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Nicotine vaping products: Compliance and enforcement

21 September 2021

Introduction

Effective from 1 October 2021, all nicotine vaping products will be regulated under the Therapeutic Goods Act 1989 (the Act) as Schedule 4 (prescription only) medicines in the Poisons Standard[1].

Both personal importation and domestic purchases require a prescription. A community pharmacy in Australia is required by law to dispense in accordance with that prescription. Commercial importation and all subsequent supply must be carried out in accordance with the requirements of the Act. This included, broadly, that there is a reasonable belief that the ultimate supply will be in accordance with an Authorised Prescriber or Special Access Scheme B approval from the TGA.

Domestic supply also requires relevant state and territory therapeutic good licences. For example, in NSW a business importing nicotine vaping products for domestic supply must have a 'licence to supply by wholesale poisons and/or restricted substances for therapeutic use'. For more information, see NSW Health application for a licence to supply[2].

The supply to individuals must be in accordance with both a prescription and an Authorised Prescriber or Special Access Scheme B approval from the TGA (as well as state and territory law).

This plan sets out the education and compliance activities that will be undertaken to support the regulatory requirements for importation and supply of nicotine vaping products after
1 October 2021. The activities reflect an intelligence-informed, risk-based approach to compliance and enforcement activity.

Our partnerships with external agencies, such as Australian Border Force and state and territory health departments, are an important part of the successful delivery of this compliance and enforcement plan. These partnerships will be supported by guidance material, including that published on the TGA website, and distributed to stakeholders including the members of the Therapeutic Goods Advertising Consultative Committee[3] as appropriate.

The desired outcome from the activities in this plan is a reduction in inadvertent or deliberate non-compliance with the legislation. This will support the purpose of the scheduling changes—that adolescents and young adults do not take up the use of nicotine vaping products and existing users or smokers only do so under the guidance of a doctor and with a prescription, if the doctor and patient believe that nicotine vaping products are appropriate for smoking cessation. Through education measures the burden on stakeholders should be reduced as supply of all nicotine vaping products moves into the therapeutic goods regulatory environment.

Other information on access to nicotine vaping products is available on the Nicotine vaping products hub[4].

Changes to TGA’s regulation of nicotine vaping products, effective 1 October 2021, mean that, for the first time, a Commonwealth legislative instrument prohibits their import without a valid prescription (for individual patients) or a state/territory pharmaceutical wholesale licence (for commercial imports for subsequent supply).

Although the sale of nicotine vaping products is illegal in every Australian state and territory, until that date, there have been no powers to prevent the entry into Australia of these products.

On and after 1 October 2021, products without a valid prescription or licence can be intercepted at the border. These products will be referred to the TGA, and if evidence of the relevant prescription or licence is not available, the nicotine vaping products will be destroyed. Depending on the nature of the case, education or enforcement actions will be undertaken. Enforcement options include infringement notices, enforceable undertakings, and court action.

Some products imported or supplied, even with a licence or prescription, may not be labelled as containing nicotine. Where there are reasonable grounds to suspect they contain nicotine, these can be intercepted and tested for nicotine by the TGA’s laboratories. Enforcement actions can also be undertaken in these cases.

Planned Activities

The activities below are categorised (see hyperlinks below):

Policy

Activity Outcome/Key messaging

Pharmacies and pharmacy marketing groups, able to inform the public that they stock nicotine vaping products

Advertising permission issued under the Therapeutic Goods Act 1989, s42DK, and associated guidance published

  • To make consumers aware of where they can lawfully purchase nicotine vaping products with a prescription
  • Businesses know how to comply with the nicotine advertising permission and the limitations on advertising to consumers (e.g. specific products cannot be mentioned)

