31\epublic of tbe ~btlipptn s

~upreme <!Court
;fflllanila

EN BANC

THE DEPARTMENT OF G.R. No. 200431

HEALTH, REPRESENTED BY
SECRETARY ENRIQUE T. ONA, Present:
AND THE FOOD AND DRUG
ADMINISTRATION, GESMUNDO, Chief Justice,
REPRESENTED BY DIRECTOR PERLAS-BERNABE,
SUZETTE HENARES-LAZO, LEONEN,
Petitioners,
CAGUIOA,
HERNANDO,
CARANDANG,
SENATORS PILAR JULIANA LAZARO-IAVIER,
"PIA" S. CAYETANO and INTING,
FRANKLIN "FRANK" M. ZALAMEDA,
DRILON, LOPEZ, M.,
Petitioners-Intervenors, GAERLAN,
ROSARIO, and
LOPEZ, J., JJ
-versus-

PHILIPPINE TOBACCO
INSTITUTE, INC.,
Respondent.

REPRESENTATIVE EDCEL C.
LAGMAN, Promulgated:
Respondent-Intervenor. July 13, 2021

x--------------------------------------------L~-------x
DECISION )
 Decision 2 G.R. No. 200431

LEONEN, J.:

Tobacco products are undoubtedly "health products" within the

definition provided under Republic Act No. 9711, or the Food and Drug
Administration Act of 2009, due to their harmful effects on health. As to
their health aspect, tobacco products fall under the regulatory authority of
the Food and Drug Administration.

This Court resolves the Petition for Review on Certiorari assailing the
Regional Trial Court's ruling, 1 which nullified certain provisions of the
Rules and Regulations Implementing Republic Act No. 9711 insofar as it
regulates tobacco products and the tobacco industry.

In 1963, the Food and Drug Administration was established under the
Department of Health per Republic Act No. 3720, or the Food, Drug, and
Cosmetic Act. It was tasked with administering and implementing laws that
guarantee "the safety and purity of foods, drugs and cosmetics being made
available to the public." 2 The agency was abolished in 1982, and its
functions were undertaken by the Bureau of Food and Drugs. 3 In 1987,
certain provisions of Republic Act No. 3720 were amended by Executive
Order No. 175. 4

In 2009, Republic Act No. 9711 was enacted to reinforce the

regulatory capacity of the Bureau, 5 which was then renamed the Food and
Drug Administration, 6 now holding regulatory authority over all health
products. 7

In 2011, following Section 22 of the law, 8 the Department of Health,

in coordination with the Food and Drug Administration, promulgated the
pertinent Implementing Rules and Regulations of Republic Act No. 9711
(Implementing Rules).

Rollo pp. 73-78. The January 27, 2012 Decision was penned by Acting Presiding Judge Romulo SG.
/
Villanueva of the Regional Trial Court of Las Pifias City, Branch 255.
2
Entitled "An Act to Ensure the Safety and Purity of Foods, Drugs, and Cosmetics Being Made
Available to the Public By creating the Food and Drug Administration which shall administer and
enforce the laws pertaining thereto" otherwise known as the "Foocl, Drug and Cosmetics Act" (1963).
See Executive Order No. 85 (1982), sec. 4.
4
Executive Order No. 175 amended, among others, the title of Republic Act No. 3720 to "Foods, Drugs
and Devices, and Cosmetics Act."
5
An Act Strengthening and Rationalizing the Regulatory Capacity of the Bureau of Food and Drugs
(BFAD) by Establishing Adequate Testing Laboratories and Field Offices, Upgrading its Equipment.
Augmenting its Human Resource Complement, Giving Authority to Retain Its income, renaming it the
Food and Drug Administration (FDA), Amending Certain Sections of Republic Act No. 3720, as
amended, and appropriating funds thereof.
6
Republic Act No. 971 l (2009), sec. 1.
7
Republic Act No. 9711 (2009), sec. 3 and Republic Act No. 3720 (1963), sec. 4, as amended by
Republic Act No. 9711 (2009), sec. 5.
Republic Act No. 971 I (2009), sec. 22 reads:
Section 22. Implementing Rules and Regulations. - The DOH shall promulgate, in consultation with
the FDA, the implementing rules and regulations of this Act within one hundred twenty (120) days
after the passage of this Act.
 Decision 3 G.R. No. 200431

The controversy in this case arose when the Philippine Tobacco

Institute, Inc. (PTI) filed a Petition for Declaratory Relief with Application
for the Issuance of a Temporary Restraining Order and/or Writ of
Preliminary Injunction9 before the Regional Trial Court. PTI sought to
prohibit the enforcement of the Implementing Rules, and to declare it void
for disregarding Republic Act No. 9711 and Republic Act No. 9211, or the
Tobacco Regulation Act of2003. 10

PTI argued that under Republic Act No. 9211, the Inter-Agency
Committee Tobacco (IAC-Tobacco) had exclusive jurisdiction over tobacco
products, 11 including its health aspect. 12 It also contended that Section 25 of
the Republic Act No. 9711 explicitly prohibited the Food and Drug
Administration from taking cognizance of health products already regulated
by other agencies. 13 The provision states:

SECTION 25. Coverage. - This Act shall govern all health

products: Provided, That nothing in this Act shall be deemed to modify the
sole and exclusive jurisdiction of other specialized agencies and special
laws only insofar as the acts covered by these specialized agencies and
laws, including, but not limited to, those covered by Republic Act No.
9211, Executive Order No. 245, Executive Order No. 18, and Presidential
Decree No. 1468.

PTI added that per congressional deliberations, the legislature

intended to exclude tobacco products from the Food and Drug
Administration's regulatory power. 14 It argued that even if the Health
Secretary was designated as the permanent Vice Chairperson of the IAC-
Tobacco under Republic Act No. 9211, the Department of Health's authority
over tobacco products is limited to its membership in the committee; 15 as
such, it could not allegedly issue rules on tobacco products and the tobacco
industry. 16

PTI then contested Book II, A1iicle III of the Implementing Rules,
which classified tobacco products as "health products," placing them under
the Food and Drug Administration's regulatory authority. 17 It states:

9
Rollo, pp. 179-226, Petition for Declaratory Relief.
10 Id. at 179.
11
Id. at 182.
12
Id. at I 95.
13
Id. at 198-199.
14
Id. at 198-200.
15
Id. at 194.
16
Id. at I 89.
17
Id. at 187-188.
 Decision 4 G.R. No. 200431

BOOK II

ARTICLE Ill
Tobacco and Other Products

SECTION I. Rationale. - The FDA has full jurisdiction over the

regulation of all health products.

SECTION 2. Tobacco. - The DOH, tasked with protecting the

public's health against the injurious effects arising from the use of tobacco
and tobacco products, has the responsibility of regulating tobacco and
tobacco products through the FDA.

a Rules and Other Issuances to Implement this Section. Within a

reasonable period from the date of effectivity of these Rules
and Regulations, the FDA shall prepare and recommend for the
approval to the Secretary of Health, the appropriate rules and
regulations and other issuances to implement this Section.

b. Protection against Tobacco Industry Interference. The FDA

shall act to protect the formulation and implementation of rules
and regulations under this Section from commercial and other
vested interests of the tobacco industry, including
organizations, entities, associations, individuals, and others that
work to further the interests of the tobacco industry.

The FDA shall not deal with the tobacco industry or individuals or
entities that work to further the interests of the tobacco industry, except to
the extent strictly necessary to effectively regulate, supervise, or control
the tobacco industry in relation to tobacco and tobacco products.

SECTION 3. Other Products. - Nothing in the FDA Act of 2009

shall be deemed to modify the jurisdiction of other specialized agencies
and special laws only insofar as the acts covered by these specialized
agencies and laws except the health aspects of such products.

SECTION 4. Identification of Policy Areas. - The FDA shall

promulgate the appropriate rules and regulations and other issuances to
identify and define the policy areas that are not covered by specialized
agencies and special laws, including, but not limited to, those covered by
Republic Act No. 9211, Executive Order No. 245, Executive Order No.
18, and Presidential Decree No. 1468.

PTI similarly pointed out that the restriction in the dealings between
the Food and Drug Administration and the tobacco industry under Section
2(b ), paragraph 2 above not only lacked statutory basis, but also violated the
equal protection clause. 18 Limiting the Food and Drug Administration's
interaction with the tobacco industry only on matters necessary for effective
regulation "unduly discriminate[ d] against the tobacco industry and ma[ de]
an invalid classification as it fail[ed] to impose the same burden on other
private industries with interest in other health products regulated by the
[Food and Drug Administration]." 19
JJ
18
ld.at216-218.
19
ld.at219.
 Decision 5 G.R. No. 200431

PTI also assailed Book II, Articles I, II, and V 20 of the Implementing
Rules, which cover tobacco products. PTI argued that under Republic Act
No. 9211, the !AC-Tobacco had 'Jurisdiction over the regulation of labeling,
advertisements, promotions, sponsorships and marketing activities involving
tobacco products." 21 The assailed provisions state:

BOOK II

ARTICLE I
Licensing ofEstablishments and Registration ofHealth Products

SECTION 1. General Provisions. -

a. The manufacture, importation, exportation, sale, offering for sale,

distribution, transfer, non-consumer use, promotion, advertising, or
sponsorship of any health product without the proper authorization
from the FDA is prohibited.

ARTICLE II
Labeling ofHealth Products

SECTION 1. General Provision. - Consistent with the state

policy of protecting the consumer against hazards to health and safety and
providing information and education to facilitate sound choice in the
proper exercise of their rights, all health products must be labeled and
conform to the requirements on labeling set by the FDA.

ARTICLEV
Advertisements, Promotions, Sponsorship, and Other Marketing Activities

SECTION 1. General Provision. - Consistent with the state

policy of protecting the consumer against misleading, deceptive, false,
erroneous impression regarding any health product's character, value,
quantity, composition, merit, or safety, efficacy or quality, and in order to
provide information and education to facilitate sound choice in the proper
exercise of their rights, all advertisements, promotions, sponsorship, and
other marketing activities about the health product must adhere to the
standards, guidelines, and regulations of the FDA. For this purpose,
advertisements, promotions, sponsorship, and other marketing activities on
health products shall refer to those addressed to the general public in any
form of media.

