REPUBLIC OF THE PHILIPP Dcp,nru,," of-H<"lth .. Food & Drug At1minh;:pl1')n

REGIONAL TRIAL COURT Lc~al Scrvim Divi <iull

NATIONAL CAPITAL JUDICIAL R 'GI0l'Jl\ E eEl V F D OFFICE OF THE CLERK OF CO RT _ -

• Date: 04 · LAS PINAS CITY By: ~

PHILIPPINE TOBACCO INSTITUTE Con<rul #

INC. ~~~~~~--------~

-versus-

THE DEPARTMENT OF HEALTH, Represented by SECRETARY ENRIQUE T. ONA and THE FOOD AND DRUG ADMINlSTRATION, represented by DIRECTOR SUZEITE HENARES­LAZa, X------- - ----------------------- X

5 UMMONS TO:

For: Petition for Declaratory Relief (With Application for the Issuance of a Temporary Restraining Order and/or Writ of Prelimindry Injunction)

THE FOOD & DRUG ADMINISTRATION

GreetIn g s :

Represented by Secrelilry Director SUZEITE HERNARES-LAZa BFAD Building Divic Drive, Filinvest Corporate City Alabang, Muntinlupa City

YOU ARE HEREBY REQUIRED to file with the Office of the Clerk of Court of the Regional Trial Court of Las Pinas City within FIFTEEN (15) DAYS after the service of this Summons upon you, your answer to the Complaint/Petition, a copy of which together with the annexes is hereto attached and served upon you, and to serve a copy of said ANSWER within the same period upon the Pldintiff/s/ Compiaint/ s. If you fall to answer witrlin the time aforelnentioned, U1e plaintiff wiU take judgment against you by default dnd demand from said Court the relief applied for in said Complaint.

You are remained of the Provision in the IBP OCA Memorandum on Policy Guidelines dated Macch 12, 2002 to observed RESTRAINT in filing a MOTION 'fO

DISMISS and instead alJeged the ground thereto as defense in your answer.

WITNESS THE HONORABLE ELIZABETH YU GURAY Executive Judge, this 4th day oO ulv 201'1.

Clerk 0

I kp:'I:wt.'rll ~It ! 1e-.JIIl! I , l lld ,-I.: Drl!g ·\Jmtnb.T<Jtam

I c~ , ; 'l e rVII .. 't.> .. I ) ;VI '; llf/l

R. I·: C E'l V E f)

REPUBLIC OF THE PHILIPPINES REGIONAL TRIAL COURT

I ) !I.c:

NATIONAL CAPITAL JUDICIAL REGIO·tL~' '.-:. " ~" . .:..': '_' =======_.J OFFICE OF THE CLERK OF COURT

LAS PINAS CITY

PHILIPPINE TOBACCO INSTITUTE INC.

-versus-

THE DEPARTMENT OF HEAL TIl, Represented by SECRETARY ENRIQUE T, ONA and TIlE FOOD AND DRUG ADML'JISTRATION, represented by DIRECTOR SUZETTE HENARES­LAZO, X------------ - ------------------X

SCA NO, 11-0013 For: Petition for Ded,Halory Relief (With Application for the Issuance of a Temporary Restraining Order and/ or Writ of Preliminary Injunction)

DeIY-,,11llCnt of H.allb f Ol\d & Orug Adminisrrutitm

Legal Serv ices Divi iion

RECEIVED lIy:

nail:

NOTICE OF RAFFLE To:

Gr e etIngs :

THE FOOD AND DRUG ADMINISTRATION Represented by its DillEC[OR DR SUZETTE HENARES-LAZO BFAD Building, Civic Drive, Filinvest Corporate City AJabang Muntinlupa City

Pursuant to the Sec. 4© Rule 58, of the 1997 Rules of Civil PT(Kedure, you are hereby noti.fied and enjoined to attend the raffle of the above entitled case before tile .. } Sala of the Executive Judge loca~d at the Ground Floor, RTC Branch 202, Hall of Justice Bldg., LIs Pinas City Hall Compound, Las Pinas City on Tuly 4, 2011 at 2:00 o'clock in the a fternoo n,

Las Pinas City July 4, 2011.

ZAND

REI'UIJLlC OF TIlE PlIl LlPl'1 ES REG IO NAL TRIAL COU RT

OITICE or: TI-IE EXECUTIVE JUDGE LAS rtNAS CITY

PHILIPPINE TOBACCO INSTITUTE, INC.,

j )efifiol1er,

- versus -

TliE DEPA RTM ENT OF HEALT H, represented by SECRETARY EN RIQ Ur: T. ON A, and TIlE FOOD AND DRUG ADMINISTRATION, represented by DIRECTOR SUZETTE HE AlmS­LAZO,

R ejjJonclenls.

x-------------------------------------------------x

~CA ~" 1 1 - 0 0 I 3 SCA Case No. _ _ __ _

MOTION FO R SPECIAL RAFFLE A D FOR ISSUANCE OF AN

EX-PARTE TEMPORARY RESTRAINING ORDER PURSUANT TO SEC. 5, RULE 58

PETITIO ER. PJ-IILlPPI NE TOBACCO I STITUTE. INC. . by the undersigned counsel

and utHO this Honorable Court , most respectfully stales that:

I. I'lainti ff in the above entitled case has filed a Complaint for Declaratory Relief

with application lor temporary restraining order and preliminary injunction, to question the

legality and comtitutionulity of the Implement ing Rules and Regulations (" IRR") of Republic

Acl No. 9711. otherwise known as the Food and Drug Administration Act ("I'DA Act")

2. As stated in the Complai nt. the I R.R subject of the declaratory relief has al ready

taken effect and peti tioner will suffer grave and irreparable injury should the enforcement of the

IRR be allowed to proceed. It is plain that the IRR violates two laws: the FDA Act and

Republic Act No. 92 11, otherwise known as the "Tobacco Regulation Act" ("TRA"). As

extensively discussed in the Complaint. the IRR inval idly expands and modifies the FDA Act , as

well as the TRA. by placing the regulat ion and supcl'\'ision of tobacco products under the FDA.

3. Thus, Petitioner PTI is cxposed to an" invalid and baseless regulation by

government agencies (0011 ami rOA ) that were deprived of any authority and jurisdiction over

tobacco products. This will consequently entail additional regulatory costs that arc neither

contemplated under the FDA Act nor the TRi\.

4. Accordingly, as tim e is of th e csscnce, there is extrcmc urgcncy to issue an EX-

PARTE TEMPORARY RESTR AINING ORO KR in accordance with Section 5, Rule 58 of

the Rules of Court to restrain the enforcemcnt of the subject lRR in order to prevent the issues in

the principal case from becoming moot before the case is heard and to avert irreparable damage

which may be caused to petitioner by virtue or the illegality and unconstitutionality ofthc IRR.

5. rurthermore, considering that the ramc of cascs of the Regional Trial Courts of

Las Pinas is held every each Thursday of the weck. then there is likewise a need for a special

rame to be conductcd so that the pctition 1111' declaratory relief be immediately ass igned to a

Branch for immcdiate action on the application Il,," tcmporary rcstraining ordcr and preliminary

injunction.

PHAYER

WlIERErORE, premises considered. it is respectfully prayed of the Honorable Executive

Judge of the Regional Trial Court of Las Piiias City that an Ex-Parte Restraining Order be issued

in accordance with Scetion 5, Rule 58 of the Rules of Court to restrain the enforcement of the

subject IRR in order to prevent the issues in the principal case from becomi ng moot before the

case is heard and to avert irreparable damage which may be caused to petitioner by virtue of the

illega lity and unconstitu ti onality orthe IRR.

Furthermore, considering that the rank or cases of' the Regional Trial Courts of Las Pinas

is held every each Thursday of the week . thcn there is likewi se a need for a special rame to be

conducted so that the pctition for declaratory re lief be immediately assigned to a Branch for

immcdiate action on the application for tempor,IIY restraining order and preliminary injunction

Petitioner prays for such other rel ie f' as Inay be just and equitable under the

ei reull1stanees.

Las Pinas City, Metro Manila, 0-1 .Iuly 2011.

2

LEOVILLE<;?cAI'f COl/ llscl("r Philippille Tobacco IllSlil ll lC

146 Gloria Diaz Street BFRV. Talon Dos

Las Pi r1as Ci ty 1740 Rol l No . 39109

IBP No. 854443102- 10-1 I IQC Chapter 17TR No , IOI2II12J /OI-13- II /Las Pinas

MCLE Compliance No, IIl -000658211 2-09-09

I£XI' LANATI ON

Copies of the foregoing lVere served thrOUgh?:'Cgist7 mail due to time constrain ts and lack of l11essengerial service,

~

LrWVfL~,IV r. E~MA

The Office of the Clerk of COllrt RTC-Las Pinas

GREETI GS:

N OTI C I£

Kindly submit the foregoing motion lor considerat ion and approva l of the Honorable Executi ve Judge immediately upon receipt hereof.

~ ~d/

L EOVIL'LE1. ECi\~ COllmel jor Philippine Tobacco Ill.l'lilllle

3

REP UBLIC OF THE PHILIPPINES REGIONAL T RI AL CO URT

LAS PI AS CITY Branch __

PHILIPPINE TOBACCO INSTITUT E, INC.,

Per;r;oner.

- versus -

THE DEPARTM ENT OF HEALT H, represented by SECRETARY ENRIQ UE T. ONA, and THE FOOD AND DRUG ADM INISTRATION, represented by DIRECTOR SUZETTE H ENARES­LAZO,

Respondenrs.

x----------- --------------------------------------x

SCA Case No. ____ _ _

PETITION FOR DECLARATORY RELIEF [Wirl! Application/or rl!e Issuance ufa TemporCIIY Restraining Order and/or

Writ 0/ Pre!iminCIIY Injunction}

Petitioner Philippine Tobacco Institute, Inc. ("PTI"), by undersigned counsel ,

unto thi s Honorable Court, most respcctfull y states :

PREFATORY ST ATEMENT

This petition seeks to prohibit the Department of Health ("DOH") and the

Food and Drug Administration ("FDA ") from enforcing the Implementing Rules and

Regulations ("iRR") of Republic Act No. 97 11 , otherwise known as the Food and

Drug Administration Act ("FDA Act"), and to declare it null and void for directl y

contravening the provisions of thc FDA Act and Republic Act No. 9211 , otherwise

known as the "Tobacco Regulation Act" ("TRA").

