@FDAtobacco authorized sales of Philip Morris' IQOS despite scientific evidence of its health Risks

FDA Disregarded its Own Scientists’ Recommendations and Independent Research Showing that IQOS Presents Carcinogenic, Genotoxic, Hepatotoxic, Cardiovascular, and Pulmonary Risks and Misapplied the Law

Lauren Lempert and I just published “Analysis of FDA’s IQOS marketing authorisation and its policy impacts” in Tobacco Control that raises serious questions about how FDA assesses whether new tobacco products are “appropriate for the protection of public health,” the standard in the 2009 Family Smoking Prevention and Tobacco Control Act that gave FDA jurisdiction over tobacco products.

IQOS is a “heated tobacco product” that generates a nicotine aerosol by heating a slick of tobacco rather than a liquid, which is how e-cigarettes work.  (IQOS can be thought of as a solid e-cigarette.)

Our analysis of FDA’s April 2019 marketing order granting Philip Morris authorization to market its IQOS heated tobacco product raises alarms about how FDA might reach decisions on hundreds of premarket tobacco product applications (PMTAs) for e-cigarettes and other new tobacco products that must be submitted to FDA September 9 to keep these products on the market.

FDA allowed marketing of IQOS because they products lower levels of some toxins than combustible cigarettes.  FDA minimized the fact that IQOS produces higher levels of other toxins than cigarettes.

We conducted a line-by-line analysis of the FDA’s decision and reviewed the scientific evidence available to FDA on IQOS, including from previous FDA submissions and published independent research, and found that FDA ignored or did not consider important scientific evidence, some of which FDA’s own scientists pointed out. Some of these findings include:

• Although FDA found there are lower levels of some harmful and potentially harmful constituents (HPHCs) in IQOS compared to cigarettes, IQOS produces higher levels than cigarettes for at least 56 other toxins, including glycerol and propylene glycol which FDA has since proposed to add to the existing HPHC list
• Philip Morris’ own data failed to show consistently lower risks of harm in humans using IQOS compared with conventional cigarettes
• FDA failed to consider its own scientists’ findings and independent analyses showing potential carcinogenic, genotoxic, cytotoxic, mutagenic, hepatotoxic, cardiovascular, and pulmonary impacts in IQOS, some of which are not associated with conventional cigarettes
• FDA’s scientists as well as independent researchers found that the IQOS PMTA did not adequately address concerns about youth use and the potential for dual use, and FDA’s decision depends largely on Philip Morris’ unsubstantiated claim that smokers will “switch completely” to IQOS
• FDA’s own scientists and independent researchers found that consumers do not accurately perceive the addiction risk of IQOS, and the required warning (“nicotine is an addictive chemical”) is not effective to help adolescents understand the risks  

FDA turned the law on its head and issued a permissive marketing order based primarily on its finding that IQOS was not proven to be more dangerous than cigarettes.

FDA’s decision in the IQOS case raises concerns that FDA will not appropriately consider available science and will not properly apply the law to data submitted in impending PMTA assessments including for e-cigarettes and other new tobacco products.

In addition, Philip Morris submitted a supplemental PMTA for its new generation IQOS 3 in March 2020, making FDA’s earlier decision even more significant.

Many of the PMTAs will be for products that are currently being sold (many, like Juul, have been on the market for several years) with absolutely no FDA review or authorization, and include e-cigarettes, e-cigarette flavor pods, nicotine pouches, nicotine-laced toothpicks, and other tobacco products that have been responsible for an explosion of tobacco use among kids and young adults. These decisions may have adverse public health impacts in the US and abroad.

Here is the abstract:

Background: Philip Morris Products SA (PMPSA) submitted a premarket tobacco application (PMTA) to US Food and Drug Administration (FDA) seeking an order permitting it to market IQOS in the USA. US law requires FDA to deny marketing authorization if applicants fail to demonstrate that their product is ’appropriate for the protection of the public health’. FDA issued a marketing order for IQOS in April 2019, which Philip Morris is using to promote IQOS outside the USA.

Methods: We analyzed FDA’s Technical Project Lead Review and marketing order for IQOS, relevant law and guidance on PMTAs and independent research on the health impacts of IQOS.

Results: FDA found that the evidence PMPSA submitted did not demonstrate reduction in long-term disease risks and that IQOS aerosol emits toxins with carcinogenic and genotoxic potential, some at higher levels than conventional cigarettes. PMPSA did not appropriately consider the health impacts of dual use, the product’s attractiveness to youth or data showing that consumers do not accurately perceive the addiction risks of IQOS. Despite FDA’s own scientists’ recommendations and independent research showing that IQOS presents serious risks to users including cytotoxic, genotoxic, hepatotoxic, cardiovascular and pulmonary risks, FDA concluded that IQOS is “appropriate for the protection of the public health.”

Conclusion: FDA’s decision allowing IQOS to be marketed in the USA disregarded valid scientific evidence and misapplied the public health standard mandated by law. This decision may have important health impacts, influence marketing IQOS outside the USA and erode public confidence in FDA’s future PMTA decisions.

The full citation is: Lempert LK, Glantz S. Analysis of FDA’s IQOS marketing authorisation and its policy impacts Tob Control Epub ahead of print: [30 June 2020]. doi:10.1136/ tobaccocontrol-2019-055585