3.2. Nicotine (heated tobacco products)

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

3.2. Interim decision in relation to nicotine (heated tobacco products)

Interim decision

Pursuant to regulation 42ZCZN of the Regulations, a Delegate of the Secretary has, in relation to the proposed amendment, made an interim decision not to amend the current Poisons Standard in relation to nicotine as proposed in this application, that is, to exempt nicotine in tobacco prepared and packed for heating from Schedule 7.

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

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

• The application to amend the current Poisons Standard with respect to nicotine;
• Joint Meeting of the Advisory Committee on Medicines Scheduling and the Advisory Committee on Chemicals Scheduling's advice as required by sub-section 52E(3) of the Therapeutic Goods Act 1989;
• The public submissions received in response to the pre-meeting consultation;
• As required by sub-section 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 that the Secretary considers necessary to protect public health;
• Scheduling Policy Framework (SPF 2018) as required by sub-section 52E(2);
• 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 show that IQOS is not detectably different from conventional cigarettes; and
• FDA News Release dated 30 April 2019: FDA permits sale of IQOS Tobacco Heating System through premarket tobacco product application pathway.

Summary of Joint ACCS-ACMS advice/recommendations to the Delegate

The reasons for the advice included:

The Joint Meeting of the Advisory Committee on Chemicals Scheduling and the Advisory Committee on Medicines Scheduling recommended that the current scheduling of nicotine remains appropriate as there is insufficient evidence to support an exemption from Schedule 7 for nicotine in heated tobacco products (HTPs).

Members noted that the relevant matters the Secretary is required to consider by subsection 52E(1) of the Therapeutic Goods Act 1989 include (a) the risks and benefits of the use of a substance; (b) the purpose for which a substance is to be used and the and 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 that the Secretary considers necessary to protect public health.

The matters considered by the committee under subsection 52E(1) include:

1. risks and benefits of the use of a substance
   • The Committee did not identify any benefits of the use of nicotine when in tobacco when prepared and packed for heating, advising that the available evidence does not support that HTPs are a safer alternative to traditional tobacco products. The Committee identified the following risks:
     • Nicotine addiction either for new users of HTPs or new or continuing users of nicotine in tobacco prepared and packed for smoking.
     • Re-normalising smoking especially among young people who would otherwise be at low risk of initiating nicotine addiction.
     • Insufficient evidence regarding the nature of any risk of long-term use. HTPs contain harmful and potentially harmful constituents.
     • Risk of accidental exposure to children.
2. the purpose for which a substance is to be used and the extent of use
   • The Committee identified the purpose for which nicotine when in tobacco when prepared and packed for heating as a new nicotine-delivery device for the non-therapeutic use of tobacco.
3. the toxicity of a substance
   • The Committee noted the following in relation to the toxicity of nicotine when in tobacco when prepared and packed for heating:
     • In vitro data indicates that HTP aerosol can be cytotoxic and mutagenic, can produce pathophysiological changes in human tissues.
     • The response produced by HTP aerosol is similar to that produced by cigarette smoke with respect to the development of precancerous lesions such as hyperplasia and squamous metaplasia in the respiratory tract epithelium.
     • On scientific and toxicological grounds nicotine when in tobacco when prepared and packed for heating meets Schedule 7 factors - that is it has a high to extremely high toxicity, presents a high health hazard, requires special precautions for handling, and has a high potential for causing harm at low exposure.
4. the dosage, formulation, labelling, packaging and presentation of a substance
   • The Committee advised that:
   • Nicotine when in tobacco when prepared and packed for heating functions by way of reconstituted tobacco leaf and excipients heated and consumed via inhalation.
   • An HTP delivers comparable levels of nicotine as conventional combustible tobacco products.
5. the potential for abuse of a substance
   • The Committee advised that nicotine when in tobacco when prepared and packed for heating when used as intended carries a high risk of dependence.
6. any other matters that the Secretary considers necessary to protect public health
   • The Committee advised that the current pathway for approval to supply products for smoking cessation is available for an HTP. 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.

