Huge FDA announcement on future tobacco and nicotine strategy

It came as a surprise, but today’s announcement from FDA on tobacco policy is huge.  The video of Dr Gottlieb’s […]

FDA’s Scott Gottlieb: “new comprehensive plan for tobacco and nicotine regulation”

It came as a surprise, but today’s announcement from FDA on tobacco policy is huge.  The video of Dr Gottlieb’s speech and background is available here and speech text here.

The new Commissioner, Scott Gottlieb calls for FDA to develop a ‘new comprehensive plan for tobacco and nicotine regulation’ and announced ‘bold and far-reaching measures’ based on ‘ a firm foundation of rules and standards for newly-regulated products’.  FDA announced it would “begin a public dialogue about lowering nicotine levels in combustible cigarettes to non-addictive levels through achievable product standards“.

FDA Press announcement: FDA announces comprehensive regulatory plan to shift trajectory of tobacco-related disease, death

Some highlights…

  • Breathing space. Gives additional four years for submitting vapor product application (now PMTAs must be submitted by 8 Aug 2022 for e-cigarettes – it was previously 2018) to “provide manufacturers additional time to develop higher quality, more complete applications informed by additional guidance from the agency.” I hope this will be enough to keep a diverse industry alive.
  • Product standards. “FDA intends to develop product standards for e-cigarettes to protect against known public health risks” – standards provide certainty and transparency, and if sensibly defined, should lower the costs of participating in the market and provide meaningful benefits to consumers.
  • Process clarity. “FDA plans to issue foundational rules to make the product review process more efficient, predictable, and transparent for manufacturers, while upholding the agency’s public health mission“.  As well as the cost, the opaque assessment and approval procedure has been a major concern, so this is a really important advance.
  • Reduced nicotine cigarettes. “Begin a public dialogue about lowering nicotine levels in combustible cigarettes to non-addictive levels through achievable product standards.” Misguided in my view, but a public dialogue is a long way from a rule.
  • Flavors. “Will seek input from the public on a variety of significant topics, including approaches to regulating kid-appealing flavors in e-cigarettes and cigars“.
  • Medicinal nicotine. “Examine actions to increase access and use of FDA-approved medicinal nicotine products“. I suspect this means new ‘indications’ for harm reduction.
  • Redeploy resources. Assess whether to abandon the backlog of substantial equivalence (i.e. trivial) applications.  Sensible move, but another free ride for cigarettes.

Some quick reactions from me…

Grand strategy… The desire to have a rethink and introduce a comprehensive approach to nicotine is exactly right, necessary and urgent. The positive messages from Dr Gottlieb about harm reduction and his discussion of nicotine, addiction and harm from the delivery system show that he gets it.  These statements are really important and show that FDA leadership is getting to grips with the concept of exploiting differential risks in tobacco products for public health gain. And unlike the past,  the warm words are backed by at least some deeds.

Saving the vapor category…? The easing of some of the regulatory stress from the vapor technologies is essential.  The four-year delay of a requirement to submit PMTAs to 2022, the promise to simplify and clarify the application process, and the emphasis on standards and rules all mark the opening moves in a new regulatory philosophy, in my view. This is an important practical and concrete deliverable from the announcement.

Reducing nicotine in cigarettes… I was initially surprised to see FDA load itself up with the taking forward the reduced-nicotine concept when it has so much else to get right or wrong. Yet this was a headline part of the announcement. But on reflection, this has a number of merits. If FDA is going to have “a new comprehensive plan for tobacco and nicotine regulation” then it would have been strange to omit any consideration of this approach, especially as FDA has spent perhaps ~$100m on research in this area.  Three useful things could come of the inclusion of the reduced nicotine strategy: first, we really do need a full-throated debate on the utility of this idea to stress test it; second, it is an end-game holy grail for some in tobacco control and their opposition would be inevitable without its inclusion; third, it serves as a warning to the tobacco companies – even as only a threat that never crystallizes into action – that the future needs to look different and that reduced-risk products are where this regulated market is heading.

