Public submissions on proposed amendments to the Poisons Standard Subdivision 3D.2 of the Therapeutic Goods Regulations 1990 (the Regulations) sets out the procedure to be followed where the Secretary receives an application under section 52EAA of the Therapeutic Goods Act 1989 (the Act) to amend the current Poisons Standard and decides to refer the proposed amendment to an expert advisory committee. These include, under regulation 42ZCZK, that the Secretary publish (in a manner the Secretary considers appropriate) the proposed amendment to be referred to an expert advisory committee, the committee to which the proposed amendment will be referred, and the date of the committee meeting. The Secretary must also invite public submissions to be made to the expert advisory committee by a date mentioned in the notice as the closing date, allowing at least 20 business days after publication of the notice. Such a notice relating to the scheduling proposals initially referred to the November 2016 meeting of the Joint Advisory Committee on Medicines and Chemicals Scheduling (Joint ACMS-ACCS #14) was made available on the TGA website on 4 August 2016 and 22 September, closing on 1 September 2016 and 20 October 2016 respectively. Public submissions received on or before these closing dates were published on 2 February 2017 on the TGA website in accordance with regulation 42ZCZL.

Public submissions relating to the rescheduling of nicotine are published again here in accordance with regulation 42ZCZL of the Regulations. Also in accordance with regulation 42ZCZL, the Secretary has removed information that the Secretary considers confidential.

Under regulation 42ZCZN of the Regulations, the Secretary, after considering the advice or recommendation of the expert advisory committee, must (subject to regulation 42ZCZO) make an interim decision in relation to the proposed amendment. If the interim decision is to amend the current Poisons Standard, the Secretary must, in doing so, take into account the matters mentioned in subsection 52E(1) of the Act (including, for example, the risks and benefits of the use of a substance, and the potential for abuse of a substance) and the scheduling guidelines as set out in the Scheduling Policy Framework for Chemicals and Medicines (SPF, 2015), available on the TGA website.

Under regulation 42ZCZP of the Regulations, the Secretary must, among other things, publish (in a manner the Secretary considers appropriate) the scheduling interim decision, the reasons for that decision and the proposed date of effect (for decisions to amend the current Poisons Standard, this will be the date when it is expected that the current Poisons Standard will be amended to give effect to the decision).

Also in accordance with regulation 42ZCZP of the Regulations, the Secretary must also invite the applicants and persons who made a submission in response to the original invitation under paragraph 42ZCZK(1)(d), to make further submissions to the Secretary in relation to the interim decisions by a date mentioned in the notice as the closing date, allowing at least 10 business days after publication of the notice. Such a notice relating to the interim decisions of substances initially referred to the November 2016 meeting of the Joint Advisory Committee on Medicines and Chemicals Scheduling (Joint ACMS-ACCS #14) was made available on the TGA website on 2 February 2017 and closed on 16 February 2017.

Public submissions received on or before 16 February 2017 are published here in accordancewith regulation 42ZCZQ of the Regulations. Also in accordance with regulation 42ZCZQ, theSecretary has removed information that the Secretary considers confidential. Secretary has removed information that the Secretary considers confidential information.

Part 1

Privacy statement

The Therapeutic Goods Administration (TGA) will not publish information it considers confidential, including yours/other individuals’ personal information (unless you/they have consented to publication) or commercially sensitive information. Also, the TGA will not publish information that could be considered advertising or marketing (e.g. logos or slogans associated with products), information about any alleged unlawful activity or that may be defamatory or offensive.

For general privacy information, go to https://www.tga.gov.au/privacy. The TGA is part of the Department of Health and the link includes a link to the Department’s privacy policy and contact information if you have a query or concerns about a privacy matter.

The TGA may receive submissions from the public on a proposed amendment to the Poisons Standard where there has been an invitation to the public for submissions on the proposal in accordance with the Therapeutic Goods Regulations 1990. These submissions may contain personal information of the individual making the submissions and others.

The TGA collects this information as part of its regulatory functions and may use the information to contact the individual who made the submissions if the TGA has any queries.

As set out above, the TGA is required to publish these submissions unless they contain confidential information.

If you request for your submission to be published in full, including your name and any other information about you, then the TGA will publish your personal information on its website. However, if at any point in time, you change your mind and wish for your personal information to be redacted then please contact the Scheduling Secretariat at medicines.scheduling@health.gov.au so that the pubic submissions can be updated accordingly.

Please note that the TGA cannot guarantee that updating the submissions on the TGA website will result in the removal of your personal information from the internet.

Please note that the TGA will not publish personal information about you/others without your/their consent unless authorised or required by law.

From:To: Medicines SchedulingSubject: Scheduling delegates" interim decisions and invitation for further comment: ACCS/ACMS, November 2016

[SEC=No Protective Marking]Date: Friday, 3 February 2017 7:36:02 PM

Dear Sir/Madam

I am writing to you today to express my horror and outrage that an interim decision hasbeen made to continue restrictions on the use of nicotine in e-cigarettes.

I am a 27 year old male . For the last twoyears I have been trying to quit as I recognised the impact that the unfiltered self-rolledcigarettes I smoke would be having on my health.

I have tried various treatments all with no to minor success. I have been on the prescriptiondrug champix which was a horrible experience with episodes of psychosis and aggression.This prescription drug was the closest I came to quitting with about 8 weeks smoke free,but also with genuinely terrifying side-effects.

Then everything changed in June 2016. I purchased an e-cigarette. I have not touched tobacco since that time. I have noticed

a marked improvement in my health and various other aspects of my life since changing toan e-cigarette.E-cigarettes have been so successful for me that I actually turn down ciggies when they areoffered to me, this is the first time in my adult life I have been able to do that. It's not acase of resisting the cravings, the cravings for cigarettes are simply no longer there.

My partner has also been able to quit her smoking habit and I would have considered hereven more addicted to traditional cigarettes than I was.

Fellow smokers in the city often ask me about my e-cigarette and how the experience wastransitioning off ciggies. I always recommend it to people, I have never had a non-smokershow any interest in my e-cigarette.

Your decision to continue restrictions on e-cigarettes is short sighted at best and anabhorrent morally bankrupt tax-grab at worst. It will cost people their lives and you knowit, I am appalled your organisation would force nicotine addicts to keep buying ciggies andchoose to uphold a ban on a less harmful alternative.

For shame.

Regards

From: To: Subject:

Date:

Medicines Scheduling Scheduling delegates" interim decisions and invitation for further comment : ACCS/ACMS, November 2016 [SEC=No Protective Marking]

Friday, 3 February 2017 9:00:45 PM

To whom this may concern

I am quite angry and upset regarding your decision to continue to make e-cigarette and nicotine liquid still illegal.

I have been a full time smoker for 10 years.

Last year I managed to successfully quit smoking thanks to e-cigarettes. I have not have a cigarette since April 2016.

Using an e-cigarette was my last hope. I had tried patches, gum, spray, hypnosis, quit help line and lastly champix (twice). My attempts at quitting had fai led every time, the longest I had quit for using these methods was 4-6 weeks. Champix was by far the worst method I had tried , I had an extremely bad experience with it, I had nightmares that would send me into anxiety based panic attacks that kept me up for hours, psychosis, severe depression on top on my already hard to manage depression, and what I would describe as my body going into a state of shock, almost unable to move. It was the most traumatising thing I have ever experienced.

I was a pack-a-day smoker before i came across an e-cigarette. The transition was so easy, I have seen significant change in my health and feel so much better after nearly 12 months of using an e-cigarette.

I often get stopped on the street by smokers and am asked about my e-cigarette, I can not recommended them enough. I tell everyone where I bought mine from and where to get the from in the hopes it will save someone else some money and help their health . I have never had a non-smoker ask me about them, I usally get dirty looks and nasty comments.

I have saved about $6000 in the last 10 months not buying cigarettes. I have spent roughly $200 in 10 months on I have saved money, made a huge change for the better to my health and genuinely feel better about myself after switching to e-cigarettes.

Do the right thing, help other long term smokers, lift the harsh restrictions on nicotine liquid.

Submission for the Scheduling medicines and poisons Date of submission invitation 4th August 2016 Submission relating to the application for the proposal to exempt nicotine from Schedule 7 at concentrations of 3.6 per cent or less of nicotine for self-administration with an electronic nicotine delivery system (‘personal vaporiser’ or electronic cigarette’) for the purpose of tobacco harm reduction

I, , Age 52, residing at in the state of New South Wales, would like to submit the following in support

of the above mentioned application.

• • I was a packet of twenty five (25) cigarettes a day smoker for over thirty five (35)

years. • I suffered greatly from lack of breath, and was well aware of the risks of smoking as

my mother died from emphysema. • I tried numerous methods and products recommended to smokers wanting to quit,

some of them many times. These included cold turkey, patches, gum, inhalers, and Champix (twice, at significant cost to the government).

• I did have some success using these products, and gave up smoking many times, but it never lasted long. In times of stress I always went back to smoking.

• I discovered e-cigarettes during a holiday in Hawai’i, and on my return to Australia, did some research. Then purchased an e-cigarette and e-liquid online.

•

• I have not had a cigarette, or any other combustible tobacco product, since four (4)

days after receiving my e-cigarette over three (3) years ago. • I have noticed significant health improvements since I have stopped smoking. I

breathe easier and have recovered my sense of taste and smell. Overall I have a better feeling of wellbeing, I am more active, feel more rested, and bouts of colds and flu are far less frequent.

•

• I am aware that the importation of e-liquid is not illegal. However I am concerned that the possession of it puts me at risk of prosecution.

• I fear that more restrictive regulation or legislation may lead me back to smoking, and prevent access to this alternative to many current smokers.

In closing my submission is to:

Decriminalise the possession of e-liquid containing nicotine, and make it available as a consumer product, in the strength applied for in the application.

• I support making e-liquid available as a consumer product through responsible retail outlets.

• I support limited regulation that is proportionate to the risk. This may include ensuring it is made to a standard of quality, is correctly labelled, has child-proof caps and is not available to minors under the legal smoking age.

I give my consent for this submission to be posted on any website with the parts highlighted not for publication omitted I make this submission in accordance with relevance to the aforementioned proposed amendment and feel addresses the matter mentioned in section 52E of the Therapeutic Goods Act 1989. Signed and Dated this the 19th day of August 2016 By .

Comments on the Interim Decision for the Scheduling of medicines and poisons Submission relating to the application for the proposal to exempt nicotine from Schedule 7 at concentrations of 3.6 per cent or less of nicotine for self-administration with an electronic nicotine delivery system (‘personal vaporiser’ or electronic cigarette’) for the purpose of tobacco harm reduction

I, would like to submit the following comments

on the interim decision relating to the above mentioned application.

