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Republic of the Philippines Ye
HOUSE OF REPRESENTATIVES

Quezon City

SIXTEENTH CONGRESS ct
First Regular Session

HOUSEBILLNO, _ 2294

Introduced by REP. PHILIP A. PICHAY

Explanatory Note

This bill seeks to develop a healthy Filipino child through breastfeeding and to strengthen
Executive Order No, 51, the National Milk Code of 1986.

A mother’s milk is the only natural food in the world and is the best way to show her
love. It is the healthiest nourishment for a baby. Health experts recommend that all infants 0 to
6 months old should be exclusively breastfed and all children up to 2 years should be breastfed
along with complimentary foods.

However, the prevalence of breastfeeding in the Philippines has not changed over the past two
decades. A survey shows that 88 percent of children bom in the five years preceding the 2008 National
Demographic Health Survey (NDHS) had been breastfed at some time (ever breastfed), meaning that the
other 12 percent were not breastfed at all. The proportion of children ever breastfed in the previous NDHS
surveys was 87 percent in 2003, 88 percent in 1998, and 87 percent in 1993.

This amendment seeks to improve the health of Filipino children by promoting
breastfeeding, It will provide lactation support programs and rooming in provision for every
healthcare facility. Once approved, a National Board will be created to promote breastfeeding
It will also prevent the dumping of inferior milk substitutes and artificial milk support products,
thus further promoting the public’s welfare. Furthermore, it will guide the advertising,
‘marketing and promotion of breast milk substitutes and inform the public about the hazards of
formula feeding

In light of the foregoing, the immediate passage of this 1 sought
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Republic of the Philippines
HOUSE OF REPRESENTATIVES
Quezon City

SIXTEENTH CONGRESS
First Regular Session

2294

HOUSE BILL NO.__

Introduced by REP, PHILIP A. PICHAY

AN ACT
TO PROTECT, PROMOTE AND SUPPORT PROPER INFANT AND YOUNG CHILD
FEEDING BY REGULATING THE MARKETING OF CERTAIN FOODS FOR
INFANTS AND YOUNG CHILDREN

Be it enacted by the Senate and the House of Representatives in Congress assembled:

CHAPTER I
GENERAL PROVISIONS

SECTION 1. Title ~ This Act shall be known as the “Milk Code 2”.
SEC 2. Objectives — This Act shall have the following objectives:

a) To promote, protect and support breastfeeding as the optimal and unparalleled
means of providing the safe and adequate nutrition for infants and young children
up to three (3) years of age and even beyond, Child malnutrition on the first three
(3) years of life is irreversible and affects an individual’s intelligence, mental and
emotional stability and physical health;

b

To promote, protect and support exclusive breastfeeding, as defined herein, as the
means of nourishment for the first six (6) months of life;

°)

To promote and support proper and timely complimentary feeding, which
includes the giving of low cost yet nutritionally adequate indigenous food;

d

To preserve and protect the integrity of the Philippine Healthcare System by
regulating the marketing, promotional and sales practices and/or strategies of
manufacturers, distributors and marketing personnel;


8)

h)

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k)

To properly inform the general public, especially pregnant women, nursing
mothers and members of their families, of the hazards of the use and misuse of
breast milk substitutes, including non-human milk and other products marketed as
infant or baby food, by making readily available adequate, consistent, objective
and updated information;

To promote a mother and baby-ftiendly environment in every healthcare
institution, facility, healthcare organization and association, office, school and
public place, conductive to the advancement of the breastfeeding culture;

To ensure compliance with pertinent provisions of binding international
commitments and covenants entered upon by the Philippines, including
specifically the 2002 Global Strategy on Infant and Young Child Feeding, the
International Code on the marketing of Breast milk Substitutes and other related
products, and subsequent resolutions of the World Health Assembly which the
Philippines supports;

To widely promote and protect breastfeeding as a simple yet cost-effective means
of alleviating poverty and decreasing dependence on imports,

To encourage the general public to form breastfeeding groups or associations to
develop suitable programs and further the growth and empowerment of the
country's women and children under the international ethical standard;

To encourage the revival of wet and shared/cooperative nursing, among mothers
and for infants without mothers including but not limited to those in orphanages
and other child care centers;

To encourage the revival of Filipino indigenous practices that sustained
breastfeeding in the past, such as the use of baby slings that keep the baby on an
eye-to-knee level; massage techniques of healing touch that relaxes the mother,
encouraging the production of breast milk; the complimentary feeding of
indigenous foods with more calcium and other essential nutrients than cow’s milk,
reducing our dependence on the expensive importation of non-human milk,
family and community support for breastfeeding mothers; and wt nursing and
shared/cooperative nursing as stipulated above;

SEC. 3. Statement of Policy ~ It is the policy of the State to promote breastfeeding as the
best possible source of food and nutrition and the only way to enhance and maximize the
immune system of infants and young children as non-human milk could never do. This policy is
in consonance with its duty to protect the people’s right to health under the Constitution and
International Law.

The State shall regulate the marketing of foods for infants and young children, as well as
feeding bottles, treats and pacifiers, as unrestrained marketing practices for these products


undermine the ability of Filipino mothers to breastfeed their children thereby compromising each
child’s right to safe and adequate nutrition and the highest attainable standard of health as
provided for in the United Nations Convention on the Rights of the Child.

In its pursuit of sustainable economic development and the reduction of poverty, the State
shall ensure optimal child growth and development for all Filipino children and the health of the
mother through the promotion of appropriate feeding practices and educating the public on
inappropriate feeding practices and their consequences as recommended by international
authorities on public health.

The body of a mother responds to the psychological, emotional, nutritional.
immunological and other needs of her baby at any moment in time; only the mother can give the
ideal nourishment especially to prematurely born babies. Therefore, the state shall pursue a
policy to conform to the WHO/UNICEF hierarchy of priority values with respect to infant
feeding: the first priority being breastfeeding by the child’s own mother; the second priority
being expressed breast milk from the child’s own mother; the third priority being wet nursing or
shared nursing by a person other than the child’s mother; the fourth priority being expressed
breast milk from a person other than the child’s mother; the fifth priority being stored breast milk
from a human milk bank; the last resort being non-human milk prepared in accordance with
applicable Codex Alimentarius Standards.

