Since July 2018, the TGA has been the sole handling body for complaints relating to the advertisement of medicines, medical devices and other therapeutic goods. In October, the TGA released its inaugural report on its complaint handling activity in the 2018-19 financial year. The report reveals that the vast majority of complaints related to alleged advertising of illegal therapeutic goods and in terms of product categories. The most complaints - by a significant margin - were made in relation to cosmetic products. The report appears to reveal a very limited understanding among the industry and consumers regarding the regulatory framework for cosmetic products and services which are therapeutic in nature.
Therapeutic goods are subject to special advertising requirements which are specified in the Therapeutic Goods Act 1989 (Cth) (Act) and the Therapeutic Goods Advertising Code (Code). These requirements go beyond what is required for everyday consumer goods. This is because therapeutic goods, by definition, are intended to have a therapeutic effect on the health and wellbeing of the people that use them. In addition, often people who seek information about therapeutic goods may be in a vulnerable position due to health concerns.
The TGA's Advertising Compliance report for 2018-19 is intended to provide an overview of the TGA's complaint handling activity over the last financial year. In 2018-19, the TGA received 1,468 complaints about alleged non-compliant advertising of therapeutic goods. The report highlights the key compliance concerns arising from those complaints in terms of product category, the types of breaches and actions taken by the TGA.
In summary:
- More complaints were made about therapeutic goods which are not entered in the ARTG than medicines, medical devices, biologicals or other therapeutic goods that are entered in the ARTG;
- The most common contravention of the Act was the advertisement of illegal goods, being goods that should be entered in the ARTG but are not;
- Of the top 10 most common complaint categories overall, schedule 4 cosmetics were the most common by a substantial margin, followed by disease detection and screening then general health and wellbeing.
'Schedule 4 cosmetics' include for prescription medicines which are used for cosmetic procedures (e.g. wrinkle reduction and filling) such as botulinum toxins, hyaluronic acid and polycaprolactone. These products, although approved, may only be administered on the prescription of a health practitioner and may not be advertised to the public at large.
The report suggests that there is widespread misunderstanding among advertisers of cosmetic products and procedures regarding the regulatory framework for such products and advertisements. This is unsurprising given the complex and often tenuous distinction between cosmetic products which fall outside of the therapeutic goods regime and those that must comply with the regulatory framework set down by the TGA. Nonetheless, the consequences of advertising non-compliance under the therapeutic goods regime may be catastrophic for some businesses. In 2018-19, the TGA investigated one company for breaches of the advertising rules for medicines, including the ban on advertising prescription-only medicines to the public and the Federal Court of Australia ordered a $10 million penalty against the company.
What does this mean for cosmetic product and service providers?
All cosmetic product and service providers should seriously consider their current promotional strategies and materials. If you advertise one or more products which are intended to have a therapeutic effect on the body, you must comply with the advertising framework set down by the TGA. This includes all cosmetic injections, cosmetic products which are intended to be taken orally and may include other cosmetic products which are intended to change the appearance of the skin, teeth, hair or other part of the body by physiological means.
If you are unsure how the products or services you offer may be advertised, or would like to know more about the regulation of cosmetic products and services generally, contact one of our experts today.
