Non-Prescription Cosmetic Skin Care & Creams Governance Policy

Applies to: All non-prescription cosmetic skin care and creams (including Korean skincare) imported, stocked, recommended or sold in Thailand.

1. วัตถุประสงค์

1.1 This policy sets strict governance rules for the importation, storage, advertising, recommendation and sale of non-prescription cosmetic skin care and creams in Thailand, including Korean skincare brands.^{1 5}

1.2 It is designed to ensure full alignment with the Cosmetics Act B.E. 2558 (2015), its amending Cosmetics Act (No. 2) B.E. 2565 (2022), and associated ministerial notifications of the Ministry of Public Health and Thai FDA.^{1 2}

1.3 The policy also aligns clinic practice with Thai FDA rules on cosmetic notification, labelling, manufacture/import site control, and inspection regimes.^{4 5}

1.4 Where personal data or skin-health information is collected in connection with cosmetic products, this policy cross-references obligations under the Personal Data Protection Act B.E. 2562 (2019) (PDPA).^{17 18}

1.5 If there is any conflict between commercial convenience and legal safety, this policy requires the stricter interpretation that favours patient safety, regulatory compliance and traceability.^{1 23}

2. ขอบเขต

2.1 This policy applies to all non-prescription cosmetic skin care and creams handled by the clinic, including cleansers, toners, serums, moisturisers, sunscreens, spot treatments, eye creams, masks and exfoliants.^{3 6}

2.2 It covers products that are imported (e.g. Korean skincare) or locally sourced but introduced into the Thai market under the clinic’s brand, distribution network or related entities.^{3 10}

2.3 It applies to all staff, contractors, influencers, promoters, and referral partners involved in importation, warehousing, counselling, sale, distribution, advertising or online promotion of cosmetic products.^{3 23}

2.4 The policy extends to all sales channels, including in-clinic retail, clinic-run e-commerce platforms, social media, livestream sales, and cross-border digital marketing targeting Thai residents.^{5 18}

2.5 It does not apply to prescription drugs, medical devices, herbal products, or CBD / hemp-based cosmetics, which are subject to separate governance and, by default, are not permitted under this policy unless explicitly approved by Thai FDA and the Governance Committee.^{6 7}

3. Definitions

3.1 Cosmetic: “Cosmetic” has the meaning given in Section 4 of the Cosmetics Act B.E. 2558 (2015): a substance or preparation intended to contact external parts of the body or oral mucosa for cleaning, perfuming, changing appearance, correcting body odour, or protecting/maintaining in good condition, without therapeutic effect.^{1 3}

3.2 Non-prescription cosmetic skin care / cream: A cosmetic product regulated under the Cosmetics Act and Thai FDA cosmetic notifications, which is not classified as a drug, medical device or hazardous substance, and can be sold without prescription.^{1 6}

3.3 Notifier / Importer: A Thai-registered business (manufacturer, contract manufacturer, repackager or importer) that notifies cosmetic product details to the Thai FDA and is legally responsible for safety, compliance and labelling.^{3 10}

3.4 Manufacturer: The entity that produces the cosmetic product, including overseas factories, contract manufacturers and brand owners responsible for GMP and quality systems.^{6 10}

3.5 Personal-use import: Importation of limited quantities of ready-made cosmetics by individuals for personal use only, under Thai FDA traveller guidelines, which cannot be used to stock or supply clinic retail or professional use.^{7 16}

3.6 Adverse cosmetic event: Any unwanted or harmful local or systemic reaction temporally associated with use of a cosmetic product, whether or not causality is proven.^{1 23}

3.7 Personal data / sensitive health data: Personal data and sensitive personal data (including health-related information, photographs of skin conditions and treatment histories) as defined under PDPA and related guidance.^{17 19}

4. Legislative and Regulatory Framework

4.1 Cosmetic control in Thailand is governed primarily by the Cosmetics Act B.E. 2558 (2015) and Cosmetics Act (No. 2) B.E. 2565 (2022), which regulate cosmetic definition, notification, labelling, inspection powers and penalties.^{1 2}

4.2 These Acts align Thai law with the ASEAN Cosmetic Directive (ACD) and provide a notification-based system rather than individual product licensing.^{4 12}

4.3 Thai FDA issues ministerial notifications covering manufacture/import rules, record-keeping, notification receipts, and cosmetic labelling standards, which are legally binding.^{5 13}

4.4 Guidance such as the Guideline on Cosmetics Category clarifies which products qualify as cosmetics, lists prohibited substances, and sets limits on restricted ingredients.^{6 12}

