Guidelines on EO No. 51 Implementation by IAC

Authority, policy, and purpose

The State policy is to protect and promote the right to health and instill health consciousness.
The guidelines are issued to help ensure safe and adequate nutrition for infants by protecting and promoting breastfeeding and by ensuring proper public information and appropriate regulation of marketing and distribution of breastmilk substitutes, supplements, and related products.
The IAC is the inter-agency body created pursuant to E.O. No. 51, s. of 1986, composed of the Department of Health (as chair), Department of Trade and Industry (DTI), Department of Justice, and Department of Social Welfare and Development.
The guidelines are issued based on Section 12(a)(3) and Section 6(a) of E.O. No. 51, in relation to Section 12, Rule V of Administrative Order (AO) No. 2006-0012 and its Revised Implementing Rules and Regulations (RIRR) for E.O. No. 51, which direct the IAC to prescribe internal and operational procedures.

Key definitions and terms

“Code” refers to E.O. No. 51 (the Milk Code).
“IAC” refers to the inter-agency committee created under E.O. No. 51, s. 1986, tasked with reviewing, evaluating and/or approving advertisement, promotion, sponsorship and/or marketing activities, including but not limited to research and donation of equipment, funds, products, by companies/manufacturers of covered products.
“Nuisance Application” refers to an application that may be denied outright by the IAC for reasonable grounds, including applications already screened and denied by the IAC, or applications substantially the same as previously denied applications (including only corrected typographical errors).
“Technical Resource Persons” refers to individuals invited by the IAC with formal education, technical knowledge, and training in their fields, including doctors, nurses, nutritionists, dieticians, lactation and media consultants, and persons from government, private sector, international organizations, or civil society.

Composition, representation, and conflicts

The IAC is composed of the Secretaries of Health, Trade and Industry, Justice, and Social Welfare and Development, with the Secretary of Health as Chairman. (Section 3)
Each IAC member designates a duly authorized representative and an alternate to every IAC meeting.
The designated representative/alternate decides and votes on behalf of the absent Secretary, but only when authority is given through an official issuance in the format attached as Annex “A”, signed by the represented Secretary.
The duly authorized representative/alternate must be responsible for reporting, giving feedback, and/or communicating matters transpired during IAC meetings to the represented Secretary.
IAC members and their duly authorized representatives must accomplish a declaration of conflict of interest form under oath (Annex “B”). (Section 3)

IAC duties and Secretariat powers

The IAC must review all advertising and marketing, including sponsorships, promotional and other materials for products within the Code’s scope, including materials in written, audio, visual, cinema, theater, audio-visual, electronics (such as email, text messages, telephone calls, and website advertising).
The IAC must also review any information/communication materials intended for public distribution for products within the Code’s scope. (Section 4)
The IAC must approve or disapprove, delete objectionable portions, and prohibit printing, publication, distribution, exhibition, and broadcast of advertising and marketing materials within the Code’s scope. (Section 4)
The IAC must develop and update guidelines for reviewing advertising materials and must prescribe internal and operational procedures for exercising its powers and performing duties. (Section 4)
The IAC must determine whether donations by milk companies and companies with other Code-covered products (and their agents/representatives), in kind or in cash, will be accepted. (Section 4)
The IAC must promulgate rules and regulations necessary for implementing Section 6(a) of the Code. (Section 4)
The Food and Drugs Administration (FDA) is designated as the Secretariat of the IAC. (Section 5)
The IAC Secretariat must accept applications, conduct pre-evaluation/review, and examine advertising materials under IAC requirements. (Section 5)
Under the RIRR of E.O. No. 51, the Secretariat has power to investigate and verify reports of violations and, when appropriate, apply administrative sanctions against violators. (Section 5)
Under the RIRR, the Secretariat may issue a Cease and Desist Order signed by the IAC Chairman for any release/printing/broadcast/dissemination of violative advertising or marketing/promotional material. (Section 5)
The Secretariat must prepare agendas and notify members/resource persons; provide administrative and technical assistance; inform applicants of IAC results; receive and act on reports/complaints; issue Cease and Desist Orders; and post final resolutions/decisions of decided cases on the web. (Section 5)

