Thai FDA Approval 2026: How a US or Foreign Brand Gets Food, Dietary Supplements, Cosmetics and Medical Devices Registered in Thailand, Timelines, Penalties and Document Legalisation

Key takeaways

• Thailand's Food and Drug Administration (Thai FDA, under the Ministry of Public Health) regulates four groups of products: food (including dietary supplements), cosmetics, medical devices, and drugs and herbal products. A US FDA registration, clearance or approval carries no weight by itself; the Thai licence or registration must be in place before the goods are imported, or they stop at customs.
• The applicant must be a Thai-registered company whose registered business covers the product and which has a storage site inspected by the Thai FDA. The registration belongs to that company, not to the brand. A US brand can own the importer itself, since the US-Thai Treaty of Amity lets US-majority companies operate in most sectors without the 49% foreign ownership limit.
• Cosmetics are notified online; low-risk products receive a 10-digit notification number automatically on payment, valid for 3 years under section 15 of the Cosmetics Act. The manufacturer's GMP must meet ISO 22716 or the ASEAN cosmetic GMP.
• Food is sorted into four categories. The importer first obtains a food import licence (Or. 7, valid to 31 December of the third year), then registers each product or files its label to obtain a 13-digit food serial number. A US dietary supplement is a "food supplement" in Thailand, a standard-category food with maximum daily levels of vitamins and minerals that many US formulas exceed.
• Medical devices fall into four risk classes: class 1 listing, classes 2 and 3 notification, class 4 licensing, all in the ASEAN CSDT format and with ISO 13485 from class 2 upward. A device already approved by the US FDA can use the concise evaluation route.
• Thai labelling is a condition of customs clearance, not something added after arrival. Advertising of food and dietary supplements needs prior approval; cosmetic advertising does not, but therapeutic claims are prohibited.
• Penalties, checked against the Acts: importing food without a licence, up to 3 years' imprisonment or a fine of THB 30,000 (Food Act section 53); importing cosmetics without notification, up to 6 months or THB 50,000 (Cosmetics Act section 62); importing unsafe cosmetics, up to 5 years or THB 500,000 (section 74); importing medical devices without the required approval, up to 3 years or THB 300,000 (Medical Device Act section 86); evading import controls, up to 10 years or THB 500,000 with forfeiture (Customs Act section 244). Directors can be liable alongside the company.
• US documents (certificates of free sale, GMP and ISO certificates, test reports, letters of authorisation) must be legalised through the US Department of State and a Royal Thai Embassy or Consulate until Thailand's accession to the Hague Apostille Convention takes effect on 28 February 2027. After that date an apostille should replace the consular step.

US food, beauty and medical device brands have a good name in Southeast Asia, but more than half of the Thai FDA matters that reach our Bangkok office are not about a refused application. They are about three structural mistakes made before the application was filed. This guide goes through each product class under the law in force in 2026: who may apply, the procedure, timing, documents and penalties, and the two things a US company most often gets wrong, the legalisation of its documents and the ownership of its registrations.

One point of naming first. The Thai FDA has the same initials as the US FDA and a similar remit, but nothing transfers between them. A US establishment registration, a 510(k) clearance or a GRAS determination is at most supporting evidence in Bangkok.

1. Why foreign brands run into trouble at the Thai FDA

• Shipping first and applying later. Thai customs checks the import declaration against the Thai FDA's records before releasing regulated goods. A controlled product without a licence number is held, and the importer is then prosecuted under the Food Act, the Cosmetics Act, the Medical Device Act and the Customs Act as applicable.
• Registering in the distributor's name. A brand appoints a Thai distributor to apply. Two years later it wants to change distributors and discovers that every Thai FDA registration is the distributor's property, that the brand cannot take them back, and that the new distributor starts from zero.
• Legalising documents the wrong way. A US company obtains an apostille for its certificates because that is what works in most countries. Until 28 February 2027 the Thai FDA does not accept apostilles, and the documents come back.

2. Common to every class: who may apply and what must be in place

A US company has one option that other foreign brands lack. Under the US-Thai Treaty of Amity a company majority-owned by US citizens or US companies, with US nationals in the majority of its board, may own and run a Thai business in most sectors on the same footing as a Thai company, outside the reserved sectors (communications, transport, fiduciary functions, banking with depository functions, exploitation of land and natural resources, land ownership, and domestic trade in indigenous agricultural products). Importing and distributing cosmetics, packaged food, supplements or devices is not reserved. The practical result is that a US brand can hold its own Thai FDA registrations through a wholly owned Thai importer. How the Treaty of Amity, BOI promotion and the Foreign Business Licence compare, and how to set the company up, is in Setting Up a Company in Thailand 2026 for Foreign Investors: The 49% Rule, Nominee Shareholder Risk, Capital and Work Permit Ratios, BOI and the New DBD Checks .

