Some see FDA plan as saving tobacco

Scott Gottlieb, U.S. Food and Drug Administration commissioner, appears at a Senate committee hearing in October. Gottlieb has said new approaches to smoking cessation eventually could prevent 8 million smoking-related deaths.
Scott Gottlieb, U.S. Food and Drug Administration commissioner, appears at a Senate committee hearing in October. Gottlieb has said new approaches to smoking cessation eventually could prevent 8 million smoking-related deaths.

An unprecedented anti-smoking plan being fashioned by the Food and Drug Administration is seen by some as paving the way to an 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 "reduced-risk" products, such as e-cigarettes, and whether such products 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 they are essentially non-habit-forming. For those who can't or won't quit, allow lower-risk products that deliver nicotine without the health risks 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 be on sale as early as February. Philip Morris already sells the product in about 30 countries, including Canada, Japan and the United Kingdom.

The product, called iQOS (pronounced EYE-kose), 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 tobacco companies' history of manipulating public opinion and government efforts against smoking. In 2006, a federal judge ruled that for more than 50 years the companies had deceived the American public about the effects of smoking. The industry defeated a 2010 proposal by the FDA to add graphic warning labels to cigarette packs.

"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.

"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 that the FDA plan could eventually prevent 8 million smoking-related deaths.

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 extremely habit-forming, 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.

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 main product, which remains enormously profitable.

Warner, the public policy professor, said he would be "astonished" if the 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.

photo

AP/Philip Morris

Philip Morris’ iQOS product is designed to heat tobacco sticks without burning them, delivering nicotine with less tar and other toxic byproducts of burning tobacco.

Business on 01/20/2018

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