Resource disqualification and compensation

A technical resource person is automatically disqualified if there is any finding of possibility, direct or indirect, of conflict of interest related to affiliation/association with milk companies/industry and other covered products.
Disqualified persons must accomplish, under oath, the conflict of interest declaration form (Annex “C”). (Section 6)
IAC members, the IAC Secretariat, and technical resource persons are entitled to collect from E.O. No. 51 funds their honorarium, per diems, actual transportation costs, and other incidental expenses, subject to accounting and auditing rules and regulations. (Section 7)

Application, filing, and pre-screening procedure

Applicants seeking approval to conduct sales promotion and/or advertise Code-covered products must secure an application form (Annex “D”) from the FDA-IAC Secretariat or from the FDA website (bfad.gov.ph). (Section 8)
The accomplished form must be submitted to the IAC Secretariat with required documents and proof of payment of the filing fee prescribed by the FDA. (Section 8)
Filing fees must be reviewed every three (3) years by the DOH for possible amendments.
Application fees are non-refundable and non-transferable. (Section 8)
Each type of advertising material must be applied for separately, whether part of a broader advertisement wave or not. (Section 8)
The IAC Secretariat must not accept incomplete documents. (Section 8)
Applications and accompanying documents must be filed on or before the first Friday of each month to be included in IAC screening for that month; otherwise, they are considered in the next scheduled screening. (Section 8)
Only materials submitted with a duly accomplished application form and payment of required fees may be pre-screened by the IAC Secretariat and reviewed by IAC members. (Section 8)
Any modification on the submitted material before IAC deliberation is treated as withdrawal of the application. (Section 8)
Any amendment on a material previously screened by the IAC is treated as a new application, and the same application and fee procedures apply. (Section 8)
Requests for extension of materials are treated as new material, following the same procedures for new applications. (Section 8)
The IAC Secretariat must determine the number of applicants it will accept and pre-screen per month before deliberation. (Section 8)

Application content and attachments

A new review/examination application must be filed in a form prescribed by the IAC and submitted in seven (7) hard copies (colored) plus a soft copy. (Section 9)
The application must include (among others) the applicant’s name; marketing firm/advertising agency (if any); brand/product and age bracket (if applicable); sponsor/manufacturer name; title of advertising material (if any); nature/type of material; specific channels for dissemination; specific time and date of airing/dissemination; intended/target audience; coverage/venue; period/duration of dissemination; approximate time duration for film/video/CD/sound tape; proposed comprehensive design/storyboard; and a declaration that no milk advertisement shall be aired/printed before/within/after any government TV/radio programs or other health-related programs. (Section 9)
Visual (print) applications must include colored text and visual layout copies and may cover merchandising materials (posters, banners, streamers, billboards, tarpaulins, train ads, vehicle ads, etc.) and print ads (magazines, newspapers, inserts, flyers, leaflets, pamphlets, advertorials). (Section 10(A))
Audio applications must include text/script and spiels, and hotlines; recorded materials (vehicles with accompanying streamers and sound). (Section 10(B))
Audio-visual applications must include for TV/cinema/theater including plugs/interviews/indirect advertisements in scripts; colored storyboards; scripts/spiels; final audio-visual; and a second material (radio or commercial showing through TV/theater/cinema). (Section 10(C))
New technologies/new ways of dissemination may include podcasts, webcasts, websites (full frame/streaming including company websites), light effects, interactive interfaces, electronic ads, SMS/cellphone text messages, social networking sites, and other methods. (Section 10(D))
Applications must include:
- A copy of a valid Certificate of Product Registration (CPR) issued by the FDA and the approved product label, with validity existing at least ninety (90) days prior to filing; (Section 11(1))
- Copies of supporting documents, presentation materials, and references submitted to the Philippine Board of Advertising or Clearance prior to release (if any); (Section 11(3))
- For audio-visual materials, an electronic copy; (Section 11(4))
- Submission of seven (7) original copies of the material. (Section 11(5))
Applications may be denied motu proprio by the IAC Secretariat on grounds of insufficient documents, nuisance applications, materials with health and nutrition claims for 0-36 months, and feeding bottles and teats. (Section 12)

