Some trade-off must be made between objectives 1 and 2 – harm reduction and harm prevention. Making products more accessible for smokers to switch to a safer alternative also increases the likelihood that non-smokers will use new products and potentially also go on to smoke tobacco, increasing their health risks. This is particularly of concern for those who would not otherwise have gone on to smoke, in the absence of the introduction of the new product. The Ministry of Health considers that e-cigarettes set a benchmark and that any products approved in future should have a similar risk to benefit profile as ecigarettes. One study has modelled the impact of e-cigarettes using four different levels of risk ranging from 2.5 percent to 25 percent relative to the risk of smoking (ie, 97.5 percent to 75 percent safer than smoking). Under this model, using a 5 percent risk estimate, there is a net public health benefit associated with e-cigarettes, resulting in 21 percent fewer smoking-attributable deaths and a 20 percent reduction in life years lost (Levy et al 2016). For people in this model who would never have started smoking, over 80 percent would have to seriously try e-cigarettes (ie, not just puff on someone else’s device) for net harms to appear, assuming a 5 percent level of health risk associated with e-cigarette use (Levy et al 2016; McRobbie 2016). The net benefit of any new product depend on the level of risk associated with its use. However, it is expected that in order for a product to be approved or suitable to be notified, it should be broadly similar to the harm associated with the use of e-cigarettes.
Table 6: Comparison of high-level options for sale via vending machines Options Option 1: status quo Option 2: Option 3: Option 4: The sale of smokeless tobacco products is prohibited, including via vending machines are no restrictions on the sale of nicotine-delivery products via vending machines (but restrictions are intended to be applied to ecigarettes and eliquid) Restrict the use of vending machines so that products can only be accessed be a salesperson for sale to those aged 18 and over Restrict sale via vending machines to R18 settings Allow sale of all smokeless tobacco and nicotine-delivery products via vending machines, without restrictions to limit sales to under-18s Pros Supports proposed ban on sales to minors Provides smokers with greater access to potentially reduced-harm products Supports proposed ban on sales to minors Supports proposed ban on sales to minors Provides better access for smokers to option 2 Consistent with Cabinet’s decisions on e-cigarettes Differentiates between smoked tobacco and reduced-harm products Increases smokers’ access to potentially harm-reduced products Cons Reduces smokers’ access to potentially reduced-harm products Would be inconsistent with government’s decisions on ecigarettes and e-liquid Reduces smokers’ access to potentially harm-reduced products, with disproportionate impact on smokers 18 years Would be inconsistent with government’s decisions on ecigarettes Reduces smokers’ access to potentially harm-reduced products, with disproportionate impact on smokers under 18 years Increases young people’s access to nicotine products (inconsistent with Ministry of Health’s recommendation under issue 2(a) above)
Table 14: Comparison of options for regulating product safety for smokeless tobacco and nicotine-delivery products Options Option 1: status quo No specific product safety controls Option 2: Adopt existing product safety standards under the Fair Trading Act (Commerce Commission enforces) Option 3(a): Make regulations/notices/ guidelines etc. under the SFEA without product registration (Ministry of Health regulates) Option 3(b): Make regulations/notices/guidelines, etc under the SFEA with product registration (Ministry of Health regulates) Pros No costs to manufacturers, importers or retailers to implement and comply No cost to government to enforce Risks to health mitigated Smokers have access to products they can have confidence in, which may encourage them to switch Risks to health mitigated Smokers have access to products they can have confidence in, may encourage them to switch Ministry of Health is government agency with the best understanding of regulating products to reduce risks to health (eg, medicines, psychoactive substances) SFEA has some provisions already to allow product safety requirements to be set by regulation As for Option 3(a) Self-certification associated with product registration facilitate compliance Regulator has register of products by manufacturer/importer to facilitate post-market activity (eg, recall of products to be causing harm) Consistent with decisions for and e-liquid Cons Nicotine, which has addictive and toxic properties, is unregulated except where it is regulated as a medicine or HSNO thresholds are met Other constituents of products, some of which may be harmful, are unregulated Uneven playing for industry – some businesses will meet standards; others will sell cheaper, lower-quality products Experience suggests it is unlikely consumers would seek redress under the Consumer Guarantees Act Costs to industry to implement, which may be passed on to consumers Costs to government to implement and enforce Difficulty in identifying international best practice standards to adopt Enforcement is passive, in response to complaints and product failures Costs to industry to implement, which may be passed on to consumers Costs to government to implement and enforce As for Option 3(a) but greater costs to industry associated with more active regulation
