Should FDA mandate lower nicotine content in cigarettes?

In June 2009, then-President Barack Obama signed into law the Family Smoking Prevention and Tobacco Control Act, authorizing FDA to regulate the nicotine content of cigarettes. The only real limit to FDA's new authority was a provision prohibiting FDA from “requiring the reduction of nicotine yields of a tobacco product to zero.”

Prior to that legislation, in 2007 only three states required cigarette makers to submit data on the nicotine content of their products. According to studies by Harvard and the Massachusetts Department of Public Health, nicotine levels in cigarettes inched up about 1% to 1.5% overall per year 1997-2005, some brands more than others. Cigarette makers denied any attempts to boost nicotine levels in their products.

Mandating reduced nicotine content in cigarettes has been proposed repeatedly for decades, based on research that smokers would be more likely to quit entirely over time if higher nicotine products were not available. Today the FDA could actually do it, but hasn't yet signaled any plans to.

A study published in the New England Journal of Medicine supports the argument for harm reduction by reducing nicotine content. However, smokers were no more likely to quit during the short 6 week follow-up.

Smokers (n=839) were randomized to get free regular cigarettes or low-nicotine cigarettes (and were blinded to their assignment). Those smoking the lower nicotine cigarettes smoked about 6 fewer cigarettes per day (16 vs. 22).

But smoking cessation rates were hardly different between groups. And the the between-group difference wasn't a real "reduction" because the control patients smoked more than their pre-study baseline (because, free cigarettes!).

Twice as many of the low-nicotine patients did report trying to quit (34% vs 17%).

"Puff volume" was also measured, and researchers were surprised to see the smokers given the lowest-nicotine cigarettes inhaled less deeply, rather than more.

"We believe these data support exploration of a national nicotine-reduction policy, and we recommend that additional attention be paid to low-nicotine cigarettes as a potential clinical smoking-cessation resource," wrote editorialists Michael Fiore, MD, MPH, MBA, and Timothy Baker, PhD.

The study should allay concerns that reducing nicotine content in cigarettes would simply cause smokers to smoke more cigarettes more deeply, potentially worsening health outcomes. However, other than the apparent increased intent to quit among the low-nicotine smokers, the study does not support the conclusion that mandating low nicotine products would lead to more smoking cessation.

Rather than smoking cessation, a greater benefit from mandating reduced nicotine content in cigarettes could result over decades from fewer new addicted smokers. If cigarettes are less addictive and pleasurable to smoke, fewer young people who try them will become lifelong smokers. This premise is probably impossible to test in a controlled study, but could be done observationally if lower nicotine content products were mandated in one geographic area, but not another.

Laws mandating smoke-free public places and workplaces, along with cigarette taxes, are believed to have had the greatest effect in lowering U.S. rates of smoking over the past decades.

The FDA has not flexed its new regulatory muscle on cigarette manufacturers, choosing instead to focus on e-cigarettes initially. Additional research on low-nicotine cigarettes is ongoing through the FDA's Center for Tobacco Products.

Read more:

Randomized Trial of Reduced-Nicotine Standards for Cigarettes. N Engl J Med; 373:1340-1349