Company tries to sell ‘heat not burn’ cigarettes as safer

A man uses a Philip Morris iQOS smoking device. Jaime Saldarriaga / Reuters

“The HeatStick contains a tobacco plug consisting of crimped cast tobacco sheet made from ground tobacco powder,” the FDA says in a statement released ahead of the meeting.

“It is designed to function with the IQOS Holder to produce an aerosol when the plug is heated. It is a filtered, non-combusted cigarette.”

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Philip Morris says it has already sold the product to 3.7 million people in countries including Canada, Colombia, France, Britain and Spain.

The FDA advisers are asked to decide whether Philip Morris should be able to sell the product in the U.S. with the claim that the product is less harmful than cigarettes. They’ll be asked if the studies presented by Philip Morris hold up and they’ll be asked if smokers will really switch to the product if it is offered.

Medical groups are dubious.

“This is something that really requires careful FDA review,” the Lung Association’s Erika Sward said.

“It is clear that Philip Morris cannot be trusted with the data that it submits to FDA. They have clearly left out some key parts of their analysis. FDA needs to make sure that it is appropriate for the protection of the public health.”

Philip Morris is one of the companies ordered to run a year’s worth of advertisements

admitting to having lied for years about the dangers of cigarettes, and admitting to deliberately making them more addictive.

Unclear benefits of smoking less

The FDA points out some weaknesses in Philip Morris’s arguments in its own briefing documents given to the committee.

“First, the studies were not designed to be representative of all smokers in the U.S. For example, light (i.e., less than 10 cigarettes per day) or non-daily smokers were not recruited into the studies,” the FDA said.

Sward said that the tobacco company’s data only compares heavy smokers to people using the new product, which may not represent most of the U.S. smoking market.

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And, the FDA noted, “the health benefit of reducing cigarette consumption instead of quitting completely is unclear.”

Public health researcher Noel Brewer of the University of North Carolina led a team that also questioned the application.

“Philip Morris’s claim is misleading,” they said. “For an exposure modification order, an applicant must demonstrate that consumers ‘will not be misled’ into believing the product is less harmful than another product. The study in the application by Philip Morris instead shows that consumers were misled into believing IQOS is less harmful than cigarettes,” they said.

“Misleading 26 percent of the 36 million smokers in the U.S. means misleading millions of people. These messages could also mislead millions of susceptible nonsmokers, including adolescents. Clearly, Philip Morris has not met the requirements for an exposure modification order.”

So-called consumer freedom groups urged the FDA to approve the application. “For the many smokers who want to quit using cigarettes, there is now genuine hope that this goal can be achieved,” the right-leaning Heritage Foundation said in a statement supporting the application.

“By stepping out of the way, the FDA can fulfill its obligation to support tobacco and tobacco-alternative technological innovations, thereby allowing the market to do what decades of public health campaigns have failed to accomplish: provide smokers with satisfying alternatives to fully quit tobacco or practically eliminate tobacco-related harms,” Michelle Minton of the Competitive Enterprise Institute said in her group’s comments.

Congress gave the FDA the authority to regulate tobacco products in 2009, although the FDA may not ban them. Health groups have been clamoring for the FDA to crack down more on tobacco companies.

The

Centers for Disease Control and Prevention says cigarettes kill 480,000 Americans a year, and tobacco use costs $170 billion in direct medical costs and $156 billion in lost productivity.

“Cigarette smoking among U.S. adults has been reduced by more than half since 1964, yet remains the leading preventable cause of disease and death in the United States. It kills more than 480,000 Americans each year,” the CDC says.