Advertising cosmetic services that include schedule 4 substances

Posted 15 May 2017

A media release from the Australian TGA:

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 $10,800 for an individual and $54,000 for a body corporate[1].

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:

  • Restylane, Perlane, Dermalive, Juvéderm (hyaluronic acid)
  • Hylaform (hyaluronan, sodium hyaluronate)
  • Collagen, Zyderm, Zyplast, Cosmoplast, Cosmoderm (collagen)
  • Botox, Dysport (botulinum toxin)
  • Newfill, Nufill, Sculptra (polylactic acid)
  • Aquamid (polyacrylamide)
  • Radiesse (calcium hydroxyapatite)
  • Ellansé (polycaprolactone)
  • 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, lips and neck, or for improving the appearance of submental fat.

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:

  • cosmetic injections
  • anti-wrinkle injections/treatments
  • wrinkle injections/treatments
  • injections/treatments for lips
  • injections/treatments for fine lines/folds/age lines .wrinkle and lip enhancement/fulfillment/augmentation
  • injections to enhance pouting of the lips .injections which reduce the depth of fine lines/wrinkles around the face/lips .injections to improve the appearance of chin/neck/jaw line

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 or abbreviations of the medicine’s name, 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 PO Box 100, WODEN ACT 2606 Email [email protected] Phone +61 2 6232 8757 Fax +61 2 6232 8659


1.These will increase on 1 July 2017 to $13,200 for individuals and $63,000 for body corporates.

Tags: medical devices, medicines scheduling


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