Delegates' interim decision

The delegates' interim decision is the current scheduling of nicotine remains appropriate.

The delegates considered the relevant matters under section 52E (1) of the Therapeutic Goods Act 1989: 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; f) any other matters that the Secretary considers necessary to protect the public health.

• The Delegate did not thoroughly take into account “the risks and benefits of the use of a substance.” Only focusing on the risks. They also ignored “the purposes for which a substance is to be used and the extent of use of a substance;” i.e. by adults who already smoke and who are unwilling or unable to quit. This decision appears to be solely based on the potential risks, and ignores the fact that even the staunchest critics of tobacco harm reduction admit that there is clear scientific evidence that the use of ENDS is less harmful than smoking.

The reasons for the interim decision are the following:

There is a risk of nicotine dependence associated with use of Electronic Nicotine Delivery System (ENDS). The potential for nicotine dependence is much higher with third generation ENDS and is greater than with the nicotine replacement therapy products marketed in Australia. In countries such as the USA where there has been more ready access to ENDS there is some evidence that ENDS use in never-smoking youth may increase the risk of subsequent initiation of cigarettes and other combustible products during the transition to adulthood when the purchase of tobacco products becomes legal. There is some dual use of conventional cigarettes and ENDS in smokers. There are several published studies showing that youth who initiate smoking with e-cigarettes are about three times more likely to be smoking conventional cigarettes a year later. There is a risk that ENDS will have a negative impact on tobacco control and may re-normalise smoking. If exempt from Schedule 7, availability of ENDS in children may cause an increase in smoking as they transition to adulthood, which raises public health concerns.

• There are many “risks” and “potential risks” that “may” cause something outlined in this paragraph. It appears that the TGA has some doubt about its decision.

• The delegate has not taken into account the relative cost. In countries such as the USA it is far cheaper to smoke than to use ENDS. This would drive ENDS users to cigarettes. The same cannot be said about Australia.

• If ENDS are not available, those “never-smoking youth” would be “smoking-youth”. • The availability of ENDS and cigarettes will be the equal for children. If a child is of a mindset

to smoke, and ENDS are unavailable, they WILL acquire cigarettes. Would not the less harmful option be preferable?

• The delegate seems it is OK to use terms like: “there is some evidence”, when the evidence is negative. There is also “some evidence” to show that ENDS are NOT a gateway to smoking.

• If the delegate feels that there is a risk that ENDS will renormalise smoking, maybe water should be “prescription only” as it promotes the drinking of alcohol.

There is little evidence regarding the safety of long term nicotine exposure via ENDS. Exposure to nicotine in adolescents may have long-term consequences for brain development, potentially leading to learning and anxiety disorders. The toxicity of long term exposure to nicotine delivered by ENDS is unknown. Long-term exposure to excipients via the ENDS route of exposure is uncertain.

• Little evidence of long term safety, is also little evidence of long term danger. • There is over 50 years of evidence for long term use of snus, and 30 years of evidence for

NRTs, is this being ignored? • Another paragraph filled with “may have”, “potentially leading to”, “unknown” and

“uncertain”. The consequences of smoking tobacco are KNOWN and they ARE available! • Those adolescents are already getting long term exposure to nicotine via legal, deadly

cigarettes. • If long term use of nicotine is a concern, then why are all NRT products approved for long

term use, even for a 12 year old child?

· Nicotine can cause nausea, vomiting, convulsions, bronchorrhoea, high blood pressure, ataxia, tachycardia, headache, dizziness, confusion, agitation, restlessness, neuromuscular blockade, respiratory failure and death in overdose.

• So “can” Caffeine. • Nicotine is already available to adults in the form of cigarettes, and to children as young as

12 as patches, gum, lozenges and mouth spray. • Would the symptom of vomiting negate the risk of fatal poisoning outlined in the paragraph

below? • No mention of the positive effects? Improve cognitive performance. Improved prospective

memory (PM). Prevents Parkinson’s disease. It has an anti-oxidant effect. It is an anti-depressant. It relieves stress. It improves visual attention and working memory and can relieve the symptoms of Tourette’s and schizophrenia.

· The dosage, formulation, labelling, packaging and presentation of the nicotine as would occur if the scheduling was amended would allow nicotine to be too accessible as a liquid which has higher risks and requires appropriate controls.

• No more so than bleach, oven cleaner or any one of thousands of toxic chemicals sold over the counter in supermarkets around Australia.

· The proposed maximum amount of 900 mg of nicotine per pack is within the estimated lower limit causing fatal outcome (500 mg to 1g). There have been reports of unintentional ingestion of ENDS liquid by children with severe outcomes in some cases. The proposed maximum concentration of 36 mg of nicotine per mL is high (the EU Tobacco Product Directive specifies a maximum concentration of 20 mg/mL). The amount of nicotine in 5 mL of a 3.6% solution in ENDS is 180 mg, which would likely cause significant toxicity in a young child (5 mL would be one swallow for a toddler). Child-resistant packaging would reduce the risk of unintentional exposure to the solution in children.

• I agree this is a significant concern, however it is important to remember that although e-liquid tastes delicious when inhaled, it does taste disgusting when ingested.

• Not allowing low strength nicotine only encourages the importation on high strength nicotine, in large volumes, which increases the risk of poisoning.

• The inclusion of “dripper tops” would avoid the risk of ingestion in “one gulp”, forcing a concerted effort to consume the foul tasting liquid.

• There are any number of household chemicals available in the supermarket that are far more toxic than nicotine.

· In the USA, accidental poisonings associated with e-cigarettes have increased from one per month in 2010 to 215 per month in 2014 including one death.

• This is again very concerning, however we need to weigh the risks against the benefits. ENDS have the potential to save the lives of thousands of smokers that are unable to quit smoking using traditional methods.

• In the USA in 2014 there were: 11,115 poisonings per month associated with analgesics in adults. 28,202 poisonings per month associated with other prescription drugs in adults. 5,351 poisonings per month associated with household cleaning substances in

adults. 12,544 poisonings per month associated with cosmetics in children under 6. 9,850 poisonings per month associated with cleaning substances in children

under 6. 949 poisonings per month associated with analgesics in children under 6. 133 deaths associated with analgesics. 127 deaths associated with other prescription drugs. 28 deaths associated with household cleaning substances.

Why are these products allowed to be sold?

· ENDS is used for Tobacco Harm Reduction, assistance with cessation of smoking and for recreational use. Public health authorities have varying views about the benefits of ENDS to tobacco harm reduction and as an aid in smoking cessation. Currently about 9% of current smokers and recent quitters in Australia use ENDS. Excepting nicotine from Schedule 7 would likely result in increased nicotine exposure via ENDS (based on countries such as the UK and USA where these products are more widely available, and the increase in Australia in recent years). In the UK 19% of smokers and 8% of ex-smokers currently use ENDS.

• Most Western Health authorities now recognise the benefits of ENDS, even recommending and promoting them.

• We hope for an increase in nicotine exposure via ENDS, coupled with a decrease in nicotine exposure via cigarettes.

• “In the UK 8% of ex-smokers currently use ENDS.” The delegate fails to understand that this equates to over 675,000 smokers that have quit smoking!

· The use of a label warning statement ‘not to be sold to a person under the age of 18 years’ is not likely to be effective unless there is enforcement of this requirement. There is a risk there will be inappropriate marketing and advertising of nicotine for use with ENDS if nicotine for use with ENDS is exempted from Schedule 7.”

• Cigarettes continually fall into the hands of children even though the laws are enforced. • I’m sure most consumers would welcome any enforcement of this requirement. • There is no reason why the marketing and advertising of liquid nicotine cannot be managed

appropriately, as it has been with cigarettes.

In closing …….

I implore the TGA to reconsider its decision to retain the current scheduling of nicotine.

This decision by the TGA can have lethal or life-saving consequences. The TGA is obliged under the law to make an objective assessment of all factors involved and to make a decision that protects the public health. Nothing in the arguments supporting the interim decision suggests that any of the potential benefits have been considered.

Consumers demand a practical regulation of low strength nicotine. Australians are turning to e-cigarettes as a method of harm reduction, despite the almost total absence of marketing and the fact that the sale, possession and use of nicotine in these devices is illegal without prescription. This proposal offers a viable way of de-scheduling nicotine that would satisfy the needs of most e-cigarette users.

This decision leaves Australia with a disadvantage compared to other progressive western countries where liquid nicotine is either legal, or in the process of being legalised.

Many thousands of Australians have switched to nicotine e-cigarettes because they could not stop smoking using the approved methods. If a consumer is presented with a choice of breaking the law, or early death from smoking, their decision to break the law is not surprising. The only reason I see for deadly tobacco and traditional NRTs to be the only nicotine products exempt from Schedule 7, is to protect the tobacco and pharmaceutical industries from competition. Please explain why a safer product should be more difficult to access than the far more dangerous alternative? The lack of choice is harmful to consumers. The danger from the toxicity of nicotine is over stated by the TGA, low strength nicotine is no more toxic than many other products found in the average home. Practical scheduling decisions have been made for such substances to reflect real world use despite a toxicity similar to low strength nicotine. As ENDS devices offer a viable way for adult consumers to minimise the health risks associated with tobacco smoking, they will continue to use these products. It is time for the TGA to stop protecting tobacco & pharmaceutical companies and the cigarette market. It is time for the TGA to examine the latest scientific evidence provided by the world’s most prominent scientists and public health experts. It is time for e-cigarette users to be proud citizens, not criminals. It is time for Australia to accept that practical regulation of nicotine has the potential to save the lives of thousands of Australians who still smoke cigarettes.

I give my consent for these comments on the interim decision to be posted on any website with the parts highlighted not for publication omitted. (Please do not heavily redact this document in a similar fashion to my initial submission)

Signed and Dated this the 15th day of February 2017 By

Australian Self-Medication Industry Ltd.

