May 5th, 2014

Regulation of e-cigarettes – general ideas

Warning symbols

Be careful out there…

I’m chairing a panel on “Vapor Industry Standards” at the SFATA spring conference today, and thought it was a good day to publish some general thoughts on regulation. This is part one of two…  I always learn a lot at gatherings like this, so I will publish more specific thoughts on nicotine regulation after the conference once I have stolen digested all the good ideas and insights. I hope this prompts discussion and is a useful step on the road to the must-attend Global Forum on Nicotine in Poland at the end of June, where further discussion will follow. 

Introduction

All responsible players in the e-cigarette industry want some sort of regulation or standard setting for e-cigarettes – but what should those standards be?  The industry recognises that dangerous products, disreputable marketing practices, poor user experience can harm the whole category even if caused by a single firm or product, and consumers tend to agree – up to a point.  On the other hand, too much or the wrong sort of regulation, and there can be adverse effects for businesses, consumers and public health.  In a situation, where the new products are competing with a dangerous established incumbent, cigarettes, too much regulation of the wrong type can amount to a regulatory protection of the product that all agree to be the most harmful.  It is imperative to avoid that error, but how do we strike the right balance?

Defining the problem

The first question should be “what is the problem the proposed regulation is intended to address?”.  After ASH published data on e-cigarette use in Britain, showing an extremely encouraging picture from a public health perspective, I am tempted to ask “what exactly is the problem?” and why does anything need to be done at all beyond the normal consumer protections? I do think some specific regulation is justified as it happens, and I will discuss that below.

Is there a common language for discussion the regulatory challenges?

Many public health advocates adopt the language of pharmaceutical regulation when discussing e-cigarettes, stressing ‘safety, quality and efficacy’ of e-cigarettes. However, this is grounded in a long-standing and remarkably persistent misunderstanding of the role these products play.  E-cigarettes are legal recreational drugs, not ‘smoking cessation’ medicines.  These words can be misleading because they have meanings related to specific medical challenges, which do not easily translate to recreational drug use:

  • Safety: primarily refers to the active drug and to side effects or drug interactions. We already know nicotine is safe enough to be on widespread sale in NRT or tobacco. Obviously, there is a safety agenda for e-cigarettes related to mechanical, thermal, electrical safety and contaminants in ingredients and breakdown products in vapour. But this is different to the meaning in medicines regulation.
  • Quality: in the pharma mindset this is really about achieving consistency and stability of dose delivery – important for drugs, less so for recreational nicotine products.  Obviously, there is a quality agenda for e-cigarettes just as there is for any other products, but it is more usual for consumers to ‘regulate’ that through what they decide to buy and keep buying.
  • Efficacy:  this really refers to whether a medicine does what it says – whether it is effective in treating or preventing disease or beneficially altering physiological functions. E-cigarette manufacturers generally do not make therapeutic claims to ‘treat or prevent disease’, and the question of whether they are an adequate substitutes for smoking is highly individual and product specific, involving a wide range of factors, not just nicotine pharmacokinetics.

Where should a regulator be involved, and what is a matter for market forces?

It is important not to rely on regulators to achieve things that should emerge from the interactions of consumers and producers in a market.  As is the case with food, it is fine to ask a regulator to ensure that cheese is not full of Listeria, but it is not the job of a regulator to determine what a good cheese is.  Regulators are there to guard consumers from risks to their health and safety and to ensure they are not misled.

Similarly, the role of the law in regulating use of vapour products in indoor public spaces is excessive. The coercive powers of the law should be reserved for situations where there is material harm to bystanders or workers – or perhaps a collective action problem that does not deliver adequate smoke-free places.  The decisions on vaping should really be left to the owners or operators of public spaces, and controlled by standard occupational air quality limits as a protective floor standard.

Is the problem already covered by other regulation?

There has been a (misplaced) panic in some quarters about children drinking toxic e-liquid.  There is already extensive regulation in the European Union (the CLP regulation) covering classification, labelling and packaging of hazardous substances.  Not only is this built on decades of experience and design evolution, it is based on an established approach to managing these risks. It provides everything needed to address the risks arising from containment of e-liquids.  More internationally, there are established standards, ISO 8317 for reclosable packaging. It’s not hard, the industry should just comply with these and thus deal with the issue.