Where a Thai distributor will be the importer, the distribution agreement must say three things: (1) the beneficial right to the Thai FDA registrations belongs to the brand, and the distributor will consent in writing to their transfer when the relationship ends; (2) the distributor will not register the same products in its own name separately; (3) the brand may appoint a second importer at any time. Without those three clauses the distributor holds your Thai market.

3. Cosmetics: notification, the fastest route and the most inspected

3.1 The law

Section 14 of the Cosmetics Act B.E. 2558 (2015) requires anyone who manufactures or imports cosmetics for sale to notify the Thai FDA of the product's details and obtain a notification receipt before manufacturing or importing. Notification is not pre-market review. The importer declares the formula and label, and the Thai FDA issues a 10-digit notification number. Under section 15 the receipt is valid for 3 years and is renewed before expiry.

3.2 Procedure and timing

Official fees are a few hundred to a few thousand baht per notification depending on the product type, plus agent fees. For a brand with many SKUs the real cost is the formula review and the Thai label.

3.3 What US beauty brands most often meet

• Restricted ingredients. Some US formulas contain substances that Thailand prohibits or limits at a lower concentration, among them certain skin-lightening agents and preservative levels. The Thai FDA keeps updating the lists in line with the ASEAN Cosmetic Directive, so check against the current version before filing.
• Claims. A cosmetic may not claim to treat or prevent disease or to change a physiological function ("eliminates wrinkles", "kills bacteria", "slimming"). Under sections 41 and 84 of the Cosmetics Act, improper advertising carries up to 1 year's imprisonment or a fine of THB 100,000, and the product is taken off the market. A US product sold at home as an over-the-counter drug-cosmetic needs its Thai classification checked before anything else.
• Labelling. The Thai label must show the product name, ingredients, purpose, directions, net content, name and address of the manufacturer and importer, batch number, manufacturing date, notification number and warnings. English may appear alongside Thai, but Thai is mandatory. A non-compliant label is an offence for the importer under section 67, up to 6 months or THB 50,000.
• A number is not an approval. The Thai FDA tests products after they are on the market. A formula that does not match the notification, or that contains a prohibited substance, leads to revocation and prosecution. Joint inspections with the consumer protection police at trade fairs and shopping centres have increased, so a brand testing the market at an exhibition should notify first.

4. Food and dietary supplements: four categories decide the procedure

4.1 The law and the categories

The Food Act B.E. 2522 (1979) lets the Ministry of Public Health sort food into four categories by risk.

What the United States calls a dietary supplement is a "food supplement" in Thailand, a standardised food under Ministry of Public Health Notification No. 293. Its ingredients and daily maximums are fixed by notification; an ingredient outside the permitted lists goes through a safety assessment (Sor. Bor. 3) first. Most packaged snacks, teas, seasonings, supplements and drink mixes fall into the standardised or must-bear-a-label categories.

4.2 Procedure and timing

4.3 Three gates for a US dietary supplement

• Maximum daily levels. The Ministry sets maximum daily amounts for vitamins, minerals and plant extracts (Notification No. 293 and its amendments, most recently No. 448 of 2023, which fixes maximum daily levels for 26 vitamins and minerals and requires any declared vitamin or mineral to supply at least 15% of the Thai reference daily intake). A product formulated under the US dietary supplement rules, where high doses are common, often has to be reformulated for Thailand.
• Claims. No claims to treat, prevent or cure disease, to cause weight loss, to enhance sexual performance or to whiten skin. The structure-function claims used on US labels are not a category Thai law recognises; the permitted functional claims are few and need scientific support.
• Test reports. Heavy metals (lead, arsenic, mercury, cadmium), microbiology, and pesticide residues for some products. The Thai FDA accepts reports from ISO 17025-accredited laboratories; a US laboratory report is usable once legalised.

4.4 Labelling

A Thai label is a condition of clearance. It carries the product name, serial number, ingredients in descending order, net content, manufacturer and importer, manufacturing and expiry dates, storage instructions, allergens, nutrition information for certain categories and warnings. Food supplements must carry the statutory warning that the product has no effect in treating or preventing disease. A label that breaches a notification is an offence under section 51 of the Food Act, with a fine of up to THB 30,000.

5. Medical devices: risk class decides everything

5.1 The law and the classes

The Medical Device Act B.E. 2551 (2008), as amended by the Act (No. 2) B.E. 2562 and in force in its current form since 2021, provides three control mechanisms under section 6, which map onto the four ASEAN risk classes.