Reasons for interim decision

I have made a decision 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 decision, I agree with the Committee that the most relevant parts of the SPF 2018, for the application for exemption of nicotine when in tobacco when prepared and packed for heating from Schedule 7, are the Scheduling Factors for Schedule 7, which currently captures nicotine in HTPs. Schedule 7 substances have a high to extremely high toxicity, present a high health hazard, require special precautions for handling, and have a high potential for causing harm at low exposure.

I also note the guidance in the Scheduling Handbook on the principle of 'reasonable safety' when assessing whether a substance is suitable for exemption from scheduling. Although the principle of reasonable safety is framed within the context of medicine scheduling, there are a number of relevant matters regarding the risks and benefits from wider availability for consumers.

I agree with the Committees view that the relevant provisions of section 52E of the Therapeutic Goods Act 1989 are (a) the risks and benefits of the use of a substance; (b) the purpose for which a substance is to be used and the and 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 that the Secretary considers necessary to protect public health. I also note the Committee's view that the purpose of HTPs is to provide a new nicotine-delivery device for non-therapeutic use of tobacco.

Having considered the Applicant's proposal, including the data provided with the application, I find 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.

In my assessment of the literature, I have not identified compelling evidence to establish a public health benefit from greater access to nicotine in HTPs. My views are consistent with the Committee's advice, in which a number of risks were identified with no clear, substantiated benefits. The available data indicate that HTPs contain toxic compounds including carcinogens and that HTPs aerosol can be cytotoxic and mutagenic and, can potentially produce pathophysiological changes in human tissues comparable to those produced by cigarette smoke. Independent researchers^[1] analysing data that Philip Morris provided to the US FDA in support of marketing of their IQOS HTP product found no statistically detectable difference between IQOS and conventional cigarettes for 23 of the 24 non-cancer biomarkers of potential harm measured in Americans, and 10 of 13 measured in Japanese.

I consider 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. 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. I am not persuaded that HTPs would not attract 'never smokers' including youth. 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 also note the information provided by the NSW Poisons Information Centre (NSW PIC) in their submission. The NSW PIC manage approximately half of Australia's poisons-related calls. Of particular relevance, I note that the NSW PIC reported that over 82% of calls relating to tobacco exposures were accidental paediatric exposures. I agree with the concerns raised by NSW PIC that HTPs may increase the risk of exposure to greater quantities of tobacco in accidental paediatric exposures.

Harm reduction has been cited by the Applicant and in public submissions advocating for the scheduling proposal, with these submissions also claiming that HTPs are another harm reduction tool, similar to nicotine replacement therapy products. However, I did not identify compelling evidence in support of these claims. Existing nicotine replacement products are therapeutic goods that require approval by the TGA in order to be supplied in Australia. Further, unlike HTPs, existing smoking cessation pharmacotherapies (including nicotine replacement therapies) included on the ARTG have an established safety profile and have been shown to be effective for the purposes of smoking cessation.

In making my decision I have also considered the firm opposition to down-scheduling nicotine in HTPs expressed by many peak health bodies and State and Territory Health Departments. Of the thirty-six (36) submissions received in total, twenty-three (23) submission were opposed the scheduling proposal including those from: The ACT Health Department, The Royal Australian College of General Practitioners, The Stroke Foundation, The Cancer Council Australia, The National Heart Foundation of Australia, The Australian Council on Smoking and Health, The Pharmaceutical Society of Australia, The Australian Medical Association, and The Pharmacy Guild of Australia among others. I note the strong concerns raised in these submissions; that the wide availability of HTPs would carry significant public health risks and that claims of relative safety have not been substantiated.

I have considered the regulatory status of HTPs internationally and the guidance from the WHO^[2]. I note, that in the US HTPs are not Food and Drug Administration (FDA)-approved, which is a requirement for a tobacco product to be marketed with reduced exposure or risk claims. Further, the FDA has confirmed that all tobacco products are potentially harmful and addictive and have recommended that people who do not currently use them should continue not to use them.^[3]

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.