DIRECTIVE SPECIFIC TO THE CHANGE IN THE USE OF THE PHRASE “NO APPROVED THERAPEUTIC CLAIM” IN ALL ADVERTISEMENT, PROMOTIONAL, AND/OR SPONSORSHIP ACTIVITIES OR MATERIALS CONCERNIN…

I. RATIONALE/BACKGROUND

Article II, Section 15 of the 1987 Constitution expressly declares as
a policy of the State to “protect and promote the right to health
of the people and instill health consciousness among them.”
Pursuant to the above policy, Republic Act No. 3720, as amended by
Executive Order (EO) No. 175, authorized and mandated the Department of
Health, through the Food and Drug Administration to “(a) Establish
standards and quality measures for foods, drugs, and devices and
cosmetics; and (b) Adopt measures to ensure pure and safe supply of
foods and cosmetics, and pure, safe, efficacious and good quality drugs
and devices in the country.”

Further, Republic Act No. 7394 or the Consumer Act of the Philippines
reiterates the policy of the State to protect the interests of the
consumers against deceptive, unfair and unconscionable sales acts or
practices, misleading advertisements and fraudulent sales promotion
practices; promote his general welfare; and to establish standards of
conduct for business and industry. To achieve the above policies, the
State, through its proper Department, was mandated to implement measures
to protect the rights of consumers on matters against deceptive, unfair
and unconscionable sales acts or practices and provide information and
education to facilitate sound choice and the proper exercise of the
rights by the consumer.

Recently, Republic Act No. 9711 or “Food and Drug Administration
(FDA) Act of 2009,” was enacted empowering 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 the health products as
covered in the Act.”

While it is mandatory, pursuant to Bureau Circular No. 2 series 1992
and Memorandum Circular No. 25 series 1992, for every manufacturer,
distributor or owner of food/dietary supplements, as well as their
agents to reflect the message or phrase “No Approved Therapeutic
Claim” in every label, advertisements, promotions and other
marketing materials for such products, the above message or phrase is,
in one way or another, confuses the public particularly on the claims
being used for a particular food/ dietary supplement. More often, such
phrase is being abused by the owners of such food/dietary supplements
and/or their advertisers or agents. Corollary, a growing concern on
food/dietary supplements with dubious, inaccurate, false, deceptive or
misleading claims about their efficacy and/or nutritional, medicinal or
health-enhancing attributes, character, value, merit, or safety are
being raised by the members of the public, hence, this Administrative
Order.

II. PURPOSE AND OBJECTIVE

This Administrative Order is promulgated to provide directives
specific to the change in the use of the message or phrase “No Approved
Therapeutic Claim” in all advertisement, promotion and/or sponsorship
activities or materials concerning Food/ Dietary Supplements with the
end view of promoting and protecting the consumers’ health and welfare
and fostering their right to proper information and education to
facilitate sound choice.

III. SCOPE

This Administrative Order shall cover the change of the use of the
message or phrase “No Approved Therapeutic Claim” in all advertisement,
promotion and/or sponsorship activities or materials concerning
Food/Dietary Supplements, as well as, owners, manufacturers,
distributors, advertisers and/or their agents of such products, and the
Advertising Standards Council, Television Networks, Radio Stations and
other concerned offices, establishments, or person.

For purposes of this Order, Food/Dietary Supplement
shall mean a processed food product intended to supplement the diet that
bears or contains one or more of the following dietary ingredients:
vitamin, mineral, herb, or other botanical, amino acid, and dietary
substance 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 usually is in the
form of capsules, tablets, liquids, gels, powders or pills and not
represented for use as a conventional food or as the sole item of a meal
or diet or replacement of drugs and medicines.

IV. DIRECTIVES

In issuing this Order, the Department of Health, through the FDA,
hereby reiterates that it shall be unlawful for any person to
disseminate or to cause the dissemination of any false, deceptive or
misleading advertisement, promotion, or other marketing materials by
Philippine mail or in commerce by print, radio, television, outdoor
advertisement or other medium for the purpose of inducing or which is
likely to induce directly or indirectly the purchase of a particular
food/dietary supplement. An advertisement, promotion, sponsorship and
other marketing materials in the various media of food/dietary
supplements shall be deemed false, deceptive or misleading if it is not
in conformity with the provisions of Republic Act No. 3720 as amended by
Executive Order No. 175 and Republic Act No. 9711; and Republic Act No.
7394; as well as their respective rules and regulations issued thereto,
or if it is misleading in a material respect, or if it is in violation
of this Order.

