3.3.2 Nicotine (heated tobacco products)

3 Final decisions on proposed amendments to the current Poisons Standard under regulation 42ZCZR

3.3 Final decisions on proposed amendments referred to the Advisory Committee on Medicines and Chemicals Scheduling in joint session (Joint ACMS-ACCS #24, March 2020)

Final decision in relation to nicotine (heated tobacco products)

Final decision

Pursuant to regulation 42ZCZR of the Regulations, a Delegate of the Secretary has made a final decision to confirm the interim decision, which is not to amend the current scheduling of nicotine in the Poisons Standard, specifically, not exempt from Schedule 7 nicotine when in tobacco when prepared and packed for heating.

Materials considered

In making this final decision, the Delegate considered the following material:

• The application to amend the current Poisons Standard with respect to nicotine (heated tobacco products);
• The 36 public submissions received in response to the pre-meeting consultation under regulation 42ZCZK of the Regulations;
• The advice received from the Joint meeting of the Advisory Committees on Medicines and Chemicals Scheduling (Joint ACMS-ACCS#24);
• The 85 public submissions received in response to the interim decision consultation under regulation 42ZCZP of the Regulations;
• Subsection 52E(1) of the Therapeutic Goods Act 1989, in particular (a) the risks and benefits of the use of a substance; (b) the purposes for which a substance is to be used and the extent of use of a substance; (c) the toxicity of a substance; (d) the dosage, formulation, labelling, packaging and presentation of a substance; (e) the potential for abuse of a substance; and (f) any other matters considered necessary to protect public health;
• The Australian Health Ministers' Advisory Council's Scheduling Policy Framework (SPF 2018);
• The Scheduling handbook: Guidance for amending the Poisons Standard;
• World Health Organisation Heated tobacco products (HTPs) market monitoring information sheet;
• PMI's own in vivo clinical data on biomarkers of potential harm in Americans an analysis of Phillip Morris International data which shows their tobacco heating system is not detectably different from conventional cigarettes;
• US Food & Drug Administration (FDA) News Release dated 30 April 2019: FDA permits sale of IQOS Tobacco Heating System through premarket tobacco product application pathway;
• The Analysis of FDA's IQOS marketing authorisation and its policy impacts which found that the evidence PMPSA submitted did not demonstrate reduction in long-term disease risks and that IQOS aerosol emits toxins with carcinogenic and genotoxic potential. This research also outlined further risks to users, including hepatotoxic, cardiovascular and pulmonary risks.
• FDA Authorizes Marketing of IQOS Tobacco Heating System with 'Reduced Exposure' Information from 7 July notes that authorisation for HTP now includes requirements for the company to conduct post market surveillance, including monitoring its increased use amongst youth.
• PMI's heated tobacco products marketing claims of reduced risk and reduced exposure may entice youth to try and continue using these products from the British Medical Journal, assessed the potential misunderstanding of reduced risk claims of HTP and thereby increasing the risk of tobacco initiation.
• WHO statement on heated tobacco products and the US FDA decision regarding IQOS
• The WHO, 2020, Heated tobacco products: A brief which recommends the preventing the introduction of HTPs.
• Heated tobacco products: information sheet - 2nd edition from the World Health Organisation (WHO) 10 July 2020 which states there is no evidence to demonstrate that HTPs are less harmful than conventional tobacco products. This information sheet also states that all forms of tobacco are harmful, inherently toxic and contains carcinogens, even in its natural form.
• The Australian Institute of Health and Welfare National Drug Strategy Household Survey 2019 report which shows a decrease in smoking rates in Australia.
• The Centers for Disease Control and Prevention webpage on Heated Tobacco Products from 17 July 2020 which advises that the use of any tobacco product - including heated tobacco products - is harmful.

Reasons for the final decision (including findings on material questions of fact)

I have made a final decision to confirm my interim decision, which is not to amend the current scheduling of nicotine in the Poisons Standard, specifically, not exempt from Schedule 7 nicotine when in tobacco when prepared and packed for heating. In making my final decision, and further to the reasons set out in my interim decision, I have taken into consideration the 85 public submissions received before the second closing date in response to the call for further submissions published on 10 June 2020 under regulation 42ZCZQ of the Regulations.

I note the submissions from the Lung Foundation, Cancer Council Australia, Australian Council on Health and Smoking and National Heart Foundation supported the interim decision, reiterating their strong concerns about the public health risks of exempting heated tobacco products from scheduling. There was one submission from a consumer who was concerned about the use of nicotine products amongst youths.