4.5 Recent Thai FDA guidance strengthens inspection of cosmetic manufacturing, import and storage sites, and refines notification rules for reformulated products and high-risk presentations such as ampoule, vial and syringe forms.^{13 15}

4.6 The PDPA B.E. 2562 (2019) governs the collection, use and disclosure of personal data, including sensitive health-related information captured through skincare assessments, loyalty programs and adverse event reports.^{17 18}

4.7 Thai FDA’s general mandate is to protect consumer health by ensuring safety, quality and efficacy of regulated health products, including cosmetics, in line with national legislation.^{20 23}

5. Roles and Responsibilities

5.1 Board / Owners: The Board or owners must approve this policy, allocate budget for compliance activities, and ensure any commercial strategies involving skincare respect Thai law.^{1 22}

5.2 Governance / Compliance Lead (Thailand): The Governance Lead is responsible for overseeing cosmetic regulatory compliance, including product selection, legal review, notification, labelling, audits and liaison with Thai FDA.^{3 5}

5.3 Notifier / Importer Entity: The Thai notifier/importer must be a Thai-registered business with valid FDA authorization to act as manufacturer, contract manufacturer or importer and is legally responsible for the accuracy of notifications, safety of products placed on the market, and compliance with inspection requirements.^{10 11}

5.4 Medical Director / Surgeons: The Medical Director and surgeons must ensure skincare recommendations remain clearly within the cosmetic definition and do not drift into unapproved therapeutic claims or drug-like positioning.^{1 3}

5.5 Product Safety Officer / Pharmacist (if appointed): Where appointed, the Product Safety Officer or pharmacist oversees ingredient review, contraindication checks, adverse event assessment and recall decision-making.^{6 13}

5.6 Marketing, Social Media and Sales Staff: Marketing and sales staff must use only pre-approved cosmetic claims, respect Thai advertising and labelling rules, and must never imply that a cosmetic is a medicine or medical device.^{5 8}

5.7 All Staff: All staff must report suspected non-compliance, unlabelled stock, adverse reactions or misleading claims immediately to the Governance Lead and must not bypass regulatory processes using personal-use import loopholes.^{7 16}

6. Product Selection and Due Diligence

6.1 Before any Korean or foreign skincare product is considered, the clinic must obtain full INCI ingredient lists with exact concentrations from the manufacturer or brand owner.^{6 9}

6.2 Ingredients must be screened against Thai lists of prohibited and restricted substances, as well as ASEAN-aligned cosmetic ingredient controls.^{6 12}

6.3 Products containing cannabis, hemp or CBD extracts are not to be selected unless Thai law changes and explicit written authorisation is obtained from Thai FDA and the Board.^{7 22}

6.4 Manufacturers must demonstrate appropriate cosmetic GMP or quality systems, with supporting certificates and inspection reports retained in the Product Information File (PIF).^{6 13}

6.5 Where the clinic or Thai distributor does not own the Korean brand, there must be a formal Letter of Authorisation or licence agreement allowing notification and distribution in Thailand, as required by Thai FDA.^{10 14}

6.6 The Governance Lead must ensure that product names, claims, packaging formats and marketing plans are clearly consistent with cosmetic classification, especially for high-tech formats like ampoules or syringe-like containers.^{6 15}

7. Importation and Cosmetic Notification

7.1 No cosmetic product may be manufactured or imported for sale in Thailand until a complete cosmetic notification has been filed with Thai FDA and a notification receipt issued.^{1 4}

7.2 The notifier must be a Thai-registered company with valid FDA authorization to act as manufacturer, contract manufacturer or importer.^{3 10}

7.3 Notification must at least cover notifier details, manufacturing/import sites, product names, categories, ingredient lists, conditions of use and presentation forms.^{4 5}

7.4 The notification receipt is generally valid for three years, and renewal processes must be commenced well before expiry to avoid gaps in legal status.^{9 11}

7.5 Any change in product name, formulation, packaging form or claims requires internal review and, where applicable, variation or new notification in line with current Thai FDA guidance.^{8 13}

7.6 Products imported under “personal-use” thresholds are strictly prohibited from being used as clinic retail stock, tester units, staff samples for resale, or professional back-bar products.^{7 16}

7.7 Importers must comply with any controlled-goods or permit requirements and ensure FDA permits are properly linked to the customs system where relevant.^{5 22}

8. Labelling, Packaging and Claims Governance

8.1 All cosmetic products sold or used in the clinic must carry Thai-language labelling meeting Thai FDA minimum requirements before they are offered for sale or supplied to patients.^{5 8}