It is ironic that Section 25 of the FDA Act, which is the law intended to be

implemented through the issuance of the lRR, clearly deprived the FDA of

jurisdiction over tobacco products. Aside from the clear language of Section 25 of

the FDA Act, the intent behind the law's enactment, as shown by the deliberations of

the members of Congress, indubitably establish that the Legislature intended to

exclude tobacco products from the regulatory powers of the FDA.

To escape the legal effects of Section 25 of the FDA Act, the DOH makes it

appear that it is the agency tasked to regulate the "health aspect" of tobacco products

through the FDA. This argument is likewise without any legal basis . It is clear that

the TRA govellls the regulat ion of tobacco products, including their "health aspect".

Since Section 29 of the TRA vests the implementation and enforcement of its

provisions solely and exclusively upon the Inter-Agency Committee-Tobacco ("IAC­

T"), neither the DOH nor the FDA have authority to assume jurisdiction over the

regulation of tobacco products, even in relation to their "health aspect" .

Consequently, any concems that the DOH or the FDA have over the "health aspect"

of tobacco products should still be brought to the attention of the IAC-T.

Thus, in order to preserve the clear mandate of the FDA Act in excluding

tobacco products from the jurisdicti on of the rDA, and to keep both the DOH and

FDA within the legal boundaries of their rule making powers, Petitioner PTI invokes

the power of the eoul1s to set aside and nullify the lRR issued by the DOH.

Otherwise, PTI and the stakeholclers of the tobacco industry will be exposed to an

unlawful and illegal regulation by respondents who are bereft of any legal authority

to do so.

2

PA RTIES

I. Petitioner PTI is a corporation duly organized and existing under the

laws of the Republic of the Philippines, with principal office at 146 Gloria Diaz

Street, BF Resort, Talon II , Las Pinas City.

1.1. PTI IS an association of the stakeholders of the tobacco

industry.

1.2. PTI is represented herein by its President, Rodolfo F. Salanga,

who is duly authorized to file the present petition, as shown by a Secretary's

Cel1ificate attached hereto as ANNEX "A" .

1.3. PTI may be served with notices, orders, resolutions, and other

processes of thi s Honorable Coul1 through undersigned counsel.

2. Respondent DOH is the principal hcalth agency in the Philippines. It

is represented herein by its Department Secretary, Dr. Enrique T. Ona.

2.1. The DOH may be served with noti ces, orders and other

processes by the Honorab le COUJ1 at the San Lazaro Compound, Sta. Cruz,

Manila.

3. Respondent FDA is an attached bureau of the DOH which is presently

exercising authority over "health products" as detlned under the FDA Act. It is

represented herein by its Director, Dr. Suzette Henares-Lazo.

3

3.1. The FDA may be served with notices, orders and other

processes by the Honorable Court at the BF AD Building, Civic Drive,

Filinvest Corporate City, Alaballg, Muntinlupa City.

NATURE AND PURPOSE OF THE PETITION

1. This Petition for Declaratory Relief is filed pursuant to Rule 63 of the

Rules of Couti, seeking the declaration by this Honorable Court of the invalidity of

the IRR.

2. The jurisdiction over tobacco products has been bestowed by the TRA

exclusively and solely upon the lAC-I. The IRR in question amends and repeals the

TRA by vesting upon the DOH and the FDA jurisdiction over tobacco products. The

IRR also amends and expands the FDA Act by including tobacco products under the

regulatory authority of the FDA. The issuance of the IRR amounts, therefore, to an

unconstitutional usurpation by respondents of an exclusively legislative function and

exceeded the limits of respondents' rule-making power.

A certified true copy of the IRR is attached hereto and made an integral part

hereo f as ANNEX " 8 ".

3. Section I of Rule 63 of the Rules of Court, in pertinent part, reads:

"Section I. Who /JIay file petitioll.---Any person interested under a deed , will, contract or other written instrument, whose rights are affected by a statute, executive order or regulation, ordinance, or any other governmental regUlation may, before breach or violation thereof, bring an action in the appropriate Regional Trial COUtt to determine any question of construction or validity arising, and for a declaration of his rights or duties, thercunder. .. "

4

4. lt is plain from the face of the lRR and the aforementioned Rule, that:

(i) The subject matter of the issue for resolution is a govenunent regulation (i.e. lRR), which expanded, modified and, in effect, repealed the FDA Act and the TRA when respondents placed tobacco products under the regulatory authority of the FDA;

(ii) Due to the patent illegality and unconstitutionality of the IRR, its validity requires judicial construction in order to detennine the rights and obligations of the members of the tobacco industry under its provIsions;

(iii) Neither the PTI nor any of its members have breached or violated the lRR;

(iv) There is an actual justiciable controversy or the "ripening seeds" of one, existing between the parties since PTI and its members are exposed to regulation and possible administrative penalties under the lRR for acts that they may perfonn in connection with their legitimate business;

(v) PTJ has a legal interest in the controversy as it is an association of the stakeholders of the tobacco industry; and

(vi) The issue invoked by PTI is ripe for judicial detennination since the threat of unlawful regulation is imminent in view of the illegal, ultra vires and unconstitutional provisions of the IRR.

5. PTI paid the required docket and other lawful fees and the deposit for

costs simultaneous with the filing of this pctition.

STATEMENT OF FACTS

6. On 23 June 2003 , Congress passed into law the TRA (Republic Act

No. 9211), which governs the regulation of the sale, use, marketing, and distribution

of tobacco products . This is clear under Section 3 of the TRA, which enumerates the

law's purposes as follows:

(a) promote a healthful environment;

(b) infonn the public of the 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;

5

(e) protect the youth from being initiated to cigarette smoking and tobacco use by prohibiting the sale of tobacco products to 1l11nOrS;

(I) assist and encourage Filipino tobacco fanners to cultivate alternative agricultural crops to prevent economic dislocation; and,

(g) create an Inter-Agency Committee on Tobacco to oversee the implementation of the provisions of the TRA.

7. Under the TRA, the power to implement and administer its provisions

is exclusively lodged with the IAC-T. The composition and powers of the IAC-T are

set out under Section 29 of the TRA:

"Section 29. Implementing Agency. - An Inter­Agency Committee - Tobacco (lAC-Tobacco), which shall have the exclus ive power and function to administer and implement the provisions of this Act, is hereby created. The lAC-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 lAC-Tobacco shall have the following as members:

a. Secretary of the Department of Agriculture CDA); b. Secretary of the Department of Justice (DOJ); c. Secretary of the Department of Finance (DOF); d. Secretary of the Department of EnvirolUnent and Natural Resources (DENR); e. Secretary of the Depaltment 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 i. A representative from a nongovenunent organization (NGO) involved in public health promotion nominated by DOH in consultation with the concerned NGOs;

6

The Depat1ment Secretaries may designate their Undersecretaries as their authorized representatives to the lAC." (Emphasis supplied)

7.1. Under Section 29 of the TRA, the DOH is only a member of

the IAC-T, which is headed by the Secretary of the Department of Trade and

Industry ("DTI").

8. On 11 September 2009, the FDA Act became effective.

9. The FDA Act renamed the Bureau of Food and Drugs as the Food and

Drug Administration. It also streamlined the administrative and regulatory powers

of the FDA, among other purposes.'

I O. The FDA Act has an exclusionary provision that ensures that the

FDA 's jurisdiction does not overlap with other regulatory agencies covered by

special laws. Section 25 of the FDA Act thus 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"

Republic Act No. 9211, specifically mentioned in the above-quoted section,

is the TRA.

, Section 4 of the FDA Act provides for the following specific objectives:

(a) To enhance and strengthen the admillisLr<lIive and technical capacity of the FDA in the regulat ion of establishments and products under its jurisdiction.

(b) To ensure the FDA's monitoring and regulatory coverage over establishments and products under its jurisdiclion; and

(c) To provide coherence in the FDA's regulatory system for estab lislunents and products under its jurisdiction.

7

ll. On 21 July 2010, the First Public Consultation on the Draft

Implementing Rules and Regulations of the FDA Act was held at the U,P, Law

Center. The Second Public Consultation on the Draft Implementing Rules and

Regulations of the FDA Act was held in Cebu on 6 August 2010,

12, On 14 March 2011 , the DOH announced the approval of the IRR,

13, On 23 April 2010, the Depat1ment of Justice ("DOl"), through then

Assistant Secretary Jose De Castro, reported during the meeting of the IAC-T that

based on the text of the FDA Act and the Congressional intent behind its enactment,

the FDA has no jurisdiction over tobacco products as such jurisdiction is exclusively

vested with the lAC-T,

A printed copy of the DOl's PowerPoint presentation during the 23 April

2010 meeting of the IAC-T is attached hereto and made an integral part hereof as

ANNEX "c",

14, On 30 March 201 1, the JRR was published in pages E-l to E-4 of the

Malaya - a local publication - and was submitted to the University of the Philippines

Law Center on the same date,

14, l. Under Book IV, Article II , Section 3 of the IRR, the same

shall take effect "after fifteen (15) days following its publication in a

newspaper of national circulation and upon submission to the University of

the Philippines Law Center.

14,2, Thus, the IRR would have taken effect on 14 April 2011,

8

Copies of pages E·I to E-4 of the Malaya arc attached hereto and made an

integral part hereof as ANNEXES "0" to "D·3".

15. Under the IRR, the DOH places tobacco products within the

regulatory authority of the FDA and classified such products as "health products".

This is clear under Book II, Article III of the IRR, which in part reads:

"A RTICLE III Tohacco and Other Products

Sec.!. Rationale. The FDA has full jurisdiction over the regulation of all health products.

Sec. 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."

• *. * .. •••

16. While the DOH and the FDA had assumed, in general tenns,

jurisdiction over the regulation of tobacco products under Book II, Aliicle III ,

Sections I and 2 of the IRR, they implicitly recognized that the TRA is a special ized

law goveming tobacco products. Thus, to reconcile the provisions of the IRR on one

hand, and the provisions of the TRA on the other, Scction 3 of the IRR states that the

DOH and the FDA would still maintain jurisdiction over products govemed by

speciali zed agencies and special laws only insofar as the "health aspects" of such

products are concemed. Book II, Anicle 1II, Section 3 of the IRR thus states:

"Sec. 3. Other Products. Nothing in the FDA Act of 2009 shall be deemed to modi fy 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."

