G.R. No. 200431 - Separate Concurring Opinion

G.R. No. 200431, July 13, 2021,
♦ Decision, Leonen, [J]
♦ Concurring Opinion, Perlas-Bernabe, [J]
♦ Dissenting Opinion, Caguioa, [J]
♦ Dissenting Opinion, Hernando, [J]
♦ Separate Concurring Opinion, Lazaro-Javier, [J]

THE DEPARTMENT OF HEALTH, REPRESENTED BY SECRETARY ENRIQUE T. ONA, AND THE FOOD AND DRUG ADMINISTRATION, REPRESENTED BY DIRECTOR SUZETTE HENARES-LAZO, PETITIONERS,

SENATORS PILAR JULIANA "PIA" S. CAYETANO AND FRANKLIN "FRANK" M. DRILON, PETITIONERS-INTERVENORS, VS. PHILIPPINE TOBACCO INSTITUTE, INC., RESPONDENT.

I concur in the erudite ponencia of Justice Marvic M.V.F. Leonen that tobacco and cigarettes are health products which are subject to regulation by the Department of Health (DOH) through the Food and Drugs Administration (FDA). But aside from that, I vote to dismiss the petition for declaratory relief of respondent Philippine Tobacco Institute (PTI) for lack of actual case or controversy.

The most apparent defect of this case is the absence of any allegation of injury or threat of injury to respondent PTI. Where there is no such allegation of injury or threat of injury, there would also be no actual case or controversy,1 an element in obtaining judicial review.2 In the absence of both injury or threat of injury and an actual case or controversy, this case is not ripe for adjudication and must be dismissed.3

I am aware that this case was pursued as a petition for declaratory relief. However, this action is not exempt from either the injury or threat of injury or the actual case or controversy requirements.

Petitioners call upon us to disregard procedural rules on account of the alleged novelty and transcendental importance of the issue involved here. However, the transcendental importance doctrine cannot remedy the procedural defects that plague this petition. In the words of former Supreme Court Chief Justice Reynato Puno, "no amount of exigency can make this Court exercise a power where it is not proper." A petition for declaratory relief, like any other court action, cannot prosper absent an actual controversy that is ripe for judicial determination.

For a petition for declaratory relief to prosper, it must be shown that (a) there is a justiciable controversy, (b) the controversy is between persons whose interests are adverse, (c) the party seeking the relief has a legal interest in the controversy, and (d) the issue invoked is ripe for judicial determination. We agree with the CA when it dismissed De Borja's petition for being premature as it lacks the first and fourth requisites. We hasten to add that the petition, in fact, lacks all four requisites.

First, we find that De Borja's petition does not present a justiciable controversy or the "ripening seeds" of one as to warrant a court's intervention. A justiciable controversy is a definite and concrete dispute touching on the legal relations of parties having adverse legal interests, which may be resolved by a court of law through the application of a law. It must be appropriate or ripe for judicial determination, admitting of specific relief through a decree that is conclusive in character. It must not be conjectural or merely anticipatory, which only seeks for an opinion that advises what the law would be on a hypothetical state of facts.

In his five-page petition for declaratory relief, De Borja failed to provide factual allegations showing that his legal rights were the subject of an imminent or threatened violation that should be prevented by the declaratory relief sought. He simply went on to conclude that the construction or interpretation of the reckoning point of the 15-kilometer range of municipal waters under the 1998 Fisheries Code would affect his rights as he is "now exposed to apprehensions and possible harassments that may be brought about by conflicting interpretations of the said statute x x x." As to how these apprehensions and harassments shall come about, De Borja did not elaborate. Clearly, therefore, there is no actual or imminent threat to his rights which is ripe for judicial review....

A perusal of private respondents' petition for declaratory relief would show that they have failed to demonstrate how they are left to sustain or are in immediate danger to sustain some direct injury as a result of the enforcement of the assailed provisions of RA 9372. Not far removed from the factual milieu in the Southern Hemisphere cases, private respondents only assert general interests as citizens, and taxpayers and infractions which the government could prospectively commit if the enforcement of the said law would remain untrammelled. As their petition would disclose, private respondents' fear of prosecution was solely based on remarks of certain government officials which were addressed to the general public. They, however, failed to show how these remarks tended towards any prosecutorial or governmental action geared towards the implementation of RA 9372 against them. In other words, there was no particular, real or imminent threat to any of them.