The State adheres to the November 2001 BOHA Declaration on the TRIPS agreement
and public health, adopted by the 2001 World Trade Organization Ministerial Conference that
affirms the flexibility of member states to take measures to protect and advance public health
over private gain, such as circumventing patient rights for better access to essential medicines

SEC. 4. Aid to Construction — All doubts in the implementation and interpretation of the
provisions of this Act shall be resolved in favor of and for the promotion and protection of
breastfeeding and appropriate infant and young child feeding practices as against the marketing
of non-human milk, follow-n formula, and other products marketed or otherwise represented as.
suitable for feeding infants and young children

SEC. 5. Definition of Terms ~ For the purpose of this Act, the following definition of
terms shall govern

a) Advertise refers to the making of any representation by any means whatsoever for the
purpose of promoting the sale or distribution of a designated product as herein defined,
regardless of whether the same is done via written, audio, visual or electronic media or
transmission including, but not limited to, the following:

1, Postal mail, electronic mail, SMS or text messaging, telephone calls and website
advertising;

2. Television, radio, film, video, facsimile, cinematic, theatrical and other audio-visual
presentations, rallies or assemblies, whether as direct advertisements or subliminally
as part of the presentation or program,

3. Signages, billboard displays and notices;


4, Exhibits featuring pictures, images or actual models and/or mascots;

5. Promotional activities and events and other gatherings under the guise of educational
lectures, seminars and similar activities; and

6. Newspaper and magazine articles and features, flyers, texts in educational books and
teaching materials.

b) Breastfeeding women refers to women who provide breast milk to children directly
and/or through breast milk expression as a means of nourishment whether or not the
children are their own

©) Complimentary food refers to any food or product except non-human milk, whether
manufactured or locally prepared, suitable as a complement to breast milk, when breast
milk becomes, for any reason, insufficient to satisfy the nutritional requirements of an
infant or young child, The use of complimentary food as an appropriate component of
infant and/or young child nutrition is referred to as “Complementary Feeding”

d) Cooperative of shared mursing refers to the act of an infant breastfeeding from a person
other than his own mother.

e) Department refers to the Department of Health
f) Deplid refers to the Department of Education,

8) Designated products refers to:

‘Any product marketed as infant formula;

Any other product marketed or otherwise represented as suitable for infants up to the
age of six (6) months;

Follow-up or follow-on formula;

Complementary food;

Feeding bottles, treats, pacifiers;

All milk products including but not limited to those intended for pregnant women
and/or nursing mothers; and

7. Such other products as the Department, by proper publication, declare to be a
“Designated product” for purposes of this Act.

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h) Distributor refers to a person, corporation or any other entity in the public or private
sector engaged in the business, directly or indirectly, of distributing and/or delivering, at
the wholesale or retail level, a designated product. This shall include any corporation or
other entity principally engaged in providing marketing services, insofar as it shall act on
behalf or in the interest of such distributor.

i) DSWD refers to the Department of Social Welfare and Development.

j) Exclusive breastfeeding refers to the nourishment of infants and young children by means
of breast milk, without adding, diluting or supplementing the same with non-human milk,


water, teas, juice, vitamins, herbal preparations or other food or liquids and without using
artificial nipples, bottled and pacifier.

k) FDA refers to the Food and Drug Administration. RA 9711 created the FDA which is
formerly known as the Bureau of Food and Drugs (BFAD)

1) Follow-up formula refers to a milk or milk type product of animal or vegetable origin
formulated industrially in accordance with applicable Codex Alimentarius Standard for
Follow-up Formula and marketed or otherwise represented as suitable for feeding infants
and young children older than six (6) months of age. It is also known by other

descriptive terms such as, but not limited to, “follow-on formula”, “growing-up milk”,
“school-age milk” “milk supplements”, etc

m) Gifts refers to any form of financial, personal or commercial reward, inducement,
incentive, including intangible favors provided directly or indirectly by manufacturers,
distributors, marketing personnel and their agents or representatives, including but not
limited to any incentives given by manufacturers and distributors to promote designated
products to their own employees or employees of other companies like free samples or
special sales paid by installments like salary deductions.

1n) Government refers to the national government and all local government units, as well as
departments, regulatory agencies, instrumentalities and implementing units of the same

0) Healthcare facility refers to governmental, nongovernmental or private institutions,
organizations, hospitals, clinics or other operational venues engaged directly or indirectly
in providing healthcare services including but not limited to those intended to provide
care for pregnant women, mothers, infants and young children, as well as nurseries or
child care institutions.

p) Healthcare system refers to the aggregation, within the Philippines, of all healthcare
facilities, healthcare workers, groups of healthcare professionals in private practice, as
well as governmental agencies, instrumentalities and entities whose functions and
responsibilities impact on healthcare. For purposes of this Act, the healthcare system.
shall include pharmacies and other established sales outlets selling or otherwise dealing,
in Department products.

q) Healthcare worker refers to a person working, whether formally or informally, on a full-
time or part-time capacity, whether professional or non-professional, including volunteer
workers whose job or profession impacts on health

1) Indigenous foods refers locally grown or produced foods which are neither artificial nor
processed.

s) Infant refers to a person twelve (12) months old or younger.


1) Infant formula refers to a milk or milk-like product of animal or vegetable origin
formulated industrially in accordance with applicable Codex Alimentarius Standard for
infant formula and intended to satisfy, by itself, the nutritional requirements of infants
from birth and/or during the first six (6) months and includes products that continue to
meet part of an infants nutritional requirements after the first six (6) months

u) Inter-Agency Committee (IAC) refers to the Committee set up under Section 28 of this
Act.

v) IYCF refers to infant and young children feeding principles and practices, as described
under the Global Strategy on Infant and Young Child Feeding jointly developed,
recommended and endorsed by the World Health Organization (WHO) and the United
Nations Children’s Fund (UNICEF) to improve, through optimal feeding, the nutritional
status, growth and development, health and survival of infant and young children.

w) Label refers to any tag, brand, mark, pictorial or any other descriptive matter, including
but not limited to enclosed literature, written, printed, stenciled, marked, embossed or
impressed on, or attached to a container of any designated product.

x) Lactation support refers to the general care towards mother and infant during the
mother’s prenatal, immediate postpartum and postnatal periods. It includes educating
and providing information to pregnant women and nursing mothers on the advantages of
breastfeeding, the physiology, commencement and maintenance of lactation, proper care
of the breasts and nipples, and such other matters that would contribute to successful
breastfeeding, emphasizing thereby the hazards of bottle-feeding and the consumption of
non-human milk to mother and child health,

y) Manufacturer refers to a corporation or other entity, whether in the public or private
sector, engaged in the business or function (whether directly or through an agent or entity
controlled by or under contract with it) of manufacturing of producing a Designated
product. This shall include any corporation or other entity principally engaged in
providing marketing services, insofar as it shall act as an agent, or otherwise on behalf or
in the interest, of such manufacturer.