Consultation As part of its 2016 consultation on the regulation of e-cigarettes, the Ministry of Health asked whether there were other products that should be regulated as consumer products at the same time as e-cigarettes. A number of submitters thought that there were and named a wide range of potential products. More recently, the Ministry of Health held targeted discussions on the regulation of smokeless tobacco and nicotine-delivery products with tobacco sector stakeholders including health sector agency staff, academics, the tobacco companies which have a presence in New Zealand, and a number of vape retailers. Views varied widely. Process for providing authorisation to market A few stakeholders, including academics and two tobacco companies, thought that no smokeless tobacco product should ever be regulated as a consumer product and that New Zealand should maintain its existing prohibitions. However, most of these stakeholders were open to regulating nicotine-delivery products as consumer products. Most stakeholders seemed to favour a pathway on pre-market approval. Some of those favouring a pre-market approval process noted that their rationale for this preference is that it is better to set the regulatory bar higher in the first instance as it is easier to relax overall requirements than to strengthen them once products are on the market. One tobacco company preferred a notification/self-certification process as it considered the US pre-market approval process was too strict. There was a strong view by academics and the health sector in particular that there should be processes in place to ensure that evidence on the risks and benefits of products was independently assessed (eg, independent advisory committees). Some stakeholders were particularly concerned about independent assessment if a notification/self-certification system was adopted. Some considered that provisions should be made for approving classes of products in some cases (eg, for products that have been used for decades with well-known risks and benefit, such as snus). Many stakeholders suggested that it may not be worth considering legalising existing smokeless tobacco products, as newer products are cleaner and more likely to be used in New Zealand. In particular, some academics and a couple of tobacco companies suggested that oral tobacco products, such as snus, should not enter the New Zealand market as there is no market for them.
Appendix One: Comparison of international regulatory frameworks Country Legal framework Market authorisation to under 18s Smokefree Advertising, promotion, display Product safety United Kingdom: implementing the EU Tobacco Product Directive (TPD) Provides a regulatory framework for and smokeless tobacco products to be lawfully marketed. Regulations require a six-month notification of intention to market a novel tobacco product. Notification requirements include the provision of toxicological and behavioural information. No approval is required provided notification requirements are met. Sales prohibited to people under 18. There is no prohibition on novel and smokeless tobacco product use in legislated smokefree areas in the UK. Regulations include a requirement for health warnings on smokeless and tobacco products. TPD outlines that novel tobacco products are subject to the safety requirements for smokeless or smoking tobacco products, depending on which product definition they fall under. Canada Lawful. The Tobacco Act 1997 applies to all tobacco products (including heated tobacco product), and regulatory controls apply. No notification or marketing authorisation requirements. prohibited to people under 18. Differs across provinces. Provincial legislation regulates smoke-free spaces. Imposes tobacco prohibitions, including on advertising that appeals to young people, ‘lifestyle’ advertising, sponsorship, give-aways. Restricts sales promotions to R18 settings. Advertising and point-of-sale promotion must be consistent with regulations. No specific product safety requirements for novel tobacco products – generic consumer products legislation is relied upon.
United States The Federal Food and Drug Administration (FDA) regulates all tobacco products, including and future tobacco products. FDA requires a Tobacco Application for and future tobacco products. The applicant must provide toxicological, behavioural, and physiological information. The product can be marketed only the FDA has evaluated it as being ‘appropriate for the protection of public health’ and issued a marketing approval. prohibited to people under 18. Products sold in vending machines can only be made available in R18 settings. Differs across states. State legislation covers smokefree places. Requires that all tobacco products and advertisements for them include an addictiveness warning label statement. Provides regulations on advertising, and restrictions to individuals 18. Prohibits distribution of free samples. A new product cannot be marketed unless a manufacturer demonstrates that the product meets the relevant public health standard and has an approval from the FDA to market the product.