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    5. Claim Requirements
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    5. Claim Requirements

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    General Foods
    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

    5.1.1 Types & Definitions

    Nutritional Claims

    Definition

    A nutrition claim is the display of expressions or any information related to food nutrition such as the indicated quantity of energy, protein, fat, carbohydrate, and vitamins or minerals. Nutrition claims can be classified into 3 categories: nutrient content claim, comparative claim, and nutrient function claim [1]. 

    A. Nutrient content claim 

    It is the claim of nutrient or energy level in that food such as “source of calcium”, “high in fiber and low in fat”, etc.

    The claims of “Free” or “Low” shall not be allowed to be used, if that food or the natural content of that food conforms to conditions without being passed through any special production process, special adjustment process, or formula improvement for nutrient content to be reduced to the claimed conditions. This is to avoid misleading the consumers to believe that such a producer is the only possessor of the claimed food specification. For example, it is not allowed to display “Free of energy”, or “Low fat” on drinking water since every drinking water producer possesses that specification. 

    However, for food that is produced by formula improvement or different from general raw materials used so that the nutrient content conforms to the claimed conditions, the producer shall be able to display a nutrient content claim of “Free from”, or “Low”.

    B. Comparative claim

    It is the comparison of the quantity of nutrients or energy of two kinds of foods, or more. This includes claims of “less than or fewer”, “more than”, “reduced”, “lite, light”, “added, fortified, enriched”, etc.

    In the case of a quantitive comparative claim, the food, called “Reference food”, is compared to the claimed food. There are two categories of allowed reference foods to be used in a comparative claim, i.e., the claimed food shall be compared to the following:

    1. Producer’s own normal formula products
    2. Similar products, which represent such food in general, and are sold within the country

    The compared product shall be of the same kind or similar product, such as seasoning sauce shall be compared to seasoning sauce only. It is important to prohibit the use of a comparative claim if the quantity of nutrients or energy in the reference food already conforms to “Low”, or “Less” conditions.

    With regards to the display of a comparative claim:

    • The category name of the referenced food shall be specified
    • Comparative nutrient or energy level that is decreased or increased in percentage or fraction to the reference food shall be specified
    • The quantity of nutrient per serving size shall be displayed on the label such as the claim of “Reduced Sodium” shall be accompanied by the expression “Sodium is reduced to 50% compared to normal sauce formula, with low sodium sauce which has sodium 200 mg per 30 ml, where sodium content in normal sauce formula is 400 mg per 30 ml”.

    Health Claims

    Definition

    Health claim means the presentation of a picture, photograph, invented design, mark, trademark, or any text on a label relating to food, food ingredients, or nutrients directly or indirectly relevant to health. Health claims are classified into 3 types as follows [2]:

    1. Nutrient function claims: presentations of properties or benefits that describe the physiological role of the nutrient in growth, development, and normal functions of the body. Example: "Calcium can help in forming strong bones and teeth. Product A is a source of calcium."
    2. Other function claims: presentations of properties or benefits that describe 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. Example: "Substance A affects (naming the effect of substance A on improving or modifying a physiological function or biological activity associated with health in a positive way). Food Product B contains x grams of substance A.”
    3. Reduction of disease risk claims: presentations of properties or benefits relating to the consumption of a food or food constituents, in the context of the total diet, to the risk reduction of developing a disease or health-related condition. Risk reduction means significantly altering a major risk factor(s) for a disease or health-related condition. However, diseases have multiple risk factors, and altering one of these risk factors may or may not have a beneficial effect. Example: "A diet low in nutrient or substance A may reduce the risk of disease B. Food product C is low in nutrient or substance A."

