October 25th, 2017

FDA wants to reduce nicotine in cigarettes - what could possibly go wrong (and right)?

Some things don’t have to be used to be useful

On 28th July, FDA announced that it wants to hold a “public dialogue” about regulating to reduce nicotine levels in cigarettes to “non-addictive levels”. I’ve previously written about this idea in my critique of ‘tobacco endgame’ ideas, and I was pleased to present on the subject at SRNT 2017 conference.  Generally, I’ve taken the view that the idea is crazy, unworkable, unethical and will never happen, and I have a hefty bet against it.

But now that FDA has announced it, everyone should ask: might any good come of it?  That has prompted me to reconsider my previously entirely hostile approach. So here are some updated views in a report done in collaboration with Dr Carrie Wade, Director of Harm Reduction Policy at the R Street Institute, Washington DC.

The three minute version…

  • The reduced nicotine measure amounts to a prohibition of the dominant product in a market worth $94 billion, of which over $40 billion is federal and states tax revenue. Cigarettes without nicotine are no longer cigarettes, just as whiskey without alcohol is no longer whiskey.
  • The reaction of the market – consumers, legal suppliers, criminal enterprise – to such a huge intervention is highly unpredictable and cannot be assessed by research into how people use reduced nicotine cigarettes, which they are willing to do in trials but will not in real life. The risks of unintended consequences are high and hard to dismiss in the absence of relevant evidence. The ethics of forced quitting of a personal behaviour are at best questionable and will generate political resistance in many of the 38 million Americans who smoke. The practical, fiscal, stakeholder, legal and political difficulties of introducing this measure will likely be overwhelming.
  • There are more manageable options to reduce the appeal of smoking, if that is the FDA’s policy intent.  For example raising taxes, reducing selected toxins, control of additives and removal of branding. FDA will have to show that nicotine reduction will be superior to these approaches, but it has very little evidence with which to do this.
  • However, the reduced nicotine measure is useful.  It is an important signal of a direction of travel – the end of combustible tobacco products as nicotine delivery products. This could make it an ‘agency threat’ – a big stick that has influence in setting direction and pressing companies and their investors to respond.
  • Furthermore, for such a proposal to work it has to be credible and FDA will have to work to overcome the many objections. The internal logic of FDA’s approach calls for the availability of high quality low-risk alternatives to smoking that are acceptable to most smokers – otherwise the degree of forced quitting is excessive.  FDA therefore needs to address the excessive regulatory burdens it has applied to vaping products, smokeless and heated tobacco products. It needs to apply its technical-legal ingenuity to come up with a standards-based risk-proportionate regulatory framework. It also needs to make this pathway attractive to smokers by telling the truth about relative risk and allowing companies to do the same.
  • These are good things to do in their own right, but they are prerequisites for a reduced nicotine rule. The final paradox is that if the market for alternatives is made to work, it will become unnecessary to actually introduce the reduced nicotine rule.  The rule will have had its beneficial effect as a market signal and powerful agency threat.
  • Rules, like nuclear weapons, don’t have to be used to be useful. But they do have to be credible: and FDA has a lot of work to do to make the reduced nicotine proposal credible.

The report table of contents

1 Introduction

2 Summarizing FDA strategy

3 The challenge of nicotine reduction and nicotine-seeking behavior

4 Issues FDA will need to address

4.1 A rule reducing nicotine to non-addictive levels is a cigarette prohibition in practice

4.2 The pressure to broaden the scope of the rule

4.3 The compliance fallacy – people will not act as expected or desired

4.4 The research base does not address the key policy questions

4.5 The weak legal mandate

4.6 The weak political mandate

4.7 Fierce, diverse and legitimate stakeholder opposition

5 Alternative and complementary approaches

5.1 Reduce toxins relative to nicotine

5.2 Taxation

5.3 Other tobacco control measures

5.4 Creating a credible framework for non-combustible nicotine products

6 The coercion paradox

7 The real value of the reduced nicotine rule – an agency threat

8 Conclusion

About the authors

Enjoy! Please let us have your thoughts in the comments… I’m looking forward to discussing this at FDLI conference on 26 October. Here is my presentation:

21 comments to FDA wants to reduce nicotine in cigarettes – what could possibly go wrong (and right)?

  • yeah, true the cigarette black market would definitely grow, if there are no cigarettes with nicotine available anymore. Plus it’s also irresponsible for the addicted ones.

  • Irish Lass

    Clive, I am disgusted and disappointed. And I never thought I would say that to you about your blogs.
    NO, no, no, no. no!!!!!!!

    No.

    Just…………………………..NO!

  • Roberto Sussman

    I don’t know how the VLNC will work in the USA, but can say with confidence it would be a disaster for developing countries in which illicit cigarette black markets are very widespread (as is the case of Mexico).

    Let’s say that the FDA launches this proposal, let’s say that the tobacco control bureaucracy goes along. Sooner or later it will spread globally, making it mandatory that “official” legal cigarettes be sold everywhere without nicotine or with very low nicotine levels (plus future plans for imposing plain packaging and higher tax). This will definitely boost the existing illegal trade. There is no doubt that the DEA will be working extra to deal with Mexican and Colombian cartels smuggling cigarette to the USA. This is worrying for countries like Mexico and Colombia where state efforts (demanded by the USA) to fight illegal drug trade have produced exponential rise in criminality plus a host of social and political decomposition.

    Clive, if you have a chance of discussing “what can go wrong with VLNC”, please mention its potential effects in terms of the drug wars: it will likely add another “substance department” for existing cartels (or produce new cartels) in this unwinnable war.

    The irony is that simply promoting low risk nicotine delivery products *without* unduly coercive measures does the trick of reducing cigarette smoking (see Sweden and Japan for empiric evidence).

    • Clive Bates

      I agree completely… it’s one of the strongest reasons not to do this measure. It will establish a criminal infrastructure…

      • Roberto Sussman

        Besides the criminality issue, there would be serious technical problems in enforcing the VLNC regulation. How could enforcers verify the nicotine content of cigarettes being smoked by millions of smokers in the streets? Will they carry portable cotinine measurement kits to stop smokers for verification? DEA agents will (at best) be able to enforce the law by decommission of illegal nicotine-full cigarette shipments, but not once they are consummed. It is a well known fact that illegal drugs seized by decommission are a tiny proportion in comparison with those consumed. The detection of illegal consumption will be even harder for illegal cigarettes given the fact that externally the legal and the illegal product look identical and function identically.

        Practical enforcement impossibility will likely happen in a law abiding country like the USA. It would be much worse in countries with lax enforcement of the law.

        By the time the proponents of this absurd regulation are planing how to enforce and police it in the USA, drug cartels south of the border (who live in the real world not in fantasy la la land) will have already sorted out the logistics of the supply chains.

        Perhaps an ongoing disaster produced by the VLNC regulation is the necessary explosive fiasco that could force a global change of regulation paradigm towards serious THR without further coercion and “de-normalisation” on smokers.

  • Bill Godshall

    Since FDA’s Deeming Rule already banned sales of all new vapor products and all truthful health claims about vapor products on August 8, 2016, and since the rule bans the sale of ALL of the 5+ million vapor products on August 8, 2022 (originally 2018), I was disappointed that your recommendations listed in
    “5.4 Creating a credible framework for non-combustible nicotine products”
    failed to suggest the best ways for FDA to create a credible framework for vapor and other smokefree alternatives to remain on and to be introduced into the US market, including:

    – FDA should rescind the Deeming Regulation and replace it with reasonable and responsible low cost standards for vapor products (similar to those in Duncan Hunter’s bill (HR 2198).

    – Congress should exempt vapor and perhaps other smokefree tobacco/nicotine products from the Tobacco Control Act, and should require FDA to promulgate reasonable and responsible low cost standards for vapor products (by enacting the HR 2198 or similar legislation).

    – FDA should truthfully inform the public that all smokefree tobacco and nicotine alternatives are far less harmful than cigarettes, and should encourage all smokers to switch to smokefree products.

    – FDA should plot each tobacco and nicotine product category on the continuum of risk (from 1-100, where NRT is 1 and cigarettes are 100) based upon the existing scientific evidence, and should widely promote this info to smokers and the American public.

    and

    – FDA should withdraw its recently proposed standard for smokeless tobacco products, which will ban >90% of smokeless tobacco products.

    As I’ve been pointing out since 2014 (before FDA even proposed the Deeming Regulation), PMTA and MRTP applications for low risk smokefree products will cost >$20 million for each product.

    The only companies that have the highly technical R&D staff, the money, and the necessary understanding of FDA CTP regulations and processes to be able to submit PMTA and MRTP applications (that FDA would actually review) are PMI, Altria, BAT/Reynolds, JTI and Imperial.

    Even if FDA simplified guidances for PMTA and MRTP applications, those same five tobacco companies would probably still be the only companies with adequate resources to submit applications to FDA.

    In sum, as long as the FDA’s Deeming Regulation remains law in the US, a credible framework for non-combustible nicotine products cannot exist.

    • Clive Bates

      Thanks Bill, these are all options… but they are not likely to work. So I have stuck to options that might work because of the intended audience for this report. There is always scope for raising things we think should happen, but probably won’t, given the committed stance FDA took on 28 July.

      • Bill Godshall

        Why do you believe that all of my suggested options “are not likely to work”?

        Back when I campaigned to enact the 1987 Pittsburgh Smoking Pollution Control Ordinance (that banned smoking in hundreds of thousands of workplaces in our city), I was repeatedly told that the smoking ban would never happen.

        In 1990 when I campaigned to ban cigarette vending machines in Pittsburgh in locations accessible to children (the first US city to ban hundreds of them),
        I was repeatedly told that our campaign would never succeed.

        In 1991, when I successfully campaigned to increase PA’s cigarette tax rate (as a strategy to reduce cigarette consumption), I was repeatedly told it would never be approved. Since then, PA has raised its cigarette tax four more times, and all other states have increased their cigarette tax.

        From 1988-1996 when I urged many attorneys, law firms, and State AGs to file lawsuits against cigarette companies, I was repeatedly told that nobody would ever win a lawsuit against a cigarette company.

        In 1997/98 when I mobilized public health advocates to oppose the Global Tobacco Settlement (negotiated and agreed to by State AGs, cigarette companies and CTFK) because it protected cigarettes at the expense of public health and civil justice, I was repeatedly told that there was no chance of stopping that deal in Congress. Yet, in 1998 we convinced a majority of US Senators to reject that deal, which paved the way for the 46 state MSA.

        In 2009, I was repeatedly told (by many THR advocates and vaping advocates) that the lawsuits filed against FDA by SE and NJOY (challenging FDA’s e-cigarette import ban) had no chance of success. And yet, those lawsuits are the only reason the sale of vapor products in the US has been legal during the past 6 years.

        Two years ago, I was repeatedly told (by many THR and vaping advocates) that the Cole bill (reintroduced this session as the Cole/Bishop bill) had no chance of being enacted.

        And yet, FDA Commissioner Scott Gottlieb’s 4 year delay of the vapor industry’s execution date (from 2018 to 2022) accomplished nearly everything the Cole bill sought to achieve.

        In sum, nothing can be achieved unless an effort is made to do so.

        But I’d really like to know why you don’t think any of my suggestions to repeal or rescind the FDA’s Deeming Regulation (that bans all vapor products) would work (as I hate to waste my time, money and energy, and that of others, on things that won’t work).

  • vapingpoint

    Do you not see that the suggestion “There are more manageable options to reduce the appeal of smoking, if that is the FDA’s policy intent. For example raising taxes, reducing selected toxins, control of additives and removal of branding. FDA will have to show that nicotine reduction will be superior to these approaches, but it has very little evidence with which to do this.” is disgusting?

