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Twitter [http://twitter.com/pruenrichard @pruenrichard] | Twitter [http://twitter.com/pruenrichard @pruenrichard] | ||
Below are letters and documents sent in advocacy efforts, as a record and should anyone wish to use them for ideas. | |||
[[File:FDA comment.pdf|thumb|alt=Comment on R-U FDA review |Comment on R-U FDA review ]] | [[File:FDA comment.pdf|thumb|alt=Comment on R-U FDA review |Comment on R-U FDA review ]] | ||
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[[File:TGA consult 8-sept-2023 my response.pdf|thumb|alt=Response ID ANON-EJTE-W3QH-B Submitted to Proposed reforms to the regulation of vapes Submitted on 2023-09-08 21:15:44 Survey contents Privacy and your personal information I consent to the TGA collecting the information requested in this survey about me, including any sensitive information, for the purposes indicated above. Agree: Yes Acknowledgement I agree. Yes.: Yes Introduction 1 What is your name? Name: Richard Pruen 2 What is your email address? Email: richard@pruen.co.uk 3 What is your organisation name? Organisation name or N/A: n/a 4 Please choose a stakeholder group that best describes you or your organisation. Others* *If other, please specify:: Consumer 5 Which best describes your response? I am responding as an individual. 6 Are you an authorised prescriber? No (please go to next page Conflicts of interest (actual or perceived) 1 Have you or your organisation ever received services, assistance or support (whether monetary or non-monetary in nature) from the tobacco industry and/or e-cigarette industry? If this scenario applies to you or your organisation, please provide relevant details in the textbox. Yes If you have selected yes, please provide details here. Otherwise, please state 'Not Applicable':: I owned a company testing electronic cigarettes for compliance with UK and other standards, as well as carried out investigations of failures including battery failure. I also worked on R&D and provided consulting services on for example battery protection circuits, chargers etc. Payment was from user fees for testing, government agencies (trading standards), trade associations, and sometimes individuals or companies carrying out due diligence testing or failure mode analysis. Ended 2016 since then I have been a consumer only and have not received any funding from any company (of any sort), government agency, or researchinstitution. 2 Have you or your organisation ever provided services, assistance or support (whether monetary or non-monetary in nature) to the tobacco industry and/or the e-cigarette industry? If this scenario applies to you or your organisation, please provide further information in the textbox. Yes If you have selected 'yes', please provide details here. Otherwise, please state 'Not Applicable': I assisted in writing standards for UK vaping products (PAS 54115 A guide for the importation and sale of electronic cigarettes and directly related products, with product safety testing methods) and proposed an IEEE standard project number P2800. Several sampling machines were supplied to others testing electronic cigarettes, and other custom test equipment, the supplied equipment presumably used to carry out tests on electronic cigarettes as designed. As academic and test houses purchased this equipment it is assumed this was paid for by test fees, or grants to carry out tests on electronic cigarettes, again possibly linked to taxes etc from tobacco and or electronic cigarette sales. The same funding source as government agencies, politicians and others working in the field. Again since 2016 I have been a consumer only. Proposal 1 -Restrictions on importation, manufacture and supply of all vapes . 1 Do you support the proposed approach to ban disposable single use vapes absolutely and all other vapes, except those for legitimate therapeutic use in compliance with the TG Act? No 2 How would you anticipate industry and consumers to respond to a ban on the importation, manufacture and supply of non-therapeutic vapes? * Please provide answer here. : Demand will remain, along with the risk of vaping being seen as cool because it is something disallowed. The tightening of rules is unlikely to be enforceable, so illicit supply will continue to be the primary supply to the population. The population know vaping is safer than smoking, thus it will be very difficult to curb demand. Prohibiting drugs such as cocaine and cannabis fails, vaping prohibition will almost certainly follow the same pattern. 3 Do you support removal of the personal importation scheme exception for vapes? If not, what would be the impact on you? No (* if not, what would be the impact on you?) * What would be the impact on you?: Vaping products that are acceptable and usable are likely to only be available via illicit sales, and criminal gangs. Particularly as research shows flavours to be vital for the prevention of release to smoking. These products will not be tested or regulated in any way, importing allows users who have a prescription to import what they need to stay smoke-free, thus not relapse to smoking and potentially death. Importantly importing from somewhere with a regulated legal market, they can be sure of the quality and contents of the products they buy. The one-size-fits-all approved vapes that consumers will find at pharmacy outlets is unlikely to be effective since most of the features that make an effective substitute for cigarettes will be regulated out. 4 Do you agree with the proposal to retain a traveller’s exemption, including the proposed limits? Yes 5 Do you support the proposed approach to prohibiting the advertisement of all vapes (subject to limited exceptions)? No 6 [If applicable] Suppliers, what part of supply chain do you occupy? Not applicable * Other -specify your role in supply chain.: Consumer 6 (a) What proportion of your sales volumes is attributable to vape sales [i.e. quantity of vapes sold]? Please provide details here: (or mark Not applicable).: N/A6 (b) What proportion of your sales revenue is attributable to vape sales [i.e. revenue earned from sales]? Please provide details here: (or mark Not applicable).: N/A 6 (c) What impact would the proposed measures have on your sales volumes? Please provide details here: (or mark Not applicable).: not a vendor, none 6 (d) What impact would the proposed measures have on your sales revenues? Please provide details here: (or mark Not applicable).: none not a vendor 6 (e) What proportion of your vapes sales is attributable to disposable single use vapes versus refillable products? Please provide details here: (or mark Not applicable).: not a vendor 6 (f) How would restricting the importation, manufacture and supply of disposable single use, and non-therapeutic, vapes in Australia impact you? Please provide details here: (or mark Not applicable).: not a vendor N/A 6 (g) How much stock do you have in Australia currently and how long would it take to sell that stock? Please provide details here: (or mark Not applicable).: not a vendor N/A 6 (h) What would be the cost to you if you were required to dispose or otherwise move on existing stock? Please provide details here: (or mark Not applicable).: N/A Proposal 2 -Changes to market accessibility requirements, including better regulation of device components. 7 Do you support the approach to require a pre-market notification of compliance with TGO 110? No 8 [If applicable] For suppliers of therapeutic vapes, what impact would the proposed notification system have on your supply model and what transition period would you require to comply with the new notification requirement? Please provide details here: (or mark Not applicable).: not a vendor 9 Do you support the proposed access to vapes under the SAS C notification system? No 9 (a) What impact would this pathway have on facilitating patient access to therapeutic vapes? Please provide details here: (or mark Not applicable).: Vaping works in the rest of the world as a product substitute, providing a safer alternative to a deadly (cigarettes) product. In the UK and NZ smoking decline has accelerated significantly past that in Australia, due to the adoption of consumer vaping, slightly less so in the US where the regulator is not so certain. The prescription model in Australia has failed, smoking has not continued to decline and may have increased possibly. Vaping is also higher in Australian youth than UK and NZ, the current policy has backfired and should be reversed. It is absolutely obvious at this point that unless you have unlimited resources for enforcement, the current policy is not workable, and never will be. The time has come to use what has worked elsewhere and start again.10 [If applicable] For prescribers, would the proposed new pathway likely change your approach to prescribing therapeutic vapes? How? Not a prescriber of vapes * How new pathway will change your approach to prescribing ttherapeutic vapes?: 11 [If applicable] For prescribers, which access pathway (SAS B, SAS C, or AP) would you envisage using to prescribe therapeutic vapes? Why? Not a prescriber of vapes Please tell us why: 12 [If applicable] For prescribers, would integration of SAS or AP applications or notifications into existing clinical software systems ease the administrative burden and/or encourage you to use the new pathway? Not a prescriber of vapes 13 Do you agree with the proposal to regulate both e-liquid and device components of unapproved vapes under the same part of the TG Act for simplicity? No 14 Will these changes have direct or indirect impact on you? Please provide details. Yes (please provide details below) Please provide details here:: As a consumer I want safer options to be available to me and to every person who smokes tobacco or would smoke tobacco for lack of a viable alternative. Sadly some kids will do adult things even if you try to stop them (for example drinking alcohol, unsafe sex, taking drugs, smoking) while they should not be encouraged to vape, it still offers a harm reduction if it diverts them from smoking, like it or not, this is true because safer is safer. 