G.R. No. 200431 , July 13, 2021
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. REPRESENTATIVE EDCEL C. LAGMAN, RESPONDENT-INTERVENOR.

FACTS

The Department of Health (DOH) and the Food and Drug Administration (FDA) filed a petition for review on certiorari seeking to reverse the Decision of the Regional Trial Court of Las Piñas City, which declared void the provisions of the Rules and Regulations Implementing Republic Act (R.A.) No. 9711 (the FDA Act of 2009) insofar as they regulate tobacco products and the tobacco industry. The respondent, Philippine Tobacco Institute, Inc. (PTI), assailed these provisions for including tobacco within the FDA’s regulatory authority. Petitioners and petitioner-intervenors argue that the FDA’s mandate and the definition of “health products” under R.A. No. 9711 are broad enough to encompass tobacco products. PTI contends that R.A. No. 9711 does not cover tobacco, and the DOH overstepped its quasi-legislative authority by including it in the implementing rules.

ISSUE

Whether the case presents an actual case or controversy ripe for adjudication, and whether the DOH, through the FDA, acted within its rule-making authority under R.A. No. 9711 by regulating tobacco products.

RULING

In his dissenting opinion, Justice Caguioa disagrees with the ponencia’s grant of the petition. He argues that the requirement of an actual case or controversy is satisfied in this case. There is a contrariety of legal rights between the parties based on their conflicting interpretations of R.A. No. 9711 and the validity of the DOH’s implementing rules. The issue is ripe for adjudication because the challenged regulation has a direct adverse effect on PTI’s member companies, who would have to comply with FDA regulations if the provisions are upheld. The dissent emphasizes that an actual case may exist even without overt acts, as the mere enactment or issuance of a challenged rule can ripen a judicial controversy. The dissent maintains that the DOH cannot expand the application of R.A. No. 9711 through its implementing rules to include tobacco regulation, as this effectively amends the law—a power reserved for Congress.