Application for amendment of Schedule 7 entry for nicotine
29 June 2016
New Nicotine Alliance (AU)
(A National Not for Profit Organisation)
Ph. 0437 686 594
PO Box 3
Chelsea Vic 3196
www.nnalliance.org.au
CONTENTS
CONTENTS 2
Confidentiality 3
MEDICINE DETAILS 4
Applicant’s Details 5
Declaration 6
PART 1 - Summary of the Application 7
Proposed Rescheduling 7
Overview 8
Part 2 – Body of the Application 14
Background 14
Current scheduling status 14
Historical context 14
Chemistry 15
Detailed Claims Against the Requirements of the Scheduling Policy framework 16
PART 2.1 Criteria Which Must Be Addressed – proposals to change Part 4 of the Poisons Standard – scheduling or rescheduling of substances 16
(A) Risks and Benefits Associated with the Use of a Substance 16
Risks 16
Benefits 20
(B) The purposes for which nicotine is to be used and the extent of use 21
Purpose 21
Extent of use 21
(C) Toxicity and Safety of nicotine 21
(D) Dosage, Formulation, labelling, packaging and presentation of a Substance 27
(E) Potential for Misuse/Abuse of nicotine 28
(F) Any Other Matter that May be Relevant to the Scheduling of nicotine 28
PART 2.2 – Consideration of the factors for Schedule 7 set out in Chapter 3 of the Scheduling Policy Framework 28
Overall conclusions 31
Part 3 – Supporting Data 32
Supporting Data 32
PART 4 – Bibliography 33
References 33
Confidentiality
This application contains no material claimed to be commercial-in-confidence
MEDICINE DETAILS
1 / Name of substance requiring scheduling / Nicotine2 / Active ingredient name(s) / N/A
3 / Dosage form / N/A
4 / Container type / N/A
5 / Indications of medicine / N/A
6 / Current poisons schedule (if applicable) / Schedule 7
7 / Proposed poisons schedule / Unscheduled
Applicant’s Details
1 / Applicant’s [Sponsor’s] name / New Nicotine Alliance (AU)*2 / Applicant’s [Sponsor’s] Business Address / PO Box 3
Chelsea Vic 3196
3 / Business name (if applicable) / NA
4 / Date of submission / 29 June 2016
5 / Contact person / Donna Darvill
6 / E-mail Address of contact person /
7 / Postal address of contact person / PO Box 3
Chelsea Vic 3196
8 / Phone Number of contact person / 0437686594
9 / Fax Number of contact person / NA
*The New Nicotine Alliance Australia is a not for profit organisationworking towardsimproving public health through a greater understanding of risk-reduced nicotine products and their uses. It receives no funding from tobacco, e-cigarette or pharmaceutical companies or their affiliates. http://nnalliance.org.au/
Declaration
We, the undersigned, on behalf of New Nicotine Alliance (AU):
· declare that the information provided in this application is true and current;
· undertake to treat as confidential information, and not publicly disclose, the notice of interim decision in respect of this application, until (if relevant i.e. following referral to an expert advisory committee) the interim decision is published pursuant to subsection 42ZCZP of the Therapeutic Goods Regulations 1990, or the final decision is published pursuant to subsection 42ZCZS of the Therapeutic Goods Regulations 1990.
Dr Attila DankoPresident – New Nicotine Alliance (AU)
0428412353
28 June 2016 /
Donna Darvill
Board Secretary – New Nicotine Alliance (AU)
0437686594
28 June 2016 /
Jennifer Stone
Board Member – New Nicotine Alliance (AU)
28 June 2016 /
PART 1 - Summary of the Application
Proposed Rescheduling
The New Nicotine Alliance (AU) requests an amendment to Schedule 7 as detailed below (amending words in red and underlined)
NICOTINE except:
a) when included in Schedule 6;
b) in preparations for human therapeutic use; or
c) in tobacco prepared and packed for smoking; or
d) in preparations for use as a substitute for tobacco when packed and labelled:
(i) for use in an electronic nicotine delivery system (ENDS)
(ii) nicotine concentration up to 3.6%
(iii) maximum nicotine per container: 900mg
(iv) in a child resistant container
(v) labelled with the concentration of nicotine and other ingredients
(vi) labelled with the statement ‘Keep out of reach of children’
(vii) labelled with the statement ‘Not to be sold to a person under the age of 18 years’
Overview
The purpose of this application is to propose that nicotine in low-concentrations be exempted from Schedule 7 of the Standard for the Uniform Scheduling of Medicines and Poisons (SUSMP) so that it may be available for self-administration with an electronic nicotine delivery system (ENDS, also known as ‘personal vaporiser’ or ‘electronic cigarette’) for the purpose of tobacco harm reduction (THR).
