Influencer marketing is growing as a popular medium for marketing goods. However, in the case of therapeutic goods, influencer marketing is now strictly regulated. As a business owner or employee, it is important to know what regulations apply to you so you can design your marketing campaigns accordingly.
If you are in the therapeutic goods industry, here are the updated rules that apply to your marketing and communication efforts.
What are Therapeutic Goods?
Therapeutic goods refer to goods that have a health effect on the human body. The definition is very broad and includes medicines, medical devices, certain foods and cosmetic products as well.
Additionally, any products that claim to have an impact on the body fall under the definition of therapeutic goods and the regulations of the TGA. These claims can be ‘removes toxins’, ‘anti-virus’, ‘pain-relieving’, ‘reduces inflammation’, etc.
Regulations of Therapeutic Goods Advertisements
Therapeutic Goods Administration (TGA) regulates all therapeutic goods including medicinal drugs and devices. It ensures the safety of use, efficacy and availability of therapeutic goods. Under TGA laws, the advertisement of these goods can be a statement or pictorial representation that intends on promoting the safe use or supply of goods. The statement can be presented on
- The label of the products
- The packaging of the products
- Any material included with the packaging.
The definition of advertisement for therapeutic goods is broader than for other goods. The Therapeutic Goods Advertising Code offers guidelines for what is considered an advertisement.
All promotional material is considered to be advertising even if it promotes the use or supply of the goods in an indirect way. On the other hand, all factual information that is disseminated solely for educational purposes does not come under the umbrella of advertisements.
Characteristics Of Promotional Material And Advertisements
The information which is likely to be considered promotional has the following characteristics. It comprises unsolicited information and unbalanced information emphasising the positive qualities of the product while downplaying and ignoring the possible side effects. Use of superlatives, such as ‘the best in the market’ or ‘works fastest’ or emotive descriptions, such as ‘absolutely brilliant’ or ‘life-changing’ also fall under promotional material.
Additionally, any information that is conveyed regularly such as multiple social media posts or content repeated during the news can be considered as an advertisement effort. Information spread by individuals, companies or any entities that have a financial interest in the sale of the product is also considered to be promotional material.
Social Media Advertisement
Similar to conventional media advertisements, social media posts that directly or indirectly promote the use of therapeutic goods are considered to be advertisements. Repeated dissemination of information by the company, influencers or any other entities that seek to gain financially from the sale of the goods fall into the category of promotions.
Changes in the Code
The Therapeutic Goods Advertising Code 2021 came into effect in January 2022 and advertisers have until June 2022 to complete the transition to the new code. There have been a few changes in the new code; the major changes are as follows:
1. Rules Regarding Testimonials And Endorsements In Advertisements
Continuing with the 2018 Code, the 2021 Code also allows genuine unpaid testimonials in advertisements. However, paid or incentivised testimonials cannot be included. This includes individuals engaged in the production, marketing, sale and distribution of the goods as well as influencers. Prohibitions on endorsements by health professionals have been extended to former health professionals as well.
2. Simplification Of Mandatory Statement Requirements
The new code simplifies the mandatory statements that must be included in advertisements about therapeutic goods , as well as a reduction in the number of these statements. This change will be complemented with a consumer education program in 2022.
The Code has also introduced a new mandatory statement for products that cannot be bought by the consumers; “This product is not available for purchase by the general public.” All such products are only supplied through health professionals.
Additionally, the new code also offers a distinction between products that consumers can physically see before purchase and those which they cannot see. Consumer health warnings should be present on the labelling and packaging for purchases made in person. For online purchases, the relevant warnings should be displayed in the advertisement at the point of purchase. Hence, the consumer should be aware of all warnings, both online and in person.
3. Expansion Of Permitted Product Samples
The 2021 code has included additional samples of goods such as sanitisers, masks, face masks and gloves, nicotine replacement therapies, etc, that can be offered as therapeutic goods. It also clarified that these should be included in the Australian Register of Therapeutic Goods. The TGA will also offer guidelines on how requests for product addition will be assessed.
4. Prohibited Representation Rules and Regulations
The Code no longer contains references to prohibited representations. They have been removed from the Code and have been consolidated in the Therapeutic Goods Regulation 1990.
5. Rules Regarding Safe And Proper Use
Rules regarding Safe and Proper Use have been expanded as well. They now prohibit the use of advertisements that cause undue fear, alarm or distress for the viewers.
Key Takeaways
- The use of paid endorsements and testimonials are prohibited under the new Therapeutic Goods Advertising Code 2021. The code came into effect in January 2022 and advertisers have until June 2022 to complete the transition to the new code.
- Therapeutic goods are goods that are intended to have a health effect on the body. These can be medicinal drugs, devices, cosmetic or food products.
- The sale and marketing communications of therapeutic goods is regulated by the Therapeutic Goods Administration through legislation and the advertising code.
- Any posts, media that directly or indirectly encourage the sale or use of therapeutic goods are considered as promotional materials.
- The 2021 Code features updated definitions of terms used in the Code, additions in the list of therapeutic goods as well as guidelines for advertisements.
Seeking Legal Counsel?
The amendments and additions in the Therapeutic Goods Advertising Code 2021 can be tricky to understand and implement. As a business, you will have to re-evaluate your current campaigns and redesign future campaigns accordingly. The revisions have implications not only for manufacturers but also those engaged in the advertising, marketing and sale of these products.
If you’re in the industry, we strongly urge you to reach out to a business lawyer to fully understand the revisions as well as the implications on your business. Moving forward, these will be the foundation of your marketing campaigns in the near future. If you are looking for an expert lawyer, connect with our business lawyers at Lazarus Legal for any concerns you may have.
You may also like
Mark Lazarus
Mark Lazarus, the visionary behind the business and the fresh blood of the Lazarus Legal team, Mark (or Laz as he is often known) owes much of his success to his past experiences. And he’s made it his personal goal to bring that wisdom and formula to the firm.
