For beauty and skincare brands seeking expansion into Southeast Asia—particularly the Thai market—regulatory compliance serves as the cornerstone for a successful product launch.
The Cosmetics and Hazardous Substances Control Bureau under the Thailand Food and Drug Administration (Thai FDA) has published its latest Guidelines for Notification and Claims of Cosmetic Products with Specific Efficacy: Ingredient Claims (Issue No. 1/2569). Addressing two of the market’s most prominent categories—Whitening e Anti-Acne products—this guideline explicitly delineates product notification parameters, authorized active ingredient lists, and permitted versus prohibited claim phrasing.
The following is an in-depth analysis of the core requirements from this regulatory update:
I. Key Regulatory Requirements for Whitening Products
1. Product Name Notification Guidelines
If a product name incorporates terms such as “WHITENING”, “LIGHTENING”, “BRIGHTENING”, or similar expressions, the product formulation must contain one or more of the following designated ingredients:
- Alpha Hydroxy Acids (AHAs): Glycolic Acid, Lactic Acid, Tartaric Acid, Citric Acid, Malic Acid, Mandelic Acid.
- Beta Hydroxy Acid (BHA): Salicylic Acid.
- Polyhydroxy Acid (PHA): Gluconolactone.
- Other Approved Ingredients (including but not limited to):
- Arbutin
- Glycyrrhiza Glabra (Licorice) Root Extract, Morus Alba (Mulberry) Root Extract
- Ascorbic Acid and its derivatives, Kojic Acid and its derivatives
- Tranexamic Acid: Concentration must not exceed 3%, and it is strictly prohibited in oral care products.
- Niacinamide (Vitamin B3 / Nicotinamide)
- Botanical Extracts: Chamomilla Recutita Flower Extract, Aloe Barbadensis Leaf Extract (containing Aloesin), Arctostaphylos Uva-Ursi Leaf Extract (containing Arbutin), Artocarpus Altilis/Incisa Wood Extract (containing Oxyresveratrol), Citrus Unshiu Peel Extract (containing Nobiletin), Magnolia Officinalis Bark Extract (containing Magnolignan), Paeonia Suffruticosa Root Extract, Punica Granatum Peel Extract (containing Ellagic Acid), Vitis Vinifera Seed Extract (containing Proanthocyanidins), etc.
- 4-Butylresorcinol, Thiodipropionic Acid, Isobutylamido Thiazolylresorcinol (Thiamidol).
- Unlisted Ingredients: Any ingredient not included on this designated list requires supporting scientific literature to be submitted to the Thai FDA for evaluation by an appointed expert committee.
2. Efficacy Claims Guidelines
| Examples of Allowed Claims | Compliance Conditions | Prohibited Claims |
| • Helps reduce factors that trigger dull skin • Helps revitalize skin affected by UV radiation • Helps fade dark spots/pigmentation • Addresses dull skin at its source within the epidermal layer | 1. Formulations must strictly comply with the authorized ingredient rules above. 2. Claims must clearly communicate that results vary based on individual skin type and natural skin tone. 3. Claims must not suggest altering human physiological structure (e.g., changing natural skin tone). | Statements claiming to significantly alter skin tone, make skin fairer than one’s natural skin tone, or any equivalent phrasing are strictly prohibited. |
II. Key Regulatory Requirements for Anti-Acne Products
1. Product Name Notification Guidelines
If a product name contains “ACNE”, “ANTI-ACNE”, or “BLACKHEAD”:
- Thai Name Restrictions: The Thai name must use direct transliteration rather than a semantic translation.
- Designated Ingredient Requirements: Formulations must contain at least one of the following ingredients:
- Salicylic Acid
- Triclosan
- Tea Tree Oil (Melaleuca Alternifolia Leaf Oil)
- Sulfur (concentration must not exceed 3%)
- Water-Soluble Zinc Salts
- Garcinia Mangostana (Mangosteen) Peel Extract
- Unlisted Ingredients: Subject to submission of scientific literature and review by a Thai FDA expert committee.
2. Efficacy Claims Guidelines
| Examples of Allowed Claims | Compliance Conditions | Prohibited Claims |
| • Helps reduce excess sebum (a contributing factor to clogged pores) • Cares for acne-prone skin • Helps reduce factors contributing to acne formation • Controls excess oil at the source • Suitable for acne-prone skin | 1. Formulations must strictly comply with the authorized ingredient rules above. 2. Text or visuals must not reference specific types of acne (e.g., cystic acne, inflammatory acne, pustules, etc.). | Any text or imagery implying or stating therapeutic, preventive, inflammatory reduction, or curative properties regarding acne is strictly prohibited. |
III. Compliance Recommendations and Summary for Brands
Section 4(1) of Thailand’s Cosmetic Act B.E. 2558 (2015) explicitly stipulates that cosmetic claims must not convey medicinal treatment, symptom relief, or disease cure meanings, nor lead to material misrepresentation of the product.
- Maintain a Strict Distinction Between “Cosmetics” and “Drugs”: Whitening products cannot claim to “bleach” or “genetically alter skin tone.” Anti-Acne products cannot claim to “reduce inflammation, act as an anti-inflammatory, or cure acne.”
- Adhere to Specific Ingredient Limits: Note restricted thresholds, such as Tranexamic Acid (maximum 3%, prohibited in oral care) and Sulfur (maximum 3%).
- Audit Packaging and Translation Copy: English efficacy terms in Thai notification names (such as “Acne”) must be precisely transliterated into Thai rather than translated. Marketing copy must systematically include mandatory disclaimers such as “Results may vary depending on individual skin conditions.”
For cosmetics brands targeting the Thai market, aligning formulations against these mandatory ingredient lists during product R&D—and auditing marketing copy against these review standards—will ensure smooth notification approvals and secure market expansion.
