The FDA Will Limit How Much Nicotine Can Be in Cigarettes

The agency may have also hinted that Big Tobacco should switch to making e-cigs.

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Jul 31 2017, 7:31pm

Peter Dazeley/Getty Images, Bloomberg/Getty Images

The Food and Drug Administration announced on Friday that it wants to lower the nicotine levels in cigarettes, bringing them down to so-called "non-addictive" levels. It's the first time the agency has used its power to regulate (but not eliminate) the nicotine in cigarettes since it was granted in 2009. Following the announcement, addiction scientists applauded the move and cigarette manufacturer stocks dropped. But researchers also cautioned that determining exactly what a "non-addictive" level might be is more complicated than it sounds.

"I've seen the science in this area and believe it holds much promise," FDA commissioner Scott Gottlieb said in a prepared speech, arguing that lowering nicotine levels can make cigarettes "minimally addictive or non-addictive." He cited the harms of cigarette smoke, describing it as containing more than 7,000 chemicals and reminded people that smoking kills 480,000 Americans every year. He called for "a fresh look at nicotine itself," separating the addiction it causes from the harm done by its delivery systems.

That means envisioning a world where smoking is less addictive, he said, so smokers would theoretically inhale less tar and other lung-harming substances. It would also mean, for adults, patches and e-cigarettes rather than combustible cigarettes—nicotine delivered in a potentially less harmful way than by burning tobacco. As Gottlieb put it, "a world where less harmful alternative forms, efficiently delivering satisfying levels of nicotine, are available for those adults who need or want them."

For now, cutting nicotine levels means changing today's cigarettes, either through genetically modified tobacco plants or by removing nicotine during the manufacturing process. Gottlieb and the FDA haven't said what nicotine levels are considered "non-addictive," though, and the science around that question remains to be settled.

"I guess I personally would frame it as less addictive, because I'm not sure about that, 'non-addictive,'" Eric Donny, director of the Center for the Evaluation of Nicotine in Cigarettes at the University of Pittsburgh, told STAT News. His research has shown that cutting nicotine by about 90 percent can make people less dependent on cigarettes; he suggested regulators consider cutting the levels by 95 to 97 percent.


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That would be a start, Donny said. But other variables come into play: how much people inhale with a single drag, and how their bodies process nicotine. Any regulations would have to account for that variability.

The FDA, in other words, is at the very beginning of a long and complex process, headed into uncharted waters. Scientists who study addiction are cautiously optimistic, hopeful that a less-addictive, less-terrible-for-you cigarette will be here sooner rather than later.

Interestingly, Gottlieb also announced on Friday that the FDA is giving e-cigarette manufacturers four more years to comply with regulations that they get FDA approval before making advertising or labeling claims for products introduced after February 15, 2007. Before the delay, many products faced being removed from shelves next year if they didn't comply.

Taken together, these actions could push people toward vapes, which often contain nicotine and will remain largely unregulated in the near future, if they take the FDA announcement as meaning that e-cigs are the safer option, or if the agency requires a new max level of nicotine in combustible cigarettes before the e-cig rules kick in in 2022.

The delay could prove beneficial for companies like Altria Group that make both traditional cigarettes (Marlboro) and e-cigs: they now have more time to ramp up their e-cig business; the announcements are a "smoke signal" if you will.

E-cigarettes are generally considered safer but since they're so new, doctors don't know the long-term effects of using them. For what it's worth, Gottlieb did tell the New York Times: "I wouldn't say we are encouraging people to use e-cigarettes, but certainly we'd like to see smokers use FDA-approved cessation packages like gums and patches.''

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