Sept 2023 Following on from Minister of Health, Mark Butlers announcement of a plan to ban vaping, the TGA has been commissioned to run yet another vaping regulatory change consultation this time aimed at banning vaping altogether in Australia (including non nicotine vaping products currently legally sold in specialist vape stores).
Following on from Minister of Health, Mark Butlers May 2023 announcement of a plan to ban vaping, the TGA has been commissioned to run yet another vaping regulatory change consultation this time aimed at banning vaping altogether in Australia (including non nicotine vaping products currently legally sold in specialist vape stores).
The concerning difference in this consultation
This consultation is being rushed through (running for less than 2 weeks in duration), its incredibly difficult to impossible to locate, and following an overwhelming amount of participation from adult vapers in past submissions, this consultation appears to be limiting contributions to anti-vaping organizations and small businesses not currently breaking the law facing closure.
The TGA is seeking input from targeted stakeholders regarding support for, and the impact of, the proposed reforms.
How to find the 2023 Australian Vape Ban Consultation
The Consultation paper is located in an incredibly difficult to find webpage here --> https://consultations.tga.gov.au/medicines-regulation-division/df36e4a0/ .
What are the key changes?
Last consultation (Dec 2022 - Jan 2023)
Following the last consultation, after disregarding the majority of submissions that he didnt agree with, Minister for Health and Aged Care Mark Butler announced an intent to implement the following measures coined as "Vaping Reforms";
- Ban on the personal importation scheme for nicotine vaping products; meaning adult vapers would no longer be able to purchase nicotine from overseas (with or without a prescription).
- Ban on flavours - pharmaceutical vapes would be limited to Mint and Tobacco only.
- Pharmaceutical Packaging - another term for Plain Packaging
- Reduction of maximum nicotine concentration to 20mg/mL; Meaning typical vapes will deliver less than half of the nicotine in a typical cigarette, while also prohibiting nicotine concentrates used to mix with zero nicotine eliquids legally sold in Australian vape stores.
- Ban on disposable, single use vaping products; currently 99% of the blackmarket.
- Ban on sale of vaping related products in convenience stores and specialist vape retailers.
Current consultation (Sept 7th - Sept 21st 2023)
The current consultation covers 4 extended areas of the above vaping reforms including.
Proposal 1: Ban on importation, manufacture and supply of all vaping products in Australia outside of pharmacy.
This means.
- Ban on all disposable single use (closed system) vapes, irrespective of nicotine content or therapeutic claims, with minor exceptions, for example for clinical trials and scientific research.
- Ban on importation of all vapes (including both e-liquid and device components) unless a the importer is a pharmaceutical company importing products the TGA has pre-approved for sale in pharmacy settings.
- Ban on the domestic manufacture and supply of vapes (including non nicotine) even for export.
- Ban on importation through the personal importation scheme, based on a strange assumption that the 12m black market vapes per month arriving in shipping containers are somehow clearing customs because the importer holds a vape prescription.
- Ban on all advertising related to vaping products. This likely relates to limiting awareness & promotion of vaping products with prescribers and pharmacy given the ban on domestic supply and importation of vaping products.
- Travelers Exemption (e.g. New Zealanders visiting Australia) would be permitted to bring vaping products in "appropriate limits" based on the amount of time they spend in Australia provided they have a letter from a GP in their home country.
The consultation paper does acknowledge this will disproportionally impact the few stakeholders who do follow the law, but deems an out-right ban on vaping (including non-nicotine) necessary to address the black-market.
"This will have a significant impact on businesses currently lawfully importing, manufacturing or supplying zero nicotine vapes (particularly e-liquids). However, stricter controls are considered necessary to address the serious public health risks posed by vaping."
Questions included in the consultation:
1. Do you support the proposed approach to ban disposable single use vapes absolutely and all other vapes not approved for sale in pharmacy by the TGA?
2. How would you anticipate industry and consumers to respond to a ban on the importation, manufacture and supply of non-therapeutic vapes?