9

17. Apart from the above, the DOH also restricted the dealings of the

FDA with the members of the tobacco industry under Book II , Article IJI, Section 2,

paragraph 2 of the IRR, which provides:

***

"ARTICLE III Tobacco and Other Products

*** ***

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

18. Aggrieved by the issuance of the IRR, particu larly the assumption of

juri sdiction of the DOH and the FDA over matters which are exclusively within the

competence and authority of the IAC-T, PTI was constrained under the

circumstances to fil e the present petit ion.

GRO UN DS IN SUPPO RT OF TH E PETITION

I. T HE DOH AN D FDA HAVE NO J URISDICTION OVER TOBACCO PROD UCTS.

A. The IAC-T, not the DOlI , has jurisdiction over tobacco products.

B. The TRA regulates the health aspect of tobacco.

C. In view of the regulat ion of the health aspec t of tobacco products under the TRA, the FDA Aet it self excluded tobacco products from the jurisdiction of th e FDA.

D. Even ass uming for the sake of argument that the FDA Ac t did not exclude tobacco and tobacco products from the jurisdiction of the FDA, the FDA Act nevertheless does not a uthor ize the FDA to regulate these products.

10

E. Likewise, it is the IAC-T, not the DOH, which has jurisdiction over the regulation of labclin o advertisements, promotions, ", sponsorships and marketing activities involving tobacco products.

F. The DOJ confirmed before the members of the IAC-T that the FDA has no jurisdiction over tobacco products.

II. THE RESTRICTION OF THE FDA'S ENGAGEMENT WITH THE TOBACCO INDUSTRY BY TIlE DOH VIOLATES THE CONSTITUTION AND VARIOUS LAWS.

III. TI-IE IRR CONTRAVENES, AMENDS, MODIFIES, AND REPEALS THE FDA ACT.

DISC USS ION

I. THE DOH AND FDA HAVE NO JURISDICTION OVER TOBACCO PRODUCTS.

A. The IAC-T, not the DOH , has jurisdiction over tobacco products.

19. Under Book II, Article Ill , Section 2 of the IRR, the DOH assumes

jurisdiction over tobacco products by claiming that it has the "responsibility of

regulating tobacco and tobacco products t1uough the FDA."

20. While the DOH bestows upon itself the jurisdiction and authority

over the regulation of tobacco products through the mere issuance of the lRR, such

ultra vires act, however, will not suffice to circulllvcnt the legal effects of the TRA,

which is the primary law on tobacco regulation.

21. Needless to state, the DOH - as a single entity - has been divested of

the power and authority to issue rules, regulations and administrative orders that

affect tobacco products and the tobacco industry tlu'ough the cnactment of the TRA.

II

22. It is true that the powers of the DOH under the Administrative Code

of 1987 ("Administrative Code") are broad, as shown below:'

(i) Define the national health policy and fonnulate 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;

(ii) Provide for health programs, services, facilities and other requirements as may be needed, subject to availability of funds and administrative rules and regulations;

(iii) Coordinate or collaborate with, and assist local communities, agencies and interested groups including intel11ational organizations 111

activities related to health;

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

(v) Collect, analyze and disscminate statistical and other relevant infonnation on the country's health situation, and require the reporting of such information from appropriate sources;

(vi) Propagate health infonnation and educate the population on important health, medical and environmental matters which have health implications;

(i) Undertake health and medical research and conduct training in suppOt1 of its priorities, programs and activities;

(viii) Regulate the opcration of and issue licenses and pennits to govelllmcnt 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;

(ix) Issue orders and regulations concel11ing the implementation of established health policies; and,

2 Title IX, Chapter 1, Section 3 of the Administrative Code.

12

(x) Perfoml such other functions as may be provided by law."

23. With respect to tobacco products and the tobacco industry, however,

the TRA, as discussed above, governs. The DOH caillot invoke its broad regulatory

powers under the Administrative Code to assume jurisdiction over matters which are

properly regulated under the TRA and properly within the jurisdiction of the IAC-T.

24. The purpose and scope of the TRA are stated in Sections 3 and 30

thereof, which respectively state:

"S ECTION 3. Purpose. - It is the main thrust of this Act to:

a. Promote a healthful environment; b. Infonn the public of the health ri sks 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 sa le of tobacco products to lTIlnOrS;

f. Assist and encourage Filipino tobacco fanners to cultivate alternati ve agricultural crops to prevent economic dislocation; and

g. Create an Inter-Agency Committee on Tobacco (lAC-Tobacco) to oversee the implementation of the provisions of this Act.

**. *** ***

SECTION 30. Application to Tobacco Products. _ The provisions of this Act shall apply to all tobacco products placed into commerce in the Philippines. Except as provided below, no provision of thi s Act shall apply to tobacco products intended or offered by the manufacturer for exp0l1 and not for [retail] sale in the Philippines.

Tobacco products intended or offered for export shall be subject only to the requirement that the shipping container shall be prominent ly marked on the outside "EXpOI1 Only:" Provided, That, tobacco products which are marked for export, but are so ld/traded or distributed in the Philippine market, shall be subject to immediate confiscation and destruction."

13

25. While the DOH has the power to administer all laws, rules and

regulations in the field of health , the passage of the TRA has the inevitable effect of

amending the DOH'sjurisdiction insofar as tobacco products are concerned .

26. The rule is that on a specific matter, the special law shall prevail over

the general law, which shall be resorted to only to supply deficiencies in the fanner.

[n Vinzons -ChalO v. Forlllne Tobacco Corporalion,] thc Supreme Court elucidated

on this issue in this wise:

"A general law and a special law on the same subject are statutes in pari materia and should, accordingly, be read together and hallllonized, if possible, with a view to giving effect to both. The rule is that where there are two acts, one of which is special and patiicular and the other general which, if standing alone, would include the same matter and thus conflict with the special act, the special law must prevail since it evinces the legislative intent more clearly than that of a general statute and must not be taken as intended to affect the more patiicular and specific provisions of the earli er act, unless it is absolutely necessary so to construe it in order to give its words any meaning at all."

27. Under the TRA , which govems and regulates the use, sale,

distribution, advertising and promotion of cigarette products, whether or not such

matters relate to the "health aspect" of such products, the power to implement and

administer its provisions is exclusively lodged with the IAC-T. This is clear under

Section 29 of the TRA, which statcs:

"Section 29. Implcmcnting Agcncy. - An Inter­Agency Committee - Tobacco (lAC-Tobacco), which shall have the exclusivc powel' and function to administer and implement the provisions of this Act, is hereby created. The lAC-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.

] G.R. No. 141309. JUlie 19,2007.

14

The lAC-Tobacco shall have the following as members:

a. Secretary of the Department of Agriculture

(DA); b. Secretary of the Depat1ment of Justice (001); c. Secretary of the Department of Finance (DOF); d. Secretary of the Department of Envirotu11ent 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 i. A representative from a nongovernment organization (NGO) involved in public health promotion nominated by DOH in consultation with the concemed NGOs;

The Department Secretaries may designate their Undersecretaries as their authorized representatives to the IACT." (Emphasis supplied)

27.1 . Where a statute directs the perfonnance of certain things in a

particular manner or by a particular person, it implies that it shall not be done

otherwise or by a different person. ' Thus, the DOH cannot meddle in matters

that are exclusively vested with the lAC-T.

28. In addition, the exclusive jurisdiction of the IAC-T over tobacco

products is clear under the Congressional deliberations which preceded the

enactment of the TRA. During the Congressional deliberations, it was clarified that

the regulation of tobacco products under the TRA goes beyond the health concems

associated with tobacco use but covers all concerns related to the tobacco industry.

This is why Congressman Baham Mitra emphasized the need to designate the

Secretary of the DTI as the head of the IAC-T and the Secretary of the DOH only as

4 Republic of the Philippines vs. Court of Appeals. G.R. No. 103882, November 25,1998.

15

its Vice-Chainnan. Since the TRA was intended to address all industry concerns

and not only health concerns, there was no need for the Secretary of the DOH to act

as Chainnan of the lAC-T because his concerns would only be limited and not

industry-wide. As stated during the Congressional deliberations:

"REP . MITRA. Please allow us to ask that the committee will (sic) be chaired by the Secretary of the Depat1ment of Trade and Industry.

THE CHAIRMAN (SE . FLAVIER). Yes.

REP. MITRA. Vice the Secretary of Health because we feel that this is already an industry concern, not just a health concern .

THE CHA IRMAN (SEN. FLAV IER). Yes.

REP. MITRA. And the Secretary of the Department of Health can act as the vice chair, the sole vice chair or together with another department.

THE CHAIRMA 1 (SEN. FLA VIER). Because of your birthday, accepted.

REP. MITRA. Thank you, Mr. Chairman." (Emphasis suppl ied)

A copy of the deliberations of the Bicameral Conference Committee dated 2

June 2003, II :01 a.m. is attached hereto and made an integral part hereof as ANNEX

"E". The relevant portion appears on page 3.

29. Clearly, the power of the DOH over tobacco products is limited to its

capacity as a mere member of the IAC-T, along with other agencies of the

govenunent even though the Secretary of the DOH is designated under the TRA as

the pennanent Vice-Chainnan of the IAC-T.

16

B. The TRA regulates tbe health aspect of tobacco.

30. Based on the IRR, it appears that the DOH is assuming juri sdiction

over the health aspect of tobacco products by implicitly classifying the latter as a

health product.

3 I. In Book II , Article III of the IRR, which is entitled "Tobacco and

Other Products", Section I innocuously states that "[tJhe FDA has full jurisdiction

over the regulation of all health products." Section 2 thereof, which expressly

govems tobacco, however, concludes - on the basis of this premise - that "[tJhe

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." In other words, the DOH

implicitly assumed jurisdiction over tobacco products by classifying them as health

products.

32. Notwithstanding the classification made by the DOH of tobacco

products as health products, their regulation, however, remains exclusively and

solely under the juri sdiction of the IAC-T.

33. The TRA regulates the health aspect of tobacco products. This is

clear from the law's provisions.