The possibility of abuse in the implementation of RA 9372 does not avail to take the present petitions out of the realm of the surreal and merely imagined. Such possibility is not peculiar to RA 9372 since the exercise of any power granted by law may be abused. Allegations of abuse must be anchored on real events before courts may step in to settle actual controversies involving rights which are legally demandable and enforceable.

Thus, in the same light that the Court dismissed the SC petitions in the Southern Hemisphere cases on the basis of, among others, lack of actual justiciable controversy (or the ripening seeds of one), the RTC should have dismissed private respondents' petition for declaratory relief all the same.

Here, respondent does not allege any injury it has suffered or any threat of suffering such injury as a result of the action of the FDA to classify tobacco as a health product and issue Article III, Book II of the Rules and Regulations Implementing RA 9711 (The Food and Drug Administration Act of 2009). What respondent could only refer us to are apprehensions and speculations of harassments that may be brought about by the conflicting interpretations of the breadth of rule-making authority given to the FDA in light of the amendments to its charter, RA 37206 (1963), by RA 9711.7

The importance of actual facts of injury or threats of injury cannot be overstated. This is because without such actual facts, the Court would in effect be rendering an opinion on a state of assumed and hypothetical facts. Other countries like Canada, India, and Nauru allow such process through what they call reference petitions, but the Philippines and the United States have no authority to do so because of the requirement of an actual case or controversy. Hence, for this doctrinal reason, it is my respectful stand that the Court ought to have called the attention of the courts below about this fatal defect and dismissed this case.

The absence of actual facts nesting the claim injury or threats of injury and actual case or controversy is critical for another reason – it deprives the Court of the exact boundaries of the relief to which respondent as then petitioner may perhaps be entitled and the obligations which petitioner now as respondent then must discharge or endure. The result of the our approach here is to establish an overbroad and over-encroaching binding doctrine – here, that the FDA has absolutely no jurisdiction over tobacco, period.

This is a dangerous precedent because we provide here no context as to when this doctrine would or should kick in. The actual facts of the injury or threat of injury would have supplied that limiting context.

By the end of our discussion here, we are unfortunately left with the same issue that this case should have properly resolved had there been actual facts – in what instances would the FDA have jurisdiction over tobacco and in what instances would it have to give way to other agencies' jurisdictions per Section 258 of RA 9711?

By delving and resolving this issue sans actual facts, we might inappropriately adopt a policy decision as legally binding doctrine – I respectfully say a POLICY decision since we totally ease out here the FDA without providing specific relief to a specific injury or threat of injury to respondent.

No doubt, I am crying for actual facts of injury or threat of injury, and of actual case or controversy. The reason is that the delineation of jurisdiction among the concerned administrative agencies, the FDA and the Inter-Agency-Tobacco Committee (under RA 92119) included, is not all clear and brightly divided or apportioned. There are gaps and omissions and obvious difference of opinions on the impact of these gaps and omissions, which would have been clarified by the actual injury or threat of injury that respondent allegedly suffered as a result of the issuance of the assailed FDA implementing rule.

Has the FDA interfered with the advertisement and packaging of and sponsorship by tobacco products? Has the FDA meddled in the identification of smoking areas or the employment of minors in the sale of tobacco products? Has the FDA regulated respondent's tobacco manufacturing or pre-sale activities and if yes in what aspects? We do not and will never know because respondent posthaste filed the petition for declaratory relief just after the issuance of the assailed FDA implementing rule.

Indeed, had we required the statement of an actual case or controversy, inclusive of injury or threat of such injury, we would have clarified the boundaries of the relief we are giving to respondent. However, as things stand, we have decided to totally eliminate the FDA from anything about tobacco without the benefit of an actual case or controversy and without any injury or threat of injury. Courts are not like Congress which does not deal with justiciable controversies and adjudicative facts but policy decisions arising from legislative or social facts involving multitudes of peoples.10 This is not the role of the courts since courts decide matters incrementally on a case-by-case basis.

In his Dissenting Opinion, my esteemed colleague Justice Caguioa insists that an actual case or controversy does not require overt acts showing a violation of one's rights. According to Justice Caguioa, "[t]he only necessary and undisputed fact in this case is the DOH's promulgation of the Rules and Regulations Implementing RA 9711,11 which gives rise to an actual controversy susceptible of judicial resolution." Other than that, facts are not important in the case at bar. In support of his theory, Justice Caguioa invokes the Court's rulings in Samahan ng Progresibong Kabataan (SPARK) v. Quezon City12 and Inmates of the New Bilibid Prison v. De Lima,13 which purportedly rejected the proposition that there should be concrete acts before the case becomes justiciable.

