Two nurses fined for allegedly importing unapproved cosmetic injectables

The Therapeutic Goods Administration (TGA) has issued 4 infringement notices totalling $13,656 to 2 registered nurses for allegedly importing unapproved prescription-only medicines, medical devices containing prescription-only medicines, and advertising prescription-only medicines.

• A Victorian-based registered nurse has been issued with 2 infringement notices totalling $6,600 for allegedly importing vials of unapproved botulinum toxin type A, which is a cosmetic injectable product often used as a wrinkle relaxer, and pre-filled syringes containing hyaluronic acid and lidocaine.
• A Queensland-based registered nurse has also been issued 2 infringement notices totalling $7,056 for allegedly importing vials of unapproved botulinum toxin type A, and advertising prescription-only medicines on social media websites.

The individuals did not have approval or authority to import these products, and these products are not on the Australian Register of Therapeutic Goods (ARTG). This means that they are not approved for supply in Australia (which includes patient use), have not been reviewed for safety or quality, and pose an unacceptable risk to consumer health. Any unapproved cosmetic injectable product comes with an increased risk of side effects.

All prescription-only products on the ARTG have been assessed by the TGA to ensure they meet quality standards, including that they are sterile, contain only the labelled ingredients, and were manufactured in a suitable facility. Unregistered products do not come with these assurances.

Advertising prescription-only medicines, directly to consumers is prohibited under the Therapeutic Goods Act 1989. This includes cosmetic injectables. Any references to prescription-only medicines such as cosmetic injectables, either overt or by implication, through abbreviations or the use of colloquialisms are unlawful.

Businesses must understand their legal obligations prior to importing, advertising, or supplying therapeutic goods. Consequences for non-compliance with relevant laws may include not only financial penalties, but also civil or criminal proceedings.

Consumers and patients can read our information on cosmetic injections and use our cosmetic injections checklist before engaging with a business. They should ensure the business they engage with:

• has appropriate credentials to provide the service
• only supplies prescription products after a consultation with a suitably qualified health practitioner who has assessed whether the products are right for each patient, and
• only supplies products that are approved for supply and use in Australia (are on the ARTG).

If you suspect non-compliance in relation to therapeutic goods, you can report illegal or questionable practices online to the TGA.

Contact for members of the media:

• Email: news@health.gov.au  
• Phone: 02 6289 7400