33.1 . First, it is the goal of the TRA to protect the populace from

hazardous products and promote the public ' s right to health. In addition, the

state is mandated to regulate the use of tobacco products in order to promote

a healthful environment. As stated under Section 2 of the TRA :

"SECTION 2. Policy. - It is the policy of the State to protect the JloJlu lace from hazardous products and

17

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 wei fare, to safeguard the interests of the workers and other stakeholders in the tobacco industry. For these purposes, the goverrunent 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 famlers , growers, workers and stakeholders are not adversely compromised."

33.2. Second, the purposes of the TRA under Section 3 thereof

reveal the law's intent to rcgulate the health aspect of tobacco products.

Thus:

"SECTION 3. Purpose. - It is the main thrust of this Act to:

a. Promote a healthful environment; b. Infonn 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 ancl encourage Filipino tobacco fanners to cultivate altemative agricultural crops to prevent economic dislocation; ancl g. Create an Inter-Agency Committee on Tobacco (IAC-Tobacco) to oversee the implementation of the provisions of this Act."

34. Aside from the foregoing provisions of the TRA, the following

relevant excerpts from the sponsorship speech of Senator Juan Flavier, the author of

the TRA, reveals the intention of the law to regulate all health concems relating to

tobacco products and tobacco use, to wit:

*** *** ***

"As the Chainnan of the Committee on Health and Demography, I CaIUlot comprehend why in our own

18

country, no law exists to address the public health hazard that is smoking. x x x

••• *** •••

This proposal has been opposed by advertisers and the tobacco industry for being radical. I cannot agree more with how they describe the bill. It is so because it needs to be so. We are waging a campaign to prevent senseless deaths and diseases associated with tobacco use and tobacco abuse which, among others, include lung cancer, fetal abnormalities, emphysema, genetic deficiencies and cardiovascular diseases. We need to take action against the only legal product that, when used as intended, is lethal. The passage of this bill is therefore necessary if we are to save Filipinos from contracting deadly diseases and ultimately dying from smoking.

The objective of this proposal is foremost to protect the health of children and adults from exposure to the harms of smoking. x x x

••• ••• ***

Our Constitution seeks to promote the right to health of the people and instill health consciousness among them. We are merely doing what the basic law of the land demands of us. To help us better achieve this, a comprehensi ve program must be instituted, as a matter of official govenunent policy, to safeguard public health and ensure the physical well-being of smokers and non-smokers alike by di scouraging cigarette smoking and tobacco use."

A copy of the sponsorship speech of Senator Juan Flavier delivered during

the 23 October 200 I session of the Senate is attached hereto and made an integral

part hereofas ANNEX "F".

35 . Moreover, the Congressional deliberations relating to the FDA Act

confim1ed that the TRA likewise governs the health aspect of tobacco products.

This will be discussed in the immediatel y succeeding sub-section.

19

C. In view of the regulation of the health aspect of tobacco products under the TRA, the FDA Act itself excluded tobacco products from the jurisdiction of the FDA.

36. The FDA Act specifically excluded tobacco products from the

jurisdiction of the FDA.

37 . It is a well-entrenched principle in statutory construction that when

the law is clear and unambiguous, the cout1 is left with no alternative but to apply the

same according to its clear language.'

38. Here, the FDA Act clearly excludes tobacco products from the

jurisdiction of the FDA.

39. Under Section 25 of the FDA Act, the jurisdiction of the FDA over

"health products'" is limited and ci rcumscribed by the "sole and exclusive

jurisdiction" already exercised by "other specialized agencies and special laws."

Among these agencies and/or laws, the FDA Act enumerates the following:

(a) The TRA;

(b) Executive Order o. 245 (Implementing the Consolidation of all tobacco agencies and the creation of the National Tobacco Administration);

(c) Executive Order No. 18 (Creation of the Sugar Regulatory Administration); and,

(d) Presidential Decree No. 1468 (Revising Presidential Decree No. 961 or the Act codi fying the laws dealing with the development of the Coconut and other Palm Oil Induslties).

l Quijano v. Devetopment Bank of the Philippines. G.R. No. L-264 19. October 16. 1970.

6 Health products are defined in Section 10(ff) of the FDA Act as "food, drugs, cosmetics, devices. biologicals. vaccines, in·vi lro diagnostic reagetlls 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 hea lth which require regulations as determined by the FDA."

20

40. Section 25 of the FDA Act limited the seemingly all -encompassing

jurisdiction of the FDA. Consequently, the FDA is prohibited under Section 25 of

the FDA Act to assume jurisdiction over "health products" which are regulated by

other regulatory agencies.

41. Note that when Congress excluded health products that are already

governed by other laws (e.g. tobacco) it did not deem it necessary to give the FDA

Act a suppletory application to such special laws. As a result, Congress did not

include in the final version of the FDA Act the proposed Section 26 which states that

"[The FDA Act] shall be applied in a suppletory manner to other special laws"

because Congress intended to delineate the jurisdiction of the FDA from the

jurisdiction already exercised by other specialized agencies.

42. Assuming that the FDA Act is ambiguous and requires construction in

order to determine the intent of the Legislature, the deliberations of the Bicameral

Conference Committee on the FDA Act show that the FDA was not supposed to

encroach on matters already covered by speciali zed laws and regulated by

specialized agencies:

"SEN. LEGARDA. And on page 40, just to make sure that thi s law does not duplicate existing laws, Madam Chair, Section 27 in House Bill 3293 and Section 23 in our version. It says, the amendment states, 'However, this Act shall not cover products or goods which are not covered by Special Laws including but not limited to those covered by Republic Act 9211.

*** *** ***

This amendment is subject to style and simply to make sure that the laws which are in existence will not be duplicated by new regulations under this measure."

21

A copy of the deliberations of the Bicameral Conference Committee dated 23

February 2009, 12:25 p.m. is attached hereto and made an integral part hereof as

ANNEX "G". The relevant portion appears on page I.

43. Specifically, it was emphasized during the Bicameral Conference

Committee hearings that the intention of the proponents of the FDA Act was to

specifically exclude tobacco products from its coverage:

"THE CHAIRPERSO ' (SEN. CAYETANO. So, Atty. Polig, to repeat, there is an amendment to exclude certain products - tobacco, sugar, counterfeit medicine, etcetera - the assumption being that this is already covered by existing laws and need not be covered here. So we just want your confinnation that in fact the intention is not to apply this law.

MR. POLIC. Yes, Madam Chainnan. While the definition on health products, paI1icularly the last portion, practically covers every other products [sic) that may have an effect on health, it is my opinion that since the law on ... covers like tobacco is a special law. hindi no po siva kasamo dilO, Yo III' Honor. [It is no longer included, Your Honor.]" (Underscoring and translation supplied)

A copy of the deliberations of the Bicameral Conference Committee dated 23

February 2009, 12 :35 p.m. is attached hereto and made an integral part hereof as

AN EX " 1'1". The relevant portion appears on page 3.

44. Moreover, it was clarified that the FDA Act was not intended to

amend these special laws or expand the jurisdiction of these specialized agencies

beyond what is already presently provided by existing legislation. Thus, the "sole

and exclusive jurisdiction" of these specialized agencies to regulate products that

may otherwise be covered by the FDA Act is limited to those matters al ready set

forth in these specialized laws and alread y exercised by these specialized agencies.

22

45. The clear intent of Congress is to delineate the jurisdiction of the FDA

as distinct and separate from the jurisdiction already exercised by other specialized

agencies. This would prevent the exercise of conCUlTent jurisdiction by the FDA over

matters already reposed by special laws upon other agencies and bodies.

46. Therefore, applying the provIsIons of the FDA Act to tobacco

products, the FDA has no power to regulate tobacco products and the tobacco

industry since jurisdiction over the same is undoubtedly vested with the IAC-T, the

agency specifically created by Congress for this purpose.

D. Even assuming for the sake of argument that the FDA Act did not exclude tobacco and tobacco produ cts from the jurisdiction of the FDA, the FDA Ac t nevertheless docs not authorize the FDA to regulate these products.

47. The FDA Act does not grant the FDA the authority to regulate tobacco

and tobacco products.

48. Again , it is well -established that while administrative agencies possess

quasi- legislati ve or rule-making powers, or the power to make rules and regulations

for the implementation of laws duly enacted by Ihe Legislature, such power results in

delegated legislation which should be, among others, only within the confines of the

granting statute.7

The power of administrative officials to promulgate rules in the

implementation of a statute is necessarily limited to what is provided in the legislative

enactment. 8

7 Sman Communications, Inc. vs. Nationa l Teleconmlunications Commission, 408 SCRA 678 (2003).

8 Blaquera vs. Alcala, 295 SCRA 366 (1998); UnJled SF Homeowners Association vs. BF Homes, Inc., 310 SCRA 304 (1999).

23

49. The relevant provision of the FDA Act state:

"SECTION 2. The State policies as embodied in Article II, Section 15 of the 1987 Constitution, that: 'The State shall protect and promote the right to health of the people and instill health consciousness among them' and in Section 12, Article XlII of the 1987 Consti tution, that: 'The State shall establish and maintain an effec tive food and drug regulatory sys tem and undcI1ake appropriate health manpower development and research, responsive to the country's health nceds and problcms' are reiterated.

SECTION 3. In the implementation of the foregoi ng policies, the Govcmment, through the Depal1ment of Health, shall , in accordance with the provisions of thi s Act:

(a) Establish standards and quality measures for foods, drugs and devices and cosmetics. (b) Adopt measures to ensure pure and safe supply of food s and cosmetics, and pure, safe, efficacious and good quality drugs and devices in the country. (e) Adopt meas ures to ensure the rational usc of drugs and devices, such as, but not limited to, banning, reca lling or withdrawing from the market drugs and dev ices which are not register ed, unsafe, inefficacious or of doubtful therapeuti c value, the adoption of an official ' ational Drug Formulary, and the use of generic names in the labeling of drugs.

(d) Strengthen the Bureau of Food and Drugs .