3. Do you support the proposal to remove the personal importation scheme exception for vapes? If not, what would be the impact on you?
4. Do you agree with the proposal to retain a traveller’s exemption, including the proposed limits?
5. Do you support the proposed approach to prohibiting the advertisement of all vapes (subject to limited exceptions)?
Questions included in the consultation aimed at the Australian Vape industry:
6. What part of the supply chain do you occupy? For example, are you an importer, manufacturer, warehouser, wholesaler, retailer or a combination of these (please specify)?
a. What proportion of your sales volumes is attributable to vape sales [i.e. quantity of vapes sold]?
b. What proportion of your sales revenue is attributable to vape sales [i.e. revenue earned from sales]?
c. What impact would the proposed measures have on your sales volumes?
d. What impact would the proposed measures have on your sales revenues?
e. What proportion of your vapes sales is attributable to disposable single use vapes versus refillable products?
f. How would restricting the importation, manufacture and supply of disposable single use, and non-therapeutic, vapes in Australia impact you?
g. How much stock do you have in Australia currently and how long would it take to sell that stock?
h. What would be the cost to you if you were required to dispose or otherwise move on existing stock?
Proposal 2: Changes to market accessibility requirements.
Pre-Market Notification
The consultation document notes that presently, there is no vape registered on the ARTG and any requirement for therapeutic vapes to be TGA-registered will likely result in no therapeutic vapes being available in Australia for many years.
The consultation document proposes to create a "Unapproved" pre notification register that requires pharmaceutical companies to provide supporting documentation to the TGA who will "approve the sale of an unapproved vaping product" provided it meets the criterias of TGA110 (the TGAs minimum vaping product standards).
Streamlined access under SAS and AP schemes
Proposed amendments to the Special Access Scheme and Authorised Prescriber scheme "reduce the administrative burden" for prescribers to be able to lawfully prescribe "unapproved vaping products that the TGA have approved for sale in pharmacy".
Inclusion of vaping device componants into product standards
Currently vaping device componants (batteries, coils, pod cartridges etc) are not directly covered by the TGA, the consultation document proposes to bring them under control of the TGAs reach and dictate a minimum level of product safety, quality and performance requirements.
Proposal 3: Changes to vaping product standards.
Packaging and labelling changes
- Devices Colours limited to Black, White or Grey.
- Packaging: White background with Black or Grey lettering
- Required Health Warnings:
- "THIS PRODUCT CONTAINS NICOTINE, WHICH IS A HIGHLY ADDICTIVE SUBSTANCE”
- “KEEP OUT OF REACH OF CHILDREN”
- “Avoid contact with eyes”
- “Avoid contact with skin”
- Standard for labels of prescription and related medicines (including batch numbers, importer details, ingredients and expiry dates)
Flavours & Ingredients
The document specifies Mint and Tobacco with a standardized flavour description for each.
"Mint flavour: the taste and aroma commonly associated with herbaceous plants in the Mentha genus of the family Lamiaceae, including for example peppermint, spearmint, horsemint and corn mint."
"Tobacco flavour: the taste and aroma derived from a combination of substances commonly associated with herbaceous plants in the Nicotiana genus of the family Solanaceae."
Ingredients of eliquids will be limited to nicotine, propylene glycol, glycerine, tobacco flavour, mint flavour and water; with a maximum concentration of 20mg/mL nicotine and mint / menthol flavorings limited to levels significantly below what current brands contain.
Container Capacities
Container capacities are proposed to be limited to 120ml for bottles, and 2ml for pod cartridges.
Proposal 4: Increased Enforcement.
Creation of new criminal offence and civil penalties for the commercial possession, manufacture and supply of vapes to consumers outside of a pharmacy
The proposal notes penalties will not apply to personal possession, i.e. consumers will not be risking fines or criminal charges for possessing vaping products not purchased from a pharmacy.
Increased power to enforcement officers at a state level.
Increased oversight with lab testing of "unapproved vaping products approved by the TGA for sale in pharmacy"