IQOS Cigarette Alternative Suffers a Blow at FDA Panel

By Betsy McKay and Saabira Chaudhuri
Updated Jan. 25, 2018 7:35 p.m. ET
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Scientists advising U.S. regulators dealt a setback to the tobacco industry’s multibillion-dollar quest to bring a cigarette alternative to market, saying there wasn’t enough evidence a hand-held device that heats but doesn’t burn tobacco reduces the risks of tobacco-related disease.

The advisory committee to the Food and Drug Administration said scientific evidence was insufficient to support an ambitious marketing claim proposed by Philip Morris International Inc. PM -1.55% for the U.S. market. The claim said switching completely to the IQOS device from conventional cigarettes could reduce the risk of tobacco-related disease. The panel did agree with the company’s proposed claim that switching completely from smoking cigarettes to using IQOS reduces the body’s exposure to harmful chemicals.

The FDA’s review of IQOS is being closely watched, because it will have enormous implications for the tobacco industry and U.S. public health.

The safety and role of alternatives to cigarettes are a matter of intense debate. Critics believe they perpetuate smoking and an addiction to nicotine, while supporters argue they help smokers quit conventional cigarettes, which release toxic chemicals when the tobacco in them burns.

Tobacco companies have spent billions of dollars in recent years to research and market tobacco heating and other new products they believe will help lure existing smokers from conventional cigarettes, whose sales are in decline globally.

While tobacco companies have so far been able to offset declining volumes with rising prices, that strategy is seen as having limits, and companies are scaling back investments in traditional tobacco operations.

The advisory panel members said unanimously they didn’t believe Philip Morris had shown consumers would understand the risks of using IQOS from its labeling and advertising. A majority of panelists also said the likelihood was low U.S. smokers would switch completely to IQOS.

A Philip Morris spokesman said, “We are confident in our ability to address the valid questions raised by the Committee with the FDA as the review process for our application continues.”

IQOS is a hand-held device that heats tobacco but doesn’t burn it, so it doesn’t produce smoke when users inhale. It differs from other smoking alternatives like e-cigarettes that produce vapor from nicotine-laced liquid.

Philip Morris already sells IQOS in 29 countries, often in sleek boutiques. Now the company, through U.S. partner Altria Group Inc., MO -1.23% hopes to sell the device in the U.S. to people who want to quit smoking, with the claim it cuts the risk of tobacco-related diseases such as cancer and benefits public health. It has submitted two separate FDA applications: One to sell IQOS in the U.S. and another to market it as safer. The advisory panel hearing focused on the second one.

IQOS is one of a wave of smoking-alternative products the tobacco industry is counting on for growth. Japan Tobacco Inc. sells a device called Ploom Tech, which uses tobacco capsules. British American Tobacco PLC has its own heat-not-burn product similar to IQOS called Glo and plans to apply this year for FDA approval.

The findings of the Tobacco Products Scientific Advisory Committee will go to the FDA, which will make the decision on both applications.

Mitch Zeller, director of the FDA’s Center for Tobacco Products, said the agency would weigh the committee’s findings along with public input and other information to reach its decision.

A go-ahead from the FDA could pave the way for regulation that pushes cigarette smokers to newer, safer alternatives, said David Sweanor, a tobacco-control expert and adjunct professor of law at the University of Ottawa. “The substitution of non-combustion products has huge health potential,” he said.

Some analysts and tobacco experts said the advisory panel’s position would make it difficult for the FDA to approve Philip Morris’s claim that IQOS reduces disease. Jefferies analyst Owen Bennett said he expects the FDA to approve the tobacco giant’s application to sell IQOS in the U.S. without making a claim that IQOS is safer than conventional cigarettes.

“It was almost impossible for a vote to be ‘yes,’ ” said Mr. Bennett, noting the high burden of proof and ambiguity in the statements members were asked to vote on.

Philip Morris could submit more evidence or propose a less-ambitious claim, said Michael Eriksen, dean of Georgia State University’s School of Public Health and principal investigator of the university’s Tobacco Center of Regulatory Science. “The claims could be restated,” he said. “I think it’s a process, and they’re in the middle of it.”

The Marlboro maker has invested over $3 billion to develop IQOS and other cigarette alternatives. Since 2008, Philip Morris has hired over 400 scientists and experts to do research and development, housing them in a glass building in Neuchâtel, Switzerland, nicknamed “the cube.”

The company is seeking a reduced-risk marketing claim to help it tap a large potential market. Of the 36.5 million adult smokers in the U.S., 67% of men and 69% of women want to quit, according to the Centers for Disease Control and Prevention. Philip Morris is counting on lower taxes and looser marketing restrictions for IQOS than those levied on conventional cigarettes to push smokers to switch to the new product. “The regulatory environment has to differentiate the products,” said Philip Morris Chief Executive Andre Calantzopoulos in an interview last year.

In the FDA advisory-committee meeting, Philip Morris officials presented studies asserting that IQOS produces fewer toxic chemicals than conventional cigarettes, reducing molecular changes in cells and tissue that could lead to disease. The company projected that six million smokers would switch to IQOS in 10 years and that use of the product could have saved more than 90,000 lives between 1990 and 2010.

It also said Altria would urge smokers to switch completely to IQOS in its U.S. marketing.

“The objective is to move as many American smokers as possible away from cigarettes,” said Moira Gilchrist, Philip Morris International’s vice president of scientific and public communications.

Several committee members expressed concern that young people who don’t currently smoke could be lured by IQOS marketing. “We have to use the e-cigarette experience,” said Deborah Ossip, professor in the department of public-health sciences at the University of Rochester Medical Center. Some 11.3% of high-school students reported using e-cigarettes in 2016, according to the CDC.

The majority of votes among the panelists said the likelihood was low U.S. smokers would switch completely to IQOS, partly because the device is expensive. “People are going to have to put out a good deal of money,” said Michael Weitzman, professor of pediatrics at New York University.

Philip Morris’s evidence that using IQOS exclusively exposes the body to fewer toxic chemicals than smoking cigarettes was compelling, committee members agreed. But they found the assertion that IQOS could reduce disease risk vaguely worded and lacking in evidence. “I don’t think I’d be able in good conscience to say this has been really demonstrated to reduce harm,” Dr. Weitzman said.

“Based on the scientific evidence presented, my read is it would be premature to make such a claim,” Dr. Ossip said.