• ** .** ***

CHAPTER III Crcation of the Food and Drug Administration"

*** *** *.*

"SECTION 4. To carry out the provisions of this Act, there is hereby created an office to be called the Food and Drug Administration (FDA) in the Department of Health (DOH). Said Administration shall be under the Office of the Secretary and shall havc the following functions, powers and duties :

(a) To administer the effectivc implementation of this Act and of the rules and regulations issued pursuant to the same; (b) To assume primary jurisdiction in the collection of samplcs of hea lth products;

24

(c) To analyze and inspect health p roducts in connection with the implementation of this Act; (d) To establish analytical data to serve as basis for the preparation of hea lth 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 spot­check for compliance with regulations regarding operation of manufacturers, importers, exporters, distributors, wholesalers, drug outlets, and other estab li slU11ents and facilities of health products, as detennined by the FDA; (I) To levy, assess and collect fees for inspection, analysis and testing of products and materials submi tted in compliance with the provisions of thi s Act. (g) To certi fy batches of an ti-b iotic and anti­biotic p repara tions in compl iance with the provis ions 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, retai lers, consumers, and non-consumer users of hea lth prod ucts to repOJl 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; (j) To issue cease and desist orders motu propio or upon verified complaint for hea lth 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 onl y after due process has been observed; (k) After due process, to order the ban, recall, and/or withdrawal of any health prod uct 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 ~II concerned to implement the risk management plan which is a requirement fo r 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 invo lving such products; (m) To develop and issue standards and appropriate authorizations that would cover

25

establislunents, facilities and health products; (n) To conduct, supervise, monitor and audit research studies on health and safety issues of health products undertaken by entities duly approved by the FDA; (0) To prescribe standards, guidelines, and regulations with respect to infonnation, advertisements and other marketing instruments and promotion, sponsorship, and other marketing activities about the health p roducts as covered in this Act; (p) To maintain bonded warehouses and/or establish the same, whenever necessary or appropriate, as detennined 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 perfonn such other functions as may be necessary to carry out its duties and responsibilities under this Act." (Emphasis and underscoring supplied)

*** *** ***

50. There is nothing in the foregoing which would show that the FDA has

the authority to regulate tobacco or tobacco products.

51. On the contrary, it is clear that the FDA only regulates food, drugs,

devices, cosmetics, household/urban hazardous substances and health products.

Based on the definitions provided under Section 10 of the FDA Act, tobacco and

tobacco products do not appear to fall under tbe definition of any ofthem9

9 "(e) 'Food' means any processed substance which is mlcnded for human consumption and includes drink for man, beverages, chewing gum and any substances which have been used as an ingredient in the manufacture, preparation or treatment of food.

(f) 'Drug' means: (I) articles recognized in official pharmacopeias and formularies, including official homeopathic pharmacopeias, or any documentary supplement to any of them, which

are recognized and adopted by the FDA; (2) articles intended for use in the diagnosis. cure, mitigation, treatment. or prevention of disease inman or other animals; (3) anic1es (other than food) intended to affect the structure orany function of tile body of humans or animals; or (4) articles intended for use as a component of any articles spec ified in clauses (1). (2), or (3) but do not include devices or their components. pans or accessories.

(g) 'Device' means medical devices, radiation devices and health-related devices.

xxx

(h) 'Cosmet ics' means any substance or preparation intended to be placed in contact with the various external parts of the human body or with the teeth and the mucous membranes of the oral cavity, with a view exclusively or mainly to cleaning them, perfuming them, changing their appearance and/or correcting body odor, and'or protecting the body or keeping them in good condition.

xxx

26

52. As mentioned above, the IRR included tobacco and tobacco products

on the rationale provided in Book II, Article Ill, Section I of the IRR that the FDA

"has full jurisdiction over the regulation of all health products." It does not appear,

however, that tobacco or tobacco products can be deemed included in the definition

of "health products" in Section 10 (ft) of the IRR.

53. Wliile the definition of "health products" in Section 10 (ft) of the IRR

includes "products that may have an effect on health which required regulations as

(11) "Food additive" means any substance the intended use of which results or may reasonably be expected to result, directly or indirectly. in its becoming a component or otherwise affecting the characteristics of any food (including any substance intended for use in producing, manufacturing. packing, processing, preparing, treating, packagmg, transporting. or holding food; and including any source of radiation intended for any such use), if such substance is not generally recognized, among experts qualified by scientific training and experience to evaluate its safety, as having been adequately shown through scientific procedures to be safe under the conditions of its intended use.

xxx

(ee) 'Food/dietary supplement' means a processed food product intended to supplement the diet that bears or contains one or more of the followi ng dietary ingredients: vitami n, mineral, herb, or other botanical, amino acid, and dietary substance to increase the total daily intake in amounts confortning to the latest Philippine recommended energy and nutrient intakes or in ternationally agreed minimum daily requirements. It usually is in the form of capsules, IDblets, liquids, gels, powders or pills and not represented for use as a conventional food or ns the sale item of a meal or diet or replacement of drugs and medicines.

(fO 'Health producls' means food , drugs, cosmetics, devices, biologicals, ,'accines, in-"itro diagnostic reagents and household/urban hazardous subslances and/or a combination of and/or a derivative thereof. It shall also refer to products (hatll1:.1Y have an effect on health which rcquire regulations as determincd by th c FDA .

(gg) 'llollsehold/urban hazardous substancc' IS:

(I) Any substance or mixture of substances mtended for

individual or limited purposes and which is toxic, corrOSive, an irritant, a strong sensitizer, is fl ammable or combustible, or generates pressure through decomposition, heat or other means, if such substance or mixture of substances may cause subs tantial injury or substantial illness during or as a proximate result of any customary or reasonably foreseeable ingestion by children, but shall not include agricultural fertilizer, pesticide, and insecticide, and other economic poisons, radioactive substance, or substances intended for use as fuels, coolants. refrigerants and the like;

(2) Any substance which the FDA finds to be lInder the categories enumerated in clause ( I) oflhis paragraph;

(3) Any toy or other articles intended for use by children which the FDA may determine to pose an electrical, chemical, physical, or thermal hazard; and

(4) This term shall not apply to food. drugs, I.:osmetics, devices, or 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 an agricultural pesticide but which is a hazardous substance, as construed in paragraph (I) of this section, by reason of bearing or containing such harmful substances described therein.

(hh) 'In-vitro diagnostic reagents' arc reagents and systems intended for use in the diagnosis of disease or other conditions, including a determination of the state of health, in order to cure, mitigate. treat or prevent disease or its sequelae."

27

detennined by the FDA", this cannot be interpreted to include tobacco or tobacco

products considering that tobacco or tobacco products do not fall under the respective

definitions of "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' as enumerated above.

54. Following the doctrine of ejusdem gelleris (where general words

follow an enumeration of persons or things by words of a particular and specific

meaning), such general words are not to be construed in their widest extent, but are to

be held as applying only to persons or things of the same kind or class as those

specifically mentioned. ' 0

55. Moreover, the FDA Act enumerates the different Centers of the FDA

"per major product category regulated", none of which include tobacco or tobacco

products:

'·SECTION 5.The FDA shall have the following centers and offices:

(a) The Centers shall be established per major product category that is regulated , namely:

(I) Center for Drug Regulation and Research (to include veterinary medicine, vaccines and biologicals); (2) Center for Food Regulation and Research; (3) Center for Cosmetics Regulation and Research (to include household hazardous/urban substances); and (4) Center for Device Regulation, Radiation Health , and Research.

These Centers shall regulate the manufacture, importation, exportation, distribution, sale, offer for sale, transfer, promotion, advertisement, sponsorship of, and/or, where appropriate, the use and testing of health products. The Centers shall likewise conduct research on the safety, efficacy, and quality of health

'0 Republic of the Philippines vs. Heirs of Julio Ramos, G.R. No. t 69481 , February 22, 20 I O.

28

products, and to institute standards for the same." (Emphasis and underscoring supplied)

56. The foregoing all the more show that tobacco and tobacco products are

not included in the category of "health products" as they arc used in the FDA Act.

57. Neither would tobacco or tobacco products fall under

"household/urban hazardous substance", which has a specific definition as quoted

above, which includes the qualification that "such substance or mixture of substances

may cause substant ial inju ry or substantial illness during or as a proximate result of

any customary or reasonably foreseeable ingestion by children."

58. In fact, the deliberations of the Bicameral Conference Committee

confi lm that tobacco products are not to be treated or classi fi ed as health products.

As clarified and pointed out by Congressman Edcel Lagman:

"THE CHA IRPERSON (SEN. CAYETANO, P.). So, the general statement is this act shall govern all the products. The exception is provided that it shall not be deemed to modify the existing special laws-if you wanna include the ...

SEN LEGARDA. 00, yeah.

REP. LAGMAN. I think that is much clearer, Madam Chair, and moreover, it would exclude the assumption that tobacco products are health products because they arc not health products. So, I think il could be rephrased in this wise: 'This act shall govern all health products. Coverage shall not extend to products under the sole and exclusive jurisdiction of other specialized agencies and covered by special laws including but not limited to etcetera. '" (Emphasis supplied)

A copy of the deliberations of the Bicameral Conference Committee dated 19

May 2009, 2:05 p.m. is attached hereto and made an integral part hereof as ANNEX

" I" . The relevant portions appear on pages 3 and 4.

29

59. In view of the foregoing, it is clear that the FDA Act does not grant the

FDA the authority to regulate tobacco and tobacco products.

E . Likewise, it is the IAC­T , not the DOH, which has jurisdiction ovcr the regulation of labeling, advertisements, promotions, sponsorships and ma rketing activiti es involving tobacco products.

60. Under Book II , Article II of the IRR, the FDA assumes jurisdiction

over the labeling of health products, which under Book II, Article III of the IRR

includes tobacco products. Specificall y, Book II, Article II, Section I of the IRR

states:

"ARTICLE II Labcling Health Products

Sec. 1 General Provision. Consistent with the state policy of protecting the consumer against hazards of health and safety and providing infom1ation and education to facilitate sound choice in the proper exercise of their rights, all health products must be labeled and con form to the requirements on labeling set by the FDA."

61. The regulation of the labeling of health products, however, cannot be

extended to tobacco products. Book II, Article III of the IRR has no legal basis.

61.1. First, as discussed above, assuming that tobacco products can

be validly treated as health products, Section 25 of the FDA Act excluded it

from the regulatory authority of the FDA.

61.2. Secol/d, assuming that tobacco products can be validly treated

as health products, the regulation of its labeling is govemed by thc TRA,

which is subject to the excl usive and sole jurisdiction of the IAC-T.