It’s no secret that I think the reduced nicotine idea is both misguided and unnecessary, but I am happy to see it debated and I am confident, in this case, that reason will prevail.   Here’s my presentation on why I think is a well-intentioned but misguided idea (clue: it’s not a scientific issue, it’s a question of political economy) complete with notes in the downloadable Powerpoint. Is nicotine reduction a viable strategy for tobacco control? No,  definitely not. I also wrote about it in my critique of ‘end-game’ ideas.

Flavors… Dr Gottlieb referred to a need to crack down on “obviously kid-attracting flavors“.  Actually, very little is obvious about this issue. Are childish-sounding flavours actually attractive to at-risk adolescents or is it a retro thing for adults? Are these flavours attractive enough to change behaviour? If they do change behaviour, what is the nature of the change in vaping, in smoking? Is this change of behaviour harmful or beneficial, taking account of smoking behaviour? Will it mean fewer adults switch or quit, or more relapse? All that is to be all be fought over in the rule-making process. If the scope of a ban on flavours is narrow (eg. to trademarked candy names) then it is not the end of the world, if it is a sweeping ban on whole sub-categories then it is very problematic. My views on the flavor issue here: Are e-liquid flavours really ‘hooking another generation of kids’?

Overall very positive… Basically, I’m calling a big ‘win’ for the pro-harm reduction public health camp in the United States, consumer advocates as well as those who have been working tirelessly at every level of the industry from vape shop to multinational. On the public health side, please see AG Miller’s letter (June) and the NTRI letter (July) to Dr. Gottlieb for read-overs to the announcement – full details of these initiatives here: American experts call for risk-based reform of FDA regulation of tobacco and nicotine.

My own paper on FDA policy reforms is here: Rethinking nicotine: implications for U.S. federal tobacco policy: a discussion paper (June 2017).

Update 9 August, 2017 AG Miller’s response to FDA’s 28 July 2017 announcement: Miller, Health Policy Experts Applaud FDA Tobacco Control Shift

Much good work done, much still to do!

Comments please.  Am I being too nice about this…?

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33 thoughts on “Huge FDA announcement on future tobacco and nicotine strategy”

  1. Yes, you are being much too nice. This is a horrible and anti-humane plan of the worst type – making cigarettes unattractive and thereby forcing smokers onto Nicorette and force nicotine from the tobacco industry into the hands of Big Pharma. That’s what this plan is intended to do.

    No one should be in doubt about that. Take a look at the FDA-chief’s conflict of interests. This man is owned by Big Pharma – they have his will in their back pocket.

    By The Numbers: Trump’s Choice For FDA Chief Is Versatile, Entrenched In Pharma:

    1. Clive Bates

      I think you are massively over-interpreting this. Gottlieb was also criticised for conflicts of interest with an e-cigarette company Vaping Venture Poses Potential Conflict for Trump’s FDA Nominee.

      If he wanted to do what you say, I don’t think that it would be worth changing course – they could have just carried on and that would be the result.

      My view is the ‘reduced nicotine’ thing is to give the antis something to cheer about. It is a VERY long way from coming to pass.

      1. “My view is the ‘reduced nicotine’ thing is to give the antis something to cheer about.”

        Yes, that’s exactly what it is. And it had the intended result; the headlines in the mainstream press were all “FDA Proposes Reduced Nicotine in Cigarettes” and not “Trump Administration Gives Gift to Big Tobacco, Enslaves Youth to Nicotine Addiction.”

        Make no mistake, if they hadn’t thrown a bone to the TobCon establishment, it would’ve been the latter and not the former.

        Reduced-nicotine cigarettes will never actually happen. Hell, it’s already the law of the land that nicotine content may not be listed on any product package or in any product advertising. So let’s not overreact as though this is an actual thing in the real world, because it isn’t.

        1. “Reduced-nicotine cigarettes will never actually happen.”

          Huh? It happened by the orders of EU-directive 90/239 of May 17. in 1990, and again in EU-directive 2001/37 of June 5. in 2001.

          Why should it not happen again?

        2. This post is not about the EU. We’re talking about the US. If VLNC ever goes beyond the hypothetical-nonsense stage and becomes actual FDA policy, I will buy everyone here a new car.

      2. Over-interpreting? Really? Health authorities have been working for decades to make smoking less attractive in society and thus, to make smokers’ lives unhappier. Deliberately. The nicotine-reducing plan is no different – it’s just another brick in the wall of imposing more misery on smokers.