9 February 2017 The Secretary Scheduling Secretariat GPO Box 9848 Canberra ACT 2601 Email: Medicines.Scheduling@tga.gov.au Dear Sir or Madam, Re: Scheduling delegates' interim decisions and invitation for further comment: ACCS/ACMS, November 2016 We refer to the notice inviting further comment under subsection 42ZCZP of the Therapeutic Goods Regulations 1990 and would like to provide comment on the Delegate’s Interim Decisions arising from the November 2016 meeting of the ACMS. The comments submitted below address matters raised in s.52E of the Therapeutic Goods Act 1989. ASMI (Australian Self Medication Industry) is the peak body representing companies involved in the manufacture and distribution of consumer health care products (non-prescription medicines) in Australia. ASMI also represents related businesses providing support services to manufacturers, including advertising, public relations, legal, statistical and regulatory consultants. ASMI has considered the Delegate’s Interim Decisions and Reasons for Decisions and would like to comment on the following scheduling proposals: Paracetamol when compounded with caffeine For the reasons outlined in our submission of 1 September 2016, ASMI supports the Delegate’s interim decision that combination products containing paracetamol and caffeine should be exempt from Schedule 2 in accordance with the amendments recommended by ACMS. Vardenafil ASMI does not support the Delegate’s interim decision regarding vardenafil. In our view, a new Schedule 3 entry should have been prepared as proposed by the applicant.

In reviewing the summary of the ACMS advice, and the delegate’s subsequent considerations, we note that the three reasons given all apparently involve irrelevant considerations (i.e. outside of the s.52E criteria) or mistaken considerations, for example:

While acknowledging that “Erectile dysfunction can be a marker of an underlying cardiovascular disease, diabetes or endocrine disorder …”, the ACMS and the Delegate both ignore the very real likelihood that Schedule 3 availability of vardenafil will lead to an increase in discussions between men and healthcare professionals (as has been seen in New Zealand).

Both the ACMS and the Delegate indicate that “The rescheduling of vardenafil would most likely not reduce internet purchasing and access to overseas supply of vardenafil”. However, no evidence to support this position is provided and it seems very likely that the availability in pharmacy of safe, high quality, properly regulated products would have to reduce internet purchases of products which are likely to be unsafe.

Most significantly, both the ACMS and the Delegate note that “additional pharmacist training and use of a specific supply protocol cannot be mandated for the supply of pharmacist-only Schedule 3 medicines”. We suggest that this is entirely irrelevant to the consideration of whether or not a substance should be included in Schedule 3 and if such a consideration were relevant then, by this logic, no substance could be included in Schedule 3 at all. This consideration completely ignores the network of legal, professional and ethical obligations already acting on pharmacists to make sure that: (a) they are involved in the S3 transaction, and, (b) they recommend the appropriate product in the circumstances. The existence of this network makes mandating training and supply protocols unnecessary.

Also of concern is the following statement in the summary of the ACMS advice to the delegate:

The Committee recommended adding this issue to the SPF review - Schedule 3/Schedule 4 boundary for 'switch' products.

It is unclear to us what “boundary” the ACMS is referring to. It is also unclear exactly what “issue” in the proposal ought to be added to the SPF review. More detail would assist stakeholders and might allay concerns that the ACMS were taking irrelevant considerations into account. (i.e. .by considering issues that were outside of the s.52E criteria and outside the Factors for Pharmacist Only Medicines in the SPF). Nicotine For the reasons outlined in our submission of 1 September 2016, ASMI supports the Delegate’s interim decision that the current scheduling of nicotine remains appropriate. Cetirizine For the reasons outlined in our submission of 1 September 2016, ASMI supports the Delegate's interim decision that the Schedule 2 and Schedule 4 entries for cetirizine hydrochloride be amended so that cetirizine will be exempt from scheduling when in a maximum pack size of 10 days' supply.

Thank you for the opportunity to comment on the above interim decisions. Please contact me should you have any further queries. Yours sincerely,

1

Proposed Amendment to the Poisons Standard Schedule 7 entry for nicotine – Submission in response to the Interim Decision of the Advisory Committee on Medicines Scheduling

On 2 February 2017 the Advisory Committee on Medicines Scheduling (ACMS) released its interim decision on the application made to exempt nicotine from Schedule 7 of the Poison Standard at concentrations of 3.6 per cent or less of nicotine for self-administration with an electronic nicotine delivery system (ENDS). The interim decision rejects the application and proposes that the current scheduling of nicotine remains appropriate.

Nicoventures Holdings Limited (Nicoventures) made submissions on the application dated 30 August 2016. In addition to those submissions, Nicoventures makes the following observations on the interim decision.

Nicoventures strongly urges the ACMS to reconsider its position and approve the proposed amendment.

The ACMS has failed to have adequate regard to the parties most affected by the current scheduling of nicotine, current smokers, and the impact of maintaining the status quo, continued cigarette smoking. E-cigarettes with nicotine are legal and available in numerous jurisdictions including within the European Union1 (including specifically the United Kingdom2), and the United States3, and are in the process of being legalised in others, for example Canada4 and New Zealand5. Australia is out of step with these jurisdictions, instead having an intense focus on the potential risks of e-cigarettes while ignoring the huge population benefits of using e-cigarettes for tobacco harm reduction.

As noted in Nicoventures submissions on the application, it is clear that the current scheduling approach for nicotine is not fit for purpose. A growing number of Australian smokers are acting outside regulation to access a product that many globally recognised public health experts agree is less harmful than combustible cigarettes. Prohibition isn't working. It also perpetuates harm by preventing adult smokers from using a potentially less harmful nicotine product. A practical and regulated solution that allows Australian smokers legal access to nicotine containing e-liquid is urgently required.

As discussed below the interim decision relies on reasoning that is unbalanced and ignores the weight of international evidence.

1. Risk of nicotine dependence.

The interim decision states that there is a risk of nicotine dependence associated with use of ENDS. However, this objection is misconceived. It ignores that cigarettes, cigars, cigarillos, pipe and roll your own tobacco and nicotine replacement therapies (NRT) which, are already legally available to adult consumers in Australia, can all cause nicotine dependence. The potential for addiction already exists therefore, but in the case of smoked tobacco, it is coupled with additional risk - that associated with the smoking process. It is widely accepted by health experts that nearly

1 DIRECTIVE 2014/40/EU OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL, found at: http://ec.europa.eu/health//sites/health/files/tobacco/docs/dir 201440 en.pdf

2 E-cigarettes: regulations for consumer products, found at: www.gov.uk/guidance/e-cigarettes-regulations-for-consumer-products#history

3 Vaporizers, E-Cigarettes, and other Electronic Nicotine Delivery Systems (ENDS), found at: www.fda.gov/tobaccoproducts/labeling/productsingredientscomponents/ucm456610.htm#regulation

4 Government of Canada Announces Next Steps in Tobacco Control, found at: http://news.gc.ca/web/article-en.do?nid=1130369&tp=1

5 Policy Options for the Regulation of Electronic Cigarettes: A consultation document, found at: www.health.govt.nz/publication/policy-options-regulation-electronic-cigarettes-consultation-document

2

all the health risks associated with the use of smoked tobacco come from the tar, chemicals and other substances found in the smoke, not from nicotine.

The Royal College of Physicians notes that ENDS offer smokers the delivery of nicotine, in the absence of the vast majority of the harmful constituents of tobacco smoke (or at least at negligible levels), in a way that enables accurate self-titration.6 It is because of this, and that ENDS also offer a number of the cues associated with cigarette smoking, that ENDS have the potential to be an effective smoking substitute.7

Action on Smoke and Health (ASH) UK similarly states that: "The harm from smoking is caused primarily through the toxins produced by the burning of tobacco. By contrast, non-tobacco, non-smoked nicotine products, although addictive, are considerably less harmful. Electronic cigarettes consequently represent a safer alternative to cigarettes for smokers who are unable or unwilling to stop using nicotine."8

Thus this reasoning of the interim decision proposes to continue to deny access to ENDS for one of the very reasons that they should be made available – to provide an effective nicotine delivery system as a substitute for combustible cigarettes.

In addition, the fact that ENDS are not legally available within Australia does not mean that they will not be sought out and used as people seek to find potentially safer nicotine alternatives. It simply drives a black market in such products. A legal and properly regulated market in such products would result in greater safety for consumers.

2. Risk of initiation of cigarette smoking.

The interim decision also asserts that ENDS use may increase the risk of subsequent initiation of cigarettes (the alleged 'gateway' hypothesis) and may re-normalise smoking. However, this ignores the weight of international evidence showing that e-cigarette use has not resulted, in any appreciable extent, in the initiation of smoking in either adults or children. Rather, the evidence suggests that "Use of the devices in young people is rare and is confined almost entirely to those who currently or have previously smoked."9

The studies relied on in the interim decision that claim that youth who initiate smoking with e-cigarettes are about three times more likely to be smoking conventional cigarettes, do not establish that it is the use of e-cigarettes that leads to smoking, or if individual characteristics predict both e-cigarette use and future smoking. As one expert stated in respect of one these studies: "… if you look more closely at the paper any assumptions that one leads to the other are not supported, as is the case with previous studies. In particular in this paper, more frequent use (compared to experimentation) of both e-cigarettes and tobacco at baseline and follow up was low and did not significantly increase – around 8% for e-cigarettes and 4% for tobacco at both time points… This study does not provide evidence that e-cigarettes are a gateway to regular smoking in teenagers."10

A recent systematic review of the literature undertaken by the University of Victoria, Centre of Addictions Research of British Columbia, also concludes that: "There is no evidence of any gateway effect whereby youth who experiment with vapour devices are, as a result, more likely to take up tobacco use. The available evidence is that tobacco use by youth has been declining while use of vapour devices has been increasing." The report noted that: "[f]our population survey

6 Royal College of Physicians. Nicotine without smoke: Tobacco harm reduction. London: RCP, 2016, at pp 63-64.

7 Ibid.

8 ASH UK Briefing, Electronic cigarettes, February 2016.

9 ASH UK Fact Sheet May 2016, Use of electronic cigarettes (vapourisers) among adults in Great Britain

10 Prof. Linda Bauld, Professor of Health Policy at the University of Stirling, Deputy Director of UK Centre for Tobacco and Alcohol Studies, and Chair in Behavioural Research for Cancer Prevention at Cancer Research UK, available at http://www.sciencemediacentre.org/expert-reaction-to-study-of-e-cigarette-use-and-cigarette-smoking-in-children/

3

studies found that tobacco use rates among youth were declining as vapour device prevalence increased. The two regression analysis studies provided the strongest evidence that vapour device use does not lead to tobacco use among youth, as US adolescents with access to vapour devices had lower rates of tobacco uptake than those who were banned from the legal purchase of vapour devices." 11

The authors state:

"Policy should not be driven by ungrounded fears of a “gateway effect” but, rather, be geared towards helping tobacco smokers quit and ensuring that only the safest devices are legally available, thereby reducing harm from both direct and second hand exposure."12

More fundamental still, however, is the fact that there are studies that contradict re-normalisation concerns and instead indicate that e-cigarettes may contribute to lower smoking prevalence rates. For example, a study following vapers over a 12-month period found that 22% of dual tobacco and e-cigarette users had stopped smoking after one month and 46% after one year.13 A review of the available evidence by Public Health England concluded as follows:

"Since EC [electronic cigarettes] were introduced to the market, smoking prevalence among adults and youth has declined. Hence there is no evidence to date that EC are renormalizing smoking, instead it’s possible that their presence has contributed to further declines in smoking, or denormalisation of smoking."14

3. Lack of evidence regarding the safety of long term nicotine exposure via ENDS.

The interim decision states that there is little evidence regarding the safety of long term nicotine exposure via ENDS. We agree that more research is needed into the long-term effects/relative risk of the use of ENDS and that ongoing research is an essential component of any sensible strategy. Nevertheless, the reasoning of the ACMS ignores the strength of existing international evidence and opinions of public health authorities that the risk of ENDS products “is likely to be extremely low, and certainly much lower than smoking.” 15 On that basis, adults who would otherwise continue smoking should have the choice to switch to alternative products now. To restrict or ban products under the “precautionary principle” would be a hugely wasted opportunity.