Understanding the costs of regulation

Regulation is not a one way bet: more regulation does not necessarily mean a better safer world. It is for this reason that many governments have developed machinery for challenging ‘red tape’ and for improving the quality of regulation. Negative effects of regulation include:

  • Increased costs in design, manufacturing, distribution and marketing
  • Loss of competitiveness to products or jurisdictions more lightly regulated
  • Greater complexity requiring specialist staff and more staff time
  • Restrictions that limit the potential appeal of the product to the target customer base
  • Inhibition of innovation, creativity and experimentation
  • Slowing the pace of innovation
  • Diversion of staff time and executive attention to compliance activity at the expense of customer focus – it may even negatively contaminate the creative culture of a company
  • Reducing the diversity of products available and eliminating niche products for which the costs of regulation and compliance exceed the market value
  • Increased concentration of firms and elimination of small players – relatively light regulation (e.g. food) allows large players to coexist with a long tail of small players. Heavy regulation does the opposite.
  • Vulnerability to interest-group lobbying or firms seeking commercial advantage through regulations that favour them

It is for these reasons that governments have established principles that aim to constrain regulators to be evidence based, proportionate, non-discriminatory – see below. They are also reasons why proper impact assessment is essential and that benefits of regulation can be shown to justify the costs.

Principles of good regulatory policy and practice

Much has been written on principles of good regulation. The new ‘Regulators’ Code‘ in the UK is a good example of the type of principles applied.  I’m not going to draw all the various sources (EU, UK, US etc) together but I would suggest the following principles are relevant and commonly found in the ‘good regulation’ literature. In each jurisdictions there will be different emphasis and legal standing, but the ideas will be basically the same…

Evidence-based: in departing from general commercial freedoms, some evidence or good reasons are required that intervention is necessary and justified to control risks or realise opportunities. The evidence should show that the proposed regulation addresses the problem that justifies it.

Risk based: regulation should identify and manage material risks to health, safety, the environment and to the consumer. A risk assessment framework would also recognise risks or unintended consequences that might arise from regulation itself – for example in the case of e-cigarettes, a reduction in consumer choice, a loss of innovation, which may in turn lead to more smoking. Risk-based also means recognising that society has a ‘risk appetite’ and a level of ‘tolerability of risk’ that is above zero – we do not try to eliminate all risk.  It is not the role of regulators to manage risks down to the minimum possible level, but to find an acceptable level of risk without creating excessive or ‘disproportionate’ costs and to use an appropriate risk management framework.

Proportionate: that setting regulatory standards should produce material benefits, or risk reductions, that people value and that the costs and burdens of regulation are not excessive compared to the benefits. This important principle pervades regulatory good practice, but is often overlooked.

Non-discriminatory: comparable situations must not be treated differently and different situations must not be treated in the same way unless such treatment is objectively justified. This means consistent approaches to risk should be taken across different products, processes and techniques – and that products that pose low or negligible risk should not be treated in the same way as products that pose high risks.  Regulation should not be a form of trade protectionism or an anti-competitive regime designed to provide unjustified advantages to particular businesses.

Lawful: regulations designed to achieve a given outcome should not violate established legal principles.  In the case of the EU, this means regulation should have a robust legal base and not infringe general principles of the EU treaties (including those above). For the US, regulations should not violate the constitution. It may also mean complying with other international treaties or conventions such as the Technical Barriers to Trade treaty of the WTO or respecting legal principles in relation to patents or intellectual property.  It might be that a regulator regards these principles as wrong or obsolete, but that is a cause for amending them if they can gain agreement, not for overriding or ignoring them.

Legitimate: regulators are granted powers by a legislature (parliament), but should not misuse those powers to do things that go beyond the intent of the legislature.  For example, a regulator could demand evidence that it is impossible for a producer to provide (e.g. asking questions that would require a 60 year cohort study to resolve).  In doing so they would create a a de facto ban on the products, even though that was never the intention of the legislature.

Engaged:  regulators should consult those they intend to regulate and those who they hope to be the beneficiaries of regulation. Regulators should work with industry representatives and individual firms to understand costs, benefits and burdens of regulation and ensure these are proportionate to the benefits and kept to a minimum consistent with achieving the public policy objectives.

Transparent: regulators should ensure that clear information, guidance and advice should be available to help those they regulate meet their responsibilities to comply. In the case of the new FDA deeming regulation for example, it is impossible for e-cigarette producers to know what hurdles they will be required to surmount to have their products approved as ‘new tobacco products’.

Accountable: regulation should be based on clear evidence based documented justification and impact assessment, that examines all the costs and benefits that would arise from regulation. Regulators should expect scrutiny and challenge within their own government and should be ultimately open to challenge in court if their actions are disproportionate or unjustified.

