PMI is using the FDA to sell IQOS outside the US

A friend outside the US sent me this flyer, which PMI is using to promote IQOS (high quality JPEG image):

Here are some reactions from my colleague Lauren Lempert (with a little editing by me). 

The first thing that jumps out is that PMI starts with saying "FDA has authorized the marketing of IQOS....," and then legalistically included the asterisk in a lighter font that blends into the background explaining that "authorization does not mean this product is safe or FDA approved." 

It is likely that most people perceive the words "FDA has authorized" to mean "FDA has approved."  PMI cherry-picked the language from FDA's announcement, but had it printed the entire section, it gives a different message:

While today’s action permits the tobacco products to be sold in the U.S., it does not mean these products are safe or “FDA approved.” All tobacco products are potentially harmful and addictive and those who do not use tobacco products should continue not to. Additionally, today’s action is not a decision on the separate modified risk tobacco product (MRTP) applications that the company also submitted for these products to market them with claims of reduced exposure or reduced risk. 

So essentially PMI's is advertising that if an organization as tough as FDA approves this thing, it must certainly be good enough for the rest of the world to smoke.

Next, PM selects three toxins (carbon monoxide, acrolein, and formadlehyde) and proclaims that IQOS produces lower levels of these toxins as compared to combustible cigarettes, deceptively summarizing FDA's "science-based review" to conclude that "the aerosol produced by IQOS contains fewer toxic chemicals than cigarette smoke."  Of course a careful review of PMI’s application to FDA shows that IQOS produces higher levels of many toxins, and that PM did not report data for all of the FDA’s “Harmful and Potentially Harmful Compounds”. Also, FDA did not consider whether IQOS produces more, rather than fewer, toxins as compared to other products on the market such as e-cigarettes.

The Mitch Zeller quote gives the strong impression that he and FDA believe that IQOS would not have a negative impact on youth use, and has the potential to "move adult smokers away from the use of combustible cigarettes," completely ignoring the reality of dual use that PM's own analysis shows (because of the way PM defines "complete switching" to mean 70% use of IQOS).

More importantly, the Zeller quote states in bold that marketing IQOS "is appropriate for the protection of the public health,"  but as we argued in our analysis, FDA did not properly apply the public health standard, and instead determined that IQOS may be "no worse than cigarettes." 

Meanwhile, Altria plans to launch IQOS in Atlanta in August or September.  They may be trying to target the large middle- and upper-middle-class African American market there (including the "premium" cigar customers), and they may be trying to get product placements in the big movie industry there.  

If they use this ad or similar advertising in Atlanta, FDA should find that it is deceptive and makes an implicit reduced harm claim before PMI has received Modified Risk Tobacco Product (MRTP) authorization allowing them to do that. Tobacco Control Act Section 911 provides that a MRTP product requiring an MRTP marketing order includes a product with a "label, labeling, or advertising [that] represents explicitly or implicitly that" the product presents a lower risk of disease or is less harmful, or "its smoke contains a reduced level of a substance or presents a reduced exposure to a substance..."  Isn't that exactly what this ad says?