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FDA TPSAC meeting on PMI/Altria's MRTP for Marlboro Heat Sticks and IQOS

Discussion in 'FDA Regulations' started by Bill Godshall, Jan 24, 2018.

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  1. Bill Godshall

    Bill Godshall Executive Director
    Smokefree Pennsylvania
    ECF Veteran

    Supporting member
    Apr 2, 2009
    FDA TPSAC is now meeting (January 24/25) to discuss PMI’s MRTP application for IQOS and Marlboro Heat Sticks (can be watched live); the public comment period is from 8AM-9AM on January 25.
    2018 TPSAC Meeting Materials and Information

    At the bottom of FDA's webpage is a link to watch the meeting live.
     
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  2. retired1

    retired1 Administrator Admin Verified Member ECF Veteran

    Supporting member
    Apr 5, 2013
    Texas
    • Informative Informative x 2
  3. papergoblin

    papergoblin Super Member Verified Member ECF Veteran

    Nov 16, 2013
    alabama
    The FDA wants cigarettes gone. I don't see a way for this to go through as from what I saw you still have to buy cigarettes to put in the device that heats them. This won't get people off of smokes, it will push them into them more.

    They'll invest in buying the device and when it quits working or they realize it doesn't work, they'll start smoking again. It's just like their half tailed release of Snus, they purposely make stuff that doesn't work, but say they are trying.

    The cigarette companies would be better focused at supplying a different product that is legal in California, Colorado and such. That's about the only way they're going to stay in business, the government is out for blood.
     
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  4. Bill Godshall

    Bill Godshall Executive Director
    Smokefree Pennsylvania
    ECF Veteran

    Supporting member
    Apr 2, 2009
    My statement this morning to FDA's TPSAC (actually to Mitch Zeller, who was sitting there) is below.

    I’m Bill Godshall, founder and executive director of SmokeFree Pennsylvania, which has campaigned to reduce cigarette smoking since 1990 by reducing secondhand smoke exposures, reducing cigarette marketing to youth, holding cigarette companies accountable, and increasing cigarette taxes.

    Since 2004, we’ve also informed the public that cigarettes cause >99% of all tobacco attributable morbidity, disability, mortality and healthcare costs, and that smokefree alternatives are below 2 on the Continuum of Risk in which cigarettes are 100 and NRT products are 1.

    We’ve also advocated keeping ALL low risk smokefree alternatives legal to manufacture, market and use, which is why we opposed the Tobacco Control Marlboro Monopoly Act that was negotiated and agreed to in 2004 by Philip Morris, RWJF financed Matt Myers and then-GSK lobbyist Mitch Zeller, which banned sales of new smokeless tobacco products more than a decade ago.

    We also opposed Josh Sharfstein’s unlawful cigarette protecting 2009 FDA e-cigarette import ban, and Mitch Zeller’s 2016 cigarette protecting Deeming Rule that banned sales of all new vapor products 18 months ago, banned truthful health claims for vapor products, and bans all vapor products in the near future (unless the Deeming Rule is significantly changed).

    For disclosure, neither I nor SmokeFree Pennsylvania have ever received any funding the US DHHS or from any tobacco, drug or vapor company. So no financial conflicts.

    Recent studies indicate Marlboro HeatSticks & IQOS are about 90% less harmful than cigarettes. But far more extensive scientific and empirical evidence has consistently found snus, moist snuff, dissolvables and vapor products are about 99% less harmful than cigarettes.

    So why is FDA considering approving MRTPs for Philip Morris Marlboro products that appear 90% less harmful than cigarettes after FDA banned the sale of vapor products that appear 99% less harmful than cigarettes, have already helped millions of Americans quit smoking (something FDA & CDC have refused to acknowledge), and have helped cut youth smoking in half since 2010?

    And why has FDA refused to accept 367 PMTAs, but is considering PMTAs for Marlboro HeatSticks?

    A key reason is because Philip Morris and Altria spent hundreds of millions of dollars lobbying to enact the 2009 Tobacco Control Act and to impose FDA’s 2016 Deeming Rule because both policies protect Marlboro’s Cigarette Monopoly and Marlboro HeatSticks from market competition by thousands of small smokeless tobacco and vapor companies that cannot afford $100 million to submit PMTA and MRTP applications.

    If FDA approves MRTPs and PMTAs for Marlboro HeatSticks, PM and Altria will spend hundreds of millions of dollars more to protect their new Marlboro HeatStick Monopoly by lobbying to keep vapor products banned, including the Cole-Bishop bill in Congress.

    Before creating another multi billion dollar Marlboro monopoly, the FDA should rescind its disastrous Deeming Rule that bans millions of lifesaving vapor products, and begin to truthfully inform the public that ALL smokefree tobacco/nicotine alternatives are far less harmful than cigarettes.
     
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  5. Bill Godshall

    Bill Godshall Executive Director
    Smokefree Pennsylvania
    ECF Veteran

    Supporting member
    Apr 2, 2009
    The following sentence in the Reuters article is key, as Mitch Zeller and/or Scott Gottlieb will decide (regardless of TPSAC's vote).

    "The FDA is not bound to follow the recommendations of its advisory panels and may not agree with the group’s logic."
     
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  6. Bill Godshall

    Bill Godshall Executive Director
    Smokefree Pennsylvania
    ECF Veteran

    Supporting member
    Apr 2, 2009
    Interestingly, among the 30 presenters at today's TPSAC meeting's public comment period,
    only four tobacco controllers urged FDA TPSAC to reject and/or delay PMI's MRTP for IQOS.
    - Gregory Connolly from Boston,
    - Lauren Lempert (who works at UCSF with Stan Glantz)
    - David Dobbins of the so-called Truth Initiative
    - Matt Myers from CTFK

    Meanwhile, 24 presenters (many/most of whom were funded by PMI or Altria) urged TPSAC
    to approve PMI's MRTP for IQOS (because they think it will benefit public health).

    But of course, FDA has never allowed any THR advocate to serve as a voting member of TPSAC,
    so nobody should be surprised by their votes.

    Then there was my presentation (which was directed at Mitch Zeller, who was sitting 15 feet away) urging Mitch to fix his disastrous Deeming Ban on vapor products before approving PMI's MRTP for IQOS, and giving him many reasons to do so.

    A rep from PETA also spoke criticizing PMI for killing lots laboratory animals for no reason,
    and criticizing FDA for requiring lots of studies that kill laboratory animals for no reason.

    I left the meeting shortly after the public comment period ended, and just drove back to Pittsburgh.
     
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  7. Bill Godshall

    Bill Godshall Executive Director
    Smokefree Pennsylvania
    ECF Veteran

    Supporting member
    Apr 2, 2009
    BTW Regardless of TPSAC's votes, everyone in the room (including Mitch Zeller and Matt Myers) realized that THR won the debate today and is here to stay.
     
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  8. Rossum

    Rossum Surly Curmudgeon Verified Member ECF Veteran

    Supporting member
    Dec 14, 2013
    SE PA
    If I was a betting man, I would wager that the MRTP for IQOS will not be approved, but that a PMTA will. This will allow IQOS to be sold in the USA, but without any claim(s) regarding the relative safety compared to smoking.
     
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  9. Bill Godshall

    Bill Godshall Executive Director
    Smokefree Pennsylvania
    ECF Veteran

    Supporting member
    Apr 2, 2009
    I tend to agree. The PMTA won't allow PMI/Altria make any MRTP claims, but PMI/Altria appear interested in negotiating slightly different MRTP claims with FDA.

    And if FDA approves the PMTA, the news media will tell everyone that IQOS is purportedly less harmful than smoking cigarettes (even though PMI/Altria cannot/won't those claims),
     
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  10. sofarsogood

    sofarsogood Vaping Master ECF Veteran

    Oct 12, 2014
    Is there some place the sessions are recorded? I listened to most of the second day session at work. I'd like to hear the rest.

    There were some excellent speeches in the morning. The panel discussion phase was lame lame lame. I blame the FDA for that by giving the panel sophomoric multiple choice answers to questions that requiire nuance. The flaws in the FDA imposed process yeilded a low quality result regardless of the merits of the science.

    One of the things that annoys me about this entire process is the absense of anyone representing the perspectives of actual, authentic, former smokers. The sign at the hearing room door might as well have said, smokers and former smoker opinions NOT welcome. They claim to be science based but many of their concerns have no basis in sciience. Their self interested "common sense" proves the science will never be good enough. They are fossils. How do we get them out of the conversation?

    I predict kids will favor vaping over heat sticks for the same reasons that vaping makes more sense than smoking. For the kids who want clouds vaping wins. For kids who prefer to be discrete the puff-at-a-time pattern of vaping wins again. I expect heat sticks will cost about the same as cigarettes, significantly more than vapinng, another win for vaping . Then again, don't these considerations apply the same to "grownups"?
     
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  11. jack1010

    jack1010 Full Member

    Jun 24, 2015

    If MRTP for iqos is not approved. FDA can scrap this MRTP because no companies will ever attain it. Even after spending 3 billion on R&D is not suffice on PMI side.

    Their voting seems to contradict. They believed that IQOS is safer but also thinks that continue smoking vs using IQOS will not have much difference in health benefits. :shock:
     
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  12. Bill Godshall

    Bill Godshall Executive Director
    Smokefree Pennsylvania
    ECF Veteran

    Supporting member
    Apr 2, 2009
    FDA has rejected Swedish Match's MRTP application for General Snus products during the past 3 years, but FDA simultaneously urged SM to submit a PMTA for General Snus (which FDA approved) and SM has submitted a slightly different MRTP application for General Snus (that is still being considered by FDA).

    And PMI has insisted (after TPSAC's vote) that it will continue working with FDA to get its MRTP approved.

    I suspect FDA will approve SM's MRTP application for General Snus before it approves PMI's MRTP application for IQOS.
     
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  13. jack1010

    jack1010 Full Member

    Jun 24, 2015
    Approving MRTP for IQOS will probably solve alot of issues which FDA is currently concern about. Which are lung diseases.
     
  14. Bill Godshall

    Bill Godshall Executive Director
    Smokefree Pennsylvania
    ECF Veteran

    Supporting member
    Apr 2, 2009
    If FDA was concerned about lung diseases (or cancers or heart diseases), it wouldn't have banned e-cigarettes in 2009, wouldn't have lied about them since 2009, and wouldn't have banned them again via the 2016 Deeming Rule. I suggest Jack read the statement (above) I made to TPSAC last week regarding IQOS.
     
    • Agree Agree x 1
  15. jack1010

    jack1010 Full Member

    Jun 24, 2015
    So what do you think of the final results? Will FDA approved MRTP for IQOS or will listen to the TPSAC to reject the claims? If Scott Gottlieb rejected this he may never see another product being put up for MRTP submission again as it seems like an impossible task to the rest of the smaller tobacco companies. Scott Gottlieb has repeated stated that FDA was looking at heat not burn technology many times before the TPSAC for IQOS.

    What is FDA concern about this then?
     
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