The legal regime for specialized food products in Bangladesh is set for a significant transformation with the introduction of the Safe Food (Health Supplements/Dietary Supplements, Food for Special Dietary Uses, Food for Special Medical Purposes, Prebiotic and Probiotic Food) Regulations, 2025 - yes, that’s a long name. Gazetted on February 23, 2025, by the Bangladesh Food Safety Authority (BFSA) under the Ministry of Food, the detailed regulation (S.R.O. No. 50-Act/2025) are poised to come into effect six months after the publication date i.e. on August 23, 2025. This landmark regulatory framework aims to ensure the safety, quality, and appropriate labeling and marketing of a rapidly growing category of food products, providing clarity for manufacturers, importers, and consumers alike.
Scope and Foundational Definitions
The Regulations bring under a unified legal umbrella several distinct categories of specialized foods. As per Regulation 2, key definitions that underpin the framework include:
- Health Supplement/Dietary Supplement: Foods or food ingredients intended to supplement the normal diet to enhance total dietary intake or maintain good health and protection, not for treating diseases. These can include botanicals, minerals, vitamins, proteins, amino acids, enzymes, probiotics, and bioactive substances.
- Food for Special Dietary Uses (FSDU): Specially processed or formulated foods to satisfy particular dietary requirements that exist due to specific physiological or health conditions such as low weight, obesity, diabetes, pregnancy, lactation, old age, celiac disease, weight management, or for athletes.
- Food for Special Medical Purposes (FSMP): Specially processed or formulated food intended for the dietary management of individuals whose nutritional requirements cannot be met by normal foods alone, used under medical/dietitian/nutritionist advice. This category covers foods for individuals with limited or impaired capacity to ingest, digest, absorb, metabolize, or excrete ordinary foodstuffs or certain nutrients.
- Prebiotic Food: Food containing gut-friendly ingredients that beneficially affect the host by selectively stimulating the growth and/or activity of one or a limited number of bacteria in the colon.
- Probiotic Food: Food containing an adequate number of live microorganisms which, when consumed, confer one or more demonstrated health benefits on the host.
The Regulations also define “Non-specified Food/Ingredients,” “Osmolality,” “Osmolarity,” “Enteral Nutrition or Tube feeding,” and “Formula Food,” among others, providing a clear lexicon for this specialized sector.
General Rules for All Specialised Foods
The Regulations establish general conditions that apply to all categories of these specialised foods. A key point is that these products must be clearly different from regular foods due to their special formulation or purpose. Natural foods like vegetables, grains, or fruits are not considered health supplements or special dietary/medical foods unless they are specifically processed or formulated to meet the regulatory criteria.
Important general conditions include:
- Product Forms: These foods can be supplied in various forms (e.g., powders, tablets, liquids) or as conventional food items (e.g., bars, biscuits), but their special nature must be clearly labelled.
- Use by Children: Generally, these foods are not intended for children under five years old, unless specifically formulated for children aged two to five and recommended by a qualified health professional.
- Approved Ingredients: Ingredients must be from permitted lists (detailed in Schedules to the Regulations). Use of any unlisted ingredient or additive requires prior approval from the Bangladesh Food Safety Authority (BFSA). Plant or botanical ingredients with a history of safe use may be permitted with BFSA approval.
- Purity and Standards: Products must meet purity standards set by the BFSA. If national standards are not available, internationally recognised standards (e.g., Codex Alimentarius, WHO, EU) will apply.
- Nutrient Levels: The amount of added nutrients should not exceed the Recommended Dietary Allowance (RDA) established by the government, or international standards if an RDA is not specified. Formulations must be based on sound nutritional science.
- Prohibited Substances: Products must not contain hormones, steroids, narcotics, or psychotropic substances as defined by relevant Bangladeshi law.
- Labelling and Registration: All products must comply with existing packaged food labelling rules, as well as specific new labelling requirements. Importantly, any business involved in producing, processing, marketing, importing, or exporting these specialised foods must register their products with the BFSA.