Stable: regulation should not be arbitrary or capricious but should set a clear medium term direction that can be built into product design, supply chains and marketing practice.  Over time, regulation should evolve in predictable ways with plenty of time for adjustment.

Efficient: regulators do not have unlimited resources and should not design schemes they are incapable of implementing. They should focus their efforts on the greatest risks and the commercial entities most prone to non-compliance. Where a mature industry can show effective self regulation, regulators should be testing the integrity of the system rather than duplicating it.  Regulators should be sparing in requesting information – asking for data only if it has a place in making a regulatory decision or is necessary for consumer information. They should always be asked: why do you need this and what will you do with it?  Regulators should not be a significant barrier to legitimate commerce, and should be rapid in making determinations, ideally with a service level agreement.

Businesses and consumers involved should be assertive about these principles and not deferential to regulators.  Regulators are there to serve the public and to create good conditions in the economy, not just to wield arbitrary powers – the principles above are designed to do that.

The Precautionary Principle – misunderstood and abused

I increasingly think that the precautionary principle, a worthwhile idea, has become the last refuge for scoundrels with a regulatory mission but no evidence to support it.  The European Commission published useful guidance on the precautionary principle in 2000.  It sets out six guidelines:
Where action is deemed necessary, measures based on the precautionary principle should be, inter alia:
• proportional to the chosen level of protection,
• non-discriminatory in their application,
• consistent with similar measures already taken,
• based on an examination of the potential benefits and costs of action or lack of action (including, where appropriate and feasible, an economic cost/benefit analysis),
• subject to review, in the light of new scientific data, and
• capable of assigning responsibility for producing the scientific evidence necessary for a more comprehensive risk assessment.
For our purposes the key guideline is the 4th in the list above:  the requirement to apply a symmetric assessment of risks and benefits arising from both regulatory intervention and non-intervention. In other words, if a regulator wants to come down heavily on a product like e-cigarettes because of hypothetical dangers, it has to take into account the lost benefits that might arise if it bans, restricts or otherwise reduces the positive potential of the product.  For e-cigs this is particularly salient as the benefits are to health, not just economic.  This symmetry is almost always overlooked when activists make arguments using the precautionary principle.
Precautionary principle and snus.  Disgracefully, ‘health’ campaigners and the European Commission continue to apply the precautionary principle opportunistically (and unscientifically) to justify banning snus.  Faced with insurmountable evidence that the marketing of snus has been highly beneficial in Sweden and Norway, they clutched at the PP to argue that something might still go wrong. In its impact assessment for the directive the European Commission argued:

Lifting the ban on oral tobacco (option 1) would have adverse health effects. It could also attract new tobacco users who would otherwise not have taken up tobacco consumption. Moreover, it would have a negative health impact on smokers who would otherwise have quit smoking, but who continue to use both FMC/RYO and STP (dual use) and for smokers taking up STP use who would otherwise have quit using tobacco altogether. For individuals replacing FMC/RYO with STP completely, the health effects would be positive. Considering the uncertainty in relation to substitution, an overall negative outcome under option 1 cannot be excluded. Therefore, this option raises doubts in terms of coherence with the precautionary principle

This reasoning is full of errors and fails just about every one of the Commission’s own precautionary principle guidelines, but especially the one considering about potential benefits of non-intervention.  Lars Ramström and I wrote a detailed rebuttal to the Commission’s case, dealing with the abuse of the precautionary principle at section 4 on page 16: A critique of the scientific reasoning supporting the proposed measures relating to oral tobacco They didn’t reply of course, but I hope one day there will be a legal challenge to this especially harmful directive where we can parade this in front of the court.

Finding the public health optimum

The regulatory objective is not to create the safest cleanest possible products, with the most risk averse advertising and most restrictive commercial practices.  The perfectly safe product that no-one wants to use is of no value in public health terms.  For the optimum public health outcome, the benefits to smokers who switch to e-cigarette must be weighed alongside the risks to people who use e-cigarettes.  If regulation designed to reduce the risk of e-cigarette also makes them less attractive or reduces the choice offered to smokers the overall impact of ‘tougher’ regulation may actually increase harm to health.

