Advertising of complementary medicines
ARGCM Part A: General guidance on complementary medicine regulation in Australia
The objective of the regulation of therapeutic goods advertising in Australia is to ensure that the marketing and advertising of therapeutic goods, including complementary medicines, is conducted in a manner that promotes the quality and safe use of the product, is socially responsible and does not mislead or deceive the consumer.
Advertisements for complementary medicines are regulated by both co-regulatory and self-regulatory arrangements under the Act and Regulations, and involve the TGA, the Therapeutic Goods Advertising Code Council (TGACC), the Australian Self-Medication Industry (ASMI) and the Complementary Medicines Australia (CMA).
To ensure that the standards developed for the public benefit are met, advertisements for complementary medicines directed at consumers on specified media require prior approval by a Delegate of the Secretary of the Department of Health.
Australian based websites promoting use or supply of therapeutic products are considered advertising and must comply with all aspects of the Therapeutic Goods Advertising Code.
Refer to the TGACC website for further information on advertising for therapeutic goods, including details of the approval process for advertisements, the Complaints Resolution Panel and the Complaints Register.
Prohibited and restricted representations in advertising for complementary medicines
An advertisement for a complementary medicine (including information on the label and in the package of the medicine) must not contain, expressly or by implication, a prohibited representation specified in Part 1 of Appendix 6 of the Therapeutic Goods Advertising Code.
In addition, an advertisement for a complementary medicine must not refer, expressly or by implication, to a restricted representation specified in Part 2 of Appendix 6 of the Therapeutic Goods Advertising Code, unless prior approval is given under the Act. A restricted representation is any reference expressly or by implication, to a serious disease, condition, ailment or defect which is generally accepted to be:
- not appropriate to be diagnosed and/or treated without consulting a suitably qualified health professional and/or
- beyond the ability of the average consumer to evaluate accurately and to treat safely without regular supervision by a qualified health professional.
If you, as the sponsor of a complementary medicine, wish to advertise a restricted representation, including on the label of your medicine, you must obtain prior approval from the Secretary under Section 42DE of the Act. The application must be in writing and you must provide justification why the representation is necessary for the appropriate use of your medicine. In making a decision on your application, the Delegate for the Secretary will take into consideration matters specified under Section 42DF of the Act, including any recommendations from the TGACC and any advice from TGA advisory committees.
Notices of approved and permitted restricted representations are published on the TGA website.