This is further supported by a recent study funded by Cancer Research UK which found that people who swapped smoking regular cigarettes for e-cigarettes or NRT for at least six months, had much lower levels of toxic and cancer causing substances in their body than people who continued to use conventional cigarettes.16 Dr Lion Shahab, a senior lecturer in the department of epidemiology and public health at University College London, and the lead author of the publication, stated: "Our

11 O'Leary et al. (2017), Clearing the Air: A systematic review on the harms and benefits of e-cigarettes and vapour devices: Victoria, BC: Centre for Addictions Research of BC.

12 O’Leary, R., MacDonald, M., Stockwell, T., & Reist, D. (2017). Clearing the Air: A systematic review on the harms and benefits of e-cigarettes and vapour devices. Victoria, BC: Centre for Addictions Research of British Columbia (emphasis added).

13 A longitudinal study of electronic cigarette users. Jean Francois Etter and Chris Bullen, Addictive Behaviours, February 2014. http://www.sciencedirect.com/science/article/pii/S0306460313003304

14 E-cigarettes: an evidence update: a report commissioned by Public Health England. Available at https://www.gov.uk/government/publications/e-cigarettes-an-evidence-update

15 Britton, J. and I. Bogdanovica, Electronic cigarettes: A report commissioned by Public Health England.London: Public Health England, 2014

16 Shahab et al, Nicotine, Carcinogen, and Toxin Exposure in Long-Term E-Cigarette and Nicotine Replacement Therapy Users, Ann Intern Med. doi:10.7326/M16-1107.

4

study adds to existing evidence showing that e-cigarettes and NRT are far safer than smoking, and suggests that there is a very low risk associated with their long-term use."17

In our assessment, the interim decision does not give sufficient credence to the growing body of respected evidence regarding the potential reduced health risks of e-cigarettes compared to conventional cigarettes. We submit that the final decision should do so.

4. Risk of overdose and poisoning

The concern expressed in the interim decision of the risk of overdose is entirely unbalanced and misleading and in any event could be addressed via proper regulation.

The first point, which the interim decision ignores, is that public health authorities and experts have concluded that: "overdosing on nicotine products used as directed is almost impossible."18 Cancer Research UK states: "… there’s a common misconception that you can overdose on nicotine using e-cigarettes. But you are in no danger of poisoning yourself, nor have there been any cases of overdose from inhaling the nicotine-containing fluid that an e-cigarette vaporises, known as e-liquid."19

A study carried out using electronic cigarette brands available in the UK also concluded that that there is only a low risk of overdose of nicotine or even inhaling toxic doses of nicotine using electronic cigarettes.20

The interim decision refers to the proposal for a maximum nicotine content per container of 900 mg, but fails to note that a maximum nicotine concentration is also proposed of up to 3.6%. A report commissioned for Public Health England also notes that: "Serious nicotine poisoning seems normally prevented by the fact that relatively low doses of nicotine cause nausea and vomiting, which stops users from further intake."21

The interim decision also refers to an increase in accidental poisonings associated with e-cigarettes in the USA from 2010 to 2014, but fails to put this in any context, including that:

during this period there was a dramatic increase in the use of e-cigarettes in the US22, so these increased calls are to be expected;

reports of exposures to nicotine pale in comparison to other more common household items. For example: "… in 2013, there were 1,543 exposures to nicotine reported to poison control centers; this includes all nicotine calls from exposure to chewing tobacco, regular cigarettes as well as e-liquids. In comparison, analgesics, basic over the counter pain medication, was responsible for just under 300,000 reported calls to the center. Alcohol was reported to be the cause of just over 70,000 calls; even common house or garden plants were responsible approximately 46,000 cases."23

17 Science News, E-cigarettes safer than smoking says long-term study https://www.sciencedaily.com/releases/2017/02/170207104358.htm

18 Royal College of Physicians. Nicotine without smoke: Tobacco harm reduction. London: RCP, 2016, at p57.

19 Cancer Research UK, 10 common questions about e-cigarettes answered http://scienceblog.cancerresearchuk.org/2016/05/17/10-common-questions-about-e-cigarettes-answered/

20 Goniewicz et al, Nicotine content of electronic cigarettes, its release in vapour, and its consistency across batches: Regulatory implications. Addiction, 2013. http://dx.doi.org/10.1111/add.12410

21 McNeill and Hajek, (2015) E-cigarettes: an evidence update. A report commissioned by Public Health England, p63.

22 During 2010–2013, ever use of e-cigarettes among US adults increased from 3.3% to 8.5% (King et al Trends in Awareness and Use of Electronic Cigarettes Among US Adults, 2010–2013 Nicotine Tob Res. 2015 Feb; 17(2): 219–227) and in 2014 12.6% of adults had ever tried an e-cigarette even one time (Schoenborn et al (2015) Electronic Cigarette Use Among Adults: United States, 2014 NCHS Data Brief No. 217, October 2015).

23 The Truth Behind E-Liquid Poisoning, https://info-electronic-cigarette.com/the-truth-behind-e-liquid-poisoning/

5

child proof packaging for e-liquids was only required by regulation in the US from July 2016.

The interim decision also disregards the consideration of this issue in the evidence update report commissioned for Public Health England. The report considers data on e-liquid exposures in the UK and noted that: "Exposures to poisonous liquid among children are of concern; however they should be taken in context. The [National Poisons Information Service (NPIS) report for 2013/14 also] recorded 208 exposures to liquid in reed diffusers, 1,168 exposures to pesticides and more than 600 to paracetamol. E-liquids seem to contribute towards domestic poisoning incidents but regulations, such as child safety caps, could limit this risk."24

The Public Health England report concluded that:

"With the increase in EC use, there has been an increase in calls to poison centres following accidental exposures but these remain lower than calls following such exposure from tobacco and none resulted in any serious harm … Serious nicotine poisoning seems normally prevented by the fact that relatively low doses of nicotine cause nausea and vomiting, which stops users from further intake.

…

E-liquid normally comes in 10ml bottles containing up to 360mg of nicotine (see below). This poses no risk to vapers if used as intended. The liquid however should be in ‘childproof’ packaging to prevent small children, who may find the flavouring appealing, from drinking it. This seems to have been widely accepted by the EC industry. All e-liquids we have seen so far in the UK and globally were sold in child-resistant packaging."25

In conclusion, the interim decision appears to over-estimate the risks associated with overdosing and poisoning and in any event any concerns could be adequately addressed via proper regulation.

5. Exempting nicotine from Schedule 7 would likely result in increased nicotine exposure via ENDS

The ACMS's reason for not exempting nicotine from Schedule 7 because it would likely result in increased nicotine exposure via ENDS is also misconceived. The point in exempting nicotine is so that ENDS products will be more available for current smokers to use as a potentially safer alternative to combustible cigarettes. This reason entirely disregards the evidence set out above as to the relative risks of ENDS and their use by current smokers as a substitute for combustible cigarettes.

It should be noted that the World Health Organisation (WHO) recognises the potential role of ENDS in tobacco control. In a recent report, the WHO acknowledged that "[i]f the great majority of tobacco smokers who are unable or unwilling to quit would switch without delay to using an alternative source of nicotine with lower health risks, and eventually stop using it, this would represent a significant contemporary public health achievement."26

The WHO has also acknowledged that:

The "number and level of known toxicants generated by the typical use of unadulterated ENDS/ENNDS is on average lower or much lower than in cigarette smoke"; and

24 McNeill and Hajek, (2015) E-cigarettes: an evidence update. A report commissioned by Public Health England, pp81-82.

25 Ibid at pp63-64.

26 WHO FCTC Report on Electronic Nicotine Delivery Systems ("ENDS") and Electronic Non-Nicotine Delivery Systems ("ENNDS") to the seventh session of the Conference of the Parties at paragraph 5.

6

"Based mostly on the levels and number of toxicants produced during the typical use of unadulterated ENDS/ENNDS made with pharmaceutical-grade ingredients, it is very likely that ENDS/ENNDS are less toxic than cigarette smoke."

6. The use of a label warning statement ‘not to be sold to a person under the age of 18 years’ is not likely to be effective; and risk of inappropriate marketing and advertising.

In raising concerns regarding the effectiveness of a warning statement, the interim decision again ignores the impact of maintaining the status quo, including the continuation of a black market and the risks associated with it. ENDS products are already available to youth through the black market which is entirely unregulated.

There are also existing protections against misleading and deceptive advertising under the Competition and Consumer Act 2010 (Cth) which would apply to ENDs products if they were exempted from Schedule 7.

Proper and balanced regulation of ENDS (which we advocate), coupled with robust enforcement measures would help serve to address this concern. Nicoventures would welcome the introduction of ACCC Mandatory Standards for ENDS products and liquids.

Conclusion

As discussed above, a balanced and objective approach to the evidence suggests a very different position than that stated in the interim decision.

Unfortunately, it appears that the ACMS's consideration of the application has been heavily influenced by anti-tobacco sentiment rather than objective consideration of the evidence. The alleged threat of policy being driven by 'Big Tobacco' is a misnomer. As the ACMS is aware, the application was in fact supported by many Australian academics and researchers who have no links to the tobacco industry and have actively opposed the industry.27

The reasoning of the interim decision is in stark contrast to the position reached by the Royal College of Physicians after their thorough review of the evidence, that: "…in the interests of public health it is important to promote the use of e-cigarettes, NRT and other non-tobacco nicotine products as widely as possible as a substitute for smoking in the UK."28

Accordingly, we urge the ACMS to reconsider its position and to consider the application having particular regard to the parties most affected, current smokers, and the impact of maintaining the status quo, continued cigarette smoking. Properly looked at on this basis, the weight of the scientific evidence points in favour of allowing Australian adult smokers legal access to ENDS products, consistent with the approach taken in a number of other jurisdictions, such as the US and the European Union, amongst others.