Quality, safety and labelling standard for nicotine vaping products

Therapeutic Goods (Standard for Nicotine Vaping Products) (TGO 110) Order 2021 issued, and associated guidance published
  • TGO 110 covers labelling, packaging and ingredients, including nicotine concentration for unapproved nicotine vaping products
  • Australian sponsors need to maintain records demonstrating conformance with TGO 110
  • To make consumers and prescribers aware that while the ingredient and nicotine composition standard applies, labelling and packaging requirements do not apply to products imported via the Personal Importation Scheme and how they can check that those products still have appropriate labelling/packaging

Intelligence

Topic Activity Outcome / Key messaging

Data collection and analysis

TGA collects and analyses data from collaborating agencies, reports of non-compliance from the public, and conducts “web-scraping” to identify sites allegedly selling nicotine vaping products illegally

Improved data holdings regarding nicotine vaping products to inform intelligence assessments on:

  • Import
  • Supply
  • Advertising
  • Movement
  • Volume
  • Type
  • Entities

Extraction of information for educational and operational activities

Assessment

Intelligence reporting on: To inform:

Imports

  • Personal use
  • Commercial supply
  • Consignment profiling
  • Education and engagement activities
  • Counter-detection methodologies
  • Intervention strategies in countries of origin

Advertising targeted at Australian consumers

  • Education and engagement activities
  • Intervention strategies
  • Investigations into high risk Australian-based advertisers
  • Compliance and enforcement action

High-risk entities

  • Investigations into high risk importers and suppliers
  • Company structures and responsibilities
  • Links to offshore entities
  • Counter-detection methodologies
  • Compliance and enforcement action

Education and communications

Audience Activity Outcome / Key messaging

Individual importers

Personal Importation Scheme – small quantities

Targeted education and guidance products

  • Fact sheet mailed to known importers
  • Website communications

  • Quickly educate importers about legislative changes and personal and/or corporate obligations when importing nicotine products
  • Deter and reduce unlawful conduct
  • Lessen burden on border control

Suppliers

Overseas companies – direct supply to Australian consumers

Australian companies – import and supply

Targeted education and guidance products

  • Fact sheet sent to known retailers exporting to Australia
  • Fact sheet sent to Australian-based retailers
  • Website communications
  • Educate suppliers about the regulatory changes and requirements for import, supply and advertising
  • Deter sales of nicotine vaping products which are not supported by a prescription
  • Deter illegal supply onshore
  • Deter illegal advertising of nicotine vaping products
  • Deter supply to minors
  • Reduce unlawful imports
  • Lessen burden on border control and TGA import assessments of unapproved therapeutic goods

Shipping agents

Targeted education and guidance products

  • Fact sheet sent to shipping agents which can be shared with their clients
  • Educate shipping agents about legislative changes
  • Develop collaborative partnerships
  • Ensure their clients/importers have correctly declared goods and have compliant documentation
  • Reduce unlawful imports
  • Lessen burden on border control and TGA import assessments of unapproved therapeutic goods

Community / Consumers

Publish educational resources and guidance on the TGA website and communicate through social media and mass media (including paid communication)

Work directly with consumer groups targeting culturally and linguistically diverse groups, Aboriginal and Torres Strait Islanders, disabled and carers groups

Consumers:

  • Know how to legally access nicotine vaping products
  • Understand their obligations when importing products
  • Understand how and when to report suspected non-compliance
  • Understand the regulatory changes

Health care professionals

Publish educational resources and guidance on the TGA website and communicate to doctor and pharmacy groups through media and through educational sessions

Health care professionals and consumers:

  • Know how to legally access nicotine vaping products
  • Understand their obligations when importing products
  • Understand how and when to report suspected non-compliance
  • Understand the regulatory changes

Compliance and enforcement outcomes

Information about compliance and enforcement activities published on the TGA website, posted on social media channels, and communicated through mass media

  • Educate non-compliant entities about regulatory obligations
  • Deterrence
  • Successful regulation

Engagement and collaboration

Stakeholder Activity Outcome / Key messaging

Australian Border Force (ABF)

Collaboration to:

  • Implement the regulatory changes at the border (including interception of shipments and of products accompanying incoming travellers)
  • Manage detection and referral of illegal imports
  • Information sharing
  • Collaborative partnership to manage border response
  • Efficient detection and assessment of imports
  • Known compliant importers require lower intervention and assessment

Shipping agents

Meetings to:

  • Raise awareness of the regulatory changes for offshore suppliers
  • Respond to queries about the border assessment process and state, territory, and commonwealth therapeutic goods regulations.
  • Work undertaken by shipping agents to ensure importers are complying with Australian (Commonwealth and state and territory) laws
  • Lessen burden on border control and TGA import assessments of unapproved therapeutic goods

International mail centres

TGA officers deployed on rotations to mail centres for specified time periods to assist with:

  • Detection and assessment of packages containing nicotine vaping products, or products suspected of containing nicotine
  • Collaboration and training with border force officers
  • Improved detection of nicotine vaping products at the border
  • Reduction in illegal imports
  • Greater awareness of goods that need to be assessed
  • Lessen burden on border control and TGA import assessments of unapproved therapeutic goods

State and Territory Health agencies

 Collaboration to facilitate:

  • Information sharing
  • Compliance monitoring and inspections
  • Information about non-compliance within states and territories is shared
  • Non-compliant supply in states and territories is addressed under the appropriate legislation
  • Resources are appropriately allocated based on risk of non-compliance

Offshore suppliers

Meetings with retailers

  • Supply to Australian customers is compliant
  • Products meet an appropriate standard

Operational activities

Activity Outcome / Key messaging

Border intervention

  • Lawful imports are cleared without intervention
  • Detection of non-compliant imports of nicotine vaping products (including products illegally labelled as not containing nicotine)
  • Illegal imports are destroyed
  • Serious non-compliance is investigated
  • Illegal conduct is penalised
  • Reduction in unlawful imports, and reduced access e.g. for children and adolescents to nicotine vaping products

TGA Laboratory testing

  • Products purchased based on intelligence
  • Imported products intercepted
  • Identifies counterfeit or mis-declared nicotine vaping products
  • Assessment of compliance with standard (TGO110)
  • Guides further enforcement actions and destruction of unapproved goods
  • Deterrence of purchasing non-compliant goods

Import and supply investigations

  • Intelligence-informed and risk-based
  • Monitoring and inspection activities (including with state and territory health agencies)
  • Illegal products seized and destroyed
  • Illegal import and supply ceases
  • Enforcement outcomes for serious non-compliance
  • Deterrence to less serious non-compliance

Advertising investigations

  • Intelligence-informed and risk-based
  • Non-compliant advertising is removed
  • Enforcement outcomes for serious non-compliance
  • Deterrence to non-compliance

Assessment and reporting

The regulatory reforms will be reviewed 6, 12 and 24 months after implementation. As part of these reviews, the effectiveness of compliance and enforcement activities will also be determined, particularly the impact on supply of nicotine vaping products directed at children and adolescents.

Activity Outcome / Key messaging

Regular review of import data to establish levels of compliance in goods declarations and supporting documents

  • Assess compliance
  • Determine need for increased import monitoring

Regular review of import data to assess changes in importer behaviour

  • Determine need for increased import monitoring
  • Reallocate resources for border intervention
  • Understand impact of regulatory change on product imports
  • Understand counter-detection methods

Regular review of compliance cases

  • Number of ABF referrals
  • Number of destructions
  • Compliance and enforcement outcomes
  • Determine success of border interventions to reduce illegal imports
  • Determine whether there is a reduction of compliance cases over time
  • Reallocate resources for further intervention as required

Assess success of education campaigns

  • Regulatory education and engagement reduce instances of non-compliance

Assurance reviews of whether entities have come into compliance after receiving compliance engagement

  • Data demonstrates success of regulatory education and engagement to maintain compliance

Assessment process for imported nicotine vaping products

Diagram showing the assessment process for imported nicotine vaping products