Sponsorship and donation rules

No assistance, support, logistics, or training from milk companies to health workers is permitted for any activity aimed to update health workers’ knowledge and skills on breastfeeding, promotion, protection of breastfeeding, and appropriate infant and young child feeding. (Section 13)
Sponsorships may be allowed only if:
- The recipient is a health worker;
- No sponsorship is extended to health facilities and/or health care systems;
- Sponsorships to events/programs/trade fairs/festivals/fiestas or other activities that may reach or involve individuals who are not health workers must be applied for IAC approval; and
- The applicant for approval of a sponsorship is the recipient. (Section 13)
Sponsorship applications must include a letter request addressed to the IAC Chairperson and a duly accomplished Request Form (Annex “E”). (Section 13)

Donations

Donations of products, materials defined and covered within the Code and these rules are not permitted except in instances allowable under RA 7600. (Section 14(a))
Donations of products/equipment and the like not otherwise falling within the Code’s scope, given by milk companies and their agents/representatives in kind or in cash, must be approved by the IAC and must follow conditions that:
- No name/logo, no public relations, no announcement (or similar), and no brand names of the donating company or covered products appear on donated items; and
- No name/logo of the donating company and no brand names of covered products appear on donated items. (Section 14(a))
Donation applications must include a letter of request addressed to the IAC Chairperson and a duly accomplished official Request Form. (Section 14(b))

IAC deliberations and decision outputs

Government resource persons and other partners invited by the IAC may provide guidance and inputs to clarify matters related to the Code, but they have no voting powers. (Section 15)
When deliberations involve reports of violations, the monitoring person responsible or point person must be invited to clarify the issue during investigation. (Section 15)
Travel and accommodation costs of invited guests from the monitoring team are chargeable to E.O. No. 51 funds, subject to accounting and auditing rules and regulations. (Section 15)
The IAC screens advertisements pursuant to Section 5(a) and (b) and Section 6(a) of the Code and its RIRR. Deliberations cover the general concept and details, including the particular medium used, and the IAC’s “bottom line” is the overall impact or total effect of the advertisement on the public to which it is addressed or those who would generally have access to the publication. (Section 15)
The approved product label of breastmilk substitutes, breastmilk supplements, milk formula, milk supplement, complementary foods, milk products for pregnant and lactating mothers (or their equivalent) and other Code-covered products is not an authority or approval for advertising/promotion/marketing materials and activities. (Section 15)

Results of deliberation

The IAC Secretariat issues results of deliberation within ten (10) working days after screening, categorized as:
- Approved: the material is considered compliant; or
- Disapproved: it does not conform to rules and regulations. (Section 16)

Certificate of approval, restrictions, and validity

After IAC approval of advertising materials, the applicant must submit the final copy to the IAC Secretariat for final evaluation. (Section 17)
If the final copy conforms to the IAC-approved material, a Certificate of Approval is issued within five (5) days. (Section 17)
After the Certificate of Approval is issued, no material variations or changes are allowed to the approved advertising materials. (Section 17)
If there is doubt as to conformity, the material is returned to the IAC Secretariat for recommendation to the IAC. (Section 17)
The Certificate of Approval authorizes the applicant to publish, air, disseminate, and/or release to the public the approved advertisement, provided the published/released material conforms exactly to the approved copy on file with the IAC Secretariat. (Section 17)
No advertisement of Code-covered products may be aired, published, disseminated, or released to the public without a Certificate of Approval issued by the IAC. (Section 17)
Violations subject manufacturers, advertisers, radio/TV stations (including magazines/newspapers/other media carrying the violative advertisement) to the appropriate sanctions provided by law. (Section 17)
The partners in Code implementation must be notified of pertinent information concerning issued Certificates of Approval. (Section 17)
If the IAC or Secretariat finds discrepancies between the approved material and the published/aired material, the IAC Secretariat must issue a recall order of the Certificate of Approval at any time. (Section 17)

Validity and renewal limits

A Certificate of Approval is valid for three (3) months and may be renewed at most three (3) times, provided the total validity period does not exceed one (1) year. (Section 18)
Renewal requires payment of required fees for each renewal application.
Each renewal applicant must execute an undertaking under oath that there are no changes in the original approved material. (Section 18)