    Nutrient function claim 

    It is the claim of a function of a nutrient in the human body, under the following conditions:

    1. The nutrient claim shall be prescribed in Thai RDI (Recommended Daily Intakes) for ages 6 years and up.
    2. The nutrient content of the claimed product in the level of reference serving size and serving size as displayed on the label shall be classified as “source of”. For the case of non-prescribed serving size, and that food is not similar in consumption behavior to the food with prescribed serving size, the quantity of serving size of the product shall be calculated per 100 g or 100 ml.
    3. The nutrient function claim shall be the claim of nutrients as stipulated in Thai RDI for ages 6 years and up (Thai RDI), without a specific product claim.
    4. That claim shall be based on reliable scientific evidence.
    5. The claim shall not be expressed or meant to lead the consumers to understand that the consumption of such nutrients is able to prevent or cure any diseases. Examples of nutrient functional claims:
      1. “Calcium is an important component of bones and teeth.” 
      2. “Calcium assists in the building process of bones and strong teeth.”
      3. “Folate is an important component to build red corpuscle.” 
      4. “Vitamin B1 and vitamin B12 assist in the function of the nervous system.”

    See [4] for the list of permitted claims and note that nutrient function claims shall be approved by the Thai Food and Drug Administration (FDA).

    5.1.2 List of Prohibited Claims

    No permission for other function claims and reduction of disease risk claims [2] if those foods contain:

    • more than 13 grams of fat, or
    • more than 4 grams of saturated fat, or 
    • more than 60 milligrams of cholesterol, or 
    • more than 360 milligrams of sodium

    in the amount of one recommended serving size and one serving size declared on labels, or if no recommended serving size is specified, nutrient content in 100 grams or 100 milliliters is calculated [2].

    It is prohibited to use such claims as "no/free/reduced a nutrient" if that natural food content conforms to the condition of the claims for those nutrients [1]. Example: It is prohibited to use the claim "Low, low in, low source of, little of fat" if the total fat content in that natural food is naturally not more than 3 g.

    5.2 Nutritional Claims

    5.2.1 Permitted Claims

    Permitted nutrient function claims

    Permitted nutrient function claims for 29 types of nutrients are specified in the "Announcement of the Food and Drug Administration Re: The Display of Statements Claiming the Functions of Nutrients" [4].

    Conditions for nutrition claims 

    They are specified in Appendix No. 4 of the Notification of the Ministry of Public Health No. 182 B.E. 2541 (1998) Re: Nutrition Labeling [1]: 

    • Table No. 1: Conditions of Nutrition Claims per Quantity of Serving Size 
    • Table No. 2: Conditions of Nutrition Claims per 100 g or 100 ml

    Other conditions of nutrition claims 

    Shall there be any specific mention of type and food quantity displayed on the label but outside the nutrition data display box and without intention for nutrient claims but for consumers' information only, including the mention of type and quantity as part of food name, in which such food is not in the conditions to display nutrient claim, such display of type and quantity shall be allowed and accompanied by the expression of no intention for any nutrition claim, such as “Sodium content of 200 mg per 30 ml – not low sodium food”.

    5.2.2 Nutritional Claim Registration

    N/A

    5.3 Health Claims

    5.3.1 Permitted Claims

    Permitted nutrient function claims

    For permitted nutrient function claims, refer to Section 5.2.1.

    The list of permitted other function claims and reduction of disease risk claims are not available and shall be evaluated by the Thai FDA.