2) Logo refers to an emblem, picture or symbol by means of it a company or a product is
identified

aa) Marketing refers to the aggregation of all activities and efforts to present a product in the
general public, composed of elements of promotions, distribution and sales, advertising,
public relations, information services, internet, promotion and communication and all
forms of information dissemination including, but not limited to, postal mail, electronic
mail, SMS or text messaging, communicating via telephone or facsimile, or advertising
via website, television, motion picture, theatrical performances, videos, newspapers,
magazines, flyers, stage and radio programs, whether live or taped. Any activity deemed
a component of marketing herein shall, for purposes of this Act, be deemed as marketing,


bb) Marketing personnel refers to any person whose functions involve, directly or indirectly,
the marketing of any designated product.

cc) Milk complement refers to non-human milk, follow-on milk, or other foods given in
addition to breast milk from six (6) months onwards. “Milk Supplement” refers to the
same when intended to replace breast milk

dd) Mother’s milk refers to breast milk from the newborn’s own mother.

ee) Non-human milk refers to the so called breastfeeding substitutes such as infant formula,
artificial milk, and any milk other than that sourced from humans whether or not
industrially formulated in accordance with applicable Codex refers Almentarius
standards. It also covers non-dairy milk, soy milk, coconut milk prepared for children,
animal milk, evaporated, condensed, skimmed or low-fat, reconstituted milk and milk
prepared at home in which case it is described as “Home-prepared”

£8) Nursing mothers refer to mothers of infants and/or young children, regardless of whether
they actually breastfeed such infants and/or young children

29) Other milk refers to a milk or milk like product other than non-human milk or follow-on
formula that may or may not be marketed or represented as suitable for feeding infants
and young children

hh) Prescribed or as prescribed refers to prescribed or as prescribed by rules or written
decision made pursuant to this Act.

ii) Promotion refers to the employment of any method of directly or indirectly encouraging
a person to purchase or use a designated product

ji) Rooming-in refers to the practice of placing and maintaining the newborn infant beside
his/her mother immediately after delivery up to discharge from the healthcare facility, so
as to facilitate mother-infant bonding and to allow prompt initiation of breastfeeding, For
such purpose, the infant must share his/her mother’s bed

kk) Sample refers to single units or small quantities of a product provided for free or without
cost as a promotional marketing strategy.
Il) Secretary refers to the Secretary of the Department of Health.

mm) Shared nursing or cooperative nursing refers to mutual assistance between friends
and relatives to breastfeed their children when one of them cannot breastfeed due to a
temporary or permanent reason.

rn) Sponsorship refers to the provision of funds, equipment, materials, awards or benefits in
whatever form, as a form of support for games, sports, activities, charities, dances,
cultural events, lectures, conventions, meetings, programs and the like, offered and given
by corporations and other entities or their representatives for the purpose, whether or not


such is disclosed or manifestly intended, or otherwise having the effect of promoting
directly or indirectly specified products

00) Wet nursing refers to time honored profession of women who breastfeed children that are
not their own. Their services are employed due to a temporary or permanent
breastfeeding cessation by the child’s own mother, These women need not have recently
given birth because regular sucking on a woman’s breast can elicit the production of
breast milk via a neutral reflex through production of prolactin.

pp) WHA refers to the World Health Assembly
qq) WHO refers to the World Health Organization

1) Young child refers to a person from the age of more than twelve (12) months up to the
age of three (3) years

CHAPTER I
RIGHTS OF BREASTFEEDING WOMEN

SEC. 6. Breastfeeding Not Indecent Exposure ~ No provision of law or ordinance on
indecent exposure shall apply to breastfeeding of a child. A woman may breastfeed a child in
any location, public or private, where the mother is otherwise authorized to be, even if not done
discreetly, irrespective of whether the nipple of the mother’s breast is uncovered during or
incidental to the breastfeeding.

CHAPTER IIT
INFORMATION AND EDUCATION

SEC. 7. Responsibility — The government, through the Department, shall take measures.
including the design, development, and dissemination of information and educational materials,
to promote, protect, support and monitor appropriate infant and young child feeding (TYCF)
practices, in line with UNICEF/WHO international recommendations. It shall be its duty to
provide updated, objective and consistent information on IYCF principles and practices to
women, families and general public, and those involved in the fields of infant nutrition and
maternal health. It shall educate the public about the consequences and risks that not following,
such practices may create for infants, young children and mothers as well.

It shall also ensure that information materials produced by all government agencies and
private entities and persons are not inconsistent with the provisions of this chapter.

SEC. 8. Standards — Informational or educational materials produced by any person,
whether written, audio or visual, which refer to infant and young child feeding shall

a) Contain only correct and current information and shall not use any picture
or text that encourage bottle feeding or discourage breastfeeding;
b) _Be written in English and Filipino or the appropriate dialect;


©) Not give an impression or create a belief that a designated product is
equivalent to, comparable with or superior to breast milk or to
breastfeeding;

4) Nor contain the name or logo of any designated product nor of any
manufacturer or distributor of a designated product; and

©) Clearly and conspicuously explain each of the following points:

°
°

SEC. 9. Information and E

‘The benefits and superiority of breastfeeding;

The value of exclusive breastfeeding for a minimum of six (6)
months followed by sustainable breastfeeding for three (3) years and
beyond;

How to initiate and maintain exclusive and sustainable
breastfeeding;

Why it is possible but difficult to reverse a de
breastfeed;

‘The importance of introducing complimentary foods from the age of
about six (6)months;

How and why any introduction of bottle feeding or early
introduction of complementary foods negatively affects
breastfeeding;

That complimentary foods should only be introduced when the infant
reaches six (6) months of age and can easily be prepared at home
using local ingredients;

‘That the non-human milk is not a sterile product and may contain
harmful microorganisms; and

Include the social and financial implications of the use of non-human
milk.

ion not to

jucational Materials About Non-human Milk, Follow-up

Formula or Feeding Bottles — If due to medical reasons, mothers need to receive information on
non-human milk feeding, it should be produced separately from materials on breastfeeding, On
the other hand, materials on breastfeeding should not contain information on bottle feeding as
this gives the impression to the readers that the two modes of feeding are of equal value or bottle
feeding can replace breastfeeding. Any information on non-human milk feeding should be
produced separately and distributed only to mothers who will be advised by medical
professionals to use non-human milk due to medical reasons.

‘The educational material must also include the following points:

1. Instructions for the proper preparation and use of the product, including cleaning and
sterilization of feeding utensils, and in the case of powdered non-human milk and
follow-up formula, such instructions should adhere to guidelines formulated by the
WHO and the Food and Agriculture Organization of the United Nations;

2. How to feed infants with a cup;

The health hazards of bottle feeding and improper preparation of the product,

4. Why non-human milk itself may not be sterile and the possibility of industrial errors;


5. The approximate financial cost of feeding an infant with such a product in the
recommended quantities; and
6. Infant formula is not a sterile product and may contain harmful organisms.