        These are disgusting anti-human politics, and you know as well as I about Big Pharma’s economic role in these politics. Why would GlaxoSmithKline and Pfizer pay anti-tobacco “experts” for decade after decade without a reason for it?

        Of course they wouldn’t. Big Pharma is a business and it needs revenue. Unfortunately this revenue comes from sick and unhappy people – the more sickness and misery in the world the higher the revenues. The pharma industry has a massive conflict of interest in all health policy questions.

        Of course the new FDA-chief’s former relation to a small vaping retailer does not nullify his years of strong economical ties to the pharma giants, GSK and Pfizer. With Gottlieb, the giants have clearly got their man in at the end of the table in the FDA.

  2. Doug Neaves

    Reducing nicotine in cigarettes is a daft idea, and I have always thought so. However, the FDA cannot ban cigarettes. The FDA can make them less satisfying, presumably for the same cost as un-neutered cigarettes. If ENDS are the new solution to smoking, there is an escape route for smokers. Pharmaceutical ENDS, Big Tobacco ENDS and e-cigarettes, can all exist in the marketplace. Oh, Pharmaceutical ENDS, they cannot sin-tax them, they are medicine.

    One thing that was not clarified, who pays the compensation to the people put out of business by the incompetent, botched regulatory attempt.

  3. Andrew Thompson

    Am I being too nice about this…?
    While I am concerned about the possible effects of reducing nicotine in combustible cigarettes, after watching the video, I am also reassured that Dr Scott Gottlieb will be able to deliver most of the potential I suspected he had to rescue THR products from the destructive effects of the deeming regulations as they stood.

    Taken together, perhaps the FDA CTP can avoid facilitating a burgeoning black market in combustible tobacco. It will be important to ensure that the change of rhetoric about nicotine and THR precedes the introduction of the low nicotine measures. Smokers have been misled for so long that it will take time to correct the public misconceptions in regard to what is actually dangerous about cigarettes.

    I also imagine that the tobacco companies that have strong THR product lines will be encouraged to push forward with their plans, and those without such products will get the kick in the pants they need in order to encourage them into the fray.
    Much good work done, much still to do!
    True, and now I’m reinvigorated to helping American advocates with that work in whatever way I can.

  4. The “reducing nicotine in cigarettes” might not be as daft as it might at first sound, if you also read between the lines.

    Currently, in the U.S. (and a number of other countries), vaping repeatedly gets lumped in as if it was part of the problem (rather than a potential solution), and has been presented in a demonized way to make it sound as if E-liquid Vape Device [EVD] products are as addictive as tobacco (and therefore guilty by inferred association).

    So for legislative purposes, many of the politicians, legislators, senators (etc.) start off with a preconceived impression and decision against vaping. By presenting it as if consideration should be given to approaches that would reduce the nicotine addiction in cigarettes [e.g. removing the addictive boosters in tobacco to make the nicotine more addictive], it may be a way to lead them to listen to the argument “as vape products already do” [since we don’t use boosters to make the product more addictive].

    While not specifically stated, it almost sounds like a way to lead them to “vape products have already shown that a huge reduction in dangerous addiction levels can be achieved” — i.e. vaping is already huge steps ahead in accomplishing what needs to be done in cigarettes, and should therefore not be demonized as being the same as smoking addiction or intent.

    While still too early to tell for sure, it almost sounds like an opening is being made to help us separate from the cigarette nicotine addiction so that there may be less reluctance to consider vaping as a positive tool rather than automatically starting off with the misinformed “stop vaping in order to reduce smoking” propaganda many of the anti-vaping supporters currently begin with.

    Like I said, too early to tell yet… but that may have been an intentional opening left for us to use.

    1. Clive Bates

      There is something in this… The advocates of reducing nicotine idea need high-quality, low-risk products to improve the credibility of the proposal – see here: Reduced nicotine content cigarettes, e-cigarettes and the cigarette end game, for an example of this argument.

      Unless the proponents can say “well, people can switch” then reducing nicotine in cigarettes looks, and is, really coercive and prohibition-like. To the extent there are good alternatives it is an easier sell.

      But here’s the catch…. to the extent there are high-quality low-risk alternatives, the need to force people off cigarettes is ever more unnecessary – the switch is made because the alternatives are better, not by force.

