Clear Difference Between Health Supplements and Supplemented Foods (2025 Update)

Want to sell health-related food products in Vietnam? Don’t confuse “Health Supplements” with “Supplemented Foods”! Understanding the legal classification is the first step to successful registration and compliance.

Introduction

In Vietnam, the terms Health Supplements/ Dietary Supplement and Supplemented Food/ Fortified Food often appear similar, but they are legally distinct categories under food regulations. This article clarifies the key differences based on Decree 15/2018/ND-CP, the primary legal framework. We will also touch upon the current legal landscape in 2025, including a significant upcoming amendment, to help importers, manufacturers, and distributors ensure full compliance.

Key Distinction: Definitions under Vietnamese Law (2025)

What are Supplemented Foods?

As defined by Vietnamese food laws, supplemented foods are regular foods fortified with specific nutrients or functional ingredients. These products may include:

• Vitamin- or mineral-fortified food;

• Foods enriched with micronutrients (e.g. iron, calcium);

• Infant and maternal nutrition formulas.

Supplemented foods are not classified as functional foods. They are consumed like ordinary food but offer added nutritional benefits.

What are Health Supplements?

Health supplements also referred to as Thực phẩm bảo vệ sức khỏe- are a type of functional food (thực phẩm chức năng) regulated as dose-based products. They are intended to support body functions, improve health, or reduce disease risk, but are not medicines.

Key features of health supplements:

• Delivered in controlled doses: capsules, tablets, powders, liquids;

• Contain one or more bioactive ingredients: vitamins, minerals, amino acids, fatty acids, enzymes, probiotics, plant extracts, etc.;

• May originate from natural, animal, plant, or mineral sources;

• Must be labeled with the mandatory term “Thực phẩm bảo vệ sức khỏe” (Health Supplement) and include a health-related function claim.

Regulatory Procedures: Self-Declaration vs. Registration (2025)

The biggest procedural difference lies in the type of notification or approval required by the Ministry of Health (Vietnam Food Administration – VFA):

A. Supplemented Foods – Self-Declaration Procedure

• Legal basis: Decree 15/2018/ND-CP, Article 4.

• Responsible party: The food business operator (manufacturer, importer, or distributor).

• Procedure:

  • Prepare product dossier with composition, label, and food safety documentation;

  • Submit to the local Department of Health or via the National Single Window;

  • Product may be circulated immediately after submission

• Applicable to: Fortified foods, enriched products, standard formula powders for mothers and children.

No prior approval is required, but post-market control is enforced.

B. Health Supplements – Registration for Product Declaration of Conformity

• Legal basis: Decree 15/2018/ND-CP, Article 6.

• Responsible party: Local legal entity holding market authorization.

• Procedure:

  • Prepare scientific dossiers, safety evidence, and testing results;

  • Submit an application to the Vietnam Food Administration (VFA);

  • Wait for official approval and issuance of registration number before circulation.

• Applicable to: Dose-based products supporting health (capsules, liquids, powders).

Market Strategy & Compliance Tips

• Use the Correct Legal Name: Always label and market your product under its officially registered classification to avoid penalties.

• Prepare Mandatory Documents: For imported Health Supplements, a valid Certificate of Free Sale (CFS) and GMP certification from the country of origin are mandatory prerequisites for registration.

• Substantiate All Claims: Any health claims made on the label or in advertising must be scientifically substantiated and consistent with your registration dossier.

• Anticipate Local Testing: Be prepared for product testing at accredited Vietnamese laboratories if requested by authorities during post-market inspections.

Risks of Misclassification

• Mislabeling or incorrect classification can result in import delays, product recall, or administrative penalties.

• Using the term “Supplemented Foods” (from foreign documents) may not always match Vietnam’s “health supplement” category. Always consult legal advisors.

• Changes in formulations may require re-declaration or re-registration.

Future Legal Outlook: The Upcoming Amendment

As of August 2025, stakeholders should be aware that the Ministry of Health is actively gathering public feedback for a new draft Decree set to comprehensively amend Decree 15/2018/ND-CP.

While this new legislation is pending, all business activities must strictly adhere to the current Decree 15. However, it is advisable to monitor these upcoming changes, as they may impact future registration strategies, labeling requirements, and ingredient classifications.

Conclusion

Understanding the distinction between health supplements and supplemented foods is critical for legal compliance in Vietnam. While supplemented foods follow a simplified self-declaration route, health supplements require full registration with the Vietnam Food Administration. By aligning your products with the correct classification and procedure, you can avoid costly delays and ensure smooth market entry in 2025.

Need help registering your supplement in Vietnam? Contact Green NRJ for expert support with product classification, testing, and registration procedures.