SECTION 2. General Rules on Advertisements, Promotions,

Sponsorship, and Other Marketing Activities of any Health Product. -

a. No health product that has not been registered or authorized shall

be advertised, promoted or subjected to any marketing activities;
/
20
Id. at 208-213.
21 Id. at 208.
 Decision 6 G.R. No. 200431

b. No claim in the advertisement, promotion and sponsorship, and

other marketing activities shall be made other than those contained
in the approved label or packaging of the health product, or as duly
approved by the FDA[.]

On the other hand, the Department of Health and the Food and Drug
Administration insisted on the valid exercise of their rule-making power22
and regulatory authority over tobacco products. They argued that tobacco
products were allegedly "health products" under Section 10(ff) of Republic
Act No. 3720, as amended by Republic Act No. 9711, due to their
detrimental effects to health. 23 Section I0(ff) states:

SECTION 10. For the purposes of this Act, the term:

(ff) 'Health products' means food, drugs, cosmetics, devices,

biologicals, vaccines, in-vitro diagnostic reagents and
household/urban hazardous substances and/or a combination of
and/or a derivative thereof. It shall also refer to products that may
have an effect on health which require regulations as determined
by the FDA. (Emphasis supplied)

They added that under Section 25 of Republic Act No. 9711, the Food
and Drug Administration allegedly "retain[ed] jurisdiction over all health
products (including tobacco products) on matters that are not covered by
special laws." 24 They denied stripping the !AC-Tobacco of its exclusive
authority to implement Republic Act No. 9211, the latter's powers being
distinct from them. 25

As to the protection against tobacco industry interference, the

Department of Health and the Food and Drug Administration contended that
the Implementing Rules were allegedly "consistent with the State's
constitutional mandate to protect public health, as recognized in the various
provisions of the [World Health Organization Framework Convention on
Tobacco Control (WHO FCTC)]." 26

On September 28, 2011, the Regional Trial Court denied PTI's move
for injunction, 27 and on December 15, 2011, denied its move for
reconsideration. 28

Later, in a January 27, 2012 Decision, 29 the Regional Trial Court ruled

22
f'
Id. at 260, Answer.
23
Id. at 232-236.
24
Id. at 242.
25
Id. at 249.
26
Id. at 254.
27
Id. at 1140-1144, RTC Order.
28
Id. at 73, RTC Decision.
29
Id. at 73-78.
Decision 7 G.R. No. 200431

on the merits and granted30 PTI's pet1t1on. Relying on Section 25 of

Republic Act No. 9711, it declared that tobacco products were expressly
excluded from the coverage of the law, and hence, beyond the ambit of the
Food and Drug Administration's regulatory power. Recognizing the IAC-
Tobacco's exclusive jurisdiction over tobacco products under Republic Act
No. 9211, the trial court ruled that it was improper for the Department of
Health and the Food and Drug Administration to include tobacco products
under Book II, Article III of the Implementing Rules. It also agreed with PTI
that the other contested provisions, which consequently applied to tobacco
products, would encroach on IAC-Tobacco's authority over the same
activities under Republic Act No. 9211. 31

The trial comi also explained that Section 25 of Republic Act No.
9711 conformed with existing statutes, particularly with Republic Act No.
9211, the "primary law on regulating tobacco products." 32 It pointed out that
congressional deliberations relevant to the enactment of Republic Act No.
9711 recognized the IAC-Tobacco's exclusive authority over tobacco
products, citing the following testimony of Atty. Emilio Polig (Atty. Polig),
Head of the Food and Drug Administration's Legal Department:

MR. POLIG (Head, Legal Department, Bureau of Food and Drugs) Yes,
Madam-Chairman. While the. definition on health products, particularly
the last portion, practically covers every ... every pro ... other products
that may have an effect on health on it is my ... my opinion that since the
... the law on that covers like tobacco is a special law, separate ... hindi
na po siya kasama dito Your Honor. (Exhibit D 45-46). 33 (Emphasis in the
original)

The trial court ruled that the Department of Health, as a member of the
!AC-Tobacco through the Food and Drug Administration, could only
regulate tobacco products through the !AC-Tobacco by providing inputs and
proposals for the body's deliberation. Thus, it declared that the Department
of Health and the Food and Drug Administration exceeded their rule-making
powers in including the contested provisions of the Implementing Rules. 34

The dispositive portion of the Regional Trial Court Decision reads:

WHEREFORE, premises considered, the petition is hereby

GRANTED. The Implementing Rules and Regulations of R.A. No. 9711,
insofar as it regulates tobacco products and the tobacco industry is
declared void. Public Respondents Department of Health and Food and
Drug Administration are hereby directed to refrain from enforcing the
Implementing Rules and Regulations on tobacco products and the tobacco
industry.
/
30
Id. at 78.
31
Id. at J6-77.
" Id. at 77.
33 Id.
34
Id. at 76.
 Decision 8 G.R. No. 200431

SO ORDERED. 35

On March 29, 2012, the Department of Health and the Food and Drug
Administration, through the Office of the Solicitor General, filed this
Petition for Review. 36

On August 28, 2012, PTI filed its Comment37 to the Petition.

On April 11, 2013, petitioners-intervenors Senators Pilar Juliana S.

Cayetano and Franklin M. Drilon filed their Petition-in-Intervention. 38

On December 17, 2013, respondent-intervenor Representative Edee!

C. Lagman filed his Opposition-in-Intervention. 39

On September 9, 2014, this Court required the parties and intervenors

to file their memoranda. 40

Petitioners insist on the valid exercise of their regulatory powers. 41 To

them, Section 25 clearly says that Republic Act No. 9711 governs all health
products except those matters covered by special laws. Hence, the Food and
Drug Administration allegedly retained its regulatory powers over tobacco
products on matters affecting public health, which are not covered by
Republic Act No. 9211. 42 Moreover, congressional deliberations allegedly
reveal the lawmakers' intent to grant the Food and Drug Administration
authority over the health aspects of all products, including tobacco. 43

Petitioners repeat that due to their effects on health, tobacco products

are "health products" under Section lO(ff) of Republic Act No. 3720, as
amended, and thus fall under the regulatory authority of the Department of
Health through the Food and Drug Achninistration. 44 This is despite the lack
of a center under Section 5 of Republic Act No. 3720, as amended, which
regulates tobacco products. After all, for petitioners, the Food and Drug
Administration is empowered to create additional organizational units. 45

Petitioners emphasize that the Department of Health's primary

responsibilities of formulating and implementing health policies and

35
Id. at 78.
36
Id. at 13-72, Petition for Review.
37
Id. at 498-538, Comment.
38
Id. at 1089-1139, Petition-in-Intervention.
39
Id. at 1214-1290, Opposition-in-Intervention.
40
Id. at 1893-1894.
41
Id. at 25, Petition for Review.
42
Id. at 45-50.
43
Id. at 53-55 and 1868-1870.
44
Id. at 56-58, 1857, and 1860.
45
Id. at 61--<52 and 1858-1859.
---
Decision 9 G.R. No. 200431

programs were neither amended nor repealed by Republic Act No. 9211. 46
Republic Act No. 9711, on the other hand, was enacted to strengthen the
State's regulatory and enforcement capacity over health products. 47 These
laws do not confuse or merge the functions of the Food and Drug
Administration and the !AC-Tobacco, petitioners say. 48

Petitioners also explain49 that of Book II, Article III, Section 2(b ),
paragraph 2 of the Implementing Rules on protection against tobacco
industry interference is consistent with Department Memorandum Order No.
2010-0126 50 and Joint Memorandum Circular No. 2010-01, 51 and conforms
to the Philippines' obligations under the WHO FCTC to protect public
health policies from the vested interests of the tobacco industry. 52

Moreover, petitioners argue that the tobacco industry's distinct

classification allegedly rests on valid and reasonable standards and do not
violate the equal protection clause. 53

To these, petitioners-intervenors add that Section 25 of Republic Act

No. 9711 did not diminish petitioners' powers to promulgate rules and
regulations over tobacco products. 54 The proviso allegedly provides a
limitation only insofar as certain acts have been covered by the special laws
and agencies specified. 55 As to acts not covered, including the health aspect
of tobacco products, they say that the law has suppletory application and that
these remain within the regulatory authority ofpetitioners. 56

Petitioners-intervenors also contend that Republic Act No. 9211 does

not address all obligations required under the WHO FCTC. 57 It "regulates
only certain aspects [of the tobacco industry], particularly sale and
distribution, signages, smoke-free places, textual warnings on cigarette
packages, advertisements, promotions and sponsorship." 58 The IAC-
Tobacco's task is merely compliance monitoring and program development,
petitioners-intervenors say, while the implementation of programs and
projects lies with the member-agencies of the IAC-Tobacco. 59

46
Id. at62 and 1864--1865.
47
ld. at 65.
48
Id. at 1874 and 1876.
49
Id. at 32-35 and 1852-1853.
50
Id. at 86-96. Protection of the Department of Health, including all of its Agencies, Regional Offices,
Bureaus or Specialized/Attached Offices/Units against Tobacco Industry Interference.
51
Id. at 98-104. Protection of the Bureaucracy against Tobacco Industry Interference.
52
Id. at 37, 1850, and 1856.
53
Id. at 39-43 and 1853-1855.
54
Id. at 1098.
55
ld.atl097.
56
Id. at 1097-1099 and 1838.
57 Id.at 1113.
58
Id. at 1111.
59
ld.at1115-lll6.
 Decision 10 G.R. No. 200431

Also citing congressional deliberations, petitioners-intervenors argue

that "the consensus of the legislators was to include tobacco products within
the coverage of [Republic Act No. 9711] and the regulatory authority of the
[Food and Drug Administration.]" 60 They add that the trial court
erroneously relied on a mere opinion by Atty. Polig, as cited by respondent,
which was also just a portion of the deliberations of the Bicameral
Committee on February 23, 2009 and is not the intent of the Committee. 61

Petitioners-intervenors echo petitioners in that tobacco products

undeniably qualify as "health products" for their detrimental effects on
health. 62 They say that ejusdem generis only applies in case of ambiguity
and would not be "controlling where the plain purpose and intent of the
Legislature would thereby be hindered and defeated." 63 Restricting the
law's coverage only to the list under the definition of health products or of
the same class as the latter, they say, would defeat the law's very objective. 64

On the other hand, respondent counters that Republic Act No. 9211
bestows on the IAC-Tobacco the exclusive jurisdiction to regulate tobacco
products, which includes their health aspect. 65 It asserts that the Department
of Health cannot regulate tobacco products on its own, and that its authority
is limited to being part ofIAC-Tobacco. 66

