The legal answer to how functional foods differ from ordinary food is short: ordinary food is self-declared, while health-protection food (functional food) requires a registered product announcement and may circulate only once the authority issues a registration number. But the difference does not stop at paperwork — it pulls in GMP production conditions, advertising control and the burden of proving claimed effects. This article covers the full picture.
Registered announcement: dossier and receiving authority
Under Articles 6 to 8 of Decree 15/2018/ND-CP, the organisation marketing a health-protection food files its announcement dossier with the Food Safety Authority of the Ministry of Health (via the online public-service system). Core contents: the standard-form product announcement; the production facility’s food safety eligibility certificate or equivalent (for imports, a certificate of free sale and/or home-authority documents); product safety test results; and scientific evidence supporting any claimed supportive effect of the ingredients. Domestically produced products must be made at facilities meeting the conditions and the GMP roadmap for health-protection foods set by the Ministry of Health — a barrier that leaves many small contract manufacturers unqualified to produce functional foods.
Issuance timing and post-registration management
Appraisal time depends on dossier completeness: missing effect evidence or insufficient test criteria trigger supplementation requests and corresponding delay; well-prepared dossiers commonly complete within weeks, while repeatedly supplemented ones can take months. After the registration number issues, the product remains under post-market control: inspectors may sample circulating products for re-testing; changes to composition, claimed effects or the production facility require re-registration or notification as prescribed and cannot simply ride on the old number. Registration is revoked where the product is no longer safe or the dossier contained untruthful elements.
Advertising: the second control layer unique to functional foods
Health-protection food is the only everyday food category whose advertising content must be confirmed by the competent authority before advertising under the Advertising Law 16/2012/QH13 (as amended by Law 75/2025/QH15), and content may not exceed the registered effects. The most-sanctioned errors: using patient images and testimonials implying cure; claiming ‘treatment’ or ‘cure’ where the product is registered only for support; and running unconfirmed ads via livestreams and social media. From 15/5/2026, advertising penalties follow Decree 87/2026/ND-CP replacing Decree 38/2021/ND-CP with higher fines for misleading advertising, alongside food-safety fines under Decree 115/2018/ND-CP where circulation conditions are also breached.
Recommendations
Build the dossier on a ‘prove every claim’ discipline: every effect on the label must trace to scientific material in the file; verify the contract manufacturer’s GMP status before signing; and run a two-layer ad-clearance process — registration number plus advertising confirmation — before any content is published, including content produced by hired KOLs.
Frequently Asked Questions
Must functional foods be registered with the Food Safety Authority?
Yes. Health-protection foods fall under registered announcements in Articles 6-8 of Decree 15/2018/ND-CP, filed with the Food Safety Authority of the Ministry of Health, and may circulate only once a registration number is issued — unlike ordinary food self-declaration.
What does the registration dossier contain?
The standard-form announcement; the facility’s food safety/GMP certificate (for imports: free-sale certificate and home-authority papers); safety test results; and scientific evidence for any claimed effect.
What restricts functional-food advertising?
Content must be confirmed before advertising, must not exceed registered effects, and must not imply cure. Violations are fined under Decree 87/2026/ND-CP (replacing Decree 38/2021 from 15/5/2026) on advertising and Decree 115/2018/ND-CP on food safety.
How long does a registration number take?
It depends on dossier completeness: strong dossiers often complete in weeks; dossiers needing effect-evidence or testing supplements can take months. Scientific documentation quality and facility conditions at first filing are decisive.
This article has been quality-reviewed by the FLAW AI Legal Council