The key is to retain the appeal to smokers and to balance risks associated with the e-cig products with risks of continuing but avoidable smoking if smokers are deterred from switching.  In other words, the opportunity to have smokers switch should play a large part in the regulatory optimisation and therefore sustaining and encouraging the appeal of these products to smokers matters a great deal.  ‘Appeal’ is not something regulators are used to dealing with.  Most regulated products are not in competition with a pervasive market leader than is far more dangerous that the new entrant category.  Three examples serve to illustrate the point:

1. Flavours.  Medicines do not need to come in 300 flavours, they just need to be palatable.  But flavours are integral to the e-cigarette value proposition to smokers – frivolity, experimentation and personalisation are part of the appeal.  So if a regulator is excessively risk averse towards flavours (for example requiring that they have been tested for medical inhalation use) then they risk causing consequential harm through extra smoking that may be far worse than the harm they wish to avoid by limiting the available choice of flavours.  

2. Regulatory costs. Regulation may raise costs of e-cigarettes, but there are several elasticities to consider – if the price goes up, then all other things being equal, the demand will fall in relative terms.  This this would likely mean more smoking than there otherwise would be. So any estimate of the health value of raising costs of e-cigs by imposing exacting standards must be offset be the expectation there is a detriment arising from more smoking.   Note that this effect may be offset by greater consumer confidence, and a willingness to pay for quality assured products.  So we may wish to strike a balance between customer assurance and excessive cost, bearing in mind, the comparator is smoking. Get this balance wrong, and the regulators causes more harm than they prevent.

 3. Limiting nicotine liquid strength. This may appear to have the benefit of reducing the risk of accidental poisoning (a claim wholly without basis – see scientists letter to EC), but it would have the negative effect of removing from the market liquids used by about 25% of users.  These users may be those making the initial conversion, or those with stronger dependence on nicotine.  Banning these liquids might also mean a loss of innovation – more compact products might benefit from higher nicotine concentrations, for example.

I think the risks of e-cigarette use can probably reduced to a low level quite cheaply and easily, and certainly without elaborate pharmaceutical regulation. The critical challenge for public health is to ensure that highly risk-averse, over-zealous regulators do not wantonly destroy the ‘value proposition’ of e-cigarettes to smokers and thereby increase risk that they are not directly accountable for in the name of reducing risks they are accountable for.

Population effects – challenge the case for taking these into account

Regulators and many activists evoke the concern over ‘population effects’ to make a case that a very much safer product than cigarettes might actually be somehow more dangerous.  These potentially negative population effects include:

  • Increased initiation among non-smokers
  • Increased relapse among ex-smokers
  • Reduced quitting among smokers
  • The general idea that e-cigarettes will ‘renormalise’ smoking and perhaps increase exposure to secondhand smoke

Is this approach legitimate at all?  The motorcycle helmet thought experiment.  First of all, we should not simply accept that population effects should form part of regulatory determinations without question.  The ethics of this are not at all straightforward – it might mean denying someone a life-saving safer alternative to smoking because someone else is using the product in a way the manufacturer or regulator does not intend.  Imagine the argument played out for motorcycle helmets.  Suppose wearing a helmet inclines some bikers to ride faster because they feel safer – as a result of this ‘risk compensation‘ they may do more more harm to themselves and others as a result. Would we ban motorcycle helmets to stop this? I don’t think so. Further, helmets might encourage more people to ride because it looks safer instead of driving much safer cars – more accidents and greater harm could be the result.  But would we deliberately make motorcycling more risky for bikers by banning helmets to prevent motorists ‘relapsing’ to motorbikes? No.  People worry that e-cigarettes might be used for taking illicit drugs, but we don’t ban spoons or banknotes because they are used in drug taking. Again, we can’t regulate for misuse of things intended to do something else.

Role of the state and individual. I think this gets down to where you stand on the respective role of the individual and the state. In my view, the state should not be an all-controlling health optimiser (and not just because it be bound to make terrible mess of it). For me, the responsibility of the state is to ensure that people are well informed and have good choices they can make. It is not to impose or prevent particular choices – unless they cause harm to others.  My own view is that regulators should stick to regulating individual risk for e-cigarettes in the situation where the product is used broadly as intended.

Positive population effects. For each of those negatives listed above, there is a mirror image positive population effect.

  • Decreased initiation among non-smokers as adolescents take to vaping instead of smoking
  • Decreased relapse among ex-smokers as they can vape instead of going back to smoking
  • Increased quitting among smokers as e-cigarettes are used to quit smoking and perhaps as a staging post to quitting nicotine use altogether
  • E-cigarettes will further marginalise smoking by popularising an alternative

We should note that in the best studied harm reduction example, snus use in Sweden, activists used the negative list of possible population effects above to campaign for the product to be banned elsewhere in Europe.  None of these negative effects materialised but the positive effects are clearly demonstrated in the literature and record low smoking statistics. That would suggest that these benefits may have been foregone in other countries at a cost of harm to health. It didn’t change the minds of activists though, which suggests to me these arguments were always just campaign tactics in a vaguely understood ideological campaign.  When a regulator or activist raises population effects, they should be asked to work through how they would handle the snus case, and what lessons they have learned from Sweden and the European Union.