Harm reduction is a well-documented strategy to reduce the harm of a behaviour by substituting it with a less harmful behaviour. Tobacco harm reduction provides an alternative pathway for smokers who are unable or unwilling to quit nicotine. Tobacco harm reduction has huge potential to prevent death and disability from tobacco and reduce health inequalities.
The current position
All nicotine replacement therapy (‘NRT’) products currently available in Australia for ‘therapeutic’ use are classified in the lowest risk category (unscheduled). They are considered to be ‘therapeutic goods’ because they are for use in ‘quitting’ smoking or ‘reducing to quit’. These products deliver low doses of nicotine via the dermal and oro-mucosal route. The risk of toxicity is mitigated by their low nicotine content and by their packaging and labelling.
Nicotine in products for inhalation for therapeutic use is included in Schedule 4 of the SUSMP (‘prescription only’). All nicotine-containing products for therapeutic use are required to be included as ‘registered’ medicines in the Australian Register of Therapeutic Goods before they can be marketed in Australia.
Nicotine for use ‘as a tobacco substitute’ is covered by the Schedule 7 entry in the SUSMP which is given effect through State and Territory legislation. As a non-therapeutic purpose, this falls outside TGA’s jurisdiction. When the current Schedule 7 entry was formulated, ENDS had not been invented. These products first came into widespread use around 2006.
Marketing nicotine products for human use within the strictures of Schedule 7 is not feasible or practical. We are not aware of any approvals being issued to vendors to sell or individuals to possess and use non-therapeutic, non-pesticide nicotine under State or Territory legislation, nor are we aware of any State or Territory health department that has procedures in place to facilitate applications for approvals to sell, obtain, possess or use nicotine products for THR purposes. These nicotine products are in effect ‘prohibited’.
Prior consideration
The scheduling of nicotine was considered by the National Drugs and Poisons Committee (NDPSC) in October 2008. The proposed amendment was to exclude nicotine from Schedule 7 ‘in electronic cigarettes prepared and packed as an alternative to traditional smoking’. The committee agreed that the current scheduling remained appropriate and that the Schedule 7 parent entry for nicotine should remain unchanged (NDPSC Oct 2008).
Since that earlier consideration there has been considerable development in the public health understanding, smoker adoption and regulation of these products globally. This application will update the committee on these developments, with the conclusion that the scheduling of nicotine in Australia for non-therapeutic purposes should be amended.
Tobacco harm reduction (THR)
Most smokers want to quit and forty per cent of Australia smokers try to quit at least once each per year. 1 However, nicotine dependence is a powerful substance use disorder (DSM 5) and the great majority of attempts are unsuccessful. Even treatment with first-line pharmaceutical smoking cessation therapies only increases the percentage of smokers who are abstinent at 6 months by 10-15% over those on placebo, and half of these will subsequently relapse. 2
Tobacco harm reduction is a strategy to minimise the harm in smokers who are unwilling or unable to quit. 3 The rationale is to provide smokers with an alternative way of getting the nicotine to which they are addicted without the tobacco smoke that causes almost all of the adverse health effects of smoking.
Cigarette smoking is recognised as the most harmful way to use nicotine. 4 Nicotine can be delivered in less harmful forms. A recent review of drugs for harm reduction, found that only nicotine and opiates met all eight criteria for a maintenance drug. ‘While nicotine has not been promoted widely or used for maintenance, it has the potential to fulfil that role’. 5
Although nicotine is the main psychoactive agent in tobacco, it has relatively minor health effects. It is not a carcinogen, does not cause respiratory disease and has only minor cardiovascular effects. 6 Even in overdose, the risk of harm from nicotine is small. Most cases result in prompt vomiting and serious outcomes are rare. 7-9
THR is consistent with the National Tobacco Strategy 2012-2018 10 and is listed as one of the three pillars of the policy along with demand reduction and supply reduction. THR is a potentially powerful complement to other tobacco control policies, particularly for the relatively highly addicted and typically disadvantaged smokers who are likely to find it most difficult to quit. 3
The long-term use of snus in Sweden confirms the safety of nicotine when used as a long-term tobacco substitute in humans. Snus is a moist, smokeless, low-nitrosamine tobacco which is placed in the mouth and provides nicotine blood levels similar to smoking. The use of snus has resulted in Sweden having the lowest adult daily smoking rate in Europe (10.7% in 2015. OECD) with substantial public health benefits. 11-13 See section 2.1 (C) below.
