National Drug Strategy
National Drug Strategy

British American Tobacco Australia - Response to the draft National Tobacco Strategy 2012-2018 - 25 June 2012

Consider further regulation of the contents, product disclosure and supply of tobacco products and non therapeutic nicotine delivery systems;

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Disclosure

BATA notes the Department of Health & Ageing (DoHA) has commissioned Allen + Clarke to prepare a “white paper” on product disclosure by the tobacco industry. BATA has been engaged in this process and seeks to engage whenever possible. In
our meetings with Allen + Clarke we have sought to raise some of our concerns with additional and possible counter-productive disclosure requirements.

Amongst other things, we noted that disclosure of emissions in particular can carry a significant risk of actually undermining public health strategies. This is because requiring disclosure of this type, runs the risk of repeating past difficulties arising from disclosure of emissions information in the past.

From the 1950's, public health authorities encouraged tobacco companies to develop "lower tar" or "light" or "mild" cigarettes, taking the view that such products would be less harmful. Subsequently, Governments required companies to publish "league tables" showing the tar and nicotine yield levels of their various products, so consumers could choose products which they thought would be less harmful to their health. Eventually governments required these yield levels to be printed on cigarette packaging.

Governments have changed their stance and public health authorities now say that consumers should not have been encouraged to switch to lower-yield products and that should instead to have been encouraged to quit.

Today, consumers are given the very clear message to quit, accompanied by clear warnings on and off pack such as "Smoking Kills". A potential consequence of disclosing detailed information about (for example) ingredients and emissions is that consumers will use the information to compare and choose different products, as they were encouraged to do earlier with tar and nicotine yield information. This has the danger of leading consumers to make choices, presumably for health reasons, without any reliable scientific basis; and undermining the "Quit" message which is now the government's key advice to smokers.

Further, mandatory disclosure of tobacco companies’ confidential information may violate Australia’s WTO obligations and in particular, its obligations under the Technical Barriers to Trade (TBT) Agreement.

The obligation to disclose product specific information could readily be considered to be a technical regulation for the purposes of the TBT Agreement. A violation of Article 2.2 of the TBT will occur if a technical regulation (1) is trade restrictive and (2) does not materially contribute to the achievement of the legitimate policy objective or does not contribute better to achievement of the legitimate policy objective than could be achieved by some other, less trade restrictive means.

A technical regulation is “trade restrictive” if, amongst other things, it adversely affects competitive opportunities, creates a disincentive to export to the country concerned or raises import costs. It could be argued that this option is trade-restrictive because of (1) the additional costs that are being imposed of submitting detailed information and of doing additional testing in order to supply the kind of information that is required; and (2) the potential disclosure of business confidential information, the protection of which is not guaranteed. The uncertainty about the lack of protection of business confidential information arguably operates as a strong disincentive to export to Australia.

A technical regulation that is trade restrictive and that does not materially contribute to the achievement of the objective is clearly “more trade restrictive than necessary,” and is thus an “unnecessary” obstacle to trade. In this regard, the lack of protection of business confidential information does not contribute to any legitimate objective. Furthermore, simply providing additional information to the government does not directly serve the protection of health.

Regulation Impact Statement on electronic nicotine delivery systems and smokeless tobacco products

DoHA has also recently engaged the Allen Consulting Group to undertake a Regulation Impact Statement (RIS) which explores options for further regulation of
electronic nicotine delivery systems (ENDS) and smokeless tobacco products in Australia. Again, BATA has been involved in this stakeholder consultation process and has provided its response to the Allen Consulting Group on this.

The draft NTS states that “Some international jurisdictions (notably the US FDA) have begun to develop responses to “e-cigarettes” to protect public health.”34 E-cigarettes and other products made or derived from tobacco can be regulated as "tobacco products" under the US Tobacco Control Act unless they are marketed for therapeutic purposes (in which case, the products would be regulated as “drugs”, “devices”, or combination products under the medicines regulatory regime).

The FDA has stated that it will issue regulations to bring these other categories of “tobacco products” under its regulatory ambit. However, there is no current indication on when draft regulations will be issued for public consultation.

The draft NTS also states that “Other jurisdictions (notably the United Kingdom) have announced they are exploring the potential benefits of these devices.”35 In February 2010, the UK Medicines and Healthcare products Regulatory Agency (MHRA) held a public consultation36 on the regulation of nicotine containing products. The responses to this consultation are available on the MHRA website37 and include comments from key UK public-health focused organisations such as:
It is “imperative that efforts to help smokers quit smoking continue. From a public health perspective, complete smoking cessation remains the “gold standard” in terms of preferred outcome. However, because relapse is high and nicotine addiction is so strong, a harm reduction approach which helps smokers switch from dangerous smoked tobacco products to safer alternative nicotine delivery devices should be encouraged since most of the harm comes from inhaling tobacco smoke…some people have managed to quit smoking by switching to E-cigarettes…The sudden withdrawal of E-cigarettes and other novel nicotine delivery devices from the market would adversely affect those people who have already switched from smoking to using these alternative devices, since it can be assumed that many would revert back to smoking…”
“A majority of smokers in the UK want to quit smoking completely, yet still relatively few have turned to medicinal nicotine products to either help them quit, or to use, either short term or long term, as a reduced harm alternative to smoking. This failure of uptake of alternative nicotine sources probably arises from a range of factors, including ignorance of the relative health hazards of medicinal and smoked nicotine, the high cost of medicinal nicotine products, the limited availability and attractiveness of medicinal products, and the fact that no available nicotine product mimics the pharmacokinetic nicotine delivery characteristics of the cigarette…It is therefore important that any new regulatory system actively encourages competition in the nicotine market by making it much easier for innovations to reach the smokers who need safer nicotine products, and does not, through putting strict regulatory barriers to market access, end up perpetuating the status quo… Rational nicotine regulation should regulate all nicotine products, with increasing restriction in relation to the harm they cause…”
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“Smokers should be given access to nicotine in a form and at a price that is attractive as an alternative to smoking. These products should meet basic safety requirements prior to being put forward as viable alternatives to smoking.”

