Bangladesh regulates health supplement/dietary supplement products under its food-safety framework through the Food Safety (Health Supplement/Dietary Supplement, Food for Special Dietary Use, Food for Special Medical Purpose, Prebiotic and Probiotic Food) Regulations, 2025. These are provided by the Bangladesh Food Safety Authority (BFSA).
This guide explains the process of health supplement registration in Bangladesh with reference to the requirements of BFSA & DGDA, documents required, labelling, import compliance, etc.
Regulatory Authority for Dietary Supplements in Bangladesh
In Bangladesh, two bodies handle dietary supplements and their functions:
BFSA
The Bangladesh Food Safety Authority (BFSA) provides regulations for health support food/supplementary food. It also offers Safe Food (Advertisement and Claim Regulations, 2025) under the Ministry of Food. BFSA puts health supplements under the Safe Food category.
DGDA
The Bangladesh Directorate General of Drug Administration (DGDA) provides import and local production regulations under the Drugs and Cosmetics Act, 2023. This means the registration procedure for these supplements falls under the DGDA. DGDA categorizes dietary supplements under the “Drugs” category.
What Are Health/Dietary Supplements Under Bangladesh Regulations?
The BFSA regulations cover health/dietary supplements as foods that supplement human nutrition by increasing total dietary intake or maintaining good health and health protection. These supplements don’t intend to treat or cure any disease or disorder.
The regulation specifically identifies one or more of the substances, including vitamins, minerals, amino acids, fatty acids, enzymes, probiotics, metals, compounds, herbs, animal-derived ingredients, bioactive substances, and related ingredients.
Health Supplements Import Registration Process in Bangladesh
The BFSA regulation expressly states that a person wishing to manufacture, repackage, market, sell, offer for sale, distribute, import or export any brand of Health Support Food/Supplementary Food must apply for registration in the manner and on payment of the fee prescribed by the Authority and must renew the approved registration.
Separately, the DGDA notice states that the products covered by its scope must be registered under the Drugs and Cosmetics Act, 2023. It also states that commercial import of supplement-type products without DGDA registration does not qualify for a DGDA opinion or NOC for release from the customs house or port.
Here’s the import registration process to follow:
Step 1: Confirm Whether the Product Requires Registration
Under Section 29(1), manufacturing, importing, exporting, selling, distributing, stocking, or displaying such products without registration is a punishable offence. For commercial imports of the covered supplement-type products, DGDA will not issue an opinion or NOC for customs/port release where the products have not been registered with DGDA.
There’s an exception for small quantities intended for personal use and, where specifically required, specialised medical treatment, for which an NOC may be considered.
Step 2: Check the Applicable Reference-Country Requirement
For registration of imported products, DGDA identifies the following as reference countries:
- European Union Member States
- Switzerland
- Canada
- Australia
- Japan
- South Korea
- Singapore
- Russia.
The product must be registered/marketed under the same brand name in the relevant reference country.
Step 3: Prepare the Import Application
The applicant must submit an application on the importer’s official letterhead, together with an Authorisation Letter from the manufacturing company. The application documentation also includes a certificate/attestation issued by the Chamber of Commerce of the manufacturing country.
Step 4: Prepare the Free Sale and Country-of-Origin Documentation
A Free Sale Certificate (FSC) issued by the regulatory/control authority of the manufacturing country and authenticated by the Bangladesh Embassy is required under the import document.
Where the manufacturing country is outside the reference countries, the document requires a Country-of-Origin document, an FSC or Certificate of Pharmaceutical Product (CPP) from one of the specified reference countries, and the applicable authentication by the Bangladesh Embassy.
Step 5: Prepare the Technical and Quality Documentation
The official DGDA document identifies the Material Safety Data Sheet (MSDS), Certificate of Analysis (COA), Product Test Method, and Composition Details for the import application. The document also requires information relating to the manufacturing process, stability data, including accelerated and shelf-life/real-time stability data, and Good Manufacturing Practice (GMP) certification/documentation.
Step 6: Pay the Applicable Fee and Submit the Application
The DGDA document states that applications submitted after payment of the required fee, as well as applications already submitted to DGDA, will be forwarded to the Drug Control Committee (DCC) for disposal.
Step 7: Drug Control Committee Review
The document states that applications are disposed of in accordance with the decision of the Drug Control Committee (DCC).
Step 8: Complete Registration Before Commercial Import
Commercial manufacture, import, sale, distribution, stocking, or display without the required registration is subject to the legal restriction described under Section 29(1) of the Drugs and Cosmetics Act, 2023.
Where registration has not been obtained, the document states that DGDA has no provision to issue an NOC for commercial release of those products from the customs house or port.
For Local Manufacturing–
For locally manufactured dietary supplements or similar products, the DGDA notice states that the prevailing drug-registration procedures and applicable rules shall be followed.
Documents Required for Import Health Supplement Applications in Bangladesh
DGDA demands administrative, technical, and quality documents for health supplement registration & import approval in Bangladesh.
- Application form and authorisation documents.
- A certificate of Pharmaceutical Product (CPP) and/or Free Sale Certificate (FSC).
- GMP certificate
- The composition and specifications of products.
- Certificate of Analysis (COA)
- Manufacturing process details
- Stability data
- Material Safety Data Sheet (MSDS)
- Create label and packaging artworks.
- Product Test method
- Chamber of Commerce Certificate
- Wholesale licence
- Draft packaging materials
- Fee payment proof/ challan
The DGDA notice also distinguishes country-of-origin documentation requirements for imported products and refers to FSC/CPP documentation authenticated through the Bangladesh mission in the relevant circumstances.