Evidence on population effects: an impossible ask? So far there is nothing to support concerns that e-cigarettes may be causing negative population effects, and to the extent that there is evidence it is consistent with e-cigarettes reducing smoking.  But how would a company prove this one way or the other, either in general or, harder still, specifically for its own product?  The FDA in its authorisation procedure for new tobacco products (PMTA p15) states:

The statute provides that the basis for this finding shall be determined: with respect to the risks and benefits to the population as a whole, including users and nonusers of the tobacco product, and taking into account ─

(A) The increased or decreased likelihood that existing users of tobacco products will stop using such products; and

(B) The increased or decreased likelihood that those who do not use tobacco products will start using such products.

But how could this be determined? There is no parallel world that can be compared with the real world to see what would have happened in the absence of the product.  It would be impossible to do as a trial.  It would take years until all the possible transitions between smoking, vaping, dual use and abstinence had worked through.  It is impossible to do for a single product, as real world behaviour may involve many different transitions and products.

The prohibitive default. Note that the formulation of population effects is open and symmetric (‘increased or decreased likelihood’). But what would the regulator do if the evidence was unclear – as it is likely to be?  If they refused to authorise the products in the absence of clear evidence showing no negative population effects, they would potentially be causing population harm by forgoing positive population benefits – exactly what happened over snus in Europe.

Maintaining perspective: keeping comparators in mind

Many commentators have automatically assumed that the best reference point for considering e-cig regulation is NRT, and that regulation should borrow heavily from that. Whilst one can see the logic, I think that may be worth keeping other comparators in mind instead or as well.  NRT has not been especially successful, nor have the manufacturers been very innovative.  The best health results achieved have been with smokeless tobacco as a substitute for smoking in Sweden – in this case the regulatory control of the product itself was very light, there were no requirements for pharmacokinetic profiling or requirements for consistent ‘dosing’ etc.  The product functions successfully as an alternative to smoking because it comes positioned as a recreational product, not a smoking cessation aid.  No-one takes of ‘efficacy’ when it comes to snus, it just works out that way.  Coffee is also a useful reference point – we do not require regulators to assess caffeine dose and we know users partly control this by choosing Americano or Expresso, or how much coffee they place in a filter. With coffee we do not demand intimate knowledge of the chemistry, even though the high temperature roasting process creates may de novo chemicals, including known carcinogens. The analogy is not exact of course, as vapour is drawn into the lungs, rather then the less sensitive digestive tract for coffee. However, regulators should keep in mind comparators that reflect our normal risk appetites and tolerability of risk.

Watch out for regulatory predators

You can’t rely on industry players to identify the right type or stringency of regulation for the health of the market as a whole or for public health.  This because each is interested primarily in its own position in the market and regulations can work to competitive advantage and disadvantage.  So…

Large players may favour raising regulatory barriers to entry to small players, exhausting their balance sheets and borrowing before they can comply

  • Pharma companies will want regulation that suits the pharma business model
  • Bricks and mortar based companies may talk up peril in internet sales
  • Small marketing-orientated companies may wish to cut corners
  • Incumbents may favour marketing restrictions in order to hold on to market share
  • Cig-a-like manufacturers may see the messy but effective threat from 2nd & 3rd generation tanks and mods as something to slow down or stop dead with regulation
  • Most companies want less competition and fewer able competitors –  market and consumers usually thrive on the opposite

This isn’t to be especially cynical, but it is important for regulators (and public health establishment) to recognise vested interests in regulation, and these are not always in favour of having looser regulation.   It is no accident that the first company that will bring a product to market in the UK that is fully aligned with the strict medical regulation is likely to be British American Tobacco’s subsidiary Nicoventures.  It’s a credit to that company that it has made the necessary investments of tens of millions of pounds in facilities, staff, IT and science – but making that standard mandatory for the whole category might have had many perverse consequences.