15 Do you require time to adjust to these requirements? If yes, how long? Yes 15 (a) How long do you require to adjust to these requirements? More than 12 months Proposal 3 - Improving quality standard for unapproved (unregistered) vapes) 16 Are the definitions of nicotine and mint flavours appropriate? If not, please provide reasons. No (* please provide reason below) * Please provide reason here.: Nicotine itself does not have a flavour, the flavour should be correctly referred to as "artificial tobacco flavour" There is no evidence that human flavour preference varies by age and none particularly that it changes at 18. It is therefore impossible to target age groups with specific flavours, thus limiting flavours on this basis has no merit whatsoever. 17 Do you agree with the proposed upper limit on the concentration of menthol in vapes? If not, please provide reasons. No (* please provide reason below) * Please provide reason here: It is trivial to add menthol to vapes, this simply encourages users to add more if they prefer, opening a can of worms and the potential for contamination or incompatible ingredients. This seem unwise for very little if any benefit. 18 [If applicable] Importers, manufacturers and suppliers, would the restrictions on flavour proposed above impact you? Not applicable 19 Do you agree with the proposal to require pharmaceutical-like packaging and presentation for vapes, e.g., vapes manufactured in black, white or grey coloured materials, predominantly white background on packaging, clear warning statements and other restrictions on labels in addition to other selective TGO 91 requirements for vapes? No (* please provide reason below)20 [If applicable] What impact will the labelling and packaging changes have on you? * Please provide detail here.: It will probably backfire, making legal products undesirable is likely to increase the number of people using illicit products, particularly if access remains easy, without enforcement that is most likely to be the case. 20 (a) How long would you need to transition your product to comply with the proposed requirements? More than 12 months 21 Do you agree with our approach to allow only permitted ingredients in vapes, instead of trying to prohibit individual chemical entities from use in e-liquids? No 22 [If applicable] Importers, manufacturers and suppliers, will your therapeutic vapes need any re-formulation or other changes to comply with the permitted ingredients and ingredient quality requirements? Not applicable 22 (a) If product re-formulation is required, how long will you need to make these changes? More than 12 months 22 (b) If product re-formulation is required, what financial or business impacts would be associated with them? Provide detail here or put 'Not Applicable': Not a vendor 23 Do you support applying the same regulatory controls to zero-nicotine therapeutic vapes, as for NVPs? No 24 What is the overall business cost on you to comply with a strengthened TGO 110? Please provide details here: (or mark Not applicable).: not a vendor 25 Do you agree with the proposed requirements under TGO 110 that will apply to unapproved device components of vapes? No 26 [If applicable] Suppliers, do you intend to register any vaping device on the register as an approved medical device? No (if no, why not?) If no, why not?: not a vendor 27 [If applicable] Importers, manufacturers and suppliers, are you familiar with relevant US FDA, or MHRA guidance and/or EU standards covering vaping devices? Not applicable 27 (a) Do your vapes currently comply with relevant US FDA, or MHRA guidance and/or EU standards covering vaping devices? Not applicable 27 (b) If not, what requirements do you meet? What requirements you currently comply with?: not a vendor 27 (c) How long would it take to achieve compliance with relevant standards? More than 12 months28 [If applicable] Importers, manufacturers and suppliers, are your vapes manufactured at facilities that hold relevant international standards for Quality Management Systems, such as ISO9001 or ISO 13485? Not applicable Proposal 4 - Strengthening domestic compliance and enforcement mechanisms 29 Do you have any other comments in relation to this proposal? Yes (* provide your comments below) Comments: I reiterate that Australian policy has failed, and further moves in the same direction are likely to fail. Other countries have shown much more desirable results, the best results on smoking have been where vaping has been accepted as a consumer alternative to smoking, but the prescription model, unfortunately, has proven unworkable. Realistically you should review the past responses to enquiries, select a number of people who have successfully predicted the results of current regulations, and ask them for solutions. At least they have a track record, and proven knowledge of the real world and likely outcomes. Supplementary questions 30 [If applicable] Suppliers, please confirm if you intend to continue to supply therapeutic vapes under the proposed reforms described? Not applicable * Product range : Not a vendor, but as a consumer, I can see vendors dropping out. This will benefit the criminals and gangs who supply illicit markets, more trade for them. 30 (a) How long would it take to meet the new requirements? More than 12 months 31 [If applicable] Suppliers, please confirm if you intend to register your therapeutic vapes in the next 2 years? Not applicable What guidance and/or clarity of supporting data requirements do you need from TGA: not a vendor Publication of submissions To proceed, please select from the options below how you would like the TGA to deal with your submissions: I agree to the TGA publishing my response in full. I request the TGA to consider redacting sensitive commercial information from my response before publication: No Please specify sensitive commercial inforation you want redatced :|TGA consult 8-sept-2023 my response]] | [[File:TGA consult 8-sept-2023 my response.pdf|thumb|alt=Response ID ANON-EJTE-W3QH-B Submitted to Proposed reforms to the regulation of vapes Submitted on 2023-09-08 21:15:44 Survey contents Privacy and your personal information I consent to the TGA collecting the information requested in this survey about me, including any sensitive information, for the purposes indicated above. Agree: Yes Acknowledgement I agree. Yes.: Yes Introduction 1 What is your name? Name: Richard Pruen 2 What is your email address? Email: richard@pruen.co.uk 3 What is your organisation name? Organisation name or N/A: n/a 4 Please choose a stakeholder group that best describes you or your organisation. Others* *If other, please specify:: Consumer 5 Which best describes your response? I am responding as an individual. 6 Are you an authorised prescriber? No (please go to next page Conflicts of interest (actual or perceived) 1 Have you or your organisation ever received services, assistance or support (whether monetary or non-monetary in nature) from the tobacco industry and/or e-cigarette industry? If this scenario applies to you or your organisation, please provide relevant details in the textbox. Yes If you have selected yes, please provide details here. Otherwise, please state 'Not Applicable':: I owned a company testing electronic cigarettes for compliance with UK and other standards, as well as carried out investigations of failures including battery failure. I also worked on R&D and provided consulting services on for example battery protection circuits, chargers etc. Payment was from user fees for testing, government agencies (trading standards), trade associations, and sometimes individuals or companies carrying out due diligence testing or failure mode analysis. Ended 2016 since then I have been a consumer only and have not received any funding from any company (of any sort), government agency, or researchinstitution. 