Skepticism Over FDA Bid to Mandate Very Low-Nicotine Cigarettes

    The Food and Drugs Administration (FDA) has issued a proposed rule that would cap nicotine levels in combustible tobacco products at a very low level.

    By making cigarettes “minimally or nonaddictive” in this way, the agency declared, “the United States would be the first country globally to take such a bold, life-saving action to prevent and reduce smoking-related disease and death.”

    Many experts are far from convinced.

    The FDA’s announcement was made on January 15. The idea isn’t new—the FDA first suggested this back in 2018—but its implementation is gathering pace, with the public now invited to submit comments until September 25, which the agency will then review.

    The specific proposal is to cap the nicotine level at 0.7 milligrams per gram of tobacco in cigarettes, pipe tobacco, most cigars and rolling tobacco. That’s compared to an average of 10-12 mg of nicotine in cigarettes sold today, according to most estimates. (There’s a big range of nicotine concentrations in available products; a cigarette weighs roughly 1 gram.)

    Nicotine is the dependence-forming drug which makes people want to keep smoking. But it is not the direct cause of disease and death from smoking, which is rather the many toxic chemicals produced by combustion.

    “People smoke for the nicotine but die from the tar,” acknowledged Dr. David B. Abrams, quoting the late Professor Michael Russell, who was a leading figure in the development of tobacco harm reduction.

    Abrams, a professor of social and behavioral sciences at the NYU College of Global Public Health, has found the misconception that reducing nicotine reduces the risk of harms like cancer to be widespread. A 2018 study he co-authored, “Public misperception that very low nicotine cigarettes are less carcinogenic,” showed that almost half of people who smoke held that belief.

    “This is not true,” Abrams told Filter. “Reducing the addiction [by lowering nicotine levels] may make it easier to quit smoking, but it does not remove the chemicals inhaled in combusted tobacco.”

    “This misinformation must be corrected and clearly explained in a warning label to the public,” he warned. Failure to do so could prevent people from quitting smoking due to the false belief that their low-nicotine cigarettes are safer—a risk that his study also indicated.

    The FDA understands the distinction between nicotine and cancer-causing chemicals, even if its messaging has often failed to make it adequately clear. But the agency envisages that mandating low-nicotine cigarettes will cause more people to quit smoking because they will be less dependent.

    “In the real world, people who smoke are highly unlikely to hand over their hard-earned cash for cigarettes that contain barely any nicotine.”

    Whether that will happen in reality is very doubtful, many experts argue. They believe many people who smoke will instead adapt—either by inhaling harder or smoking more to get the nicotine they want, thus exposing themselves to more harm; or by finding alternative, unauthorized sources of higher-nicotine cigarettes.

    Some advocates also take issue with the FDA’s plan in principle.

    “A very low-nicotine mandate is not consistent with harm reduction principles,” Alex Clark, CEO of the Consumer Advocates for Smoke-Free Alternatives Association (CASAA), told Filter. “Instead, it is a top-down, coercive product standard that scoffs at the agency of people who smoke.”

    British tobacco control expert Clive Bates, of Counterfactual Consulting, echoed that sentiment. He also criticised the evidence that “supposedly” supports the new measure. The research the FDA referenced, he said, was based on what happens when participants are paid to use low-nicotine cigarettes in a trial, which rendered it “irrelevant.”

    “In the real world, people who smoke are highly unlikely to hand over their hard-earned cash for cigarettes that contain barely any nicotine,” Bates told Filter.

    Asked what would happen, he said that “if we are lucky,” people would switch to safer nicotine products, like vapes and pouches. But “if not, a massive black market [for cigarettes] will develop, and the authorities will lose control.”

    “People will find their way to unregulated markets and this will actually increase their exposure to harm.”

    Even with regular cigarettes fully available, there is already a large illicit market in the US, to evade taxation. According to some estimates, up to 21 percent of cigarettes purchased in the country are sold illegally. Organizations including the Law Enforcement Action Partnership (LEAP) have voiced concern at the potential for this market to mushroom under what would amount to the prohibition of cigarettes as we know them.

    “We know from any number of historical examples that prohibition doesn’t end the demand for these products: smokers will just go to the underground market to find what they need,” said Major Neill Franklin (Ret.), LEAP’s former executive director, in a press release responding to the FDA announcement.

    Clark concurs. “We know from decades of experience and data that people will find their way to unregulated markets and this will actually increase their exposure to harm—both in terms of questionable product and retail environments,” he said.

    “We are so far from fixing [the] prerequisites that we shouldn’t even be talking about a de facto cigarette prohibition.”

    The more optimistic scenario under the FDA proposal that Bates alluded to—larger-scale switching to reduced-risk products—would meanwhile require at least a couple of things to be in place.

    First, a wide and attractive selection of safer nicotine products would need to be readily available to consumers—when at present only a short list of vaping products, some outmoded and almost all tobacco-flavored, have been authorized by the FDA. Second, misinformation about these products, which is currently rife, would need to be robustly corrected.

    “We are so far from fixing these prerequisites that we shouldn’t even be talking about a de facto cigarette prohibition,” Bates said. In current circumstances, the new measure would be relying on “forced behavior.”

    Abrams similarly said that reducing nicotine levels in combustible tobacco will not work unless there is high-profile recognition of the harm reduction role of safer nicotine products. The public, especially people who smoke, need to have “accurate information about products’ relative harms,” he said, and to know “that while nicotine is addictive and not harmless, it is not the main cause of the chronic diseases and cause of death.”

    Bates additionally questioned whether such a major intervention is even plausible. The US, he pointed out, has been unable to raise federal cigarette taxes since 2009, or to ban all tobacco advertisements, or ban menthol cigarettes—all of which have been implemented in Europe.

    “Why should we expect a huge policy measure like this to sail through US politics and courts,” he asked, “when not much else has?”

     


     

    Photograph by Lindsay Fox via Flickr/Creative Commons 2.0

    The Influence Foundation, which operates Filter, was formerly fiscally sponsored by LEAP.

    • Kiran is a tobacco harm reduction fellow for Filter. She is a writer and journalist who has written for publications including the Guardian, the Telegraph, I Paper and the Times, among many others. Her book, I Can Hear the Cuckoo, was published by Gaia in 2023. She lives in Wales.

      Kiran’s fellowship was previously supported by an independently administered tobacco harm reduction scholarship from Knowledge-Action-Change—an organization that has separately provided restricted grants and donations to Filter.

    • Show Comments