In contrast to what petitioners say, respondent argues that Republic

Act No. 9711, as supported by congressional deliberations, points to the
legislative intent to exclude tobacco products from the coverage of the law. 67
Likewise, tobacco products are allegedly not health products, they not being
mentioned in Republic Act No. 9711, nor was there a specific center created
under the law to regulate it. 68

Respondent also argues that Section 25 of the law delimited the Food
and Drug Administration's jurisdiction by explicitly divesting it of power
over matters already under the exclusive jurisdiction of other regulatory
agencies, such as the IAC-Tobacco under Republic Act No. 9211. It notes
that Congress had decided not to give Republic Act No. 9711 application "in
a suppletory manner to other special laws" 69 as seen in how this clause was
omitted in the final version. 70 It adds that the Implementing Rules unduly
encroach on the exclusive jurisdiction of the !AC-Tobacco over the labeling,
/
60
Id.atll0I.
61
Id. at I 101-1109 and Memorandum for Petitioners-lntervenors, pp. 12-19.
62
Id. at 1096.
63
Memorandum for Petitioners-Intervenors, pp. 7-8.
64
Id. at 8.
65
Rollo, pp. 506-507, Comment.
66
Id. at 508 and Memorandum for Respondent, p. 36.
67
Id. at 515 and Memorandum for Respondent, p. 22.
68
Id. at521-522.
69
Id. at 513 and Memorandum of Respondent, pp. 18-19.
70
Id.at513.
 •,-

.. Decision 11 G.R. No. 200431

advertising, sponsorship, and marketing of tobacco products. 71

Respondent adds that Book II, Article III, Section 2(b), paragraph 2 of
the Implementing Rules lacks basis and runs counter to constitutional and
statutory provisions. It notes that the WHO FCTC is allegedly not self-
implementing, which means that petitioners cannot use it as "basis of any
right or obligation"; 72 and that the restriction provided in the Implementing
Rules violates respondent's right to equal protection. 73

Respondent-intervenor supports respondent in that tobacco products

are not "health products" under Section l0(ff) of Republic Act No. 3720.74
He claims that the provision's second sentence, which states that health
products are those that have an effect on health, must be construed as "akin
in nature to those enumerated in the first sentence in application of the
doctrine of ejusdem generis." 75 Tobacco products, he argues, are not
included in the list76 or gennane to such class-unlike the health products
enumerated which "have generally beneficial use, albeit, with potential
harm[,]" 77 tobacco products have no health benefits.

Respondent-intervenor adds that Republic Act No. 9211 effectively

amended the Department of Health's general powers on health matters under
the Administrative Code. 78 He opposes the inclusion of tobacco products
and the tobacco industry in the Implementing Rules pursuant to DOH
Memorandum No. 2010-0126, Joint Memorandum Circular No. 2010-01,
and the WHO FCTC, claiming that petitioners "were tasked to implement
solely the provisions of [Republic Act No. 9711], not any administrative fiat
or international covenant which could stand on their own." 79 He adds that
the WHO FCTC is "addressed principally to the State Parties' legislature,
not to mere administrative bodies." 80

Respondent-intervenor contends that having "[d]ual jurisdiction will

definitely spawn conflicts and confusion which may be inimical to the
government's health agenda on tobacco products." 81 With the Department
of Health's vast functions in protecting the people's health, it would
allegedly "be best for a specialized agency like the !AC-Tobacco to focus on
a particular[ly] deleterious product [which is] tobacco." 82 He points out that
ascertaining the correctness of the legislature's wisdom behind excluding

71
72
Id. at 528-532.
I
Id. at 535 and Memorandum for Respondent, p. 58.
73
Id.
74
Memorandum for Respondent-Intervenor, p. 22.
75
Id. at 1228, Opposition-in-Intervention, and Memorandum for Respondent-Intervenor, p. 26.
76
Id. at 1225 and Memorandum for Respondent-Intervenor, p. 23.
77
Id. at 1229 and Memorandum for Respondent-Intervenor, p. 27.
78
Id. at 1285 and Memorandum for Respondent-Intervenor, pp. 50-51.
79
Memorandum for Respondent-Intervenor, p. 53.
so Id.
81
Rollo, p. 1245, Opposition-in-Intervention.
82
Id.
Decision 12 G.R. No. 200431

tobacco products and the tobacco industry from the coverage of Republic
Act No. 9711 is beyond the authority of any court or administrative body to
correct or defy. 83

Respondent-intervenor further argues that the Food and Drug

Administration's assumption of jurisdiction over tobacco products will yield
absurd results. It would allegedly be incredible to ensure the "safety,
efficacy, purity and quality" 84 of tobacco products, the latter being
hazardous. He adds that, although regulated, tobacco products remain to be
"legitimate articles of commerce" 85 which cannot be banned for failing to
conform to standards imposed by the Food and Drug Administration. 86

For this Court's resolution is the main issue of whether or not the
Regional Trial Court correctly nullified the Rules and Regulations
Implementing Republic Act No. 9711 insofar as it included tobacco products
and the tobacco industry in its coverage.

Subsumed under this are two issues:

First, whether or not Section 25 of Republic Act No. 9711 excludes

the regulation of the health aspects of tobacco products from the Food and
Drug Administration's authority; and

Second, whether or not tobacco products are "health products" under

the definition provided under Section lO(ff) of Republic Act No. 3720, as
amended by Section 9 of Republic Act No. 9711.

The Petition is granted.

Before delving into the issues, a brief overview of the government's

tobacco control measures to reduce tobacco use in our country is apropos.

It is the State policy to "protect and promote the right to health of the
people and instill health consciousness among them." 87 The Department of
Health, as the government agency that chiefly responds to health concerns, is
"primarily responsible for the formulation, planning, implementation, and
I
coordination of policies and programs in the field of health." 88 Specifically,

83
Id. at 1258-1259.
84
Id. at 1248.
85
ld.
86
Id.
87
CONST., art. II, sec. 15 and ADM. CODE, Book IV, Title IX, Ch. I, sec. I.
88
ADM. CODE, Book IV, Title lX, Ch. l, sec. 2.
Decision 13 G.R. No. 200431

its powers and functions are:

SECTION 3. Powers and Functions. -The Department shall:

(1) Define the national health policy and formulate and implement a
national health plan within the framework of the government's
general policies and plans, and present proposals to appropriate
authorities on national issues which have health implications;

(2) Provide for health programs, services, facilities and other

requirements as may be needed, subject to availability of funds and
administrative rules and regulations;

(3) Coordinate or collaborate with, and assist local communities,

agencies and interested groups including international
organizations in activities related to health;

(4) Administer all laws, rules and regulations in the field of health,
including quarantine laws and food and drug safety laws;

(5) Collect, analyze and disseminate statistical and other relevant

information on the country's health situation, and require the
reporting of such information from appropriate sources;

(6) Propagate health information and educate the population on

important health, medical and environmental matters which have
health implications;

(7) Undertake health and medical research and conduct training in

support of its priorities, programs and activities;

(8) Regulate the operation of and issue licenses and permits to

government and private hospitals, clinics and dispensaries,
laboratories, blood banks; drugstores and such other establishments
which by the nature of their functions are required to be regulated
by the Department;

(9) Issue orders and regulations concerning the implementation of

established health policies; and

(10) Perform such other functions as may be provided by law. 89

(Emphasis supplied)

As the national technical authority on health, the Department of

Health serves as the key government agency for promoting tobacco control
in the country. In 1987, the then Non-Communicable Disease Control /
Service,90 under the Department's Public Health Services, developed a five-
year national smoking control plan as its primary strategy in the lung cancer
prevention program. The plan aimed to reduce the national prevalence of
smoking by 10% in 1997, render all the department facilities smoke-free by

89
ADM. CODE, Book IV, Title IX, Ch. l, sec. 3.
°
9
Created under Executive Order No. 119, January 30, 1987.
Decision 14 G.R. No. 200431

1993, and ban smoking among elementary and high school students. 91 To
increase public awareness against smoking, it launched its anti-smoking
campaign in the 1990s, through its "Yosi Kadiri" iconic mascot and media
campaigns, to illustrate the detrimental effects of cigarette smoking on the
health of both smokers and non-smokers. 92

In 1992, Republic Act No. 7934 or the Consumer Act of the

Philippines was passed, aiming to protect consumer interest and promote
general welfare93 through the following measures:

a) protection against hazards to health and safety;

b) protection against deceptive, unfair and unconscionable acts and
practices;
c) provision of information and education to facilitate sound choice and
the proper exercise of rights by the consumer;
d) provision of adequate rights and means of redress; and
e) involvement of consumer representatives in the formulation of social
and economic policies. 94

The Department of Health is the implementing agency tasked to

establish and enforce consumer product quality and safety standards, 95
compulsory labeling and fair packaging, 96 and advertising and sales
promotion restrictions 97 relative to food, drugs, cosmetics, devices, and
hazardous substances. 98 It may also require that labels of packaging indicate
the following:

91 Administrative Order No. 122 (2003), A Smoking Cessation Program to support the National Tobacco
Control and Healthy Lifestyle Program.
/
92 Chino Leyco, Gov't revives 'Yosi Kadiri' mascot vs. smoking, MANILA BULLETIN, May 16, 2019,
available at <https://doh.gov.ph/sites/default/files/news_ c!ips/051619-0005.pdf> (last accessed on
August 26, 2021 ).
93 Republic Act No. 7394 (I 992), art. 2.
94 Republic Act No. 7394 (I 992), art. 2.
95 Republic Act No. 7394 (I 992), Title II, Chapters 1 to III.
96
Republic Act No. 7394 (1992), art. 75.
97 Republic Act No. 7394 (1992), art. 109.
98 Republic Act No. 7394 (1992), ai1. 4(ak) states:
ak) "Hazardous substance" means:
(I) (i) Any substance or mixture of substances which is toxic, corrosive, irritant, a strong sensitizer,
flammable or combustible, or generates pressure through decomposition, heat or other means, if such
substance or mixture or substances may cause substantial injury or substantial illness during or as a
proximate result of any customary or reasonably foreseeable ingestion by children;
(ii) Any substance which the department finds to be under the categories enumerated in clause (I) (i)
of this paragraph;
(iii) Any radioactive substance, if, with respect to such substance as used in a particular class of article
or as packaged, the Department, upon approval of the Department determines by regulation that the
substance is sufficiently hazardous to require labeling in accordance with this section in order to
protect the public health;
(iv) Any toy or other articles intended for use by children which the director may, by regulation,
determine the presence of an electrical, mechanical or thermal hazard.
(2) This term shall not apply to food, drugs, cosmetics, and devices nor to substances intended for use
as fuels when stored in containers and used in the heating, cooking or refrigeration system of a house,
but such term shall apply to any article which is not in itself a pesticide but which is a hazardous
substance, as construed in clause (a) of paragraph (1), by reason of bearing or containing such hatmful
substances described therein.
Decision 15 G.R. No. 200431

a) whether it is flammable or inflammable;

b) directions for use, if necessary;
c) warning of toxicity;
d) wattage, voltage or amperes; or
e) process of manufacture used ifnecessary. 99

In relation to tobacco's health hazards, the law required that all

cigarette packs carry a health warning: "Cigarette Smoking is Dangerous to
Your Health." 100 The Department of Health likewise enforced labeling and
packaging requirements, 101 issuing Administrative Order No. 10 in 1993. It
provided that no cigarette without the warning statement would be allowed
in the market beginning January 1, 1994, and would be seized by food and
drug regulation officers.