A. Accordingly, the use of the message or phrase “No Approved
Therapeutic Claim” shall no longer be allowed in any form of
advertisement, promotion and/or sponsorship activities or materials
concerning Food/Dietary Supplements commencing from the effectivity of
this Order. Instead, the following rules shall apply:

1. All Food/Dietary Supplement owners, manufacturers, distributors,
importers, exporters, advertisers, and/or their agents are mandated to
strictly carry, in Filipino, standard message or phrase:

“MAHALAGANG PAALALA: ANG (NAME OF PRODUCT) AY HINDI GAMOT
AT HINDI DAPAT GAMITING PANGGAMOT SA ANUMANG URI NG SAKIT.

in every advertisement, promotion and/or sponsorship activities
or any materials used concerning Food/Dietary Supplements.

2. For PRINT and other VISUAL advertisements, promotions, or
materials, the above standard message or phrase shall be at least 1/3 of
the size of the largest letter/logo and prominently (all in capital and
bold letters) printed above of every advertisement, promotional
activities or any materials used. Only the fonts Arial or Tahoma shall
be used for the above standard message or phrase.

3. For AUDIO advertisements or promotions, the message or phrase

“MAHALAGANG PAALALA: ANG (NAME OF PRODUCT) AY HINDI GAMOT
AT HINDI DAPAT GAMITING PANGGAMOT SA ANUMANG URI NG SAKIT.

shall be clearly and audibly voiced over, without being cut-off, in
the last line of the advertisement or promotions regardless of its
duration.

4. For AUDIO-VISUAL advertisements or promotions the above message
or phrase in the preceding sub-paragraph (sub-paragraph 3) shall be
clearly and prominently shown during the entire broadcast following the
size and fonts established in sub-paragraph 2 above and clearly and
audibly voiced over, without being cut-off, in the last line of the
advertisement or promotion, regardless of the duration.

B. The Food and Drug Administration of the
Department of Health – which has the 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 person shall require and see to it that
every owner, manufacturer, importer distributor, advertiser and/or
their agents, of Food/Dietary supplements strictly adhere to the above
directives.

C. In addition, all Food/Dietary Supplement owners,
manufacturers, distributors, advertisers, and/or their agents are
mandated also to strictly observe at all times the following directives,
to wit:

1. No person shall advertise, promote, or use in any sponsorship
any food/ dietary supplements unless such product is duly registered and
approved by the Food and Drug Administration.
2. No person shall use in any advertising, promotion or sponsorship
relating to such food/dietary supplement of any representation or
suggestion that such food/dietary supplement is registered with the FDA
when in fact it is not.
3. No claim shall be made in the advertisement, promotion and other
marketing materials in the various media for use of any food/dietary
supplements which is not contained in the label or approved by the FDA.
4. Any special claims must be substantiated and research results,
scientific terms, statistics or quotations must be properly used, which
must likewise be duly approved by the FDA prior to use in any
advertisement, promotion and other marketing materials in the various
media.
5. No person shall advertise, promote and use in any sponsorship any
food/ dietary supplement in any manner that is false, misleading or
deceptive or is likely to create an erroneous impression regarding its
character, value, quantity, composition, merit, or safety.
6. Where a standard has been prescribed for a food/dietary
supplement, no person shall advertise any food/dietary supplement in
such a manner that is likely to be mistaken for such product, unless the
food/dietary supplement complies with the prescribed standard or
regulation.
7. No person shall make use of any reference to any laboratory
report of analysis in the advertisement, promotion and use in other
marketing materials in the various media of any food/dietary supplement,
unless such laboratory report is duly approved by the FDA for use for
such advertisement, promotion and other marketing materials in the
various media.
8. No advertisement, endorsement or promotion of any food/dietary
supplements shall be made by any medical practitioner or health worker,
nor shall any owner, manufacturer, importer distributor, advertiser
and/or their agents, of Food/Dietary supplements sponsor any activity,
seminar, conference, or study of any medical practitioner or health
worker.

D. All Food/Dietary Supplements advertised,
promoted, and/or used in sponsorship activities that are not in
compliance with or in violation of any of the sub-paragraph in either
paragraphs A and C above shall be deemed misbranded and in violation of
Republic Act No. 9711.

For this purpose, the FDA shall call upon any erring owner,
manufacturer, distributor, or advertiser, and/or their agents to cease
and desist outright from advertising, promoting and/or using in any
sponsorship activity or material any Food/Dietary Supplement in
question, without prejudice to any action of seizure by the FDA granted
to it by Republic Act No. 9711. The applicable penalties as prescribed
by the above law and regulations shall be imposed after notice and
hearing.

V. SEPARABILITY CLAUSE

Should any of the provision(s) or part of this Order be declared
unconstitutional, all other remaining portions not so declared shall
remain valid and effective.

VI. REPEALING CLAUSE

Any existing similar issuances relating to the rules or guidelines on
the advertisement, promotion and/or sponsorship activities or materials
concerning Food/ Dietary Supplements that are inconsistent with this
Order shall be deemed repealed or abrogated accordingly.

VII. EFFECTIVITY

This Order shall take effect immediately after publication in two (2)
national newspapers of general circulation.

Adopted: 18 March 2010

(SGD.) ESPERANZA I. CABRAL, MD
Secretary of Health