An update on the new vaping regulations
Posted on October 9, 2020
THE THERAPEUTIC GOODS ADMINISTRATION held some webinars this week to update stakeholders on the new regulations on vaping and nicotine. The news from Professor Skerritt (pictured) was mixed.
The proposed regulations are based on the changes to nicotine in the Poisons Standard announced in the interim decision on 23 September 2020. Submissions are now open for further comments on this decision until 6 November. A final decision from the TGA is due in mid-December. The changes are then expected to be introduced on 1 April or 1 June 2021.
The good news
- It will be easier for doctors to prescribe nicotine than originally proposed. Doctors can apply once for an authority to write prescriptions for nicotine, which will be valid for 5 years under the Authorised Prescriber scheme. Approval for each individual patient will no longer be needed. The prescription will be valid for 12 months.
- There are no limits on the nicotine strength, flavours and format of e-liquids imported eg pods or bottles. However, this could change and further restrictions may be included in the final decision in mid-December.
- The TGA is planning to have training for interested doctors and pharmacists
- If your local pharmacy does not stock nicotine liquid, you may be able to purchase it from an online pharmacies.
The bad news
- The TGA is committed to a prescription model because of safety issues from vaping and nicotine, the teen vaping ‘epidemic’ and because visiting a GP could also provide extra support and advice to aid the quitting attempt.
- The TGA remains concerned about the ‘great dangers’ of nicotine and vaping. Professor Skerritt raised concerns about child poisoning and claimed that ‘Nicotine is not great stuff’ and ‘is quit a harmful substance’. Most vapers would disagree. In the doses used for vaping, nicotine is relatively benign and child poisoning is extremely rare.
He is convinced that vaping is a gateway for youth and believes the rate of youth uptake is ‘frightening’. Professor Skerritt also said nicotine is harmful to adolescents, although there is no evidence of this in humans (only animals).
- There will be no regulation of vaping product safety or quality as is required in the UK, US and soon to start in New Zealand. This is surprising as Greg Hunt said that child poisoning is ‘primarily caused by imported products of dubious safety and quality’. However, there appears to be no plan to change this.
- The cost of vaping will increase. There will be no international courier costs but there will be added costs from the importer, medical visits and pharmacy markup.
- It is likely that there will be a substantial reduction in the variety of products available. E-liquids will be imported by pharmacy wholesalers or importing companies. You may not be able to get your preferred flavours or prefilled pods.
- Professor Skerritt said that vape shops will still be able to sell hardware and nicotine-free liquids, so business will not be affected. This seems very unlikely.
Currently many vapers purchase flavoured liquids from the vape shop and add their own 100mg/ml nicotine to it. If vapers purchase premixed nicotine liquid from the pharmacy, there will be no need to purchase local juices which vape shops rely on for profitability. It is unclear if 100mg/ml nicotine will be available for importation for DIY mixing.
Make a submission
You can have your say on the interim decision which is available here.
Submissions can be made here. The closing date for submissions is 6 November 2020.
Posted by Colin Mendelsohn, email@example.com