1. Definition of health supplement in Vietnam
According to Decree 15/2018/ND-CP, Circular 43/2014/TT-BYT and Circular 05/2018/TT-BYT, health supplement (also known as food supplement, dietary supplement) is used as a supplement to the daily diet to improve user’s health and immunity which may contain one or more of the following substances:
Vitamins, minerals, amino acids, fatty acids, enzymes, probiotics and other biologically active substances;
Substances derived from animals, minerals, plants in the form of extracts, isolates, concentrates or metabolites;
Combined sources of the substances mentioned above.
Health supplement may be in the form of soft gels, pellets, tablets, granules, powder, liquid and other dosage form divided into smaller doses.]
2. Competent Authority
Vietnam Food Administration under Ministry of Health
3. Regulation Framework
General requirements of functional food (including health supplement): Circular 43/2014/TT-BYT
Labeling requirements: Circular 34/2014/TTLT-BYT-BNNPTNT-BCT
Health supplement registration: Decree 15/2018/ND-CP
4. Compliance Requirements
Health supplement food registration
In order for health supplement to be sold on the market, it is a mandatory requirement to be registered with Vietnam Food Administration.
5. Registration Requirements
Labeling
MOH’s Circular 43/2014/TT-BYT in 2014 which became effective in February 2015 is the key legislation for the labeling of functional food Circular 43 entering into force on 01 February 2015.
The labeling of these products must comply with the requirements set out by MOH. Other than complying with standard regulations, the labeling requirements are as such:
Product label must show the specific phrase for product's sub-group such as health supplement, supplemented food, special food for medical purposes, and food for special dietary use.
The label must also display the nutrient contents, for instance the quantity of vitamins, minerals, amino acids, biological substances, enzymes, fatty acids, must be displayed on the label.
The statement that "This product is not a medicine, nor effective to replace medicine" must be printed directly after the effects or recommendations of the products. The statement is required to have a contrasting font color to the label's background color. In addition, the font size must be at least 1.2 mm high.
If the name of the health supplement product happens to be the same as one of the main active ingredients, this ingredient quantity must be listed on the label.
Safety and Hygiene
All firms and product owners who want to manufacture and trade health supplements must fulfill conditions on health, safety and hygiene in order for products to be licensed and sold. The Certificate on Satisfaction of Standards on food hygiene and safety must be obtained and all standards in regards to health, safety and hygiene must be maintained and improved as long as the business is valid. Such maintenance applies to workshops or stores, processors, importers, equipment, any premises used for production, storage, sales and serve, according to Hygienic Environmental Requirements.
The establishment’s owner and all employees from the stage of production to sales who will have direct contact with the health supplement must go through a periodic health check-up to ensure that their health conditions satisfy the standards by MOH. A training certificate is mandatory as well for establishment’s owner and employees to make sure they fully understand the requirements for food safety and hygiene, and will perform their jobs in accordance with these regulations.
Application Dossier
Health supplements are food and thus producers and businesses that produce and market health supplement in Vietnam must submit what is called product self-declaration or product declaration registration to MOH, pursuant to Article 6.1, 8.1.a of Decree No. 15/2018/ND-CP.
Registration Procedure
The registration process of health supplement dossiers will take 3 to 4 weeks upon submission. Once approved, the certificate is issued by MOH and does not have termination.
For health supplement imported to Vietnam, the required documents shall include:
Declaration form
Original notarized copy of food safety testing result of product that is issued within 12 months before the date of submission made by a designated laboratory or a laboratory complying with ISO 17025
Scientific evidence of the effects of product or ingredients (original or authenticated copy). If scientific evidence of effects of ingredients is used, daily dose must be greater or equal to 15% of the content of such ingredients mentioned in the document
Certificate of Good Manufacturing Practice (GMP) or an equivalent certificate. This is applicable starting 01 July 2019 (authenticated copy)
Expert Consultation is Highly Recommended
Market entry to Vietnam may be challenging for many foreign entrepreneurs. You may not be familiar with the business environment, not to mention you need to comprehend all its regulations, particularly those related to health supplement registration. This is why it is best to consult with an expert who understands every single detail of health supplement registration in Vietnam.