  5. Am I being too nice about this?

    I don’t think so. I always encourage everyone to read any pronouncements from government, particularly related to tobacco/nicotine with a very skeptical eye. I encourage people to always assume that a regulatory body will exercise all the authority it has (or claims) to do the worst. The prior record of the FDA and CTP gives should give one pause before falling into irrational exuberance.

    But I pronounce your statement as not guilty.

    The upside to this announcement (which was completely gratuitous and did NOT need to be done other than for a demonstrated desire to change things) is hugely significant. The vapor industry can live to fight another day. And there will be many fights.

    I agree with your concerns about flavors that “obviously” appeal to youth. That gives me great pause. And yet, I don’t remember a U.S. bureaucrat at FDA, CDC, Surgeon General ever specifically indicating that nicotine is part of the solution and that flavors play a role in helping smokers quit/switch.

    From 35,000 foot view, I see this as a sign that Gottlieb does NOT want to go down in history as an example of “who got it wrong” five or ten years from now in the U.S. while other western nations (primarily U.K. and New Zealand so far but even EU got it more right).

    Much, much work to be done. But it seems we have an audience that will be more transparent (ANPRM vs the way they adopted NNN rule for smokeless) and more willing to listen (genuinely listen) to and consider viewpoints that FDA/CTP has been quick to discard previously.

    You would know much better than I, but I also hope this gives some comfort to those academics and researchers who have boldly stepped forward in support of tobacco harm reduction and provide encouragement to those who might like to do so but are afraid. I also hope it’s a signal that government research and grants will be expanded to not find data to be twisted to demonize vapor products or smokeless, but to actually validate their harm reduction potential.

    Well done!

  6. vapingpoint

    “It’s no secret that I think the reduced nicotine idea is both misguided and unnecessary, but I am happy to see it debated and I am confident, in this case, that reason will prevail.”

    Well, it hasn’t prevailed yet.

    Reduced nicotine cigarettes are more fatal than the old pre-tobacco control ones. Smokers smoke more – simple. Reduced nicotine is not prohibition as you suggest It is selling a product to people that can never be satisfying with malice aforethought, causing them to inhale more smoke. Demanding these is a criminal action to my mind.


    Tobacco Control meddling for nearly 40 years must be responsible for thousands of unnecessary deaths, while they have promoted nicotine as the enemy and forced reduced nicotine cigarettes on smokers who then inhale more smoke.

    It’s common sense. Common sense becomes eradicated when ideology takes over the mind. Reduced nicotine cigarettes and selling cigarettes in packs of 20 rather than 10’s is an example of deranged thinking.

    It’s shameful!

    Too nice? No, ensnared.

    1. Clive Bates

      I don’t think anyone can accuse me of being ‘ nice’ about the nicotine reduction strategy! I’ve spilt an ocean of poisonous ink on it… going back years, including when I was Director of ASH. E.g. see this in 2000 WHO Bulletin Taking the nicotine out of cigarettes – why it is a bad idea.

      If removing nicotine will not work, what is the alternative? It should be recognized that nicotine is a widely used, addictive and legal drug in society — but its delivery system kills one in two long-term users, and this level of harm justifies serious regulatory controls and interventions. Regulators should be concentrating on cleaning up the delivery system, and tending to increase the amount of nicotine in the smoke relative to toxic smoke constituents such as tar and carbon monoxide. Regulatory pressure may be used to force selective reduction of tobacco toxins relative to nicotine by the use of chemically active filters, a switch from burning to heating tobacco, and greater use of oral tobacco, tobacco distillates and perhaps, ultimately, to nicotine delivery devices that do not use tobacco at all but, unlike current nicotine replacement therapies (patches and gum, etc.), deliver a psychoactive and satisfying dose of nicotine to the addict. None of these approaches avoids all harm — far from it — but the evolution (rather than prohibition) of addictive nicotine delivery products represents an important strategy in reducing tobacco-related deaths in the 21st century.

      Pro-vaping before vaping even existed!

