New smoking device safer than cigarettes, but FDA says not safe enough

  • An iQOS product from Philip Morris. (Philip Morris) Philip Morris

Los Angeles Times
Thursday, January 25, 2018

Tobacco giant Philip Morris had mixed success Thursday in its bid to sell a federal advisory panel on the wisdom of offering U.S. smokers a potentially safer alternative to cigarettes.

After two days of meetings outside Washington, D.C., the Food and Drug Administration’s Tobacco Products Scientific Advisory Committee offered a lukewarm endorsement of a product called IQOS, which Philip Morris and its American partner, Altria, hope to introduce to the American market.

In an 8-1 vote, the panel — made up of nine experts on tobacco and its health effects — endorsed the idea that the heated-tobacco device proposed by Philip Morris “significantly reduces your body’s exposure to harmful or potentially harmful chemicals.”

But when asked to judge whether that reduction would translate into better health for smokers who switched to the new product, the panel signaled that it was not convinced by the company’s research.

By a vote of 5-4, the members narrowly rejected the claim that “switching completely to IQOS presents less risk of harm than continuing to smoke cigarettes.”

Their skepticism does not seal the fate of the tobacco giant’s plan to market its cigarette alternative to the 42 million Americans who continue to smoke.

The final say will be had sometime this spring by FDA Commissioner Scott Gottlieb, who has said the agency aims to “clarify ... the role that potentially less harmful tobacco products could play in improving public health.”

FDA commissioners often follow the advice of their expert panels. But they don’t have to, and Gottlieb has several options for how to proceed.

He could block the sale of the IQOS system in the United States altogether. He could also green-light its sale without allowing marketing claims that it is less dangerous than traditional cigarettes.

Or, he could overrule the panel and allow the tobacco giant to sell IQOS and advertise it as a “reduced risk” product.

The IQOS system is already sold in close to 30 countries, including the United Kingdom and Japan. While Philip Morris touts it as an innovation that will open a safer new chapter in the history of tobacco use, critics charge that it would weaken smokers’ resolve to make the safest choice — quitting tobacco outright.

Critics argue that by offering past smokers, never-smokers and young people an alternative they perceive as safer, the number of Americans addicted to nicotine could actually rise.

The Campaign for Tobacco-Free Kids is particularly concerned that IQOS will appeal to young people who would otherwise stay away from cigarettes.

Philip Morris “failed to provide FDA any evidence about the impact of the product on nonsmoking youth,” the campaign’s president, Matthew L. Myers, said in a statement after Thursday’s vote.

Myers noted that the panel was deeply skeptical that smokers would switch completely to IQOS. By a vote of 8-1, the members concluded that many smokers would become long-term dual users of both IQOS and traditional cigarettes. If so, that would negate the idea that IQOS would be a net benefit for public health, he added.