30

62. The regulation of the labeling requirements of tobacco products

pcrtains to the exclusivc authority of the IAC-T. This is clear under Section 3 (d) of

the TRA, which provides:

"SECTION 3. Purpose. - It is the main thrust of this Act to:

*** *** ***

d. Regulate the labeling of tobacco products."

*** *** ***

63. In thi s cOimection, the only labels required under the TRA are

exclusively specified under Section 13 thereof, which states:

"SECTION 13. Warnings on Cigarette Packages.-

Under this Act:

a. All packages in which tobacco products are provided to consumers withdrawn from the manufacturing facility of all manufacturers or imported into the Philippines intended for sale to the market, starting I January 2004, shall be printed, in either English or Filipino, on a rotating basis or separately and simultaneously, the following health warnings:

'GOVERNMENT WARNING: Cigarette Smoking IS

Dangerous to Your Health;'

'GOVERNMENT Addictive;'

WARNING: Cigarettes are

'GOVERNMENT WARNING: Tobacco Smoke Can Hann Your Children;' or

'GOVERNMENT WARNING: Smoking Kills.'

b. Upon effectivity of this Act until 30 June 2006, the health warning shall be located on one side panel of every tobacco product package and occupy not less than fifty percent (50%) of such side panel including any border or frame.

c. Beginning I July 2006, the health warning shall be located on the bottom portion of one (\) front panel of every tobacco product package and occupy not less than

31

thirty percent (30%) of such front panel including any border or frame. The tcxt of the waming shall appear in clearly legible type in black text on a white background with a black border and in contrast by typography, layout or color to the other printed matters on the package. The health waming shall occupy a total area of not less than fifty percent (50%) of the total warning framc.

d. The warnings shall be rotated periodically, or separately and simultaneously printed, so that within any twenty-four (24) month period, the four (4) variations of the warnings shall appear with proportionate frequency.

e. The waming shall not be hidden or obscured by other printed infonnation or images, or printed in a location where tax or fi scal stamps are likely to be applied to the package or pla<:cd in a location where it will be damaged when the package is opened. If the waming to bc printed on the package is likely to be obscured or obliterated by a wrapper on the package, the waming must be printed on both the wrapper and the package.

f. In addition to the health waming, all packages of tobacco products that are provided to consumers shall contain, on one side panel, thc following statement in a clear, legible and conspicuous manner: "NO SALE TO MINORS" or "NOT FOR SALE TO MINORS." The statement shall occupy an area of not less than ten percent (10%) of such side panel and shall appear in contrast by color, typography or layout with all the other printed material on the side panel.

g. No other printcd warnings, except the health warning and the message required in this Section, paragraph f. shall be placed on cigarette packages."

64. Pertinently, Section 13 (g) of the TRA above mandates that no other

printed wamings, except the health waming and the message required in paragraph

CD of Section 13 shall be placed on cigarette packages. Respondents disregarded this

mandatory provision of the TRA when they assumed jurisdiction over the labeling of

tobacco products.

65 . Thus, the IRR has the effect of expanding the coverage of, and

modifying the TRA by requiring all heal th products to be labeled in accordance with

the requirements set by the FDA.

32

66. Aside from unlawfull y regulating the labeling of tobacco products,

which the DOH and FDA appears to have classified as health products under the

IRR, the IRR grants the FDA the authority to regulate the advertising, sponsorship,

and marketing activ ities of tobacco companies under Book II , Article V of the IRR,

the relevant parts of which provide:

"A RTICLE V Advertisemcnts, Promotions, Sponsorship and

Other Marketing Activities

Sec. 1. Gencral Provis ion. Consistent with the state policy of protecting the consumer against misleading, deceptive, false, en·oneous impression regarding any health product's character, value, quantity, composition, merit or safety, efficacy or quality, and in order to facilitate sound choicc in the proper exercise of their rights, all advel1isements, promotions, sponsorship, and other markcting 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.

Sec. 2. G ener al Rules on Adve rtisements, 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;

b. No claim of the advel1isement, 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;

*** *** ***

67. In this connection, it appears that under Book II, At1icle I, Section I

(a) of the IRR, the FDA can require the registration of health products, which under

Book II, Article III ofthc IRR includes tobacco products, prior to the conduct of any

33

promotion, advertising and sponsorshIp activities. Book II , Article I, Section I (a) of

the IRR provides:

"A RTIC LE I Licensing of Es tablishments and R egistra tion of

Health Products"

Sec.!. General Provisions.

a. The manufacture, importation, exportation, sale, offering for sale, distribution, transfer, non-consumer use, promotion, adverti sing or sponsorship of any health product without the proper authorization from the FDA is prohibited ."

••• *** ***

68. As di scussed above, the IAC-T has been granted the sole and

exclusive authority to implement and administer the provisions of the TRA, which

notably includes the following aspects of the tobacco industry: (i) advertising, II (ii)

promotion,12 (iii) sale, and (iv) sponsorship I) of tobacco products. This sole and

exclusive authority is established by Section 29 of the Tobacco Regulation Act

which in part provides:

"SECTION 29. Implementin g Agency. - An Inter-Agency Committee - Tobacco (lAC-Tobacco), which shall have the exclusive power and fun ction to administer and implement the provisions of this Act, is her eby crea ted. The lAC-Tobacco shall be chaired by the Secretary of the Department of Trade and Industry (DTI) wi th the Secretary of the Department of Health (DOH) as Vice Chairperson. The lAC-Tobacco shall have the following as members:

***

" See Sections 14 to 22 of the TRA.

Il See Section 23 of the TRA.

tl See Sections 25 to 26 of the TRA.

*** ***

34

69. Therefore, sll1ce the regulation of the labeling, advertisements,

promotions, sponsorships and other marketing activities conducted by tobacco

companies is vested with the IAC-T, respondents cannot regulate the same activities

concurrently with the IAC-T.

F. The before the IAC-T that jurisdiction products.

DOJ confirmed members of the the FDA has no

over tobacco

70. The DOJ rendered a rep0l1 before the members of the IAC-T

confirming that the FDA has no jurisdiction over tobacco products.

71. Note that the IAC-T requested the DOJ , in the latter's capacity as a

member of the IAC-T and as the principal law agency of the Govenunent," to study

the FDA Act and how it affects the jurisdiction of the IAC-T vis-ii-vis the jurisdiction

of the DOH and the FDA.

72. During the 23 April 2010 meeting of the IAC-T, the DOJ, through

then Assistant Secretary Jose De Castro, reported that based on the text of the FDA

Act and the Congressional intent behind its enactment, the FDA has no jurisdiction

over tobacco products as such jurisdiction is exclusively vested with the IAC-T.

A copy of the minutes of the 23 April 2010 meeting of the IAC-T is attached

hereto and made an integral pat1 hereof as A NEX "J ".

73 . In arriving at its opinion that the FDA, and consequently the DOH,

does not have jurisdiction over tobacco products, the DOJ studied the deliberations of

the Bicameral Conference Committee on the FDA Act. The DOJ quoted the

"Section t , Chapter I, Title lll, Book IV of the Administrative Code.

35

following relevant pOIiions of the Bicameral Conference Committee 111 its report,

which are also previously quoted above:

" SEN. L EG ARD A. And on page 40, just to make sure that this law does not duplicate existing laws, Madam Chair, Section 27 in House Bill 3293 and Section 23 in our version. It says, the amendment states, 'However, this Act shall not cover products or goods which are not covered by Special Laws including but not limited to those covered by Repub lic Act 9211.

••• ••• •••

This amendment is subject to style and simply to make sure that the laws which are in existence will not be duplicated by new regulations under this measure.""

••• ••• •••

"THE CHAIRPERSO N (SEN. CAYET ANO). So, Atty. Polig, to repeat, there is an amendment to exclude certain products - tobacco, sugar, counterfeit medicine, etcetera - the assumption being that this is already covered by existing laws and need not be covered here. So we just want your confinnation that in fact the intention is not to apply this law.

MR. POLIG. Yes, Madam Chainnan. While the definition on health products , particularly the last portion, practically co vcrs every other products [sic] that may have an effect on health, it is mv opinion that since the law on ... covers like tobacco is a special law, hindi na po siva kasama dito, Your Honor. [It is no longer included, Your Honor.l" '6 (Underscoring and translation supplied)

74. In light of the foregoing, the DO) gave the following observations

before the members of the JAC-T:

••• • •• ***

(ii) Section 25 of the FDA Act was introduced to avoid duplication of laws;

" Sec the DO) Report during the 23 April IAC·T meeting, citing the Bicameral Deliberations, 23 February 2009, 12:25 p.m., page I, attached hercto as Allnex "C".

16 See the DOl Report during the 23 April 2010 lAC· T meeting, citing the l3icameral Deliberations, 23 February 2009 , 12:35 p.m., page 3, attached hereto as Annex "C".

36

(iii) The TRA is a special law;

(iv) The IAC-T is a specialized agency;

(v) Tobacco products are not included within the coverage of "health products" that are subject to the jurisdiction of the FDA, insofar as they are covered by the TRA; and,

(vi) Products and activities covered by the TRA and under the sole and exclusive jurisdiction of the IAC-T are not covered or affected by the FDA Act17

•

75. The views of the other members of Congress during the Bieameral

Conferenee Committee also confimled the opinion of the DOH, thus:

"SEN. LEGARDA. I'm a non-smoker and I'm one of the authors of RA 9211 with Flavier 'no. Just to-yes, because all your concerns are covered by the law which we authored. Meaning. the advertising. the health aspects so what this wavs was. whatever is covered bv 9211 should not be covered anvmore bv this new law we're doing.

*** ••• •••

"REP. LAGMAN. The health issues with respect to tobacco are already covered hy Republic Act No. 921l. So there is no need to duplicate that power and jurisdiction under the BFAD. (Emphasis and underscoring supplied)

••• •••

• ••

A copy of the deliberations of the Bicameral Conference Committee dated 19

May 2009, 1:45 p.m. appearing on pages 6 and 7 is attached hereto and made an

integral part hereof as AN EX" K". The relevant pOl1ions appear on pages 6 and 7.

