Thai FDA Food & Supplement Registration Thailand

Thai food regulation is divided into three layers. First, the business and its premises — importing food for sale requires an import licence (Or.7) under Section 15 of the Food Act, and this licence is issued to the Thai importer and its storage premises. Second, the product — each item needs a food registration number (เลขสารบบอาหาร), and the form used to obtain it is decided by the product type. Third, labelling and advertising — the Thai label is aligned with the Notification, and efficacy advertising obtains pre-approval.

These three are separate procedures with a fixed order. Registration cannot start on formulation documents alone; the importer and storage premises must be in place before the product application can proceed. Brands with no Thai entity, or that do not want the licence tied to a particular distributor, look at license holding under Doosigan's name together with IOR.

Thailand divides food into four groups by risk level, and product-specific Ministry of Public Health Notifications set the specifications, labelling and registration method for each type. A product with the same name can require a different form and different documents once its type changes.

Items for which the FDA has issued determination guidance follow it; products the guidance does not settle are put to a formal food-type determination (วินิจฉัยประเภทอาหาร). For a new product where even the responsible bureau is unclear, the classification desk of the Bureau of Innovative Health Products is the starting point.

Brand tip: do not assume the same route in Thailand because the product is a health functional food in Korea. Setting out the raw-material form, content, daily intake and claims first narrows the type and the need for additional documents quickly.

The registration form is decided by the product type. The order is not to pick a form first and fit the product to it.

• สบ.7 (Sor Bor.7) — the food registration number route for general foods and most processed foods. It follows a pre-market sequence: self-assessment by the business, a manufacturing or import premises number, officer approval, then number issue. The documents required vary with the Notification type.
• สบ.5 (Sor Bor.5) — the route for food supplements, royal jelly products and similar. On approval a food registration certificate (สบ.5/1) is issued.
• อ.17 (Or.17) — the food formula registration application for specifically controlled foods (infant formula, food for infants and young children, foods for special purposes and so on). It is distinct from the certificate issued on approval (อ.18). It is not a common step for all foods.

In consultations the romanised names shift between Sor Bor, Sorbor, Orr and Aor, so we confirm by the Thai form number. The system has changed so that original test reports are submitted after the registration number is obtained, but before applying, the business itself must confirm that the reports meet every requirement of the Notification.

Domestic manufacturing premises are inspected under GMP Notification No. 420; overseas manufacturing sites substitute a manufacturing-system certificate. Recognised standards are those equivalent to Notification No. 420 — GHP, GMP, HACCP, ISO 22000 and others — and the certificate must state the standard, the site's name and address, the certification scope (the food type and manufacturing process must cover the imported products) and the issuing body. A certificate whose scope leaves out the imported products is the most common reason for rejection, and there is a channel for confirming validity with the FDA through a pre-inquiry before import.

Where an on-site inspection of the overseas manufacturing premises is required, the FDA runs remote inspections by video conference and email. A manufacturer that has its documents and records organised for a remote inspection changes the schedule considerably.

Additives are used only within the usage limits of Ministry of Public Health Notification No. 281 and the FDA additives manual. Additives that do not meet the limits, unlisted probiotic strains and novel foods not in the ingredient compendium go through a safety assessment first, and for novel foods the confirmation of status comes before that. Foods containing cannabis, hemp or CBD have separate Notifications and detailed guidance and follow a procedure different from ordinary foods.

Fortified products have set limits on added vitamins and minerals, and both food supplements and general foods have tolerance criteria between declared label values and analytical values, so label figures must be aligned with the analysis results.

We review the Thai product name, principal ingredients, allergen information, directions for consumption, dates and storage conditions, and any applicable nutrition labelling and warning statements. Product names are subject to naming rules set in the product-specific Notification, so they are checked first to avoid refusal. If a label rejection is a concern, a label pre-inquiry can be submitted to the FDA.

Under Section 41 of the Food Act, copy, audio and video must be reviewed before efficacy, quality or effects are advertised for commercial purposes; advertising that meets the conditions is handled more simply through the self-assessment route. Health claims go through a separate evaluation. The violations actually found are wording that differs from what was approved, using partial approval as if the whole advertisement were approved, and exaggerated claims such as treating, preventing or detoxifying disease.

Point to note: do not translate the immunity, weight-management and disease-related wording used abroad as it is. Share the sales page and package messaging first and we set out together what evidence can support them and which expressions need to change.

Food import clearance is linked to the FDA's electronic procedures such as the virtual number (เลขเสมือน) system, and raw-material imports (FM) are distinguished from imports of general food for sale (FG). Even for a registered product, a partial label amendment, a formulation change, a change of manufacturer, and adding an export-only product name or label each follow a different procedure. Minor label amendments have a simpler route than a full change approval, so that is reviewed first.

• Trying to start with product registration. The import licence and storage premises come first.
• Choosing the form first. Type determination sets the form, specifications and labelling.
• Not checking the scope of the manufacturing-site certificate. If the imported products' type and process are not in the scope, it is not recognised.
• Expecting the registration number to cover advertising. Efficacy advertising needs pre-approval; health claims need a separate evaluation.
• Checking novel ingredients too late. Novel-food confirmation and safety assessment come before registration.
• Not cross-checking label figures against analytical values. Falling outside the tolerance criteria is a labelling violation.

We link formulation, manufacturer, licence details and label version for each SKU, and set out the items to review when a partner is added or a product changes. The use of license holding and IOR is assessed on the basis of the food import licence, the storage premises and the actual responsibility structure.

Discuss your food and supplement formulation and registration route · Learn about IOR import services

For this product category, we coordinate overseas manufacturer documents with the Thai applicant's existing licenses, product scope and distribution plan. We review new SKUs, label changes and renewal or amendment needs before filing. The applicant and permit scope are assessed for each project.

Where needed, explore Thailand license holding or Importer of Record services alongside your product requirements.