Cosmetic or Therapeutic? How SFDA Classification Affects Your Customs Clearance
The difference between cosmetic and pharmaceutical products under SFDA — classification criteria, fees, required certificates, and marketing phrases that change your product classification.
Cosmetic or Therapeutic? How SFDA Classification Affects Your Customs Clearance
A client had been importing a face cream as a cosmetic product for two years with no issues. In the third year, the shipment was held at Jeddah Port for 12 days because SFDA reclassified it as therapeutic based on a new ingredient in the updated formulation. Cost difference: additional fees + strict registration requirements + demurrage penalties.
This guide explains how SFDA distinguishes between the two categories, and why your product’s classification might change without your knowledge.
The Fundamental Difference Between the Two
Cosmetics
Products used on the body surface (skin, hair, nails, teeth, external mucous membranes) for aesthetic purposes only:
- Cleansing
- Perfuming
- Beautifying and decorating
- Changing appearance
- Protecting or maintaining good condition
Examples: Shampoo, moisturizing cream, perfumes, lipstick, hair dye, toothpaste.
Pharmaceuticals / Therapeutic Products
Products with pharmacological effect on the body, used to:
- Treat a disease or condition
- Prevent disease
- Modify physiological function
- Diagnose a medical condition
Examples: Anti-inflammatory cream, medicated dandruff shampoo, therapeutic Vitamin A moisturizer, over-the-counter (OTC) medications.
SFDA’s 4 Classification Criteria
SFDA relies on 4 combined criteria to determine product classification:
1. Active Ingredients
| Ingredient | Default Classification |
|---|---|
| Glycerin, Hyaluronic Acid | Cosmetic |
| Retinol (>0.3%) | May become therapeutic |
| Hydroquinone | Therapeutic (lightening treatment) |
| Salicylic Acid (>2%) | Therapeutic |
| Benzoyl Peroxide | Therapeutic (acne) |
| Minoxidil | Therapeutic (hair loss) |
| Ketoconazole | Therapeutic (antifungal) |
Rule: If your product contains an active ingredient at a concentration exceeding the cosmetic limit, it’s classified as therapeutic.
2. Intended Use
What the manufacturer claims about the product determines its classification:
| Claim | Classification |
|---|---|
| ”Moisturizes skin” | Cosmetic |
| ”Treats acne” | Therapeutic |
| ”Reduces appearance of wrinkles” | Cosmetic |
| ”Removes hyperpigmentation” (with medical claim) | Therapeutic |
| ”Protects against sun” SPF<30 | Cosmetic |
| ”Protects against skin cancer” | Therapeutic |
3. Method of Application
- Surface application only = cosmetic tendency
- Inside the body (mouth, eye, nose, ear) = therapeutic tendency
- Injection, inhalation, ingestion = definitely therapeutic
4. Packaging & Claims
Phrases on the packaging can shift a product from cosmetic to therapeutic:
- ❌ “Treats” — forbidden word on cosmetics
- ❌ “Cures” — shifts classification to therapeutic
- ❌ “Doctor recommended” — may trigger classification scrutiny
- ❌ Substantiated health claims (lowers cholesterol, boosts immunity)
Practical Examples That Confuse Importers
Example 1: Cream with Vitamin A
- 0.1% Retinol → Cosmetic
- 1% Retinol → Gray area, clarification may be requested
- 2%+ Retinol → Definitely therapeutic (requires prescription)
Example 2: Shampoo
- Regular shampoo with argan oil → Cosmetic
- “Anti-dandruff shampoo” (with Zinc Pyrithione 1%) → Gray area
- “Therapeutic shampoo” (with Ketoconazole 2%) → Definitely therapeutic
Example 3: Dietary Supplements
- Vitamin C 500 mg for health maintenance → Food/supplement
- Vitamin C 1000 mg “Supports Immunity” → Functional food (additional requirements)
- Glucosamine for joint inflammation treatment → Therapeutic
Why Classification Changes Without Your Knowledge
Reason 1: SFDA Updates Its List Periodically
Every few months, SFDA reviews its lists based on:
- World Health Organization (WHO) recommendations
- US FDA and European EMA recommendations
- Local Saudi studies on the effects of certain materials
Result: an ingredient that was cosmetic becomes therapeutic (or vice versa).
Reason 2: Supplier Reformulation
The manufacturer may change the product formula without notifying you:
- Increased percentage of active ingredient
- Added new ingredient
- Changed intended use on label
Every change = potential reassessment in clearance.
Reason 3: Changes in Marketing Phrases
You imported a product for years described as “Moisturizing Cream”. This year, the supplier added “Treats Dry Skin” to the label. Result: SFDA may reclassify it as therapeutic.
Practical Implications of Each Classification
| Aspect | Cosmetic | Therapeutic |
|---|---|---|
| Regulatory Body | SFDA — Cosmetics Dept. | SFDA — Drugs Dept. |
| Required Registration | ”Ghad” platform (cosmetic) | eSDR (drugs) |
| Registration Duration | Days to weeks | Months |
| GMP Certificates | Usually not mandatory | Strictly mandatory |
| Saudi Legal Representative | No (for foreign mfr) | Required |
| Registration Fees | Moderate | High (thousands of SAR) |
| Clearance Requirements | Registration + Arabic label | Registration + GMP + efficacy certs |
| Port Release Time | 24-48 hours typically | 5-15 days |
How to Avoid Reclassification
Before Shipping — Review the Product
- Request full formulation from supplier (with percentages of each ingredient)
- Review the label word by word — no medical claims on cosmetics
- Consult SFDA or an expert if there’s any doubt about classification
- Pre-register the product in “Ghad” before the first shipment
When Changing Supplier or Formulation
- Request complete new formulation before the first shipment of the updated version
- Compare it to the previous version (any new ingredient, any percentage change?)
- If there’s a substantial change — re-verify classification before shipping
For Functional Food Products
Avoid on the label:
- “Supports Immunity”
- “Boosts Energy”
- “Improves Brain Function”
- “Anti-Aging”
- “Clinically Proven”
These phrases may shift the product from regular food to functional supplement requiring different registration.
Pre-Verification of Classification
How to verify before shipping?
- Consultation with SFDA via their portal — official response within ~2 weeks typically
- Consultation with an experienced broker — knows patterns from past cases
- Review ZATCA tariff codes for similar items — reveals the trend
Common Mistakes
❌ Assuming this year’s classification = next year’s classification
❌ Ignoring supplier warnings about formulation changes
❌ Using the same HS Code for years without review
❌ Health claims on cosmetic labels for “better marketing”
❌ Importing before product registration in “Ghad” (cosmetic) or eSDR (therapeutic)
How OBOOR Helps
We offer for cosmetic and pharmaceutical importers:
- Pre-shipment classification review
- Registration on SFDA platforms (Ghad, eSDR, MDMA)
- Label and claims consultation
- Tracking SFDA updates for your registered items
- Fast clearance for shipments with correct classification from the start
Book a free pharma consultation — review your products’ classification before the next shipment.
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