The importance of phasing and time

Generally, the tougher the regime the longer it requires for introduction.  Unless authorities are taking emergency action – and there is nothing to justify that with e-cigarettes – they should introduce standards in a way that doesn’t needlessly destroy viable businesses selling popular products that are compliant with existing law and are safe enough. This doesn’t mean that over time we can’t raise industry standards to a level that would be highly disruptive if they were introduced overnight right now.  The problem with going for tough regulation is that the long lead time means there is weak or no regulation in the interim.  So the ideal approach is graduated – the first step will be straightforward safeguards that can be introduced easily, or even just rigorous application of law that already exists.  For example, in the EU there is already the Classification, Labelling and Packaging Regulation that governs the containment of hazardous substances.  Just gaining compliance with this would be a considerable advance (and render much of the Tobacco Products Directive superfluous).

 

26 comments to Regulation of e-cigarettes – general ideas

  • […] the product, it’s clear that e-cigarettes only really need a “light-touch” approach, much like that used in Sweden to regulate snus. However, we shouldn’t let that mislead us into thinking that no regulation is acceptable: at […]

  • Chris Price

    If we are discussing real-world regulation then perhaps some mention should be made of regulatory capture. A good regulatory system needs to have inbuilt protection from regulatory capture, otherwise it is worthless. This is probably the most difficult of all provisions; but without it, all else really is worthless.

    It often seems that regulation is doomed from the start, because it always becomes owned by those with an agenda (assuming the market is big enough to generate sufficient funds to warp the process).

    The most successful and long-lasting examples of regulation are trade systems such as the goldsmiths and silversmiths, which have endured in critical product areas for hundreds of years; with some good modern examples such as consumer credit. There are also appalling failures such as the press, of course. The most notably consistent failures are in large industries with huge markets and huge funds, such as pharmaceuticals, which are textbook examples of corruption. The effect on society of such corruption is an insidious, acidic, vicious destruction of the entire political process such that the entire system becomes institutionally corrupt.

    Discussion of regulatory systems probably needs examples of the good and the bad, and lessons to be learnt from each. EU and FDA regulation of vapourisers will be textbook examples of corruption, destruction and resulting loss of life. Unfortunately, nobody cares. It is tempting to conclude that the political system is broken, so there isn’t much point in worrying about the details. Normal, law-abiding people will need to resort to the black market in order to stay healthy – and that indicates the entire system is broken.

  • We’re on.

    And, yes, I don’t think that I am making a modified annuity pledge to the Clive Bates cycling equipment fund! But as Neils Bohr and Yogi Berra have observed, “prediction is difficult, especially about the future.”

  • Clive – as usual, more thought-inducing words! Ouch, my brain is hurting!

    I would suggest that you strike your #2 suggestion or at least modify it substantially to exclude “Congressional options” (google “Benghazi” as an indicator of the level of functioning there). A more appropriate and useful suggestion is to submit comments, based on evidence and data to the maximum extent possible, to the docket. This is where the action is and on what FDA will predominantly rely when finalizing the rule. And suffice to say that there are submissions that need addressing (e.g., https://tobacco.ucsf.edu/fda-should-use-information-2014-surgeon-general-report-when-finalizing-its-deeming-rule).

    As to our wager, fortunately, we do not have to depend on your recall. I owe you 5GBP (happy to meet up during UKNSCC??) for my inability to nudge you one micron off of your established positions on meds regulations for NCPs. Happy to pay up. And let the record reflect that our other wager reads like this:

    “Wager 2: Within 10 years of 28 June 2013, the US FDA will have promulgated, implemented, and begun enforcement of nicotine product standard that progressively reduces nicotine content in combustible cigarettes.
    Stakes: If Joe wins, Clive has to publicly state/write that until he started working with Joe Gitchell, he really didn’t understand enough about tobacco control policy.
    If Clive wins, Joe has to publicly state/write that he is an ass; always was and always will be.
    Oh, and $1000 (not inflation adjusted).”

    That’s how my contemporaneous notes read–are you still game?

    • Clive Bates

      Yes – I don’t know what Congress is capable of. Probably nothing, but I added it for completeness.

      I’ll take that bet. You really think something like that is going to come in before 28 June 2023?

  • Thanks for the encouragement, Clive–I will resist simply typing “treat it like a medicine”!

    My one quibble is with your characterization of the PMTA process within the FSPTCA as being virtually impossible. I would certainly agree that both it and the MRTP process were “calibrated” to fight the last war (low-tar), so the question is whether, as implemented, will they be more like the Maginot Line or an Exocet missile? My own sense, and backed up by the array of FDA’s specific questions posed within the proposed deeming rule, that they can employ substantial discretion.