An Australian study found 20% of current smokers were interested in trying a low-nitrosamine smokeless tobacco product (such as snus) as a smoking substitute if it was available. 14
Other examples of successful harm reduction strategies include clean needles and syringes to intravenous drug users to reduce the risk of infection and promoting condom use by sex workers.
Harm from tobacco in Australia
Currently 15.8% of Australians (aged 14+) smoke tobacco (3 million people) and smoking is increasingly concentrated in lower-socioeconomic and disadvantaged groups, and is the largest cause of health inequalities. 15
Smoking is the single greatest preventable cause of death and disease in Australia killing 15,500 smokers each year. 16 As many as two out of three lifelong smokers in Australia die as a direct consequence of their smoking 17 and smokers lose an average of about 3 months of life expectancy for every year smoked after the age of 35. 18, 19 Smokers who don’t quit lose around 10 years of life. 18, 19
Tobacco also causes harm from secondhand and thirdhand smoke, is the largest preventable cause of adverse pregnancy outcomes, causes fires, litter and associated environmental contamination of waterways through discarded cigarette butts and exacerbates poverty.
Electronic Nicotine Delivery Systems
The devastating burden of smoking-related disease suggests novel public health interventions are needed to reduce the harm from smoking. One such option is Electronic Nicotine Delivery Systems (ENDS).
For those who are unwilling or unable to quit smoking, nicotine can be inhaled using an ENDS for the purposes of harm reduction. ENDS are battery-powered devices that heat a liquid into an aerosol for inhalation. The liquid solution contains water, nicotine (0.3-3.6%), propylene glycol, vegetable glycerine and typically also flavourings.
As well as delivering nicotine, ENDS use addresses the behavioural, sensory and social components of the smoking ritual. Users (known as ‘vapers’) rate ENDS that contain nicotine as more satisfying than nicotine replacement therapy (NRT). 20 they also appeal to smokers who are interested in a non-medicalised approach to reducing their health risk or are looking for a long-term alternative to cigarettes rather than a therapeutic product for quitting.
Nicotine delivery is determined by the concentration of nicotine, the puffing technique and the device used. 21 Earlier models delivered low doses of nicotine. However, with improved technology, experienced users with more advanced devices can achieve blood levels similar to smoking, although the speed of nicotine delivery remains much slower than from cigarettes. 22
There is general consensus that nicotine delivered via ENDS is much less harmful than when delivered via smoking tobacco. An expert panel estimated the risk of harms of ENDS to be only 5% of the harms of smoking. 23 Two further reviews of the scientific literature on ENDS published by Public Health England and the Royal College of Physicians, concluded that the evidence supports this estimate. 3, 24 Paradoxically, the current Australian laws ban a less harmful form of nicotine intake (ENDS) while allowing the sale of the most lethal form of nicotine intake (tobacco cigarettes).
While ENDS aerosol may contain small amounts of other chemicals including volatile organic compounds, carbonyls, aldehydes, tobacco-specific nitrosamines (TSNAs) and metal particles, research indicates that they are present at much lower levels than in cigarette smoke.25 In normal conditions of use, toxin levels in inhaled ENDS aerosol are below prescribed threshold limit values for occupational exposure, in which case significant long-term harm is unlikely. 26
ENDS are very popular with a substantial minority of smokers and are more popular than nicotine replacement therapies. 20 Their use has been growing rapidly in Australia in spite of the current legal restrictions and difficulties of access. Many have switched completely from cigarettes to ENDS. Preliminary results from the Australian arm of the ITC 4 country survey found that 14.6% of smokers were current ENDS users in 2014, 27 rising from 0.8% in 2010 and 8.9% in 2013. 28 43% of Australian users reported using nicotine in an ENDS device. 28
The vast majority of ENDS use in Australia is by current smokers using them to reduce the number of cigarettes they smoke or to switch completely from cigarettes to ENDS as a complete substitute. 29, 30 There is little evidence of harm from ENDS use in Australia, in spite of many being sold without child resistant lids, warning labels etc.
Proposed change
This application proposes that nicotine in ENDS for non-therapeutic use (as a tobacco substitute) be exempted from Schedule 7. The current Schedule 7 classification is not appropriate for low concentrations of nicotine for use in ENDS. Schedule 7 substances include arsenic and strychnine and is described in the SUSMP as follows (page iv):