76. Accordingly, as mandated under Section 25 of the FDA Act, matters

already covered by special laws (i.e. the TRA) are no longer within the competence

and jurisdiction of the FDA.

17 See the DO) Report during the 23 April 20 I 0 IAC-T meeting, attached hereto as Annex "C".

37

ll . THE RESTRICTION OF THE FDA'S ENGAGEMENT WITH THE TOBACCO INDUSTRY BY THE DOH VIOLATES T HE TRA.

77. The restriction of the dealings by the FDA with the tobacco industry

under Book II, Article Ill , Section 2 (b), and paragraph 2, is contrary to the express

mandate of the TRA.

78 . Article 1Il, Section 2 (b), and paragraph 2 of the lRR respectively

provide:

***

"ARTICLE III Tobacco and Other Products

***

Section 2. Tobacco. x x x

***

b. Protection against the Tobacco Industry Interference. The FDA shall act to protect the fonnulation and implementation of the 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."

79. The restriction quoted above imposed upon the FDA by the DOH has

no legal basis and in fact contravenes various constitutional and statutory provisions.

38

80. First, there is no provision in the FDA Act which either allows or

suggests the restriction of the FDA 's dealings with any industry under its regulatory

h . 18 aut onty.

81. Secolld, the Constitution recogmzes the indispensable role of the

. . . 19 private sector and encourages pnvate enterpnsc.

82. Third, several laws recognize the right of the people to participate in

policy-making processes that affect their rights.

82.1. The Administrative Code provides for the right of the people

to effective and reasonable participation at all levels of social, political and

economic deci sion-making and rcquires the State to provide consultation

h · '0 mec alllsms.-

82.2. Republic Act No. 6713, otherwise known as the Code of

Conduct and Ethical Standards for Public Officials and Employees, also

requires public officials to cnsure "public consultations and hearings

whenever appropriate" and to "encourage suggestions. ,,21

82.3 . Section 2 of the TRA, which specifically governs the dealings

and interaction between the government and the stakeholders of the tobacco

industry, lays down, in no uncel1ain tenns, the clear policy of the Philippine

Govenunent that with respect to tobacco use, sale and advertisements of

II Assuming that tobacco products are under the regulatory authority of the FDA.

19 Article II, Section 20 of the Constitution.

20 Book tI , Chapter t, Seclion 1 (7) of the Administrative Code.

1I Section4(c).

39

tobacco products, both the interests of the health sector and tobacco

stakeholders are given due consideration:

"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 weI fare, to safeguard the interests of the workers and other stakeholders in the tobacco industry. For these purposes, the govenunent 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 fanners, growers, workers and stakeholders are not adversely compromised." (Underscoring supplied)

82.3.1. Clearly, the TRA mandates that the interest of the

"stakeholders" of the tobacco industry should also be protected and

the DOH carmot unceremoniously restrict the interaction and dealings

between the FDA and the members of the tobacco industry.

83. FOllrth, the restriction of the FDA's dealings with the members of

the tobacco industry under Book II , At1icle Ill, Section 2(b) and paragraph 2 of the

IRR violates PTI's right to the equal protection of the laws.

83.1. Equal protection requires that all persons or things similarly

situated should be treated alike, both as to rights conferred and

responsibilities imposed. Similar subjects should not be treated differently,

so as to give undue favor to some and unjustly discriminate against others.

The guarantee means that no person or class of person shall be denied the

same protection of laws which is enjoyed by others persons or other classes

in like circumstances. Reasonable classification may be made, but this

classification must confonn to the following requirements:

40

(i)

(ii)

(i i i)

(iv)

It must be based upon substantial distinctions;

It must be gCn11ane to the purposes of the law;

It must not be limited to existing conditions only; and

22 It must apply equally to all members of the class.

83 .2. While factual differences need not be prominent and neither

are fine distinctions between two classes prohibi ted,23 the classification must

be real and factual, and not wholly abstract, artificial, or contrived.24

83.3. Limiting the interaction between the FDA and the tobacco

industry to those strictly necessary for the latter's effective regulation,

supervision and control unduly discriminates against the tobacco industry and

makes an invalid classification as it fails to impose the same burden on other

private industries with interest in other health products regulated by the FDA.

83.4. This assumes that the commercial and vested interests of the

tobacco industry are automatically inconsistent with and contrary to public

health po licies without any legal basis for establishing such bias against the

tobacco industry. It does not appear that a similar bias has been created with

respect to other industries that also have commercial interests in public health

policies. It is pm1 of sound policy-making to consult stakeholders,

particularly the players who have a day-to-day experience in operations, sales

and marketing. Concerned industries have a right to freely convey their

concerns on regulatory matters so that regulations are practical and feasible.

Putting exclusive and restrictive conditions on the interaction between

22 Ambros vs. COA, 462 SCRA 572 (2005).

23 Peralta vs. COMELEC, 82 SCRA 30 (1978).

14 Cemr.18.nk Employees Associalion, Inc. vs. 8angka Semral ng Pilipinas, 446 SCRA 299 (2004).

41

regulators and the tobacco industry discriminates against the latter without

legal basis.

83.5. Under the IRR, other industries with an interest in public

health are not similarly restricted from interacting with public officials who

detennine the govenunent's public health policies. Conversely, the tobacco

industry does not possess a singular characteristic that would distinguish it

from other industries with a public health interest and would make public

officials in their interaction with them be more prone to influence.

83.6. Therefore, there is no valid classification to sustain Book II,

Article Ill, Section 2(b) and paragraph 2 of the lRR, and is thus,

constitutionally infinn for being violative of the equal protection clause.

III . T HE IRR CONTRA VE 'ES, AMEN DS, MODI FIES AN D REPEALS T HE FDA ACT.

84. The fundamental rule in administrative law is that, to be valid,

administrative ru les and regulations must be issued by authority of law and must not

contravene the provisions of the Constitution. The rule-making power of an

administrative agency may not be used to abridge the authority given to it by

Congress or by the Constitution. Nor can it be used to enlarge the power of the

administrative agency beyond the scope intended . Constitutional and statutory

provisions control with respect to what rules and regulations may be promulgated by

administrati ve agencies and the scope of their regulations25

85 . Moreover, although an administrative agency is authorized to exercise

its discretion in the exercise of its power of subordinate legislation, nevertheless, no

2l Department of Agrarian Reform v. Sutton, G.R. No. 12070, October 19,2005.

42

similar authority exists to validate an arbitrary or capricious enactment of rules and

regulations. Rules which have the effect of extending or conflicting with the

authority-granting statute do not represent a valid exercise of rule-making power but

constitute an attempt by the agency to legislate. In such a situation, it is said that the

issuance becomes void not only for being u/lra vires but also for being unreasonable.

The law therefore prevails over the administrati ve issuance.26

86. It is a time-honored doctrine tilat, in case of conflict, the law prevails

over the administrative regulations implementing it. The authority to promulgate

implementing rules proceeds from the law itself. To be valid, a rule or regulation

must confonn to and be consistent with the provisions of the enabling statute. As

such, it cannot amend the law either by abridging or expanding its scope. As held by

the Supreme Court in United SF Homes Association vs. SF Homes, Inc. :27

"As early as 1970, in the case of Teoxon vs . Members of the Board of Administrators (PVA), we ruled that the power to promulgate rules in the implementation of a statute is necessarily limited to what is provided for in the legislative enactment. Its terms must be followed for an administrative agency cannot amend an Act of Congress. "The rule-making power must be confined to details for regulating the mode or proceedings to carry into effect the law as it has been enacted, and it cannot be extended to amend or expand the statutory requirements or to embrace matters not covered by the statute." [f a discrepancy occurs between the basic law and an implementing rule or regulation , it is the fonner til at prevails."

87. [n the present case, the DOH went beyond its authority when it issued

an IRR which bestows upon the FDA authority to regulate tobacco products even

though the FDA Act itself excludes such products from its jurisdiction.

16 R E . I e: ntlt ement 10 Hazard Pay of SC Medical and Dental Clinic PersOIUlel, A.M. No. 03-9-02-SC November 27,2008. '

17G .R. No. 124873, July 14, 1999.

43

88. In issuing the IRR, the DOH disregarded the provisions of Section 25

of the FDA Act, which mandates the exclusion of, among others, tobacco products

from the jurisdiction of the FDA.

ALLEGATIONS IN SUPPORT OF THE APPLICATION FOR TEMPORARY RESTRAINING ORDER/WRIT OF PRELIMINARY INJUNCTION

89. The foregoing allegations are repleaded herein by reference.

90. PTI has the Constitutional right to due process of law, particularly to

be regulated only by an administrative agency which has the legal mandate to

exercise jurisdiction over it. It has every right to expect that the rule of law shall

prevail and that the Government is on that upholds it rather than strikes it down. As

such, PTf is entitled to the relief IH.:rein prayed for, the whole or part of which

consists in restraining and prohibiting the enforcement of the IRR against PTI and

the other members of the tobacco industry, either for a limited period or perpetually.

91. PTI will suffer grave and irreparable injury should the enforcement of

the IRR be allowed to proceed. It is plain that the IRR violates two laws: the FDA

Act and the TRA. As discussed above, the IRR invalidly expands and modifies the

FDA Act, as well as the TRA, by placing the regulation and supervision of tobacco

products under the FDA.

92. As a result, PTI is exposed to an invalid and baseless regulation by

goveI11ment agencies (DOH and FDA) that were depri ved of any authority and

jurisdiction over tobacco products. This wi ll consequently entail additional

regu latory costs that are neither contemplated under the FDA Act nor the TRA.

44

93. In addition, PTI and its members are exposed to hefty administrative

penalties for poss ible violations of the IRR even though the FDA has no jurisdiction

over tobacco products. Such penalties are provided under Book II , Article XI ,

Section 5 of the IRR, whi ch provides:

"Sec. 5. imposition of Administrative Penalties. - The Director-General shall have the power to impose administrative penalties upon the respondent, if warranted, and even if these have not been prayed for by the complainant but required by the nature of the violation, to wit:

(I) The seizure and condemnation, destruction and/or appropriate disposition of the subject health product;

(2) The imposition of an administrative fine in such amount as deemed reasonable, which shall in no case be less that Fifty Thousand Pesos (50,000.00) nor more than Five Hundred Thousand Pesos (Php500,000.00) depending on the gravity of the offense, and the additional administrative fine of not more than One Thousand Pesos (Php 1,000.00) for each day of continuing violation;

(3) Suspension of the validity of the License To Operate (LTO), Certificate of Product Regi stration (CPR), or other appropriate authorizations for a period which shall not exceed one (1) year;

(4) Revocation of LTO, CPR or appropriate authorization;

(5) Closure of the establishment; and

(6) Other penalties provided by relevant laws being administered or implemented by the FDA."