Facts are important. Facts are needed for a contextualization of respondent's arguments using factual and evidentiary bases.

The reason for the need for facts is Section 25 of RA 9711, Food and Drug Administration Act of 2009:

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. (emphases and underscoring added)

Clearly, the FDA is not prohibited from exercising its jurisdiction over health products unless such exercise intrudes into acts covered by the respective charters of other tobacco agencies. Hence, we need facts in this case to determine if the FDA has intruded into the other agencies' jurisdictions.

In other words, if respondent's only fact of interest is the passage of the DOH IRR confirming FDA jurisdiction over tobacco products, this is clearly insufficient. We need more facts if indeed the FDA has intruded into the acts covered by these specialized agencies and laws. This is because not every act of jurisdiction of the FDA over tobacco products is ultra vires for being outside of the FDA's mandate and for being intrusive of other agencies' respective mandates. It depends on the acts of the FDA being complained of. It cannot just be because FDA has been confirmed by the DOH IRR to have some jurisdiction over tobacco and its devices.

Had Section 25 of RA 9711 been clear, categorical, and absolute that FDA had utterly no jurisdiction over tobacco and its devices, the mere enactment of the DOH IRR giving FDA jurisdiction over tobacco and its devices would have been enough to establish an actual case or controversy. This is because the mere enactment is the clear act or conduct that ripens the seeds, if not already the seeds themselves, of violation of another agency's right or mandate.

With all due respect to Justice Caguioa, his reliance on SPARK and Inmates is misplaced. For in these cases, there were clear and concrete acts which made the cases before the Court justiciable, i.e., the controversy was actual and ripe for adjudication.

[f]ollowing the campaign of President Rodrigo Roa Duterte to implement a nationwide curfew for minors, several local governments in Metro Manila started to strictly implement their curfew ordinances on minors through police operations which were publicly known as part of 'Oplan Rody.'... The case is likewise ripe for adjudication, considering that the Curfew Ordinances were being implemented until the Court issued the TRO enjoining their enforcement. The purported threat or incidence of injury is, therefore, not merely speculative or hypothetical but rather, real and apparent. (emphases and undersoring added)

Meanwhile, in Inmates, the Court held that the mere fact of petitioners' incarceration and continued incarceration provided the actual case or controversy even sans the overt act of an actual denial of a good conduct time allowance (GCTA) application. This is because, as the Court expressly stressed, "[w]ith the prisoners' continued incarceration, any delay in resolving the case would cause them great prejudice. Justice demands that they be released soonest, if not on time. . . ."

Verily, neither SPARK nor Inmates supports Justice Caguioa's claim that the only fact necessary here is the issuance of the Rules and Regulations Implementing RA 9711. They do not serve as justification to entertain respondent's petition for declaratory relief. Without the necessary ripening of seeds, the trial court should have dismissed respondent's petition.

I rest my case on the Court's recent ruling in Manning Group Inc. v. Social Security System14 penned by Chief Justice Alexander G. Gesmundo and concurred in by Justice Caguioa, among others, no less. thus:

An actual case or controversy means an existing case or controversy that is appropriate or ripe for determination, not conjectural or anticipatory, lest the decision of the court would amount to an advisory opinion. The rule is that courts do not sit to adjudicate mere academic questions to satisfy scholarly interest, however intellectually challenging. The controversy must be justiciable — definite and concrete, touching on the legal relations of parties having adverse legal interests. In other words, the pleadings must show an active antagonistic assertion of a legal right, on the one hand, and a denial thereof, on the other; that is, it must concern a real, tangible and not merely a theoretical question or issue. There ought to be an actual and substantial controversy admitting of specific relief through a decree conclusive in nature, as distinguished from an opinion advising what the law would be upon a hypothetical state of facts.

Corollary to the requirement of an actual case or controversy is the requirement of ripeness. A question is ripe for adjudication when the act being challenged has had a direct adverse effect on the individual challenging it. For a case to be considered ripe for adjudication, it is a prerequisite that something has then been accomplished or performed by either branch before a court may come into the picture, AND the petitioner must allege the existence of an immediate or threatened injury to himself as a result of the challenged action. He must show that he has sustained or is immediately in danger of sustaining some direct injury as a result of the act complained of.