27 See e.g. Nicotine for vaping should be legalised in Australia: 40 international and Australian experts, available at https://newsroom.unsw.edu.au/news/health/nicotine-vaping-should-be-legalised-australia-40-international-and-australian-experts.

28 Royal College of Physicians. Nicotine without smoke: Tobacco harm reduction. London: RCP, 2016, at p190.

February 2017

Therapeutic Goods Administration. Scheduling delegates' interim decisions and invitation for further comment: ACCS/ACMS, November 2016.

Joint meeting of the Advisory Committee on Chemicals and Medicines Scheduling (ACCS-ACMS #14) 2. 1 Nicotine, 2 February 2017

COMMENT ref: Proposed Amendments to the Poisons Standard (Medicines)

factasia thanks the Committee for its consideration of the above and notes the opportunity to comment further in the framework of Section 52e of the Therapeutic Goods Act 1989 as follows.

SUMMARY

Having previously submitted its statement in support of the NNA's application, factasia reads

with disappointment the advice of the joint ACCS-ACMS and its interim decision not to

allow the proposed rescheduling of nicotine.

In general, the case made by the Committee for continuing to restrict the availability of nicotine, which is so widely available in other forms (notably cigarettes, which the WHO says will kill more than a bill ion people durng the 21st century and which we are all surely in favour of eradicating) deliberately exaggerates the risks and overlooks the proven benefits of the substance in question for the pupose of the application - ie, assist ing smokers to quit smoking. We question the wisdom of such a lack of balance and would seek to ask its basis.

factasia contends, in common with Tobacco Harm Reduction experts throughout the world, that the benefits of the use of the substance in question, to quote Section 52 of the Therapeutic Goods Act 1989, outweigh the risks. This has been proven in deve loped nations by the numbers in the mill ions (of adult smokers) who have successfu lly quit with the aid of new nicotine products that do not burn tobacco, in comparison with the insignificant amount of harm caused by misuse of nicotine.

Rational analysis shows the actual harm caused by misuse of nicotine is a t iny fract ion of that caused by common letha l household killers such as cosmetics, plants and vitamins 1, assuredly no greater than a child

Fact Asia Consu ltants ltd

accidentally ingesting a mouthful of household bleach, which as TGA knows is widely available without prescription.

In summary, the Committee's interim decision is hardly a surprise, given that many of those submitting to the TGA negative assessments of new nicotine products as a harm reduction and public health boon have close ties to major pharmaceutical companies, which have a very close vested interest in maintaining the high levels of death and disease associated with ensuring that smokers' ability to choose alternative delivery methods is restricted to ineffectual ones that they themselves manufacture and profit from (ie gums and patches that have a demonstrated high rate of recidivism). However, factasia adds its voice (on behalf of consumers throughout Australia) to the many others in harm reduction asking for the Committee to reconsider its decision, and approve this cautious amendment to the Schedule as proposed by NNA.

COMMENTS ON MAIN POINTS opposing the proposal

The risks and benefits of the use of a substance

The Committee concludes “there is a risk that ENDS will have a negative impact on tobacco control and may re-normalise smoking.”

If there is any logic at all to this assertion, though it appears to be a contradiction (“by not doing something, you re-normalise it”), it would be the association that vaping somehow leads to smoking – with the implication that there is the much hyped 'gateway effect' where non-smokers are somehow tempted into combustible cigarette use by non-combustible nicotine delvery systems. Experience with snus – one area where long-term evidence is available, undeniable and apparently ignored in the Committee's deliberations – demonstrates quite the opposite effect: the lowest smoking rates in the world in the countries where snus has been an alternative nicotine delivery method for many decades. 2

The TGA's interim verdict points out that “there is little evidence regarding the safety of long term nicotine exposure via ENDS”. It is self-evident that a new technology has no long-term longitudinal studies. But it is incorrect to claim that there is no evidence or insight into possible long-term effects of a new technology. The Committee itself provides no rationale (although one of its advisors, outside the framework of the Committee, has made a scurrilous and mendacious attempt to deny its logic and scientific basis) for rejecting the evidence of Public Health England 3 and the Royal College of Physicians (London) 4 which provided a guideline assessment that e-cigarettes are likely to be at least 95 percent lower risk than smoking. RCP's summary was:

“Although it is not possible to precisely quantify the long-term health risks associated with e-cigarettes, the available data suggest that they are unlikely to exceed 5% of those associated with smoked tobacco products, and may well be substantially lower than this figure". (Section 5.5 page 87)

The ACCS-ACMS advice does not provide any basis for disputing this cautious expert assessment or present any theory to suggest why very much lower toxic exposures would not translate into a substantial reduction in death and disease.

The purposes for which a substance is to be used and the extent of use of a substance

The TGA's interim verdict says there is “limited and highly conflicting evidence internationally regarding the effectiveness of using e-cigarettes as a smoking cessation aid (with or without nicotine).” That rather

Fact Asia Consultants Ltd

page 2

subjective assessment conflicts with evidence already presented and also with further studies and research published since the consultation last year, notably “E-cigarettes confirmed to be safer than smoking in long-term study” 5 (a UK study published in the Journal of the American College of Physicians), summarised thus:

“Some reports claim to show that e-cigarettes are as harmful as smoking but the study authors say those reports are based on studies that bear little relationship to exposure of e-cigarette users in the real world. In the first study of its kind, researchers measured the intake of potentially harmful chemicals in e-cigarette users and compared them to people using licensed nicotine patches and cigarettes. The study found that when smokers switched completely to e-cigarettes, their intake of cancer-causing chemicals dramatically fell to a level found in people using nicotine patches while their intake of nicotine remains largely unchanged. Using e-cigarettes or nicotine replacement patches while continuing to smoke cigarettes does not seem to offer the same benefit.”

Clearly, the alleged benefits of switching from smoking to vaping should increase with the rate of substitution; thus replacement of smoking with vaping should be something to applaud.

The toxicity of a substance

The symptoms listed by the Committee, and by other detractors, do not occur in actual usage (of personal vaporisers or other new nicotine products) and there have been no reports of overdosing among users – no more than reports of overdosing on nicotine-containing chewing gum. Vapers self-regulate: they stop vaping when they sense they have taken in enough nicotine 6 .

The dosage, formulation, labelling, packaging and presentation of a substance

The Committee contends that nicotine might become “too accessible as a liquid”. To suggest that 900mg of a substance might be so dangerous as to ban it while maintaining open sale of litres of equally or more dangerous chemicals (household cleaners, for example) defies logic. In any case, in common with all other harm reduction proponents, factasia recommends child-resistant packaging, appropriate warnings and advice for anyone exposed. (factasia also supports any recommendation that new nicotine products be kept away from youth – ie under-18s – as with other lifestyle choices for adults. To suggest that something should be banned because some retailers break the law in supplying it is disingenuous at best 7).

The Committee's own summary mentions “a risk of nicotine dependence associated with use of Electronic Nicotine Delivery System (ENDS). The potential for nicotine dependence is much higher with third generation ENDS and is greater than with the nicotine replacement therapy products marketed in Australia.” An analysis of this statement shows that: ENDS are more effective at delivering nicotine so will be used more (than patches and gums). Those switching (or wishing to be allowed to switch) from smoking to ENDS are already, almost by definition, dependent on nicotine.

Indeed the Committee acknowledges that ENDS is used for Tobacco Harm Reduction, assistance with cessation of smoking and for recreational use. factasia cannot understand why the Committee does not see that as a positive statement – opportunity rather than problem. Cessation of smoking is surely the goal of us all, on both sides of this seemingly unbridgeable chasm of faith versus science

.................. (ends)

Fact Asia Consultants Ltd

page 3

NOTE

factasia.org is an independent, not-for-profit, consumer-oriented advocate for rational debate about – and sensible regulation of – the rights of adult citizens throughout Asia to choose for themselves within sensibly defined guidelines. factasia supports rational debate and sensible legislation.

factasia is currently concentrating on the issue of consumers' ability to choose tobacco harm reduction in numerous countries across Asia-Pacific including Hong Kong (with presentations to the Legislative Council) and Malaysia (discussions with Minister of Health and officials at the Trade Ministry), as well as Australia and New Zealand.

factasia does not promote smoking or the use of nicotine, opposes all under-age use of cigarettes or any other product containing nicotine, and does not (and will not) engage in any manufacturing, distribution or retailing activities. factasia aims to act as a messenger, facilitating constructive dialogue between scientists and medical experts, legislators, regulators and the general public.

Fact Asia Consultants Ltd

page 4

REFERENCES

1 James B. Mowry PharmD, Daniel A. Spyker PhD, MD, Daniel E. Brooks MD, Naya McMillan DrPH, MS & Jay L. Schauben PharmD (2015) 2014 Annual Report of the American Association of Poison Control Centers’ National Poison Data System (NPDS): 32nd Annual Report, Clinical Toxicology, 53:10, 962-1147, [link]

2 Lee PN. Epidemiological evidence relating snus to health - an updated review based on recent publications. Harm Reduct J. England; 2013;10(1):36. [link]

3 Public Health England. E-cigarettes around 95% less harmful than tobacco estimates landmark review. [link] E-cigarettes: an evidence update 19 August 2015. [link]

4 Royal College of Physicians (London), Nicotine without smoke: tobacco harm reduction. 28 April 2016 [link]

5 E-cigarette users who stopped smoking cigarettes substantially reduced their intake of tobacco-related carcinogens and toxins – Abstract: http://annals.org/aim/article/doi/10.7326/M16-1107 6 Dawkins LE, Kimber CF, Doig M, Feyerabend C, Corcoran O. Self-titration by experienced e-cigarette users: blood nicotine delivery and subjective effects. Psychopharmacology (Berl). 2016 May; [link]

7 given the current situation surrounding illicit import and consumption of conventional tobacco products, which is costing the Treasury upwards of AUD1.5 Billion per year in lost revenue, the whole law-enforcement argument is for another stage

Fact Asia Consultants Ltd

page 5

1

Response to the scheduling delegates’ interim decision on nicotine, dated 2 February 2017

2

Conjoint Associate Professor Colin Mendelsohn School of Public Health and Community Medicine The University of New South Wales, Sydney, Australia

3

16 February 2017 The Delegates of the Secretary Joint Advisory Committees on Medicines and Chemicals Scheduling Therapeutic Goods Administration By e-mail: medicines.scheduling@health.gov.au Dear Delegates, We would like to submit a response to the interim decision on the Application for amendment of Schedule 7 entry for nicotine on the Poisons Standard (dated 2 February 2017). We are Australian academics, researchers and clinicians who were co-authors of submissions to support the original application (1, 2) We believe there are two fundamental flaws in the TGA’s reasons listed on page 84 of the report, ‘Interim decisions & reasons for decisions by delegates of the Secretary to the Department of Health’.

