Market entry & registration

In Vietnam, dietary supplements are regulated as a sub-category of functional foods (thực phẩm chức năng) under the Food Safety Law. The Law on Food Safety recognises three classes of functional foods: dietary supplements, health protection foods (thực phẩm bảo vệ sức khỏe — TPBVSK), and medical nutrition foods. The supplements category sold under brand names in Vietnam typically falls in the TPBVSK class. Decree 15/2018/NĐ-CP introduced a two-track product-declaration system: • Self-declaration (tự công bố sản phẩm) — for ordinary processed foods. The business posts the declaration on its own portal and notifies the local competent authority; products can be distributed immediately. • Registered declaration (đăng ký bản công bố sản phẩm) — mandatory for TPBVSK, medical nutrition foods, foods for special dietary uses, infant nutrition for children up to 36 months, and certain new food additives. The dossier is filed with the Vietnam Food Administration (Cục An toàn thực phẩm — VFA, under MOH); a Certificate of Registered Product Declaration must be issued before the product is placed on the market. Statutory review time: 21 working days for TPBVSK; 7 working days for medical nutrition, special-dietary, and child-nutrition products. Domestic TPBVSK manufacturers must hold a Good Manufacturing Practice (GMP) certificate for health-protection food production issued by MOH. Pharmaceutical manufacturers that already hold a drug-GMP certificate from DAV are exempt from holding a separate food-safety eligibility certificate when also producing functional foods, but TPBVSK-GMP scope must still be evidenced. Imported TPBVSK must come from facilities that meet equivalent GMP standards.

Food Safety Law: • Law on Food Safety No. 55/2010/QH12 — passed 17 June 2010, effective 1 July 2011. Establishes the framework for food safety management, product declaration, advertising, labelling, testing, and inspection. Implementing decree (current): • Decree 15/2018/NĐ-CP — issued 2 February 2018. Replaced Decree 38/2012/NĐ-CP. Introduces the self-declaration vs registered-declaration system; sets dossier requirements, review timelines, and the role of the Vietnam Food Administration (VFA). Functional foods management: • Circular 43/2014/TT-BYT — issued 24 November 2014, effective 15 January 2015. Detailed management rules for functional foods including dietary supplements, health-protection foods, and medical-nutrition foods. Replaced Circular 08/2004/TT-BYT. A draft amendment is in public consultation (per VFA). Manufacturing standards: • MOH guidance on GMP for health-protection-food production — required for domestic TPBVSK manufacturers from 1 July 2019. • Pharmaceutical manufacturers with a drug-GMP certificate under Circular 35/2018/TT-BYT (see Medicine → Regulatory Affairs) benefit from a partial exemption when also producing functional foods.

2024–2025 — Decree 15/2018 amendment in consultation: VFA has published a draft decree amending Decree 15/2018/NĐ-CP to tighten declaration dossiers for TPBVSK, formalise post-declaration sampling, and expand the list of products requiring registered declaration. Status as of 2025 is public consultation; the final text has not yet been issued. 2019 — Mandatory TPBVSK-GMP for domestic manufacturers: From 1 July 2019, domestic facilities producing health-protection foods must hold a TPBVSK-GMP certificate issued by MOH. Imported TPBVSK must come from manufacturers with an equivalent GMP standard. 2018 — Decree 15/2018 took effect: Decree 15/2018/NĐ-CP replaced Decree 38/2012/NĐ-CP, introducing the self-declaration vs registered-declaration split. Most ordinary foods moved to self-declaration; TPBVSK and high-risk categories remained at registered declaration with MOH/VFA.