See. 10. Product Information for Health Workers — Manufacturers and distributors may
give materials about Designated products to health workers if such materials:

© Are restricted to scientific and factual matters regarding the technical aspects
and methods of the use of the product,

* Provide references to published studies to support any representation that states
or suggests that a relationship exists between the product or constituent thereof
and health, growth or development; and

Are otherwise in accordance with this chapter.

See. 11. Submission of Materials to the IAC ~ Any person who produces or distributes
any materials referred to in this chapter shall submit copies to and seek the approval of the Inter-
Agency Committee created under Section 28 of this Act according to procedures as shall be
prescribed

CHAPTER IV
TRANSPARENCY RESEARCH

See. 12. Transparency and Public Disclosure in Cases of Conflict of Interest. ~ The
government, through the Department, shall ensure that research conducted for public policy
purposes, relating to infant and young child feeding should, at all times, be free from any
commercial influence or bias; accordingly, the health worker or researcher involved in such must
disclose any actual or potential conflict of interest with the company/person funding the research
to the Department, or to a responsible committee that it may organize for purposes of this
chapter. In any event, such research and its findings shall be subjected to independent peer
review.

For purposes of transparency, a disclosure and/or disclaimer of the sponsoring company
should be done by the company itself, health worker or researcher involved through verbal
declaration during the public presentation of the research and in print upon publication,
according to procedures as shall be prescribed

CHAPTER V
PROHIBITIONS.

Sec. 13. Advertising, Promotion, Marketing, Sales and Sponsorship —
1a) No person shall distribute for free or for sale, sell, stock or exhibit for sale any
designated product that


1. Isnot registered according to rules and regulations of the FDA or is not in

accordance with the conditions of its registration; or

Has reached its expiration date; or

3. Has a container or label which is not in accordance with the requirements
contained in this chapter.

v

b) No advertising, promotional or marketing materials, sponsorships and/or
similar activities for designated products intended for infants and young
children up to three (3) years of age shall be allowed. This includes any of the
same which, while not referring directly to designated products, tend to convey
subliminal messages or impressions that undermine or compete with breast
milk and breastfeeding, and/or exaggerate the benefits and value of designated
products,

©) No advertising, promotional or marketing materials, sponsorships and/or
activities for milk products primarily intended for pregnant women and nursing
mothers shall be allowed. This prohibition seeks to avoid among others, the
common misconception that breast milk causes allergies in infants and/or
young children in cases where such allergies are in fact actually caused by the
presence of large protein molecules from non-human milk ingested by the
breastfeeding mother

d) No allowable promotion advertising and marketing of designated products
shall in any case undermine or have the effect of undermining breast milk or
breastfeeding as the optimal source of infant and young child nutrition. The
total effect of any such promotion should not direcily or indirectly suggest that
use of the product so promoted would develop better individuals, translates to
or is a manifestation of greater love for the infant or young child, or
significantly enhances such infant or young child’s health and nutrition,
intelligence or other abilities, or make any other similar claims,

e) The following shall, in no event, be included in any advertising, promotional,
sponsorship and/or marketing campaign, literature or materials:

1) Texts, pictures, illustrations or other images, or information which
discourage or tend to undermine the benefits or superiority of
breastfeeding;

2) Any message, text or image, whether direct or subtle, which suggests or
tends to suggest that non-human milk is required by breastfeeding
mothers to produce mother’s milk,

3) Pictures or images of babies, children, mothers (pregnant or otherwise),
fathers, siblings, grandparents, other relatives or caregivers (such as
‘yayas), when such advertisement pertains to designated products; and

4) The terms “humanized”, “maternalized”, “close to”, or “equal to” in
conjunction with or with reference to mother’s milk, or similar words
or phrases, to describe breast milk substitutes such as non-human milk.


bo)

8)

h)

No publication or announcement of health, nutritional or developmental claims
or findings pertaining, whether directly or incidentally, to designated products
shall be allowed except in scientific journals through scientifically proven
studies embodied in peer-reviewed papers or professional publications, All
health and nutrition claims of whatever tenor for designated products shall be
absolutely prohibited in any allowable advertisement or promotional or
marketing activity. For this purpose, any phrase, word or image that connotes
‘or contributes to the notion of increased or more rapid development of
‘emotional, intellectual, physical and other abilities of the infant and young
child, and other like impressions, shall be disallowed. Further, false,
inaccurate, incomplete or misleading information or claims made by or on
behalf of manufacturers, distributors and marketing personnel are prohibited
and will be subject to the severest penalty.

All point of sale advertising and any other promotional or marketing device
intended or tending to induce sales and directed towards consumers at the retail
level, such as special displays, discount coupons, premiums, rebates, special
sales, bonus, tie-in sales, loss leaders, raffles, games and contests, prizes or
gifts, pertaining directly or indirectly to designated products intended for Zero
(0) to thirty six (36) months, shall be prohibited. However, nothing herein
shall restrict efforts to establish and maintain pricing policies and practices
intended to make available designated products at lower prices on a long term
basis.

Importation of any designated product that has been recalled or withdrawn
from any market outside the Philippines due to contamination or for any reason
whatsoever, shall be deemed as illegal importation of a prohibited and/or
dangerous drug, and the distributor, relevant marketing personnel and importer
of the same shall be dealt with accordingly

No milk product shall carry on its label and/or advertising, the words “This is
not a breast milk substitute” or words to that effect, to remove it from the
purview of this Act, only the IAC, not the manufacturer or advertising agency,
is authorized to determine whether or not such product is within the purview of
this Act,

See. 14. Prohibitions on Marketing Personnel, Manufacturers and Distributors.

a)

Marketing personnel or any person employed by manufacturers and
distributors shall not as part of their job responsibilities or in any professional
capacity, perform educational or other public service functions or duties in
relation to pregnant women or nursing mothers or women of reproductive age
(WRA) or their families.


b) Marketing personnel and all persons employed by manufacturers and
distributors shall, at all times, and regardless of their designated functions and
duties, make only objective, accurate, consistent and updated statements about
the pertinent designated product, maintaining and upholding at all times and in
any event the superiority of mother’s milk over any designated product
including, but not limited to, the brand and product which he/she has been
employed to sell or promote or market when such marketing and promotion is
allowed under this Act,

c) It shall be prohibited for manufacturers, distributors and marketing personnel
to distribute, sell, give, or deliver, or promise to do the same, directly or
indirectly, in any manner and at any place, samples and/or units of designated
products or gifts, giveaways, or promotional items of any sort, to any pregnant
woman, nursing mothers, WRA, members of their respective families,
healthcare workers and healthcare facilities.

d) Manufacturers, distributors and marketing personnel are prohibited from
offering, giving, or promising to do the same, in any form whatsoever, travel
grants or benefits, subsidies and/or allowances to doctors, healthcare workers
and other professionals or employees in healthcare facilities, However
subsidiaries or affiliates of such manufacturers and distributors whose business
and operations are in no way connected to designated products are not
prevented from doing so, so long as the brand or company name used does not
in any way suggest any connection to the designated product, and: Provided.
That the same is not being offered or given in order to indirectly promote or
market any designated products.