That same year, the Department of Health issued Administrative

Order No. 8, prohibiting smoking in all its offices, agencies, hospitals, and
premises nationwide. A 100% smoke-free policy was later established for
all government agencies, local government units, and state universities, 102 as
well as in public utility vehicles and land transportation terminals. 103

In 1999, Republic Act No. 8749 or the Philippine Clean Air Act also
prohibited under Article 5, Section 24 smoking in public buildings or
enclosed public places, including public vehicles and other means of
transport. It also banned smoking in any enclosed area outside one's private
residence, private place of work, or any duly designated smoking area.

99 Republic Act No. 7394 (1992), art. 77.

100 Republic Act No. 7394 (I 992), mt. 94 provides:
Article 94. Labeling Requirements of Cigarettes. - All cigarettes for sale or distribution within the
country shall be contained in a package which shall bear the following statement or its equivalent in
Filipino: "Warning" Cigarette Smoking is Dangerous to Your Health". Such statement shall be located
in conspicuous place on every cigarette package and shall appear in conspicuous and legible type in
contrast by typography, layout or color with other printed matter on the package. Any advertisement of
cigarette shall contain the name warning as indicated in the label.
101 Republic Act No. 7394 (1992), mts. 6 and 75 state:
A1ticle 6. Implementing Agencies. - The provisions of this A1ticle and its implementing rules and
regulations shall be enforced by:
a) the Department of Health with respect to food, drngs, cosmetics, devices and substances;
b) the Depmtment of Agriculture with respect to products related to agriculture, and;
c) the Depaitment of Trade and Industry with respect to other consumer products not specified above.
Article 75. Implementing Agency. - The Depmtment of Trade and Industry shall enforce the
provisions of this Chapter and its implementing rules and regulations: Provided, That with respect to
food, drugs, cosmetics, devices, and hazardous substances, it shall be enforced by the concerned
department.
102 Civil Service Commission Memorandum Circular No. 17 (2009),
<https://www.tobaccocontrollaws.org/files/live/Philippines/Phiiippines%20-
%20CSC%20Memo%20Circular%20-%20national.pdf> (last accessed on July 30, 2021).
103 Department of Transpo1tation and Communication, Land Transportation Franchising and Regulatory
Board Memorandum Circular No. 2009-036
https://www.tobaccocontrollaws.org/files/live/Philippines/Philippines%20-
%20LTFRB%20Memo%20Circular%20%20-%20national.pdf> (last accessed on July 30, 2021).
Decision 16 G.R. No. 200431

To further curtail the increasing tobacco consumption and its negative

effects on health and the economy, Republic Act No. 9211 or the Tobacco
Regulation Act was enacted on June 23, 2003. It regulated the use, sale, and
advertisement of tobacco products while promoting healthy environments
and mandating health programs and withdrawal clinics. 104 Smoking in
public places like hospitals, clinics, and enclosed public places are
banned. 105 All fonns of mass media advertising were banned by July 1,
2008, 106 including the sponsorship of cultural and sporting events by the
tobacco industry. 107

The law adds that, by 2004, cigarettes advertisements and packs must
bear a warning on specific health hazards caused by smoking. Warnings
should include, on a rotating basis, separately or simultaneously, messages
such as, "Cigarette Smoking is Dangerous to Your Health," "Cigarettes are
Addictive," "Tobacco Smoke can Harm Your Children," or "Smoking
Kills," 108 amending Article 94 of the Consumer Act. 109 The law also
requires that all tobacco packages contain either of the messages "NO SALE
TO MINORS" or "NOT FOR SALE TO MINORS" on one panel. 110 The
law expressly repealed DOH Administrative Order No. 10, as well as
Administrative Order No. 24, series of 2003, which had also provided
guidelines on cigarette labeling and adveiiisements. 111

Under Section 29, the law also created the !AC-Tobacco, which was
vested with the exclusive power and function to administer and implement
the provisions of the law. Accordingly, the !AC-Tobacco issued
Memorandum Circular No. 1, series of 2004, or the Implementing Rules and
Regulations of the Tobacco Regulation Act of2003. 112 As with the Tobacco
Regulation Act, these Implementing Rules and Regulations cover a range of
topics on tobacco control-providing definitions and standards for
designated smoking areas, access restrictions, and restrictions on advertising,
promotions, and sponsorships, among others.

Shortly after, on September 23, 2003, the Philippines became a

signatory to the World Health Organization Framework Convention on
Tobacco Control (WHO FCTC), which was ratified on June 6, 2005. 113 The
WHO FCTC embodies the WHO's tobacco-free initiative, recognizing that

104
Republic Act No. 9211 (2003), sec. 33.
105
Republic Act No. 9211 (2003), sec. 5.
106
Republic Act No. 9211 (2003), sec. 22.
107
Republic Act No. 9211 (2003), sec. 26.
108
Republic Act No. 9211 (2003), sec. 13.
'°'
110
Republic Act No. 9211 (2003), sec. 39.
Republic Act No. 9211 (2003), sec. 13.
111
Republic Act No. 9211 (2003), sec. 39.
112
Took effect on April 9, 2004, 15 days after its publication on March 25, 2004.
113
United Nations Treaty Collection.
<https://treaties. un.org/pages/ViewDetails.aspx?src=TREA TY &mtdsg_no=IX-
4&chapter=9&clang~_en> (last accessed on July 30,202 I).
Decision 17 G.R. No. 200431

the enjoyment of the highest attainable standard of health 1s a basic

constitutional right. 114

Being a paiiy to the WHO FCTC, the Philippines committed to

implement tobacco control measures such as price and tax policies. 115 It also
committed to "adopt and implement effective legislative, executive and
administrative or other measures" to reduce tobacco demand and
consumption, including:

1. protection from exposure to tobacco smoke in indoor

workplaces, public transport, indoor public places, and
other public places; 116

2. regulation of tobacco products' contents, emissions, 117

and disclosures·,118

3. packaging and labelling regulations; 119

4. education and public awareness measures; 120

5. comprehensive ban/restrictions on tobacco advertising,

promotion and sponsorship; 121

6. measures to combat illicit trade; 122

7. prohibition of sale by, and to, minors; 123

8. measures to promote cessation of tobacco use and

adequate treatment for tobacco dependence; 124 and

9. reduction of tobacco industry interference in setting and

implementing public health policies. 125

The treaty also provides for international cooperation to support

tobacco control, including scientific, technical, and legal cooperation and
information sharing. 126 Finally, each state party is required to submit
periodic reports on its implementation of the Convention. 127

114
Annex 2, WHO Framework Convention on Tobacco Control (2003), available at
<http://apps.who.int/iris/bitstream/handle/l 0665/4281 1/9241591013.pdf;jsessionid~8F790DD80F 1614
I
2C3D60D0EB85235957?sequence~l> (last accessed on July 30, 2021).
115
WHO Framework Convention on Tobacco Control (2003), art. 6.
116
WHO Framework Convention on Tobacco Control (2003), art. 8.
117
WHO Framework Convention on Tobacco Control (2003), art. 9.
118
WHO Framework Convention on Tobacco Control (2003), art. 10.
119
WHO Framework Convention on Tobacco Control (2003), art. 11.
120
WHO Framework Convention on Tobacco Control (2003), art. 12.
121
WHO Framework Convention on Tobacco Control (2003), art. 13.
122
WHO Framework Convention on Tobacco Control (2003), art. 15.
123
WHO Framework Convention on Tobacco Control (2003), art. 16.
124
WHO Framework Convention on Tobacco Control (2003), art. 14.
125
WHO Framework Convention on Tobacco Control (2003), art. 5(3).
126
WHO Framework Convention on Tobacco Control (2003), art. 20.
127
WHO Framework Convention on Tobacco Control (2003), art. 21.
'. , Decision 18 G,R. No. 200431

In accordance with the WHO FCTC, the Department of Health

institutionalized the National Tobacco Prevention and Control Program,
which would focus on five priority areas: (1) tobacco dependence and
cessation; (2) protection from exposure to tobacco smoke; (3) education,
communication, and training; (4) regulation of tobacco product disclosure;
and (5) regulation of tobacco products' contents. 128

In line with Articles 7 and 11 of the WHO FCTC, the Department of

Health issued Achninistrative Order No. 2010-0013 129 on May 25, 2010,
requiring graphic health information on tobacco product packages and
prohibiting the promotion of any tobacco product using misleading
descriptors. Also, aligned with the WHO FCTC, the Civil Service
Commission and the Department of Health issued Joint Memorandum
Circular No. 2010-01, 130 which provides guidelines for interactions with the
tobacco industry under the policy protecting the bureaucracy against tobacco
industry interference. The Department of Health further issued
Memorandum No. 2010-0126, 131 with the same purpose but specific to
protecting the Department against tobacco industry interference.

In 2011, the Department of Health, through the Food and Drug

Administration, issued the Rules and Regulations Implementing Republic
Act No. 9711 (Implementing Rules), incorporating provisions on tobacco
product regulation and protection against tobacco industry interference.