Health Supplement Registration Timelines & Costs in Bangladesh
There’s no official timeline for when the registration procedure will be finished. Similarly, there are no fixed costs for dietary supplements.
Review timelines will vary depending on the completeness of the dossier, the authentication of documents, and regulatory evaluation. Health supplement registration costs in Bangladesh may arise from document authentication, embassy processing, testing, translation, GMP documentation, and regulatory support.
Compliance Checklist for Health Supplement Imports in Bangladesh
Prior to submitting an application to DGDA, companies should check:
- The product meets the regulatory definition of Health Support Food/Supplementary Food (Health Supplement/Dietary Supplement).
- The formulation complies with the permitted ingredients and nutrient requirements.
- Applicable registration requirements under the BFSA regulations have been addressed.
- Applicable DGDA registration requirements have been addressed for products covered by the DGDA notice.
- Import documentation is complete where the product is imported.
- GMP documentation, manufacturing information and stability data are available where required by the DGDA notice.
- Labelling complies with the 2025 BFSA regulation and applicable packaged-food labelling requirements.
- Claims comply with the Food Safety (Advertisement and Claims) Regulations, 2025.
Ingredient & Formulation Requirements for Dietary Supplements in Bangladesh
Products covered by the regulations may contain ingredients listed in Schedules 1, 2, 3 and 4, while additives may be used in accordance with Schedule 5 and the Food Additives Regulations, 2017. Ingredients or additives not mentioned in the regulations may be used only where permitted under the applicable approval requirements.
Plant or plant-part ingredients or extracts not listed in the regulations may be used where a documented history of safe use exists, including at least 30 years in the country of origin or 15 years in Bangladesh. Added nutrients must not exceed the Recommended Dietary Allowance (RDA) prescribed by the government or internationally recognised food standards such as Codex where no government level has been specified.
Food covered by the regulations must not contain hormones, steroids, narcotic drugs, or psychotropic substances as defined under the Narcotics Control Act, 2018, or its rules and regulations.
Vitamins and minerals
The regulation permits specified vitamins and mineral sources and provides specific provisions for derivatives, salts, esters and chelates. Food Business Operators must notify BFSA in writing when using the specified vitamin/mineral esters, derivatives, salts or chelates, and additional safety data or information must be supplied if requested by the Food Authority.
Nutrient overages
Appropriate vitamin and mineral overages may be used on the basis of scientific rationale, subject to the permitted percentages unless scientifically justified otherwise. The label must declare “appropriate overages added” in the composition declaration panel.
Labelling Requirements for Health Supplements in Bangladesh
Labels of food covered by these regulations must comply with the Packaged Food Labelling Regulations, 2017. For covered food categories, the front of the package must prominently and in bold type state the applicable category, including “HEALTH SUPPORT FOOD/SUPPLEMENTARY FOOD”.
Unless an exemption applies to the relevant category, the label must prominently state “NOT FOR MEDICINAL USE”. It must also state the recommended quantity of use and duration of use.
The label must clearly state that the recommended daily amount must not be exceeded and must include warnings where excessive consumption may create a health risk or where use may cause adverse reactions, side effects or interactions with medicines.
It must state “KEEP OUT OF REACH OF CHILDREN”. The quantities of nutrients and/or ingredients having physiological effects present in the food must be declared. The label, instructions and advertising must provide clear and understandable information about the product’s nature, purpose, intended use, directions and precautions.
For Health Support Food/Supplementary Food specifically, nutrition information must be declared per 100 g, per 100 ml, or per serving/dose, and negligible or absent carbohydrate, sugar, fat, sodium, or cholesterol must be stated where applicable. The amount of a nutrient present in these products should generally not be less than 15% of the relevant RDA.
Health Claims and Advertising Regulations for Dietary Supplements in Bangladesh
The Food Safety (Advertisement and Claims) Regulations, 2025, apply conditions to food advertising and claims.
Companies should avoid the following:
- Misleading, false information, or deceptive claims
- No superiority claims, comparing or disparaging related products
- Hiring a doctor, nutritionist, or expert in a commercial food ad to endorse a brand or product
- Such people or institutions shouldn’t recommend the products
- Unregistered supplements shouldn’t be advertised
- No implication that a balanced and varied diet cannot provide adequate nutrition
Claims concerning food ingredients, qualities or characteristics must be true, clear and easily understood.
Conclusion
BFSA’s food safety rules and DGDA’s Drug and Cosmetics Control Act 2023 regulate health supplements in Bangladesh, and it is necessary to obtain their approval before importing and commercialising. Companies need to harmonise the product classification, documentation, labelling, GMP records, and import requirements before entering the market.
Artixio assists global supplement companies in registering supplement products in Bangladesh, meeting the requirements of the Directorate of Medicines Administration (DGDA), obtaining import authorisation, reviewing the labelling, and developing the regulatory strategies for market access in a fast and compliant manner. To know more, you can get in touch with us at info@artixio.com.
FAQs
Do health supplements require registration in Bangladesh?
Yes. The health/dietary supplements are required to be subject to approval/registration before they can be imported and commercialised.
Are foreign manufacturers allowed to register supplements in Bangladesh?
Foreign manufacturers are required to secure an importer/exporter based in Bangladesh or an authorised representative for submission of documents to DGDA and import business.
Which documents are needed to register for a health supplement in Bangladesh?
Common documents are FSC/CPP, GMP certificate, COA, product composition, stability data, manufacturing data, and artwork for the label.