¢) No manufacturer, distributor or marketing personnel, nor medical doctors or
other professionals hired by any of them, shall be allowed to appear.
participate, conduct or be in any manner involved in any activity or event
promoting or supporting breastfeeding, or in the production, publication and/or
dissemination or literature and other materials on breastfeeding, or in classes or
seminars for pregnant women, nursing mothers, or WRA, and members of their
families.

{) A manufacturer or distributor who wishes to contribute to breastfeeding
education, awareness and support shall do so through donating funds directly
to the Department, the Department’s receipt of which shall in any event be on
the condition that such donation shall be without any onerous, promotional or
marketing implications relating to the use of the company name, logo or other
mark identifying a product or range of products in the utilization of the donated
funds, Manufacturers and distributors are likewise prohibited in the
distribution of any materials produced in the utilization of such donated funds.

2) Manufacturers, distributors and marketing personnel are prohibited from
employing, requesting the participation of, and using in any manner, healthcare


h)

oD)

)

)

workers, healthcare workers, healthcare facilities and the healthcare system in
the production, dissemination, distribution and promotion of designated
products.

Manufacturers, distributors and marketing personnel shall be prohibited from
offering, delivering or otherwise giving gifts of any kind, regardless of whether
the same bear the company name, slogan, logo, or product or brand name, to
any member of the general public, hospitals and other healthcare facilities
including their personnel and members of their families. The practice of
invoicing product sales, carrying them as accounts receivable, and thereafter
taking them off the books as bad debts, shall be deemed as a means employed
to circumvent this provision and is absolutely prohibited

No manufacturer, distributor or marketing personnel shall be allowed to
conduct or be involved in any activity or event promoting breastfeeding, in the
production and distribution of information and educational materials on
breastfeeding, or the holding of or participating as speakers in classes or
seminars for women and children’s activities, for the purpose of avoiding the
use of these venues to market their products, brands or company names.

Manufacturers, distributors and marketing personnel are prohibited from
offering, donating, giving, delivering, or promising to do the same, directly or
indirectly, samples and supplies of designated products to any organization or
group of individuals involved in the distribution of goods in disaster, calamity
or emergency areas, as this may result in the use of unclean or contaminated
water in its use and preparation , and considering further its potential misuse
and abuse, and the potential resulting addiction thereto by mothers, infants and
young children, all of which undermine breastfeeding and the other purposes of
this Act.

In any event, no allowable advertising, promotion, marketing, sponsorship and
and/or similar activities for complimentary food shall:

1) Take place in a healtheare facility; and
2) Undermine breastfeeding in any way.

Manufacturer or distributor shall not himself or herself, or by any other person
on his or her behalf:

1) Donate or provide at lower than the published wholesale price where
one exists, and in its absence, lower than eighty percent (80%) of the
retail price, any quantity of a designated product to a health worker or a
healthcare facility;

2) Donate to or distribute within a healthcare facility equipment including,
furniture and appliances, services, ,or materials such as pens, calendars,


posters, notepads, growth charts and toys, which refer to or may
promote the use of a designated product;

3) Offfer or give any gift, contribution or benefit to a health worker or to
associations of health workers including, but not limited to,
fellowships, research grants or funding for meetings, seminars,
continuing education courses or conferences;

4) Sponsor events, contests, telephone counseling lines or campaigns
related to reproductive health, material and child health, infant or young,
child feeding or related topics; or

5) Include the volume of sales of designated products when calculating
employee remuneration or bonuses, nor set quotas for sales of
designated products

SEC. 15. Prohibition on Healthcare Workers. ~ A healthcare worker shall not:

a) Accept any gift, contribution or benefit, financial or otherwise, of whatever
value from a manufacturer or distributor or any person on his or her behalf,

b) Accept or give samples of designated products to any person; and

©) Demonstrated the use of non-human milk except to individual mothers or
members of their families in very special cases of need, and in such cases, shall
give a clear explanation of the risks of the use of non-human milk as well as
information on appropriate TYCF practices

SEC. 16. Prohibition Related to Labels of Designated Products

a) A manufacturer or distributor shall not offer for sale or sell a designated
product if the container or label affixed thereto includes a photograph, drawing,
or other graphic representation other than for illustrating methods of
preparation.

b) A manufacturer or distributor shall not offer for sale or sell a designated
product, other than a feeding bottle, teat or pacifier unless the container or label
affixed thereto indicates in a clear, conspicuous and easily readable manner, in
English and Filipino, the following particulars:

1, Instructions for appropriate preparation and use in words and in easily
understood graphics;

2, The age after which the product is recommended in numeric figures and in the
case of a complementary food, the recommended age shall not be less than six:
(6) months;

3. A warning that the product may not be sterile or may be dangerous due to
deficient or excessive components or contaminated.


4. A warning about the health risks of improper preparation and of introducing
the product prior to the recommended age;

5. The ingredients used;

6. The composition and nutritional analysis,

7. The required storage conditions both before and after opening, taking into
account climatic conditions;

8. The batch number, date of manufacture and date before which the product is
to be consumed, taking into account climatic and storage conditions,

9. The name and national address of the manufacturer or distributor, and

10. Such other particulars as may be prescribed.

c) All health and nutritional claims for any designated product are absolutely
prohibited in any advertisement, promotion, marketing, sales and sponsorship
A manufacturer or distributor shall not offer for sale or sell a designated
product if the container or label affixed thereto contains any representation that
states or suggests that a relationship exists between the product or constituent
thereof and health, including the physiological role of a nutrient in the
physical, emotional, or intellectual growth and development or normal
functions of the body.

SEC. 17. Prohibitions Related to Labels of Follow-Up Formula/Non-Human Milk, Milk
Complement or Milk Supplement ~ No manufacturer, distributor or marketing personnel shall
offer for sale nor sell any follow-up formula/non-human milk, milk complement or milk
supplement unless the container or its label conforms to all of the following

a.

Contains the words “IMPORTANT NOTICE” in capital letters and in red color
indicated there under, the statement “Breastfeed milk is the only ideal milk for the
healthy growth and development of infants and young children up to three years
and beyond. It protects against diarrhea and many other illnesses”

This message shall be printed in all capital letters in red at the center lowermost
level of the principal display panel, the font type is arial and the font size of which
must be one-half (1/2) of the size of the biggest letter on the label in English and
Filipino.

Contains the word “WARNING” and indicated there under, the statement

There is no substitute for breast milk.

