WASHINGTON — Imagine if cigarettes were no longer addictive and smoking itself became almost obsolete; only a tiny segment of Americans still lit up. That’s the goal of an unprecedented anti-smoking plan being carefully fashioned by U.S. health officials.

But the proposal from the Food and Drug Administration could have another unexpected effect: opening the door for companies to sell a new generation of alternative tobacco products, allowing the industry to survive — even thrive — for generations to come.

The plan puts the FDA at the center of a long-standing debate over so-called “reduced-risk” products, such as e-cigarettes, and whether they should have a role in anti-smoking efforts, which have long focused exclusively on getting smokers to quit.


“This is the single most controversial — and frankly, divisive — issue I’ve seen in my 40 years studying tobacco control policy,” said Kenneth Warner, professor emeritus at University of Michigan’s school of public health.

The FDA plan is twofold: drastically cut nicotine levels in cigarettes so that they are essentially non-addictive. For those who can’t or won’t quit, allow lower-risk products that deliver nicotine without the deadly effects of traditional cigarettes.

This month the government effort is poised to take off. The FDA is expected to soon begin what will likely be a years-long process to control nicotine in cigarettes. And next week, the agency will hold a public meeting on a closely watched cigarette alternative from Philip Morris International, which, if granted FDA clearance, could launch as early as February.

The product, called iQOS, is a penlike device that heats Marlboro-branded tobacco but stops short of burning it, an approach that Philip Morris says reduces exposure to tar and other toxic byproducts of burning cigarettes. This is different from e-cigarettes, which don’t use tobacco at all but instead vaporize liquid usually containing nicotine.

For anti-smoking activists these new products may mean surrendering hopes of a knockout blow to the industry. They say there is no safe tobacco product and the focus should be on getting people to quit. But others are more open to the idea of alternatives to get people away from cigarettes, the deadliest form of tobacco.

Tobacco companies have made claims about “safer” cigarettes since the 1950s, all later proven false. In some cases the introduction of these products, such as filtered and “low tar” cigarettes, propped up cigarette sales and kept millions of Americans smoking. Although the adult smoking rate has fallen to an all-time low of 15 percent, smoking remains the nation’s leading preventable cause of death and illness, responsible for about one in five U.S. deaths.

Anti-smoking groups also point to Big Tobacco’s history of manipulating public opinion and government efforts against smoking: In 2006, a federal judge ruled that Big Tobacco had lied and deceived the American public about the effects of smoking for more than 50 years. The industry defeated a 2010 proposal by the FDA to add graphic warning labels to cigarette packs. And FDA scrutiny of menthol-flavored cigarettes — used disproportionately by young people and minorities — has been bogged down since 2011, due to legal challenges.

“We’re not talking about an industry that is legitimately interested in saving lives here,” said Erika Sward of the American Lung Association.

But some industry observers say this time will be different.

“The environment has changed, the technology has changed, the companies have changed — that is the reality,” said Scott Ballin, a health policy consultant who previously worked for the American Heart Association.

Under a 2009 law, the FDA gained authority to regulate certain parts of the tobacco industry, including nicotine in cigarettes, though it cannot remove the ingredient completely. The same law allows the agency to scientifically review and permit sales of new tobacco products, including e-cigarettes. Little has happened so far. Last year, the agency said it would delay the deadline for manufacturers to submit their vapor-emitting products for review until 2022.

The FDA says it wants to continue to help people quit by supporting a variety of approaches, including new quit-smoking aids and opening opportunities for a variety of companies, including drugmakers, to help attack the problem. As part of this, the FDA sees an important role for alternative products — but in a world where cigarettes contain such a small amount of nicotine that they become unappealing even to lifelong smokers.

“We still have to provide an opportunity for adults who want to get access to satisfying levels of nicotine,” but without the hazards of burning tobacco, said FDA Commissioner Dr. Scott Gottlieb. He estimates the FDA plan could eventually prevent 8 million smoking-related deaths.

‘Smoke-free future’

Philip Morris International and its U.S. partner Altria will try to navigate the first steps of the new regulatory path next week.

At a two-day meeting before the FDA, company scientists will try and convince government experts that iQOS is less-harmful than cigarettes. If successful, iQOS could be advertised by Altria to U.S. consumers as a “reduced-risk” tobacco product, the first ever sanctioned by the FDA.

Because iQOS works with real tobacco the company believes it will be more effective than e-cigarettes in getting smokers to switch.

Philip Morris already sells the product in about 30 countries, including Canada, Japan and the United Kingdom.

iQOS is part of an elaborate corporate makeover for Philip Morris, which last year rebranded its website with the slogan: “Designing a smoke-free future.” The cigarette giant says it has invested over $3 billion in iQOS and eventually plans to stop selling cigarettes worldwide — though it resists setting a deadline.