    Those are ‘options’?

    They are examples of the manipulation of Tobacco Control that has infected the world with malice aforethought, on the basis of a the lie of the ‘dangers’ of second hand smoke.

    The comment that “The total disbandment of Tobacco Control would likely be the quickest, most efficient and least harmful option toward achieving a smokefree world.” is spot on!

    We do NOT need the tobacco control industry. It’s a vile, immoral thing. Instead of allowing education to enlighten smokers, it has forced through regulation that has altered society with profound collateral damage. And it DOESN’T CARE.

    Worldwide it has given horrendous tyrants and all governments permission to control their citizens. And it has now encompassed vaping. Three months imprisonment for vaping. Hundreds of dollars in fines. Vaping is a criminal offence.

    You have been the vaper’s friend, Clive. But the rotten core of thinking that tobacco control is a ‘good’ thing is the actual problem. Tobacco Control is the model for an immoral ‘endgame’ that is being used for repression and money making.

    “raising taxes, reducing selected toxins, control of additives and removal of branding” to “reduce the appeal of smoking”?

    NO!

    You wrote a paper for Ash. called ‘About Tobacco’ or something similar. with a byline ‘The truth about the tobacco industry…in its own words’

    It exposed the business discussions of the Tobacco Companies and how they covered up the danger of smoking.

    It would be wonderful, if, sometime before I die, you could write another paper exposing the lies, the deceit, the corruption, the money cycle between Tobacco Control, the Government and The Pharmaceutical Companies, and its promotion of tyrants.

    You could call it ‘About Tobacco Control – ‘The truth about the tobacco control industry…in its own words’

    I’m old Clive and could die any time soon – just saying!

    • Fully agree with vapingpoint here Clive! You know the ins and outs and tricks of the Antismokers better than anyone who’s never been in there working with them, and even if you still agree with their goals regarding smoking, you must, by now, have developed some disgust for their methods now that you see the same weapons being used against vaping.

      You really SHOULD write something to expose them in all their dirty underwear.

      – MJM

    • Luc Van Daele

      A friend of mine switched from vaping to smoking those VLNC’s and even the most rabat anti-smokers who complain even to a wimp of nicotine vaper outdoors, are fine with being exposed to the SHS of VLNC’s indoors. Nicotine = danger, so no nicotine = no danger has been the new-speech propaganda for 5 decades already. My friend since his main motivation to have switched to vaping was not to harm others is of course stimulated in his decision by the overwhelming reactions he gets from his environment, and I feel pretty lonesome claiming the complete opposite of what has been socially engineered by the ministry of truth. If your objective is not to do no harm you listen in the 1st place to those around you who claim to be harmed by your actions.

      I must agree with Vapingpoint here: you can’t undo the effects of decades of deliberate lies just by well intentioned wishful thinking.

      So VLNC’s do have the advantage to smokers that they can freely smoke again as they please and anti-smokers are perfectly fine with it. And you can’t even set them straight: we agree the dangers of SH smoke are imaginary, we agree the dangers of SH PV-VG vaper do not exist, the only thing in their minds I disagree with are the perceived dangers of SH nicotine. But if there is no danger to SH nicotine either, why do we impose total prohibition in prisons and psychiatric hospitals, why do we deny surgery to smokers,…? VLNC’s since it all fits the same endgame strategy encourages people to start asking the right questions about it.

      So I consider VLNC’s to be a good thing; it confuses the debate even more and exposes the discriminating fascists in their black-and-white tunnel vision even more then vaping did. And so the total disbandment of TC comes a step closer. Nothing wrong about dreaming of a better TC-free world, isn’t it? Especially since you have to do nothing to achieve it. Since the introduction of vaping TC is so focused on destroying the world as we know it with their endgame, and as usual being deprived of any sense of reality they just entered the self-destruct mode instead.