2 Have you or your organisation ever provided services, assistance or support (whether monetary or non-monetary in nature) to the tobacco industry and/or the e-cigarette industry? If this scenario applies to you or your organisation, please provide further information in the textbox. Yes If you have selected 'yes', please provide details here. Otherwise, please state 'Not Applicable': I assisted in writing standards for UK vaping products (PAS 54115 A guide for the importation and sale of electronic cigarettes and directly related products, with product safety testing methods) and proposed an IEEE standard project number P2800. Several sampling machines were supplied to others testing electronic cigarettes, and other custom test equipment, the supplied equipment presumably used to carry out tests on electronic cigarettes as designed. As academic and test houses purchased this equipment it is assumed this was paid for by test fees, or grants to carry out tests on electronic cigarettes, again possibly linked to taxes etc from tobacco and or electronic cigarette sales. The same funding source as government agencies, politicians and others working in the field. Again since 2016 I have been a consumer only. Proposal 1 -Restrictions on importation, manufacture and supply of all vapes . 1 Do you support the proposed approach to ban disposable single use vapes absolutely and all other vapes, except those for legitimate therapeutic use in compliance with the TG Act? No 2 How would you anticipate industry and consumers to respond to a ban on the importation, manufacture and supply of non-therapeutic vapes? * Please provide answer here. : Demand will remain, along with the risk of vaping being seen as cool because it is something disallowed. The tightening of rules is unlikely to be enforceable, so illicit supply will continue to be the primary supply to the population. The population know vaping is safer than smoking, thus it will be very difficult to curb demand. Prohibiting drugs such as cocaine and cannabis fails, vaping prohibition will almost certainly follow the same pattern. 3 Do you support removal of the personal importation scheme exception for vapes? If not, what would be the impact on you? No (* if not, what would be the impact on you?) * What would be the impact on you?: Vaping products that are acceptable and usable are likely to only be available via illicit sales, and criminal gangs. Particularly as research shows flavours to be vital for the prevention of release to smoking. These products will not be tested or regulated in any way, importing allows users who have a prescription to import what they need to stay smoke-free, thus not relapse to smoking and potentially death. Importantly importing from somewhere with a regulated legal market, they can be sure of the quality and contents of the products they buy. The one-size-fits-all approved vapes that consumers will find at pharmacy outlets is unlikely to be effective since most of the features that make an effective substitute for cigarettes will be regulated out. 4 Do you agree with the proposal to retain a traveller’s exemption, including the proposed limits? Yes 5 Do you support the proposed approach to prohibiting the advertisement of all vapes (subject to limited exceptions)? No 6 [If applicable] Suppliers, what part of supply chain do you occupy? Not applicable * Other -specify your role in supply chain.: Consumer 6 (a) What proportion of your sales volumes is attributable to vape sales [i.e. quantity of vapes sold]? Please provide details here: (or mark Not applicable).: N/A6 (b) What proportion of your sales revenue is attributable to vape sales [i.e. revenue earned from sales]? Please provide details here: (or mark Not applicable).: N/A 6 (c) What impact would the proposed measures have on your sales volumes? Please provide details here: (or mark Not applicable).: not a vendor, none 6 (d) What impact would the proposed measures have on your sales revenues? Please provide details here: (or mark Not applicable).: none not a vendor 6 (e) What proportion of your vapes sales is attributable to disposable single use vapes versus refillable products? Please provide details here: (or mark Not applicable).: not a vendor 6 (f) How would restricting the importation, manufacture and supply of disposable single use, and non-therapeutic, vapes in Australia impact you? Please provide details here: (or mark Not applicable).: not a vendor N/A 6 (g) How much stock do you have in Australia currently and how long would it take to sell that stock? Please provide details here: (or mark Not applicable).: not a vendor N/A 6 (h) What would be the cost to you if you were required to dispose or otherwise move on existing stock? Please provide details here: (or mark Not applicable).: N/A Proposal 2 -Changes to market accessibility requirements, including better regulation of device components. 7 Do you support the approach to require a pre-market notification of compliance with TGO 110? No 8 [If applicable] For suppliers of therapeutic vapes, what impact would the proposed notification system have on your supply model and what transition period would you require to comply with the new notification requirement? Please provide details here: (or mark Not applicable).: not a vendor 9 Do you support the proposed access to vapes under the SAS C notification system? No 9 (a) What impact would this pathway have on facilitating patient access to therapeutic vapes? Please provide details here: (or mark Not applicable).: Vaping works in the rest of the world as a product substitute, providing a safer alternative to a deadly (cigarettes) product. In the UK and NZ smoking decline has accelerated significantly past that in Australia, due to the adoption of consumer vaping, slightly less so in the US where the regulator is not so certain. The prescription model in Australia has failed, smoking has not continued to decline and may have increased possibly. Vaping is also higher in Australian youth than UK and NZ, the current policy has backfired and should be reversed. It is absolutely obvious at this point that unless you have unlimited resources for enforcement, the current policy is not workable, and never will be. The time has come to use what has worked elsewhere and start again.10 [If applicable] For prescribers, would the proposed new pathway likely change your approach to prescribing therapeutic vapes? How? Not a prescriber of vapes * How new pathway will change your approach to prescribing ttherapeutic vapes?: 11 [If applicable] For prescribers, which access pathway (SAS B, SAS C, or AP) would you envisage using to prescribe therapeutic vapes? Why? Not a prescriber of vapes Please tell us why: 12 [If applicable] For prescribers, would integration of SAS or AP applications or notifications into existing clinical software systems ease the administrative burden and/or encourage you to use the new pathway? Not a prescriber of vapes 13 Do you agree with the proposal to regulate both e-liquid and device components of unapproved vapes under the same part of the TG Act for simplicity? No 14 Will these changes have direct or indirect impact on you? Please provide details. Yes (please provide details below) Please provide details here:: As a consumer I want safer options to be available to me and to every person who smokes tobacco or would smoke tobacco for lack of a viable alternative. Sadly some kids will do adult things even if you try to stop them (for example drinking alcohol, unsafe sex, taking drugs, smoking) while they should not be encouraged to vape, it still offers a harm reduction if it diverts them from smoking, like it or not, this is true because safer is safer. 15 Do you require time to adjust to these requirements? If yes, how long? Yes 15 (a) How long do you require to adjust to these requirements? More than 12 months Proposal 3 - Improving quality standard for unapproved (unregistered) vapes) 16 Are the definitions of nicotine and mint flavours appropriate? If not, please provide reasons. No (* please provide reason below) * Please provide reason here.: Nicotine itself does not have a flavour, the flavour should be correctly referred to as "artificial tobacco flavour" There is no evidence that human flavour preference varies by age and none particularly that it changes at 18. It is therefore impossible to target age groups with specific flavours, thus limiting flavours on this basis has no merit whatsoever. 17 Do you agree with the proposed upper limit on the concentration of menthol in vapes? If not, please provide reasons. No (* please provide reason below) * Please provide reason here: It is trivial to add menthol to vapes, this simply encourages users to add more if they prefer, opening a can of worms and the potential for contamination or incompatible ingredients. This seem unwise for very little if any benefit. 