Australia
Australia treats palmitoylethanolamide in two ways. It is a permitted ingredient in listed medicines for people. Since 1 October 2024 it also has an entry in the Poisons Standard, with two exemptions that cover most products on sale.
Listed medicines for people
The Therapeutic Goods Administration (TGA) approved palmitoylethanolamide as an ingredient for listed medicines in late 2019. The first approval covered Gencor’s Levagen ingredient, with a two-year exclusive period that ended in December 2021.
A listed medicine carries an AUST L number on its label. The TGA files its compositional guideline for the ingredient under the official name, palmidrol.
The Poisons Standard entry
On 27 September 2024 the TGA published a final scheduling decision. It took effect on 1 October 2024.
Palmitoylethanolamide, excluding derivatives, is now in Schedule 6, except:
- in preparations for therapeutic use, or
- in preparations for dermal cosmetic use that contain 1% or less of palmitoylethanolamide.
The index cross-references the entry to palmidrol.
What that means
- Medicines and other therapeutic preparations are outside Schedule 6. The first exemption removes them from the entry.
- Skin cosmetics at 1% or less are outside Schedule 6. The decision notes that cosmetic products on the market contained 0.3% to 1.0%. In cosmetics the ingredient is labelled palmitamide MEA.
- Anything else falls in Schedule 6. Schedule 6 is the “Poison” schedule. It brings labelling and packaging rules that the states and territories enforce.
How the decision was reached
The applicant asked for a Schedule 6 entry with an exemption for listed human medicines only. The final decision used a wider exemption, for all preparations for therapeutic use, and added the cosmetic exemption after a public submission supplied safety data.
The decision cites a cosmetic ingredient safety review, the pain meta-analysis by Lang-Illievich 2023, and a 2021 review by Clayton and colleagues.
It was not made a prescription medicine. Palmitoylethanolamide does not appear in Schedule 4.
Products for animals
The Australian Pesticides and Veterinary Medicines Authority (APVMA) regulates veterinary products. Whether a particular animal product needs registration depends on its ingredients and on the claims made for it. This site does not assess individual products.
Sources
- TGA: final decisions on palmitoylethanolamide and glycopyrronium, 27 September 2024
- TGA: compositional guideline for palmidrol
- Federal Register of Legislation: the Poisons Standard
- NutraIngredients, January 2020: Gencor’s ingredient gains TGA approval
Checked 21 September 2026. This page is general information, not legal advice.