistry question and that’s why tobacco regulatory science exists. It got started after the 2009 act.

The FDA is going to be listening very closely to see what scientists have learned about how the other additives interact. Scientists have become important stakeholders in influencing policy. Hopefully, the new director of the FDA will listen.

Speaking of science, a new study published Thursday in the British Medical Journal suggests e-cigarettes can help people quit traditional cigarettes. Or is that overstating it?

Unfortunately, the BMJ study is not conclusive because of the way it was designed. It’s a cross-sectional survey, and it’s looking at the quit rates for combustible tobacco products among people who used e-cigarettes versus those who haven’t used e-cigarettes. The study found the quit rate was higher in people who used e-cigs versus the people who did not.

But that’s just one conclusion. The other conclusion you could make is that the people they surveyed were going to quit combustible cigarettes anyway and switching to e-cigarettes was just one of many things they were doing. They were motivated and may have been using other aids like a patch or nicotine gum to help them quit.

To prove that e-cigarettes can help you quit smoking, you have to design a randomized controlled trial. With that type of design, you could make a strong causal argument as to whether e-cigarettes help you quit smoking. This study is an important step in the evidence base, but because of the design, it’s a limited step.  

Where are you with regard to your own smoking studies?

We are recruiting now for the new ICanQuit.org study. This study will compare two different apps for smoking cessation and the goal is to determine the effectiveness of both apps.

We’re looking for adults who smoke at least five cigarettes a day who’d like to quit in the next 30 days. It’s a national study and is all online, so no blood draws, no driving to Fred Hutch. It’s really simple. We’re recruiting 2,000 people and each of them can earn up to $105 for participating.

We’re testing cutting-edge app technology. We’re integrating the latest in addiction science, the data we’ve gleaned from our prior research trials and the latest innovations in software technology and design to make the apps engaging and enjoyable and useful for consumers.

It’s a double-blind study so we can’t say what’s in the apps or how they’re different from each other. People will be randomly assigned, like a coin toss.  But both apps use science-based techniques to help them quit smoking. It’s a win-win for participants.

Diane Mapes is a staff writer at Fred Hutchinson Cancer Research Center. She has written extensively about health issues for NBC News, TODAY, CNN, MSN, Seattle Magazine and other publications. A breast cancer survivor, she blogs at doublewhammied.com and tweets @double_whammied. Email her at dmapes@fredhutch.org.

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