FDA needs to suspend its approval of IQOS until there is evidence that it will not cause the same lung disease as e-cigs

While the nation is reeling from the scary reports of more than 500 severe lung illnesses and at least 9 deaths tied to e-cigarette use (and these numbers are expected to grow), Altria is rapidly moving to roll out is new IQOS heated tobacco product, beginning in Atlanta.  Like Juul, IQOS boasts a sleek, modern design that imitates Apple products, and is sold in stores around the world that imitate Apple stores.  Like Juul, IQOS is recharged electronically. And like Juul, IQOS comes in two menthol flavors (and these flavors are co-branded with Marlboro -- Marlboro Smooth Menthol and Marlboro Fresh Menthol). Nevertheless, Altria claims that IQOS will not be popular with youth, claims that the FDA has accepted.

Likely in response to concerns over e-cigs and lung disease, PMI announced that “IQOS is not related to the vaping illness in the U.S.” This may be true right now, since IQOS is not yet available in the U.S.  Indeed, in many ways an IQOS is a solid e-cigarette in which the nicotine aerosol is produced by heating up “Heatsticks” that contain a lot of propylene glycol (PG) and vegetable glycerin (VG). In fact, a published peer-reviewed analysis of  PMI’s own data submitted to FDA and found that the aerosol in IQOS emissions has higher levels of PG and VG compared to emissions from a conventional cigarette. (IQOS aerosol has 638% higher PG and 141% higher VG than in cigarette emissions.) The application PMI submitted to FDA to get IQOS approved did not contain any studies assessing the kind of lung damage that was found in the experimental study of e-cigarettes such as the one by researchers at Baylor University.  

This was reasonable at the time because the experiment that Baylor did showing how the PG/VG could be messing up lungs had not yet been published.

However, now we have the Baylor study showing that the lipoid pneumonias that have afflicted hundreds of young, otherwise healthy e-cig users in the U.S. may be connected to inhaling the heated solvents (vegetable glycerin (VG) and propylene glycol (PG)) that are used in the e-liquids.  And last month FDA proposed adding VG and PG to its list of “harmful and potentially harmful constituents” because these compounds are identified by the National Institute for Occupational Safety and Health (NIOSH) as having adverse respiratory effects.

While the FDA got caught flat-footed on the mysterious lung disease linked to e-cigarettes (despite individual case reports going back to 2011), they should not make the same mistake with IQOS, which is not yet in wide distribution in the US. 

Before IQOS becomes another public health emergency, FDA should suspend IQOS’s marketing order and insist that studies are completed demonstrating that the PG and VG in IQOS that is heated and inhaled by users is not causing the same problems that have been observed in e-cigarettes.  In particular, they should require PMI to complete studies following the Baylor protocol.   If those studies come up positive, the IQOS marketing order should be revoked.

And if PMI’s studies come up negative, FDA should do their own independent studies to make sure that PMI didn’t miss anything.

When challenged about the appropriateness of approving IQOS, the FDA has said that any problems could be picked up in post-market surveillance.  What that means in practical terms is that IQOS users must first get sick and die before FDA will start to think about what steps it should take to protect the public.

Given what is happening with e-cigarettes, that is not an appropriate solution. 

Lauren Lempert and I collaborated to prepare this blog post.