5.2 Procedure and timing

5.3 The concise route for devices approved by the US FDA

The Thai FDA accepts the US FDA, EU notified bodies (CE marking), Japan's MHLW, Australia's TGA and Health Canada as reference regulatory agencies for class 2 to 4 devices, and the WHO prequalification for in-vitro diagnostics. A device that holds an approval from one of them can apply for the concise evaluation route, which roughly halves the review time. The notification attaches further conditions, including a period on the market under the reference approval, so check the current conditions before filing. Singapore's HSA and, since 1 May 2026, Malaysia's MDA have separate reliance arrangements with the Thai FDA.

For a US manufacturer the documents that matter are the FDA clearance or approval letter, the Certificate to Foreign Government issued by the FDA's Center for Devices and Radiological Health, and a current ISO 13485 certificate from a certification body. The FDA's quality system regulation has been aligned with ISO 13485 since 2026, but an FDA inspection does not produce a certificate, and the Thai FDA asks for one.

5.4 Software and AI

Software as a medical device is classified by function under the Thai FDA's own guidance. New labelling rules in force from 20 June 2026 brought software devices into the unique device identification requirement for the first time. Most diagnostic and decision-support software from the United States lands in class 2 or 3; confirm the class before building the dossier.

6. Drugs and herbal products: the boundary to know

• Drugs. The Drug Act B.E. 2510 (1967) requires product registration. Review is measured in years, new drugs need clinical data and generics need bioequivalence studies. Foreign pharmaceutical companies usually enter through a Thai licensee or distributor.
• Herbal products. The Herbal Products Act B.E. 2562 (2019) allows a simplified notification for traditional formulas. A US botanical product filed as a herbal product has to fit the Thai herbal pharmacopoeia or come with safety data.
• The boundary. A supplement containing botanical ingredients can be classified by the Thai FDA as a herbal product rather than a food, and the two procedures differ greatly. Ask for a pre-classification before filing.

7. Penalties: the company and its directors

The section numbers and amounts below were checked against the Royal Gazette texts of each Act.

The typical outcome of a Thai FDA inspection is withdrawal and destruction of the product, suspension of the importer's licence and a fine, with referral to the prosecutor in serious cases. For a foreign brand the larger loss is being placed on the inspection list, after which every shipment is sampled. How a foreign director becomes personally liable under sector laws of this kind, and what protects them, is in Director Liability in Thailand 2026 for Foreign Directors: Civil Exposure, Criminal Risk, Signing Authority and the Work Permit Trap .

8. US documents: what to obtain and how to legalise them

The Thai FDA requires foreign documents (certificates of free sale, GMP and ISO certificates, test reports, letters of authorisation) to be legalised. Thailand deposited its accession to the Hague Apostille Convention on 30 June 2026 and the Convention enters into force for Thailand on 28 February 2027. Until then, Thai authorities, the Thai FDA included, do not accept apostilles, and a US document goes through consular legalisation.

The Royal Thai Embassy in Washington legalises only documents issued in its own jurisdiction (the District of Columbia, Alabama, Delaware, Florida, Georgia, Louisiana, Maryland, Mississippi, North Carolina, South Carolina, Tennessee, Texas, Virginia, West Virginia and Puerto Rico); documents from other states go to the Royal Thai Consulates-General in New York, Chicago or Los Angeles. The Washington embassy requires prior authentication by the Secretary of State and the US Department of State, charges USD 15 per Department of State seal, and quotes 15 to 21 business days by mail with no expedited service. It states expressly that it does not accept an apostille in place of the Department of State seal.

Two practical points. The Thai FDA expects documents to be no more than one to two years old, so legalise everything at once rather than piecemeal. And confirm with the Thai FDA or your agent which US certificate it will accept as the "certificate of free sale" for the product in question, since the US FDA's certificates carry different titles for different product classes.

From 28 February 2027 a US apostille, issued by the Secretary of State of the relevant state or by the US Department of State for federal documents, should replace the consular step. Check the Thai FDA's practice at the time before relying on it for a filing close to that date.

9. Three structures for holding the registrations

Most foreign brands start with the second structure and move to the first in the third year. The transfer of a Thai FDA registration needs the written consent of the current holder, which is why the clauses in section 2 matter. A brand that runs its own e-commerce site or app for Thai consumers also falls within Thailand's data protection law, which applies to foreign sellers offering goods to people in Thailand; see Thailand PDPA Compliance 2026: What the First THB 21.5 Million in Fines Means for Foreign Companies, Cross-Border Transfers to Head Office, SCC and the New BCR Rules . And the brand name and packaging should be in the trademark queue before the product is listed, since Thailand is a first-to-file country; see Trademark Registration in Thailand 2026 for US and Foreign Brands: Fast Track 4 Month Plus+, Madrid vs Direct Filing, and the First-to-File Rule .

