Post-market surveillance

Vietnam runs a post-declaration surveillance system for functional foods — placing a product on the market is the start, not the end, of regulatory attention. The regime covers inspection, sampling, recall, and penalty. Authorities: • Vietnam Food Administration (VFA) under MOH — leads inspections of TPBVSK and processes recalls and penalty decisions in its scope. • Provincial Departments of Health and inter-sectoral inspection teams — conduct on-the-ground sampling and inspections, especially at retail and manufacturing sites. • Market Surveillance authorities (Quản lý thị trường, under MOIT) — handle counterfeit, smuggled, and unregistered supplements in commerce. Common triggers for enforcement: • Periodic sampling under the annual surveillance plan. • Consumer complaints lodged via the public health portal. • Adverse reactions reported by clinicians (cross-reference: see Medicine → Pharmacovigilance for ADR-type reporting; suspected drug-spiked TPBVSK cases are typically referred to both VFA and DAV). • Online monitoring of e-commerce, livestream, and social-media listings. Recall procedures under Decree 15/2018/NĐ-CP require the responsible declarant to notify VFA within 24 hours of discovering a safety risk, submit a recall plan, and report on completion. Voluntary recalls are encouraged but VFA can impose mandatory recall and product destruction.

Recall & post-market obligations: • Decree 15/2018/NĐ-CP — recall procedures and post-declaration sampling obligations for functional foods. • Circular 43/2014/TT-BYT — chapter on post-market obligations for functional foods, including periodic quality testing. • Law on Food Safety 55/2010/QH12 — Articles on prevention, stopping, and remedying food-safety incidents. Administrative penalties: • Decree 115/2018/NĐ-CP — issued 4 September 2018. Administrative penalties for food-safety violations. Sets maximum fines, supplementary measures, and jurisdiction for sanctioning authorities. • Decree 124/2021/NĐ-CP — issued 28 December 2021, effective 1 January 2022. Amends and supplements Decree 115/2018 and Decree 117/2020 (health-sector penalties): expanded penalty authority, increased maximum fines (up to 7x the value of violating goods), and clarified violation categories. Criminal route (severe cases): • Penal Code 100/2015/QH13 — Article 317 on production and trading of foods that fail safety standards (referenced for cases involving prohibited substances or serious harm).

2024–2025 — Sustained crackdown on online supplements: Joint enforcement by VFA, DAV, Market Surveillance, and platform operators has continued targeting TPBVSK and unregistered supplements sold via livestream commerce, social media, and cross-border e-commerce. Common findings: products spiked with sildenafil analogues, sibutramine, glibenclamide, dexamethasone, or anabolic steroids; missing declaration certificate; mandatory disclaimer hidden or absent. 2022 — Decree 124/2021 took effect: On 1 January 2022, amended penalties under Decree 124/2021/NĐ-CP came into force, expanding the authority of inspectorate, public security, customs, and market-surveillance officers to sanction food-safety violations, and raising the cap on fines tied to the value of violating goods. Standing — Periodic VFA bulletins: VFA publishes recurring bulletins of warned and recalled TPBVSK products, and of confirmed advertising-content violations. These are the primary open-source signal of post-market enforcement intensity.