1. The report focusses only on the potential risks of nicotine for ENDS use, but ignores the substantial potential benefits for adult Australian smokers. Any risk assessment is meaningless unless it considers the benefits as well as the risks and this is required under subsection 52E (1) of the Therapeutic Goods Act 1989. Cigarettes are the most lethal consumer product ever invented and kill two out of three Australian smokers. (3) In the European Union alone it is estimated that over 6 million smokers had quit smoking using e-cigarettes by 2014. (4) On the evidence available, the risk-benefit analysis strongly favours the use of nicotine in ENDS for smokers who are unable to quit with other cessation methods. It is unethical and unscientific to exempt nicotine in tobacco products and to deny smokers access to a much safer alternative. Assessments of the benefits include the following recent statements from comprehensive, reviews by independent public health organisations:

‘E-cigarettes appear to be effective when used by smokers as an aid to quitting smoking.’ (5)

‘Recent studies support the Cochrane Review findings that EC can help people to quit smoking and reduce their cigarette consumption. There is also evidence that EC can encourage quitting or cigarette consumption reduction even among those not intending to quit or rejecting other support. More research is needed in this area.’ (6)

‘Taking the totality of evidence including controlled trials, observational studies, changes in population smoking and ENDS use, the experience of nicotine replacement therapy, and widely reported user experience, there is confidence that ENDS are helping many smokers to quit smoking.’ (7)

‘Overall, there is encouraging evidence that vapour devices can be at least as effective as other nicotine replacements as aids to help tobacco smokers quit.’ (8)

Denying the exemption for nicotine for use in ENDS denies Australian smokers a harm reduction opportunity and thereby contributes to an increase in smoking-related disease and its cost to the individual and the community.

4

2. In the reasons for the interim decision, the risks attributed to nicotine are exaggerated and are not supported by the empirical evidence or the overseas experience

a. ‘There is a risk of nicotine dependence’ ENDS are used almost exclusively by smokers or recent ex-smokers who are already dependent on nicotine. (5, 7, 9) Users are transferring their dependence to another delivery system which has the benefit of delivering ‘clean nicotine’ without all the products of combustion which cause almost all the harm from smoking. Some will continue to use nicotine long-term. Others will use it temporarily. However, the net effect is a significant improvement in health, even in dual users. (10, 11)

b. ‘There is some evidence that ENDS use in never-smoking youth may increase the risk of subsequent initiation of cigarettes and other combustible products’ 10 years of experience in the UK, US and Europe suggests that the opposite is true — that ENDS may be diverting adolescents away from smoking.

A recent comprehensive review from Canada concluded that ‘fears of a gateway effect are unjustified and overblown’ and that ‘vaping is replacing—rather than encouraging—the smoking of tobacco cigarettes among young people.’ (8) Independent reviews from the UK agree with this finding. (5) It is obviously better for young people not to use e-cigarettes, but vaping is preferable to smoking as it is at least 95 per cent safer. (5)

The clear evidence from international experience is that most e-cigarette use by young people is experimental and short-lived and regular use by non-smoking adolescents is rare. (7, 12-16) Many young smokers use e-cigarettes to help them quit (17, 18) and the great majority do not use nicotine.(19, 20) It is therefore no surprise that smoking rates in young people are falling rapidly in countries where e-cigarettes are available. In the US for example, the rate of decline in smoking over the last 4 years is the fastest on record. (19)

c. ‘There is some dual use’ Dual use is in many cases a transition stage for vapers who are trying to quit and there is good evidence that many of them go on to complete cessation. (21, 22) Most dual users significantly reduce the number of cigarettes they smoke (9) and studies show substantially reduced biomarkers (23-25) although one study showed no change when cigarette reduction was minimal (26). Dual use is still associated with improvements in health, such as COPD (27), asthma (28) and hypertension (11). Dual use is recommended in NRT users and promotes cessation and it is likely the same effect will be seen with ENDS. (29)

Some dual users admit to using ENDS in places where they cannot smoke, but the proportion is small. Furthermore, there is no evidence that this prevents smoking cessation.

d. ‘There is a risk that ENDS will have a negative impact on tobacco control and may re-normalise smoking’ Overseas evidence suggests the opposite. According to Public Health England, ‘There is no evidence that e-cigarettes are undermining the long-term decline in cigarette smoking among adults and youth, and may in fact be contributing to it.’ (6) The United Kingdom Centre for Tobacco & Alcohol Studies concluded ‘there is confidence that ENDS are … not having negative effects like renormalising smoking, reducing quit rates or creating gateway effects.’ (7) The UK Royal College of Physicians reached a similar conclusion. (5)

5

e. ‘Exposure to nicotine in adolescents may have long-term consequences for brain development’ Almost all research in this area has been done on animals and often includes chronic, high dose exposure to nicotine. (30) It is unclear how animal research translates to normal doses used in humans. Nicotine replacement therapy is approved from the age of 12 years and there is no evidence of adverse cognitive effects after over 30 years of use. (31) An expert Australian panel convened by GlaxoSmithKline concluded that ‘NRT can be safely used by adolescent smokers to help them quit’. (32)

f. ‘There is little evidence regarding the safety of long term nicotine exposure from ENDS’ Although it is the main addictive chemical in tobacco, long-term use of nicotine is regarded as low risk (except in pregnancy), based on over 50 years of snus use (moist, oral tobacco used in Sweden) (33) and over 30 years of nicotine replacement therapy, such as nicotine patches. (31) Nicotine is not the harmful ingredient in tobacco. It does not cause cancer or lung disease and has only minor effects on the cardiovascular system. (34)

Most importantly, ENDS with nicotine are not delivering the products of combustion that cause most of the harm to health from smoking, so the overall benefit to health from switching from smoking to ENDS is substantial.

g. ‘Nicotine can cause nausea, vomiting, convulsions …’ There is almost no risk to ENDS users from nicotine toxicity as vapers regulate their nicotine intake. (35) The blood nicotine levels from long-term ENDS users are the same as from long-term users of nicotine replacement therapy which is freely available. (26)

h. ‘The dosage, formulation, labelling, packaging and presentation of the nicotine as would occur if the scheduling was amended would allow nicotine to be too accessible as a liquid which has higher risks and requires appropriate control’ The risks from low-concentrations of liquid nicotine in childproof containers are similar to other potentially poisonous household chemicals. (6) Furthermore, the availability of legal nicotine liquids would reduce the risks of an unregulated black market and home mixing with very high concentrations of nicotine liquid. Risks are associated with many products from which society benefits. Instead of banning them, we advocate proportionate approaches to managing the risks.

i. ‘In the USA, accidental poisonings associated with e-cigarettes have increased’ Reports of accidental poisonings have increased with greater availability, but the absolute rate is still extremely low. In 2013, ENDS and e-liquids accounted for 0.06% of calls to US Poisons Centres. (36) The rate of poisonings has been declining in the US since its peak in 2014. (37)

Furthermore, the level of risk is extremely low. Most cases of accidental nicotine exposure result in prompt vomiting and rarely cause serious harm. (38, 39) Only 2 cases of death from poisoning with nicotine have been reported internationally. According to Public Health England, the risk of poisoning from ingestion of e-liquids is comparable to similar potentially poisonous household substances. (6)

Toxic substances are ubiquitous in the modern world and are managed by childproof containers, education, keeping out of the reach of children and information about managing poisoning, not by prohibition.

j. ‘Public health authorities have varying views about the benefits of ENDS to tobacco harm reduction and as an aid in smoking cessation’ This is correct. Some public health organisations in the US are driven by an abstinence-only approach which is opposed to all other approaches. Harm minimisation supporters takes a more pragmatic view and understand that some people are simply unable to quit smoking or nicotine and that the main goal is to reduce smoking-related death and disease. For many smokers, ENDS are the only

6

effective solution. The cessation benefits of ENDS are recognised by Public Health England (6), the UK Royal College of Physicians (5), The UK Centre for Tobacco & Alcohol Studies (7) and the University of Victoria, BC, Centre for Addictions Research of BC, Canada (8) and many other organisations.

k. ‘Excepting nicotine from Schedule 7 would likely result in increased nicotine exposure via ENDS’ There is no evidence for this statement. The experience is that ENDS users titrate their nicotine intake to maintain levels at or below those of smoking. (35) Millions of smokers have quit with the aid of ENDS, thereby eliminating nicotine intake altogether. (4, 40) Uptake of nicotine-containing ENDS is almost exclusively confined to existing smokers and ex-smokers. (5-7)

l. ‘The use of a label warning statement ‘not to be sold to a person under the age of 18 years’ is not likely to be effective unless there is enforcement of this requirement’ This rule has already been introduced in most states. Enforcement should be mandated, just as it is with tobacco products and alcohol.

m. ‘There is a risk there will be inappropriate marketing and advertising of nicotine for use with ENDS’ A regulatory code for ENDS has been established in the UK. (41) This enforces socially responsible advertising that must not appeal to people under 18 year or show people who appear under 25 years, must not encourage non-smokers to use ENDS etc. These regulations could and should be incorporated into the existing framework under Australian consumer law.