Frequently asked questions (FAQ)

Can a US company apply to the Thai FDA directly?

No. The applicant must be a company registered in Thailand whose business objects cover the product and which has an inspected storage site. A US brand either sets up a Thai subsidiary, which the Treaty of Amity allows it to own outright, or appoints a Thai importer of record under a contract that secures the registrations for the brand.

Does my US FDA clearance or registration count in Thailand?

Not by itself. It is supporting evidence. For medical devices it does more: a device approved by the US FDA qualifies for the Thai FDA's concise evaluation route, which roughly halves the review time. For food, supplements and cosmetics there is no equivalent shortcut.

How long does a cosmetic notification take, and how long is it valid?

For a low-risk product the system issues the notification number automatically once the fee is paid; with premises registration and corrections, one to three weeks in practice. Under section 15 of the Cosmetics Act the receipt is valid for 3 years and is renewed before expiry. The premises must already be registered and the formula must contain no prohibited or over-limit ingredient.

How is a US dietary supplement regulated in Thailand?

As a food supplement, a standardised food under Notification No. 293. The formula is reviewed (Sor. Bor. 5), which takes about two to six months, and the maximum daily levels of vitamins and minerals under Notification No. 448 of 2023 often require a US formula to be adjusted. Disease, weight-loss and similar claims are prohibited, and any advertising, including social media, needs prior approval.

Which medical device class is hardest, and does a US approval help?

Class 4 (implantable and other high-risk devices), which needs a licence, a statutory review period of up to 300 days and 6 to 12 months in practice. Class 1 listing is the quickest, usually a matter of weeks. A device approved by the US FDA, by an EU notified body, or by the Japanese, Australian or Canadian regulators can apply for the concise route, subject to the conditions in force.

Can the registration be moved from the distributor to the brand?

Yes, with the written consent of the current holder. The distribution agreement should provide for the transfer on termination; without that clause the distributor can refuse.

Does a US certificate of free sale need an apostille?

Not yet, and an apostille will be refused. Until 28 February 2027 a US document is authenticated by the Secretary of State and the US Department of State and then legalised by the Royal Thai Embassy or Consulate for the state where it was issued (USD 15 per document at the Washington embassy, 15 to 21 business days). From that date Thailand applies the Apostille Convention and an apostille should be enough, subject to Thai FDA practice at the time.

What happens if we import without registration?

For food, up to 3 years' imprisonment or a fine of THB 30,000 (Food Act section 53); for cosmetics, up to 6 months or THB 50,000 (Cosmetics Act section 62); for medical devices, depending on class, up to 3 years or THB 300,000 (Medical Device Act section 86); and under section 244 of the Customs Act, evading import controls carries up to 10 years or THB 500,000 with forfeiture of the goods. A director who ordered the act or failed in a duty to prevent it is liable with the company.

How Louis Group can help

The Thai FDA is not the hardest market-access regulator in the region, but it is the one where sequence matters most: first the Thai company and the warehouse, then the legalised US documents, then the registration, and only then the shipment and the advertising. When a foreign brand gets into trouble in Thailand, it is almost always because the sequence was reversed or because the registrations were left in someone else's name. Louis Group's Bangkok office assists US and other foreign food, beauty and medical device brands in English with pre-classification, formula and label review, importer structures under the Treaty of Amity and distribution agreements, e-Submission filings, advertising approvals and the legalisation of documents. If your product is heading for Thailand, have the Thai FDA route assessed before you sign with a distributor.

Author: Dr. Yvonne Wei (Arisa Pailinsiri) , Senior Partner, Louis & Partners Thailand. She advises on foreign investment, product regulation and intellectual property, and has long assisted foreign brands entering the Thai market.

This article is based on the Thai Food Act, Cosmetics Act, Medical Device Act and Thai FDA notifications in force in November 2026 and is general information, not legal advice on any particular case. Thai FDA review times, fees and ingredient lists change frequently, and the document legalisation rules change on 28 February 2027; consult a Thai-qualified lawyer or Thai FDA agent before filing.

Related reading

• Setting Up a Company in Thailand 2026 for Foreign Investors: The 49% Rule, Nominee Shareholder Risk, Capital and Work Permit Ratios, BOI and the New DBD Checks
• Trademark Registration in Thailand 2026 for US and Foreign Brands: Fast Track 4 Month Plus+, Madrid vs Direct Filing, and the First-to-File Rule
• Director Liability in Thailand 2026 for Foreign Directors: Civil Exposure, Criminal Risk, Signing Authority and the Work Permit Trap