As to price and tax measures, Republic Act No. 10351 or the Sin Tax
Law was signed into law in 2012. In considerably increasing the specific
excise tax on tobacco and tobacco products, the law raised the consumer
price of cigarettes, discouraging consumption. The law also provided funds
for the Universal Health Care Law. 132

On July 15, 2014, Republic Act No. 10643 or the Graphic Health
Warnings Law was enacted, recognizing the Philippines' obligation under
the WHO FCTC "to inform every person of the health consequences of

126
DOH Administrative Order No. 2007-0004 (2007), available at
<https://dmas.doh.gov.ph:8083/Rest/GetFile?id~336699> (last accessed on August 31, 2021).
129
Requiring Graphic Health Information on Tobacco Product Packages, Adopting Measures to Ensure
that Tobacco Product Packaging and Labeling Do Not Promote Tobacco By Any Means That are
False, Misleading, Deceptive, or Likely to Create an Erroneous Impression, and Matters Related
Thereto, available at <https://dmas.doh.gov.ph:8083/Rest/GetFile?id~336829> (last accessed on July
30, 2021).
130
Protection of the Bureaucracy Against Tobacco Industry Interference. available at
<https://www.tobaccocontrollaws.org/files/1 ive/Phi lippines/Philippines%20-%20JM C%2020 I 0-
01 %20-%20national.pdf> (last accessed on July 30, 2021).
131
Protection of the Department of Health, including all of its Agencies, Regional Offices, Bureaus or
Specialized/Attached Offices/Units, against Tobacco Industry Interference, available at
<https://www.tobaccocontrollaws.org/files/l ive/Ph ii ippines/Philippines%20-
%20DO H%20 Dept%20 Memo%20on%20 Industry%20 Interference%20-%20national. pdf> (last
accessed on July 30, 202 I).
132
Republic Act No. 10351 (2012), sec. 5.
Decision 19 G.R. No. 200431

tobacco consumption and exposure to tobacco smoke; to enact effective

measures to curb and reduce tobacco use, especially among the youth; and to
protect public health policy from the commercial and vested interests of the
tobacco industry." 133 The law also acknowledged the Philippines' duty
under Article 11 of the WHO FCTC to adopt and implement effective health
warnings on tobacco products. 134 It expressly repealed Section 13 of
Republic Act No. 9211 on cigarette package warnings, and DOH
Administrative Order No. 2010-0013. Republic Act No. 10643 is
135
implemented by administrative orders issued by the Department of Health
which establish the templates of the required graphic health warnings.

This narrative clearly establishes that the Department of Health has

been at the forefront of policymaking and implementation on matters
affecting public health, including tobacco control programs.

II

This case involves the validity of the Implementing Rules of Republic

Act No. 9711, insofar as it included the health aspects of tobacco products in
the regulatory authority of the Department of Health through the Food and
Drug Administration under Book II, Article III.

Respondent primarily argues that the inclusion of tobacco products

disregards Republic Act No. 9211, which vested in the !AC-Tobacco
exclusive power to regulate tobacco products, and Section 25 of Republic
Act No. 9711, which excludes tobacco products from the Food and Drug
Administration's jurisdiction. 136 Ruling for respondent, the Regional Trial
Court held that petitioners erred in including tobacco products under Book
II, Article III of the Implementing Rules. 137

The Regional Trial Court is incorrect.

II (A)

The enactment of Republic Act No. 9711, geared toward

strengthening the State's regulatory capacity and enforcement of compliance
with regulations over health products, 138 finds support in the Constitution.
J
133
Republic Act No. 10643 (2014), sec. 2.
134
Republic Act No. 10643 (2014), sec. 2.
135
Administrative Order No. 2014-0037, as amended by Administrative Order Nos. 2014-0037-A, 2014-
0037-B, and 2019-0009.
136
Rollo, p. 75, RTC Decision.
137
Id. at 77.
138
Republic Act No. 9711 (2009), sec. 3 provides:
Section 3. It is hereby declared a policy of the State to adopt, support, establish, institutionalize,
improve and maintain structures, processes, mechanisms and initiatives that are aimed, directed and
designed to: (a) protect and promote the right to health of the Filipino people; and (b) help establish
Decision 20 G.R. No. 200431

Article II, Section 15 states:

SECTION 15. The State shall protect and promote the right to
health of the people and instill health consciousness among them.

Meanwhile, under Section 12 of Article XIII, on social justice and

human rights, states:

SECTION 12. The State shall establish and maintain an effective

food and drug regulatory system and undertake appropriate health
manpower development and research, responsive to the country's health
needs and problems.

Republic Act No. 9711 created the Food and Drug Administration,
which is tasked to carry out its provisions. 139 Aligned with the constitutional
declarations, Republic Act No. 9711 aims:

(a) To enhance and strengthen the administrative and technical capacity of

the FDA in the regulation of establishments and products under its
jurisdiction;

(b) To ensure the FDA's monitoring and regulatory coverage over

establishments and products under its jurisdiction; and

(c) To provide coherence in the FDA's regulatory system for

establishments and products under its jurisdiction. 140

Section 5 of Republic Act No. 9711, which amends Republic Act No.
3270, explicitly provides the specific functions and duties of the Food and
Drug Administration:

(a) To administer the effective implementation of this Act and of the

rules and regulations issued pursuant to the same;

(b) To assume primary jurisdiction in the collection of samples of

health products;

(c) To analyze and inspect health products in connection with the

implementation of this Act;

( d) To establish analytical data to serve as basis for the preparation of

and maintain an effective health products regulatory system and undertake appropriate health
manpower development and research, responsive to the country's health needs and problems. Pursuant
to this policy, the State must enhance its regulatory capacity and strengthen its capability with regard
to the inspection, licensing and monitoring of establishments, and the registration and monfroring of
health products. (Emphasis supplied)
139
Republic Act No. 9711 (2009), sec. 4.
140
Republic Act No. 971 I (2009), sec. 4.
Decision 21 G.R. No. 200431

health products standards. and to recommend standards of identity,

purity, safety, efficacy, quality and fill of container;

(e) To issue certificates of compliance with technical requirements to

serve as basis for the issuance of appropriate authorization and spot-
check for compliance with regulations regarding operation of
manufacturers, importers, exporters, distributors, wholesalers, drug
outlets, and other establishments and facilities of health products, as
determined by the FDA;

(f) To levy, assess and collect fees for inspection, analysis and testing
of products and materials submitted in compliance with the provisions
of this Act.

(g) To certify batches of anti-biotic and anti-biotic preparations m

compliance with the provisions of this Act.

(h) To conduct appropriate tests on all applicable health products

prior to the issuance of appropriate authorizations to ensure safety,
efficacy, purity, and quality;

(i) To require all manufacturers, traders, distributors, importers,

exporters, wholesalers, retailers, consumers, and non-consumer users
of health products to report to the FDA any incident that reasonably
indicates that said product has caused or contributed to the death,
serious illness or serious injury to a consumer, a patient, or any
person;

G) To issue cease and desist orders motu proprio or upon verified

complaint for health products, whether or not registered with the
FDA: Provided, that for registered health products, the cease and
desist order is valid for thirty (30) days and may be extended for sixty
(60) days only after due process has been observed;

(k) After due process, to order the ban, recall, and/or withdrawal of
any health product found to have caused the death, serious illness or
serious injury to a consumer or patient, or is found to be imminently
injurious, unsafe, dangerous, or grossly deceptive, and to require all
concerned to implement the risk management plan which is a
requirement for the issuance of the appropriate authorization;

(1) To strengthen the post market surveillance system in monitoring

health products as defined in this Act and incidents of adverse events
involving such products;

(m)To develop and issue standards and appropriate authorizations

that would cover establishments, facilities and health products;

(n) To conduct, supervise, monitor and audit research studies on

health and scifety issues of health products undertaken by entities duly
approved by the FDA;

(o) To prescribe standards, guidelines, and regulations with respect to

information, advertisements and other marketing instruments and
promotion, sponsorship, and other marketing activities about the health
products as covered in this Act;
Decision 22 G.R. No. 200431

(p) To maintain bonded warehouses/ and/or establish the same,

whenever necessary or appropriate, as determined by the director-
general for confiscated goods in strategic areas of the country
especially at major ports of entry; and

(q) To exercise such other powers and perform such other functions as
may be necessary to carry out its duties and responsibilities under this
Act. 141 (Emphasis supplied)

At the core of the present controversy is Section 25 of Republic Act

No. 9711, which reads:

SECTION 25. Coverage. - This Act shall govern all health

products: Provided, That nothing in this Act shall be deemed to modify the
sole and exclusive jurisdiction of other specialized agencies and special
laws only insofar as the acts covered by these specialized agencies and
laws, including, but not limited to, those covered by Republic Act No.
9211, Executive Order No. 245, Executive Order No. 18, and Presidential
Decree No. 1468. (Emphasis supplied)

Petitioners argue for including tobacco products in the Implementing

Rules, these being health products due to their hazardous effects on
health. 142 Petitioners contend that under Section 25, the Food and Drug
Administration "retains jurisdiction over health products (including tobacco
products) on matters delving on the protection of public health-the same
not being within the jurisdiction of other specialized agencies." 143

Respondent counters that Republic Act No. 9211 encompasses the

regulation of health matters concerning tobacco products and tobacco use. 144
While Section 25 acknowledges the Food and Drug Administration's
authority over health products, it explicitly excluded products and industries
governed by other laws. 145 Says respondent, the Food and Drug
Administration "has no jurisdiction over tobacco products and the tobacco
industry, which are under the sole and exclusive jurisdiction of the IAC-
T[ obacco], as provided under [Republic Act No. 9211 ]." 146

We rule for petitioners.

The mere acknowledgment in Section 25 of Republic Act No. 9711

that nothing in that law "shall be deemed to modify the sole and exclusive
jurisdiction of other specialized agencies[,]" such as the IAC-Tobacco under ti
Republic Act No. 9211, does not automatically place tobacco products /.
outside the Food and Drug Administration's regulatory authority. Quite the
141
Republic Act 3720 (1963), sec. 4, as amended by Republic Act No. 9711 (2009).
142
Rollo, pp. 1857-1858 and 1871, Memorandum for Petitioners.
143
Id. at 46, Petition for Review.
144
Memorandum of Respondent, pp. 39---41.
145
Id. at 18-19.
146
Id. at 19.
Decision 23 G.R. No. 200431

contrary, the !AC-Tobacco's authority under Republic Act No. 9211 does not
cover the regulation of the health aspects of tobacco products.