This message shall be printed in all capital letters in red at the center lowermost
evel of the principal display panel, the font type is arial and the font size of which
‘must be one-half (1/2) of the size of the biggest letter on the label in English anil
Filipino.

Before deciding to supplement or replace breastfeeding with this product, seek the
advice of a health professional. It is important for your baby's health that you


{follow all preparation instructions carefully. If you use a feeding bottle, your
‘baby may refuse to feed from the breast. It is more hygienic to feed from a cup”

This message shall be printed in all capital letters in red at the center lowermost
level of the principal display panel, the font type is arial and the font size of which
must be one-half (1/2) of the size of the biggest letter on the label in English and
Filipino.

c. States in preparation instructions for non-human milk that it is not a sterile
product and may be contaminated with microorganisms during the manufacturing,
process or may become contaminated during preparation;

d. Includes a feeding chart in the preparation instructions;

Does not use the terms ‘maternalized”, “humanized” or terms similar thereto or
any comparison with breast milk;

f£ Does not use text or pictures that may tend to discourage breastfeeding or idealize
bottle feeding;

8 Specifies the source of the protein; and

h, In the case of follow-up formula, states that the product shall not be used for

infants less than six (6) months old.

SEC. 18. Prohibitions on Related to Complementary Food. — A manufacturer or
distributor shall not offer for sale or sell complementary food unless the container or label
affixed thereto, in addition to the requirements of Section 17 contains the word “WARNING”
and indicated there under, the statement “Before deciding to supplement breastfeeding with this
product, seek the advice of a health professional. It is important for your baby’s health that you
follow all preparation instructions carefully”

This message shall be printed in all capital letters in red at the center lowermost level of
the principal display panel, the font type is arial and the font size of which must be one-half (1/2)
of the size of the biggest letter on the label in English and Filipino.

SEC. 19. Prohibitions Related to Labels of Other Milks. - A manufacturer or distributor
shall not offer for sale or sell any milk, that is not defined as a designated product, in powder or
liquid form, unless the container or label affixed thereto contains the words “WARNING: This
product should not be used to feed infants and young children.

This message shall be printed in all capital letters in red at the center lowermost level of
the principal display panel, the font type is arial and the font size of which must be one-half (1/2)
of the size of the biggest letter on the label in English and Filipino.


SEC. 20. Prohibitions Related to Labels of Feeding Bottles and Teats ~ A manufacturer
or distributor shall not offer for sale or sell a feeding bottle or teat unless the package or label
affixed thereto, in addition to the requirements of Section 11, indicates in a clear, conspicuous
and easily readable manner, in English and Filipino, the following particulars

a.

e.

The words “IMPORTANT NOTICE” in capital letters and indicated there under,
the statement “Breastfeeding is best. Breast milk is the only ideal milk for the
healthy growth and development of infants and young children up to three years
and beyond. It protects against diarrhea and many other illnesses”. This message
shall be printed in all capital letters in red at the center lowermost level of the
principal display panel, the font type is arial and the font size of which must be
‘one-half (1/2) of the size of the biggest letter on the label in English and Filipino.

‘The statement “WARNING: It is important for your baby’s health that you follow
the cleaning and sterilization instructions very carefully. If you use a feeding
bottle, your baby may no longer want to feed from the breast. Children should
not be left to self-feed for long periods of time because extended contact with
sweetened liquids, including non-human milk, may cause dental carries and
misalignment. It is more hygienic to feed from a cup.” This message shall be
printed in all capital letters in red at the center lowermost level of the principal
display panel, the font type is arial and the font size of which must be one-hal!”
(1/2) of the size of the biggest letter on the label in English and Filipino.

Instructions for cleaning and sterilization in words and graphics;

A statement explaining that feeding with a cup is more hygienic than bottle
feeding;

The name and national address of the manufacturer or distributor.

SEC. 21, Prohibitions Related to Labels of Pacifiers. — A manufacturer or distributor
shall not offer for sale or to sell a pacifier unless, in addition to the requirements of Section 16
(a), it is labeled with the statement “WARNING: Use of a pacifier can interfere with breast
feeding and may cause dental carries and misalignment”. This message shall be printed in all
capital letters in red at the center lowermost level of the principal display panel, the font type is
arial and the font size of which must be one-half (1/2) of the size of the biggest letter on the label
in English and Filipino.

CHAPTER VI
QUALITY AND STANDARDS

SEC. 22, Quality. — The quality of products is an essential element for the protection of
the health of infants and young children and therefore shall be of highly recognized standard


SEC. 23. Standards. - Food products covered by this Act, when sold or otherwise
distributed, meet applicable standards recommended by the Codex Alimentarius Commission
and also the Codex Code of Hygienic Practice for Foods for Infants and Children

SEC. 24. Against Adulteration and the Like — To prevent quality deterioration
adulteration or contamination of food products within the scope of this Act, distribution outlets
shall not be allowed to open cans and boxes for the purpose of retailing them by the cup, bag, or
in any other form,

CHAPTER VII
HEALTHCARE WORKER RESPONSIBILITIES

SEC. 25. Healthcare Worker Responsibilities, — Heads of healthcare facilities and
national and local health authorities shall take measures to encourage and protect breastfeeding
and to promote this Act. They shall ensure that health workers are supported to breastfeed their
own children for three years and beyond, are familiar with all of the information specified in this
Act and give information and advice to health workers regarding their responsibilities under this
Act. In this regard, health workers shall:

a. Encourage, support and protect breastfeeding. They are expected to know the
provisions of this Act, particularly the information specified in Chapters III, V
and this chapter;

b. Shall work to eliminate practices that directly or indirectly retard the initiation and
continuation of breastfeeding, such as pre-lacteal feeds and separation of mother
and child during their stay in healthcare facilities; and

¢. Shall make in writing a report to the head of his or her workplace, who shall in
turn report to the IAC, of any offer he or she receives for a sample or gift or other
benefit from a manufacturer or distributor or any other contravention of the
provisions of this Act.

CHAPTER VIII
ADMINISTRATION

SEC. 26. Implementation. — The Department is principally responsible for the
implementation of this Act. The Secretary shall, when necessary, call upon other departments to
ensure the implementation and enforcement of this Act.