      1. vapingpoint

        Quote –

        “The problem with the nicotine-removal idea is that tobacco users would continue to seek nicotine up to the level that provides a satisfactory dose. This is the reason why ‘light’ cigarettes are such a fraud. With light cigarettes, the smoke is diluted with air drawn through ventilation holes in the filter, but smokers respond by taking in more of the weaker smoke to attain the nicotine they need. The machines used for measuring cigarettes do not respond in this way, so the light cigarettes give low tar and nicotine readings on machines but unchanged doses to the smoker. Switching from full-flavour cigarettes to light cigarettes is a little like trying to reduce alcohol intake by switching from wine to beer. With light cigarettes the tobacco is almost the same as in conventional cigarettes, and an attempt to reduce its nicotine content would make matters worse: the smoke would not be diluted, but it would have a lower concentration of nicotine. This means smokers would be taking in more undiluted smoke to attain the nicotine they need. If this happened their toxic exposure would increase and the health impact would be serious — possibly adding millions to the expected tobacco-related death toll.

        I see that in your article. And thank you. Did anyone listen?

        Perhaps smokers affected should press criminal charges against Tobacco Control?

        Maybe you ARE too nice, too polite, too politically correct? A gentleman crying in the wilderness of an arrid ideology that to my mind has failed to protect smokers, but actively HARMS them in three ways.

        1. Interfering with the ‘product’ so it is worse now than it ever was.
        2. Interfering with society to promote division and hatred ON PURPOSE.
        3. Interfering with the minds of smokers (and all who see) with nocebos in advertising on billboards, media and on tobacco products, that induce illness in the viewer.

        Such interference is in the name of ‘health’!

        In the face of such evil, someone needs to speak up. Tobacco Harm Reduction is when Tobacco Control stops its criminal actions.

        I am not a smoker. I am an embittered vaper who sees that the heart of the ALL our problems, both smokers and vapers, is Tobacco Control.

        1. Clive Bates

          Did anyone listen? Yes, basically they do, this is the normal view outside the United States – most people understand this through their understanding of why ‘lights’ don’t reduce exposure.

  7. John Walker

    The extra four years for the evidence that ecigs are helping to reduce smoking and are not ‘the end of the world ‘ etc is a big positive. And the change in ‘attitude ‘ is even more encouraging. On the other hand the core of the TC establishment; its bully BS culture, that won’t change , it will continue on.

    1. BTW

      Fachidioten : professional idiots seems an apt description for most of TCs ‘top dogs’

      “While the great majority of people in the knowledge economy do routine work, the past three decades have seen an explosion of experts on almost every imaginable issue, from different sub-diseases and parts of the human body to all aspects of human life, from diversity management to sexual therapy.

      These experts are often given lots of autonomy within boundaries, yet they are marooned in a very narrow universe. They may do their particular job well, but they do it without much heed to the broader issues. As they pour all their intellectual energy into specialised work, they can become what Germans call Fachidioten – roughly, professional idiots. They know a lot about a specific issue, but are clueless beyond their very narrow domain.

      But by claiming a narrow sub-discipline, you can exude an aura of technical expertise. This can give the would-be specialist a sense of power, status, and self-confidence. It can also have the lucrative side effect of helping them carve out and defend what can often be very lucrative market niches with few competitors.

      Innovation gains from a broader outlook though, an ability to see potential connections between different subfields, the capacity to question certain assumptions and to think differently. Most problems are not isolated.

      Having many experts each working away on their own little aspect of a wider problem can create many unforeseen problems too. Organisations can find themselves expanding because there are more experts employed. Inevitably these experts will start to develop plans, procedures, rules, routines and activities and demand compliance from everybody else. The result is often to multiply bureaucracy, with an organisation’s core work suffering as people are forced to spend time responding to the experts’ demands.”

      Read more:
      Follow us: @FinancialReview on Twitter | financialreview on Facebook

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  9. You know call me odd but haven’t we been there before with reduced nicotine cigarettes?? Would it be more intelligent to reduce nicotine enhancers and research the role wta’s in addiction and whether these could be used in NRTs.

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  11. Yeah, let’s reduce the nicotine…

    Not the tar, the ammonia or any of the other crap – the nicotine.

    The suggestion is sociopathic, there is no other way to interpret it – because no-one could possibly be so stupid as to think that increasing the ratio of poison to nicotine is in any way useful.

