Applies to: All NCD staff involved in skincare recommendation/retail

1. Purpose & Regulatory Context

To establish a comprehensive governance framework for selection, recommendation, sale, and monitoring of non-prescription skin care products at NCD. This policy ensures compliance with Australian law and standards, including AHPRA advertising rules, TGA Therapeutic Goods Advertising Code, ACCC Australian Consumer Law, AICIS cosmetic ingredient regulations, OAIC privacy, and relevant NSW Health obligations. ^{1 2 3 4 5 6 7}

2. Scope & Applicability

Applies to all non-prescription topical products (cosmetics, cosmeceuticals, OTC actives) recommended or sold by NCD staff. Includes cleansers, moisturisers, serums (e.g., vitamin C, niacinamide), exfoliants (AHA/BHA), barrier products, and non-prescription pigment/anti-acne aids. Excludes Schedule medicines and medical devices requiring prescriptions or ARTG-only use.

3. Definitions

• Cosmetic (AICIS): a product intended to clean, perfume, change appearance, protect, keep in good condition, or correct body odours, without therapeutic claims.
• Therapeutic claim (TGA): a claim relating to prevention, diagnosis, cure, or alleviation of disease/conditions; products with such claims may be therapeutic goods and require ARTG inclusion.
• Excluded Goods (TGA): products declared not to be therapeutic goods if meeting specific conditions (e.g., some cosmetics).
• Primary vs secondary sunscreens: primary sunscreens are therapeutic goods (ARTG); some secondary sunscreens (e.g., moisturisers with SPF) may be regulated differently.

NCD will classify each product and its marketing language against these definitions prior to approval. ^{2 4 8 9}

4. Legislative & Regulatory Framework

• AHPRA Advertising: prohibits misleading claims/testimonials; requires accuracy, no unreasonable expectations, and proper practitioner identification where relevant.
• TGA Advertising Code: applies when therapeutic claims are made or for products regulated as therapeutic goods (e.g., sunscreens).
• ACCC Australian Consumer Law: prohibits false/misleading representations and mandates fair trading and safety claims substantiation.
• AICIS: ingredient introduction category, labelling, and record-keeping for cosmetics; supplier must be AICIS-compliant.
• OAIC: collection, storage, and use of client data (skin photos, consultations).
• NSW Health: storage/handling where any scheduled ingredients may appear in OTC products; recall/incident processes.

NCD will only stock products with compliant labelling and claims, and will verify supplier regulatory status (AICIS) and, where relevant, ARTG inclusion for therapeutic categories (e.g., sunscreens). ^{1 2 3 4 6 7 9}

5. Product Selection & Approval

1. Supplier due diligence: obtain regulatory statements (AICIS compliance), SDS, ingredient lists (INCI), batch/expiry, storage conditions, and recall policy.
2. Classification check: confirm product category (cosmetic vs therapeutic good); verify ARTG for sunscreens or therapeutically-claimed products.
3. Label & claim audit: ensure claims are cosmetic in nature unless ARTG-listed; no disease/condition claims (e.g., “treats acne”) without appropriate regulation.
4. Evidence file: maintain credible substantiation for efficacy/safety claims; ensure claims are truthful, not misleading, and proportionate to evidence.
5. Stock control: log batch numbers, expiry, temperature sensitivities; rotate stock; quarantine damaged or expired product.

Approval is granted by the Responsible Medical Practitioner or delegated governance lead after all checks are complete. ^{2 3 4 8 9}

6. Pre-Consultation Screening & Documentation

• Collect relevant skin history, allergies, pregnancy/lactation status, and current routine; obtain consent to record this information (privacy notice).
• Assess skin type (Fitzpatrick), barrier integrity, sensitivity, and current/previous reactions to actives.
• Identify red flags needing medical review (active dermatitis/infection, suspected allergic contact dermatitis, recent ablative procedures).

Document discussion, product selection rationale, and instructions. Offer to capture baseline photos with explicit consent and secure storage. ^{6 8}

7. Informed Consent (Retail Skin Care Use)

• Explain purpose, expected results, and limitations of cosmetic products (no guaranteed therapeutic outcomes).
• Discuss common reactions for actives (e.g., mild tingling with AHA/BHA; transient dryness with retinoid esters).
• Explain patch testing protocol and step-up introduction schedules.
• Provide written instructions and safety-net advice (when to stop and seek help).