    The proof will be in the pudding, like always, but as you know (recall our wager! I’m sure you do!), I have a lot of confidence in FDA CTP mostly getting things right. I’m sure sentiment will not be met with widespread agreement on this list, but I almost always learn a LOT more from people who disagree with me than those who agree….

    • Clive Bates

      Hi Joe – I think you are probably right about this. Much will depend on the underlying attitude of the FDA. If it wants to create obstacles and slow things down as much as possible, then the PTMA is the ideal instrument for that purpose. If, however, they are open minded about harm reduction (as Zeller must surely be, given his heritage), then they could deal with a lot of the grotesque burdens of the PTMA regime generically for the industry as a whole and potentially have a light touch approval process. However, reading the documentation I’d say it reveals deep hostility to these products – and their own assessment is that only 20-80 PTMAs will come forward in the first 24 months. Given one is needed for each flavour, strength, device etc – that would represent a dramatic contraction of product diversity, and firms. There really needs to be a three part approach:

      1. A political and media offensive, with the companies working together with common messages and well-founded evidence – this needs to change the way FDA approaches the issue;

      2. A legal and procedural approach to the constraints of the relevant legislation and Congressional options – this needs to find a practical approach that FDA can implement. Should it focus on broadening the applicability of the ‘substantial equivalence’ route to market, simplify the Pre Market Tobacco Authorisation regime, or focus on changes to the law through Congress?

      3. A technical and engineering counter-offer built on the many ideas circulating the room, but not so onerous that it kills of the innovative flair of the industry. Much needs to be done here – and the answer is definitely not to apply medicines like approach. Nor is it to do nothing.

      I recall I won our wager… and that you in the end declined to accept my wager that there would be FDA reducing nicotine content in tobacco products by 2017 (?) – or was it later? I don’t think they’ll ever do that, as it would fail their own PMTA population harm test.

  • I think that the simple fact that the TPD 2014 Definitions in Article 1 are not even in alphabetical order (which they were in the draft) is indicative of a hash job. There’s not even a definition of “nicotine containing liquid” which is used in the Directive – one would have thought a rather important definition to include. In addition, the “nicotine containing products” article (article 18) and definition from the draft Directive is no longer present either, and the section titled “Non-Tobacco Products” has been removed and replaced by the section titled: “Electronic Cigarettes and Herbal Products for Smoking”. It seems odd to remove the general section titled “Non-Tobacco Products” and replace it with two very specific products only. What happens to those non-tobacco products, that are not e-cigarettes and not herbal cigarettes? One can only presume they are not classified – in a way like e-cigarettes are now (pre TPD 2014). It also seems odd to put e-cigarettes (non combustable) together in the same title and section with herbal cigarettes (combustable) and one of the two products containing nicotine and the other without nicotine. No-one seems to know why or how these bizarre outcomes have been possible. There are so many questions left outstanding on this very important issue.

    • Clive Bates

      Far too polite! Taken as whole, I would say the Tobacco Products Directive 2014/40/EU is a costly exercise in hyperactive meddling, bureaucratic harassment and missing the point.

  • Mark Dickinson

    Typically thoughtful and well-argued, Clive – many thanks. I particularly appreciated the arguments around the Precautionary Principle and the point that regulators are unused to dealing with the concept of appeal.
    I look forward to the next installment :-)

    • Clive Bates

      Hi Mark, Joe

      If you (or others) have views on this do let me know…

      As long as you don’t say ‘treat it like a medicine’!

      Clive

  • Very well expressed and put, Clive–nicely balanced.

    I particularly found the motorcycle helmet analogy compelling and it reminded me of how well you used the “life saver” analogy when talking about NRT in the past.

    Thank you.

    Joe

  • […] I'm chairing a panel on "Vapor Industry Standards" at the SFATA spring conference today, and thought it was a good day to publish some general thoughts on regulation. This is part one of two… I …  […]

  • […] I'm chairing a panel on "Vapor Industry Standards" at the SFATA spring conference today, and thought it was a good day to publish some general thoughts on regulation. This is part one of two… I …  […]

  • Dodderer

    “It didn’t change the minds of activists though, which suggests to me these arguments were always just campaign tactics in a vaguely understood ideological campaign.”

    I think the ideological campaign is understood very well by the main players – their imperviousness to evidence and reason in relation to both snus and ecigs is striking.The only difference is that ecigs have become established and need a slower and wider strategy.

    They must rue the RPC’s intervention in relation to MLX364 – with hindsight the ‘reasonable’ option proferred by the MHRA – licensing within 15 months – was a trick given that no new NRT product had ever achieved a licence within 4 years of initial trial.