SEC. 27. Powers and Functions. — For the purpose of implementing this Act the
Secretary has the following powers and functions:

a) To promulgate such rules as are necessary or proper for the implementation of
this Act and the accomplishment of its purposes and objectives;

b) To call for consultations with and request for assistance from government
agencies, nongovernment organizations, civil society representatives, concerned
international agencies and other interested parties to ensure implementation of this,
Act, and to monitor and enforce strict compliance thereto and to the rules
promulgated hereunder;


Outsource monitoring functions to nongovernment organizations duly accredited
by the Department of Health;

Outsource training of internationally recognized lactation experts to man
maternity wards of hospitals and other healthcare facilities;

To cause the enforcement of this Act; and

To exercise such other powers and functions that may be necessary for or
incidental to the attainment of the purposes and objectives of this Act, including
but not limited to:

1, Advising the President on national policy for the promotion and protection
of breastfeeding;

2. Creating regional committees to carry out the functions of the IAC at the
regional level, as may be prescribed;

3. Advising the President on designing a national strategy for developing
communication and public education programs for the promotion of
breastfeeding: information and educational materials on the topics of
infant and young child feeding; continuing education for health workers
on lactation management and the requirements of this Act; curricula for
students in the health professions that include lactation management and to
ensure widespread distribution of and publicity concerning this Act, in a
method as may be prescribed; and

4. Reviewing and reporting violations or other matter
and when appropriate, filing the necessary admi
and/or criminal action.

concerning this Act
strative, civil action

SEC. 28, The Inter-Agency Committee (IAC). ~ For purposes of Chapters Il and V of
this Act, an Inter-Agency Committee composed of the following members is hereby created:

a)
b)
°)
d)
°)
)
gs)

Secretary of Health;

Secretary of Trade and Industry;

Secretary of Justice;

Secretary of Social Welfare and Development;

Secretary of Education;

Head of the Food and Drugs Administration; and

Representative from one (1) nongovernmental organization, which advocates
breastfeeding: Provided, That it adheres to the standards of international ethics,
does not hold any clearly conflicting interests and does not receive donations or
support of any kind from manufacturers, distributors and marketing personnel.

The Secretary of Health shall convene and chair the IAC with the FDA acting as its
member/secretariat. The members may designate their duly authorized representative to every
meeting of the IAC: Provided, That such representative must be familiar with the provisions of
this Act and has competence and experience in the field of public health policy-making and/or
project implementation. No representative to the IAC shall have direct or indirect material
interest in any manufacturer or distributor of any designated product.


SEC, 29. Powers and Functions of the IAC. — The 1AC shall have the following powers
and functions:

a) To review and examine all advertising, promotion or other marketing materials,
whether written, audio or visual, including, but not limited to, those shown in
cinemas and theater and those transmitted through TV, radio, newspaper, mail,
email, text messages, telephone calls and websites on covered products which are
not included in the absolute advertising ban under Section 13 (b) of this Act;

b) To approve or disapprove, delete objectionable portions from and prohibit the
printing, publication, distribution, exhibition and broadcast of, all advertising
promotion or other marketing materials, whether written, audio or visual,
including, but not limited to, those shown in cinemas and theater and those
transmitted through TV, radio, newspaper, mail, email, text messages, telephone
calls and websites on covered products which are not included in the absolute
advertising ban under Section 13(b) of this Act;

a

To presoribe the internal and operational procedure for the exercise of its powers
and functions as well as the performance of its duties and responsibilities, and

4) To receive a written complaint lodged by any person relating to a violation of any
provision of this Act or its implementing rules and regulations (IRR) and on the
basis thereof, immediately order the investigation of the complaint by the BFAD
and, within thirty (G0) days from receipt of the complaint, recommend actions to
be instituted against the offending company, person or persons.

SEC. 30. Prior Written Consent and Approval of the IAC. - No advertising, promotion or
other marketing materials whether written, audio, visual, audio-visual, and electronic for covered
products intended for children thirty-six (36) months onwards which are marketed as partial or
total replacement of breast milk, including bottle-fed complementary foods and feeding bottles,
teats and pacifiers shall be printed, published, distributed, exhibited and broadcasted or in any
manner released to the public without the prior written consent and approval of the TAC.

Such written approval must be specific in product and time bound, In no case shall a
blanket or general approval be allowed.

SEC. 31. Authority of the IAC Secretariat (FDA) to Issue Cease and Desist Orders
(CDOs). ~ The IAC Secretariat (FDA) shall have the authority to determine if any advertising,
marketing, promotional, or information and educational material violate this Act and all other
pertinent laws and IRR. Immediately upon receipt of the report of violation, the investigating
officer shall conduct an ex parte examination of the evidence presented. If a prima facie case is
established, a CDO shall be issued by the FDA, stopping the further release, printing, broadcast,
or dissemination of the offending advertising, marketing, promotional, or information and
educational material


Noncompliance with the CDO shall be ground for the imposition of sanctions as stated in
Section 37 hereof, The issuance of the CDO shall be without prejudice to the imposition of the
appropriate administrative sanction, if so warranted, after due notice and hearing

SEC, 32. Role of Food and Drug Administration (FDA). — The FDA shall investigate and
verify reports of violations and shall report its findings to the IAC and to the Department. When
appropriate, it shall apply administrative sanctions against the violators, and/or cause the filing of
criminal complaints against persons and entities found to have violated, singly or repeatedly, the
provisions of this Act or its IRR.

SEC. 33, Citizen Suits. ~ For purposes of enforcing the provisions of this Act or its IRR,
any citizen may file an appropriate civil, criminal or administrative action, including one for
damages for any harm suffered as a result of a violation of any provision of this Act, in proper
courts against

a) Any person violates or fails to comply with the provisions of this Act or its IRR;

b) Any person who violates the terms and conditions set forth by the Department or
the IAC; and

©) Any public officer, including any member of or representative to the IAC, who
willfully or grossly neglects the performance of an act especially required as a
duty by this Act or its IRR; or abuses his/her authority in the performances of
his/her duty; or, in any manner, improperly performs his/her duties under this Act
or its IRR: Provided, however, That no suit can be filed until after thirty (30) days
from notice given to the concerned public officer and the alleged violator or
violators, and no appropriate action has been taken thereon.

The court shall exempt such action from the payment of filing fees, except fees for actins
not capable of pecuniary estimation, and shall, likewise, upon prima facie showing of the non-
enforcement or violation complained of, exempt the plaintiff from the filing of an injunction
bond for the issuance of a preliminary injunction

Within thirty (30) days, the court shall make a determination if the complaint filed herein
is malicious and baseless and shall accordingly dismiss the action and award attorney’s fees and
damages, as it may deem appropriate

SEC. 34. Independence of Action. ~ The filing of an administrative suit against any
person or entity under the preceding section does not preclude the right of any other person to
file any criminal or civil action. Such criminal and/or civil action shall proceed independently.

SEC. 35. Suits and Strategic Legal Actions Against Public Participation and the
Enforcement of this Act. ~ Where a suit is brought against a person who filed an action as
provided in Section 33 of this Act, or against any person, institution or government agency that
implements this Act, it shall be the duty of the investigating prosecutor or the court, as the case
may be, to immediately make a determination not exceeding thirty (30) days, whether such legal
action has been filed to harass, vex, exert undue pressure, or stifle legal resources of the person
complaining or of enforcing the provisions of this Act. In case of such determination, the


investigating prosecutor or the court shall dismiss the case and award attorey’s fees and
damages, as it may deem appropriate.

