Legal provisions on the trading of health supplements

With increasing consumer demand, the health supplement market presents growing opportunities for businesses. However, ensuring product quality and safety, and compliance with legal regulations is essential for sustainable development and for safeguarding consumer rights. NPLaw invites readers to explore the legal issues surrounding the trading of health supplements.

I. Current status of the trading of health supplements  

Today, with rising public interest in improving health and preventing disease, many businesses have invested in the production and distribution of functional foods and health supplements. However, this market also harbors risks related to product quality and misleading advertising.

Many health supplements sold on the market have unclear origins or unverified efficacy. In addition, false advertising, such as exaggerating product benefits or using unauthorized images of doctors or medical institutions to build consumer trust, is still common. These practices can easily deceive consumers and pose potential health risks.

II. Legal provisions on the trading of health supplements

1. What are the requirements to trade health supplements?

According to Articles 6, 7, and 9 of Decree No. 67/2016/ND-CP, entities trading in health supplements must meet the following conditions:

- Adequate space for product display, storage, and convenient transportation of raw materials and goods;

- The facility must not be affected by flooding, animals, insects, or other sources of contamination;

- Construction must match the nature and scale of business and be built from hygienic, safe materials;

- Walls and ceilings must be smooth and light-colored, made from durable materials, not leaking or moldy, and resistant to dirt;

- Sanitary areas must be separated from food areas, and restroom doors must not open directly into food storage zones;

- A system (manual or digital) must be in place for managing food items throughout the business process;

- The facility must be equipped with appropriate tools for preserving and monitoring food safety according to manufacturer requirements;

- Adequate waste collection tools with lids must be available and regularly cleaned;

- Importing products must have a separate warehouse or designated storage space suited to preservation requirements;

- If products are sold at a pharmacy, a separate display area with proper signage and guidance is required.

In short, businesses must meet all the above conditions to trade health supplements safely and in compliance with legal standards, ensuring public health protection.

2. Procedures for registering product declaration when trading health supplements

According to Articles 7 and 8 of Decree No. 15/2018/ND-CP, the steps for registering a product declaration are as follows:

Step 1: Preparing an application dossier
The dossier typically includes:

- Product declaration form;

- Certificate of eligibility for food safety (unless exempt);

- Scientific evidence proving the product’s efficacy (for health supplements);

- Valid product testing results (within the past 12 months);

- Product label or label images.

Step 2: Submitting the dossier

- Submitting directly, via post, or online through the Ministry of Health’s Public Service Portal;

- Receiving authority: Vietnam Food Administration – Ministry of Health.

Step 3: Appraisal and certificate issuance

- Processing time: 21 working days from receipt of the valid dossier;

- A Certificate of receipt of product declaration will be issued if requirements are met.

Step 4: If the dossier is incomplete or invalid

- The authority may request amendments only once;

- There is a written explanation with legal basis for the request;

- Within 7 working days from receiving the supplementary dossier, the authority must re-appraise and respond.

III. Questions on the trading of health supplements

1. What are the fines for trading health supplements without product declaration registration?

According to Clause 2, Article 3 and Clause 2, Article 21 of Decree No. 115/2018/ND-CP, failure to register product declarations for products that require it will be fined as follows:

- Individuals: Fine from 40,000,000 VND to 50,000,000 VND;

- Organizations: Double the fine for individuals, i.e., 80,000,000 VND to 100,000,000 VND.

In addition to fines, violators may be subject to partial or full suspension of production or importation activities related to the products for 01 to 03 months (Clause 3, Article 21, Decree 115/2018/ND-CP).

Authorities may also impose additional measures under Clause 4, Article 21, including:

- Mandatory recall of non-compliant products;

- Forced change of use or recycling;

- Mandatory destruction if the product fails to meet safety standards.

Thus, the trading without declaration registration can result in monetary fines and suspension, and possibly mandatory recall or destruction of the product.

2. Which authority is responsible for issuing product declaration registration certificates?

According to Clause 1, Article 8 of Decree No. 15/2018/ND-CP, the Ministry of Health is the competent authority to issue Product Declaration Registration Certificates for health supplements. Organizations and individuals must submit their dossiers to the Ministry for the following products:

- Health supplements;

- Mixed food additives with new uses;

- Food additives not included in the permitted list.

3. What is the processing time for a product declaration registration certificate?

Per Clause 2, Article 8 of Decree No. 15/2018/ND-CP, the processing time is 21 working days for health supplements. If the dossier is complete and valid, the Ministry will appraise and issue the Certificate of Receipt within this period.

4. Is a special business license required to trade health supplements?

Vietnamese law does not currently require a special license to trade health supplements (e.g., functional foods or health-protective products). However, businesses must comply with all applicable legal requirements, especially product declaration registration, to ensure quality and safety.

Thus, while no special license is needed, compliance with food safety laws and product regulations is mandatory.

5. What are the advertising regulations for health supplements?

Under Articles 15 and 26 of Decree No. 15/2018/ND-CP, advertising health supplements must comply with the following:

- Businesses must register the advertisement content with the agency that issued the product declaration certificate;

- Advertisement content must match the declared use and effect of the product;

- Prohibited use of images/information of medical units, doctors, pharmacists, or thank-you letters from patients;

- Must include a clear disclaimer: “This product is not a medicine and does not replace medical treatment.”

- For audio/visual advertisements, the disclaimer must be read aloud. For ones shorter than 15 seconds, it may be displayed instead of read.

Therefore, businesses must ensure their advertisements follow these rules to avoid fines.

6. What standards must be met for lawful trading of health supplements?

According to Articles 6, 7, and 9 of Decree No. 67/2016/ND-CP, businesses must:

- Have adequate space for display, storage, and transport;

- Operate in facilities free from flooding, contamination, pests, mold, or mildew;

- Use a system (manual or digital) to manage food;

- Have appropriate storage areas matching manufacturer’s conditions;

- Display products in a designated area with proper signage.

These standards are essential to ensure product safety and consumer protection.

IV. Legal advisory services for the trading of health supplements

The above is an article by NPLaw on legal aspects of health supplement trading. With a team of experienced lawyers and legal consultants, NPLaw is always ready to assist clients with legal advice related to the trading of health supplements. For further legal assistance, please contact: