Republic of the Philippines
HOUSE OF REPRESENTATIVES
Quezon City

FIFTEENTH CONGRESS
First Regular Session

2
House Bit No.__ 3396

Introduced by HON. ANNA YORK P. BONDOC, MD; HON. GLORIA MACAPAGAL-
ARROYO; HON. ALFREDO D. MARANON III; HON. ANGELICA M. AMANTE-
MATBA; HON. 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.

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

However, in the 20 years that the Milk Code has been in effect, tragically, less than
1% of Filipino infants are exclusively breastfed at 2 months of age. Worse, 13% of infants
were never breastfed. (Data from National Demographic and Health Survey 1998). This
actually means that 99% of Filipino infants are formula fed with cow’s milk.

Cow’s milk infant formula is the best selling consumer product in the Philippines,
besting even cell cards and beer. However, contrary to popular belief, infant formula is
not a healthy substitute for breast milk. Formula feeding causes reduced brain power,

and increased risk of asthma, allergy, infection, diabetes, heart disease, obesity and
DEATH.

In 2007, 82,000 Filipino children under 5 years old died and 16,000 of these
deaths could have been prevented by breastfeeding. From these alarming statistics, the
failure to promote breastfeeding is a public health emergency. There is an urgent need to
strengthen the National Milk Code.

‘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. It will create a National Board to promote breastfeeding. It will
also prevent dumping of inferior milk products and will eventually regulate the sale of
breast milk substitutes and artificial milk support products. It will also guide the
advertising, marketing and promotion of breast milk substitutes and inform public about
the hazards of formula feeding.

Indeed, breast is best {and most economical), for a healthy baby and eventually, a
healthy and strong Filipino nation.

In light of the foregoing, the immediate passage of this bill is earnestly sought.

A aa: -
Chan Tak J DYLAN
ANNA YORK P- BONDOC, ads NA

a

A. PICHAY



Republic of the Philippines
HOUSE OF REPRESENTATIVES
Quezon City

FIFTEENTH CONGRESS
First Regular Session

_ 3396

HOUSE BILL NO.

Introduced by HON. ANNA YORK P. BONDOC, MD; HON. GLORIA MACAPAGAL-
ARROYO; HON. ALFREDO D. MARANON III; HON. ANGELICA M. AMANTE-
MATBA; HON. 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 House of Representatives of the Philippines 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 safe and adequate nutrition for infants and young
children up to three (3) years of age and even beyond. Child malnutrition in 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 complementary 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;

(e) 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-friendly environment in every healthcare
institution, facility, healthcare organization and association, office, school and public
place, conducive to the advancement of the breastfeeding culture;

(g) 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;

(h) To widely promote and protect breastfeeding as a simple yet _ cost-effective


means of alleviating poverty and decreasing dependence on imports; an

(i) 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 an 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.

(k) 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 complementary feeding of indigenous
foods with more calcium and other essential nutrients than cow’s milk, reducing our
dependence on the expensive importation on non-human milk; family and community
support for breastfeeding mothers; and wet 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, teats 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 patent
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-on formula, and


other products marketed or otherwise represented as suitable for feeding infants and
young children.

SEC. 5. Definition of Terms. - For the purposes 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 primary 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:

() 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;

8) 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 refer to women 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.

(c) Complementary 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 complementary
food as an appropriate component of infant and/or young child nutrition is
referred to as “Complementary Feeding”.

(a) Cooperative or shared nursing refers to the act of an infant breastfeeding
from a person other than his own mother

(ec) Department refers to the Department of Health.
(f) DepEd refers to the Department of Education.

(g) Designated product refers to:

(1) Any product marketed as Infant formula;

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

(3) Follow-up or follow-on formula;

(4) Complementary food;

(5) Feeding bottles, teats, pacifiers;

(6) 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.

(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.

(i) 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 (FDA) created pursuant to
Republic Act No. 9711, formerly known as the Bureau of Food and Drugs
(BFAD).

() Follow-up formula or follow-up milk refers to a milk or milk-like 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 refer 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.

(n) 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 Designated products.

(@) 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.

()_ Indigenous foods refer to locally grown or produced foods which are neither
artificial nor processed.

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

(t) 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 infant’s nutritional


requirements after the first six (6) months.

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

(v) IYCF refers to infant and young child 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
infants and young children.

(w) Label refers to any tag, brand, mark, pictorial or 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 directed 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 an entity controlled by or under contract with it) of manufacturing or
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 which a company or
a product is identified.

(aa) Marketing refers to the aggregation of all activities and efforts to present
a product to the general public, comprised 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 necessarily 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.

(ce) 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.

(ce) 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 Alimentarius 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”.

(f) Nursing mothers refer to mothers of infants and/or young children,
regardless of whether they actually breastfeed such infants and/or young
children.

(ga) 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.

(ij) 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 or sales strategy.

(ll) 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.

(nn) 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 entitics 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.