      You can’t smoke inhere because of the nicotine; you can’t vape inhere as well because of the nicotine; you can’t smoke VLNC’s inhere because of the ni… scratch that, there is no nicotine, because of the smoke; you can’t vape inhere because of the sm…, scratch that as well there is no smoke, because… doh I don’t know any longer, well what the heck because we do not like it! Their case for going as far as denying smokers medial care is getting very thin and they will have indeed a really hard time keeping this all credible. Nothing wrong with that…

    • Clive Bates

      That carefully worded sentence includes the phrase ” if that is the FDA’s policy intent.”

      This report is intended to engage with the internal logic of the 28 July announcements. My own view is that nothing done by the FDA is an improvement on the situation before 8 May 2016 – and the deeming rule.

  • Bill Godshall

    The only positive thing a VLN cigarette policy by FDA could achieve is that the resulting rapid decline (e.g. by >95% in the first year) in legal sales of real cigarettes (and RYO, cigar and pipe tobacco) would result in an equally rapid decline in TCA mandated payments by tobacco companies to the FDA, which would sharply reduce the anti-THR junk science, propaganda and regulatory activism that FDA has funded (in collaboration with NIH, NIDA and CDC) for the past seven years.

    But I doubt that will ever happen because when FDA CTP funding recipients realize that their so-called Tobacco Regulatory Science funding will plummet if/when FDA imposes a VLN regulation for combustible tobacco products, I suspect that many of those funding recipients will begin to acknowledge some of the many disastrous ramifications of the VLN regulatory policy that FDA’s Zeller is now promoting.

    Similarly, after Governors, State legislative leaders and State AGs, members of Congress, perhaps even Mayors and City Councils of NYC and Chicago, and thousands of recipients of the $46 billion appropriated annually from federal, state and local tobacco tax revenue and MSA revenue realize that >95% of their tobacco based funding will disappear within a year if FDA imposes a VLN policy for combustible tobacco, I strongly suspect that many of them will vehemently oppose FDA’s proposal.

    • Clive Bates

      No, one really positive thing would be if FDA and reduced nicotine supporters acknowledge that for the Big Idea to have any coherence, then a diverse and innovative market in low-risk non-combustible consumer nicotine products is a prerequisite. And that basically is the point of this report.

      • Bill Godshall

        Unfortunately, the statements by Mitch Zeller in July and several weeks ago at
        http://www.ustream.tv/recorded/109085799
        confirm that Mitch Zeller fully intends to maintain the Deeming Regulation’s ban on truthful claims about vapor products, its ban on vapor products not on the market by 8/8/2016, and its 8/8/2022 ban of ALL 5+ million vapor products now on the US market (unless/until FDA approves a PMTA and MRTP application for each vapor product, which will cost a manufacturer tens of millions of dollars).

        Unless the Deeming Regulation is repealed or rescinded, it will be impossible for Gottlieb or Zeller to achieve their stated goal (to encourage low risk product innovation and encourage smokers to switch to noncombustibles in conjunction with their very low nicotine cigarette regulation).

        We need to convince Gottlieb that FDA must rescind (or that Congress must repeal and replace) the Deeming Regulation long before his proposed low nicotine cigarette policy can be implemented (in order to reduce the many disastrous impacts of the low nicotine cigarette regulation (i.e. cigarette ban).

  • Jonathan Bagley

    Reducing the nicotine level would inevitably result in people smoking more tobacco, to try and get the same amount of nicotine, so putting themselves at higher risk of lung cancer.

    • Clive Bates

      Doubt anyone will ever buy reduced nicotine cigarettes… they are a device to dignify a de facto prohibition. The real question is what is the consumer/market legal/illict response?

      • John Walker

        Clive
        Interesting point, are they dumb enough to think that ‘ you can buy grog, as long as it is , alcohol free,’ is not , prohibition? And all that goes with that.

        Suspect that they are that , dumb….

  • Paul McNamara

    The total disbandment of Tobacco Control would likely be the quickest, most efficient and least harmful option toward achieving a smokefree world. Needless to say, such an option is completely unthinkable to those whose job it is to offer solutions.

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