    Conditions for health claims

    • The claimed benefit should arise from the consumption of a reasonable quantity of the food or food constituents in the context of a healthy diet and shall not depend on the benefit from consumption together with other food although it is normal practice to consume together (just as breakfast cereal is consumed with milk) [2].
    • Nutrients related to nutrient function claims shall be in the list of Thai RDI (Recommended Daily Intake) nutrients at the age of 6 years & up as in the Notification of the Ministry of Public Health regarding Nutrition Labels. [1]
    • Nutrients related to nutrient function claims shall be classified as “source of” or “high” in one serving declared on the labels if it's recommended to intake more, or those nutrients shall be in the level of “low”, “reduced” or “free” in one serving declared on the label if it's recommended to intake less as per the requirements specified in Notification of the Ministry of Public Health regarding Nutrition labels [1].
    • If those foods contain total fat >13g, saturated fat >4g, cholesterol >60mg, or sodium >360mg in the amount of one recommended serving size and one serving size declared on labels, or if no recommended serving size is specified, nutrient content in 100 grams or 100 milliliters is calculated and statement of the content of total fat, saturated fat, cholesterol or sodium which exceed such level of content shall be consecutively attached to the statement of claim on the label in big size or the most eminent; the size of the attached statement shall not be less than a half of the claim statement.
    • Health claims shall be based on relevant and available scientific evidence which is sufficient to prove a relation between such claim and health. It consists of 2 parts of data including: 
      • Information on the physiological role of the nutrient or on an acceptable relationship between diet and health;
      • Information on the composition of the product that is relevant to the physiological role of the nutrient or the acceptable relationship between diet and health unless the relationship is based on whole food or foods whereby the research does not link to specific constituents of the food.

    Whenever there is accessible updated knowledge, a review shall be made of the scientific evidence for reasonable health claims.

    The amount of constituents of the food or nutrient shall also be analyzed with a validated method.

    5.3.2 Health Claim Registration

    For health claims of food or food ingredients, a prior application is required to be submitted for health claim assessment to the FDA and shall follow the criteria and conditions of application for health claim assessment and criteria for advertisement permission [2].

    Notes:

    • For claims that are taken from the positive list (i.e. approved nutrient function claims), it is not required to submit a substantiation document during product registration.
    • For claims with no positive list (i.e. other function claims and reduction of disease risk claims), they shall be evaluated by Thai FDA in a separate prior application. Once the claims are approved, manufacturer shall include the Thai FDA approval number when submitting the product dossier for registration. It is not necessary to re-submit the claim substantiation at this stage. 

    (a) The process of requesting an assessment of a new health claim: 

    1. An applicant shall prepare complementing evidence document and make an online appointment in advance via the Bureau of Food website. The applicant shall be able to provide details and information of applied products and also have the authority to decide and sign to accept for defectives (if not a business operator or authorized director of the legal entity, a letter of power of attorney shall also be attached).
    2. An applicant shall submit the application form with its correct and complete evidence document in the sequence as in a checklist. Requesting letter for consideration of health claim assessment shall be signed by a business operator. For other documents, a person who is able to sign includes the business operator or authorized director, or authorized person.
    3. If the applicant intends to keep confidential parts or whole information of evidence documents, the applicant shall make a list of the documents intended for confidentiality with reasons for such confidentiality. 
    4. Processing time will start whenever receiving the correct and complete documents. If the application is complete, the receiving officer will hand it over to a specialist for processing within 10 working days.
    5. Additional evidence documents may be required based on the assessment result. The time for applicants to add documents is 30 working days.

    (b) The receiving authority agency: 

    Regulation Development Group

    Address: The Food and Drug Administration (FDA) Room 324, 3rd floor, Building 3 of FDA

    88/24 Ministry of Public Health Tiwanon Rd., Nonthaburi, 11000.

    Telephone no.: 02 5907178-9

    Service hours: Monday (excluding if official holiday) from 8.30 to 16.30 (except lunch break)

    • To accept an application with Evidence Document: 08.30 - 10.00
    • To ask for additional information: 10.30 - 12.00
    • To consider completion of the document and summarize consideration result: 13.00 – 16.00
    • To notify the result: 16.00 – 16.30 

    Online appointments can be made via http://203.157.72.105/foodbooking/ or by telephone at 02 5907187 or 0 25907011.

    (c) Scientific evidence documents for substantiation of health claims: 

    1. For nutrient function claims other than prescribed by the FDA:

    • A systematic review of the literature and meta-analysis published in reliable journals or;
    • Recognized and reliable technical opinions from internationally recognized agencies, organizations, or expert committees or;
    • A full copy of a well-designed human intervention study or other reasonable human intervention studies with a number of samples and a sufficient preliminary study for consideration that is published in reliable journals as Full Text.

