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    5. Claim Requirements
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    5. Claim Requirements

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    General Foods
    Philippines

    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

    Nutrition Claims

    Philippines FDA adopts the Codex Alimentarius Commission Guidelines for Use of Nutrition and Health Claims (CAC/GL 23-1997, Rev. 1- 2004) [1] in the evaluation of the use of nutrition and health claims in food labeling and in the advertisement of food products.

    Nutrition claim means any representation which states, suggests, or implies that a food has particular nutritional properties including but not limited to the energy value and to the content of protein, fat, and carbohydrates, as well as the content of vitamins and minerals.  

    1. The nutrient content claim is a nutrition claim that describes the level of a nutrient contained in a food. (Examples: “source of calcium”; “high in fiber and low in fat”.)
    2. The nutrient comparative claim is a claim that compares the nutrient levels and/or energy value of two or more foods. (Examples: “reduced”; “less than”; “fewer”; “increased”; “more than”.)
    3. Non-addition claim means any claim that an ingredient has not been added to a food, either directly or indirectly. The ingredient is one whose presence or addition is permitted in the food and which consumers would normally expect to find in the food.

    Conditions for making these claims follow CAC/GL 23-1997 [2].

    Health Claims

    Health claim means any representation that states, suggests, or implies that a relationship exists between a food or a constituent of that food and health. Health claims include the following:

    1. Nutrient function claims mean nutrition claims that describe the physiological role of the nutrient in the growth, development, and normal functions of the body. Example: "Nutrient A (naming a physiological role of nutrient A in the body in the maintenance of health and promotion of normal growth and development). Food X is a source of/ high in nutrient A.”
    2. Other function claims concern 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. Examples: “Substance A (naming the effect of substance A on improving or modifying a physiological function or biological activity associated with health). Food Y contains x grams of substance A.”
    3. Reduction of disease risk claims are claims relating the consumption of a food or food constituent, in the context of the total diet, to the reduced risk 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. Diseases have multiple risk factors and altering one of these risk factors may or may not have a beneficial effect. The presentation of risk reduction claims must ensure, for example, by use of appropriate language and reference to other risk factors, that consumers do not interpret them as prevention claims. Examples:
      1. “A healthful diet low in nutrient or substance A may reduce the risk of disease D. Food X is low in nutrient or substance A.”
      2. “A healthful diet rich in nutrient or substance A may reduce the risk of disease D. Food X is high in nutrient or substance A.”

    Conditions for making these health claims follow CAC/GL 23-1997 [2]: 

    • Health claims must be based on current relevant scientific substantiation and the level of proof must be sufficient to substantiate the type of claimed effect and the relationship to health as recognized by generally accepted scientific review of the data and the scientific substantiation should be reviewed as new knowledge becomes available. The health claim must consist of two parts:
      1. Information on the physiological role of the nutrient or on an accepted diet-health relationship; followed by 
      2. Information on the composition of the product relevant to the physiological role of the nutrient or the accepted diet-health relationship unless the relationship is based on a whole food or foods whereby the research does not link to specific constituents of the food.
    • The claimed benefit should arise from the consumption of a reasonable quantity of the food or food constituent in the context of a healthy diet.
    • If the claimed benefit is attributed to a constituent of the food, there must be a validated method to quantify the food constituent that forms the basis of the claim.

    5.1.2 List of Prohibited Claims

    Section VII of Administrative Order 2014-0030 [3] stipulates misleading declarations, representation, and prohibited claims: 

    • That the food, because of the presence or absence of certain dietary properties, is adequate or effective in the prevention, cure, mitigation, or treatment of any disease or symptom of an illness;
    • That a balanced diet of ordinary foods cannot supply an adequate amount of nutrients;
    • That the food has dietary properties when such properties are of no significant value or need in human nutrition;
    • That a synthetic vitamin in food is superior to a natural vitamin;
    • Claims which could give rise to doubt about the safety of similar food or which could cause or exploit fear in the consumer;
    • Claims which highlight the absence or addition of any food additive or nutrient supplement, if the addition of such food additive or nutrient supplement is not permitted or prohibited;
    • Claims on the absence of beef or pork or its derivatives or lard or added alcohol are prohibited if the food does contain such ingredient;
    • Claims on the presence of any substance when the food does not contain such ingredient;
    • Claims that a product is superior to any other existing product of the same kind that cannot be substantiated;
    • Claims stating that any given food will provide an adequate source of all essential nutrients, except in the case of well-defined products for which a Codex standard regulates such claims as admissible claims or where the FDA has accepted, through an issuance, that the product is an adequate source of all essential nutrients (Codex General Guidelines on Claims CAC/GL 1-1979, Amended 2009, Section 3.1 on Prohibited Claims);
    • Claims as to the suitability of a food for use in the prevention, alleviation, treatment, or cure of a disease, disorder, or particular physiological condition unless they are:
      • in accordance with the provisions of the Codex standards or guidelines for foods as developed by the Committee on Nutrition and Foods for Special Dietary Uses and follow the principles set forth in these guidelines; or 
      • in the absence of an applicable Codex standard or guideline, permitted by the FDA.
    • Meaningless claims including incomplete comparatives and superlatives; and
    • Claims as to good hygienic practice, such as "wholesome," "healthful" or "sound."