    The CNC/Intellicig MA application would have run out of funds in June 2011 and never made it onto BAT’s radar – nothing else had a hope of approval.

    If they can deny the long-term real-world evidence on snus then ecigs don’t stand a chance.The war is against the tobacco industry – anything that benefits TI is a legitimate target.

    • Jon Fell

      Really interesting discussion, thanks Clive and to others who have posted comments. Dodderer, I wonder if one thing in e-cigs’ favour is that the genie is out of the bottle to some extent because of the widespread user-base that it’s difficult to pin down to an ‘evil tobacco’ industry at this stage. Snus has been easier to traduce because usage is only really significant in two countries, and they’re largely being left to get on with their own thing. That doesn’t mean e-cigs are home and dry by any means, but it might suggest that the ‘grass-roots’ voice should continue to play an important role. As you maybe hint, there’s perhaps a role too for attempts to counter some of the sillier misconceptions about the tobacco industry (not that it’s likely to be easy).

      • Clive Bates

        I think this is right… they banned snus because there wasn’t a broad enough base of users. Some activists argue that there would have never been many users because it was not culturally familiar. But that is wrong in two ways: even if just one person wants to use it, there is no reason to stop them; it ignores the prospect of changing culture (who would have thought people would use tanks/mods?); and ignores potential for innovation which is rather pointless ever to try if the product is banned.

        David Sweanor tells the story of the Rhinoceros Party, an frivolous political party established in Canada some years ago. Its manifesto contained the commitment ‘to invade Belgium’. Asked why they had this commitment, the answer was:

        “Because we think we can win”.

        They have just reiterated the ban on snus with no legal, ethical or scientific justification – because they think they can win. I suspect that this is also behind the ban on menthol flavour in cigarettes. A few users mainly concentrated in Eastern Europe. We, the mighty institutions of the European Union legislature, we think we can win that one!

  • Alan Fletcher

    It is perfectly obvious that the TPD was designed specifically for the pharma and tobacco industries. If 25% of ecig-users use nicotine concentrations higher than 20 mg/ml then a medical license is needed. Big Tobacco and Pharma are the only two industries that can afford the necessary tests and will thus secure 25% of the market for themselves. There is absolutely nothing fair or proportionate in the TPD. Look what happened to Snus.

  • Tim Triple

    A great piece as a primer for me (and others, I’m sure) on the principles and codes for effective regulation.

    However, it does put into stark relief the apparent fact that much of the common-sense guidance for good regulation has been ignored in the framing of the TPD and Deeming Regulations (at least so far).

    One can only conclude that there is an ‘agenda’ guiding the regulatory process, that has already defined the outcome required and determined
    The steps that are/were necessary to achieve it.

    The Holy Trinity of Government, Big T and Big P are only too well aware that electronic cigarettes are now unstoppable, but they can slow them down and try to have some control of the endgame. The tools at their disposal are politicians, regulation and the traditional media.

    My reading of the endgame (though I could be being somewhat unfair. I hope so), is that Big T gets the mass cigalike market (tobacco products),
    Big P get the 2nd/3rd Gen market (medicines) and Government gets the tax on cigalikes (as they contain the legal drug nicotine and they are not medicines).

    The poor old consumer gets reasonable quality, but ineffective /expensive, cigalikes and medical quality, but limited choice/expensive, vapour tanks.

    Of course, the enormous health benefits from harm reduction would seem to be entirely secondary. If they were not, you sensible approach to the regulation of these products would have already been adopted.

    • Jonathan Bagley

      The TPD effectively bans refillable devices via “leakage” issues. I suspect the Pharma products will involve very expensive disposable cartridges containing a small volume of high, perhaps 45 mg/ml, nicotine.

  • Tom Gleeson

    One of the things most regulations are keen to include is bans on public use. Along with advertising bans and possibly distance sales.So far from most proposed regulation the end point seem to be regulation of use rather than product, except in so far as the product can be regulated to reduce use, low nic content, limited tank capacity and limiting battery efficiency.
    If we are to successfully get regulation that improve the standards of product, we need to recognise that elimination the product is the aim of the regulators (or at least the ones calling for regulation) I doubt evidence will sway the opponents and I fear legal challenges will be the only way to limit regulation to product specific concerns.

  • Jonathan Bagley

    Thank you for the explanation of the Precautionary Principle.

  • A very good piece Clive. I look forward to receiving the next instalment.

    Jeannie

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