PMI/Altria sold iQOS in US on 8/8/16, to submit MRTP and PMTA applications to FDA soon

[Bill Godshall]

PMI/Altria plan to submit a 2-3 million page MRTP application for iqos to FDA by end of 2016, to submit PMTA for iqos to FDA in 2017, and claim iqos is currently available in 10 cites (but didn’t say where), documenting that iQOS was sold in the US (in select undisclosed location(s)) on August 8, 2016.
Philip Morris’s Cigarette Alternative Could Hit U.S. in 2017
Philip Morris Readies iQOS for the U.S.

The the only other MRTP application submitted to FDA by Swedish Match (for General snus brands) was more than 180,000 pages long. Both of these MRTP applications vindicate my calling FDA's draft Guidance for MRTP applications a "Ten million dollar truth tax" since 2012 (in my oral and written testimonies to FDA, and in many of my presentations and writings).


Also on IQOS (marketed as "Marlboro heat-sticks" in Japan) last week, Philip Morris International (PMI):
- reported a 5.4% cigarette volume decline in 3Q16 (as vapor sales keep increasing);
- reported a 755% increase in Marlboro HeatSticks (iQOS) shipment volume (to 2.1 Billion units); and
- attributed PMI's 5.8% cigarette volume decline in Japan partly to skyrocketing sales of Marlboro HeatSticks, which now have 3.5% of Japan's cigarette+iQOS market share.
PMI.com 2016 Press Releases
Philip Morris' cigarette shipments hurt earnings
Philip Morris Earnings Flat as Cigarette Shipments Decline

 

[bobwho77]

2-3 MILLION pages!?!?!?
The regulations, as written are flatly impossible to comply with, but I'm pretty sure that was the point.
BTW... Given the amount of time it would take to generate that much paper, how long ago did PMI start doing this? Just how much advance notice/knowledge of the regulations did they have? How did they get it, and who gave it to them?

 

[Stubby]

2-3 MILLION pages!?!?!?
The regulations, as written are flatly impossible to comply with, but I'm pretty sure that was the point.
BTW... Given the amount of time it would take to generate that much paper, how long ago did PMI start doing this? Just how much advance notice/knowledge of the regulations did they have? How did they get it, and who gave it to them?

The contents of the deeming have been known since 2014 when the initial proposed deeming came out. The application process for an MRTP has been known since 2009 with the tobacco control act was signed into law (actually 2007 when it was first introduced).

Plenty of time, and no grand conspiracy needed.

 

[retired1]

2-3 MILLION pages!?!?!?
The regulations, as written are flatly impossible to comply with, but I'm pretty sure that was the point.
BTW... Given the amount of time it would take to generate that much paper, how long ago did PMI start doing this? Just how much advance notice/knowledge of the regulations did they have? How did they get it, and who gave it to them?

The company has been working on this for years.

iQos Expands in Japan

A team of 400 Philip Morris International engineers, scientists and technicians in Switzerland began developing the iQOS approximately 10 years ago. Tomoko Iida, manager of scientific regulatory affairs at Philip Morris Japan, said that "90% of the toxicity is eliminated with the iQOS, compared with traditional cigarettes"—though the company cannot officially say the iQos is healthier than cigarettes because research has not yet been finalized. Findings from the Swiss research team should be ready for publication by the end of 2015.

 

[bobwho77]

The contents of the deeming have been known since 2014 when the initial proposed deeming came out. The application process for an MRTP has been known since 2009 with the tobacco control act was signed into law (actually 2007 when it was first introduced).

Plenty of time, and no grand conspiracy needed.

Maybe so (I had forgotten that the MRTP process was part of the original tobacco control act) but conspiracies are so much FUN!
2 million+ pages is still a LOT of paper. Do they really think that they can adequately/honestly review a document like that? It would almost be worth the cost/effort of producing the PMTAs for all the products a retailer like Mt Baker sells. (I know they're all from different manufacturers) just to watch their faces. You're talking about TRUCKLOADS of paperwork for each of literally thousands products.

 

[retired1]

Bear in mind, the majority of that is going to be scientific studies that they've conducted over the course of 10 years. The FDA will most likely just concern themselves with the results. It's doubtful they'll actually read through the methodology. But it all has to be on file if something crops up down the road.

For grins and giggles, that report (taking just 2 million pages into account) would be 833.5 feet high. That's a lot of pages!

 

[Myrany]

For grins and giggles, that report (taking just 2 million pages into account) would be 833.5 feet high. That's a lot of pages!

So much for paper reduction and saving trees.

 

[puffon]

So much for paper reduction and saving trees.

LOL...they may just give them a PDF, on it's own hard drive.

 

[Bill Godshall]

Since 2011, when I was urging all cigarette company executives to develop and/or buy vapor products, PMI researchers have told me they were developing a new heat-not-burn alternative to cigarettes that would likely be marketed in the US in 2017. How right they were.

 

[Bill Godshall]

I have been informed (by someone who knows) that iQOS was NOT on sale in the US on 8/8/16, and that Altria/PMI will NOT be selling iQOS in the US until after FDA approves its PMTA, which Altria just said this week (in press release below) would be submitted to the FDA in the first quarter of 2017.
Press Release

As such, the earliest iQOS could be on sale in the US is in the third quarter of 2017
(6 months after Altria/PMI file the PMTA), and the earliest Altria/PMI could truthfully inform consumers that iQOS is less harmful than cigarettes is in the fourth quarter of 2017 (12 months after Altria/PMI file the MRTP application).

I was confused by the first sentences of both news articles above, which insinuated that iQOS would be sold in the US in early 2017 (before FDA approved either the MRTP or the PMTA), which could only lawfully occur if iQOS was on sale in the US on 8/8/16.

"Philip Morris International Inc. is set to test the market for its iQOS device -- the most advanced product to come out of its multi-billion dollar push to develop cigarette alternatives -- with a U.S. rollout as soon as next year, pushing ahead even before health regulators deem it safer than traditional smokes."
and
"Through a licensing deal with Altria, Philip Morris International plans to bring a “heat not burn” product to the United States by early next year, according to a Bloomberg report."

 

[retired1]

And it's official.

Philip Morris seeks U.S. approval to market alternative cigarette

Philip Morris International Inc (PM.N) filed a much-awaited U.S. application to market a new type of cigarette that heats rather than burns tobacco and may carry fewer health risks.

The company's application is the first to seek U.S. approval to market a tobacco product as being less harmful than traditional cigarettes.

If approved by the U.S. Food and Drug Administration, the company's iQOS device could give it a significant marketing advantage over alternatives to tobacco products, including electronic cigarettes, which are not allowed to make such a claim.

This will also be a test to see if the FDA is going to use the deeming regulation to deny everything, regardless of documentation accompanying the approval request.

 

[Startle]

For grins and giggles, that report (taking just 2 million pages into account) would be 833.5 feet high. That's a lot of pages!

I cannot even fathom this. Is it a flip book with one word on each page? Laid out, 2 million pages would be 347 miles long...