Legal basis and policy intent
- Article II, Section 15 of the 1987 Constitution establishes a State policy to protect and promote the right to health of the people and instill health consciousness.
- Republic Act No. 3720, as amended by Executive Order No. 175, authorizes and mandates the Department of Health through the Food and Drug Administration to establish standards and quality measures for foods, drugs, and devices and cosmetics, and to adopt measures to ensure pure and safe supply and pure, safe, efficacious and good quality products.
- Republic Act No. 7394 (Consumer Act of the Philippines) reiterates State policy to protect consumers from deceptive, unfair and unconscionable sales acts or practices, misleading advertisements, and fraudulent sales promotion practices, and to promote general welfare and standards of conduct for business and industry.
- Republic Act No. 9711 (Food and Drug Administration Act of 2009) empowers the Food and Drug Administration under the Office of the Secretary to prescribe standards, guidelines, and regulations with respect to information, advertisements, and other marketing instruments and promotion, sponsorship, and other marketing activities about health products.
- The order is promulgated to promote and protect consumers’ health and welfare and to foster their right to proper information and education to facilitate sound choice under II. PURPOSE AND OBJECTIVE.
Key definitions for “Food/Dietary Supplement”
- “Food/Dietary Supplement” means a processed food product intended to supplement the diet that bears or contains one or more dietary ingredients: vitamin, mineral, herb, or other botanical, amino acid, and dietary substance.
- The dietary ingredients must be intended to increase the total daily intake in amounts conforming to the latest Philippine recommended energy and nutrient intakes or internationally agreed minimum daily requirements.
- It is typically in the form of capsules, tablets, liquids, gels, powders or pills.
- It is not represented for use as a conventional food or as the sole item of a meal or diet, and it is not represented as a replacement of drugs and medicines.
Prohibited marketing and “No Approved Therapeutic Claim” ban
- The order reiterates that it is unlawful for any person to disseminate or cause the dissemination of any false, deceptive or misleading advertisement, promotion, or other marketing materials for a Food/Dietary Supplement by Philippine mail or in commerce by print, radio, television, outdoor advertisement or other medium to induce—or likely to induce—purchase.
- An advertisement, promotion, sponsorship, and other marketing materials are deemed false, deceptive or misleading if they are not in conformity with Republic Act No. 3720 as amended by Executive Order No. 175 and Republic Act No. 9711; and Republic Act No. 7394 and their rules and regulations, or if they are misleading in a material respect, or if they violate this Order under IV.
- The phrase “No Approved Therapeutic Claim” is no longer allowed in any form of advertisement, promotion and/or sponsorship activities or materials concerning Food/Dietary Supplements starting from the effectivity of this Order under IV.A.
- The order replaces the banned phrase with a mandatory Filipino standard message under IV.A.1.
Mandatory standard warning message
- Food/Dietary Supplement owners, manufacturers, distributors, importers, exporters, advertisers, and/or their agents must strictly carry, in Filipino, the standard message:
- “MAHALAGANG PAALALA: ANG (NAME OF PRODUCT) AY HINDI GAMOT AT HINDI DAPAT GAMITING PANGGAMOT SA ANUMANG URI NG SAKIT.”
- For PRINT and other VISUAL advertisements, promotions, or materials, the standard message must be:
- at least 1/3 of the size of the largest letter/logo, and
- prominently printed above every advertisement or promotional material, in all capital and bold letters.
- For PRINT and other VISUAL advertisements, the standard message must use only the fonts Arial or Tahoma.
- For AUDIO advertisements or promotions, the standard message must be:
- clearly and audibly voiced over, without being cut-off, in the last line of the advertisement or promotion regardless of duration.
- For AUDIO-VISUAL advertisements or promotions, the standard message must be:
- clearly and prominently shown during the entire broadcast following the size and fonts required for visual materials, and
- clearly and audibly voiced over, without being cut-off, in the last line of the advertisement or promotion regardless of duration.
Implementation and enforcement roles
- The Food and Drug Administration under the Department of Health has primary jurisdiction on matters of advertisements of Food/Dietary Supplements.
- The Advertising Standards Council, all Television Networks, Radio Stations, and other relevant offices, establishments, or persons must require and ensure strict adherence to the directives.
- FDA and covered media entities must require that Food/Dietary Supplement owners, manufacturers, importers, distributors, advertisers, and/or their agents strictly follow the mandatory warning and the substantive restrictions on claims and sponsorship under IV.B and IV.C.
- The order directs that any non-compliant Food/Dietary Supplement used in advertising, promotion, and/or sponsorship activities is treated as misbranded and triggers FDA cease-and-desist processes and enforcement under IV.D.
Substantive rules on claims, registration, and sponsorship
- It is prohibited for any person to advertise, promote, or use in sponsorship any Food/Dietary Supplement unless the product is duly registered and approved by the FDA under IV.C.1.
- It is prohibited to use in any advertising, promotion or sponsorship a representation or suggestion that the Food/Dietary Supplement is registered with the FDA when it is not under IV.C.2.
- It is prohibited to make any claim in advertisements, promotions, and other marketing materials for Food/Dietary Supplements that is not contained in the label or approved by the FDA under IV.C.3.
- It is prohibited to use special claims unless they are substantiated, and any research results, scientific terms, statistics, or quotations must be properly used and duly approved by the FDA prior to use under IV.C.4.
- It is prohibited to advertise, promote, or use in sponsorship any Food/Dietary Supplement in a manner that is false, misleading or deceptive or likely to create an erroneous impression regarding its character, value, quantity, composition, merit, or safety under IV.C.5.
- Where a standard has been prescribed for a Food/Dietary Supplement, it is prohibited to advertise the product in a manner that is likely to be mistaken for such product unless the Food/Dietary Supplement complies with the prescribed standard or regulation under IV.C.6.
- It is prohibited to make use of any reference to laboratory report of analysis in advertisements, promotions, and other marketing materials unless the laboratory report is duly approved by the FDA for use for such marketing purposes under IV.C.7.
- It is prohibited for any medical practitioner or health worker to make advertising, endorsement or promotion of Food/Dietary Supplements under IV.C.8.
- Owners, manufacturers, importers, distributors, advertisers, and/or their agents are prohibited from sponsoring any activity, seminar, conference, or study of any medical practitioner or health worker under IV.C.8.
Misbranding, cease-and-desist, and penalties
- Food/Dietary Supplements advertised, promoted, and/or used in sponsorship activities that violate any of the rules under IV.A or IV.C are deemed misbranded and in violation of Republic Act No. 9711 under IV.D.
- The FDA must call upon any erring owner, manufacturer, distributor, or advertiser and/or their agents to cease and desist outright from advertising, promoting and/or using the Food/Dietary Supplement in question in any sponsorship activity or material under IV.D.
- The cease-and-desist directive is without prejudice to any action of seizure by the FDA granted to it by Republic Act No. 9711 under IV.D.
- The applicable penalties prescribed by Republic Act No. 9711 and its regulations are imposed after notice and hearing under IV.D.
Separability and repealing effect
- If any provision or part of the order is declared unconstitutional, all remaining provisions not declared unconstitutional remain valid and effective under V.
- Any existing similar issuances relating to rules or guidelines on the advertisement, promotion and/or sponsorship activities or materials concerning Food/Dietary Supplements that are inconsistent with this Order are deemed repealed or abrogated accordingly under VI.