Blumenthal and Durbin Statement on FDA Advisory Committee's Findings Regarding Safety Exemptions for New Smokeless Tobacco Product

[WASHINGTON, DC] – U.S. Senators Richard Blumenthal (D-CT) and Richard Durbin (D-IL) issued the following statement after a Food and Drug Administration (FDA) advisory committee found that evidence presented by Philip Morris International (PMI) was insufficient to support claims that its IQOS heated tobacco product reduces the risks of tobacco-related disease. The ruling was part of a review by the FDA Tobacco Products Scientific Advisory Committee of exemptions from federal safety standards claimed by PMI on the basis that IQOS will improve public health as an alternative to traditional cigarettes. IQOS products are smokeless tobacco mechanisms consisting of tubes that gently heat up sticks of tobacco instead of burning them.

“The FDA Advisory Committee’s conclusions make it clear that Philip Morris has failed to provide sufficient evidence to support claims that its IQOS ‘heat stick’ product will reduce the risk of tobacco-related disease. Until Philip Morris addresses the substantial shortcomings identified by the Advisory Committee, the IQOS device cannot and should not be marketed as a safer cigarette alternative,” said the Senators.

“Glaringly absent in Philip Morris’s appeal for safety exemptions is any concrete data on the product’s impact on non-smoking youth,” the Senators continued. “Big Tobacco’s signature marketing strategies targeting youth have intensified and taken new shape with the introduction of e-cigarettes and other smokeless tobacco products. We remain gravely concerned about the potential for IQOS products to attract young people who otherwise would refrain from cigarette smoking. FDA must heed the critical recommendations made by the Committee– and reject Philip Morris' tenuous claim of a safer alternative to cigarettes under the Tobacco Control Act.”

In an 8-0 vote with one abstention, the FDA committee found that the evidence presented by PMI did not justify a claim that “switching completely from cigarettes to the IQOS system can reduce the risks of tobacco-related diseases.” The committee also found that PMI demonstrated that “switching completely from cigarettes to the IQOS system significantly reduces your body’s exposure to harmful or potentially harmful chemicals.” However, a large majority of the committee found it was unlikely that smokers would switch completely to IQOS and that there is a significant likelihood that smokers would become long-term users of both IQOS and traditional cigarettes. In a final 9-0 vote, the committee found that PMI had not demonstrated that, after viewing the company’s proposed modified risk labeling and advertising, consumers would accurately understand the risks of IQOS.

In October, Blumenthal and Durbin led a letter to FDA Commissioner Scott Gottlieb expressing skepticism about PMI’s claims. Given PMI’s history of misleading marketing – including multiple cases of disproven, decades-long claims about the health dangers of cigarettes – the Senators called on the FDA to undertake a thorough review process of IQOS products before they are allowed access to the market.