Ingredient & formulation

Formulation of dietary supplements and health-protection foods (TPBVSK) is regulated by Circular 43/2014/TT-BYT and by the Food Safety Law's requirement that functional foods carry scientific evidence supporting their claimed effects. Key constraints: • Active components must have scientific documentation of safety and efficacy submitted as part of the registered-declaration dossier. • Vitamins and minerals must remain within reference-intake-derived ceilings; Vietnam typically aligns these with Codex Alimentarius and ASEAN Harmonized Requirements for Health Supplements, with national amendments published by MOH. • Prohibited substances — anabolic steroids, prescription-only active pharmaceutical ingredients, scheduled herbs, and certain stimulants — are banned in TPBVSK. The Drug Administration of Vietnam and VFA periodically publish updated lists of substances detected in non-compliant supplements. • Herbal ingredients must follow the Vietnamese pharmacopoeia or cross-referenced ASEAN/Chinese pharmacopoeia monographs where applicable; wild-collected materials need source documentation. • Novel ingredients (those without a history of safe use in Vietnam) require additional safety dossier (toxicology, allergenicity, stability) before VFA will accept a registered declaration. Combination products that mix supplement-grade ingredients with prescription-only pharmaceutical ingredients are not permitted and would be treated as unapproved drugs under the Pharmacy Law.

Core framework: • Circular 43/2014/TT-BYT — issued 24 November 2014, effective 15 January 2015. Sets out ingredient, formulation, and labelling requirements for functional foods including TPBVSK. • Decree 15/2018/NĐ-CP — dossier requirements for the registered declaration include the ingredient list, certificate of analysis, stability data, and scientific documentation supporting claims. • Law on Food Safety 55/2010/QH12 — Article 14 sets the general scientific-evidence requirement for functional foods. Cross-references: • National Technical Regulations (QCVN) and Vietnamese Standards (TCVN) on food additives, contaminants, and microbiological limits — issued by MOH and mandatory for all foods including TPBVSK. • Vietnamese pharmacopoeia monographs for herbal ingredients. • Codex Alimentarius — guidelines for vitamin and mineral supplements. • ASEAN Harmonized Requirements for Health Supplements. Note: specific numerical ceilings for individual nutrients and the full list of prohibited substances change with MOH/VFA announcements. Always check the current published list before formulating.

2023–2025 — Crackdown on prescription-drug spiking: VFA and DAV have issued repeated joint announcements about TPBVSK products found to contain undeclared prescription pharmaceutical ingredients (sildenafil analogues, sibutramine, glibenclamide, dexamethasone, anabolic steroids). These products are seized and the responsible declarants are sanctioned under Decree 115/2018 (as amended). 2022–2024 — Permitted-additive lists expanded: MOH has progressively expanded the lists of permitted food additives and flavours, broadly aligning with Codex and ASEAN positions. The lists are authoritative for all food categories including TPBVSK. Standing — Scientific-evidence enforcement: VFA continues to reject registered-declaration dossiers where the supporting scientific evidence is unsubstantiated, of poor methodological quality, or does not match the claimed effect on the label.