8.2 Labels must include at least product name, category, net content, full ingredient list, instructions for use, warnings, manufacturer details, importer/notifier details, batch/lot number, manufacture and expiry dates, and cosmetic notification number.^{1 5}

8.3 Labels and any outer packaging must accurately reflect the information notified to Thai FDA; any divergence between label and notification is treated as non-compliance.^{1 4}

8.4 Claims on labels, packaging and marketing must not suggest prevention, treatment or cure of disease, or imply pharmaceutical action or structural tissue changes.^{1 6}

8.5 Acceptable wording focuses on appearance-based benefits such as hydration, smoothing, brightening or improving the look of skin, rather than therapeutic language.^{6 9}

8.6 Translation of label text and marketing claims from Korean or English into Thai must be performed or reviewed by a fluent Thai speaker familiar with cosmetic law to prevent accidental medical claims.^{5 8}

8.7 High-risk packaging such as ampoules, vials and syringe-like containers must comply with Thai FDA guidance designed to prevent consumer confusion with injectables and misuse.^{13 15}

9. Storage, Handling and Stock Management

9.1 Cosmetic products must be stored in clean, dry, pest-free conditions, with temperature and humidity kept within manufacturer specifications and Thai inspection expectations.^{5 13}

9.2 Stock must be rotated using a first-expiry, first-out (FEFO) or first-in, first-out (FIFO) method, and expired or damaged products must be quarantined and destroyed, not discounted or repackaged.^{5 9}

9.3 Batch and lot numbers, as well as expiry dates, must be recorded for each receipt and distribution event to enable rapid recall if safety concerns arise.^{5 11}

9.4 Where third-party warehouses or fulfilment centres are used, contractual agreements must require compliance with Thai FDA and PDPA obligations, including inspection access.^{13 18}

10. In-Clinic Use, Counselling and Medical Boundary

10.1 Staff must make it clear that cosmetics are not medicines and do not replace medical diagnosis, prescription drugs or surgical interventions.^{1 3}

10.2 When recommending Korean skincare or any cosmetic product, staff must stay within approved cosmetic claims and avoid implying that products “treat”, “heal” or “cure” any dermatological condition.^{6 9}

10.3 Patients with suspected medical skin disease (e.g. severe acne, rosacea, psoriasis, eczema, infections) must be referred for appropriate medical assessment instead of being managed with cosmetics alone.^{1 23}

10.4 Post-procedure skincare recommendations must describe products as supportive cosmetic care, and any need for therapeutic topical agents must be managed under drug and medical practice rules, not this cosmetic policy.^{1 20}

10.5 Patch testing or gradual introduction protocols may be advised for patients with a history of sensitive skin or allergies, with clear documentation in their record.^{6 19}

11. Advertising, Social Media and Online Sales

11.1 All advertising and promotional material, including online content, must be consistent with the cosmetic definition, notified product details and Thai FDA labelling rules.^{5 8}

11.2 Before-and-after images must not imply cure of disease, permanent structural change or medical treatment effect, and must be in line with cosmetic-only positioning.^{6 9}

11.3 Doctors and clinic staff must not describe cosmetics as “medical-grade” in a way that suggests regulatory classification as drugs or devices under Thai law.^{1 12}

11.4 Online sales channels targeting Thai residents must assume full application of Thai cosmetic law and PDPA, even if servers or payment processors are offshore.^{18 22}

11.5 Influencers, livestream sellers and affiliates must be contractually bound to use approved scripts and claims, with monitoring for compliance.^{5 21}

12. Adverse Event and Product Quality Complaint Management

12.1 Any suspected cosmetic-related adverse event (e.g. rash, swelling, burning, pigment changes, infection) must be documented in the patient record and the central adverse event log.^{1 19}

12.2 Records must include patient identifiers, consent to record sensitive data, product name, batch/lot, usage pattern, onset, severity, management and outcome.^{17 19}

12.3 Serious, unexpected or cluster events must be escalated to the Product Safety Officer and Governance Lead for risk assessment and possible reporting to Thai FDA and the notifier.^{1 5}

12.4 Where reasonable suspicion exists that a batch is unsafe or mislabelled, the clinic must initiate a precautionary hold or recall, even before formal regulatory direction.^{5 13}

12.5 Findings from adverse event reviews must inform product selection, staff training and, where necessary, withdrawal of problematic product lines from the Thai market.^{6 13}

13. Documentation, Record-Keeping and PDPA Compliance

13.1 A Product Information File (PIF) must be maintained for each cosmetic line, containing at minimum formulation data, manufacturing details, GMP evidence, notification receipts, labels, stability and microbiological data where available.^{6 9}