18 [If applicable] Importers, manufacturers and suppliers, would the restrictions on flavour proposed above impact you? Not applicable 19 Do you agree with the proposal to require pharmaceutical-like packaging and presentation for vapes, e.g., vapes manufactured in black, white or grey coloured materials, predominantly white background on packaging, clear warning statements and other restrictions on labels in addition to other selective TGO 91 requirements for vapes? No (* please provide reason below)20 [If applicable] What impact will the labelling and packaging changes have on you? * Please provide detail here.: It will probably backfire, making legal products undesirable is likely to increase the number of people using illicit products, particularly if access remains easy, without enforcement that is most likely to be the case. 20 (a) How long would you need to transition your product to comply with the proposed requirements? More than 12 months 21 Do you agree with our approach to allow only permitted ingredients in vapes, instead of trying to prohibit individual chemical entities from use in e-liquids? No 22 [If applicable] Importers, manufacturers and suppliers, will your therapeutic vapes need any re-formulation or other changes to comply with the permitted ingredients and ingredient quality requirements? Not applicable 22 (a) If product re-formulation is required, how long will you need to make these changes? More than 12 months 22 (b) If product re-formulation is required, what financial or business impacts would be associated with them? Provide detail here or put 'Not Applicable': Not a vendor 23 Do you support applying the same regulatory controls to zero-nicotine therapeutic vapes, as for NVPs? No 24 What is the overall business cost on you to comply with a strengthened TGO 110? Please provide details here: (or mark Not applicable).: not a vendor 25 Do you agree with the proposed requirements under TGO 110 that will apply to unapproved device components of vapes? No 26 [If applicable] Suppliers, do you intend to register any vaping device on the register as an approved medical device? No (if no, why not?) If no, why not?: not a vendor 27 [If applicable] Importers, manufacturers and suppliers, are you familiar with relevant US FDA, or MHRA guidance and/or EU standards covering vaping devices? Not applicable 27 (a) Do your vapes currently comply with relevant US FDA, or MHRA guidance and/or EU standards covering vaping devices? Not applicable 27 (b) If not, what requirements do you meet? What requirements you currently comply with?: not a vendor 27 (c) How long would it take to achieve compliance with relevant standards? More than 12 months28 [If applicable] Importers, manufacturers and suppliers, are your vapes manufactured at facilities that hold relevant international standards for Quality Management Systems, such as ISO9001 or ISO 13485? Not applicable Proposal 4 - Strengthening domestic compliance and enforcement mechanisms 29 Do you have any other comments in relation to this proposal? Yes (* provide your comments below) Comments: I reiterate that Australian policy has failed, and further moves in the same direction are likely to fail. Other countries have shown much more desirable results, the best results on smoking have been where vaping has been accepted as a consumer alternative to smoking, but the prescription model, unfortunately, has proven unworkable. Realistically you should review the past responses to enquiries, select a number of people who have successfully predicted the results of current regulations, and ask them for solutions. At least they have a track record, and proven knowledge of the real world and likely outcomes. Supplementary questions 30 [If applicable] Suppliers, please confirm if you intend to continue to supply therapeutic vapes under the proposed reforms described? Not applicable * Product range : Not a vendor, but as a consumer, I can see vendors dropping out. This will benefit the criminals and gangs who supply illicit markets, more trade for them. 30 (a) How long would it take to meet the new requirements? More than 12 months 31 [If applicable] Suppliers, please confirm if you intend to register your therapeutic vapes in the next 2 years? Not applicable What guidance and/or clarity of supporting data requirements do you need from TGA: not a vendor Publication of submissions To proceed, please select from the options below how you would like the TGA to deal with your submissions: I agree to the TGA publishing my response in full. I request the TGA to consider redacting sensitive commercial information from my response before publication: No Please specify sensitive commercial inforation you want redatced :|TGA consult 8-sept-2023 my response]] | ||
[[File:Letter to pm 16 sept 2023.pdf|thumb|alt=Sent to The Prime Ministers office FAO The Prime Minister No10 downing street (via official contact form) 14:30 on 16th Sept 2023 Subject: The continuing debate around banning disposable vaping and flavoured vaping. This is continuing from my note of the 25th May 2023, I hear worrying noises around an outright ban on disposable vapes. As a consumer myself, who would surely be dead now without vaping, 15 years more smoking (I started 2008) would have seen me off, but not a user of disposables. Please however consider the following. First; evidence from Australia where vaping is prescription only and prescriptions are hard to obtain (a de-facto ban), shows that illicit markets step in to fill demand, and have done so with the cheapest and least safe disposable devices. It is entirely probable bans here would result in more disposable vapes than less. Second; There are disposable vapes designed for high security locations, such as prisons and mental health units, particularly secure ones. Please do not inadvertently ban a much safer than smoking option in such places, some of these people are suffering enough, and require our assistance. Third; Prohibition is not effective, please see the situation in Australia again, the failed implementation of alcohol prohibition, and more than 6 decades of drug war. Not one of these things has reduced the supply of the substances trying to be controlled, and there is no reason to assume it will be effective for disposable or flavoured vaping. Fourth; There are measures, some that I suggested to APPG Vaping on 28th Feb this year, the link is safernicotine.wiki/mediawiki/index.php?Title=File:Email_to_appg_vaping_28th_Feb_2023.pdf Should you wish to read it. These measures would significantly reduce the environmental impact (by a factor of 10), and place the legal devices better able to compete with illicit imports (these generally have more puffs than the UK rules currently allow), has the effect of increasing the initial cost of the device but not the cost per puff. By such changes to legal devices three main goals can be achieved 1) Compete out the illicit and illegal products that are not safety tested and approved. 2) Reduce the environmental cost, and quantity of vapes in need of recycling. 3) Reduce the affordability of such devices to young people particularly children. Legal devices could then be mandated to contain information on refillable devices that are just as easy to use, cheaper and more environmentally responsible. Measures to drive consumers to more environmentally sound products should absolutely be considered, such as paying more initially and receiving a repayment on return for recycling. This should be done with care for unintended consequences. I have kept this short as you are busy, but if there is any further information you would like please feel free to contact me by email richard@pruen.co.uk. Thank you for your time.|Letter to pm 16 sept 2023]] | |||
[[File:NSW Consult 30 sept.pdf|thumb|alt=Vaping is a direct substitute for smoking that is able to compete with cigarettes on the open market, it is unbeatable on cost compared to subsidised NRT, and far more effective, the UK NHS find 2/3 (66%) effective with support. With regulated vaping in UK youth: 0.5% use > once weekly and are never smokers (see ASHuk graph attached). Driving the product to illicit markets and criminal gangs seems to have resulted in greater access for Australian youth. While vaping is not entirely risk-free, it is known now that it poses a fraction of the risk of smoking (please see the attached risk map). Waiting for a perfect solution that may never be found is counterproductive, the reduction in risk is known to be large that much is proven (the unknown part is, is it 90% reduction in risk or 99%, to be sure will take time) While youth should not vape or smoke, some will end up doing both. If there is no safer alternative available they will all be smoking. It is also worth remembering dependence on nicotine while not desirable can be reversed, death is final, and it is smoking that kills. Like it or not vaping has a built-in off-ramp. Use an open-system vape, and use the liquid you need to prevent cravings. Then slowly reduce the nicotine strength at your own pace. On reaching zero nicotine, stop. This is also ample evidence it was developed by smokers, to help stop smoking, and then to stop vaping if that is desired. Would a tobacco company ensure a way out was built in? The population has resoundingly refused the prescription model, any of the many reasons pointed out repeatedly or all of them are to blame. They deserve a fair regulated market they can trust, if you cannot provide a better solution than criminal gangs, then that is a failure on your part. |NSW Vaping submission 30 september 2023]] | |||