Here, petitioners did not allege that they already sustained or are immediately in danger of sustaining some direct injury from R.A. No. 11199: The mere passage of the law does not per se absolutely determine the justiciability of a particular case attacking the law's constitutionality. Petitioners did not even allege that the law is already implemented against their interests. They simply gave a broad statement that "[t]he execution of Section 9-B of the 2018 SSS Law will definitely work injustice and irreparable damage to the petitioner manning agencies which are made to answer to so much liabilities as employer when it is not the seafarer's employer." Again, there must be an immediate or threatening injury to petitioners as a result of the challenged action; and not a mere speculation. (emphases and underscoring added)

In Falcis III v. Civil Registrar General,15 the Court also rejected the idea that the mere passage of a law per se makes for an actual case or controversy. Thus:

First, whether or not the mere passage of the Family Code creates an actual case or controversy reviewable by this Court...

It is not enough that laws or regulations have been passed or are in effect when their constitutionality is questioned. The judiciary interprets and applies the law. "It does not formulate public policy, which is the province of the legislative and executive branches of government." Thus, it does not – by the mere existence of a law or regulation – embark on an exercise that may render laws or regulations inefficacious ....

Ultimately, petitions before this Court that challenge an executive or legislative enactment must be based on actual facts, sufficiently for a proper joinder of issues to be resolved. If litigants wish to assail a statute or regulation on its face, the burden is on them to prove that the narrowly-drawn exception for an extraordinary judicial review of such statute or regulation applies.

When faced with speculations – situations that have not yet fully ripened into clear breaches of legally demandable rights or obligations – this Court shall refrain from passing upon the case. Any inquiries that may be made may be roving, unlimited, and unchecked. In contrast to political branches of government, courts must deal with specificities...

It is the parties' duty to demonstrate actual cases or controversies worthy of judicial resolution.

Pleadings before this Court must show a violation of an existing legal right or a controversy that is ripe for judicial determination....

Facts are the basis of an actual case or controversy. To reiterate, "there must be sufficient facts to enable the Court to intelligently adjudicate the issues." Thus, as illustrated in Southern Hemisphere Engagement Network, Inc.:

Petitioners' obscure allegations of sporadic "surveillance" and supposedly being tagged as "communist fronts" in no way approximate a credible threat of prosecution. From these allegations, the Court is being lured to render an advisory opinion, which is not its function....

Here, petitioner has no actual facts that present a real conflict between the parties of this case. The Petition presents no actual case or controversy.

Despite a goal of proving to this Court that there is a continuing and pervasive violation of fundamental rights of a marginalized minority group, the Petition is woefully bereft of sufficient actual facts to substantiate its arguments....

Petitioner presents no proof at all of the immediate, inextricable danger that the Family Code poses to him. His assertions of injury cannot, without sufficient proof, be directly linked to the imputed cause, the existence of the Family Code. His fixation on how the Family Code is the definitive [be]cause of his inability to find a partner is plainly non sequitur.

Similarly, anticipation of harm is not equivalent to direct injury. Petitioner fails to show how the Family Code is the proximate cause of his alleged deprivations. His mere allegation that this injury comes from "the law's normative impact" is insufficient to establish the connection between the Family Code and his alleged injury.

If the mere passage of a law does not create an actual case or controversy, neither can it be a source of direct injury to establish legal standing. This Court is not duty bound to find facts on petitioner's behalf just so he can support his claims. (emphases added)

I further refer to Justice Jardeleza's Concurring Opinion in Falcis III, to which Justice Caguioa also agreed, thus:

The petition presents no actual case or controversy.... Furthermore, a case is ripe for adjudication when the act being challenged has had a direct adverse effect on the individual challenging it. Something must have been accomplished or performed by either branch of Government before a court may come into the picture, and a petitioner must allege the existence of an immediate or threatened injury to him/her as a result of the challenged action.

On its face, it presents a hypothetical and contingent event, not ripe for adjudication, which is hinged on petitioner's future plan of settling down with a person of the same-sex.

