NOT PEER REVIEWED I am writing in response to sight of an article published by you about my work for the International Tax and Investment Center (ITIC). The ITIC guidebook published in 2011 "The Illicit Trade in Tobacco Products and How to Tackle it" makes it clear in the Executive Summary that it is "a compilation of facts and views from a wide range of sources including respected academics, private sector consultants, journalists, international enforcement organizations, government revenue authorities and industry". It also states in the very first footnote that the case studies were provided by industry, consultants and academics and other references include the Framework Convention Alliance, the World Bank Economic of Tobacco Toolkit, ASH Action on Smoking and Health and the WHO and Framework Convention Alliance are listed under "Interesting Links". I wrote this guidebook for ITIC as an independent consultant with academic freedom to ensure it presented a balanced picture of the issues and attributed input to the appropriate sources. I have never lobbied on behalf of an industry or individual company. As the former UK senior civil servant in a revenue authority who was privileged to lead the first UK Alcohol and Tobacco Fraud Review in 1997, my motivation in writing this guidebook has been to pass on my knowledge and experience of the illegal tobacco trade to assist officials in developing countries in improving their administration of excise taxation and anti-smuggling controls. I do not work for the tobacco industry and I have never smoked - in fact, I have suffered from asthma all my life and was delighted to see workplace smoking bans in the UK. I have never sought to undermine tobacco control policies. Rather, I have sought to help the tax and enforcement authorities to reduce opportunities for illegal trade, reduce demand and detect and prosecute the criminals and terrorists who profit from illegal trade drawing heavily on the UK experience in successfully reducing illegal trade in tobacco products from over 20% in 2000 to around 10% currently whilst maintaining one of the highest tax rates in the world. It is undeniable that products that are light, portable and subject to high levels of tax attract criminals. The guidebook (and the second edition published in 2013) makes it clear that there are, however, several drivers and facilitators of illegal trade in tobacco products including tobacco taxation policy, corruption, protectionist measures, inadequate legislation such as penalties, inadequate enforcement and public tolerance though it is my personal view that the economic drivers of supply and demand are the most important. Whilst advocating balanced tax policies in the guidebook, I went on to explain that sustaining high tax rates and maintaining manageable rates of illegal trade can only be achieved through a comprehensive strategic approach encompassing all legitimate stakeholders both public and private sector, national and international - as in the various refreshed versions of the UK Tobacco Strategy. As a former administrator I was trained and required to treat all taxpayers fairly without favouring one industry or one company over another. This has to be a key feature of effective tax and customs administration all over the world. The tobacco industry is a significant payer of excise revenue - second only to the hydrocarbon oil industry - and as long as it sells legal products and complies with legislative requirements it deserves the same treatment as any other industry. It is a feature of good tax administration to have dialogue with taxpayers and their representative associations and I have no hesitation in recommending this way of working to senior officials in Ministries of Finance and Revenue Authorities/Customs around the world. Indeed, the UK has long had and published Memoranda of Agreement with the tobacco industry as well as with other excise industries. I am puzzled by the article's criticism of a reference to Codentify in the 2011 edition of the guidebook as I do not see any such reference. The case study box on page 28 refers to International Track and Trace Standards and the information attributed to the four major international tobacco companies but Codentify is not mentioned as this is merely an illustration of the standards in place among key players in the industry. It is placed after a much more lengthy page on Article 15 of the WHO Framework Convention on Tobacco Control which the conclusions in para. 7.5 fully support but point out that rigorous enforcement, international cooperation and cooperation with the private sector are essential as legislation alone cannot eliminate illicit trade. With trillions of movements of tobacco products across the world daily there are never going to be sufficient enforcement resources to detect all illicit movements. Seizure rates, even in those countries that pride themselves on top class enforcement, do not exceed 20% to 23% and in the EU (see page 9 of the 2013 edition of the guidebook) were around 7% in 2011. Seizure rates can be expected to be considerably less in relation to illicit trade in most developing countries. So, enforcement authorities need all the help they can get from others in the public sector. This includes health and education authorities who are best placed to provide awareness campaigns and develop strategies to reduce demand and it includes help from legitimate industry who can provide additional intelligence on the markets, trends and those suspected of undermining their legal sales in the marketplace i.e. the international criminal organizations and terrorists. Moving on to the criticism of the WCO for allowing me to present a two day course on excise taxation policy, administration and enforcement, I would challenge anyone to present a meaningful course on excise taxation, administration and enforcement without referring to tobacco taxation or to illicit trade in excise products. The course included material on alcohol with input from the Spirits industry and the Beer industry and material on fuel taxation with input from the Oils industry as well as input on tobacco taxation from a representative of the tobacco industry. Customs officials have to deal with numerous products and legislation and their national training rarely provides them with material on excise taxes which they are tasked with protecting on imports, exports and transit shipments. Providing customs officials with basic broad awareness of the key excise taxes, how they work, good administrative and enforcement practices as well as stakeholder perspectives is really important in improving the performance of customs officials around the world. All the course material was thoroughly vetted by the WCO before the course so delegates were assured of receiving balanced and useful material.

Conflict of Interest:

None declared

NOT PEER REVIEWED Thanks for Mr. Middleton's information that there are local tobacco manufacturers in Hong Kong. I made a mistake when reading the materials. I have amended this in the updated version.

