The urgent case for nonaddictive cigarettes


Nicotine addiction is more prevalent than discussed

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For too long, tobacco addiction has destroyed the health of its users and laid waste to the public healthcare systems the world over. It is time for something different. Frustrated by the country’s stagnating smoking rate, one year ago, Scott Gottlieb, commissioner of the Food and Drug Administration, announced that the agency would pursue a plan to limit nicotine in cigarettes to “minimally or non-addictive levels.” Gottlieb went on to explain, “The overwhelming amount of death and disease attributable to tobacco is caused by addiction to cigarettes — the only legal consumer product that, when used as intended, will kill half of all long-term users.”

The stakes are high, but the science behind FDA’s nicotine reduction plan is sound. Though traditional tobacco companies have already raised objections, Very Low Nicotine Content, or VLNC, cigarettes are well-studied by a diverse and independent cadre of independent scientists. The National Institutes of Health has funded dozens of important clinical trials employing VLNC cigarettes. The results: Scientists have found that VLNC cigarettes reduce cravings, reduce consumption of cigarettes, and increase quit attempts. Further, the benefits of VLNC cigarettes appear to extend to adolescentsnondaily smokers, and vulnerable population groups including those with psychiatric disorders and opioid dependence.

To make these studies possible, the National Institute on Drug Abuse, the FDA, the National Cancer Institute, and the Centers for Disease Control and Prevention together developed the Spectrum line of research cigarettes. These research cigarettes are available with nicotine contents from very low through conventional levels, allowing scientists to test the behavioral outcomes of reducing nicotine to nonaddictive levels.

Some have questioned the ethics of a VLNC cigarette, suggesting that a harmful product that does not include the primary addictive chemical associated with cigarettes is somehow worse than cigarettes that do contain addictive levels of nicotine. This is dubious logic at best. It is important not to lose sight of FDA’s goal in the matter: Reducing the nicotine in cigarettes to nonaddictive levels is a means to reduce the number of addicted consumers and, ultimately, to reduce the enormous harm to public health caused by smoking.

Others point to the specter of compensation in an attempt to discredit the FDA’s plan. But researchers recently co-authored a letter to the FDA that emphatically closed the door on the myth that smokers might smoke more if cigarettes were minimally or nonaddictive: “Effectively compensating to maintain nicotine exposure is virtually impossible when switching to cigarettes with minimally addictive nicotine content.”

Making matters worse, one critic wrongly assigned a quote to authors of the “Randomized Trial of Reduced-Nicotine Standards for Cigarettes” published in the New England Journal of Medicine. The quote, which claims that participants assigned to cigarettes with very low levels of nicotine actually smoked more, was pulled from a public comment to the study made some four months after publication. To the contrary, study authors state just the opposite in their summary:

A substantial reduction in nicotine content is associated with reductions in smoking, nicotine exposure, and nicotine dependence, with minimal evidence of nicotine withdrawal, compensatory smoking, or serious adverse events.

This May, the American Heart Association, the American Cancer Association, and the American Medical Association joined dozens of other public health and medical organizations in an open letter submitted to Gottlieb, explaining:

Every day that passes means more kids moving from experimentation to addiction and more adults who want to quit and try to quit, but remain addicted to a lethal product. We urge FDA to issue a proposed rule within six months of its ANPRM.

More recently, 12 senators urged the FDA to set hard deadlines for the rule-making process and explained: “The FDA can help save millions of lives and positively impact public health for generations to come.”

In announcing the FDA’s plan to require that cigarettes that are no longer capable of initiating or sustaining addiction, the FDA has taken a bold step forward in the arena of public health. Tobacco control advocates, Congress, and the American people all must ensure that the FDA’s nicotine reduction plan quickly becomes reality.

James Vail is director of communications and Juan Sanchez Tamburrino is vice president of research and development at 22nd Century Group, a plant biotechnology company focused on tobacco harm reduction. It is the only company in the world growing tobacco with nonaddictive levels of nicotine.

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