Petitioner alleged that "the prohibition against the right to marry the same-sex injures [his] plans to settle down and have a companion for life in his beloved country." Yet as of the filing of the petition, petitioner has no partner. He lamented that his "ability to find and enter into a long-term monogamous same-sex relationship is impaired because of the absence of a legal incentive for gay individuals to seek such relationship." Significantly, however, even if he has a partner, petitioner admitted in open court that it is not automatic that his partner might want to marry him. Thus, petitioner cannot, did not or even attempted to, file an application for marriage license before the civil registry of his residence. (emphases added)

Similarly, respondent herein has never alleged that the IRR of RA 9711 is already being implemented against its interest. Thus, there has yet to be a ripening of seeds which is necessary to confer the courts with jurisdiction over respondent's petition for declaratory relief.

I would like to address the arguments raised for nullifying Article III, Book II of the Implementing Rules and Regulations of RA 9711.

1. The language of RA 9711 does not expressly include tobacco as a health product.

2. Construed in its totality, RA 9711 could not have intended to include tobacco within its regulatory mechanism since its inclusion would result in its prohibition and not merely its regulation, contrary to the legislative intent not to prohibit tobacco but only to regulate it. Prohibition will be the end-result because the FDA is statutorily mandated by RA 3270 as amended by RA 9711 to prohibit a product whose ill-effects outweigh its therapeutic effects, and the FDA has ruled that tobacco has only ill-effects and no therapeutic value whatsoever.

3. Tobacco-specific legislations, especially those expressly mentioned in Section 25 of RA 9711 have divested the FDA of jurisdiction over tobacco.

It is admitted that RA 9711 does not mention expressly tobacco. But this does not mean that RA 9711 does not apply to tobacco. We recognize though that softdrinks fall within RA 9711 because softdrinks can be classified under one of the categories regulated by RA 9711 – food.16

In the same manner, we do not have to search for the word tobacco in RA 9711 to be able to conclude cogently that tobacco falls within the ambit of this statute. So long as tobacco can be categorized under one of the regulated items in RA 9711, just like softdrinks, tobacco falls within the FDA's regulatory regime.

I most respectfully submit that tobacco falls within the definition of drug,17 and cigarette within the definition of device,18 and since both drug and device are also health products, tobacco and cigarette are also health products.19 As such, tobacco and cigarette fall, within the regulatory jurisdiction of the FDA.

The other basis of the ruling that tobacco, and especially cigarette, is not subject to FDA jurisdiction, may be re-stated as follows –

1. The inclusion of tobacco within the regulatory mechanism of RA 9711 would have meant its prohibition and not merely its regulation because tobacco's ill-effects totally outweigh its absent therapeutic value.

2. Under RA 9711 the FDA would have no choice but to ban tobacco from the market because the FDA had already concluded that tobacco had only ill-effects and no therapeutic value.

3. This inevitable action of the FDA – i.e., prohibition of tobacco – would be illegal because contrary to established legislative intent as expressed in Section 25 of RA 971120 and tobacco-specific legislations.

This rationale follows the thought-process in the United States Supreme Court case of Food and Drug Admin. v. Brown & Williamson Tobacco Corp.21 Notably, a statutory amendment to the US FDA's charter was introduced in 2009, The Family Smoking Prevention and Tobacco Control Act (Tobacco Control Act), which expanded the US FDA's authority to regulate the manufacture, distribution, and marketing of tobacco products, to address the otherwise adverse ruling in the Brown & Williamson Tobacco Corp. case and similar cases. Notably, the ruling in Brown & Williamson Tobacco Corp. was not unanimous since a vigorous dissent was registered against the exclusion of tobacco from the US FDA's jurisdiction.

Going to our own FDA, tobacco is a drug: it is an article other than food that respondent knows and offers to be used to affect the structure of any function of the body of humans or animals. The science behind this effect on the structure of any function has been explained in the dissent in Brown & Williamson Tobacco Corp., as follows:

Although I now oversimplify, the FDA has determined that once nicotine enters the body, the blood carries it almost immediately to the brain. See 61 Fed.Reg. 44698-44699 (1966). Nicotine then binds to receptors on the surface of brain cells, setting off a series of chemical reactions that alter one's mood and produce feelings of sedation and stimulation. See id., at 44699, 44739. Nicotine also increases the number of nicotinic receptors on the brain's surface, and alters its normal electrical activity. See id., at 44739. And nicotine stimulates the transmission of a natural chemical that "rewards" the body with pleasurable sensations (dopamine), causing nicotine addiction. See id., at 44700, 44721-44722. The upshot is that **1320 nicotine stabilizes mood, suppresses appetite, tranquilizes, and satisfies a physical craving that nicotine itself has helped to create – all through chemical action within the body after being metabolized.