Recognizing the need to protect the people from hazardous products

and, simultaneously, to protect the interest of various stakeholders and
workers in the tobacco industry, Republic Act No. 9211 was enacted to
further the government's "balanced policy" in regulating the use, sale, and
advertisement of tobacco products:

Section 2. Policy. - It is the policy of the State to protect the

populace from hazardous products and promote the right to health and
instill health consciousness among them. It is also the policy of the State,
consistent with the Constitutional ideal to promote the general welfare, to
safeguard the interests of the workers and other stakeholders in the tobacco
industry. For these purposes, the government shall institute a balanced
policy whereby the use, sale and advertisements of tobacco products shall
be regulated in order to promote a healthful environment and protect the
citizens from the hazards of tobacco smoke, and at the same time ensure
that the interests of tobacco farmers, growers, workers and stakeholders
are not adversely compromised. (Emphasis supplied)

Hence, Republic Act No. 9211 holds the following objectives:

a. Promote a healthfitl environment;

b. Inform the public of the health risks associated with cigarette smoking
and tobacco use;

c. Regulate and subsequently ban all tobacco advertisements and

sponsorships;

d. Regulate the labeling of tobacco products;

e. Protect the youth from being initiated to cigarette smoking and tobacco
use by prohibiting the sale of tobacco products to minors;

f. Assist and encourage Filipino tobacco farmers to cultivate alternative

agricultural crops to prevent economic dislocation; and

g. Create an Inter-Agency Committee on Tobacco (!AC-Tobacco) to

oversee the implementation of the provisions of this Act. (Emphasis
supplied)

Republic Act No. 9211 created the IAC-Tobacco, 147 which "shall have
the exclusive power and function to administer and implement" the law:

Section 29. Implementing Agency. - An Inter-Agency

Committee - Tobacco (IAC-Tobacco), which shall have the exclusive
power and function to administer and implement the provisions of this Act,

147
Republic Act No. 9211 (2003), sec. 3(g).
Decision 24 G.R. No. 200431

is hereby created. The !AC-Tobacco shall be chaired by the Secretary of

the Department of Trade and Industry (DTI) with the Secretary of the
Department of Health (DOH) as Vice Chairperson. The !AC-Tobacco
shall have the following as members:

a. Secretary of the Department of Agriculture (DA);

b. Secretary of the Department of Justice (DOJ);
c. Secretary of the Department of Finance (DOF);
d. Secretary of the Department of Environment and Natural
Resources (DENR);
e. Secretary of the Department of Science and Technology
(DOST);
f. Secretary of the Department of Education (DepEd);
g. Administrator of the National Tobacco Administration (NTA);
h. A representative from the Tobacco Industry to be nominated by
the legitimate and recognized associations of the industry; and
1. A representative from a nongovernment organization (NGO)
involved in public health promotion nominated by DOH in
consultation with the concerned NGOs;

The Department Secretaries may designate their Undersecretaries as their

authorized representatives to the IAC. 148 (Emphasis supplied)

Accordingly, the !AC-Tobacco's implementing authority is limited to

the acts under Republic Act No. 9211, which include:

I. Healthful Environment

1) Smoking Ban in Public Places 149 and Designation of

Smoking and Non-Smoking Areas in establishrnents; 150

II. Access Restrictions

1) Access restrictions to tobacco-related vending machines,

self-service facilities, and other similar mechanisms; 151
2) Retailer compliance to standards imposed on tobacco-related
self-serving facilities; 152
3) Minimum age sales of tobacco products; 153
4) Ban on sale of tobacco products near school perimeters and
other facilities frequented by minors; 154
5) Required signage on point-of-sale establishments offering
tobacco products; 155

148
Republic Act No. 9211 (2003), sec. 29.
149
Republic Act No. 9211 (2003), sec. 5.
150
Republic Act No. 9211 (2003), sec. 6.
151
Republic Act No. 9211 (2003), secs. 7 and 8.
152
Republic Act No. 9211 (2003), sec. 8.
153
Republic Act No. 9211 (2003), sec. 9.
154
RepublicActNo.9211 (2003),sec. JO.
155
Republic Act No. 9211 (2003), sec. 11.
Decision 25 G.R. No. 200431

III. Advertising and Promotion

1) Required printed warnings on cigarette packaging; 156

2) Required warnings in all forms of tobacco advertising; 157
3) Restrictions in all forms of tobacco advertising, 158 tobacco
promotions, 159 sponsorships, 160 and sampling; 161
4) Subsequent ban on tobacco advertisements 162 and
sponsorships; 163
5) Limitations on Naming Rights 164

The law also mandates the !AC-Tobacco to monitor compliance with

Republic Act No. 9211. 165 Section 33 further specifies the !AC-Tobacco's
involvement in relevant programs under the law:

SECTION 33. Programs and Projects. - For a period not

exceeding five (5) years, the National Government and the concerned
departments and agencies shall provide the following programs and
projects:

a. Tobacco Growers' Assistance Program - This program shall

be utilized to support financially the tobacco farmers who may
be displaced due to the implementation of this Act or has
voluntarily ceased to produce tobacco ....

b. Tobacco Growers' Cooperative. - This program shall

promote cooperative programs to assist tobacco farmers in
developing alternative fanning systems, plant alternative crops
and other livelihood projects ...

c. National Smoking Cessation Program. - A National Smoking

Cessation Program shall be undertaken with the approval of
the !AC-Tobacco. The implementing rules and guidelines to
reinforce this program shall be submitted to the IAC-Tobacco

156 Republic Act No. 9211 (2003), sec. 13.

157
Republic Act No. 9211 (2003), sec. 14.
158
Republic Act No. 9211 (2003), secs. 15, 16 (Print Media Advertising), 17 (Outdoor Advertising), 18
(Advertising in Cinemas), 19 (Television and Radio Advertising), 20 (Advertising in Audio, Video and
Computer Cassettes/Discs and Similar Medium), and 21 (Advertising on the Internet and Similar
Medium).
159
Republic Act No. 9211 (2003), sec. 23.
160
Republic Act No. 9211 (2003), sec. 25.
161
Republic Act No. 9211 (2003), sec. 27.
162
Republic Act No. 9211 (2003), sec. 22.
163
Republic Act No. 9211 (2003), sec. 26.
164
Republic Act No. 9211 (2003), sec. 24.
165
Republic Act No. 9211 (2003), sec. 31 provides:
Section 31. Compliance Monitoring. ~ Not later than one (I) year after the date of the effectivity of
this Act, and annually thereafter, the !AC-Tobacco shall submit to the President of the Philippines and
to both Houses of Congress a Compliance Monitoring Report on the compliance of the manufacturers
on all applicable laws and ordinances with respect to the manufacture and distribution of tobacco
products.
The report shall contain pertinent information on the methods, goals and implementation program of
said manufacturers with respect to the requirements of this Act.
Decision 26 G.R. No. 200431

by the Secretary of Health within three (3) months after the

effectivity ofthis Act.

d. Research and Development Program. - The !AC-Tobacco

shall establish a research and development program to be
spearheaded by the NTA in cooperation with the DOST, which
will undertake studies concerning technologies and methods to
reduce the risk of dependence and injury from tobacco product
usage and exposure, alternative uses of tobacco and similar
research programs.

e. National Tobacco-Free Public Education Program. - State

Universities and Colleges and Technical and Vocational
Schools shall provide scholarship programs for dependents of
tobacco growers for which the administrator of the NTA shall
provide implementing rules and guidelines. The guidelines
shall be submitted to the !AC-Tobacco within three (3) months
after the effectivity of this Act.

f. Displaced Cigarette Factory Workers' Assistance Program. -

The Secretary of Labor and Employment, with the concurrence
of the !AC-Tobacco shall establish a program to assist
displaced, terminated/separated or retrenched cigarette factory
workers as a result of the enactment of this Act. The Secretary
of Labor in coordination with the NTA and DTI shall provide
the rules and guidelines to effectuate this program and submit
the same to the !AC-Tobacco within three (3) months after the
effectivity of this Act.

g. Health Programs. - The !AC-Tobacco, in consultation with

the DOH, shall be responsible for awarding grants to all
medical institutions for the purpose of planning, carrying out,
and evaluating activities related to smoking-related illnesses.
The !AC-Tobacco shall submit to Congress and the President
of the Philippines the annual report of expenditures related to
this program.

h. Withdrawal Clinics. - The DOH shall establish smoking

withdrawal clinics to provide counseling regarding the
hazardous health effects of tobacco/cigarette smoking and to
rehabilitate smokers from the hazardous effects of such
products.

If a smoker-minor voluntarily submits himself for treatment,

counseling, or rehabilitation in a smoking withdrawal clinic
located in any medical institution in the Philippines, or through
his parent/guardian, the expenses incun-ed shall be a
reimbursable outpatient service of the Philippine Health
Insurance Corporation. (Emphasis supp lied)
f
Meanwhile, Section 25 of Republic Act No. 9711 clearly establishes
that the law shall cover all health products, except for acts covered by
special laws. Hence, matters not covered by special laws remain under the
Food and Drug Administration's broad regulatory authority. Exceptions are
strictly construed and "extend only as far as their language fairly
Decision 27 G.R. No. 200431

warrants[.]" 166 Moreover, "particular clauses and phrases of a statute should

not be taken as detached and isolated expressions, but the whole and every
part thereof must be considered in fixing the meaning of any of its parts." 167
Respondent cannot truncate Section 25 and only focus on a particular phrase
to suit its desired interpretation.

It is evident from Republic Act No. 9211 that the !AC-Tobacco has
limited jurisdiction over tobacco products and does not regulate all their
aspects. Its implementing authority is only restricted to the acts provided
under the law, which mainly include the regulation of distribution, access,
sale, labeling, advertisements, sponsorships, and promotions of tobacco
products. 168 Nothing in the law denotes that it holds authority over the
health aspects of tobacco products.

Conversely, under Republic Act No. 9711, the Food and Drug
Administration has regulatory authority over all health products, which
include tobacco products. Under Section 25, the Food and Drug
Administration retains its regulatory authority as to the health aspect of
tobacco products, it being beyond !AC-Tobacco's implementing authority
under Republic Act No. 9211. This interpretation is more in keeping with
the oft-repeated rule on statutory construction that laws are interpreted not
only to be consistent throughout its provisions, but also to be in harmony
with other laws on a similar subject, to build a coherent system. 169

Accordingly, there is no merit in respondent-intervenor's claim that

insofar as the health aspects of tobacco products are concerned, Republic
Act No. 9211 diminished the Department of Health's general authority on
health concerns under the Administrative Code. 170 Section 34 of the law
even recognized the Department of Health's capability on matters of health
when it was designated to lead the information dissemination on the harmful
effects of smoking:

Information Program

SECTION 34. Information Drive. - Consistent with the

provisions of this Act, the DOH shall, in cooperation with the DepEd and
with the assistance of the Philippine Information Agency (PIA), undertake
a continuous information program on the harmful effects ofsmoking.