Philip Morris executives say they are offering millions of smokers a better, less-harmful product.

Matthew Myers of the Campaign for Tobacco-Free Kids still sees danger. He says FDA must strictly limit marketing of products like iQOS to adult smokers who are unable or unwilling to quit. Otherwise they may be used in combination with cigarettes or even picked up by nonsmokers or young people who might see the new devices as harmless enough to try.

“As a growing percentage of the world makes the decision that smoking is too dangerous and too risky, iQOS provides an alternative to quitting that keeps them in the market,” Myers says.

It’s unclear whether existing alternatives to cigarettes help smokers quit, a claim often made by e-cigarette supporters. Research from the Centers for Disease Control and Prevention suggests about 60 percent of adult e-cigarette users also smoke regular cigarettes.

The case for lower nicotine

Experts who study nicotine addiction say the FDA plan is grounded in the latest science.

Several recent studies have shown that when smokers switch to very low-nicotine cigarettes they smoke less and are more likely to try quitting. But they also seek nicotine from other sources, underscoring the need for alternatives. Without new options, smokers would likely seek regular-strength cigarettes on the black market.

Crucial to the FDA proposal is a simple fact: nicotine is highly addictive, but not deadly. It’s the burning tobacco and other substances inhaled through smoking that cause cancer, heart disease, and bronchitis.

“It’s hard to imagine that using nicotine and tobacco in a way that isn’t burned, in a non-combustible form, isn’t going to be much safer,” said Eric Donny, an addiction researcher at the University of Pittsburgh.

A study of 800 smokers by Donny and other researchers showed that when nicotine was limited to less than 1 milligram per gram of tobacco, users smoked fewer cigarettes. The study, funded by the FDA, was pivotal to showing that smokers won’t compensate by smoking more if nicotine intake is reduced enough. That was the case with “light” and “low-tar” cigarettes introduced in the 1960s and 1970s, when some smokers actually began smoking more cigarettes per day.

Still, many in the anti-smoking community say larger, longer studies are needed to predict how low-nicotine cigarettes would work in the real world.

Legal risks

Key to the FDA plan is the assumption that the two actions will happen at the same time: as regulators cut nicotine in conventional cigarettes, manufacturers will provide alternative products.

But that presumes that tobacco companies will willingly part with their flagship product, which remains enormously profitable.

Kenneth Warner, the public policy professor, said he would be “astonished” if industry cooperates on reducing nicotine levels.

“I don’t think they will. I think they will bring out all of their political guns against it and I’m quite certain they will sue to prevent it,” he said.

In that scenario, the FDA plan to make cigarettes less addictive could be stalled in court for years while companies begin launching FDA-sanctioned alternative products. Tobacco critics say that scenario would be the most profitable for industry.

“It’s like Coke, you can have regular Coke, Diet Coke, Coke Zero, we’ll sell you any Coke you like,” said Robin Koval, president of the Truth Initiative, which runs educational anti-tobacco campaigns.

But the FDA’s Gottlieb says the two parts of the plan must go together. “I’m not going to advance this in a piecemeal fashion,” he said.

When pressed about whether industry will sue FDA over mandatory nicotine reductions, tobacco executives for Altria and other companies instead emphasized the long, complicated nature of the regulatory process.

“I’m not going to speculate about what may happen at the end of a multiyear process,” said Jose Murillo, an Altria vice president. “It will be science and evidence-based and we will be engaged at every step of the way.”

— Matthew Perrone

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  • Yul Brenner brought the Tobacco industry to its Knees in 1985. The govt. sponsored a public service announcement on TV where he said “I swear to you, I would give up every cigarette I have ever smoked, just to live one more day”. Millions quit with each announcement.
    Instead of continuing with the campaign, the govt. made a deal with Tobacco. No more govt. anti-smoking adds, Tobacco only advertised in magazines.
    Tobacco would die today if taken out of movies. Tobacco would die if govt. went into Hollywood hospices and showed your favorite stars dying of Emphysema, (Now conveniently called COPD with a cute elephant ) heart disease, stroke, and Squamous cell cancer (known for 50 years to be caused by Tobacco.)
    Do you remember one of the Green girls on Star Trek? Susan Oliver, a remarkable pilot, great actress, directress, almost killed young in a Pan AM 707, succumbed to Cancer in 1994. She could have given her opinion of Cigarettes and saved millions as well.

    I am sorry, but neither the govt. nor Big tobacco, care. Only YOU can prevent your Smoking Death.

