5. Claim Requirements

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5. Claim Requirements

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Beers, RTDs, Whisky
Thailand

This section provides information on the definition of different types of claims and any restrictions or allowance of claims as well as claim registration processes.

5.1 Overview of Claims

General requirements for product claims [1]

Claims on food labels regarding substances or other compositions in food must adhere to the following:

The claim must not pertain to foods prohibited by the Ministry of Public Health for use, production, or importation.
The claim must not involve food additives that fail to meet the conditions outlined in the relevant Notification of the Ministry of Public Health regarding food additives.
The claim must not apply to foods that naturally lack the claimed substances or in which such substances do not occur during production.
The claim must not involve prohibited substances as per the Notification of the Ministry of Public Health.
The claim must not mislead consumers about the product.

Exceptions to these requirements include claims explicitly permitted by specific Notifications of the Ministry of Public Health. Furthermore, providing factual, transparent, and verifiable information to explain or emphasize differences in a product's components is allowed, as long as it does not mislead consumers.

5.1.1 Types & Definitions

5.1.1.1 Nutrition claim [2]

A nutritional claim refers to the display of text, images, designs, marks, trademarks, or any information related to the nutritional value of food, such as energy, protein, fat, carbohydrates, vitamins, and minerals. These claims are categorized into two types:

• Nutrient Content Claims - A nutrient content claim refers to statements about the level of nutrients and energy in food, such as "source of calcium" or "high in fiber and low in fat." However, claims like "free from" or "low in" on food labels must meet additional conditions:

These claims are not allowed if the food already meets the conditions naturally, without special manufacturing or adjustment processes. This prevents consumer misunderstanding that only products from a specific manufacturer meet the claim. However, factual information can be provided about the nutritional value across all brands of that food. For instance, "vegetable oil has no cholesterol" or "vegetable oil is naturally cholesterol-free."
If a food type uses different raw materials or production processes that alter its nutritional content compared to the general norm, such as flavored and unflavored soy milk, it may make "free from" or "low" claims if it meets the criteria for such claims.

• Comparative Nutrient Claims - These claims compare the nutrient or energy levels of similar foods, e.g., "reduced sodium" or "fortified with calcium." Key rules include:

The "reference food" must either be the manufacturer’s standard product or a general market average.
Comparative claims must name the reference food and show the percentage or fraction of the nutrient increase or reduction per serving.
To declare a comparative claim of either nutrient content or energy values, the reference food shall not contain such nutrients in “Low” or “Very Low” amounts.

5.1.1.2 Health Claims [3]

“Health Claim” means any declaration of statement, image, mark, symbol, trademark, or any information related to a relationship between a food or a constituent of food and health both directly and indirectly, which can be classified into three types:

Nutrient function claim means a nutrition claim that describes the physiological role of the nutrient in growth, development, and normal functions of the body.
Other function claim means a claim of specific beneficial effects of the consumption of foods or their constituents, in the context of the total diet on normal functions or biological activities of the body. Such claims relate to a positive contribution to health or to the improvement of a function or to modifying or preserving health.
Reduction of disease risk claim means a claim of benefits of the consumption of a food or food constituent related to the reduced risk of developing a disease or health-related condition.

5.1.2 List of Prohibited Claims

Prohibited nutrition claims [2]

Claims about nutrients naturally occurring in food are prohibited. For instance, claims such as "free from" or "low in" are not allowed if the food already naturally meets these conditions without any special manufacturing or modification processes. However, claims like "vegetable oil has no cholesterol" or "vegetable oil is naturally cholesterol-free" are permitted, as these nutrients are naturally absent in vegetable oils.

Prohibited health claims [3]

Disease Treatment or Prevention Claims are prohibited. Health claims suggesting that food or its constituents can treat, relieve, cure, or prevent any disease are not allowed. Claims must not mislead consumers into believing that the food has therapeutic or curative effects.

Prohibited claims in food advertising [5]

Food advertisements must not include false claims or mislead consumers about the benefits, quality, or properties of the food. Prohibited claims include:

Exaggerated or false messages.
Claims that suggest curing, relieving, treating, or preventing diseases.
Claims of altering body structures, organ functions, or bodily systems.
Claims related to enhancing sexual organs or activities.
Claims about skin nourishment or beauty.
Claims of weight or obesity reduction, except for approved weight-control foods.
Claims of body shaping, fat trapping, or similar effects.
Use of unverified academic reports or statistics.

