FDA Panel Rejects Philip Morris’ Claim That Tobacco Stick Is Safer Than Cigarettes

A federal advisory committee recommended Thursday that the Food and Drug Administration reject a bid by Philip Morris International to market a smokeless tobacco stick as safer than cigarettes.

The product, called iQOS, is an electronic penlike device that heats tobacco sticks but does not burn them. It releases nicotine vapor, which the company says is less hazardous than smoke. It is already sold in 30 countries.

The advisory panel met for two days to consider Philip Morris’ application to sell its product under a new “modified risk” category. It was seeking to be the first company allowed by the government to claim its tobacco product is less harmful than cigarettes. Philip Morris also is moving on a separate track to get approval to simply sell the device, without making such claims but that might reduce sales.

The FDA is not bound by the panel’s recommendations, but often follows them and is expected to make a decision within a few months.

In two days of discussions, the committee members repeatedly raised questions about the quality of the science behind the company’s claims that the product is safer than cigarettes, and about the company’s certainty that it would not appeal to youths and young adults.

In an 8-1 vote, the advisory committee rejected the company’s contention that “scientific studies have shown that switching completely from cigarettes to the iQOS system can reduce the risks of tobacco-related diseases.”

The group also expressed doubt that smokers would completely switch to use of the iQOS system, saying many might become long-term dual users of the device and traditional cigarettes.

The panel did support the company’s claim that “'scientific studies have shown that switching completely from cigarettes to the iQOS system significantly reduces your body’s exposure to harmful or potentially harmful chemicals.”

The vote may prove to be an obstacle not only for the tobacco giant but also for the FDA’s commissioner, Scott Gottlieb, who has made promotion of alternatives to conventional cigarettes the centerpiece of his new tobacco control strategy, announced in July. One sticking point will likely be the company’s ability to show that the product would not appeal to youths, because it includes a sleek case and is rechargeable.

Mitch Zeller, the head of the FDA’s tobacco division, said the agency would review the recommendations, and would likely receive additional information from the company, in response to questions raised this week.