94. Hence, notwithstanding the exclusion of tobacco products from the

jurisdiction of the FDA by the FDA Act itself, PTI and its members are still exposed

to administrative penalties simpl y because the DOH usurped legislati ve functions

and included tobacco products within the regul atory authority of the FDA. ,

45

95. Worse, under Book ll , Article I, Section I (a) of the IRR, the

manufacture, importation, exportation, sale, offering for sale, distribution or transfer

of any health product, which under Book n, Article III includes tobacco products, is

prohibited unless a prior registration is made with the FDA. Thus, the business

operations of the members of PTI will be hindered by such unauthorized regulation

by the FDA.

96. In addition, unless the enforcement of the IRR is restrained, the main

relief prayed for in the present petition will be rendered academic and illusory.

97. PTI is ready and willing to post a bond in such amount as this

Honorable Court may fix in its di scretion to answer for whatever damages

respondents may sustain by reason of the restraining order or injunction issued

should it be finally detennined that PTI is not entitled thereto.

RELIEF

WHEREFORE, PTI respectfully prays that this Honorable COUl1:

(1) Issue a Temporary Restraining Order/Writ of Preliminary Injunction

after due notice and hearing enjoining the DOH and the FDA, their employees and

agents, or anyone acting on their behalf, from enforcing and/or implementing or

otherwise acting pursuant to or in accordance wi th the lRR on matters related to the

regulation and supervision of tobacco products; and,

(2) Render judgment after trial or upon the submission of memoranda by

the parties declaring the IRR null and void and making the Writ of Preliminary

Injunction penn anent.

46

PTI prays for such other reliefs as may be deemed just and equitable under

the premises.

Las Pinas City, 30 June 20 II.

L EO VILLi.(r. EC COllllsel for Philippine T baeco Illstitute

146 Gloria Diaz Street BFRV, Talon Dos

Las Pifias Ci ty 1740 Roll No. 39109

IBP o. 854443102-10- IIIQC Chapter PTR No. 10121112J /OI-13- I I/Las Pinas

MCLE Compliance '0. 111 -0006582/ 12-09-09

Copy Furnished: [By Registered Mail]

T he Department of Health San Lazaro Compound Sta. Cruz, Manila

Food and Drug Administration Civic Dri ve, Filinvest Corporate City Alabang, Muntinlupa City

SOLICITO R GENERA L 134 Amorsolo Street Legaspi Village, Makati City

EXf'LANA TlON

Copies of the forego ing were served th rough registered mail due to time constraints and lack of messengerial service.

LEovrLI~AR

47

VERIFICATION AND CERTIfICATION OF NON-FORUM SHOPPING

1, RODOLf 0 F. SALANGA, of legal age, with office address at 146 Gloria Diaz Street, SF Resort, Talon ll, Las Pifias City, after having been sworn in accordance with law, hereby depose and state:

I. I am the President of the Philippine Tobacco lnstitute, Inc. (the "Corporation"), petitioner ill this case. I am authorized to initiate and tile this action and execute fOf alld on the Corporation's behalf this Verification and Certification of Non-Foruill Shopping. A copy of the Secretmy's Certiricate showing my authority to represellt the Corporation is attached hereto as Annex " I " .

2. The Corporation has caused the preparation of this Petition which it is now filing ~vith this Honorable Court. I declare that the allegations contained therein are true and coneet of my persollal knowledge and based 011

authentic records in my posses~ ioll .

3. The Corporation has not cOlluneilc-.:d any previous action involving the same issues in this Petition before the Supreme Court, the Court of Appeals, or in any of its divisions, or in any other tribunal or agency.

4. If I or the Corporation shuuld thereatler learn that a simi 1m action or proceeding has been filed or is pre~ently pellding in the Supreme COlllt, the COLirt of Appeals, Of in allY or its divisions, or in any other tribunal or agency, I undel1ake to promptly inform this Honorable Court within five (5) days therefrom.

TN WITNESS WHEREOF, 1 afrix Illy signature this 30t h day of June 2011 in Las Piiias City.

~~q /' RODO~O F. SALANGA

Affiant

SUBSCRlBED AND SWORN to before lIle, a notary public · and for th City of Lns Pitins, on June 30, 20 I J at Las Piilas City, affiant appea IIlg before me ·th his Passport No. XX550671 0 issued 011 Febftl3ry I J, 20 J 0 at lila who is per nally known to me, who has signed the foregoing doculllent in 11Y presence, al who has swom that he understood the contents of the doculllent aJ that the Sa!

volul1tmyact.

Doc. No. ~; Book No. --91,; Page No. --Ii; Series of 20 I I

1:".

'O\RA!l C. RA"\!OS ;';UT:\k . H'BLl t'

I FP Lll!Iimt :\!t ~ mb\ :\u O.).~31, P PL~l PTHo :'0 l(jll:'::~~, Jar ary 3. ~()ll. LPC

RIIII tIl A\IO I II I:)'s ,; 0. j!JijiJ

LlntH lItf;cmbH 31. ~UII

ANNEX" A ~ I

CORPORATE SECRETARY'S CERTIFICATE

KNOW ALL MEN BY THESE PRESENTS:

'. I, CARLOS G. PLATON, filipino, of legal age and with business address

at 6u, & 7th Floors, Tuscan Building, 114 V.A. Rufino St. (formerly Herrera), Legaspi Village, Makati City, do hereby certify:

That I am the Corporate Secretary of PHILIPPINE TOBACCO INSTITUTE, INC. a corporation duly organized and existing in accordance with Philippine laws with office address at 146 Gloria Diaz St., BF Resort, Talon 2, Las Pinas City; that as such Corporate Secretary, I am the custodian of the Minute Books of the Corporation and that said Minute Books show that at a duly constituted special meeting of the Board of Directors of said Corporation on June 30, 2011, the following resolutions were unanimously adopted and

approved:

"RESOLVED, That the Corporation initiate and file legal actions/ proceedings, and apply for the issuance of provisional remedies, to restrain the food and Drug Administration and the Department of Health from implementing, enforcing or otherwise acting pursuant to, the Implementing Rules and Regulations ' of Republic Act No. 9711 (Food and Drug Administration Act), before the proper tribunal, court, agency, or other forum (the "Case");

RESOLVED, That the Corporation's President, Mr. Rodolfo S. Salanga C'Mr. Salanga") be authorized, and he is hereby authorized, to represent the Corpo1'Dtion in any and all proceedings arising out of, in corU1ection with, or relating to the Case, including, not limited to, appeals, petitions for review, petitions for certiorari or any and all other proceedings that may emana te from the Case (the "Appeal Proceedings") as well as all appeals, petitions for review, petitions for certiorari or any and all other proceedings that may emanate from the Appeal Proceedings (the "Other Proceedings") before any tribunal, court, agency, or other forum;

RESOLVED, That Mr. Salanga be autilorized, and he is hereby authorized, to cause the preparation and filing of any pleading, petition or document in any and all proceedings arising au t of, in cOimection with, or relating to the Case, the Appeal Proceedings, and the Other Proceedings before any tribunal, court, agency, or other forum, including the execution and signing of all necessary documents such as the verification and certi fi ca tion of non-forum shopping, in any and all proceedings ilI'ising out of, in cOJUlection with, or relating to the Case, the Appea l Proceedings, and tile Other Proceedings, before any tribunal, court, agency, or other forum, and to consider and decide for and in the Corporation's behalf in a pre-trial conference, mediation or judicial dispute resolution, the following matters:

(

2

a.1] The possibility of an amicable se tticment or of a submission to alterna ti ve modes of dispute resolution;

a.2] The sim plifica tion of issues; a.3] The necessity or desirab il ity of amendments to the

pleadings; a.4] The possibility of obtaining stipulations or admissions

of facts and of documents to avoid unnecessary proof; a.s] The limitation of the number of wi blesses; a.6] The advisability of a preliminary reference of issues to a

commissioner; a.7] The proprietary of rendering judgment on the

pleadings, or summary judgment or of dismissing the action should a valid ground therefor be found to exist;

·a.B] The advisability or necessity of suspending the proceedings;

a.9] Such other matters as may aid in the prompt disposition of the action; and,

a.10] To do and perform such acts and things and to execute any and all documents that will give effec t to the attainment of the foregoing purposes.

RESOLVED, FURTHER, Tha t the Corporation gives and grants unto Mr, Salanga full power and au thority to do and perform whatsoever requisite necessary to be done in and abou t the foregoing premises.

RESOLVED, FINALLY, That the Corporation ratifies and confirms, as it hereby ratifies and confirms, whatsoever Mr. Salanga shall lawfully do or cause to be done by virtue of this appoinmlent."

IN WITNESS WHEREOF, I have hereunto set my hand this 30u, day of June 2011 a t the City of Makati.

SUBSCRIBED AN D SWORN to before me on this of une 2011 at the City of Makati; affiant exhibiting to me his TIN No. 127-451-934, SSS No. 03-0401467-9 and Passport No. XX02623348 issued on December 20, 2007 and valid up to December 19, 2012 issued at Department of Foreign Affairs, Manila. Affiant is personally known to me.

Doc. No. It? Page No. J2. Book No . ....:J,----, Series of 2011. CGP/gcd P·TOBACO/SC·6-JO-201'-DNtlG

~BLIC Unti l December 31, 2011

MARIA JOSElLA TERESA M. CARDENAS Commission No. M·3S3

Nu<.>ry Public· City of Male.,i UUlil December 2012

1'btoll Man. ';z Flor ' Sao Pedro Lea!lo Law Offices o· & r floor;. TUS<'"" Building, I \4 VA. RuJino Sucet

Log.'pi VllL1ge, Makati City P'ffi No. 266ij573; 01 /0612011; M.llr..,i City

ill? Lif<liwo No. 7K8213; 04/1612009; t-labti Chapter RoU No. 56987