References 1. 40 Australian and international experts. Comment on a proposal to amend the Poisons Standard Schedule 7 entry for nicotine. 2016.Available at: http://colinmendelsohn.com.au/files/9814/7281/5038/Nicotine rescheduling proposal comment -

Final.pdf 2. Borland R, Hall W, Gartner C, Boyd M, Bonevski B, Baker A, et al. Submission in support of de-scheduling dilute solutions of nicotine from S7. 2016. 3. Banks E, Joshy G, Weber MF, Liu B, Grenfell R, Egger S, et al. Tobacco smoking and all-cause mortality in a large Australian cohort study: findings from a mature epidemic with current low smoking prevalence. BMC medicine. 2015;13:38. 4. Farsalinos KE, Poulas K, Voudris V, Le Houezec J. Electronic cigarette use in the European Union: analysis of a representative sample of 27 460 Europeans from 28 countries. Addiction (Abingdon, England). 2016. 5. Royal College of Physicians. Nicotine without smoke: Tobacco harm reduction. London: RCP. 2016.https://www.rcplondon.ac.uk/projects/outputs/nicotine-without-smoke-tobacco-harm-reduction-0 6. McNeill A, Brose LS, Calder R, Hitchman SC, Hajek P, McRobbie H. E-cigarettes: an evidence update. A report commissioned by Public Health England. PHE publications gateway number: 2015260. 2015.https://www.gov.uk/government/publications/e-cigarettes-an-evidence-update 7. Britton J, Bogdanovica I, McNeill A, Bauld L. Commentary on WHO report on electronic nicotine delivery systems and electronic non-nicotine delivery systems. UK Centre for Tobacco & Alcohol Studies. 2016. 8. O'Leary R, MacDonald M, Stockwell T, Reist D. Clearing the Air: A systematic review on the harms and benefits of e-cigarettes and vapour devices. University of Victoria, BC: Centre for Addictions Research of BC.; 2017.

7

9. Andler R, Guignard R, Wilquin JL, Beck F, Richard JB, Nguyen-Thanh V. Electronic cigarette use in France in 2014. International journal of public health. 2016;61(2):159-65. 10. Polosa R. Electronic cigarette use and harm reversal: emerging evidence in the lung. BMC medicine. 2015;13:54. 11. Farsalinos K, Cibella F, Caponnetto P, Campagna D, Morjaria JB, Battaglia E, et al. Effect of continuous smoking reduction and abstinence on blood pressure and heart rate in smokers switching to electronic cigarettes. Internal and emergency medicine. 2016;11(1):85-94. 12. Bauld L, MacKintosh AM, Ford A, McNeill A. E-Cigarette Uptake Amongst UK Youth: Experimentation, but Little or No Regular Use in Nonsmokers. Nicotine & tobacco research : official journal of the Society for Research on Nicotine and Tobacco. 2016;18(1):102-3. 13. Villanti AC, Pearson JL, Glasser AM, Johnson AL, Collins LK, Niaura RS, et al. Frequency of youth e-cigarette and tobacco use patterns in the U.S.: Measurement precision is critical to inform public health. Nicotine & tobacco research : official journal of the Society for Research on Nicotine and Tobacco. 2016. 14. Beard E, West R, Michie S, Brown J. Association between electronic cigarette use and changes in quit attempts, success of quit attempts, use of smoking cessation pharmacotherapy, and use of stop smoking services in England: time series analysis of population trends. BMJ (Clinical research ed). 2016;354:i4645. 15. Scottish Government. Scottish Schools Adolescent Liestyle and Substance Use Survey (SALSUS). Smoking Report 2015. 2016 [Available from: http://www.gov.scot/Publications/2016/10/5514. 16. Warner KE. Frequency of E-Cigarette Use and Cigarette Smoking by American Students in 2014. Am J Prev Med. 2016;51(2):179-84. 17. Kong G, Morean ME, Cavallo DA, Camenga DR, Krishnan-Sarin S. Reasons for Electronic Cigarette Experimentation and Discontinuation Among Adolescents and Young Adults. Nicotine & tobacco research : official journal of the Society for Research on Nicotine and Tobacco. 2015;17(7):847-54. 18. Khoury M, Manlhiot C, Fan CP, Gibson D, Stearne K, Chahal N, et al. Reported electronic cigarette use among adolescents in the Niagara region of Ontario. CMAJ : Canadian Medical Association journal = journal de l'Association medicale canadienne. 2016;188(11):794-800. 19. National Institute on Drug Abuse. Monitoring the Future Survey. 2016.Available at https://www.drugabuse.gov/related-topics/trends-statistics/monitoring-future 20. Hamilton HA, Ferrence R, Boak A, Schwartz R, Mann RE, O'Connor S, et al. Ever Use of Nicotine and Nonnicotine Electronic Cigarettes Among High School Students in Ontario, Canada. Nicotine & tobacco research : official journal of the Society for Research on Nicotine and Tobacco. 2015;17(10):1212-8. 21. Farsalinos KE, Romagna G, Tsiapras D, Kyrzopoulos S, Voudris V. Characteristics, perceived side effects and benefits of electronic cigarette use: a worldwide survey of more than 19,000 consumers. International journal of environmental research and public health. 2014;11(4):4356-73. 22. Zhuang YL, Cummins SE, J YS, Zhu SH. Long-term e-cigarette use and smoking cessation: a longitudinal study with US population. Tobacco control. 2016;25(Suppl 1):i90-i5. 23. O'Connell G, Graff DW, D'Ruiz CD. Reductions in biomarkers of exposure (BoE) to harmful or potentially harmful constituents (HPHCs) following partial or complete substitution of cigarettes with electronic cigarettes in adult smokers. Toxicology mechanisms and methods. 2016;26(6):443-54. 24. McRobbie H, Phillips A, Goniewicz ML, Smith KM, Knight-West O, Przulj D, et al. Effects of Switching to Electronic Cigarettes with and without Concurrent Smoking on Exposure to Nicotine, Carbon Monoxide, and Acrolein. Cancer prevention research (Philadelphia, Pa). 2015;8(9):873-8. 25. Goniewicz ML, Gawron M, Smith DM, Peng M, Jacob P, 3rd, Benowitz NL. Exposure to Nicotine and Selected Toxicants in Cigarette Smokers Who Switched to Electronic Cigarettes: A Longitudinal Within-Subjects Observational Study. Nicotine & tobacco research : official journal of the Society for Research on Nicotine and Tobacco. 2017;19(2):160-7. 26. Shahab L, Goniewicz ML, Blount BC, Brown J, McNeill A, Alwis KU, et al. Nicotine, Carcinogen, and Toxin Exposure in Long-Term E-Cigarette and Nicotine Replacement Therapy Users: A Cross-sectional Study. Annals of internal medicine. 2017.

8

27. Polosa R, Morjaria JB, Caponnetto P, Prosperini U, Russo C, Pennisi A, et al. Evidence for harm reduction in COPD smokers who switch to electronic cigarettes. Respiratory research. 2016;17(1):166. 28. Polosa R, Morjaria J, Caponnetto P, Caruso M, Strano S, Battaglia E, et al. Effect of smoking abstinence and reduction in asthmatic smokers switching to electronic cigarettes: evidence for harm reversal. International journal of environmental research and public health. 2014;11(5):4965-77. 29. Stead LF, Perera R, Bullen C, Mant D, Hartmann-Boyce J, Cahill K, et al. Nicotine replacement therapy for smoking cessation. Cochrane database of systematic reviews (Online). 2012;11:CD000146. 30. Yuan M, Cross SJ, Loughlin SE, Leslie FM. Nicotine and the adolescent brain. The Journal of physiology. 2015;593(16):3397-412. 31. Lee PN, Fariss MW. A systematic review of possible serious adverse health effects of nicotine replacement therapy. Archives of toxicology. 2016. 32. Zwar N, Bell J, Peters M, Christie M, Mendelsohn C. Nicotine and nicotine replacement therapy – the facts. Australian Pharmacist. 2006;25(12):969-73. 33. Ramstrom L, Wikmans T. Mortality attributable to tobacco among men in Sweden and other European countries: an analysis of data in a WHO report. Tobacco induced diseases. 2014;12(1):14. 34. Niaura R. Re-thinking nicotine and its effects. Schroeder Institute, Truth Initiative. 2016.Available at: http://truthinitiative.org/sites/default/files/ReThinking-Nicotine.pdf 35. Dawkins LE, Kimber CF, Doig M, Feyerabend C, Corcoran O. Self-titration by experienced e-cigarette users: blood nicotine delivery and subjective effects. Psychopharmacology. 2016. 36. Mowry JB, Spyker DA, Cantilena LR, McMillan N, Ford M. 2013 Annual Report of the American Association of Poison Control Centers ’ National Poison Data System (NPDS): 31st Annual Report. Clinical toxicology (Philadelphia, Pa). 2014;52(10):1032-283. 37. American Association of Poison Control Centers. E-Cigarettes and Liquid Nicotine 2017 [Available from: http://www.aapcc.org/alerts/e-cigarettes/. 38. Christensen L. Three cases of attempted suicide by ingestion of nicotine liquid used in e-cigarettes. Clinical Toxicology. 2013;51:290. 39. Schipper EM, de Graaff LC, Koch BC, Brkic Z, Wilms EB, Alsma J, et al. A new challenge: suicide attempt using nicotine fillings for electronic cigarettes. British journal of clinical pharmacology. 2014;78(6):1469-71. 40. Action on Smoking and Health UK. Use of electronic cigarettes (vapourisers) among adults in Great Britain. May 2016.Available at http://ash.org.uk/information/facts-and-stats/fact-sheets 41. UK Advertising Code. UK Code of Non-Broadcast Advertising. 2016.Available at: https://www.cap.org.uk/Advertising-Codes/Non-Broadcast/CodeItem.aspx?cscid=%7B49028fdc-fc22-4d8a-ba5b-ba7ccc3df99a%7D#.V83uWDU6x0x

From:To: Chemicals Schedul ngSubject: Response to TGA Inter m Decision - Nicotine [SEC=No Protective Marking]Date: Wednesday, 15 February 2017 11:28:04 AM

Response to TGA Interim DecisionThis submission is in response to the Therapeutic Goods Administration advisory committee s interim decision in respect to the proposal to exempt liquid nicotine at a concentration of3 6% and below from Schedule 7 I have no financial, or other interests, in either the electronic cigarette industry or the tobacco industryIt is interesting to note that the TGA received 71 public submissions, 54 in support of the proposal and 17 opposed It is quite stunning that the TGA chose to ignore 76% of the receivedsubmissions to favour the status quo

This submission will consider some of the factors that the advisory committee cited as reasons for the interim decision

1. Risk of nicotine dependenceThere is no credible evidence that this occurs, regardless of the type of vaping device used Many vapers actually find that they need to reduce their level of nicotine over time rather thanbecoming more and more dependent

2. Gateway to cigarettesThere is no credible evidence that young people move from vaping to smoking conventional cigarettes, the use of personal vaporisers by young people in the US and UK is minimal andconfined mostly to those who already smoke cigarettes Please refer to the reports from Public Health England and the Royal College of Physicianshttps://www gov uk/government/uploads/system/uploads/attachment data/file/457102/Ecigarettes an evidence update A report commissioned by Public Health England FINAL pdfhttps://www rcplondon ac uk/projects/outputs/nicotine-without-smoke-tobacco-harm-reduction-0

