US: FDA''s Anti-Smoking Plan May Kill Cigarettes — And Save Big Tobacco

Source from:  Omaha World-Herald 01/23/2018

Imagine if cigarettes were no longer addictive and smoking itself became almost obsolete — that 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 “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 the University of Michigan’s school of public health.

The FDA plan is twofold: drastically cut nicotine levels in cigarettes so they are essentially non-addictive; and 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 this 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 (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 that the focus should be on getting people to quit.

Others are more open to the idea of alternatives to get people away from cigarettes, which are the deadliest form of tobacco.

Tobacco companies have, since the 1950s, made “safer”-cigarette claims — 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 to 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 because of 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 nicotine 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 a key role for alternatives products, but in a world where cigarettes contain such a small amount of nicotine that they are unappealing to 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.

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

At a two-day meeting before the FDA, company scientists will try to 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.

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