Prohibited content and advertising practices

Contents undermining breastfeeding

Advertising materials must not include any texts, pictures, illustrations, or information that directly or indirectly:
- Discourage or undermine the benefits or superiority of breastfeeding; or
- Idealize breastmilk substitutes and milk supplements. (Section 19(1.1))
No pictures of a baby/babies/child/children, mother(s), father(s), siblings, grandparent(s), other relatives, caregivers (or yayas), or any combination thereof, may be used in advertisements for Code-covered products. (Section 19(1.1))
Advertising materials must not use terms such as “humanized,” “maternalized,” “close to mother’s milk,” or similar words/phrases/statements describing infant formula, breastmilk substitutes, milk supplements, or other milk products. (Section 19(1.2))
Advertising materials must not idealize the use of infant formula and milk supplements through pictures, texts, or audio materials. (Section 19(1.3))
All health and nutrition claims for Code-covered products are absolutely prohibited.
Any phrase/word/statement that indicates (or is reasonably understood to indicate) increasing emotional, psychological, intellectual, physical abilities and/or enhancement of potential/actual talents of the infant and young child and similar phrases are prohibited. (Section 19(1.4))
False or misleading information or claims of Code-covered products are prohibited. (Section 19(1.5))
Promotion of Code-covered products must be objective and must not equate or make the product appear as good as, equal to, or better than breastmilk or breastfeeding.
The advertising must not undermine breastfeeding, and its “total effect” must not directly or indirectly suggest exaggerated and unsubstantiated claims that buying or using the product would produce better individuals or greater love, intelligence, ability, harmony, or better health for the baby. (Section 19(1.6))

Prohibited acts

Corporate displays may not include announcements of program sponsorship stating “This program/special is brought to you by” and containing the names of Code-covered products. (Section 20(1.7.1))
Special displays are prohibited. (Section 20(1.7.2))
Shelf talker/vision and floor vision are prohibited. (Section 20(1.7.3))
Mobiles are prohibited. (Section 20(1.7.4))
Direct or indirect endorsement of Code-covered products by parent(s), celebrities, health workers (private or government), medical doctors, nutritionists/dietitians, midwives, nurses, private and government health professionals, scientists, government officials and employees, medical and allied health associations/organizations, and members of their families is prohibited. (Section 20(1.7.5))
Health books, CDs, educational materials, and other promotional materials are prohibited. (Section 20(1.7.6))
Infomercials—articles written by doctors or others highlighting the quality of covered products—are prohibited. (Section 20(1.7.7))
Taglines that may be associated to Code-covered products are prohibited. (Section 20(1.7.8))
Use of an approved application number for disapproved or not-yet-approved advertisements is prohibited. (Section 20(1.7.9))
The IAC determines whether specific pictures/drawings undermine breastfeeding; the following pictures/drawings are prohibited because they directly or indirectly undermine breastfeeding:
- An infant holding a feeding bottle/training cup or any container;
- An infant and a woman with a feeding bottle/training cup or any container;
- A woman with a feeding bottle/training cup or any container;
- A feeding bottle/training cup or similar container containing a white substance;
- A baby/infant/young child and the product shot in one frame;
- A feeding bottle on a principal display panel;
- Appearance of infant and mother with the brand product;
- Any container that resembles nipple such as feeding bottle and training cup;
- Children/baby with product name;
- Infant or young child;
- Print Ad on infant feeding bottles or any graduated container made of glass/plastic or similar materials usable as feeding bottles;
- Feeding bottle; and
- Picture of any animal (or characters) representing parent and offspring/siblings/family. (Section 20(1.7.10))
Print ads/product shots are prohibited as false cover/detachable inserts and on inside front/back and outside back covers. (Section 20(1.7.11))
Anything outside the approved label attached on Code-covered products is prohibited, including necktags, bundling, freebies, printed flyers, leaflets, and similar materials. (Section 20(1.7.12))
Anything outside the approved label not attached on Code-covered products is prohibited, including necktags, bundling, freebies, printed flyers, leaflets, and similar materials. (Section 20(1.7.13))
Hanging of streamers, banners, posters, bantings/banderitas, billboards in stores/trade outlets, government/private facilities, medical and allied health conventions/functions, and along highways is prohibited. (Section 20(1.7.14))
Advertisements posted/printed on any vehicle, residential/commercial/industrial buildings, schools, glass walls and panels, trees, posts, and other public places are prohibited. (Section 20(1.7.15))
Other forms of advertising materials are prohibited, including:
- Price cards containing only the product/company name and price, confined only to store/supermarket shelves for selling on display;
- Online advertisements such as email ads/spams and webpages, TV/online streaming up/down/side-streaming, full frame/crawling text/pop-ups;
- Plug-in scripts/activities within movies and on TV/Radio/Web talk shows, variety shows, and series;
- Activities within a media program that promote/relate to the products;
- Insertions/surveys/mailers/mommy and infant books and similar items;
- Trade promotions/entrepreneurial/personal enhancement/health activities and similar activities;
- Booths/gondola and similar displays at points of sale. (Section 20(1.7.16))