This physiology—and not simply smoker psychology—helps to explain why as many as 75% of adult smokers believe that smoking "reduce[s] nervous irritation," 60 Fed.Reg. 41579 (1995); why 73% of young people (10- to 22-year-olds) who begin smoking say they do so for "relaxation," 61 Fed.Reg. 44814 (1996); and why less than 3% of smokers succeed in quitting each year, although 70% want to quit, id., at 44704. That chemistry also helps to explain the Surgeon General's findings that smokers believe "smoking [makes them] feel better" and smoke more "in situations involving negative mood." Id., at 44814. And, for present purposes, that chemistry demonstrates that nicotine affects the "structure" and "function" of the body in a manner that is quite similar to the effects of other regulated substances. See id., at 44667 (FDA regulates Valium, NoDoz, weight-loss products). Indeed, addiction, sedation, stimulation, and weight loss are precisely the kinds of product effects that the FDA typically reviews and controls. And, since the nicotine in cigarettes *170 plainly is not a "food," its chemical effects suffice to establish that it is as a "drug" (and the cigarette that delivers it a drug delivery "device") for the purpose of the FDCA.

A cigarette is a health-related device as RA 971122 defines it: any device not used in health care but has been determined by the FDA to adversely affect the health of the people. A cigarette is a drug-delivery device.

Both tobacco and cigarette are health products: they are both "food, drugs, cosmetics, devices. . . " and "products that may have an effect on health which require regulations as determined by the FDA."

Justice Caguioa ripostes that practically all products have an effect on health:

Take for instance firearms, which could arguably fall within this meaning because of the risks it poses to the health and safety of its owner and the public -- not unlike the adverse and harmful effects of tobacco and tobacco products. As well, gasoline, whether ingested or used as fuel for motor vehicles, could be reasonably construed as a health product if the Court were to follow the same line of argument. That said, it is inconceivable to consider these products as health products that the FDA can regulate….

With all due respect, Justice Caguioa is comparing apples and oranges with poison.

The reason why tobacco and cigarettes are under regulation of the FDA is not because they have negative impact on health per se, but because their only purpose is to negatively impact health. Unlike firearms which could be used for safety and protection and gasoline which is an everyday commodity, tobacco and cigarettes simply don't have any other use than poison the body. Thus, our only guide in determining which agency has authority to regulate such product is its sole purpose which is to negatively impact health. Based on this criterion it is the DOH, through the FDA, which has authority to regulate such health product.

b. The FDA has jurisdiction over health products including tobacco and cigarettes

The otherwise expansive jurisdiction of the FDA is tempered by Section 25 of RA 9711. This is admitted even by the FDA itself. Section 25 states:

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.

To reiterate, it is in this portion of the rationale where the allegation and existence of the actual facts of the injury or threat of injury to respondent, if there had been any, assumes supreme importance. The nature of the injury or threat of injury – if otherwise alleged and of course proved – would have determined to what extent the FDA acted ultra vires or encroached the other agencies' respective jurisdictions. This underlying fact is extremely relevant because of the structure itself of Section 25.

Section 25 begins with an acknowledgement and affirmation of the FDA's jurisdiction over health products, which include drugs and devices (therefore tobacco and cigarettes) – "[t]his Act shall govern all health products. . . ."

It is only by way of an exception that it recognizes the jurisdictions of other specialized agencies and specialized laws. This means that without this qualification, RA 971123 would have actually amended or even repealed such statutes as RA 921124 and EO 245.25

In any event, the exception to the expansive FDA jurisdiction is qualified by two important qualifiers:

(i) the other agencies' jurisdiction must be sole and exclusive (Section 25 itself already determined that the jurisdictions under RA 9211 and EO 245 are sole and exclusive); and

(ii) the exception applies "only insofar as the acts covered by these specialized agencies and laws," here, RA 9211 and EO 245.

This means that the expansive FDA jurisdiction applies to tobacco and its derivative products except only insofar as the acts covered by RA 9211 and EO 245. Hence, we cannot immediately divest the FDA of any jurisdiction over tobacco and its derivatives without looking into the acts covered by RA 9211 and EO 245.