The DOH shall enlist the active participation of the public and private
sectors in the national effort to discourage the unhealthy habit of smoking.

166
Nazareth v. Villar, 702 Phil. 319, 340 (2013) [Per J. Bersamin, En Banc].
167
Gaanan v. Intermediate Appellate Court, 229 Phil. 139, 146 (1986) [Per J. Gutierrez, Jr., Second
Division].
168
Republic Act No. 9211 is entitled "'An Act Regulating the Packaging, Use, Sale, Distribution and
Advertisements of Tobacco Products and For Other Purposes." See also Republic Act No. 9211
(2003), secs. 5-28.
169
Dreamwork Construction, Inc. v. Jania/a, 609 Phil. 245 (2009) [Per J. Velasco, Jr. Third Division].
170
Memorandum for Respondent-Intervenor, p. 50.
Decision 28 G.R. No. 200431

SECTION 35. Instruction on the Hazardous Effect of Smoking as Part of

School Curricula. Instruction on the adverse effects of
cigarette/tobacco smoking, including their health, environmental and
economic implications, shall be integrated into the existing curricula of all
public and private elementary and high schools.

The DepEd Secretary shall promulgate such rules and regulations as may
be necessary to carry out the above stated policy hereof, and, with the
assistance of the Secretary of Health, and with the approval of the IAC-
Tobacco, shall cause the publication and distribution of materials on the
unhealthy effects of smoking to students and the general public.
(Emphasis supplied)

II (B)

Besides, tobacco products are undeniably "health products" based on

the definition provided in Section lO(ft) of Republic Act No. 3720, as
amended by Section 9 of Republic Act No. 9711, which reads:

(ff) 'Health products' means food, drugs, cosmetics, devices, biologicals,

vaccines, in-vitro diagnostic reagents and household/urban hazardous
substances and/or a combination of and/or a derivative thereof. It shall
also refer to products that may have an effect on health which require
regulations as determined by the FDA. (Emphasis supplied)

This definition is clear "that there is no room for construction or

interpretation, but only application." 171 Section lO(ft) comprises two parts.
The first part refers to an enumeration of specific products considered as
health products. The second part is a general statement that health products
"shall also refer to products that may have an effect on health which require
regulations as determined by the FDA." 172

Tobacco use, as well as exposure to secondhand smoking, pose health

hazards that cause death and disease among people. 173 Clearly, all products
affecting health-including tobacco products-are within Food and Drug
Administration's jurisdiction. The second part of the definition in Section
lO(ft) even gives the Food and Drug Administration discretionary authority
to determine which products require regulation.

171
See Wyeth Philippines, Inc. v. Construction Industry Arbitration Commission, G.R. Nos. 220045--48,
June 22, 2020, <https:l/elibrary.judiciary.gov.phlthebookshelflshowdocs/1166421> [Per J. Leonen,
Third Division].
172
See Republic Act No. 3720 (1963), sec. !0(ff), as amended by Republic Act No. 9711 (2009).
173
B. Bellew, M. Antonio, M. Limpin, L. Alzona, F. Trinidad, U. Dorotheo, R. Yapchiongco, R. Garcia,
A. Anden, J. Alday, Addressing the Tobacco Epidemic in the Philippines: Progress since ratification
of the WHO FCTC, available at
<https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4463!07/pdf/103.pdt> (last accessed on August 26,
2021).
Decision 29 G.R. No. 200431

Respondent-intervenor's view that tobacco products are not "health

products" by the ejusdem generis principle is flawed. 174 The principle only
applies in case of ambiguity, which is not the case here. Moreover, ejusdem
generis would not control since restricting "health products" to the list
provided under Section lO(ff) or to the same class would hinder the
lawmaker's intent of strengthening the Food and Drug Administration's
regulatory authority under Republic Act No. 9211. 175

To sum, it would be misplaced to construe Section 25 of Republic Act

No. 9711 as an express delineation which placed tobacco products beyond
the Food and Drug Administration's regulatory authority. It is within the
Food and Drug Administration's competence and mandate "to ensure safety,
efficacy, purity, and quality" 176 of health products which, based on the
definition under the law, clearly includes tobacco products. A contrary
reading, in that the Food and Drug Administration could regulate cosmetics
due to its effects on health but not tobacco products, would be illogical.

III

The inclusion of tobacco products in the coverage of the

Implementing Rules is not only supported by the text of the law, but also by
pertinent congressional deliberations. It likewise adheres to the Philippines'
obligations under the WHO FCTC.

The Food and Drug Administration is an attached agency of the

Department of Health. As such, the regulatory authority over the health
aspect of tobacco products not only falls within its mandate, but more so
within its competence and expertise.

This much is revealed in the deliberations of the Bicameral

Conference Committee on Section 25 of Republic Act No. 9711. The
legislative intent was that the health aspects of tobacco, sugar, and coconut
are within the regulatory authority of Food and Drug Administration,
consistent with the thrust of Republic Act No. 9211 to strengthen the
regulatory, licensing, and monitoring powers of the Food and Drug
Administration on health products. In this sense, it was made clear that
Republic Act No. 9711 applies suppletorily to the special laws, with regard
to the health effects of these products. Pertinent portions of the deliberations
cited by the petitioners-intervenors are insightful:

REP VALDEZ: Thank you, Madam Chair. Thank you, Senator Legarda,
for the honor of proposing these amendments. This is actually, Your

174
See Memorandum for Respondent-Intervenor, pp. 26-27.
175
See In re Catholic Archbishop of Manila v. Social Security Commission, 110 Phil. 606 (1961) [Per J.
Gutierrez David, En Banc]. See also Republic Act No. 9711 (2009), sec. 4(a).
176
Republic Act No. 971 I (2009), sec. 5.
Decision 30 G.R. No. 200431

Honor, a follow-up of the proceedings during the Bicameral Conference

that we had on February 23 where the Honorable Seuator Legarda sought
to clearly exclude from the coverage of the proposed law those that are
already covered by special laws particularly sugar, tobacco and coconut ..
. that the powers, Your Honor please, of the FDA shall not include those
that are already covered ....

THE CHAIRPERSON (SEN. CA YETANO, P.): But just to clarify. This

does not in any way extend beyond the actual coverage of those special
laws. So, like I said, if the special law referred to the subsidy to coconut
growers, that what we're saying that BFAD will not get involved there,
'no. But with respect to the health aspect, to the extent that BFAD
monitors all health products, then BFAD will still be involved.

REP. VALDEZ: For as long as they are covered by the special law, Your
Honor please, then it will be covered by the BF AD.

THE CHAIRPERSON (SEN. CAYETANO, P.): For as long as that act is

not covered by the special agency.

REP. VALDEZ: Yes, Your Honor.

REP LOCSIN: Madam Chair, may I ask, Your Honor, Senator Legarda,
do any of these agencies - sugar, coconut, tobacco - have the capability to
enhance FDA that we have envisioned to monitor the health effects of the
products of each of these sectors? I think none of them do, none of them
[have] the capabilities to monitor the health effects of any of these
products that the new BFAD will have. Unless there is actually a scientific
component to RA ... preventing BFAD, the new BF AD from making a
declaration against tobacco if they feel the way surgeon general in the
United States does. He probably has no authority to do it but nobody can
stop him either and say, "Whatever the tobacco, coconut or sugar industry
say, we say, 'Too much consumption of sugar is bad for your health."' I
just don't want that to be ...

SEN. LEGARD A: My only concern is, there should not be any duplication
of laws so that there's no confasion. But to prevent the new BFAD from
becoming strong in its implementation, I think, would defeat the purpose
of this law. So [,] I support you in a sense that we should, of course,
strengthen the power of BFAD. But my concern in not including all these
three commodities is the duplication and the confusion of the sectors
concerned whether these are big industries coconut, tobacco ...

REP. LOCSIN: I can see that. But, Madam Chair, perhaps in the body of
the proposed legislation, we can emphasize that the new BFAD will have
the power to investigate the health effects of any product in Philippine
agriculture.

SEN. LEGARDA: I think, if I may add, the strength of this new law,
Congressman Locsin, should also be founded in its capability. It will be
allowed to coordinate, to cooperate with already existing specialized
agencies in the exercise of its functions because it's not only the health
that is concerned, it's the economic aspect, the way it affects agriculture
Decision 31 G.R. No. 200431

and all the farmers down the drain. So I don't think we will - what's the
word, emasculate the new law or destrengthen or soften the - weaken the
powers of BFAD. We simply did not want to confuse all the various
sectors in the . . .

REP. LOCSIN: So when it comes to health, Madam Chair, BFAD's power

is all encompassing and can reach into these areas?

THE CHAIRPERSON (SEN. CAYETANO, P.): In fact[,] I was thinking

in Section 26, just to clarify this further. In the very last sentence, it says,
"This Act shall be applied in suppletory character." The intention of that
was to say that the BFAD, the new FDA law and BFAD's previous
function continues to exist but really what we really need to be sure is not
misinterpreted is that BF AD, the new FDA is the authority as far as health
concerned. So I was thinking and you did make a very simple statement
that, I guess something like, with respect to the health aspect, the FDA
shall continue to exercise its mandate. Something like that so that there is
no confusion. I think the records will bear out all that - do you hear me?
Okay.

REP LOCSIN: But, Madam Chair, I'm arguing for double jurisdiction in
the sense that unless it is clear that the tobacco authority has the
capability to monitor health consequences of the products they regulate,
then BFAD should have supervening authority to interfere[.]

THE CHAIRPERSON (SEN. CAYETANO, P.): I agree because the

confusion may arise that these special laws somehow cover the health
aspect when it is really not their expertise even if they claim that they have
some kind of say in it. So, I tend to agree with Congressman Locsin that it
should be very clear that this law, the FDA bill will be now in-charge of
the health a::,pect. And in that sense, it's suppletory to whatever the
mandate the special laws have on those products but the health aspects is
an FDA affair. 177 (Emphasis supplied)

While not controlling, these deliberations are persuasive and support

our interpretation of Section 25 of Republic Act No. 9711.

To emphasize, the IAC-Tobacco does not have sole and exclusive

jurisdiction over tobacco products and the tobacco industry, but only over
the implementation of Republic Act No. 9211. As to the health aspect of
tobacco products, petitioners have the regulatory authority under Republic
Act No. 9711. Therefore, they did not exceed their authority m
promulgating the Implementing Rules in regulating tobacco products.

