New TGA guidance: Cosmetics or therapeutic goods

The TGA has published new guidance that aims to assist sponsors and advertisers in determining if a product is a cosmetic or a therapeutic good, where the product may appear to be categorised by more than one of these definitions, and it is not initially clear whether the cosmetics or therapeutic goods regulatory scheme applies. It notes “An assessment of whether a product is a therapeutic good or a cosmetic needs to be undertaken on a case-by-case basis and, in most cases, can only be determined based on an overall consideration the factors and the characteristics of the product.”  

The guidance also describes regulatory requirements for therapeutic goods in Australia, including relevant advertising rules; examples of therapeutic and cosmetic claims for categories of products; and information about the regulation of cosmetic ingredients and products.  

CMA Advocacy on the cosmetic-therapeutic good interface 

The publication of the guidance follows targeted consultation on the draft guidance on cosmetic interface products via CMA’s involvement on the Therapeutic Goods Advertising Consultative Committee (TGACC) throughout 2023. This draft guidance was also taken to CMA’s regulatory committee for industry feedback. During this targeted consultation, CMA sought and secured a number of improvements to the draft guidance. CMA’s feedback on the second iteration of the draft included that clarification was required around aspects of the definitions of cosmetics and therapeutic goods because physiological effects compatible with the cosmetic definition of changing the body’s odour or appearance, cleansing it, keeping it in good condition or protecting it, are not generally considered therapeutic in nature; AND some claims consistent with the definition of cosmetics are included in the Permissible Indications Determination, for the purposes of providing claims for oral products that make cosmetic claims (which are declared therapeutic goods) OR providing additional claims to products with other, more therapeutic claims. For example, a product intended to relieve red skin rash (therapeutic in nature) is also likely to include ‘soothe skin’  and ‘support skin hydration’ – these permissible indications could be used on a product that is genuinely only a cosmetic and not a therapeutic good. 

Based on CMA feedback the published guidance now avoids claiming a permissible indication makes a product a therapeutic good, and instead better differentiates between the concepts of “changing skin appearance” (cosmetic) and “physiological changes” (therapeutic); and includes an example differentiating between cosmetic and therapeutic claims for moisturising products. This is expected to avoid unnecessary upregulation of cosmetics with claims that are the same or similar to permissible indications but where the product is genuinely only cosmetic in nature. 

CMA also sought clarification on the guidance to enhance stakeholder awareness regarding products taken orally that make cosmetic claims, noting that some products, such as collagen, are currently are sold both as foods and are included on the ARTG. We emphasised the importance of including clear information explaining  the Therapeutic Goods (Declared Goods) Order 2019, which requires that when used, advertised or presented for supply for oral consumption, goods that are labelled or promoted for cosmetic purposes are therapeutic goods. This has also been included in the published guidance.  

CMA welcomes additional member feedback on the published guidelines via technical@cmaustralia.org.au to determine if the TGA need to make future updates to these guidelines. 

The Guidance 

The guidance provides definitions for each category of goods:  

  • Cosmetics are typically used to change the body’s odour or appearance, cleanse it, keep it in good condition or protect it.  
  • Therapeutic goods include products that are represented in any way to be, or that are, likely to be taken for therapeutic use, whether because of the way in which the goods are presented, or for any other reason.  In relation to complementary medicines, Section 3 of the Therapeutic Goods  Act 1989 – Interpretation, defines therapeutic use as use in or in connection with: 
  • preventing, diagnosing, curing or alleviating a disease, ailment, defect or injury in persons; or 
  • influencing, inhibiting or modifying a physiological process in persons. 

The guidance notes that the determination of whether products are either cosmetics or therapeutic goods based is based on the following factors, but that these factors should not be considered in isolation. Rather, they should be considered in the context of the overall presentation of the goods, which also includes other factors such as the product name and the use of images and claims on the product label, or in advertising: 

  • The claims made about the product 

The guidance (pp. 8-9) includes questions and examples for stakeholder consideration, including: 

  • Does the product claim to change look or appearance, such as by adding colour or smoothing skin texture by adding a layer of product?  
  • Does the product claim to change an underlying physiological process to achieve a different appearance?  
  • ‘Helps your skin look even and smooth’ (cosmetic – changing its appearance) vs ‘Reduces skin pigmentation and uneven skin tone’ (therapeutic good – physiological change). 
  • ‘Helps skin look firm’ (cosmetic – changing its appearance) vs ‘Improves skin’s internal structure for firmer skin’ (therapeutic good – physiological change). 

Examples of commonly used product types with therapeutic claims which would likely be considered therapeutic goods (unless otherwise excluded) are also provided (pp. 9-10). For additional examples of products that would likely be considered to be making cosmetic claims, please see the Australian Industrial Chemicals Introduction Scheme (AICIS) website

  • The product ingredients or composition 

The guidance (pp. 10-11) provides that if a product contains an ingredient that is known to have a therapeutic use, or includes an ingredient included in Schedules 2, 3, 4 or 8 of the Poisons Standard, it may be more likely to be taken to be a therapeutic good. However, if a product does not contain an ingredient included in Schedules 2, 3, 4 or 8 of the Poisons Standard it does not necessarily mean that the product is not a therapeutic good.   

  • How the product is administered or used 

The guidance provides that cosmetics are only for use on any external part of the body or inside the mouth. Conversely, therapeutic goods can be administered in a range of different ways, including topically (applied to the external part of the body), including as a cream, ointment or transdermal patch; or orally (ingested), including as a tablet, powder or liquid.  

The guidance notes that products for topical use or for use on teeth or in the mouth may be regulated as a cosmetic or a therapeutic good depending on the circumstances, including the type of product, ingredients and the claims made. As noted above, the Therapeutic Goods (Declared Goods) Order 2019 specifies that goods labelled or promoted for cosmetic claims and used, advertised, or presented for supply for oral consumption are deemed therapeutic goods.  

The guidance provides that generally, where a product is an excluded good or is declared not to be a therapeutic good and is presented and/ or advertised for use on any external part of the body, or inside the mouth, it will be regulated as a cosmetic.  

Examples of goods declared to not be therapeutic goods, and goods excluded from being therapeutic goods are provided in the guidance, noting that if a product does not comply with all relevant requirements in the Excluded Goods Determination, it is not an excluded good, and therefore must comply with all applicable therapeutic goods regulatory requirements.  

Further assistance 

Businesses can access the services of our CMA Professional Industry Consultants for further assistance in navigating the cosmetic-medicine interface.  

TGA legislation and Resources 

Other legislation and Resources 

LinkedIn
Facebook
Twitter
Email

RECENT ARTICLES

Vale Stephen Myers

It is with great sadness that we learned of the passing of Emeritus Professor Stephen Myers late last week. Stephen was a giant in the

Read More