Ensure the patient understands product category (cosmetic) vs medicine; avoid implying therapeutic benefits unless appropriately regulated and labelled. ^{1 2 3}

8. Patient Counselling & Labelling Requirements

• Usage order (AM/PM), frequency, and quantity (pea-sized guidance), avoiding eyes/lips unless specified.
• Introduce one active at a time; escalate frequency after tolerance proven.
• SPF behaviours: daily broad-spectrum use; reapply as per label guidance; understand limits of secondary sunscreens in cosmetics.
• Storage: temperature/light sensitivity; check expiry; discontinue if odour/colour changes occur.

Ensure product labels and clinic materials avoid medical claims unless ARTG-listed (especially for acne, eczema, rosacea). ^{2 3 9 10}

9. Contraindications & Adverse Reaction Management

• Known allergy to listed ingredients; history of severe sensitivity to related compounds.
• Compromised barrier, active dermatitis/infection—defer actives; use barrier repair first or refer to clinician.
• Post-procedure skin (recent peels/laser/needling): re-introduce only after clinician clearance.
• Pregnancy/lactation: avoid certain high-dose actives; prefer gentle, non-medicated options; seek medical guidance for uncertainty.

Red flags: severe burning, swelling, blistering, exudate, or rash—stop product immediately; cool compress; medical review within 24–48 h; consider ACD work-up and reportability where appropriate. ^{8 11 12}

10. Advertising & Representation Rules

• No testimonials in clinic advertising that could contravene AHPRA rules when associated with a regulated health service.
• No disease/treatment claims for cosmetic products; avoid “treats acne/rosacea/melasma” unless product is appropriately regulated and labelled.
• Use accurate, balanced language; avoid unrealistic before-and-after depictions without compliant consent and disclosures.

All digital/print materials to be reviewed for compliance before publication; maintain an approvals register. ^{1 2 3}

11. Follow-Up, Monitoring & Product Efficacy Review

• Offer check-in at 2–4 weeks for new active regimens (tolerance, technique, adherence).
• Use photographs (with consent) and patient-reported outcome prompts to evaluate benefit; adjust plan accordingly.
• Collect and manage complaints/adverse events; update product suitability notes in the record.

Run periodic product range reviews to ensure evidence-claim alignment and to de-list non-performing or non-compliant items. ^{3 8}

12. Record-Keeping, Stock Control & Privacy

• Maintain purchase/receipt records, batch/expiry logs, and stock movement for traceability and recalls.
• Document patient advice, product name/batch, and instructions provided; file consent for photos/data use per OAIC.
• Secure storage for records with role-based access; retain records for statutory periods; dispose securely at end of life.

Incident management: log, investigate, and act on safety events; consider product withdrawal or supplier notification where indicated. ^{3 6 8}

Sources

1. AHPRA & National Boards. Advertising a regulated health service – Guidelines (2020, current). https://www.ahpra.gov.au/Resources/Advertising-hub/Advertising-guidelines-and-other-guidance/Advertising-guidelines.aspx ↩︎
2. TGA. Therapeutic Goods Advertising Code (2021) and guidance. https://www.tga.gov.au/resources/resource/guidance/therapeutic-goods-advertising-code-2021-guidance ↩︎
3. ACCC. Australian Consumer Law – product safety, claims and representations. https://www.accc.gov.au/business/advertising-and-promotions ↩︎
4. AICIS (formerly NICNAS). Cosmetic regulations – ingredients, categorisation, and notifications. https://www.industrialchemicals.gov.au/ ↩︎
5. Therapeutic Goods (Excluded Goods) Determination 2018. https://www.tga.gov.au/resources/resource/guidance/excluded-goods ↩︎
6. OAIC. Guide to health privacy – handling health information in clinics. https://www.oaic.gov.au/privacy/privacy-guidance-for-organisations-and-government-agencies/health-service-providers/guide-to-health-privacy ↩︎
7. NSW Health. Poisons & Therapeutic Goods Regulation (retail/clinic handling obligations). https://www.health.nsw.gov.au/pharmaceutical/Pages/default.aspx ↩︎
8. ACSQHC. NSQHS Standards – Medication Safety & Clinical Governance. https://www.safetyandquality.gov.au/standards/nsqhs-standards ↩︎
9. TGA. Sunscreens regulation & ARTG inclusion; primary vs secondary sunscreens. https://www.tga.gov.au/resources/resource/guidance/australian-regulatory-guidelines-non-prescription-medicines-argnm-sunscreens ↩︎
10. ARPANSA. UV radiation & sun protection fundamentals. https://www.arpansa.gov.au/understanding-radiation/radiation-sources/sun-protection ↩︎
11. RACGP. Patient communication & safety netting in primary care. https://www.racgp.org.au/ ↩︎
12. NHMRC. Evidence standards and clinical guideline development. https://www.nhmrc.gov.au/ ↩︎