Defined “Food Supplement” and “special dietary use”
- Administrative Order No. 62 s. 1968 defines Food Supplement as food used for supplementing or fortifying the ordinary or usual diet with any vitamin, mineral, or other dietary property.
- A food that is used for such fortification or supplementation is a special dietary use.
- The food remains a special dietary use even if it also purports to be, or is represented for, general use.
Labeling requirement to prevent therapeutic claims
- Food supplements must not be commercially sold or advertised with therapeutic claims.
- BFAD requires applicants for registration to print on the product label the words “no approved therapeutic claim”.
- BFAD Memorandum Circular No. 25 s. 1992 confirms the labeling requirement for the guidance of all concerned.
- The label wording requirement applies to food supplements covered by the Food Supplement definition under Administrative Order No. 62 s. 1968.
Scope and coverage of the rule
- The circular governs food supplements as defined under Administrative Order No. 62 s. 1968.
- The circular applies to commercial sale and commercial advertising of covered food supplements.
- The labeling requirement is tied to registration applicants, for the purpose of preventing therapeutic claims.
Implementation through registration applicants
- Applicants for registration must incorporate the required wording on the label when seeking registration for a food supplement.
- The labeling requirement functions as a compliance standard to ensure food supplements are not marketed with therapeutic claims.
Transitory guidance and administrative confirmation
- BFAD Memorandum Circular No. 25 s. 1992 is issued to confirm the existing BFAD requirement on label wording.
- The circular provides guidance for all concerned regarding the required label wording for food supplements.