Advertising cosmetic services that include schedule 4 substances

16 August 2017

The following advice is for health professionals and cosmetic/beauty clinics who advertise cosmetic services that involve therapeutic goods containing Schedule 4 (prescription-only) substances.

These groups are reminded that advertising of prescription-only products to consumers is illegal. Generally, it is an offence under section 42DL(1)(f) of the Therapeutic Goods Act 1989 (the Act) for a person to publish or broadcast an advertisement about therapeutic goods that contains a statement referring to goods, or substances or preparations containing goods, included in Schedules 3, 4 or 8 of the Standard for the Uniform Scheduling of Medicines and Poisons (SUSMP) (the Poisons Standard). This offence attracts a maximum penalty of $12,600 for an individual and $63,000 for a body corporate.

The Act broadly defines an advertisement in relation to therapeutic goods as including any statement, pictorial representation or design, however made, that is intended, whether directly or indirectly, to promote the use or supply of the goods.

The issue

Some health professionals and cosmetic/beauty clinics are advertising, to the general public, therapeutic goods or substances that are designated 'prescription-only' items. These products include cosmetic injections such as:

Anti-wrinkle injections

  • Botox, Dysport (botulinum toxin)

Dermal Fillers

  • Restylane, Perlane, Dermalive, Juvéderm, Emervel, Sub Q, Esthelis, Belotero (hyaluronic acid)
  • Hylaform (hyaluronan, sodium hyaluronate)
  • Collagen, Zyderm, Zyplast, Cosmoplast, Cosmoderm (collagen)
  • Newfill, Nufill, Sculptra (polylactic acid)
  • Aquamid (polyacrylamide)
  • Radiesse (calcium hydroxyapatite)
  • Ellansé (polycaprolactone)

Improvement of the appearance of submental fat

  • Belkyra, Kybella, ATX-101, Lipodissolve (deoxycholic acid)

These products are generally administered for the purpose of temporarily removing/reducing wrinkles and lines on the face, around the eyes, forehead (anti-wrinkle injections and dermal fillers), lips and neck (dermal fillers only) or for improving the appearance of submental fat (deoxycholic acid).

The products listed above contain substances that are in Schedule 4 of the current Poisons Standard and the products are therefore regulated as:

Prescription Only substances - includes substances, the use or supply of which should be by, or on the order of medical practitioners and should be available from a pharmacist on prescription.

Some of the cosmetic injections listed above may be compounded by a pharmacy for an individual patient rather than supplied by a manufacturer as a finished product. The advertising of compounded cosmetic injections that contain prescription-only substances to the public is also prohibited. See Advertising: extemporaneously compounded medicines for more information.

Acceptable general terms

To enable health professionals and cosmetic/beauty clinics to continue promoting their businesses and services to consumers, while also complying with the regulatory advertising requirements for therapeutic goods, the Therapeutic Goods Administration (TGA) advises that there should be no reference in advertisements to individual Schedule 4 items. However, the following acceptable general terms and phrases may be used in advertising (noting a therapeutic good must not be advertised for an indication or intended purpose that is not accepted in relation to the inclusion of the good on the ARTG):

  • cosmetic injections (anti-wrinkle injections, dermal fillers and submental fat)
  • anti-wrinkle injections/treatments (anti-wrinkle injections and dermal fillers)
  • wrinkle injections/treatments (anti-wrinkle injections and dermal fillers)
  • injections/treatments for lips (dermal fillers)
  • injections/treatments for fine lines/folds/age lines (anti-wrinkle injections and dermal fillers)
  • wrinkle and lip enhancement/fulfilment/augmentation (dermal fillers)
  • injections to enhance pouting of the lips (dermal fillers)
  • injections which reduce the depth of fine lines/wrinkles around the face/lips (dermal fillers)
  • injections to improve the appearance of chin/neck/jaw line (dermal fillers)
  • injections for improving the appearance of submental fat/fullness under the chin. (submental fat)

Other words and phrases with similar meaning may also be used, provided that they do not refer to specific products or ingredient names. It is not acceptable to use acronyms, nicknames, abbreviations or hashtags of the medicine's name (or some part thereof), which may be taken by a consumer to be a "reference" to a specific medicine or substance.

Advertisers, businesses and service providers are also reminded of their obligations under the Competition and Consumer Act 2010 and state and territory fair trading/consumer affairs legislation.

More information

Further enquiries may be addressed to:

The Director
Advertising Compliance Unit
Regulatory, Practice, Education and Compliance Branch
Therapeutic Goods Administration

Post PO Box 100, WODEN ACT 2606
Phone +61 2 6232 8757
Fax +61 2 6232 8659