Thai FDA Health Claims for Supplements: The Positive List Explained

A dietary supplement brand entering Thailand tends to assume health claims work the way they do at home: state the claim, back it with evidence, and let the regulator judge the science. Thailand does not run that model. Under MOPH Notification No. 447 B.E. 2566 (2023), a supplement label or advertisement may only carry a health claim that already appears on a fixed, government-published list. If the wording is not on the list, it is not permitted, no matter how well the underlying research supports it, unless it goes through a separate case-by-case scientific review. For any brand planning a Thai launch, that difference needs to shape the label copy before the file goes anywhere near submission.

A positive list, not a substantiation standard

No. 447 took effect on 2 July 2024 and replaced Thailand's earlier health claims framework. It sets out, in exhaustive detail, every claim statement a food supplement is allowed to carry. There is no equivalent to the "substantiated claim" pathway used in markets like the United States, where a brand can construct and defend a novel claim from its own evidence package. In Thailand, if the exact statement is not already codified in the notification, using it is not an option until Thai FDA's assessment committee has separately reviewed and approved it.

The transition mattered for brands already on shelf before the change. Products carrying claim approvals granted under the prior framework have until 2 July 2027 to bring their labels in line with No. 447. Any new application submitted after that point is measured against the current list from day one, with no grace period.

What the three permitted categories actually cover

No. 447 organizes permitted claims into three tiers, and each tier carries a different evidentiary bar and a different degree of label flexibility.

The first and largest tier is nutrient function claims: 135 permitted statements spanning 28 nutrient items. These describe an established physiological role, the kind of claim that says a nutrient supports a known bodily function, such as calcium's role in maintaining bone structure or iron's role in normal energy metabolism. The catch is that these are not starting points for a brand's own phrasing. The exact wording published in the notification is the wording that must appear on the label, word for word.

The second tier, other function claims, is narrower: eight permitted statements across six ingredients, covering categories like probiotic strains, omega-3 fatty acids, and plant sterols. These describe functional effects that go beyond a nutrient's basic physiological role but still fall short of a disease-risk statement.

The third tier, reduction of disease risk claims, is the tightest of the three. Only four statements are permitted, covering exactly two ingredient-condition relationships: folic acid paired with reduced risk of neural tube defects, and calcium paired with reduced risk of osteoporosis. Anything a brand wants to say about disease risk reduction outside those two pairings has no home in this framework at all.

A claim that does not fit any of the three tiers is not automatically off the table, but it does require submission to Thai FDA's health claim assessment committee (the อนุกรรมการประเมินข้อความกล่าวอ้างด้านสุขภาพ), which reviews the underlying scientific evidence on a case-by-case basis. Approval through this route is neither fast nor guaranteed, and brands relying on it should build meaningful lead time into their launch timeline rather than treating it as a formality.

Where a functional claim turns into a drug claim

Underneath the positive list sits a harder boundary: the line between a permitted functional claim and a disease claim. Under the Drug Act B.E. 2510 (1967), any statement implying that a product treats, prevents, diagnoses, or cures a named medical condition makes that product a drug in the eyes of Thai law, regardless of how it is labeled or positioned commercially. A food supplement carrying that kind of statement is not a mislabeled supplement; it is an unregistered drug.

The practical difficulty is that this line is not always intuitive to a marketing team working from a home-market playbook. A phrase like "supports healthy blood sugar balance" reads very differently to a Thai FDA reviewer than it does to a supplement brand used to US shelf language. "Reduces the risk of" is only usable for the two specific ingredient-condition pairs named above, nowhere else. And words like "prevents" or "treats," attached to any named condition, have no place anywhere in the supplement claim framework. Claims translated directly from a home market's label copy frequently do not survive that translation, and catching this before submission, not after a rejection, is the difference between a normal timeline and a rebuilt one.

The advertising layer adds a second gate

Passing the product label review is not the end of the exposure. Advertising materials, whether print, digital, or point-of-sale, are subject to a separate pre-approval requirement under Section 41 of the Food Act, administered through the Kho Or advertising approval process. A claim that clears the label can still be rejected at this stage if the advertisement frames it differently, adds emphasis the label approval did not cover, or implies something beyond the approved wording. Brands that treat label approval and advertising approval as the same review tend to discover the gap only after marketing assets are already produced.

Why home-market claim language rarely survives the transition

Brands that have already built a claims strategy for the United States, the European Union, or another ASEAN market frequently assume the same language, or a lightly adjusted version of it, will carry over to Thailand. It usually does not. A US brand accustomed to a substantiation-based system is used to defending a claim with its own evidence file, adjusting the wording as new studies come in, and treating the claim as a living asset that can be refined over time. Thailand's positive list does not work that way. The wording is fixed by the notification itself, and a brand cannot improve on it, soften it, or extend it without either finding an exact match already on the list or going through the separate assessment route described above. This means the claims strategy exercise in Thailand is less about crafting persuasive language and more about accurate matching: identifying which of the fixed statements actually applies to a given ingredient and formulation, and building the marketing plan around what is legally available rather than what reads best.

The timing consequence of getting this wrong is significant. A claim discovered to be non-compliant after label artwork has already been finalized, or after the product has already been submitted for approval with that claim attached, forces a rework of both the regulatory file and the printed packaging. Since the food serial number itself is only issued after approval, and label artwork typically is not finalized until that number is in hand, a claims error caught early costs comparatively little. The same error caught after submission, or worse, after the product has already reached retail shelves, is considerably more expensive to unwind.

Building the claims strategy before the file is submitted

The practical approach is to map every claim a brand wants on its Thai packaging and marketing against the No. 447 list before the product approval application is filed, not after a rejection forces a rewrite. Where a desired claim already exists on the list, the next question is whether the actual product formula supports the conditions attached to that specific permitted statement. Where the claim does not exist on the list, the choice comes down to whether an assessment committee submission is realistic given the evidence on hand, or whether rewording to a listed claim is the more reliable path to market. This mapping exercise also needs to account for the advertising layer described above, since a claims strategy that only checks the label and ignores planned advertising content will find the gap later, at the Kho Or stage, rather than earlier when it is still cheap to fix. DeeMED Consulting works through this claims mapping as part of our Thai FDA supplement health claims and labeling review, checking product copy against both the No. 447 positive list and the Section 41 advertising approval requirements before submission, not after.