Nicotine is not the devil, cigarettes are

Thirty years ago, as a young public health researcher and professor, I began my lectures by telling students that 480,000 Americans die each year from smoking, making it the leading cause of preventable death. Unfortunately, 30 years later, I still start my discussions with the same fact. In those 30 years, 15 million Americans died needlessly from smoking. To change that trajectory, it’s time for the FDA to adopt bold new thinking, including providing smokers with safer nicotine-containing alternatives.

It is almost impossible to comprehend that 15 million people have been lost over the past 30 years to smoking. For many of us, these people are nameless and faceless. In fact, the majority tend to be people of color, people of lower socioeconomic status, people with dual addictions, and people with co-occurring mental health conditions. Those who have no voice.

The landmark Tobacco Control Act, passed in 2009, was meant to be a tipping point and set the stage to save millions of lives. Unfortunately, he did not keep that promise. Many FDA initiatives, such as graphic warning labels, are blocked in court. Other FDA proposals will likely take years to materialize. The menthol ban has yet to happen, although it was first considered in 2011. And while the FDA eventually proposed a menthol ban this year, that too will likely be delayed in court ( although I think it will be a losing battle for the industry).

Another recent FDA proposal to establish a maximum level of nicotine in cigarettes is unlikely to produce the results the FDA wants. The concept here is to put a cap on the nicotine in cigarettes so that they are no longer addictive. It’s not a new idea. Twenty-eight years ago, scientists proposed establishing a nicotine threshold for addiction. Since then we have learned a lot more about nicotine and have conducted additional studies using reduced nicotine cigarettes. In fact, one company, 22nd Century, is testing the marketing of a reduced nicotine cigarette called VLN (very low nicotine).

To date, sales have been “modest”. This is not surprising, as such low levels of nicotine will dramatically alter the smoking experience. Assuming that a smoker primarily uses cigarettes for nicotine, then it is hard to believe that smokers would buy a product that does not meet their needs. One might conclude that this is good — then they would quit smoking cigarettes. Is it so simple? Although I tend to think that the tobacco industry often overstates the concept of the black market, in this case I think it’s a very real concern. And who would use these black market products? People of color and socioeconomically disadvantaged populations. There would likely be a robust nicotine market that is unregulated, untaxed and possibly adulterated.

To make real and meaningful progress in combating the heavy toll of smoking, it is critical that the FDA clear low-risk nicotine products, such as e-cigarettes and nicotine pouches, as well as a wallet drugs approved for smoking cessation.

In 2017, Scott Gottlieb, the commissioner of the FDA, along with Mitch Zeller, then director of the FDA’s Center for Tobacco Products, recognized the need for the FDA’s approach to tobacco regulation to consider the continuum risk for products containing nicotine. For example, e-cigarettes (or vapes) and nicotine pouches are increasingly showing that they can help smokers quit. Although these products are not safe, many believe they are significantly safer than combustible cigarettes.

Just as public health has embraced the concepts of harm reduction for opioids, alcohol, and many other areas of public health, we must also embrace them for tobacco products.

Unfortunately, although the FDA has recognized the importance of tobacco harm reduction, this does not appear to be the direction the agency is headed. Recently, the FDA issued marketing denial orders to JUUL, which means the product must be removed from the market. Today, 3 million American smokers use JUUL. What message are we sending that these 3 million Americans should smoke cigarettes? Switch to other e-cigarettes that could also receive the same marketing refusal order in a few months?

This may be difficult for many to understand, but nicotine is not the devil; cigarettes are. And when nicotine is associated with cigarettes, it joins the devil. As famous researcher Michael Russell so aptly put it: “People smoke for the nicotine, but they die for the tar. I implore policy makers and the FDA to remember this.

To be the voice of vulnerable populations and to truly embrace the concept of harm reduction, alternative nicotine products could be the game changer we needed to save lives. Isn’t that the story we want to tell the next generation of public health students 30 years from now?

• Dr. Jasjit Ahluwalia, one of five nonfederal employees of the Surgeon General’s Interagency Committee on Tobacco.

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