5.2 Nutritional Claims

5.2.1 Permitted Claims

Conditions for making nutrition claims [2]

• Criteria based on serving sizes:

Case 1: Foods with reference serving sizes as per Appendix 2 to the MOPH Notification No. 445 must calculate claims based on declared serving sizes or twice the reference serving size for foods under 30 grams or 2 tablespoons.
Case 2: Foods without specified reference serving sizes must calculate claims per 100 grams or 100 milliliters.

• Mandatory Disclosure for High Nutrient Levels:

Foods with high levels of total fat (≥13g), saturated fat (≥4g), cholesterol (≥60mg), sodium (≥300mg), or total sugar (≥13g) must disclose these levels alongside any nutrition claims, prominently displayed on the label.

Conditions for making nutrition claims for specific nutrients are specified in Table 1 and Table 2 of Appendix 4 Notification 445, including:

Table 1: Conditions for making nutrition claims (e.g. low in, free from, high in claims) based on the reference serving size and the amount consumed per serving as stated on the label (applicable to foods with criteria based on serving sizes, Case 1).
Table 2: Conditions for making nutrition claims (e.g. free, without, reduced, less, source, contains, high in claims) based on 100 grams or 100 milliliters (applicable to foods with criteria based on serving sizes, Case 2).

5.2.2 Nutritional Claim Registration

Nutrition claims must comply with the permitted claims and conditions outlined in Table 1 and Table 2 of Appendix 4 of Notification 445. The claims made and labeled will be reviewed for compliance by the Thai FDA during the label approval and product registration process. The process for approving new nutrition claims is not specified in the regulation [2].

5.3 Health Claims

5.3.1 Requirements for foods with health claims [3]

The food must be safe and comply with relevant notifications. For novel foods, a safety assessment must be completed before claims are substantiated.
The food constituent, nutrient, or other substance on which the claim is based must exist in a form and quantity that provides a demonstrable beneficial nutritional or physiological effect, as supported by generally accepted scientific evidence.
Health claims must be expressed in a manner that is easily understood by general consumers.
Claims should refer to the food in its ready-to-consume form, as per the instructions on the label, and the recommended consumption quantity must be appropriately proportioned.
Health claims must be supported by current, relevant, and generally accepted scientific evidence sufficient to substantiate the claimed physiological effect.
Scientific evidence must derive from well-designed human intervention studies conducted on the target group, using appropriate biomarkers, and must include the following details:
- The quantity and consumption pattern of the food or its constituent required to achieve the claimed effect, reasonably attainable as part of a balanced diet.
- For nutrient function claims: information on the composition of the food or its constituent relevant to its physiological role and the effect of the nutrient on that role.
- For other function claims and reduction-of-disease-risk claims: information on the composition of the food or its constituent in relation to an accepted diet-health relationship and the effect of the food or constituent on health.
The quantity of the food or food constituent that the claim is made shall be measured by a validated method.
Claims must not mislead consumers into believing that the food or its constituents can treat, relieve, cure, or prevent any disease.

5.3.2 Displaying health claims on food labels [3]

• Language and Legibility

Health claim statements must be presented in Thai, with a font size that is clear and legible. They may also be expressed in English or other foreign languages.
Translations into Thai or English must be provided by recognized government agencies or professional translation companies.
The content in English or other foreign languages must align in meaning with the Thai version and must be approved by the Thai FDA.

• Food labels must comply with the Ministry of Public Health's notification on the labeling of prepackaged foods and related regulations. Additionally, the following details must appear:

Quantity of the active constituent: For constituents or nutrients not listed in the nutrition information panel or Annex 3 of MOPH Notification No. 445 Regarding Nutrition Labeling, their type, and content must be declared in the nutrition information panel.
Consumption details: Specify the quantity of food and the pattern of consumption required to achieve the claimed benefit.
Target group: Indicate the target group, if applicable.
Instructions and warnings: Provide guidance on consumption, especially for vulnerable groups or individuals who should avoid the product.
Safety information: Include any precautions, maximum safe intake, or related warnings.
Balanced diet statement: State, “Should eat varieties of five categories of food in appropriate proportion.”
Disease disclaimer: For other function claims or reduction of disease risk claims, include, “Not intended to treat, relieve, cure, or prevent any disease.”
Additional statements: Include any statements specified in Annexes 1 and 2 of this notification.
FDA-approved statements: Any additional statements permitted by the FDA.