Parenthetically, the promulgation and enforcement of the

Implementing Rules on the regulation of tobacco products follows the
mandate of Article XIII, Section 12 178 of the Constitution to establish and
maintain an effective regulating body and system to protect public health.

177
Memorandum of Petitioners-lntervenors, pp. 13-16.
178
CONST., art. XIII, sec. 12 states:
 Decision 32 G.R. No. 200431

Moreover, the contested prov1s10ns in the Implementing Rules are

aligned with our international commitment under the WHO FCTC which
"address[es] the health, social, environmental and economic consequences
of tobacco consumption and exposure to tobacco smoke worldwide." 179
Salient provisions of the WHO FCTC read:

Article 3
Objective

The objective of this Convention and its protocols is to protect present and
future generations from the devastating health, social, environmental and
economic consequences of tobacco consumption and exposure to tobacco
smoke by providing a framework for tobacco control measures to be
implemented by the Parties at the national, regional and international
levels in order to reduce continually and substantially the prevalence of
tobacco use and exposure to tobacco smoke.

Article 5
General Obligations

1. Each Party shall develop, implement, periodically update and review

comprehensive multisectoral national tobacco control strategies, plans
and programmes in accordance with this Convention and the protocols
to which it is a Party.

2. Towards this end, each Party shall, in accordance with its capabilities:

(a) establish or reinforce and finance a national coordinating

mechanism or focal points for tobacco control; and

(b) adopt and implement effective legislative, executive, administrative

and /or other measures and cooperate, as appropriate, with other
Parties in developing appropriate policies for preventing and
reducing tobacco consumption, nicotine addiction and exposure to
tobacco smoke.

3. In setting and implementing their public health policies with respect to

tobacco control, Parties shall act to protect these policies ji·om
commercial and other vested interests of the tobacco industry in
accordance with national law.

4. The Parties shall cooperate in the formulation of proposed measures,

procedures and guidelines for the implementation of the Convention
and the protocols to which they are parties.

Section 12. The State shall establish and maintain an effective food and drug regulatory system and
undertake appropriate health manpower development and research, responsive to the country's health
needs and problems.
179
See Department of Health, WHO Framework Convention on tobacco Control, available at
<httpS://doh.gov.ph/WHO-Framework-Convention-on-Tobacco-Control> (last accessed on July 30,
2021).
 Decision 33 G.R. No. 200431

5. The Paiiies shall cooperate, as appropriate, with competent

international and regional intergovernmental organizations and other
bodies to achieve the objectives of the Convention and the protocols to
which they are Parties.

6. The Parties shall, within meai1s and resources at their disposal,

cooperate to raise financial resources for effective implementation of
the Convention through bilateral and multilateral funding
mechanisms. 180 (Emphasis supplied)

Article 5.3 of the WHO FCTC requires state parties to protect their
tobacco control policymaking from tobacco industry interference. The
WHO FCTC Guidelines reiterate this:

The purpose of the guidelines is to ensure that efforts to protect tobacco

control from commercial and other vested interests of the tobacco industry
are comprehensive and effective. Parties should implement measures in
all branches of government that may have an interest in, or the capacity
to, affect public health policies with respect to tobacco control.

The aim of these guidelines is to assist parties in meeting their legal

obligations under Article 5.3 of the WHO FCTC. The guidelines draw on
the best available scientific evidence and the experience of Parties in
addressing tobacco industry interference.

The guidelines are applicable to government officials, representatives and

employees of any national, state, provincial, municipal, local or other
public or semi/quasi-public institution or body within the jurisdiction of a
Paii:y, and to any person acting on their behalf. Any government branch
(executive, legislative and judiciary) responsible for setting and
implementing tobacco control policies and for protecting those policies
against tobacco industry interests should be accountable. 181 (Emphasis
supplied)

Moreover, the WHO FCTC stipulates price and tax measures 182 and
non-price measures to be implemented by state parties to reduce the demand
for tobacco, including:

1. Testing, measuring and regulation of the contents and emissions of

tobacco products; 183

11. Regulation of tobacco product disclosures to governmental

authorities and to the public of information about the toxic

180
WHO Framework Convention on Tobacco Control (2003), art. 5.
181
Guidelines for Implementation, Article 5.3, available at
<https://fctc.who.int/publications/rn/itern/guidelines-for-implementation-of-article-5.3> (last accessed
on July 30, 2021).
182
WHO Framework Convention on Tobacco Control (2003), art. 6.
183
WHO Framework Convention on Tobacco Control (2003), art. 9.
Decision 34 G.R. No. 200431

constituents of the tobacco products and the emissions that they

may produce; 184

iii. Packaging and labeling of tobacco products, including;

(1) Information on constituents and emissions on outside

packaging and labeling; 185

(2) Ban on packaging or labeling means that are false, misleading,

deceptive or likely to create an erroneous impression about the
product's characteristics, health effects, hazards or emissions,
including any tenn, descriptor, trademark, figurative or other sign
that directly or indirectly creates the false impression that a
particular tobacco product is less harmful than others; 186 or

1v. Ban on all forms of tobacco advertising, promotions and

sponsorship by any means that are false, misleading or deceptive or
likely to create an erroneous impression about the tobacco
product's characteristics, health effects, hazards or emissions. 187

The Philippines' entry into the WHO FCTC represents its

commitment to "give priority to [its] right to protect public health"; 188 in
particular, to implement the above-stated tobacco control measures to
"reduce continually and substantially the prevalence of tobacco use and
exposure to tobacco smoke." 189 With the Senate's concurrence, 190 the WHO
FCTC became operative as part of national law in accordance with Section
21, Article VII 191 of the Constitution.

As explained in David v. Senate Electoral Tribunal: 192

The Senate's ratification of a treaty makes it legally effective and

binding by transformation. It then has the force and effect of a statute
enacted by Congress. In Pharmaceutical and Health Care Association of
the Philippines v. Duque III. et al.:

Under the 1987 Constitution, international law can become

part of the sphere of domestic law either by transformation
or incorporation. The transformation method requires that
an international law be transformed into a domestic law
through a constitutional mechanism such as local
legislation. The incorporation method applies when, by
mere constitutional declaration, international law is deemed
to have the force of domestic law.

184
WHO Framework Convention on Tobacco Control (2003), art. 10.
185
WHO Framework Convention on Tobacco Control (2003), art. 11(2).
186
WHO Framework Convention on Tobacco Control (2003), art. l l(l)(a).
187
WHO Framework Convention on Tobacco Control (2003), art. 13(4)(a).
188
WHO Framework Convention on Tobacco Control (2003), Preamble.
189
WHO Framework Convention on Tobacco Control (2003), art. 3.
190
Memorandum for Petitioners-lntervenors, p. 27.
191
CONST., art. VII, sec. 21 reads:
SECTION 21. No treaty or international agreement shall be valid and effective unless concurred in by
at least two-thirds of all the Members of the Senate. (Emphasis supplied)
192
795 Phil. 529 (2016) [Per J. Leanen, En Banc].
 Decision 35 G.R. No. 200431

Treaties become part of the law of the land through

transformation pursuant to Article VII, Section 21 of the
Constitution which provides that "[n]o treaty or
international agreement shall be valid and effective unless
concurred in by at least two-thirds of all the members of the
Senate. •• Thus, treaties or conventional international law
must go through a process prescribed by the Constitution
for it to be transformed into municipal law that can be
applied to domestic conflicts.

Following ratification by the Senate, no further action, legislative

or otherwise, is necessary. Thereafter, the whole of government -
including the judiciary - is duty-bound to abide by the treaty, consistent
with the maxim pacta sunt servanda. 193 (Emphasis supplied)

Accordingly, as national health authority, the Department of Health,

along with the Food and Drug Administration, must consider the country's
commitments under the WHO FCTC in exercising their regulatory powers
over health products.

From the standpoint of Republic Act No. 9711, the Constitution, and
the WHO FCTC, petitioners acted within their powers in including Book II,
Article III (Tobacco Products) in the Implementing Rules. There is no
overlap of functions, as it is clear that petitioners have technical authority
over matters of public health. At any rate, the Implementing Rules explicitly
state that the rules and regulations and other issuances to be promulgated by
the Food and Drug Administration will refer to policy areas that are not
covered by specialized agencies and special laws. 194

Respondent, representing major transnational tobacco companies in

this country, proposes an interpretation of our law that will effectively
remove them from petitioners' regulation. Its desired interpretation allows
for tobacco companies to be principally regulated by the !AC-Tobacco, of
which they happen to also be members. This not only leads to an absurd
result, but it is also contrary to law and our international obligations.

WHEREFORE, the Petition is GRANTED. The January 27, 2012

Decision of the Regional Trial Court in SCA Case No. 11-0013, which
declared void the Rules and Regulations Implementing Republic Act No.

193
Id. at 614-<>15.
194
Implementing Rules and Regulations of Republic Act No. 971 l (2011), secs. 3--4 state:
SECTION 3. Other Products. - Nothing in the FDA Act of 2009 shall be deemed to modify the
jurisdiction of other specialized agencies and special laws only insofar as the acts covered by these
specialized agencies and laws except the health aspects ofsuch products.
SECTION 4. Identification of Policy Areas. - The FDA shall promulgate the appropriate rules and
regulations and other issuances to identify and define the policy areas that are not covered by
specialized agencies and special laws, including, but not limited to, those covered by Republic Act No.
921 I, Executive Order No. 245, Executive Order No. 18, and Presidential Decree No. 1468. 194
(Emphasis supp lied)
 Decision 36 G.R. No. 200431

9711 insofar as it regulates tobacco products and the tobacco industry is

REVERSED and SET ASIDE.

SO ORDERED.

Associate Justice

WE CONCUR:

PJ.,.,M,L- fl-'>- ~ ~~
,{A/). /Ltµ/
ESTELA M.PERLAS-BERNABE A FRED
Associate Justice
,,e-G--...J&'~,I, ~ lu~ 9i;

Associate Justice

Su~ e;,...~.,-j ~--- ,,,,----

AMY 4~,0-;A
C.
Associate Justice
VIER HENnt.:''yl'd,l,{/,..-f

SAMU"Tufi~N
Associate Justice Ass ciate Justice
Decision 37 G.R. No. 200431

JHOSE~OPEZ
Associate Justice

CERTIFICATION

Pursuant to Section 13, Article VIII of the Constitution, I certify that

the conclusions in the above Decision had been reached in consultation
before the case was assigned to the writer of the opinion of the court.

A /4,R G. GESMUNDO
~~Chief Justice