QuestionsQuestions (DOH ADMINISTRATIVE ORDER NO. 2010-0008)
The Order cites the 1987 Constitution (Article II, Sec. 15 on protecting and promoting the right to health), Republic Act No. 3720 as amended by EO 175 (FDA authority on standards and measures for foods/drugs), Republic Act No. 7394 (Consumer Act provisions on deceptive/unfair/misleading advertising and protection of consumers), and Republic Act No. 9711 (FDA Act of 2009 empowering FDA to prescribe standards/guidelines on information and marketing activities about health products).
The Order states that the phrase was confusing to the public about claims being used for specific food/dietary supplements and was often abused by supplement owners, advertisers, or agents, contributing to concerns over dubious, inaccurate, false, deceptive, or misleading efficacy/health-related claims.
To provide directives for changing the use of the phrase “No Approved Therapeutic Claim” in all advertising, promotion, and/or sponsorship materials concerning food/dietary supplements, with the end of promoting and protecting consumers’ health and welfare and fostering the right to proper information and education to facilitate sound choice.
It is a processed food product intended to supplement the diet containing dietary ingredients such as vitamins, minerals, herbs/botanicals, amino acids, and dietary substances to increase total daily intake in amounts conforming to latest Philippine recommended energy/nutrient intakes or internationally agreed minimum daily requirements; typically capsules/tablets/liquids/gels/powders/pills, and not represented as a conventional food or as the sole item of a meal/diet or as a replacement for drugs/medicines.
Its use shall no longer be allowed in any form of advertisement, promotion, and/or sponsorship materials concerning food/dietary supplements commencing from the effectivity of the Order.
The Order mandates that all 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.” This must appear in every advertisement, promotion, and/or sponsorship activity or material concerning the supplement.
The message must be at least 1/3 of the size of the largest letter/logo, printed prominently in all capital and bold letters above every advertisement/promotional/sponsorship material. Only Arial or Tahoma fonts may be used for the standard message.
The message “MAHALAGANG PAALALA: ANG (NAME OF PRODUCT) AY HINDI GAMOT AT HINDI DAPAT GAMITING PANGGAMOT SA ANUMANG URI NG SAKIT.” must be clearly and audibly voiced over, without being cut-off, in the last line of the advertisement or promotion regardless of its duration.
The standard message must be clearly and prominently shown during the entire broadcast following the size and fonts requirements for print/visual (as referenced by the Order), and must be clearly and audibly voiced over without being cut-off in the last line regardless of duration.
The FDA of the DOH (primary jurisdiction), the Advertising Standards Council, all television networks, radio stations, and other relevant offices, establishments, or persons shall require and ensure strict adherence by owners, manufacturers, distributors, advertisers, and/or their agents.
No person shall advertise/promote/use in any sponsorship any food/dietary supplement unless the product is duly registered and approved by the FDA.
No person shall make any representation or suggestion in advertisements/promotions/sponsorship that the food/dietary supplement is registered with the FDA when it is not.
No claim shall be made in advertising/promotion/marketing materials unless contained in the label or approved by the FDA. Additionally, special claims must be substantiated, and research results/scientific terms/statistics/quotations must be properly used and duly approved by the FDA prior to use.
Examples include: (1) No person shall advertise/promote/use a supplement in a manner that is false, misleading, or deceptive or likely to create an erroneous impression about its character, value, quantity, composition, merit, or safety; and (2) No person shall make use of any laboratory report reference in advertisements/promotional materials unless duly approved by the FDA for such use.
No advertisement, endorsement, or promotion of food/dietary supplements shall be made by any medical practitioner or health worker. Also, owners/manufacturers/distributors/advertisers/agents are prohibited from sponsoring activities, seminars, conferences, or studies of medical practitioners or health workers.
Such food/dietary supplements are deemed misbranded and in violation of Republic Act No. 9711.
The FDA may call upon erring owners/manufacturers/distributors/advertisers and/or their agents to cease and desist outright from advertising/promoting/using the non-compliant supplement in sponsorship materials. This is without prejudice to seizure actions granted to the FDA by RA 9711. Applicable penalties shall be imposed after notice and hearing.
It shall take effect immediately after publication in two (2) national newspapers of general circulation.