[[File:Letter Steve Barclay 19th oct.pdf|thumb|alt=Subject: ‘Ton of bricks’ regulation of vaping and flavours Dear Steve Barclay, I am a consumer advocate, with no ties to industry at present (for full details see my previous letter). I await your reply to my last letter on 6th July, with the requested information, including reasoning for not including representatives of consumers in the enquiry. I would also like to know if the MPs where briefed on vaping or the vaping industry, if so by whom? The point itself is brief, two short paragraphs. After your comments on regulations, I would like to draw your attention to the following peer reviewed paper https://www.mdpi.com/1660-4601/20/20/6936 this strongly suggests that young people are being diverted from smoking, vaping is at least 95% safer than them smoking, thus while not ideal vaping reduces harm. Dependence to nicotine is also not ideal, but only 0.5% youth regularly use vapes who did not first smoke. Meanwhile you risk stopping millions of adult smokers switching to vapes by eliminating flavours, these are an important thing for adults. Please read this from Clive Bates (ex ASH Director) https://clivebates.com/documents/FlavoursBriefingV1July2022.pdf. You should of course ban candyfloss and sweet flavoured alcohol, as such flavours are aimed only at children? One last point Vaping is already illegal for children, if the existing rules cannot be enforced, then further legislation will presumably not be enforced either, how would that help? Yours sincerely, Richard Pruen|Letter Steve Barclay 19th oct]] | |||
[[File:Letter to cop 10 repersentitives.pdf|thumb|alt=Subject: COP 10 WHO FCTC Dear Rosanna O’Connor, I am a consumer advocate for vaping, and do not use disposables beyond experimenting to see what they are like. I am also an engineer. I have worked in the vaping industry previously testing compliance with the standards for vaping products, and owned a now closed company BTC Battery Testing LTD (closed 2016). Currently I care for my mother who suffers vascular dementia, and as such volunteer my spare time to the cause of Tobacco Harm Reduction. I believe that consumers should be present at the COP 10 meeting, it is consumers who have the most to gain from stopping the use of combustible tobacco, and the lived experience of trying to do so. Many millions have found a way to eliminate almost all the risk via THR products. The phrase ‘Nothing about us without us’ springs to mind. Why then are the public and press excluded. I would like to see the proceedings live streamed, so those effected can see what is being done. In no way could this effect the discussions, thus is reasonable transparency. I would like an answer regarding the possibility, please. Many countries already found harm reduction useful, critical even. Be that low risk Snus (Sweden has the lowest cancer rate in Europe, and will be smoking free this year (>5%)). Vaping that the UK NHS finds almost 66% effective with support, as stated on their website. New Zealand has seen similar results, especially in native populations, reducing disparities. Japan has seen huge drops in cigarette sales due to reduced harm heated tobacco products. Please see the letter from the Lancet from Robert Beaglehole and Ruth Bonita. They were both senior officials at WHO and are now at the University of Auckland. Robert was formerly Director of the Department of Chronic Disease and Health Promotion at WHO. Ruth was formerly the Director of Surveillance in the Noncommunicable Disease Cluster at WHO. I wish to add my support for their recommendations, the article is attached (also link here https://doi.org/10.1016/S0140-6736(24)00140-5) please make sure these points are discussed at the COP 10 meeting. Yours sincerely, Richard Pruen P.S Please ensure the representatives listed on the next page can discuss before the metting and forward more widely if you agree with the sentiment. Katherine Sands Tobacco Control Team Leader Department for Health and Social Care Martin Dockrell Tobacco Control Programme Lead Department for Health and Social Care Alison Walker Senior Tobacco Control Policy Lead Department of Health and Social Care Esther Lawrence Deputy Head of Global Health UK Mission to the UN, Geneva Please find attached a letter from [THELANCET-D-24-00371] S0140-6736(24)00140-5|Letter to cop 10 representatives]] | |||
[[File:Letter PM 16th Feb 2024-draft.pdf|thumb|alt=Subject: The ban on disposable cigarettes Dear Prime Minister, I am a consumer advocate for vaping (15 years and vaper for 16), and do not use disposables beyond experimenting to see what they are like. I am also an engineer. I have worked in the vaping industry previously testing against the standards for vaping products, and owned a now closed company BTC Battery Testing LTD (closed 2016). Currently I care for my mother who suffers vascular dementia, and as such volunteer my spare time to the cause of THR. Regarding the subject. Might I remind you that Australia has already taken this path, over 50 fire bombings, at least 3 gang style murders, and a rampant illegal trade has resulted. I am aware you have children, and they are potentially at the age to start experimenting with adult products. The prohibitionist faction may have played on this, and convinced you that a ban is enforceable, sadly if Australia cannot do it, the proximity of Europe means less chance here. This is simply being realistic. The best, perhaps only, way to control the illicit trade to to make sure there is a legal trade that makes it less profitable,the US abandoned alcohol prohibition in favour of this. Please however remain focused on preventing harm, having the only source of disposable vapes (sorry to say this but it is true) that your children could possibly buy, being from a ‘dealer’ who might supply other illicit substances, that is not safer! At least if they are from a shop selling tested, safe devices, then that is a huge reduction in harm already, avoiding interaction with drug dealers. I would prefer the shop followed the law, but as we know not everyone will. Your children might also sample smoking, especially if they sensibly avoid illicit substance dealers, this too is not exactly a win, smoking being deadly and carcinogenic. You are not the only one being pressured, please see the tweet linked here: https://x.com/ASHNZ2025/status/1757930273751363892?s=20 “Disappointing that @HealthCoA lump ASH in with tobacco industry in an OIA request rather than ask us. Is a smear campaign coming our way? On the record ASH has no $$ or COI with tobacco, vape, alcohol, gambling, pharmaceutical, retail, food, or billionaire philanthropist” <a letter from the NZ government is attached to the tweet> I apologise for the somewhat robust and direct letter, but I feel you are about to make a huge mistake. I would regret it on behalf of current cigarette smokers, some of whom will die, and those who return to smoking because they use a banned product, some of those too will die. Meanwhile it will not help your children, or anyone else's to drive all sales to illicit/criminal markets. Please see the attached graph, so far regular use is not high and may be displacing cigarettes, sensible regulations to keep it that way, those would be welcome. A few truths to bear in mind: Infrequent trial use isn’t the best indicator of dependence, vaping doesn’t kill children nor is it likely ever to do so, smoking cigarettes does kill adults, reasonable regulation results in overall lowest harm. I would like to hear your thoughts, I will be happy to provide evidence to support what I have said, if required for any point please let me know. Thank you for your time, and please do not take this lightly! Yours sincerely, Richard Pruen |Letter PM 16th Feb 2024-draft]] | |||
[[File:For Attention APPG Smoking and health.pdf|thumb|alt=Dear Rt. Hon. Bob Blackman, I am contacting you as you are the contact for APPG Smoking and Health. There have been worrying sudden changes in government policy, primarily related to vaping and talk of taxes and bans on a vastly safer product, vaping, that has been successfully displacing smoking. Please see my previous letter to APPG vaping on why the disposable ban is likely to backfire; simply put, it will hand the entire market to illicit sales (these are already a problem, with oversized and higher-than-legal nicotine content). Illegal sales will likely increase sales to youth since they are already ignoring the law, and the situation in Australia with more than 50 fire bombings and three murders so far in the 'Nicotine turf wars' might be repeated here. As per my letter above, the best way to deal with illegal disposables is to have the legal market out-compete them; at least shops and retailers have fixed premises, and trading standards can take action if they don't follow the law. It is much harder to police some bloke at the pub or other informal sales. You also lose out on VAT charged on legal sales. Whatever you think about vaping, it saved my life; I started 16 years ago, very early when it was a new thing, and since then, there has been a vast amount of science (some good, some sadly terrible). Last week, 51 peer-reviewed papers and over 8,000 total papers were published. By now, vaping/nicotine is likely the most studied consumer drug ever. I had an MRI 15 years vaping (stopping smoking) of my head and upper torso. The doctors were able to confirm all the smoking damage had healed, and on explicitly asking if they could see any sign I vape, they could not (despite having found previously healed fractured ribs). Such experiences are not uncommon. A list of links to approximately 100,000 people reporting in their own words how vaping helped them. Tobacco control has a problem; please do not