Regulation Impact Statement – Department of Health
On 21 December 2020, the Therapeutic Goods Administration (TGA) within the Department of Health announced that nicotine would be rescheduled within the Standard for the Uniform Scheduling of Medicines and Poisons (the Poisons Standard), in accordance with section 52D(2) of the Therapeutic Goods Act 1989.
The rescheduling will, from 1 October 2021, make nicotine for all human use (other than when included in certain nicotine replacement therapies and when in tobacco prepared and packed for smoking) a prescription only medicine, available exclusively on prescription by a medical practitioner. This is intended to mitigate the uptake of nicotine containing e-cigarettes by adolescents and young adults, and facilitate simple and legal access to nicotine containing e-cigarettes for smoking cessation. The rescheduling also includes a requirement for nicotine refills for e‑cigarettes to include a child-resistant closure to reduce poisonings of young children.
The TGA prepared and certified a Regulation Impact Statement (RIS), which the Office of Best Practice Regulation (OBPR) assessed as good practice.
The RIS estimates the average annual regulatory cost to be $4.98 million.