--[if !supportLists]-->3

--[endif]-->Ren3 Renormalizing smoking behaviourThere is no evidence that vaping normalises smoking Drinking water looks similar to drinking vodka, but no one argues that drinking water normalises the drinking of vodka In countrieswhere vaping is accepted smoking rates have continued to fall

--[if !supportLists]-->4 . <!--[endif]-->Dual use of vaping and combustible cigarettesDual use of both products can be quite common with new vapers as they transition to vaping This is not a bad thing

--[if !supportLists]-->5 5.<!--[endif]-->Safety of long term nicotine exposureIf long term exposure to nicotine was as bad as stated, NRT would not be approved for long term use This argument forgets that people who smoke are exposed to nicotine long term Sothe only difference in this respect is that people can be exposed to clean nicotine via vaping or nicotine from smoking cigarettes which is accompanied by the carcinogenic products ofcombustion

--[if !supportLists]-->6 6. <!--[endif]-->Risks of poisoningIt has, no doubt, been pointed out to the TGA many times over that the chance of nicotine poisoning is extremely low and previous estimates of toxicity have been overstated A 3 6%solution of nicotine is not very high (some vapers use this concentration straight) The implementation of the EU Tobacco Products Directive (and ban of e-liquid over 2 0% strength) hasmeant that several hundred thousand British vapers will be no longer able to obtain a sufficient strength of nicotine to suit their needs (which increases the possibility that they will returnto smoking)Of course, there has been an increase in calls to US poison centres about nicotine in recent years as these products have become more popular but, the fact remains that far, far moreAmerican children are poisoned by medical drugs, cosmetics, and cleaning products than by nicotine

--[if !supportLists]-->7 7. <!--[endif]-->Percentages of vapersAn increase in the number of people vaping rather than smoking would be a positive outcome for public health not a negative

In conclusion, the TGA advisory committee should reconsider its interim decision as the concerns noted by the committee are unfounded by correctly conducted science Australian smokers deservethe right to switch to an alternative to smoking which has been widely (not just by one committee) estimated to carry no more than a 5% risk of smoking combustible cigarettes The current situationwhereby Australians who have made positive changes to their own health by switching from smoking to vaping are forced to break the law is ridiculous

Advisory Committee on Chemicals and Medicines Scheduling Department of Health GPO Box 9848 CANBERRA ACT 2601

Via email: chemicals. scheduling@health.gov. au CC: medicines.scheduling@health.gov.au

Dear Sir/Madam,

15 February 2017

Further submission regarding delegates' interim decision not to amend the current scheduling of nicotine

I refer to the scheduling delegates' interim decision not to amend the current scheduling of nicotine, which was released on 2 February 2017.

Cancer Council Australia would like to extend our strong support for the delegates' interim determination , and confirm that we share the concerns raised by the Joint Advisory Committee on Chemicals and Medicines Scheduling in its advice to the delegates.

As noted in documents supporting the interim decision, the toxicity of long-term exposure to nicotine and the excipients contained in 'e-liquid' is unknown. The existing evidence suggests that while ENDS may be less harmful than traditional cigarettes, they are not harmless. In addition, we note that research regarding the efficacy of ENDS as a smoking cessation aid is conflicting in its conclusions.

We reiterate the concerns expressed in our earlier submission regarding the potential for ENDS to re­normalise smoking, and act as a potential 'gateway' to tobacco smoking for children and young adults, as well as the potential for ENDS to trigger relapse among smokers who have quit or are attempting to quit.

It is Cancer Council Australia's firm view that the current scheduling of nicotine is entirely appropriate and is consistent with Australia's obligations under the WHO Framework Convention on Tobacco Control (FCTC), which commits parties to preventing and reducing nicotine addiction. The current scheduling would allow for regulation of ENDS as a prescription medicine if ultimately approved for therapeutic use following assessment by the TGA for safety and efficacy. As noted in our previous submission, this is consistent with the WHO's advice that 'while medicinal use of nicotine is a public health option, recreational use is not. '1

Research/reports published since the deadline for pre-meeting submissions -

In addition to the evidence and concerns outlined in our earlier submission, we note that a number of recent studies have been published, which further support the delegates interim decision.

For example, a study by Moheimani et al (published on 1 February 2017) suggests that regular use of ENDS is associated with increased cardiovascular risk.2

1 World Health Organisation 'Electronic Nicotine Delivery Systems', Moscow, July 2014. Available from : http://apps.who.int/gb/fctc/PDF /cop6/FCTC COP6 10-en.pdf 2 Moheimani RS, Bhetraratana M, Yin F, Peters KM, Gornbein J , Araujo JA, Middlekauff HR. Increased Cardiac Sympathetic Activity and Oxidative Stress in Habitual Electronic Cigarette Users: Implications for Cardiovascular Risk. JAMA Cardiel. Published online February 01 , 2017. Available from: http:mamanetwork. com/journals/jamacard iology/article-abstract/2600166

Research published in September 2016 indicates that flavourings commonly used in e-liquids may have acute cytotoxic effects on respiratory cells.3

Research is also beginning to emerge regarding the potential harms associated with alternative uses of ENDS. A recent study undertaken in the US (published in February 2017) indicates that a significant proportion of adolescent ENDS users in the US had tried a practice known as 'dripping' , whereby the user inhales vapour produced by dripping e-liquid directly onto a heated atomiser.4 Existing evidence suggests that the practice of dripping may result in the user being exposed to higher levels of nicotine than they would be exposed to from a standard puff of an ENDS, as thee-liquid is heated at a higher voltage.5 The potential for alternative use behaviours such as dripping is of concern, and represents an important distinction between ENDS and traditional forms of nicotine replacement therapy.

A further US study published in January 2017 raises concerns regarding the impact of ENDS on youth exposure to nicotine.6 The study notes that ENDS use among non-smoking youth appears to be increasing in the US. The authors concluded that low-risk youth in the study who had gone on to use ENDS may not have used nicotine at all if ENDS had not been available. In addition, the study did not find any evidence that e­cigarettes are responsible for the decline in youth smoking in the US.

You may also be aware that on 8 December 2016 the US Surgeon General released a comprehensive report regarding e-cigarette use among youth and young adults. A fact sheet outlining the key findings of the report is enclosed. The full report can be accessed at https://e-cigarettes.surgeongeneral.qov/resources.html

You will note that the Surgeon General has made the fo llowing important observations:

1) Use of products containing nicotine in any form among young people, including ENDS, is unsafe. 2) Because the brain is still developing until about the age of 25, youth and young adult exposure to

nicotine can disrupt the growth of brain circuits that control attention, learning and susceptibility to

addiction. 3) The effects of nicotine exposure during youth and young adulthood can be long-lasting and can

include lower impulse control, and mood disorders. The nicotine in ENDS and other tobacco products can prime young brains for addiction to other drugs, such as cocaine and

methamphetamine. 4) Nicotine can cross the placenta and has known effects on foetal and postnatal development.

Nicotine delivered by ENDS during pregnancy can result in multiple adverse consequences. 5) Ingestion of e-liquids containing nicotine can cause acute toxicity and possible death.

3 Leigh NJ, Lawton RI, Hershberger PA, Goniew icz ML. Flavourings significantly affect inhalation toxicity of aerosol generated from electronic nicotine delivery systems (ENDS) . Tobacco control. 2016 Sep 15:tobaccocontrol-2016. Available from: http://tobaccocontrol .bmj.com/contenUear1y/2016/09/15/tobaccocontrol-2016-053205 4 Krishnan-Sarin S, Morean M, Kong G, Bold "r'0N, Camenga DR, Cavallo DA, Simon P and Wu R. E-Cigarettes and "Dripping" Among High-School Youth. Pediatrics Feb 2017. Available from: http://pediatrics.aappublications.org/contenUearly/2017/02/02/peds.2016-3224 5 Talih S, Balhas Z, Eissenberg T, Salman R, Karaoghlanian N, El Hellani A, Baalbaki R, Saliba N, Shihadeh A. Effects of user puff topography, device voltage, and liquid nicotine concentration on electronic cigarette nicotine yield: measurements and model predictions . Nicotine & Tobacco Research. 2015 Feb 1;17(2):150-7. Available from: http://scholar.google.com.au/scholar?g=effects+of+user+puff+topography%2C+device+voltage&btnG=&hl=en&as sdt=O% 2C5 6 Dutra LM and Glantz SA. E-cigarettes and National Adolescent Cigarette Use: 2004-2014. Pediatrics. 2017; 139(2). Available from: http://pediatrics.aappublications.org/contenUearly/2017 /01 /1 9/peds.2016-2450?sso=1 &sso redirect count=1 &nfstatus=401 &nftoken=OOOOOOOO-OOOO-OOOO-OOOO­OOOOOOOOOOOO&nfstatusdescription=ERROR%3a+No+local+token

The report concludes that the adoption of precautionary public health strategies to protect youth and young adults from the adverse effects of ENDS is justified. We believe the report provides further support for the delegates' interim decision.

Thank you for the opportunity to comment on this important public health issue.

Should you require any further information, please do not hesitate to contact , Cancer Council Australia on

Yours faithfully,

Richard Mark

WA

15 February 2017

Dear Delegates

Scheduling delegates' interim decisions and invitation for further comment: ACCS/ACMS, 2 February 2017 – 2.1 Nicotine

I am a private individual and a consumer .

I have smoked tobacco products since I was 18, and am now 57. I have never been able to moderate my consumption of tobacco products, or quit, until November 2016, when I started “vaping”. I have now reduced my consumption of tobacco cigarettes from 35 + per day, to 5 or less. As an addict, I now feel that I am finally in control of my tobacco consumption.

By way of feedback to the Delegate’s interim decision, I attach 5 media articles for your consideration. In particular, may I please draw your attention to the first article, being an article published on the BBC website on 3 November 2016, titled Smoking 'causes hundreds of DNA changes'. Page 2 of article contains the following text:

The study, in the journal Science, was carried out by an international group, including the Wellcome Trust Sanger Institute in Cambridgeshire and the Los Alamos National Laboratory in New Mexico. The analysis shows a direct link between the number of cigarettes smoked in a lifetime and the number of mutations in tumour DNA. The authors found that, on average, smoking a packet of cigarettes a day led to:

150 mutations in each lung cell every year 97 in the larynx or voice box 23 in the mouth 18 in the bladder Six in the liver

In closing, may I respectfully suggest that the delegates consider adopting a pragmatic approach to the availability of nicotine for vaping in Australia.

Yours sincerely

R.M.