But the proposal of 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 places the FDA at the center of a long-standing debate about so-called "reduced risk" products, such as electronic cigarettes, and whether they should have a role in anti-smoking efforts, which have focused exclusively in making smokers quit smoking.
"This is the most controversial, and frankly divisive, issue I've seen in my 40 years of studying tobacco control policy," said Kenneth Warner, professor emeritus at the University's School of Public Health. Michigan.
The FDA's plan is twofold: to drastically reduce nicotine levels in cigarettes so that they are essentially non-addictive. For those who can not or do not want to quit smoking, allow lower-risk products that deliver nicotine without the deadly effects of traditional cigarettes.
This month, the government effort is about to take off. The FDA is expected to begin soon what will probably be a process of years to control nicotine in cigarettes. And next week, the agency will hold a public meeting on a closely monitored cigarette alternative to Philip Morris International, which, if granted FDA clearance, could be released as early as February.
The product, called iQOS (pronounced EYE-kose), is a pen-like device that heats Marlboro tobacco but does not burn it, an approach that Philip Morris says reduces exposure to tar and other toxic byproducts. burning cigarettes This is different from electronic cigarettes, which do not use tobacco at all, but vaporize liquid that usually contains nicotine.
For anti-smoking activists, these new products can mean giving hope for a knockout in the industry. They say that there is no safe product for tobacco and that the goal should be to get people to quit smoking. But others are more open to the idea of alternatives to keep people away from cigarettes, the deadliest form of tobacco.
Tobacco companies have made claims about "safer" cigarettes since the 1950s, all of which proved false. In some cases, the introduction of these products, such as filtered and "low tar" cigarettes, boosted cigarette sales and kept millions of Americans smoking. Although the rate of adult smokers has fallen to a record low of 15 percent, smoking remains the leading cause of death and preventable disease in the nation, responsible for about one in five deaths in the United States. UU
Anti-smoking groups also point to Big Tobacco's history of manipulating public opinion and the government's efforts against smoking: in 2006, a federal judge ruled that Big Tobacco had lied and cheated 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 the FDA's scrutiny of menthol-flavored cigarettes – disproportionately used by youth and minorities – has been bogged down since 2011 due to legal challenges.
"We are not talking about an industry that is legitimately interested in saving lives here," said Erika Sward of the American Lung Association.
"The environment has changed, technology has changed, companies have changed, that is the reality," he said. Scott Ballin, a health policy consultant who previously worked for the American Heart Association.
According to a 2009 law, the FDA obtained authority to regulate certain parts of the tobacco industry, including nicotine in cigarettes, although it can not completely eliminate the ingredient. The same law allows the agency to scientifically review and allow the sale of new tobacco products, including electronic cigarettes. Little has happened so far. Last year, the agency said it would delay the deadline for manufacturers to ship their steam-emitting products for review until 2022.
The FDA says it wants to continue helping people quit smoking by supporting a variety of approaches, including new dropouts. smoking aids and opening opportunities for a variety of companies, including drug manufacturers, 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 unattractive even for lifetime smokers.
"We still have to provide an opportunity for adults who want access to satisfactory levels of nicotine," but without the risks of burning tobacco, said FDA Commissioner Dr. Scott Gottlieb. of the FDA could prevent 8 million deaths related to smoking.
"FUTURE FREE OF SMOKE"
Philip Morris International and its US partner Altria will try to navigate the first steps of the new regulatory path next week.
In a two-day meeting with the FDA, the company's scientists will try to convince government experts that iQOS is less harmful than cigarettes, and if successful, Altria could advertise iQOS to American consumers as a product of "Reduced risk" tobacco, the first sanctioned by the FDA.
Because iQOS works with real tobacco, the company believes that it will be more effective than e-cigarettes for it. ograr that smokers change.
Philip Morris already sells the product in approximately 30 countries, including Canada, Japan and the United Kingdom.
iQOS is part of an elaborate corporate makeover for Philip Morris, who last year changed his name to The Cigarette Giant says he has invested more than $ 3 billion in iQOS and finally plans to stop selling cigars in everyone, although he is reluctant to set a deadline.
Philip Morris executives say they are offering millions of smokers a better and less harmful product.
Matthew Myers of the Campaign for Children Without Tobacco still sees danger. He says the FDA should strictly limit the marketing of products like iQOS to adult smokers who can not or do not want to quit. Otherwise, they can be used in combination with cigarettes or even picked up by non-smokers or young people who might see the new devices as harmless as 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 quit smoking that keeps them in the market," says Myers.
It is not clear whether existing alternatives to cigarettes help smokers to quit smoking, a claim often made by electronic cigarette fanatics. Research from the Centers for Disease Control and Prevention suggests that approximately 60 percent of adult users of electronic cigarettes also smoke regular cigarettes.
THE LOWER NICOTINE CASE
Experts studying nicotine addiction say that the FDA's plan is based on the latest science.
Several recent studies have shown that when smokers switch to cigarettes that are too low in nicotine, they smoke less and are more likely to try to quit smoking. But they also look for nicotine from other sources, which underscores the need for alternatives. Without new options, smokers would probably look for regular cigarettes on the black market.
Crucial to the FDA proposal is a simple fact: nicotine is highly addictive, but not lethal. It is the burning of tobacco and other substances inhaled through smoking which causes cancer, heart disease and bronchitis.
"It is difficult to imagine that the use of nicotine and tobacco in a way that does not burn, in a non-combustible way, is not." it's going to be much safer, "said Eric Donny, an addiction researcher at the University of Pittsburgh.
A study of 800 smokers conducted by Donny and other researchers showed that when nicotine was limited to less than 1 milligram per gram of The study, funded by the FDA, was instrumental in showing that smokers will not compensate by smoking more if nicotine intake is reduced enough, as was the case with "light" and "low" cigarettes. -tar "introduced in the 1960s and 1970s, when some smokers started smoking more cigarettes per day.
Still, many in the anti-smoking community say that larger and longer studies are needed to predict how cigarettes would work low in nicotine in the real world.
The key to the FDA's plan is the assumption that the two actions will occur at the same time: regulators co Nicotine in conventional cigarettes, manufacturers will provide alternative products.
But that means that the tobacco companies will voluntarily separate themselves from their flagship product, which remains enormously profitable.
Kenneth Warner, the public policy professor, said he would be "amazed" if the industry cooperates on reducing nicotine levels.
"I do not think they'll do it, I think they'll get all their political weapons against that and I'm pretty sure they'll sue to avoid it," he said.
In that scenario, the FDA's plan to make cigarettes less addictive could get stuck in the courts. for years, while companies start launching alternative products sanctioned by the FDA. Critics of tobacco say that this scenario would be the most profitable for the industry.
"It's like Coca, you can have Coca-Cola, Coca-Cola Light, regular Coca-Cola, we'll sell you any Coca-Cola that you like," said Robin Koval, president of The Truth Initiative, which conducts educational campaigns against tobacco.
But Gottlieb from the FDA says that the two parts of the plan should go together. "I'm not going to move forward gradually," he said.
When asked if the industry would sue the FDA for mandatory nicotine reductions, tobacco executives from Altria and other companies emphasized the long and complicated nature of the regulatory process.
"I'm not going to speculate about what can happen at the end of a multi-year process," said José Murillo, vice president of Altria. "It will be based on science and evidence and we will commit ourselves every step of the way."
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