    • I’m sorry, Tobacco has been cultivated by humans for millennia, and motion pictures haven’t been around nearly as long as that.

      The anti smoking industry is enormous and ever-reaching with its lies and money-making regulations that are obviously not working the way that we were told they would work.

      Only you can stop believing everything you’re told and use your own brain to make decisions for yourself, rather than unelected officials with jobs that have them set up for life on our dollar.

      The anti smoking movement is a money-making industry, nothing more or less.

    • Maybe you shouldn’t patronize businesses allowing smoking, if the few that permit it anymore bother you that much? Last I checked smoking is still a legal activity, there are MORE non-smoking than smoker-friendly businesses out there, and that business owners should have the right to permit smoking if they want to.

    • Why, because you don’t care for the rich, satisfying scent of tobacco?

      Tobacco- the plant that built this country and the British empire before it. You might think it was cotton, but we live here today because of tobacco and king James’ vow to not build his empire through conquest. Before he began using his colonies to grow tobacco, smoking was illegal in Britain because he hated it more than anything. Then he realized how broke his country was.

      What if someone didn’t like how you smell- should you be locked up for it? Stating that you don’t have a smell to be offended by makes no difference in this situation, because the other person says that they think you do. That means you are at fault due to someone saying so, regardless of evidence stating otherwise. How severe should your punishment be? I’m willing to bet it It will be far worse that your perceived offense.

      JJ Reuter is right; there is a word for a society dictated by authorities that misinform and control the population through sensationalized statements and locking down commerce for the agendas of the elite, and that word is fascism.

      There is nothing good about fascism.

  • It has always been a tactic of prohibitionists to make a product as harmful as possible to back their ideology. During alcohol prohibition the US government literally poisoned alcohol to make it a worse choice. And today’s opiate holocaust is also the result of the same ideology as regulation instead of prohibition would end the use of poisoned opiates.

    • While I agree that prohibitionists will always rely on propaganda to cultivate hysteria amongst the masses, I feel I must point out your statement regarding the current status with prescription opiates as incorrect.

      The regulation is already present. The current overblown situation has taken place while the opiates themselves were fully regulated. The only people to blame for allowing the overuse of these substances did so with their prescription pads. Yes, doctors are to blame.

      Why aren’t doctors and drug companies being vilified as tobacco users are every day? The same reasons they weren’t during the amphetamine crisis of the 1960s: they have enough money to pay their way out of trouble and keep the prohibition industry (read FDA, WHO, CDC, American Lung Association, etc.) working for them by keeping the masses misinformed and unreasonably terrified. The heads of this industry are well paid with money essentially extorted from their fellow American citizens in the form of outrageous taxation and unamerican regulation that blatantly steps on citizen’s rights and destroys businesses so that others can monopolize the industry by paying off those in control.

      Money, that’s what this is all about. Nothing else can create such controversy.

    • Pardon my last reply, I see now that I mistook your statement as advocating opiate regulation as if it didn’t already exist.

      Other than that, my thoughts expressed in my last statement remain the same- make no mistake, the FDA in particular is selling drugs and tobacco products for their bedfellows in those two industries just as they are dishing out free propaganda and lies.

      They do not care about our health, only our money.

  • Right, as they spray you and your family with nano particles of chemicals , aluminum, barium , and more .

    Right , as they try to continue the fraud of Sept 11. Right , they care . Right , sure .

  • Let’s prohibit alcohol, ban marijuana entirely, tax sugar 500%, and close the methadone clinics. Oh wait – that would severely impact the lifestyles of liberals across the nation …

  • Their website touts a 100% success rate. They are quite possibly the ONLY company on the planet with that kind of record. OR your comment is an advertisement. I’m going with the latter, in deference to P.T. Barnum.

  • But selling & smoking pot is ok…….THAT has poisoned kids, led to more DUI & accidents & can be smoked anywhere! It DOES make you high & leads to other drug use! It also kills brain cells & is addictive ……I do not want THAT around me! Yet no regs on alcohol ….DC would go into DT’S! Not to mention all the other drugs that the FDA puts out then recalls or people die from!

  • Fewer smokers=healthier population Good: lower health costs all around Bad: longer lifespans=Social Security Bankruptcy inevitability, overrun nursing homes, convalescence centers and hospices Burdened families struggling to to be wage earners and care-givers, and ever-increasingly dangerous Florida driving conditions as more blue-haired great-grandmothers continue barrelling down roads in 30 yr old Lincolns while peering through their steering wheels…….

    • Spoken like a spoiled, only-child, narcissist who thinks you’ll lose part of an inheritance you believe should be all yours.

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