THE DEPARTMENT OF HEALTH has asked the medicines regulator (the Therapeutic Goods Administration) to amend the guidelines for nicotine in the Poisons Standard. However, the proposed changes miss the opportunity to correct a glaring inconsistency in nicotine regulation.

Nicotine in its most lethal form (tobacco prepared and packed for smoking) is specifically exempt from the Poisons Standard and is freely available, while the far safer substitute (liquid nicotine for vaping) is restricted to prescription-only access.

This amounts to a de facto ban. Most doctors are unwilling to provide prescriptions as vaping is discouraged by health authorities.

This inconsistency is unscientific and unethical

ATHRA's full submission is available here. ATHRA supports the availability of nicotine liquid as a consumer product as a substitute for smoking, under the following conditions:

1. for use in an electronic vaporiser (e-cigarette)
2. nicotine concentration up to 6%
3. maximum nicotine per container: 180mg (30ml of 6% nicotine)
4. in a child resistant container
5. labelled with the concentration of nicotine and other ingredients
6. labelled with the statement ‘Keep out of reach of children’
7. labelled with the statement ‘Not to be sold to a person under the age of 18 years’

ATHRA's submission to the TGA

ATHRA's full submission is available here. Below are the key points of the submission

• We recommend that low concentrations of nicotine liquid for vaping be exempt from the Poisons Standard, regulated proportionately to risk and available as a consumer product to assist in smoking cessation
• The exemption of nicotine liquid would allow it to be regulated to improve product quality and safety and provide a range of consumer protections
• Nicotine in the low doses used for vaping is low risk and is substantially less harmful than smoking tobacco
• Nicotine vaping is an effective quitting aid for smokers who are otherwise unable or unwilling to quit and is more effective than nicotine replacement therapy
• The restriction of access to nicotine liquid is inconsistent with the growing evidence for nicotine vaping and the support of the Royal Australasian College of Physicians, the Royal Australian and New Zealand College of Psychiatrists and the Royal Australian College of General Practitioners
• Nicotine vaping has been associated with higher quit rates and falling population smoking rates in other countries. It is likely to help reduce Australia’s stagnant smoking rate and avert the premature deaths of hundreds of thousands of Australian smokers
• Exempting nicotine from the Poisons Standard will decriminalise vapers, eliminate the black market and allow regulation of safety and quality standards for nicotine liquids
• The evidence so far does not support concerns about the use of nicotine liquid - youth uptake, renormalising smoking, uptake by non-smokers and significant harms from vaping

Download submission

ATHRA's submission to the TGA on the proposed amendment for scheduling nicotine. 15 May 2020

Posted by Colin Mendelsohn, colin@athra.org.au

---