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

CHAPTER II
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 III
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 (IYCF) 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, the 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;

(c) 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;

(d) Not contain the name or logo of any Designated product nor of any
manufacturer or distributor of a Designated product; and

(e) Clearly and conspicuously explain each of the following points:

(1) The benefits and superiority of breastfeeding;

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

(3) How to initiate and maintain exclusive and sustained breastfeeding;

(4) Why it is possible but difficult to reverse a decision not to breastfeed;

(5) The importance of introducing complementary foods from the age of about
six (6) months;

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

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

(8) That the non-human milk is not a sterile product and may contain
harmful microorganisms.

(9) Include the social and financial implications of the use on non-human
milk.

SEC. 9. Information and Educational 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:

(a) 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;

(b) How to feed infants with a cup;

(c)_ The health hazards of bottle feeding and improper preparation of the
product;

(d) Why non-human milk itself may not be sterile and the possibility of
industrial errors;
(ce) The approximate financial cost of feeding an infant with such a product in
the recommended quantities; and

(Infant formula is not a sterile product and may contain harmful organisms

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

(a) Are restricted to scientific and factual matters regarding the technical
aspects and methods of the use of the product;
(b) 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.

SEC. 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 seck
the approval of the Inter-Agency Committee created under Section 28 of this Act
according to procedures as shall be prescribed.

CHAPTER IV
TRANSPARENCY IN RESEARCH

SEC. 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. -
(a) No person shall distribute for free or for sale, sell, stock or exhibit for sale
any Designated product that:

@ Is not registered according to rules and regulations of the FDA or
is not in accordance with the conditions of its registration; or


(b)

(c)

(d)

()

wo

(2) Has reached its expiration date; or
3) Has a container or label which is not in accordance with the
requirements contained in this chapter.

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.

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 directly
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.

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

i) 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.

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.

(2) 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.

(h) 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.

SEC. 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.

(©) 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 mother, WRA, members of
their respective families, healthcare workers and healthcare facilities.

(@) 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 product.

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(h)

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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 of 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.

Manufacturers, distributors and marketing personnel are prohibited from
employing, requesting the participation of, and using in any manner,
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/or similar activities for complementary food shall:

(1) Take place in a healthcare 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) Offer 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, maternal 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. Prohibitions on Healthcare Workers. — A healthcare worker shall not:

@) 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

(c) Demonstrate 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 IYCF practices.

SEC. 16. Prohibitions 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:

() Instructions for appropriate preparation and use in words and in
easily understood graphi

(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 alter 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;


2) The name and national address of the manufacturer or
distributor; and
(10) Such other particulars as may be prescribed.

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)

(b)

(c)

(a)
(e)

()
(g)

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 (¥) 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 level of the principal display panel, the font type is arial and the
font size of which must be one-half (%4) of the size of the biggest letter on
the label in English and 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 (¥4) of the size of the biggest letter
on the label in English and Filipino.

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;

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;

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

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 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 (¥%) 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 (%4) 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) 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 (%) of the
size of the biggest letter on the label in English and Filipino;

(b) 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-half (¥%) of the size of
the biggest letter on the label in English and Filipino;

3) Instructions for cleaning and sterilization in words and graphics;

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

() A warning that 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 severe tooth decay; and
CO) The name and national address of the manufacturer or the distributor.

SEC. 21. Prohibitions Related to Labels of Pacifiers. - A manufacturer or

distributor shall not offer for sale or 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 breastfeeding 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 (%4) 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 shall, 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

6


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;

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

(e) To cause the enforcement of this Act; and

6 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 matters concerning
this Act and when appropriate, filing the necessary administrative,
civil action and/or criminal action.

SEC. 28. The Inter-Agency Committee (IAC). - For purposes of Chapters III and V
of this Act, an Inter-Agency Committee composed of the following members is hereby
created:
(a) Secretary of Health;
(b) Secretary of Trade and Industi
(c) Secretary of Justice;
(d) Secretary of Social Welfare and Development;
(e) Secretary of Education;
(). Head of the Food and Drug Administration; and
(g) 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 IAC 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;

"7


(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;

() To prescribe the internal and operational procedure for the exercise of its
powers and functions as well as the performance of its duties and
responsibilities; and

(d) 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 (30) 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 IAC.

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. Ifa 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.

CHAPTER IX
ADMINISTRATIVE AND CRIMINAL ACTIONS

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 the proper courts against:

(a) Any person who 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

(c) 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 performance 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 actions 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 attorney'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 Articles 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) 1s violation - Administrative fine of a minimum of One hundred
thousand pesos (P100,000.00) to Two hundred thousand pesos
(P200,000.00) depending on the gravity and extent of the violation,
including the recall of the offending product;

(b) 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 Product Registration (CPR);

rt) 3:4 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 product, revocation of the CPR, suspension of
the license to operate (LTO) for one (1) year;

(4) 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

(ce) 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

20


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

SEC. 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. Effectivity. - ‘This Act shall take effect fifteen (15) days after its
publication in any newspaper of general circulation.

Approved,