On July 8, 2024, Philippines FDA announced a draft circular titled "Guidelines on the Use of Acceptable Nutrition and Health Claims in the Labeling, Advertisement, Sponsorships, Promotions, and Other Marketing Activities and Promotional Materials of Processed Food Products". All comments can be sent to [email protected] no later than July 29.
1. Purpose and scope
The draft circular aims to establish a list of acceptable nutrition and health claims that will be used as a reference guide for stakeholders. It covers all locally-produced and imported processed food products intended to be manufactured, used, consumed, imported, distributed, promoted, advertised, sponsored, and offered for sale in the Philippines.
2. Key terms & definitions
"Processed food" refers to food that has been subjected to substantial alteration of the initial raw material, product or ingredients such as, but not limited to, heating, smoking, curing, maturing, drying, marinating, extraction, extrusion and a combination of these processing.
"Nutrition claim" refers to any representation which states, suggests or implies that a food has particular nutritional properties including but not limited to the energy value and the content of protein, fat and carbohydrates, as well as the content of vitamins and minerals. However, please note that the following do not constitute nutrition claims:
a) the mention of substances in the list of ingredients;
b) the mention of nutrients as a mandatory part of nutrition labeling;
c) quantitative or qualitative declaration of certain nutrients or ingredients on the label if required by national legislation.
"Health claims" refer to 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 four types, namely:
1) nutrient comparative claims, e.g., "reduced", "less than", "increased", "more than";
2) nutrient function claims, e.g., "Nutrient A helps XXX. Food X is high in Nutrient A";
3) other function claims, e.g., "Substance A helps XXX. Food Y contains X grams of substance A";
4) reduction of disease risk claims, e.g., "A healthful diet low in nutrient A (or substance A) may reduce the risk of disease D. Food X is low in nutrient A (or substance A)."
3. General requirements
The Bureau Circular No. 2007-002 establishes guidelines for the use of nutrition and health claims in the labeling, advertising, sponsorships, promotions, and other marketing materials of processed food products. Besides, Annex B to E provides additional acceptable claims, on the basis of other legal references such as Consumer Act of the Philippines (RA No. 7394), the Food and Safety Act of 2013 (RA No. 10611), Codex Alimentarius Commission Guidelines (CAC/GL 23-1997, Rev. 2004), Administrative Order 2014-0030, and related regulations. Additionally, all claims must be evaluated and approved by the FDA-Center for Food Regulation and Research (CFRR) before being used in any marketing materials.
4. Detailed requirements
Only food products meeting specific nutrient criteria (see Annex A) can have nutrient content claims like "high in", "very low", "low", and "free", but limited to nutrients with established %REI/RNI.
Nutrition and health claims are not permitted on foods for infants and young children.
Nutrient claims must be supported by recent (within 24 months) lab analysis using validated methods, including the limit of detection. The nutrient amounts must comply with relevant regulations.
Advertising, promotions, etc. can only contain claims approved to be used on the product label or by the FDA.
Terms like "contributes", "helps", and "supports" can be used interchangeably, but rephrasing claims that alters the context is not allowed.
For nutrition and health claims not in the approved list, additional documentation is required:
1) justification for the alignment with Codex guidelines on substantiation of claims
2) at least 2 recent peer-reviewed human studies
3) verification by recognized expert bodies
4) proposed claim wording and conditions for use
5) justification for any proprietary information
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