Product Claims & Classification

A central question in Vietnamese cosmetic regulation is whether a product is a **cosmetic** or a **drug / medical device / functional food**. The definition in Circular 06/2011/TT-BYT — taken verbatim from the ACD — restricts cosmetics to substances or preparations applied to external parts of the human body (epidermis, hair, nails, lips, external genital organs), to the teeth, or to the mucous membranes of the oral cavity, with a **non-therapeutic** primary purpose: cleansing, perfuming, changing appearance, correcting body odours, protecting, or keeping in good condition. Products crossing into therapeutic or pharmacological territory ("borderline products") are removed from the cosmetic notification regime and require drug, traditional medicine, or medical-device licensing. Common borderline categories: • **Toothpaste** — cosmetic if claims are limited to plaque/tartar removal, freshening, or whitening. Drug if claims include caries prevention via therapeutic fluoride content, treatment of periodontitis, or anti-bacterial therapeutic action. • **Sunscreen** — cosmetic if UV filters are within Annex VII limits and the SPF claim is the dominant function. Therapeutic territory if claimed to "treat" sun damage or to contain pharmacological actives. • **Anti-dandruff shampoo** — cosmetic if marketed for "control" of dandruff using cosmetic actives (e.g., zinc pyrithione within Annex VI). Drug if claiming to "cure" seborrhoeic dermatitis. • **Anti-acne products** — cosmetic if formulated with salicylic acid <2%, BHAs, or AHAs within Annex III. Drug if marketed with benzoyl peroxide ≥2.5%, prescription retinoid analogues, or antibiotics. • **Skin-whitening products** — cosmetic if active ingredients are permitted brighteners (e.g., niacinamide, vitamin C, tranexamic acid within ASEAN limits). Drug or banned if containing hydroquinone, kojic acid above the under-review limit, mercury, or corticosteroids. The **ASEAN Cosmetic Claim Guidelines** define the categories of acceptable cosmetic claims (cleansing, beautification, perfuming, protection, maintenance, deodorisation) and prohibit therapeutic claims. Examples of prohibited claims: • "Treats", "cures", "heals", or "prevents [disease]". • Use of specific disease names: acne vulgaris, eczema, psoriasis, melasma, rosacea, vitiligo, hyperpigmentation as a medical condition. • "Regenerates tissue", "restores cells", or other pharmacological language. • "Anti-cancer", "anti-inflammatory" (therapeutic implication). • "Clinically proven" without substantiation that meets the ASEAN guideline standard. • Implied medical credentials (e.g., "dermatologist-prescribed" where no prescription product exists). Permitted claims must be **truthful, substantiated, and supported by evidence** held in the Product Information File. Substantiation may be ingredient-based, in-vitro testing, in-vivo testing, consumer perception studies, or published scientific literature, subject to the documentation standards in ASEAN Guidelines on Claim Substantiation. Advertising of cosmetics is governed by the Advertising Law 16/2012/QH13 and its implementing decrees. For most cosmetic products, advertising content must be **registered/confirmed** with the provincial Department of Health before broadcast; the content must be consistent with the notified product claims.

Definition and claim framework: • Circular 06/2011/TT-BYT, Article 2 — cosmetic definition. • ASEAN Cosmetic Directive, Article 2 — original definition. • ASEAN Guidelines on Cosmetic Claims — categories of acceptable claims and prohibited therapeutic language. • ASEAN Guidelines on Claim Substantiation — documentation standard for evidence supporting cosmetic claims. Borderline product determinations: • Law on Pharmacy 105/2016/QH13 — drug definition (the test for whether a product crosses into drug territory). • Decree 36/2016/NĐ-CP and Decree 98/2021/NĐ-CP — medical-device definition (the test for borderline products that may be medical devices). • DAV opinions on specific borderline products — issued case by case on request from manufacturers. Advertising: • Law on Advertising 16/2012/QH13. • Decree 181/2013/NĐ-CP — detailed rules implementing the Advertising Law. • Decree 70/2021/NĐ-CP — advertising in the network environment, including cross-border e-commerce. • Decree 38/2021/NĐ-CP — administrative penalties for advertising violations (amended by Decree 129/2021/NĐ-CP). • Circular 09/2015/TT-BYT — confirmation of advertising content for pharmaceutical, cosmetic, food, and medical-device products.

Enforcement trends: • Skin-whitening cosmetics with therapeutic claims (e.g., "treats melasma", "removes scars permanently") remain a primary enforcement target for DAV and provincial DOH inspectors. • Live-stream and e-commerce cosmetic sales increasingly fall under the network-advertising rules of Decree 70/2021; platform operators are required to remove non-compliant listings on notice from MOH. • Decree 38/2021/NĐ-CP raises fines for misleading cosmetic advertising up to 80 million VND for organisations (40 million for individuals), plus possible withdrawal of the advertising confirmation and suspension of the notification number. ASEAN guideline updates: • ASEAN Cosmetic Claim Guidelines were tightened in recent cycles on "natural", "organic", "vegan", and "clinically proven" claims, requiring documented standards and traceable origin. • ACSB has clarified positions on claims related to micro-biome, blue-light protection, and pollution-defence — permitted only with consumer-perception or in-vitro evidence at minimum.