let that upset the government's plans to help people stop smoking with the best available harm-reduced product to date. The NHS finds it 2/3 (66%) effective, far better than NRT at around 15% with the same support (easily found on their vaping to stop smoking web page). Please ensure that the UK policy isn't derailed by click bait media, or the following: Extract from Clive Bates (former director ASH) essay:Tobacco Control's Nervous Breakdown Fourth, the existential threat to the tobacco control complex. The public discussion of the emerging landscape of low-risk consumer products seldom focuses on the interest group that is most vulnerable to disruption: the mainstream of tobacco control. It is a complex of interests comprising nonprofit activists, academics, medical and health societies, major institutions (such as the World Health Organization or the U.S. Food and Drug Administration), philanthropists and research-funding bodies. The problem for the mainstream of tobacco control is that without serious harm, the whole movement loses its purpose and its reason to exist. When it comes to low-risk alternatives to smoking, this complex is profoundly confronted by the threat of having nothing to control, no case for intervention and no reason to be. It is a powerful incumbent interest group challenged by new technology, new suppliers and new consumer confidence. As a result, the mainstream of this interest group has rejected tobacco harm reduction as a strategy for addressing its own notional goals of reducing death and disease from tobacco use. Instead, it has mounted a rear-guard defense based on a range of strategies, including the following: Falsely implying that noncombustible products are no less risky than cigarettes, that data is too uncertain or short-term, or asserting that reduced risk is no more than a marketing claim of tobacco companies. Asserting that harm reduction is merely a commercial strategy of tobacco companies. The aim here is to attach the reputational baggage of “Big Tobacco” to these new developments. Yet, many independent experts support tobacco harm reduction, and it is good if tobacco companies adopt a business model aligned with reducing health impacts. Excluding or stigmatizing contrarian opinions and creating sealed bubbles open to groupthink. The WHO Framework Convention on Tobacco Control has taken this to new extremes. Shifting emphasis to problematize nicotine rather than the “tar” of cigarette smoke that is the cause of nearly all tobacco-related disease. We are hearing more about “addiction” and less about cancer. Yet, a dependence only meets the definition of addiction if there is serious net harm to the user. A relentless focus on the supposed interests of children without recognizing that would-be smokers among adolescents also benefit from low-risk products and that the demand for nicotine has persisted across generations for hundreds of years. Young people have an interest in the health of the significant adults in their lives as carers, breadwinners and role models. Pressing for prohibitions or equivalent regulation to cigarettes, often with manipulation of language to imply equivalent risk, for example, by stating that heated-tobacco products produce “smoke” or that all tobacco products should be treated the same even though they have very different risks. A blunt refusal to face trade-offs (for example, between the interests of youth and adults) or unintended consequences (for example, increases in smoking) arising from favored policy positions. I have watched on in horror as the leadership in tobacco control, albeit with many honorable exceptions, has dogmatically denied and suppressed the opportunity to radically reshape the recreational nicotine market to cause vastly reduced harm and avoid hundreds of millions of premature deaths. It looks like a nervous breakdown is developing in tobacco control in response to profound disruptive innovation. I doubt they will survive it. See also my Letter PM 16th Feb 2024 particularly the graph that shows frequent youth use is not increasing, trials and infrequent use have, for perspective however, vaping has been far less popular and less harmful than youth drinking. Please do what you can to ensure legislation is well thought out, measured and does not result in people being forced back to deadly smoking. Thank you for your time and urgent attention!|Email APPG Smoking and health-4 March 2024]] | |||
[[File:Letter sec state health and social care 14 March 2024.pdf|thumb|alt=Subject: Youth vaping Please see the above graph, so far regular use (greater than once a week) is not high and may be displacing cigarettes, cigarettes are the worlds most deadly consumer product. Infrequent and trial use (once in 30 days, or ever use) while undesirable does not lead to dependence, only those in the graph above can possibly be ‘hooked’, but not all will be. I do not think young people should be encouraged to vape, but I would like to know your answer to one question, please. If a young person is determined to use nicotine, would you advise them to smoke cigarettes instead of safer alternatives, and a what age should harm reduction products like vaping be made available. I look forward to receiving your answer. Please feel free to ask others what they think should be done. Personally I feel the situation in Sweden is close to the best balance, accepting some use of low risk Snus, in order to reduce the uptake of deadly smoking. This will take effect far faster than the generational tobacco ban, Sweden will be a non smoking nation this year, although nicotine use remains, they have the lowest cancer rate in Europe. The UK can easily and quickly achieve the same with vaping. I note also Sweden reduced the tax on Snus to accelerate uptake. Yours sincerely, Richard Pruen|Letter sec state health and social care 14 March 2024]] | |||
[[File:Letter sec state health and social care 11 May 2024.pdf|thumb|alt=Subject: Tobacco and vapes bill Dear Victoria Atkins, I am contacting you as a vaping consumer, and advocate for saving lives, vaping saved my life (happy to share medical records to prove that) and I aim to pass that on to as many as possible, I am not paid in any way by anyone to do so. I was disturbed to hear some of the testimony given in parliament, much of the information was incorrect, or deliberately misleading. This is not good enough when debating a serious matter of health, accurate and science backed information is critical to saving lives. I would like an answer to the following question: What was the reason to justify excluding stakeholders, the users of vaping products, other safer tobacco products, and even people who smoke? User funded charities such as New Nicotine Alliance, who take no money from the tobacco or vaping industry should have been consulted. Users themselves or NNA would have been able to counter some of the poor information given and also to provide a view from those directly affected by the legislation being discussed. Much of the information could have been corrected, quickly and easily. The main issues with the unopposed debate (no stakeholder representative, or consideration given to stakeholders, it seems); the conflation of illegal/criminal imports of untested and illegal drug products, and legal UK nicotine vaping; the lack of separation between the independent vaping industry and tobacco multinationals (they are not the same thing); the potential to harm the UK government stop to swap scheme (saving lives of people who smoke now, not a future population, years from now)… I could go on, but others like UK Vaping Industry Association have pointed out the issues, no need for a repeat. My most important question; What is being done to ensure that stakeholders are heard, and the users of these products are not swept aside? Particularly what is being done to ensure false/misleading statements are not made to parliament by the experts, or that at least someone is included on behalf of users to set the record straight? I look forward to your responses. Yours sincerely, Richard Pruen|Letter sec state health and social care 11 May 2024]] | |||
Latest revision as of 09:42, 11 May 2024
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The Site admin
Richard Pruen
Electrical and electronic engineer
Favorite band: Rush
Why spend so much time on this? It’s a fact that nicotine harm reduction (vaping and Snus) saved my life, this is my way to pay that forward, and pass along information on safer nicotine.
Running a site from the ground up, has proved interesting and worthwhile. Some of the things I have learned about Linux, and configuration of software for servers is only stuff you learn by doing.
I suspect the site will stick around, at least as long as it is required to provide links and info.
I might well put more info of my vaping / thr story here soon, this is just a test edit.
More test edit, and added some features, like babel to indicate users languages.
Site admin at Safer nicotine wiki.
ABOUT
Ecig user since 2008, consumer advocate for vaping and THR #VapingSavedMyLife #VapingSavesLives
Twitter @pruenrichard
Below are letters and documents sent in advocacy efforts, as a record and should anyone wish to use them for ideas.