More important, we cannot castrate the FDA of any jurisdiction over tobacco and its derivatives solely because this exercise of jurisdiction may actually or effectively result in the prohibition of the sale or use of tobacco and its derivatives or more likely the particular commercial products thereof.

Whether the FDA's exercise of jurisdiction will cause the prohibition of tobacco or its derivatives is not the test of the propriety of the FDA's exercise of jurisdiction, as asserted here. Rather, the test is whether the exception to the FDA's jurisdiction over health products applies.

If particularized injury or threat of injury has been alleged and proved, it would have been easy to determine if the act done by the FDA falls within its RA 9711 jurisdiction or falls within the Section 25 exception for other specialized agencies. The fact is that there are no facts, yet we proceeded to rule on this case as if there were facts constituting an actual case or controversy. Consequently, the resulting doctrines produced, I respectfully submit, are inaccurate and dangerous precedents. They do not address a particularized controversy or dispute but a social and policy decision that for this reason is overbroad and overreaching.

In any event, RA 9211 does not intend to cover the whole subject matter about tobacco. Instead, RA 9211 addresses only these specified acts and/or circumstances:

3. SECTION 7. Prohibition and/or Regulation of Vending Machines, Self-Service Facilities.

4. SECTION 8. Removal of all non-compliant tobacco-related self-Service displays or facilities, advertising, labeling and other items.

6. SECTION 10. Prohibition of Sale of Tobacco Products Within School Perimeters.

16. SECTION 20. Restrictions on Advertising in Audio, Video and Computer Cassettes/Discs and Similar Medium.

23. SECTION 27. Prohibition on the Distribution of Samples of Tobacco Products to Persons Below 18 Years Old.

24. SECTION 33. a. Tobacco Growers' Assistance Program; b. Tobacco Growers' Cooperative; c. National Smoking Cessation Program; d. Research and Development Program; e. National Tobacco-Free Public Education Program; f. Displaced Cigarette Factory Workers' Assistance Program; g. Health Programs; h. Withdrawal Clinics

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

It is glaring that RA 9211 covers only post-production acts when the tobacco or its derivative is ready to be introduced to commerce and its after-effects. Section 30 of RA 9211 is clear on this matter, viz.:

Section 30. Application to Tobacco Products - This provision of this Act shall apply to all tobacco products placed into commerce in the Philippines. xxx (emphasis added)

Justice Caguioa nevertheless argues that the Health Secretary's vice-chairmanship of the IAC-T sufficiently vests said committee with authority to regulate all health aspects relating to tobacco and tobacco products under RA 9211.26

The mere inclusion of the Health Secretary in the IAC-T does not mean that the agency surrenders its regulatory power over tobacco cigarettes in favor of the committee. Too, the policy declaration and statement of general purpose under Sections 2 and 3 of RA 9211 does not convincingly support his theory.27 For under the specific provisions of RA 9211, the IAC-T has very limited concerns in relation to the health impact of tobacco products.

Specifically, the ambit of IAC-T's mandate under RA 9211 refers only to those mentioned therein – Smoking Ban in Public Places; Designated Smoking and Non-smoking Areas; Access Restrictions based on Age; Sale of Tobacco Products Within School Perimeters; Signages; Warnings on Cigarette Packages; Warnings in Advertising; Restrictions on Advertising; Restrictions on Print Media Advertising; Restrictions on Outdoor Advertising; Restrictions on Advertising in Cinemas; Restrictions on Television and Radio Advertising; Restrictions on Advertising in Audio, Video and Computer Cassettes/Discs and Similar Medium; Restrictions on Advertising on the Internet and Similar Medium; Ban on Advertisements; Restrictions on Tobacco Promotions; Naming Rights; Restrictions on Sponsorships; Ban on Sponsorships; Restrictions on Sampling to Minors. There are also Programs and Projects for which the IAC-T are responsible for. As regards health programs, the award of grants to hospitals for researches on smoke-related illnesses is the IAC-T's mandate.

Clearly, RA 9211 does not cover, for example, manufacturing health standards and health-related use standards. These pre-commerce concerns are therefore beyond the regulatory power of the IAC-T and falls squarely within the jurisdiction fo the FDA under RA 9711. To illustrate:

To be sure, none of the provisions of RA 9211 squarely deal with the production and manufacture of tobacco and tobacco products. Surely, it would be a stretch to interpret RA 9211 as authorizing the IAC-T to regulate the production and manufacture of tobacco products when none of its provisions even make reference these activities. Thus, to fill this gap in RA 9211, the provisions of RA 9711 on the general authority of the FDA must come into play.

