TGA Scheduling Consultation: Interim Decision – palmitoylethanolamide (PEA)

The TGA has published a notice of interim decisions for palmitoylethenolamide (PEA) on their website. The public consultation, closing 17 April, relates to the Delegate’s decision to vary the applicant’s proposal to amend the current Poisons Standard in relation to PEA by creating a new Schedule 6 entry, but which excludes derivatives and preparations for therapeutic use: 

  • This means that if the interim decision is confirmed, listed and registered medicines and other therapeutic preparations containing PEA will be unaffected. 

The applicant proposed a new Schedule 6 entry for palmitoylethanolamide (PEA) with an exemption for use in listed human medicines. The proposal would require products containing PEA that are not listed as human medicines, such as veterinary products, to have distinctive packaging with strong warnings and safety directions on the label. 

CMA supported the applicant’s proposal to exempt palmitoylethanolamide (PEA) in listed human medicines from the proposed Schedule 6 entry. In addition, CMA advocated that the exemption from the Schedule 6 entry also be extended to Registered complementary medicines and extemporaneously compounded medicines. The interim decision proposing to exclude all preparations for therapeutic use has adopted CMA’s recommendation. 

A total of 19 responses were received, 17 in full support, 1 in partial support and 1 in opposition of the proposal. Of these, 3 provided a written response, 1 written response in support, 1 written response in partial support and 1 in opposition.  There are currently approximately 26 products containing ‘Palmidrol’ (PEA) on the ARTG.  

Interim decision 

The Delegate’s interim decision to amend the current Poisons Standard in relation to palmitoylethanolamide (PEA) is as follows: 

Schedule 6 – New entry 

PALMITOYLETHANOLAMIDE (excluding derivatives) except in preparations for therapeutic use. 

Index – New entry 

PALMITOYLETHANOLAMIDE 
cross reference: PALMIDROL 

Schedule 6 

The Delegate has decided to include palmidrol, the Australian Approved Name (AAN), in the index for additional clarity. The Delegate also notes that as the products currently in the market are those excluded from the new Schedule 6 entry and will be unaffected by the new scheduling of PEA, there is no reason to delay the implementation date of 1 June 2024. 

The Delegate’s reasons for the Interim decision include: 

  • The Delegate agrees with the Advisory Committee on Medicines and Chemicals Scheduling (the Committee) findings on the relevant provisions of section 52E of the Act, i.e.:  
  • Risks arise from human exposure of the ‘raw’ chemical. Corrosivity and irritant as powdered manufacturing concentrated products. 
  • PEA is used in human and animal therapeutic products and is used as an active ingredient in export only and listed medicines. 
  • The substance is to be used in manufacturing concentrate and raw material for a new veterinary product. 
  • PEA produces low oral and dermal acute toxicity. However, it can cause severe and irreversible corrosive effects on the eye and severe irritant effects on the skin. 
  • The use of PPE where the product is in powder form would aid risk mitigation, as would safety labels. 
  • Derivatives of PEA should be excluded from scheduling (for example, palmitic acid which is in Appendix B). 
  • CAS number and IUPAC nomenclature should be considered in the entry to aid readers in identification. 
  • PEA is an active ingredient in TGA listed medicines with several permitted indications, such as an anti-inflammatory, analgesic, and to maintain and support general health and wellbeing. It is also anticipated that PEA will be used more widely as a manufacturing concentrate for use in veterinary products, which triggered the scheduling proposal.       
  • The oral consumption of PEA has low acute toxicity. However, in considering the Scheduling Policy Framework (SPF), PEA has the potential to cause severe but reversable effects on the skin, consistent with scheduling factor 1 for Schedule 6, and severe and irreversible effects on the cornea, consistent with factor 1 for Schedule 7 (s 52E(1)(b)).  
  • There is a considerable risk of PEA aerosolisation when large, concentrated quantities are handled, but this risk can be managed in a manufacturing environment. Since the risks of skin and eye injury of PEA can be managed in a manufacturing environment, and with insufficient data to set any cut-offs, the Delegate is satisfied it is most appropriate to create a new Schedule 6 entry.  
  • The risks associated with the use of a PEA manufacturing concentrate differ considerably to the use of PEA in therapeutic preparations, particularly for human use (s 52E(1)(b)).  
  • Of the 26 products listed on the ARTG, 24 were in tablet or capsule formulations and 2 products were in powder formulations. The Delegate is of the view that these products (tablets or capsules) hold a very low aerolisation risk. The two products otherwise made available in powders are in much lower quantities (≤ 100 grams) and concentrations (5.9% and 15%), and are different in the way they are handled, compared to the use of PEA for manufacturing purposes.  
  • Regarding CMA and CHPA’s proposals that all products for human therapeutic use should be excluded from the proposed Scheulde 6 entry, the Delegate is of the view the reasons presented would also be relevant to human therapeutic preparations more broadly, and as no data to suggest the risks would differ for human therapeutic use than for veterinary use have been found, is considered warranted to exclude all therapeutic preparations.   
  • In accordance with the Committee’s advice that the exclusion of derivatives would prevent perverse outcomes by not scheduling substances that are chemically similar to PEA (s 52E(1)(f)), the Delegate is not aware of any major signals that calls for a need to include the scheduling of PEA derivatives at this time.  

How to respond 

Submissions to the public consultation can be made by respondents directly through the Consultation hub, by Wednesday 17 April 2024

Alternatively, members are invited to provide feedback, comments and recommendations to CMA via, preferred by Monday 15 April 2024, via technical@cmaustralia.org.au

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