    2. For other function claims or reduction of disease risk claims:  

    • A full copy of a well-designed human intervention study published in a reliable journal as Full Text AND either of the following documents;
    • A systematic review or Meta-analysis published in a reliable journal or;
    • A recognized and reliable technical opinion from internationally recognized agencies, organizations, or scientific expert committees.

    (d) List of documents and other requirements for new health claim approval

    1. Scientific evidence documents for substantiation of health claims [2] - same as Section (c) above.
    2. Supporting documents including peer-reviewed published articles, animal studies in vivo, ex vivo, or in vitro, observational evidence of epidemiological studies with results consistent with the number of well-designed studies, evidence-based reference texts, or other recognized and reliable texts (if any).
    3. Adequacy of scientific evidence document depends on the quality of evidence that supported claims on the efficacy of food or constituents and shall be consistent with recommended use, the objective of health claims, dosage form, recommended intake, duration of intake, and risk information. 
    4. Health claims shall be considered by product constituents that may be effective to such food or constituents that are being claimed.

    (e) Estimated cost and duration for new health claim approval process

    As per an announcement by the Ministry of Public Health [3]:

    • Timeline: approximately 106 business days, depending on the quality of the dossier 
    • Cost: 
      • Request for assessment of health claim: 3,000 THB/claim
      • Evaluation of technical documents related to product licensing applications that have been used for food or new chemicals or develop a new formula for claiming benefits for nutritional or medical purposes: 69,000 THB/each
      • Evaluation of technical documents related to product licensing applications for a substance that is not new but that has more claims in the field of nutrition or medical purposes: 45,000 THB/each
      • Evaluation of academic documents related to requests for amendments, products, or product labels that have been authorized for claiming benefits for nutritional or medical purposes: 45,000 THB/each

    5.4 Other Notes or Requirements for Claims

    Foods with health claims [2]:

    • Shall be safe and its standards and quality comply with regulations. If it is a novel food, there shall be prior approval on safety assessment.
    • Shall display nutrition label and follow the "Notification of the Ministry of Public Health regarding Nutrition label"; except when such food requested for health claim is a special purpose food, its label shall then follow the "Notification of the Ministry of Public Health regarding Special Purpose Foods".

    Statements of health claims both declared on the food label or advertised shall [2]:

    • Be in the Thai language, with similar size of letters and legibility, and may also be in another language, and its meaning shall be consistent with the claim made in the Thai Language;  
    • Not mislead to consuming such food or its constituents to be able to relieve, cure or prevent disease;
    • Declare statements as prescribed or approved by the FDA including the following statements: "Should routinely intake varieties of 5 food categories in an appropriate amount" and "no effect on the relief, cure or prevention of diseases".

    5.5 References

    1. Appendix 4 MOPH Notification No. 182 B.E. 2541 (1998) Re: Nutrition Labelling

    https://extranet.who.int/nutrition/gina/sites/default/filesstore/THA%201998%20Notification%20of%20the%20Ministry%20of%20Public%20Health%20-%20Nutrition%20Labelling.pdf


    2. Public Manual - Requesting for assessment of health claim

    https://www.fda.moph.go.th/sites/fda_en/Shared%20Documents/Manual/ประเมินความปลอดภัย/02%20PM%20Requesting%20for%20assessment%20of%20health%20claim.pdf


    3. Announcement of the Ministry of Public Health Subject: Expenses to be collected from applicants in the food product licensing process B.E. 2560 (Thai)

    https://www.ratchakitcha.soc.go.th/DATA/PDF/2560/E/199/23.PDF


    4. Announcement of the Food and Drug Administration Re: The display of statements claiming the functions of nutrients 

    http://www.ratchakitcha.soc.go.th/DATA/PDF/2562/E/146/T_0051.PDF


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