New TGA consultation: Legislating categories boundary and combination products

A new public consultation has been published on Legislating regulatory categories for some boundary and combination products which are relevant to products sponsored by CMA members. Feedback received in the previous consultation in Oct-Nov 2022 indicated the need for additional clarity, alignment and transparency on the appropriate regulatory pathways for some boundary and combination products. 

Products under the current proposal that are more likely to affect CMA members include: 

  • products for lice on the head and body 
  • oral care toothpastes 
  • compounded and uncompounded emollient and moisturising preparations for therapeutic use 
  • ingested weight loss treatments. 

Others in the consultation include products generated by ozone generators including disinfectants. The TGA also ask if there are any other products that should have their regulatory category clarified through legislation. 

The consultation, closing 6 August, seeks stakeholder views on: 

  • Whether legislating some products where possible to formally declare their regulatory category (e.g., medical device, not a medical device or other therapeutic good (OTG), will provide additional clarity for stakeholders. 
  • Whether a transitional period of five years is sufficient for sponsors of affected ARTG entries. 

Members can respond directly to the consultation via the online survey by 6 August or by submitting a document. The consultation questions in Proposal 1a and Proposal 2 are outlined in the consultation paper and reproduced below. 

Note on Food-Medicine Interface (FMI): This consultation is being run by the Medical Devices and Product Quality Division of the TGA, which generally does not examine the FMI, and FMI proposals have not been included. However, as the Excluded Goods Order may need updating as a result of this consultation, CMA will seek whether there is scope to update other aspects of the Order relating to FMI, such as oral products used for some cosmetic claims.  

Proposal 1a: Legislating regulatory category of some products 

Tabled below are regulatory categories for head and body lice products for humans, moisturisers and emollients, toothpastes, products generated by ozone generators and weight loss treatment – ingested products. Review the information and respond to proposal questions related to these products. 

  1. Would legislating the products, wherever possible, to be declared as per the regulatory categories mentioned in the table above provide clarity on the regulatory pathway for these products? 
  1. If your product would need to change regulatory category as per the table above, would a transitional period of five years be sufficient for you to transition your impacted product to the correct regulatory category? 
Product Mode of action Regulatory category 
Head and body lice products for humans Products that achieve the principal intended action primarily through pharmacological or chemical means such as products causing neurotoxicity to the lice. Medicine 
Products that achieve the principal intended action primarily through physical means such lice combs, lubricants and electrocution of the lice. Medical Device (exempt) 
Products that achieve the principal intended action through both pharmacological or chemical, and physical means. The action through physical means is considered ancillary. Medicine 
Moisturisers and emollients Products that incorporate active ingredient(s) and the principal intended action is primarily achieved through pharmacological or metabolic means. Medicine 
Products that achieve the principal intended action primarily through physical means such as creating barrier to retain moisture. Medical Device (Exempt) 
Products that achieve the principal intended action through both pharmacological or metabolic, and physical means, noting that the purpose of creating a barrier through physical means is considered ancillary. Medicine 
Toothpastes (dentifrices) Products that incorporate active ingredient(s) and the principal intended action is primarily achieved through pharmacological or chemical means. Medicine 
Products that achieve the principal intended action primarily through physical means such as providing protective barrier and blocking dentine pore. Medical Device (Exempt) 
Products that achieve the principal intended action through both the incorporated active ingredient and physical means, noting that the purpose of creating a barrier through physical means is considered ancillary. Medicine 
Products generated by ozone generators Products that are used for: sanitising or disinfecting a medical device or equipment, or clinical treatment in dentistry Medical Device 
Products that are hospital grade or household/commercial grade disinfectant that do not make specific claims*, and are: not intended for use internally or on skin, not intended for use on medical device, and intended for use on hard and soft surfaces. Exempt Disinfectant 
Products that are hospital grade or household/commercial grade disinfectant that make specific claims*, and are: not intended for use internally or on skin, not intended for use on medical device, and intended for use on hard and soft surfaces. Listed Disinfectant 
Products for sanitation, environmental control and environmental detoxification. Excluded Goods 
Weight loss treatment – ingested  Products such as capsules that expand in the stomach to create a feeling of satiety by occupying space. Medical Device 
Products that affect absorption of calories in the gastrointestinal system by metabolic means. Medicine 

* Virucidal, sporicidal, tuberculocidal, fungicidal or other biocidal activity are known as “specific claims”. See Disinfectant Claim Guide

Proposal 2: Other products that may require additional clarity 

The TGA has recently published updated guidance on boundary and combination products. Stakeholders are asked to review the example list of boundary and combination products and respond to the questions below. 

  1. Are there any other products that should have their regulatory category clarified through legislation? If yes, list other products that should have their regulatory category legislated for additional clarity and explain why? 

Resources 

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