Circular 43/2014/TT-BYT provides a key regulatory framework for functional foods, including product classification, declaration, labeling, advertising, production/trading conditions, recall and traceability.

QUICK SUMMARY

Regulatory scope

The Circular regulates functional food management, including product declaration, labeling, advertising, production/trading conditions, recall and traceability.

Effective date

Issued on 24 November 2014 and effective from 01 February 2015. Current application should be reviewed together with Circular 17/2023/TT-BYT and Consolidated Text 11/VBHN-BYT.

Immediate checks

Review product classification, declaration dossier, label/claims, test reports, import documents and post-clearance recordkeeping before finalizing shipment documents.

DOCUMENT INFORMATION

Field	Details
Document title	Circular on the management of functional foods
Number	43/2014/TT-BYT
Issuing authority	Ministry of Health
Issued date	24 November 2014
Effective date	01 February 2015
Signer	Nguyen Thanh Long
Application status	Apply together with the 2023 consolidated text 11/VBHN-BYT and the amendment Circular 17/2023/TT-BYT.

Translation note: This English version is for operational reference only and is not an official legal translation.

KEY POINTS FOR ENTERPRISES

Product classification

Separate supplemented foods, health supplements, foods for special medical purposes and foods for special dietary uses.

Declaration and testing

Controls conformity declaration, food-safety declaration, efficacy evidence and active-ingredient testing.

Label, advertising, claims

Controls product-group wording, health claims, mandatory disclaimer and non-medicine positioning.

AFFECTED PRODUCTS / ENTERPRISES

Importers, distributors, brand owners: product classification, declaration dossier and Vietnamese label.
Manufacturers and OEM/ODM suppliers: GMP/HACCP, formula, active substances and traceability.
Procurement, legal, compliance, operation: cross-check import documents, test reports, scientific evidence and post-clearance records.
Logistics providers: identify regulated goods early to avoid ETA without declaration/label readiness.

IMPACT ON IMPORT-EXPORT / LOGISTICS

Customs declaration: goods description, function, formula and product group should be consistent with HS code and declaration dossier.
Documents: Invoice, Packing List, B/L/AWB, C/O, contract, catalogue, original label, test report and declaration documents should match.
Timeline: declaration, testing and Vietnamese label review should be completed before ETA planning.
Compliance: maintain product dossiers, advertising claims, traceability and recall-readiness records.

ENTERPRISE CHECKLIST

Review area	Documents to compare	Risk if inconsistent	Recommended timing
Product classification	Formula, label, claims, dosage form	Wrong declaration route or labeling obligations	Before contract and label artwork
Declaration dossier	Testing result, product standard, scientific evidence, GMP	Dossier rejected or supplemented	Before ETA planning
Label and claims	Original label, Vietnamese label, ad content	Excessive medical claims; missing non-medicine disclaimer	Before printing and approval
Import documents	Invoice, Packing List, B/L/AWB, C/O, HS code	Mismatch affecting customs and food-safety inspection	Before shipment departure
Post-clearance	Dossier archive, test results, declaration receipt	Difficult post-clearance explanation or recall handling	After clearance and before market circulation

TECHNICAL TERMS

Health supplement: product supporting body functions; not a medicine.
RNI: recommended nutrition intake for Vietnamese people.
Health claims: health-related statements requiring appropriate conditions and scientific evidence.
GMP: Good Manufacturing Practice.
DEM/DET/Storage: container yard, container detention and port/warehouse storage costs caused by delayed release.