![Response ID ANON-EJTE-W3QH-B Submitted to Proposed reforms to the regulation of vapes Submitted on 2023-09-08 21:15:44 Survey contents Privacy and your personal information I consent to the TGA collecting the information requested in this survey about me, including any sensitive information, for the purposes indicated above. Agree: Yes Acknowledgement I agree. Yes.: Yes Introduction 1 What is your name? Name: Richard Pruen 2 What is your email address? Email: richard@pruen.co.uk 3 What is your organisation name? Organisation name or N/A: n/a 4 Please choose a stakeholder group that best describes you or your organisation. Others* *If other, please specify:: Consumer 5 Which best describes your response? I am responding as an individual. 6 Are you an authorised prescriber? No (please go to next page Conflicts of interest (actual or perceived) 1 Have you or your organisation ever received services, assistance or support (whether monetary or non-monetary in nature) from the tobacco industry and/or e-cigarette industry? If this scenario applies to you or your organisation, please provide relevant details in the textbox. Yes If you have selected yes, please provide details here. Otherwise, please state 'Not Applicable':: I owned a company testing electronic cigarettes for compliance with UK and other standards, as well as carried out investigations of failures including battery failure. I also worked on R&D and provided consulting services on for example battery protection circuits, chargers etc. Payment was from user fees for testing, government agencies (trading standards), trade associations, and sometimes individuals or companies carrying out due diligence testing or failure mode analysis. Ended 2016 since then I have been a consumer only and have not received any funding from any company (of any sort), government agency, or researchinstitution. 2 Have you or your organisation ever provided services, assistance or support (whether monetary or non-monetary in nature) to the tobacco industry and/or the e-cigarette industry? If this scenario applies to you or your organisation, please provide further information in the textbox. Yes If you have selected 'yes', please provide details here. Otherwise, please state 'Not Applicable': I assisted in writing standards for UK vaping products (PAS 54115 A guide for the importation and sale of electronic cigarettes and directly related products, with product safety testing methods) and proposed an IEEE standard project number P2800. Several sampling machines were supplied to others testing electronic cigarettes, and other custom test equipment, the supplied equipment presumably used to carry out tests on electronic cigarettes as designed. As academic and test houses purchased this equipment it is assumed this was paid for by test fees, or grants to carry out tests on electronic cigarettes, again possibly linked to taxes etc from tobacco and or electronic cigarette sales. The same funding source as government agencies, politicians and others working in the field. Again since 2016 I have been a consumer only. Proposal 1 -Restrictions on importation, manufacture and supply of all vapes . 1 Do you support the proposed approach to ban disposable single use vapes absolutely and all other vapes, except those for legitimate therapeutic use in compliance with the TG Act? No 2 How would you anticipate industry and consumers to respond to a ban on the importation, manufacture and supply of non-therapeutic vapes? * Please provide answer here. : Demand will remain, along with the risk of vaping being seen as cool because it is something disallowed. The tightening of rules is unlikely to be enforceable, so illicit supply will continue to be the primary supply to the population. The population know vaping is safer than smoking, thus it will be very difficult to curb demand. Prohibiting drugs such as cocaine and cannabis fails, vaping prohibition will almost certainly follow the same pattern. 3 Do you support removal of the personal importation scheme exception for vapes? If not, what would be the impact on you? No (* if not, what would be the impact on you?) * What would be the impact on you?: Vaping products that are acceptable and usable are likely to only be available via illicit sales, and criminal gangs. Particularly as research shows flavours to be vital for the prevention of release to smoking. These products will not be tested or regulated in any way, importing allows users who have a prescription to import what they need to stay smoke-free, thus not relapse to smoking and potentially death. Importantly importing from somewhere with a regulated legal market, they can be sure of the quality and contents of the products they buy. The one-size-fits-all approved vapes that consumers will find at pharmacy outlets is unlikely to be effective since most of the features that make an effective substitute for cigarettes will be regulated out. 4 Do you agree with the proposal to retain a traveller’s exemption, including the proposed limits? Yes 5 Do you support the proposed approach to prohibiting the advertisement of all vapes (subject to limited exceptions)? No 6 [If applicable] Suppliers, what part of supply chain do you occupy? Not applicable * Other -specify your role in supply chain.: Consumer 6 (a) What proportion of your sales volumes is attributable to vape sales [i.e. quantity of vapes sold]? Please provide details here: (or mark Not applicable).: N/A6 (b) What proportion of your sales revenue is attributable to vape sales [i.e. revenue earned from sales]? Please provide details here: (or mark Not applicable).: N/A 6 (c) What impact would the proposed measures have on your sales volumes? Please provide details here: (or mark Not applicable).: not a vendor, none 6 (d) What impact would the proposed measures have on your sales revenues? Please provide details here: (or mark Not applicable).: none not a vendor 6 (e) What proportion of your vapes sales is attributable to disposable single use vapes versus refillable products? Please provide details here: (or mark Not applicable).: not a vendor 6 (f) How would restricting the importation, manufacture and supply of disposable single use, and non-therapeutic, vapes in Australia impact you? Please provide details here: (or mark Not applicable).: not a vendor N/A 6 (g) How much stock do you have in Australia currently and how long would it take to sell that stock? Please provide details here: (or mark Not applicable).: not a vendor N/A 6 (h) What would be the cost to you if you were required to dispose or otherwise move on existing stock? Please provide details here: (or mark Not applicable).: N/A Proposal 2 -Changes to market accessibility requirements, including better regulation of device components. 7 Do you support the approach to require a pre-market notification of compliance with TGO 110? No 8 [If applicable] For suppliers of therapeutic vapes, what impact would the proposed notification system have on your supply model and what transition period would you require to comply with the new notification requirement? Please provide details here: (or mark Not applicable).: not a vendor 9 Do you support the proposed access to vapes under the SAS C notification system? No 9 (a) What impact would this pathway have on facilitating patient access to therapeutic vapes? Please provide details here: (or mark Not applicable).: Vaping works in the rest of the world as a product substitute, providing a safer alternative to a deadly (cigarettes) product. In the UK and NZ smoking decline has accelerated significantly past that in Australia, due to the adoption of consumer vaping, slightly less so in the US where the regulator is not so certain. The prescription model in Australia has failed, smoking has not continued to decline and may have increased possibly. Vaping is also higher in Australian youth than UK and NZ, the current policy has backfired and should be reversed. It is absolutely obvious at this point that unless you have unlimited resources for enforcement, the current policy is not workable, and never will be. The time has come to use what has worked elsewhere and start again.10 [If applicable] For prescribers, would the proposed new pathway likely change your approach to prescribing therapeutic vapes? How? Not a prescriber of vapes * How new pathway will change your approach to prescribing ttherapeutic vapes?: 11 [If applicable] For prescribers, which access pathway (SAS B, SAS C, or AP) would you envisage using to prescribe therapeutic vapes? Why? Not a prescriber of vapes Please tell us why: 12 [If applicable] For prescribers, would integration of SAS or AP applications or notifications into existing clinical software systems ease the administrative burden and/or encourage you to use the new pathway? Not a prescriber of vapes 13 Do you agree with the proposal to regulate both e-liquid and device components of unapproved vapes under the same part of the TG Act for simplicity? No 14 Will these changes have direct or indirect impact on you? Please provide details. Yes (please provide details below) Please provide details here:: As a consumer I want safer options to be available to me and to every person who smokes tobacco or would smoke tobacco for lack of a viable alternative. Sadly some kids will do adult things even if you try to stop them (for example drinking alcohol, unsafe sex, taking drugs, smoking) while they should not be encouraged to vape, it still offers a harm reduction if it diverts them from smoking, like it or not, this is true because safer is safer. 