    5.2 Nutritional Claims

    5.2.1 Permitted Claims

    The only nutrition claims permitted shall be those relating to energy, protein, carbohydrate, and fat and components thereof, fiber, sodium, and vitamins and minerals for which Nutrient Reference Values (NRVs) have been laid down in the Codex Guidelines for Nutrition Labeling [4].

    5.2.2 Nutritional Claim Registration

    N/A

    5.3 Health Claims

    5.3.1 Permitted Claims

    There is no positive list of Health Claims which can be made on foodstuffs.

    Health claims should be permitted provided that the conditions stated in Section 8.1 of CAC/GL 23-1997 [2] are met.

    5.3.2 Health Claim Registration

    Claims are evaluated during product registration.

    List of documents and other requirements required for health claim approval

    • Scientific evidence to support the claims such as technical, nutritional, or health studies or reports, market research studies, Certificate of Analysis, quantitative analysis and computations, and scientific reports or studies published in peer-reviewed scientific journals [5]. 
    • Other components of the registration dossier as stated in Section 6.2.

    Estimated cost and duration for new health claim approval process

    See details in the FDA general regulatory fees and charges [6] for the applicable product category.

    5.4 Other Notes or Requirements for Claims

    Specific labeling requirements for food-bearing health claims

    The following information should appear on the label or labeling of the food-bearing health claims:

    1. A statement of the quantity of any nutrient or other constituent of the food that is the subject of the claim.
    2. The target group, if appropriate.
    3. How to use the food to obtain the claimed benefit and other lifestyle factors or other dietary sources, where appropriate.
    4. If appropriate, advice to vulnerable groups on how to use the food and to groups, if any, who need to avoid the food.
    5. Maximum safe intake of the food or constituent where necessary.
    6. How the food or food constituent fits within the context of the total diet.
    7. A statement on the importance of maintaining a healthy diet.

    Claims other than health and nutrition claims

    Nutrition and health claims shall follow Bureau Circular 2007-002, CAC/GL 23-1997 [7], and CAC/GL 1-179 [8], and their subsequent amendments so far it does not conflict with the existing laws. 

    Claims other than health and nutrition not covered under these 3 guidelines and their subsequent amendments shall be evaluated based on submitted substantiation.

    5.5 References

    1. Guidelines in the Use of Nutrition and Health Claims in Food

    https://www.fda.gov.ph/wp-content/uploads/2021/05/Bureau-Circular-No.-2007-002.pdf


    2. CAC/GL 23-1997 Guidelines for use of nutrition and health claims  

    https://www.fao.org/ag/humannutrition/32444-09f5545b8abe9a0c3baf01a4502ac36e4.pdf


    3. Administrative Order No. 2014-0030

    https://www.fda.gov.ph/wp-content/uploads/2021/03/Administrative-Order-No.-2014-0030.pdf


    4. CXS 2-1985 Guidelines on Nutrition Labelling

    https://www.fao.org/fao-who-codexalimentarius/sh-proxy/en/?lnk=1&url=https%253A%252F%252Fworkspace.fao.org%252Fsites%252Fcodex%252FStandards%252FCXG%2B2-1985%252FCXG_002e.pdf


    5. Annex D Administrative Order No. 2014-0029 Rules and Regulations on the Licensing of Food Establishments and Registration of Processed Food, and the Other Food Products, and for Other Purposes

    https://www.fda.gov.ph/wp-content/uploads/2021/03/Administrative-Order-No.-2014-0029.pdf


    6. General Regulatory fees and charges 

    https://www.fda.gov.ph/wp-content/uploads/2018/06/FINAL-ANNEXES-for-AO-on-INCREASE-OF-FEES.pdf


    7. CAC/GL 23-1997 Guidelines for use of nutrition and health claims

    https://www.fao.org/ag/humannutrition/32444-09f5545b8abe9a0c3baf01a4502ac36e4.pdf


    8. CXG 1-1979 General Guidelines on Claims

    https://www.fao.org/fao-who-codexalimentarius/sh-proxy/en/?lnk=1&url=https%253A%252F%252Fworkspace.fao.org%252Fsites%252Fcodex%252FStandards%252FCXG%2B1-1979%252FCXG_001e.pdf






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