RELATED LEGAL DOCUMENTS TO REVIEW

Document group	Name / reference	Issuing authority	Effective date / timing	Role in compliance	Articles / appendices to note	Review note
Law	Law on Food Safety No. 55/2010/QH12	National Assembly	Effective from 01 July 2011	Foundation for food safety obligations, declaration, inspection and enterprise responsibilities.	Review according to product scope, enterprise responsibility and food safety management requirements.	Additional review is required if the dossier involves production, trading, advertising or market circulation.
Decree	Decree 15/2018/ND-CP	Government	Issued and effective on 02 February 2018	Key implementing decree for product self-declaration, registered declaration, state inspection, labeling, advertising and health supplement production conditions.	Especially relevant to health supplements, declaration dossiers, state inspection and labeling.	Should be read together with Circular 43/2014/TT-BYT and the consolidated text.
Main Circular	Circular 43/2014/TT-BYT	Ministry of Health	Issued 24 November 2014, effective 01 February 2015	Main document on functional food management.	Articles 1-21 and Appendices 01-02.	The signed PDF contains long numerical appendices; review the official PDF before applying.
Amending Circular	Circular 17/2023/TT-BYT	Ministry of Health	Issued 25 September 2023, effective 09 November 2023	Amends, supplements and repeals several food safety legal documents.	Review amendments affecting Circular 43/2014/TT-BYT.	Do not rely solely on the 2014 original when the dossier is prepared after the amendments.
Consolidated text	Consolidated Text 11/VBHN-BYT	Ministry of Health	Issued 02 November 2023	Consolidates the Circular on functional food management after amendments.	Use the consolidated text to check currently applicable wording.	Read alongside the signed 2014 PDF to distinguish original and amended content.
Labeling	Decree 43/2017/ND-CP and Decree 111/2021/ND-CP	Government	Decree 43 effective 01 June 2017; Decree 111 effective 15 February 2022	General labeling and Vietnamese supplementary label requirements for goods imported into Vietnam.	Mandatory label contents, labeling responsibility and supplementary labels.	Apply together with specific functional food/health supplement labeling rules.
Repealed prior document	Circular 08/2004/TT-BYT	Ministry of Health	Repealed when Circular 43/2014/TT-BYT became effective	Former document on functional food management.	Article 19 of Circular 43/2014/TT-BYT.	Historical reference only, not a current legal basis.

VIEW / DOWNLOAD ORIGINAL DOCUMENT

Use official sources and the signed PDF before applying the text to a real dossier.

Government source page View signed PDF Official Gazette page Consolidated text 11/VBHN-BYT

FULL TEXT / LEGAL TEXT

The official signed Vietnamese PDF of Circular 43/2014/TT-BYT contains 20 pages, including long numerical appendices. To avoid truncation or altered figures, the full text is provided below as a direct official PDF preview. This English page is an operational reference and not an official legal translation.

FULL OFFICIAL TEXT – CIRCULAR 43/2014/TT-BYT SIGNED PDF

Authoritative source: Government Legal Document Portal. The signed PDF is the reference document for the full official Vietnamese text, including appendices and numerical tables.

CURRENT APPLICATION CHECK – CONSOLIDATED TEXT 11/VBHN-BYT

The consolidated text helps review amended content. For a real import dossier, compare the original document, amending document and product-specific dossier.

FAQ

1. When did Circular 43/2014/TT-BYT take effect?

It took effect on 01 February 2015. Current application should also consider Circular 17/2023/TT-BYT and consolidated text 11/VBHN-BYT.

2. Which products are covered?

Supplemented foods, health supplements, foods for special medical purposes and foods for special dietary uses; formulated nutrition products for young children are excluded.

3. Must imported functional foods be declared/registered?

A declaration or registration route may apply depending on the current decree, product group, formula, claims and dossier. Decree 15/2018/ND-CP must be reviewed.

4. What is the key labeling risk?

Labels must correctly state the product group, users, claims and required disclaimer; health supplements must not be presented as medicines.

5. Is efficacy testing always required?

No. It is triggered by specific claims, new active substances, new formulas or special conditions. Scientific evidence must be reviewed.

6. What should be checked before ETA?

Classification, claims, Vietnamese label, testing result, declaration dossier, HS code, import documents and post-clearance archive plan.

SOLUTIONS FROM TGIMEX

For functional foods, operational risk usually arises from mismatch between formula – claim – label – declaration dossier – import documents – market circulation plan. TGIMEX approaches the shipment as a controlled compliance workflow before ETA.

1. Legal scope review

Review Circular 43/2014/TT-BYT, Circular 17/2023/TT-BYT, consolidated text 11/VBHN-BYT, Decree 15/2018/ND-CP and labeling rules to identify the product group, declaration route, claims and testing requirements.

2. Document control before ETA

Cross-check Invoice, Packing List, B/L/AWB, C/O, contract, catalogue, formula, original label, Vietnamese label, test report, scientific evidence and declaration documents to avoid data mismatch.

3. Customs and logistics coordination

Build a dossier timeline before ETA and identify risk blocks in customs declaration, food-safety inspection, specialist-document supplement, transport, trucking and warehousing.

4. Post-clearance readiness

Support dossier archiving by shipment/SKU, post-clearance evidence preparation, traceability data, Vietnamese-label review, advertising-claim control and recall readiness where relevant.

Operational recommendation: review the legal document and product dossier before locking import documents, before ETA and before label approval.

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