• Nutrition Labeling: Nutrition labeling must adhere to the Ministry of Public Health's notification on Nutritional Labeling. If the product falls under the category of food for special purposes, the labeling must comply with the relevant notification on Food for Special Purpose.

5.3.3 Permitted Claims [3]

5.3.3.1 Requirements for Nutrient Function Claims

Nutrients shall be in the list of Thai Reference Daily Intakes (Thai RDIs) as shown in Annex 3 of the MOPH Notification No. 445 Regarding Nutrition Labeling.
Nutrient function claim statements shall comply with Annex 1 of Notification No. 447 (i.e. use exact statements listed).
If food with nutrient function claims contains one or more of the following nutrients in excess of the levels listed below per reference amount and per serving, or per 100 g or 100 mL for foods without reference amount established, the amount of that or those nutrients shall be labeled with a disclosure statement of adjacent to the claim printed in largest character at least half size of the claim statement:
- Total fat: more than 13 g
- Saturated fat: more than 4 g
- Cholesterol: more than 60 mg
- Sodium: more than 300 mg
- Total sugar: more than 13 g

5.3.3.2 Requirements for Other Function Claims and Reduction of Disease Risk Claims:

Foods making other function claims or reduction-of-disease-risk claims must contain the following nutrients at levels below the specified thresholds per reference amount, per serving, or per 100 g/mL for foods without a reference amount:

Total fat: less than 13 g
Saturated fat: less than 4 g
Cholesterol: less than 60 mg
Sodium: less than 300 mg
Total sugar: less than 13 g

5.3.3.3 Permitted claims and necessary conditions:

The annexes attached to the Ministry of Public Health (MOPH) Notification No. 447 outline the permitted claims, conditions for making claims, and required documentation for submission to the FDA for evaluation and approval of health claims that are not yet authorized.

Annex Details:

Annex 1: Permitted Nutrient Function Claim Statements
Annex 2: Permitted Other Function Claim Statements
Annex 3: Permitted Reduction of Disease Risk Claim Statements
Annex 4: Documentation Required for Submission with Health Claim Assessment Applications

5.3.4 Health Claim Registration [3]

Health claim statements not included in Annexes 1, 2, and 3 of Notification No. 447 must undergo evaluation by a nutrition and health claim assessment center recognized by the Food and Drug Administration (FDA) of Thailand. The assessment report, along with the relevant information outlined in Annex 4 of Notification No. 447, must be submitted to the FDA for approval. Application form for submission of health claim assessment, including documents checklist:

5.4 Other Notes or Requirements for Claims [5]

5.4.1 Health-related claims to general foods [2]

Claims like "healthy" or "healthful" must meet these conditions:

Food must be "low fat" and "low saturated fat."
Per serving:
- Sodium: ≤300mg
- Cholesterol: ≤60mg
- Total sugar: ≤13g
- Protein: ≥5g
- At least one of the following at the Thai RDI threshold: dietary fiber (10%), vitamin A, B1, B2, calcium, or iron (15%).
Note: For fresh vegetables or fresh fruits, the requirements for protein, dietary fiber, vitamin A, vitamin B1, vitamin B2, calcium and iron are exempted.

5.4.2 Other Conditions for nutrition claim for general foods [2]

If the label mentions the type and quantity of a specific nutrient outside the Nutrition Facts box, including instances where the nutrient information is part of the food's name, but there is no intent to make a claim, and the food does not meet the criteria for a conditional claim, the label must include a disclaimer. This disclaimer should clarify that the information is not a claim.

Examples:

"Contains 200 mg of sodium per 30 ml – not a low-sodium food."
"Contains 5 mg of vitamin C per 150 grams – not a source of vitamin C."

The notes above outline the regulations on health claims for general foods. For alcoholic beverages, due to restrictions on promoting consumption and mandatory warnings about their harmful effects, health claims on product labels are not permitted.