15 Do you require time to adjust to these requirements? If yes, how long? Yes 15 (a) How long do you require to adjust to these requirements? More than 12 months Proposal 3 - Improving quality standard for unapproved (unregistered) vapes) 16 Are the definitions of nicotine and mint flavours appropriate? If not, please provide reasons. No (* please provide reason below) * Please provide reason here.: Nicotine itself does not have a flavour, the flavour should be correctly referred to as "artificial tobacco flavour" There is no evidence that human flavour preference varies by age and none particularly that it changes at 18. It is therefore impossible to target age groups with specific flavours, thus limiting flavours on this basis has no merit whatsoever. 17 Do you agree with the proposed upper limit on the concentration of menthol in vapes? If not, please provide reasons. No (* please provide reason below) * Please provide reason here: It is trivial to add menthol to vapes, this simply encourages users to add more if they prefer, opening a can of worms and the potential for contamination or incompatible ingredients. This seem unwise for very little if any benefit. 18 [If applicable] Importers, manufacturers and suppliers, would the restrictions on flavour proposed above impact you? Not applicable 19 Do you agree with the proposal to require pharmaceutical-like packaging and presentation for vapes, e.g., vapes manufactured in black, white or grey coloured materials, predominantly white background on packaging, clear warning statements and other restrictions on labels in addition to other selective TGO 91 requirements for vapes? No (* please provide reason below)20 [If applicable] What impact will the labelling and packaging changes have on you? * Please provide detail here.: It will probably backfire, making legal products undesirable is likely to increase the number of people using illicit products, particularly if access remains easy, without enforcement that is most likely to be the case. 20 (a) How long would you need to transition your product to comply with the proposed requirements? More than 12 months 21 Do you agree with our approach to allow only permitted ingredients in vapes, instead of trying to prohibit individual chemical entities from use in e-liquids? No 22 [If applicable] Importers, manufacturers and suppliers, will your therapeutic vapes need any re-formulation or other changes to comply with the permitted ingredients and ingredient quality requirements? Not applicable 22 (a) If product re-formulation is required, how long will you need to make these changes? More than 12 months 22 (b) If product re-formulation is required, what financial or business impacts would be associated with them? Provide detail here or put 'Not Applicable': Not a vendor 23 Do you support applying the same regulatory controls to zero-nicotine therapeutic vapes, as for NVPs? No 24 What is the overall business cost on you to comply with a strengthened TGO 110? Please provide details here: (or mark Not applicable).: not a vendor 25 Do you agree with the proposed requirements under TGO 110 that will apply to unapproved device components of vapes? No 26 [If applicable] Suppliers, do you intend to register any vaping device on the register as an approved medical device? No (if no, why not?) If no, why not?: not a vendor 27 [If applicable] Importers, manufacturers and suppliers, are you familiar with relevant US FDA, or MHRA guidance and/or EU standards covering vaping devices? Not applicable 27 (a) Do your vapes currently comply with relevant US FDA, or MHRA guidance and/or EU standards covering vaping devices? Not applicable 27 (b) If not, what requirements do you meet? What requirements you currently comply with?: not a vendor 27 (c) How long would it take to achieve compliance with relevant standards? More than 12 months28 [If applicable] Importers, manufacturers and suppliers, are your vapes manufactured at facilities that hold relevant international standards for Quality Management Systems, such as ISO9001 or ISO 13485? Not applicable Proposal 4 - Strengthening domestic compliance and enforcement mechanisms 29 Do you have any other comments in relation to this proposal? Yes (* provide your comments below) Comments: I reiterate that Australian policy has failed, and further moves in the same direction are likely to fail. Other countries have shown much more desirable results, the best results on smoking have been where vaping has been accepted as a consumer alternative to smoking, but the prescription model, unfortunately, has proven unworkable. Realistically you should review the past responses to enquiries, select a number of people who have successfully predicted the results of current regulations, and ask them for solutions. At least they have a track record, and proven knowledge of the real world and likely outcomes. Supplementary questions 30 [If applicable] Suppliers, please confirm if you intend to continue to supply therapeutic vapes under the proposed reforms described? Not applicable * Product range : Not a vendor, but as a consumer, I can see vendors dropping out. This will benefit the criminals and gangs who supply illicit markets, more trade for them. 30 (a) How long would it take to meet the new requirements? More than 12 months 31 [If applicable] Suppliers, please confirm if you intend to register your therapeutic vapes in the next 2 years? Not applicable What guidance and/or clarity of supporting data requirements do you need from TGA: not a vendor Publication of submissions To proceed, please select from the options below how you would like the TGA to deal with your submissions: I agree to the TGA publishing my response in full. I request the TGA to consider redacting sensitive commercial information from my response before publication: No Please specify sensitive commercial inforation you want redatced :](/mediawiki/images/thumb/8/8b/TGA_consult_8-sept-2023_my_response.pdf/page1-300px-TGA_consult_8-sept-2023_my_response.pdf.jpg)
![Subject: COP 10 WHO FCTC Dear Rosanna O’Connor, I am a consumer advocate for vaping, and do not use disposables beyond experimenting to see what they are like. I am also an engineer. I have worked in the vaping industry previously testing compliance with the standards for vaping products, and owned a now closed company BTC Battery Testing LTD (closed 2016). Currently I care for my mother who suffers vascular dementia, and as such volunteer my spare time to the cause of Tobacco Harm Reduction. I believe that consumers should be present at the COP 10 meeting, it is consumers who have the most to gain from stopping the use of combustible tobacco, and the lived experience of trying to do so. Many millions have found a way to eliminate almost all the risk via THR products. The phrase ‘Nothing about us without us’ springs to mind. Why then are the public and press excluded. I would like to see the proceedings live streamed, so those effected can see what is being done. In no way could this effect the discussions, thus is reasonable transparency. I would like an answer regarding the possibility, please. Many countries already found harm reduction useful, critical even. Be that low risk Snus (Sweden has the lowest cancer rate in Europe, and will be smoking free this year (>5%)). Vaping that the UK NHS finds almost 66% effective with support, as stated on their website. New Zealand has seen similar results, especially in native populations, reducing disparities. Japan has seen huge drops in cigarette sales due to reduced harm heated tobacco products. Please see the letter from the Lancet from Robert Beaglehole and Ruth Bonita. They were both senior officials at WHO and are now at the University of Auckland. Robert was formerly Director of the Department of Chronic Disease and Health Promotion at WHO. Ruth was formerly the Director of Surveillance in the Noncommunicable Disease Cluster at WHO. I wish to add my support for their recommendations, the article is attached (also link here https://doi.org/10.1016/S0140-6736(24)00140-5) please make sure these points are discussed at the COP 10 meeting. Yours sincerely, Richard Pruen P.S Please ensure the representatives listed on the next page can discuss before the metting and forward more widely if you agree with the sentiment. Katherine Sands Tobacco Control Team Leader Department for Health and Social Care Martin Dockrell Tobacco Control Programme Lead Department for Health and Social Care Alison Walker Senior Tobacco Control Policy Lead Department of Health and Social Care Esther Lawrence Deputy Head of Global Health UK Mission to the UN, Geneva Please find attached a letter from [THELANCET-D-24-00371] S0140-6736(24)00140-5](/mediawiki/images/thumb/4/4f/Letter_to_cop_10_repersentitives.pdf/page1-300px-Letter_to_cop_10_repersentitives.pdf.jpg)