I have considered the 82 submissions that opposed my interim decision, including 77 submissions from individuals who, in general, had family members who were trying to quit smoking or were smokers themselves, and were advocating for access to heated tobacco products (HTPs) or e-cigarettes as an alternative to smoking. I note the five submissions from peak bodies and researchers opposing the interim decision, which outlined similar arguments as made in previous opposing submissions received in response to the pre-meeting consultation under regulation 42ZCZK of the Regulations.

I have considered the applicant's submission in response to my interim decision, which, in my assessment, does not present compelling evidence to establish a public health benefit from greater access to nicotine in HTPs. There are a number of assertions made by the applicant, which I will specifically comment on:

• The statement by the applicant that smoking rates in Australia have stagnated over recent years is not supported by recent data from the Australian Institute of Health and Welfare (AIHW)^[1]. The AIHW data shows a decrease in smoking rates from 12.2 % in 2016 to 11 % in 2019, which demonstrates that smoking rates in Australia continue to decline. I note this is a 9.8% decrease since the 2016 survey.
• The applicant contends that their product contains less nicotine than conventional cigarettes, making it safer in the case of accidental paediatric exposure. As scheduling affects substances rather than an individual product, I have taken into account that the concentration of nicotine in HTP products, more broadly, is variable and potentially higher than in cigarettes. I remain concerned that HTPs may increase the risk of exposure to greater quantities of nicotine in accidental paediatric exposures.

I have further considered the regulatory status of HTPs internationally and the guidance from the CDC^[2] and WHO^[3]. I note the recent US FDA authorisation of the marketing^[4] of the IQOS tobacco heating system with 'reduced exposure' information. The FDA states: "these products are not safe, so people, especially young people, who do not currently use tobacco products should not start using them or any other tobacco product." I note that the FDA will closely monitor these products post-market, including the potential for use among youth. I also note that the FDA did not issue a risk modification order. As such, the exposure modification orders do not permit the company to make any other modified risk claims or any express or implied statements that could mislead consumers into believing that the products are endorsed or approved by the FDA, or that the FDA deems the products to be safe for use by consumers. I note the WHO statement regarding heated tobacco products and the US FDA decision on IQOS, reiterates that reducing exposure to harmful chemicals in HTPs does not render them harmless, nor does it translate to reduced risk to human health.

Having considered the Applicant's proposal, including the data provided with the application and their submission on the interim decision, I reiterate my finding that there are significant safety concerns with HTPs, notably as identified by the Committee, the various risks of use of nicotine when in tobacco when prepared and packed for heating, its toxicity and the potential for abuse with no demonstrated benefit of its use. In this regard, I consider that the Applicant's focus on using tobacco cigarettes as a relevant comparator is too narrow and does not fully reflect the matters I am required to take into account, under subsection 52E(1), when making a decision to amend the Poisons Standard.

None of the submissions provided have changed my assessment that nicotine presents a severe hazard from repeated use leading to potential addiction and a significant risk of producing irreversible toxicity, which may involve serious, acute or chronic health risks or death. I am not persuaded that HTPs would not attract 'never smokers' including youth. In this regard, I note that the application, if agreed, would exempt nicotine when in tobacco when prepared and packed for heating from all regulation as a poison, which would allow anyone, including previous or non-smokers, to access these products and potentially expose a new cohort to the health risks arising from the use of tobacco If exempted from scheduling, there would be no ability to restrict the supply of HTPs to smokers seeking to quit.

Further, I am satisfied that HTPs can expose users long term to a range of known and unknown toxicants. I am not satisfied that the dosage, formulation, packaging and presentation of nicotine in HTPs mitigates the risk profile of nicotine such as to warrant a less restrictive scheduling classification than is currently in place.

I reiterate my finding from the interim decision that I am not satisfied that there is a net public health benefit from wider availability of nicotine in the form of HTPs. I do not consider that HTPs would make a significant contribution to population harm reduction if I agreed to amend the Poisons Standard as proposed in the application. I consider that maintaining the current scheduling for HTPs is necessary to protect public health from the risks associated with introducing a new nicotine product for non-therapeutic use. I note that the current pathway to supply Schedule 4 nicotine products for smoking cessation is available for HTPs. An application for registration on the ARTG could be made, which would involve assessment of the safety, efficacy and quality by the TGA, consistent with the requirements for existing nicotine replacement products. Should current smokers wish use HTPs as a method to quit smoking, unregistered HTPs are accessible with a prescription under Schedule 4, consistent with the scheduling of e-cigarettes containing nicotine.

Date of effect of the decision

24 August 2020