It does not affect the analysis as the government taxes based on number of cigarettes sold rather than manufactured, but I sincerely appreciate your valuable advice.

For the analysis part, it is not easy to have an "official figure" of illicit cigarette consumption. During the peer review stage, I indeed have discussed with the reviewers which source is preferable. I adopt the figures provided by the tobacco sellers, but also list the Euromonitor a reviewer suggested for readers' reference. Noted that these figures lead to the same result, as the total tobacco consumption (tax + illicit) drops after the tax increasing, which rebuts the traditional economic view that tobacco duty is not an effective method because of smuggling.

It is also not an easy job to determine how much price is affordable for people esp youngsters. However when we find out that smuggling shall not be a concern when the government increases the tax rate, it is clear that tobacco duty is a powerful tool to control cigarette consumption.

Conflict of Interest:

None declared

NOT PEER REVIEWED The author appears to believe that the main problem with the FDA is that it is not doing enough to prevent new niche cigarette products reaching the market. This focus of concern is misplaced, given several thousand cigarette products are readily available and smokers are spoilt for choice with or without these new products. I have no great desire to see new cigarette products coming on the market, but is this really the most pressing agenda?

There are important issues for FDA and Congress to address, but on which the author did not comment. Allow me to suggest five:

1. FDA's governing framework for tobacco, the Tobacco Control Act, is unfit for the purpose of managing reduced risk products. It is designed to raise a high regulatory barrier to entry to a market dominated by worst products and to suppress innovation in better products. At the same time, it has protected the existing cigarette trade by 'grandfathering' the thousands of products that were on the market at 17 Feb 2007 and offering them an easy ride for subsequent modifications. A new legislative framework for recreational nicotine products is required.

2. FDA regulation is unlikely to offer a feasible route to market for most vapour products. ?Its approach will cause chaos in the marketplace, even though these products are helping many to quit smoking. The vapour category would be largely wiped out and confined to the tobacco industry's high volume commodity products if FDA proceeds on its present course. That would provide further protection for the cigarette trade and stimulate a black market. Workarounds, a change in the predicate date or simply doing nothing would be an improvement.

3. FDA's approach does little that supports and a lot that suppresses innovation, regardless of whether particular innovations are desirable for consumers. For example, under the proposed framework for vapour products to access the market, a third generation e-cigarette manufacturer would likely need to go through a new and hugely burdensome authorisation (PMTA) to introduce new safety features like temperature control or to improve nicotine delivery through better aerosol science. A notification regime with an FDA right to intervene if the evidence justifies it would be preferable to a cumbersome authorisation regime.

4. FDA applies a bizarre approach to communicating the far lower risk of products like snus to consumers. This starts with a default FDA-imposed warning that is technically correct but not truthful because it is highly misleading ("this product is not a safe alternative to smoking"). It then requires tobacco companies to calculate if they are rich enough, the data extensive enough and whether it is sufficiently in their commercial interest to go through an arduous process to convince the FDA to allow them to change the warning to something more truthful ("No tobacco product is safe, but this product presents substantially lower risks to health than cigarettes") - and face hostile resistance from tobacco control campaigner such as the author. FDA and CDC should be assessing the relative risks of these products, and communicating them clearly - so that public risk perceptions become, as far as possible, aligned with scientific reality.

5. FDA suffers from mission creep - a regulator should not be involved in campaigning. FDA should function, and be seen to function, as a neutral technocratic regulatory agency, leaving the hype to public health bodies like the CDC. In this case, there is a further problem - the scientific foundations of the new smokeless campaign are very poor and undermine FDA's credibility more generally. FDA should stick to its core mission and do it better.

Matthew L. Myers and his campaign would do better to consider the important issues in nicotine regulation, not expend time, money and credibility on marginal issues with negligible public health value.

Conflict of Interest:

I am a long-standing advocate for tobacco harm reduction and run the Counterfactual blog. I have no competing interests with respect to any relevant industry.

It is enormously helpful when researchers consider new, not-yet-tried tobacco control interventions (such as this study's consideration of warning messages on cigarette sticks), especially when researchers figure out effective ways to evaluate the not-yet-tried interventions.

Some additional possibilities related to new warnings or pack changes that might be considered:

(1) Put instructions for use in all cigarette packs that instruct smokers (with explanations) about how they can minimize the harms and risks to themselves and to others from their consumption of the cigarettes, such as:

-- Do not smoke the cigarettes

-- Do not smoke near anyone else

-- Do not smoke in enclosed spaces

-- Do not smoke by inhaling

-- If inhaled, inhale as shallowly as possible

-- Do not smoke more than a few puffs of each cigarette (or do not smoke more than halfway)

-- Do not smoke in bed or when tired

-- Make sure all smoked cigarettes are fully extinguished before discarding

-- Discard of all cigarettes carefully (do not litter, do not discard in waterways, do not leave where children or pets might consume).

(2) Make one cigarette in each pack a rolled-up scroll of information or instructions for use for smokers (which would also reduce the number of cigarettes that could be smoked in each pack, perhaps reducing consumption).

(3) Audio warnings that play each time a pack is opened or a cigarette is extracted (now possible with available technologies).

Conflict of Interest:

None declared