13.2 Distribution records must link shipments to batch numbers and clinic sites, allowing rapid recall and response to regulator queries.^{5 11}

13.3 All personal data linked to skincare purchases, assessments, loyalty schemes or adverse events must be processed in accordance with PDPA principles of lawfulness, transparency, purpose limitation and data minimisation.^{17 18}

13.4 Sensitive health-related data, including photos of facial conditions and detailed treatment histories, must only be collected and used on a lawful basis recognised by PDPA, usually explicit consent or a limited statutory exemption.^{19 20}

13.5 Privacy notices must clearly explain how personal and health-related data will be used, stored, shared and retained, and patients must be informed of their rights to access, correction and complaint.^{17 22}

13.6 Where third-party platforms, cloud services or marketing tools are used, contracts must address PDPA compliance, security safeguards and data subject rights.^{18 21}

14. Training and Competency

14.1 All staff who handle cosmetic products, counsel patients, manage stock or create marketing content must receive initial and annual training on this policy and relevant Thai law.^{1 5}

14.2 Training must cover cosmetic classification, banned and restricted ingredients, labelling and advertising rules, adverse event recognition, and data protection basics.^{6 17}

14.3 Completion of training must be documented and used as part of performance and compliance review.^{5 18}

14.4 Staff who repeatedly breach this policy or create regulatory risk may be removed from cosmetic-related duties or subject to disciplinary action.^{5 23}

15. Incident Management and Regulatory Non-Compliance

15.1 Potential non-compliance events include importing or selling un-notified products, selling unlabelled or foreign-language-only stock, using prohibited ingredients, mis-branding, or making therapeutic claims in marketing.^{1 6}

15.2 Any such event must trigger immediate stock isolation, internal investigation and review of notifications, labelling and supplier documentation.^{5 13}

15.3 Where required, the Governance Lead must coordinate communication with Thai FDA, customs, the notifier and legal counsel, and implement corrective actions including recall, re-labelling, retraining or supplier termination.^{5 22}

15.4 Serious breaches or repeated non-compliance may require reporting to owners, insurers and, where data is involved, PDPA enforcement bodies.^{18 21}

16. Policy Review

16.1 This policy must be formally reviewed at least annually or sooner if Thai cosmetic or data protection legislation materially changes or new risk patterns are identified.^{1 2}

16.2 Regulatory updates such as new Thai FDA notifications, revised site inspection manuals, new guidance on high-risk cosmetic formats or PDPA enforcement trends must be tracked and incorporated.^{13 18}

17. Disclaimer

17.1 This policy is intended to support compliance with Thai law but does not replace independent legal or regulatory advice from qualified Thai counsel.^{1 18}

17.2 Where any requirement in this policy is less strict than a current legal obligation, the legal obligation prevails and the policy must be updated accordingly.^{1 2}