“Total effect” assessment

When assessing total effect:
- All health and nutrition claims for Code-covered products are treated as potentially misleading and must not be allowed; and
- Promotions must not idealize products over breastfeeding or breastmilk, must not undermine breastfeeding, and must not directly or indirectly suggest:
  - Buying/using the product means giving love and affection by parents/relatives; or
  - Patronizing brings better health to the baby and young child. (Section 20)

Mandatory standard messages and time restrictions

The IAC requires mandatory standard messages to be written in all advertising/promotional materials. (Section 21)
For infant formula advertisements, the mandatory messages are:
- English: “BREASTMILK IS THE ONLY SAFE AND READILY AVAILABLE FOOD FOR INFANT” and “WARNING : INFANT FORMULA IS NOT A STERILE PRODUCT AND MAY CONTAIN HARMFUL BACTERIA AND MUST BE PREPARED AND USED APPROPRIATELY”
- Filipino: “ANG GATAS NG INA ANG BUKOD TANGING LIGTAS AT LAGING HANDA PARA SA SANGGOL” and “BABALA: ANG PRODUKTONG ITO AY MAARING MAY MIKROBYO NA NAGDUDULOT NG SAKIT” (Section 21(A)(a)-(b))
For milk supplements advertisements, the mandatory messages are:
- English: “The use of milk supplements must only be upon the advice of health professional;” and “The unnecessary and improper use of this product may be dangerous to your child’s health”
- Filipino: “Ang paggamit ng gatas na ito ay dapat sang-ayon sa payo ng Doctor o health professional” and “Ang maling paggamit ng gatas na ito ay maaring makasama sa kalusugan ng bataa” (Section 21(B)(a)-(b))
For complementary food advertisements, the mandatory messages are:
- English: “THIS PRODUCT IS NOT INTENDED FOR BABIES 6 MONTHS OF AGE AND BELOW”
- Filipino: “ANG PRODUKTONG ITO AY HINDI ANGKOP PARA SA BATANG ANIM NA BUWAN PABABA” (Section 21(C)(a)-(b))
For print advertisements, mandatory messages must be in Bold Arial font with at least 1/3 of the size of the biggest letter in the material, enclosed in a box with white background and black print, prominently displayed and emphasized, and must comprise at least 1/5 of the height of the material printed. Font adjustments must not make the message unreadable/unnoticeable to the intended audience. (Section 21(D))
The actual picture of a Filipino breastfeeding mother provided by the DOH must be included in the standard message, depicting mother and baby as beautiful, happy, and healthy, and the breastfeeding logo must be included alongside the standard messages. (Section 21(D))
For purely AUDIO advertisements (radio ads), the primary message must be clearly mentioned at least before the catch line or last line. (Section 21(E))
For purely AUDIO-VISUAL advertisements (TV ads), the standard message with the breastfeeding logo must be flashed second to the last frame for at least 4 seconds, and the voice-over for the primary standard message is required. (Section 21(F))
TV and radio advertisements must not be aired in primetime, weekends, in children shows, family shows, or during holidays. (Section 21(G))

Cease and desist orders and sanctions

If an advertisement is aired/published/released/disseminated:
- (i) without the corresponding Certificate of Approval or Certificate of Clearance,
- (ii) without conforming exactly with the approved copy on file with the IAC, or
- (iii) without the Certificate of Approval Number as required,
  then the IAC Secretariat must immediately issue a Cease and Desist Order (CDO) signed by the Chairman of the IAC ordering withdrawal of the promotional materials against the manufacturer, establishment, advertising company (including magazines/newspapers/other media), and the radio/TV stations concerned. (Section 22)
The IAC Secretariat has authority