The MHRA envisages that its final decision on regulation of nicotine containing products will be made in early 2013, following further scientific and market research.

There is evidence that some smokers in the UK are trying e-cigarettes in substitution for their usual cigarettes, and that, among those who have done so, a proportion have been successful in reducing their use of cigarettes or completely quitting cigarettes.

Current prevalence of use of e-cigarettes in Australia is likely to be very low due to the 2011 ban on the domestic retail sale of e-cigarettes containing nicotine. However, we think that the possibility of increasing levels of use among Australian smokers should not be discounted (as trends are indicating increasing usage in other countries), and that some of these smokers may be using these products to quit cigarettes.

For example, an article in an Australian newspaper in December 201038 reports that “Former smokers say recent tax increases and smoking bans prompted their switch to e-cigarettes. Some claim the product helped them give up cigarettes altogether” and that “Paul Medarov, chief executive of New Zealand-based company Elusion, the largest supplier of e-cigarettes in Australia with about 10,000 customers, said sales increased 200 per cent in May after the federal government announced a 25 per cent tax rise on tobacco products. Elusion sells cartridges with high, medium, low or zero nicotine. Mr Medarov said most people reduced their nicotine intake and gave up smoking completely.”

A report by Etter and Bullen39 found that among 3037 users of electronic cigarettes, 77% used these products to quit smoking or avoid relapsing and 20% stated that they used electronic cigarettes to reduce tobacco consumption with no intention of quitting smoking. Most of the ex-smokers in that study (79%) expressed concern that they might relapse to smoking if they stopped using electronic cigarettes.

Given that the Government’s policy objective is to continue in its efforts to reduce tobacco related harm in the community, then we would suggest that the current laws and regulations on potentially reduced-risk tobacco and nicotine products are not sufficient to help facilitate achievement of that objective.

We believe that additional potential regulatory options should be explored in the draft NTS. For example, a regulatory framework could be put in place that would allow more widespread availability (via domestic retail sale) of potentially reduced-risk tobacco and nicotine products for potential use by Australian tobacco consumers, facilitate monitoring of those products in use by consumers and facilitate communication of clear and accurate information to consumers to enable them to understand the relative risks of different products.

Any future regulation in the area of potentially reduced-risk tobacco and nicotine products should be based on sound scientific evidence and underpinned by a clearly defined and stated public health rationale, and developed in consultation with tobacco manufacturers and other relevant stakeholders.

We support the outlined step-by-step approach of first commissioning research on electronic cigarettes to examine the risks and/or benefits of these products which will then inform, from a robust evidence base, the most appropriate policy approach.

This approach is the same as that currently being undertaken in the UK by the MHRA which, as mentioned above, held a public consultation40 in February 2010 on the regulation of nicotine containing products. The MHRA envisages that its final decision on regulation of nicotine containing products will be made in early 2013, following further scientific and market research.

Non therapeutic tobacco

The NTS states that “Electronic cigarettes, also called “e-cigarettes”, are batteryoperated devices that generally contain cartridges filled with nicotine, flavour and other chemicals. The electronic cigarette turns nicotine (which is highly addictive), and other chemicals into a vapour that is inhaled by the user. Unlike NRT products, e-cigarettes have not been approved by the Therapeutic Goods Administration for medically-supervised use to quit smoking. A number of studies raise considerable doubt about their quality and safety, product consistency, reliability, and utility of the labelling and packaging. There is evidence of e-cigarettes and other non therapeutic nicotine products being advertised on the internet and available in Australia.”

Some international jurisdictions (notably the US FDA) have begun to develop responses to ‘e-cigarettes’ to protect public health. Other jurisdictions (notably the United Kingdom) have announced they are exploring the potential benefits of these devices.

While sale of the nicotine in the cartridges is prohibited as a Schedule 7 poison under the Standard for Uniform Scheduling of Medicines and Poisons, these delivery systems are not currently regulated in Australia. There is a need to better understand the potential risks and/or benefits of these products and determine whether there is a need to increase restrictions on their availability and use and identify the most appropriate policy approach for Australia.

The Australian Government has commissioned a regulatory impact assessment in relation to e-cigarettes and smokeless tobacco products, which is due to report in 2012.
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34. pg 36 of the draft NTS
35. Consultation Draft National Tobacco Strategy [2012-2018], pgs 36-37
36. Consultation Letter MLX 364, 1 February 2010, UK Medicines and Healthcare products Regulatory Agency
37. Medicines and Healthcare Products Regulatory Agency website
38. Banned e-cigarettes may be a health hazard, but buying them's a wheeze, Jill Stark, December 12, 2010, For more information please visit The Age website.
39. Electronic cigarette: users profile, utilization, satisfaction and perceived efficacy. Etter JF, Bullen C. Addiction 2011; doi: 10.1111/j.1360-0443.2011. 03505.x
40. Consultation Letter MLX 364, 1 February 2010, UK Medicines and Healthcare products Regulatory Agency

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