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  13. Doctor Rocker

    I see the reclassification of vape products as harm reduction devices rather than tobacco products as a definite good step in the right direction. Vaping after all does constitute harm reduction. Thank you, Dr. Gottlieb.

  14. Roberto Sussman

    The announcement by the FDA is definitely a welcome development. It is far from a final product, rather it is a firm first step in the shift from an authoritarian paradigm of nicotine regulation towards a more humanist THR approach, a shift that follows the recent policy declaration by the tobacco control plan of the British government. These events seem to signal the beginning of the end of the old regulatory “nicotine abstinence” paradigm that emerged in the 1980’s (good riddance !).

    Very low nicotine cigarettes is a very questionable measure, likely intended to make cigarettes unattractive and unpalatable to smokers, thus “inducing” them to shift to THR products. Besides the possibility to generate a black market, it is objectionable on ethical grounds: badgering smokers into consuming non-combustible nicotine delivery products. If the technology produces pleasurable enough such products, smokers can migrate to using them without institutional coercion. This should be the right THR approach.

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  16. I don’t think you are being too optimistic Clive and doubtless you have already recognised most of the caveats…
    Overall, I believe this should be considered a positive development. A negative response which stridently refutes any favourable aspects what, from an FDA perspective is something of a volt face, risks not only appearing disingenuous but also offers ammunition to the ‘opposition’.

    Gottlieb chastened that the polarizing credos on e-cigarettes requires the need for ‘both sides’ to collaborate in a new era of rapprochement. The irony that ‘one side’ has been been struggling to do so for the past five years is not lost on me!) Again, this must surely be in our favour as the dinosaurs would prefer to swallow spanners. We must be overtly transparent in our effort to engage…and register all occasions when requests for dialogue are refused.

    I have two major concerns, one is the intention to ‘increase development of medicinal FDA Approved RRP’s’. Taking a long term view, if the FDA actually manage to severely restrict nicotine in cigarettes and achieve a major reduction then as sure as eggs are chickens there will be a move to adopt the same tactics for e-liquids. The ‘End Game’ remains the Holy Grail. The other is the ‘We need to talk about flavours”.

    Perhaps controversially, I personally believe that it’s high time the industry and trade associations grew up and combined to tackle the controversy over packaging & slogans perceived to be directed towards children. The fact that ‘adults like flavours’ and the designs are not genuinely not targeted at youth is immaterial. A container shaped as an ice-cream cone printed with sprinkles and stardust labelled ‘Let it Go’ is a blatant idiocy.

    My only other caveat is the carefully orchestrated ‘piggy-backing’ of HnB products to align them with e-cigarettes. Even the nomenclature is has been duplicated. This might not be so much of a problem were it not for the insistence (by PMI) that “IQOS is the e-cigarette of the future which will not only satisfy smokers, but has a far higher cessation rate than vaping and is far easier to use”. They quote a “HnB 70% success rate over 10% e-cigarettes”, neglecting to mention that this success was achieved in Japan where vaping is prohibited. The issue of ‘flavours’ is now one of the last bastions which unites all tobacco control zealots and US states alike – enter the cavalry in the name of HnB. Only tobacco flavour, subject to excise tax, no identifiable black market at present and strictly controlled quality assurance – all it needs now is a bit of back-room miracle mongering and a deal will be brokered for a proportion of sales to be considered within the Tobacco Settlement agreement. Unlikely but not impossible. The general view of academia and tobacco harm reductionists appears to be that HnB represents a giant leap forward in harm reduction and that if Big Tobacco eventually overtakes independent vape manufacturers in the HnB and the vaping market it matters not a jot – the end justifies the means. PMI and BAT are now perfectly placed to court the FDA (who have history) into pushing flavour bans in the US and even acquiescing to reduced nicotine conventional cigarettes provided HnB and similar are given centre stage as the alternative of the future. The ineffectiveness of low-nic cigarettes have already been well documented by you and I agree with them all but the ‘threat’ of HnB has not. Finally, in the unlikely event that the FDA manage to reduce nicotine content rest assured they will not stop there – the call to reduce nic content in safer alternative products will inevitably follow. Watch this space.

    Judy Gibson (Steering Coordinator INNCO – but I commenting in a personal capacity).

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