SEC. 36, — Lien upon Personal and Immovable Properties of Violators. ~ Fines and
penalties imposed pursuant to this Act shall be liens upon personal and immovable properties of
the violator. Such lien shall, in case of insolvency of the respondent violator, enjoy preference
subsequent to laborer’s wages under Article 2241 and 2242 of Republic Act No, 386 or the New
Civil Code of the Philippines.

SEC. 37. - Liability of Manufacturers/Distributors. - Manufacturers and distributors of
the products covered by this Act shall be directly liable for any violation of the provisions of this
Act and its IRR. Should the offense be committed by a juridical person, the chief operating
officer, chief executive officer, principal investors, general manager, or the partners and/or the
persons directly responsible therefore, shall be made accountable.

Agents/representatives of the manufacturers or distributors of the products covered by
this Act, who commit any violation of its provisions or its IRR shall be jointly and solidarily
liable with the said manufacturers and distributors.

The separate and/or distinct legal personality of the manufacturer or distributor
notwithstanding, the chief operating officer, chief executive officer, and principal investors of
the proponent firm shall be jointly and severally liable for any financial liability or award of
damages made by the court. The same shall apply to transnational corporations and foreign
firms licensed to do business in the Philippines.

CHAPTER X
ADMINISTRATIVE SANCTIONS

SEC. 38. Administrative Sanctions. ~ The following administrative sanctions shall be
imposed upon any person, juridical or natural, found to have violated the provisions of this Act
and its IRR:

a) 1* violation — Administrative fine of a minimum of One hundred thousand pesos
(P 100,000.00) to Two hundred thousand pesos (P200,000.00) depending on the
gravity and extent of the violation, including the recall of the offending product,
2" violation - Administrative fine of a minimum of Two hundred thousand pesos
(P200,000,00) to Three hundred fifty thousand pesos (P350,000.00) depending
on the gravity and extent of the violation, and in addition thereto, the recall of the
offending product, and suspension of the Certificate of the Product of Registration
(CPR);

3" violation - Administrative fine of a minimum of Three hundred fifty thousand
pesos (P350,000,00) to One million pesos (P1,000,000.00), depending on the
gravity and extent of the violation, and in addition thereto, the recall of the
offending product, revocation of the CPR, suspension of the license to operate
(LTO) for one (1) year;

i)

©)


d) 4" and succeeding repeated violations - Administrative fine of Two million pesos
(P2,000,000.00), the recall of the offending product, cancellation of the CPR,
revocation of the LTO of the company concerned, including the blacklisting of
the company to be furnished the Department of Budget and Management (DBM)
and the DTI; and

e) An additional penalty of Twenty thousand pesos (P20,000.00) per day shall be
made for every day the violation continues after having received the order from
the IAC or such other appropriate body, notifying and penalizing the company for
the infraction.

For purposes of determining whether or not there is “repeated” violation, each product
violation belonging or owned by a company, including those of their subsidiaries, are deemed to
be violations of the concerned manufacturer or distributor and shall not be based on the specific
violating product alone

SEC, 39, Against Public Employees. ~ In accordance with the Revised Administrative
Code and pertinent civil service rules and regulations, erring government employees found to be
liable, and depending on the gravity of said violation, shall be imposed the appropriate penalty
by the disciplining authority.

CHAPTER XI
CRIMINAL PENALTIES

SEC. 40, Penalties. ~ Any person who violates the provisions of this Act or its IRR
shall, upon conviction, be punished by a penalty of two (2) months to one (1) year imprisonment
or a fine of not less than One hundred thousand pesos (P100,000,00) nor more than Two million
pesos (P2,000,000.00) or both, Should the offense be committed by a juridical person, the
Chairman of the Board of Directors, the president, the general manager, or the partners and/or
the persons directly responsible therefore, shall be penalized

Any importation of a designated product that has been recalled or withdrawn from the
domestic or foreign or international market due to contamination or for any reason whatsoever,
or which is past its expiry date as indicated in the label, shall be deemed as illegal importation of
a prohibited and/or dangerous drug, and those responsible shall be prosecuted accordingly. In
addition, the manufacturer, distributor, marketing personnel and importer of the same shall be
subject to fines and possible loss of its license, authority or permit to operate in the Philippines.

CHAPTER XII
MISCELLANEOUS PROVISIONS

SEC. 41. Donations Covered by This Act. ~ Donations of products, materials, defined and
covered under this Act and its IRR shall be allowed only upon the approval of the Department,

SEC. 42. Other Donations by Milk Companies not Covered by This Act. ~ Donations of
products, equipment, and the like, not otherwise falling within the scope of this Act or its IRR,
given by milk companies and their agents, representatives, whether in kind or in cash, may only


be coursed through the Department, which shall determine whether such donation can be
accepted or otherwise

SEC. 43. Continuous Review on Prescription Policy ~ The Department shall evaluate
every year, or as necessary, its policy of whether or not to subject the sale of infant formula, to
prescription,

SEC. 44, Brand Names and Corporate Logo Identification. — Brands, brand names or
trademarks of designated products must be used exclusively for the said products. Should
brands, brand names or trademarks which are identical or obviously similar to, or variants of said
designated products, the prohibition on advertising, marketing, promotions, sales and
sponsorships shall likewise apply to those products, A variant of the brand, brand name or
trademark refers to a brand, brand name or trademark on which a modifier or any work or term is.
prefixed or suffixed to the root word, The Department shall periodically review whether or not
to allow the use of corporate logos of Designated products which are similar to the logos utilized
for products not covered by this Act, including the physical appearance of the container, taking
into consideration the possibility of product confusion, the balance between a free market
economy as against the decline and fall of breastfeeding rates among mothers and WRA, and
public welfare and benefit being its ultimate yardstick. Accordingly, any modification of
existing policy should first undergo public consultations with all concerned stakeholders before
its actual implementation.

CHAPTER XIII
FINAL PROVISIONS.

45, Implementing Rules and Regulations (IRR), ~ The Department shall issue the
IRR for this Act within one hundred twenty (120) days from its effectivity

SEC. 46. Separability Clause. — If for any reason, any part or provision of this Act be
declared invalid or unconstitutional, such invalidity or unconstitutionality shall not affect the
other provisions which shall remain in full force and effect.

SEC, 47. Repealing Clause ~ All orders, issuances, and rules and regulations or parts
thereof inconsistent with this Act are hereby repealed and modified accordingly

SEC. 48. Hifectivity ~ This Act shall take effect fifteen (15) days after its publication in
any newspaper of general circulation.

Approved,