แหล่งข้อมูล

1. Thai Food and Drug Administration, Cosmetics Act B.E. 2558 (2015) (English version), Thai FDA Data Catalog, เข้าชมเมื่อวันที่ 28 พฤศจิกายน 2025, https://en.fda.moph.go.th/media.php?id=516856126617296896&name=Cosmetics%20Act%20,%20B.E.%202558%20(2015).pdf ↩
2. Thai Food and Drug Administration, Cosmetics Act (No. 2) B.E. 2565 (2022), listed under Health Products – Cosmetics (laws and regulations), เข้าชมเมื่อวันที่ 28 พฤศจิกายน 2025, https://en.fda.moph.go.th/media.php?id=482112329912295424&name=Cosmetics%20Act%20(No.2),%20B.E.%202565%20(2022).pdf ↩
3. Thai Food and Drug Administration, Entrepreneurs – Cosmetics (definition of cosmetics, notifiers, basic requirements), เข้าชมเมื่อวันที่ 28 พฤศจิกายน 2025, https://en.fda.moph.go.th/entrepreneurs-cosmetics/category/what-are-cosmetics/ ↩
4. Thai Food and Drug Administration, How to Apply for Permission on Cosmetics? (notification requirements for manufacture and import), เข้าชมเมื่อวันที่ 28 พฤศจิกายน 2025, https://en.fda.moph.go.th/entrepreneurs-cosmetics/category/how-to-apply-for-permission-on-cosmetics/ ↩
5. Thai Food and Drug Administration, Health Products – Cosmetics (list of ministerial regulations on manufacture, import, data retention, labelling and notification receipts), เข้าชมเมื่อวันที่ 28 พฤศจิกายน 2025, https://en.fda.moph.go.th/our-services-new/category/cat-cosmetics ↩
6. Department of International Trade Promotion (DITP), Guideline on Cosmetics Category (classification, prohibited substances and import procedures), เข้าชมเมื่อวันที่ 28 พฤศจิกายน 2025, https://onestopservice.ditp.go.th/download/file/4.%20Guideline%20on%20%20Cosmetics%20Category.pdf ↩
7. Thai Food and Drug Administration, Guideline of Importation for Personal Use / Bringing Health Products into the Kingdom of Thailand (cosmetics quantity limits, cannabis/hemp ban), เข้าชมเมื่อวันที่ 28 พฤศจิกายน 2025, https://en.fda.moph.go.th/guideline-of-importation-for-personal-use ↩
8. U.S. Department of Commerce, Thailand – Labelling/Marking Requirements (overview of Thai FDA label obligations for cosmetic and healthcare products), เข้าชมเมื่อวันที่ 28 พฤศจิกายน 2025, https://www.trade.gov/country-commercial-guides/thailand-labelingmarking-requirements ↩
9. Credevo, Registration of Cosmetics in Thailand – A Comprehensive Guide (notification flow, three-year validity, Thai labelling before sale), เข้าชมเมื่อวันที่ 28 พฤศจิกายน 2025, https://credevo.com/articles/2023/11/15/registration-of-cosmetics-in-thailand-a-comprehensive-guide/ ↩
10. Reach24H, Thailand Cosmetics Notification (Thai-registered company requirement, notifier responsibilities), เข้าชมเมื่อวันที่ 28 พฤศจิกายน 2025, https://en.reach24h.com/service/cosmetic/thailand-cosmetics-notification ↩
11. CIRS Group, ASEAN Cosmetics Registration – Thailand Section (need for local agent, 3-year notification validity, basic dossier list), เข้าชมเมื่อวันที่ 28 พฤศจิกายน 2025, https://www.cirs-group.com/en/cosmetics/asean-cosmetics-registration-thailand-vietnam-philippines-malaysia-singapore-indonesia ↩
12. Chemlinked, Cosmetic Act B.E. 2558 (2015) Overview (alignment with ASEAN Cosmetic Directive and key structural changes), เข้าชมเมื่อวันที่ 28 พฤศจิกายน 2025, https://cosmetic.chemlinked.com/database/view/211 ↩
13. Chemlinked, Thailand Revises Guideline for Cosmetic Manufacturing and Import Site Inspections (Thai FDA inspection manual update, 2025), เข้าชมเมื่อวันที่ 28 พฤศจิกายน 2025, https://cosmetic.chemlinked.com/news/cosmetic-news/thailand-revises-guideline-for-cosmetic-manufacturing-and-import-site-inspections ↩
14. Tilleke & Gibbins, Thai FDA Requires Proof of Authorization for Cosmetic Product Notification (need for brand owner authorisation/licence), เข้าชมเมื่อวันที่ 28 พฤศจิกายน 2025, https://www.tilleke.com/insights/thai-fda-requires-proof-authorization-cosmetic-product-notification/2/ ↩
15. SGS, Thailand Launches Guideline for Consideration of Notification of Cosmetics in Ampoule, Vial or Syringe Forms (high-risk presentations guidance), เข้าชมเมื่อวันที่ 28 พฤศจิกายน 2025, https://www.sgs.com/en-lb/news/2025/01/safeguards-00125-thailand-launches-guideline-for-consideration-of-notification-of-cosmetics-in-ampoule-vial-or-syringe-forms ↩
16. Tourism Authority of Thailand / PRD, Thailand FDA Traveller Guidelines for Importing Personal Health Products (distinction between personal use and commercial import), เข้าชมเมื่อวันที่ 28 พฤศจิกายน 2025, https://www.tatnews.org/2024/11/thailand-fda-issues-traveller-friendly-guidelines-for-importing-personal-health-products/ ↩
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21. Nishimura & Asahi, Consent or Exception; Which Way is Better Under the Thai PDPA? and Operationalising PDPA – Lawful Basis and Safeguards (lawful basis discussion and safeguards), เข้าชมเมื่อวันที่ 28 พฤศจิกายน 2025, https://www.nishimura.com/en/knowledge/publications/consent-or-exception-which-way-is-better-under-the-thai-personal-data-protection-act ↩
22. Nishimura & Asahi, Thailand Tightens Import Controls on Health Products and Controlled Goods (permit requirements and customs linkage), เข้าชมเมื่อวันที่ 28 พฤศจิกายน 2025, https://www.nishimura.com/en/knowledge/publications/20250601-112901 ↩
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