- Health and Nutrition Claims: Any claims about nutritional benefits, health advantages, or risk reduction for diseases must align with BFSA’s advertising regulations and generally require prior BFSA approval. Claims that a product can treat, cure, or prevent a specific disease are prohibited without explicit BFSA permission.
Clearer Labelling for Consumer Protection
The Regulations introduce specific labelling requirements to ensure consumers are well-informed. Beyond general labelling rules, these include:
- Clearly stating the food category on the front of the package (e.g., “HEALTH SUPPLEMENT,” “PROBIOTIC FOOD”).
- Specifying the target consumer group or age, if applicable.
- A bold declaration “NOT FOR MEDICINAL USE,” unless specifically exempted.
- Recommended usage instructions, including quantity and duration if relevant, and a warning not to exceed the recommended daily intake.
- Advisory warnings about potential health risks from overdose or side effects.
- A statement like “NOT TO BE USED AS A SUBSTITUTE FOR A NORMAL DIET” (unless the product is designed as a sole source of nutrition, such as certain FSDU and FSMP).
- The mandatory warning: “KEEP OUT OF REACH OF CHILDREN.”
- Information on the quantity of nutrients or active ingredients.
- All label information must be easy for consumers to understand.
Category-Specific Highlights
While detailed provisions exist for each category, some key aspects are:
- Health Supplements (Regulation 5): Can use chemically synthesized ingredients analogous to natural extracts (as listed in Schedules 1, 2, 3). Nutrient content should generally be at least 15% of the RDA per serving. Nutritional information must be declared per 100g/ml or per serving.
- Food for Special Dietary Uses (FSDU) (Regulation 6): Includes foods for weight management, diabetics, pregnant/lactating women, elderly, etc. Products for oral/enteral tube feeding are permitted but not for parenteral use. Strict labeling is required, including the specific dietary use and warnings about use by vulnerable groups without professional advice. Foods for athletes must not contain substances banned by WADA. Formula foods for weight management have specific energy (800-1200 kcal for total diet replacement; 200-400 kcal for partial meal replacement) and macronutrient composition requirements, including protein quality (PDCAAS score of 1.0 where possible).
- Food for Special Medical Purposes (FSMP) (Regulation 7): Categorized as nutritionally complete (standard or disease-specific formulation) or nutritionally incomplete. Their use requires robust scientific and clinical/epidemiological justification, submitted to BFSA if needed. Labeling is highly specific, including statements like “FOOD FOR SPECIAL MEDICAL PURPOSES,” “FOR THE DIETARY MANAGEMENT OF (SPECIFIC DISEASE/CONDITION),” and “NUTRITIONALLY COMPLETE/INCOMPLETE.” Again, parenteral use is prohibited. Very low-calorie diet (VLCD) formulas for total diet replacement must provide 450-800 kcal/day with specific protein, essential fatty acid, and carbohydrate minimums.
- Prebiotic and Probiotic Foods (Regulation 8): Permitted prebiotic compounds and probiotic strains are listed in Schedule 4. Prebiotic intake should not exceed 40g/day for adults. Probiotic foods must contain a minimum of 108 Colony Forming Units (CFU) of viable microorganisms per recommended daily serving, though this can be lowered with BFSA approval based on scientific evidence. Labels must specify the genus, species, and strain (with culture collection number) of probiotics, the minimum viable count at expiry, the effective dose for health claims, and proper storage instructions.
Regulatory Authority and Future Amendments
Regulation 9 empowers the BFSA to amend, change, or add to the Schedules of these regulations as needed, with such changes to be publicly notified via gazette. Regulation 10 also provides for the BFSA to publish an authenticated English translation of these regulations, with the Bangla version prevailing in case of any conflict.
The detailed regulation mark a new era for specialized foods in Bangladesh, aligning the nation with international best practices and prioritizing consumer safety and informed choice. Businesses in this sector must now proactively engage with these new rules, ensuring their products, processes, and marketing strategies are fully compliant to thrive in this evolving regulatory environment.