Applies to: All NCD clinical, administrative, and marketing staff

1. Purpose

This policy establishes an evidence-based framework for classifying all products used, supplied, or recommended by Newcastle Cosmetic Doctor (NCD) as either cosmetic or therapeutic goods. It ensures compliance with Australian law and standards—TGA, AHPRA, ACCC—and benchmarks with international authorities. ^{1 2 3 4}

2. Scope & Applicability

Applies to all NCD clinicians and staff involved in recommending, stocking, dispensing, or advertising products; covering cosmetic skincare, sunscreens, OTC products, compounded actives, and prescription topicals across in‑clinic and digital channels. ^{1 2}

3. Definitions & Legislative Framework

Cosmetic product: intended for external application to cleanse, protect, keep in good condition, or change appearance—without therapeutic effect. The Excluded Goods Determination clarifies when a product is not a therapeutic good. ^{1 5}

Therapeutic good: intended to prevent, diagnose, cure, or modify disease, or affect physiological function—requiring inclusion in the ARTG and compliance with TGA standards. ^{1 6}

Borderline or “cosmeceutical” products require assessment of ingredients, claims, and mechanism; NCD considers international comparators where appropriate. ^{7 9 10}

4. Classification Criteria & Descriptive Framework

Purpose & claim: Cosmetic claims concern appearance or maintenance (e.g., enhances radiance, improves hydration). Therapeutic claims imply prevention, diagnosis, or treatment (e.g., treats acne, removes melasma) or physiological modification; therapeutic intent requires ARTG inclusion before supply. ^{1 3 4 8}

Mechanism of action: Cosmetics act superficially on the stratum corneum/epidermis without pharmacologic, immunologic, or metabolic action; therapeutic goods alter biological processes (e.g., retinoids increasing dermal collagen turnover), triggering therapeutic classification. ^{1 8}

Ingredients & scheduling: Cosmetics use emollients, humectants, UV filters approved for cosmetic use, and low-level actives. Therapeutic goods contain scheduled substances/APIs (e.g., tretinoin, hydroquinone), requiring scheduling controls, ARTG inclusion, and appropriate prescribing/dispensing. ^{1 8}

Regulatory pathway: Cosmetics excluded from ARTG remain under general product safety and consumer law; therapeutic goods require listing/registration, GMP-compliant manufacture, labelling, and post‑market monitoring. NCD verifies ARTG status before promotion. ^{1 4}

Advertising & social media: Marketing complies with AHPRA rules and the TGA Code of Advertising; claims must be accurate and not misleading, and testimonials restricted. Therapeutic claims are prohibited for non‑ARTG cosmetics. ^{2 3 4}

Labelling & information: Cosmetic labels include ingredient lists and manufacturer details; therapeutic goods require dosage, route, warnings, scheduling where applicable, and an ARTG number; sponsors must meet GMP obligations. ^{1 4 9}

Clinical governance & prescriber role: Only authorised prescribers recommend/dispense scheduled therapeutic goods; any product with therapeutic intent requires medical assessment, informed consent, documentation, and monitoring consistent with NSQHS and privacy standards. ^{5 10}

5. Documentation & Record Management

Maintain a Product Classification Register with product name, supplier, classification rationale, ARTG number, approval, and review dates; re‑evaluate on any change. Retain records ≥7 years with role‑based access per privacy law. ⁶

6. Staff Education & Governance

All staff receive annual training on cosmetic–therapeutic distinctions, compliant wording, and pre‑publication review; the Medical Director audits marketing/supplier documentation and implements corrective actions as needed. ^{2 3}

7. Global Benchmarking

NCD references international frameworks—the FDA distinction between cosmetics and drugs, the EU Cosmetics Regulation defining function and prohibiting medicinal claims, and WHO guidance on cosmetic safety and claim substantiation—to inform harmonised best practice. ^{8 9 10}

8. Audit, Review & Continuous Improvement

Review this policy annually or earlier if TGA/AHPRA guidance changes; log and investigate adverse product events and, where indicated, report via TGA post‑market processes. ^{1 4}

Sources

1. Therapeutic Goods Administration (TGA), Therapeutic Goods (Excluded Goods) Determination 2023., viewed 24 October 2025, https://www.tga.gov.au ↩
2. AHPRA, Advertising a regulated health service – Guidelines (2024)., viewed 24 October 2025, https://www.ahpra.gov.au/Resources/Advertising-hub/Advertising-guidelines-and-other-guidance/Advertising-guidelines.aspx ↩
3. ACCC, Australian Consumer Law – Avoid misleading claims in advertising., viewed 24 October 2025, https://www.accc.gov.au ↩
4. TGA, Code of Advertising for Therapeutic Goods (2021)., viewed 24 October 2025, https://www.tga.gov.au/resources/publication/code-advertising-therapeutic-goods ↩
5. NSQHS, Clinical Governance and Medication Safety Standards., viewed 24 October 2025, https://www.safetyandquality.gov.au ↩
6. OAIC, Australian Privacy Principles., viewed 24 October 2025, https://www.oaic.gov.au/privacy/your-privacy-rights/health-and-medical-research/guide-to-health-privacy ↩
7. NSW Health, Poisons and Therapeutic Goods – Pharmaceutical Services., viewed 24 October 2025, https://www.health.nsw.gov.au/pharmaceutical/Pages/default.aspx ↩
8. U.S, FDA. Is it a Cosmetic, a Drug, or Both?, viewed 24 October 2025, https://www.fda.gov/cosmetics/cosmetics-laws-regulations/it-cosmetic-drug-or-both-or-it-soap ↩
9. European Commission, Regulation (EC) No 1223/2009 on Cosmetic Products., viewed 24 October 2025, https://health.ec.europa.eu/system/files/2021-09/2013_cosmetic_product_fiche_en_0.pdf ↩
10. World Health Organization (WHO), Global Guidance on Quality and Safety of Cosmetics (2022)., viewed 24 October 2025, https://www.who.int/publications ↩