In fact, President Duterte issued last February 2020 his Executive Order No. 106 entitled PROHIBITING THE MANUFACTURE, DISTRIBUTION, MARKETING AND SALE OF UNREGISTERED AND/OR ADULTERATED ELECTRONIC NICOTINE/NON-NICOTINE DELIVERY SYSTEMS, HEATED TOBACCO PRODUCTS AND OTHER NOVEL TOBACCO PRODUCTS, AMENDING EXECUTIVE ORDER NO. 26 (S. 2017) AND FOR OTHER PURPOSES, which recognized and utilized the FDA's jurisdiction under RA 9711 to deal with Electronic Nicotine and Non-Nicotine Delivery Systems (ENDS/ENNDS) and heated tobacco products (HTPs). Particularly, the role of the FDA was delineated as follows: (i) registration of all e-liquids, solutions or refills forming components of ENDS/ENNDS or HTPs; product standards for all devices forming components of ENDS/ENNDS or HTPs; licensing of all establishments engaged in the manufacture, distribution, importation, marketing and sale of ENDS/ENNDS, HTPs, or their components; licensing of entry/importation of ENDS/ENNDS, HTPs, and their components into the Philippine market.

On the other hand, EO 245 covers acts that are meant to "promote the development of the tobacco industry and to improve the quality of life of all those who depend upon the industry as a source of livelihood, especially the tobacco farmers" (Section 1). The powers and functions28 of the National Tobacco Administration (NTA) are circumscribed by these purposes under Section 2:

a. To improve the economic and living conditions and raise the quality of life of the tobacco farmers including those who depend upon the industry for their livelihood; and

b. To promote the balanced and integrated growth and development of the tobacco industry to help make agriculture a solid basis for industrialization.

Obviously, the NTA under EO 245 does not have jurisdiction over health aspects of tobacco and its derivatives. The NTA is concerned only with acts that can be described as economic and industry-related. Therefore, so long as the FDA does not regulate those acts referred to above as belonging to the NTA, the FDA would be within its right and authority to do so.

In the exercise of its jurisdiction, the FDA cannot act in a manner that would prevent the other specialized agencies from doing the acts covered by their specialized laws, here, RA 9211 and EO 245. This is pursuant to Section 25 of RA 9711.

But whether the FDA has breached this boundary must be resolved on a case-by-case basis.

For example, if a tobacco product has been laced with cyanide or illegal drugs, the FDA would be within its right and jurisdiction to prohibit this product from reaching the market. While this may have an impact on the NTA's mandate to protect the tobacco industry as an economic base for tobacco workers, though a small impact it may be, the resolution of this issue will not depend upon a bright-line rule but the balancing of interests. This inevitably calls for a fact-centered analysis – hence, the necessity for an actual case or controversy and the precise allegation and proof of injury or at least threat of injury. This inquiry cannot proceed on speculations or hypothetical assertions, much less, on the absence of facts as in the present case.

This segues to a clarification of the FDA's jurisdiction. Contrary to our holding, the FDA is not only concerned with a health product's safety and efficacy. There are other equally compelling standards under RA 9711 that the FDA must weigh and consider in the exercise of its jurisdiction. Some of these standards are:

In addition, the FDA is not hamstrung to simply prohibit tobacco and its derivatives. RA 9711 has provided the FDA with an arsenal of remedies and enforcement actions when its standards are breached.29 Before even that point is reached, RA 9711 has mandated FDA to observe procedural fairness before imposing any remedy or enforcement action, which includes coordinating with and hearing other specialized agencies and stakeholders.

Clearly, it is not correct for us to oust the FDA of any and all jurisdiction over tobacco and its derivatives. The language of RA 9711 precludes this conclusion. A sensible and sensitive reading of Section 25, RA 9711 and the specialized jurisdictions of other agencies disproves our conclusion. What is at stake is not an all or nothing proposition, but a nuanced harmonization and congruence of the several jurisdictions at play vis-à-vis the almighty tobacco.

ACCORDINGLY, I vote to grant the petition, reverse and set aside the decisions of the Regional Trial Court and the Court of Appeals, dismiss the petition for declaratory relief, and affirm the validity of Article III, Book II of the Implementing Rules and Regulations of RA 9711.