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) promulgated Article III, Book II of the FDA Implementing Rules and Regulations (IRR), which listed tobacco products as health products and asserted the FDA’s regulatory jurisdiction over them. The Philippine Tobacco Institute, Inc. challenged this, arguing that the DOH and FDA exceeded their rule-making authority.

ISSUE

Whether the DOH and FDA exceeded their rule-making powers in promulgating the FDA IRR provisions that list tobacco products as health products and carve out the FDA’s regulatory jurisdiction over them.

RULING

The dissenting opinion maintains that the DOH and FDA exceeded their rule-making powers. The reasoning is as follows:
1. Republic Act (RA) No. 9711 (The FDA Act of 2009) does not purport to regulate tobacco products. The law’s text does not mention tobacco products, define them, or declare a special treatment for them as a specific health concern. Its policy objectives are to strengthen the FDA’s regulatory capacity for food, medicine, and health products to ensure public safety. While delegation to the FDA to determine what constitutes health products is proper, the inclusion of tobacco in the IRR goes beyond RA 9711’s purview. Unlike the explicit delegation in the Reproductive Health Law (RA 10354) affirmed in Imbong v. Ochoa, Jr., Congress made no such delegation regarding tobacco in RA 9711. The FDA and DOH effectively determined, on their own, that tobacco products are health products subject to FDA regulation.
2. The FDA IRR provisions on tobacco unduly expand RA 9711 and are inconsistent with it and other laws. The power to promulgate implementing rules is limited to what is found in the law itself; it cannot extend or expand the law’s coverage, as that power resides solely in the Legislature (MCC Industrial Sales Corporation v. Ssangyong Corporation). Had Congress intended FDA regulation of tobacco, it could have explicitly done so, as it has in previous legislation (e.g., RA 9211). Furthermore, administrative acts are valid only when not contrary to law (Article 7, Civil Code). The IRR’s expansion of the FDA’s jurisdiction to cover tobacco products, which are not institutions or programs of higher learning, is analogous to the invalid expansion of jurisdiction struck down in Review Center Association of the Philippines v. Ermita.
3. The inclusion of tobacco products contradicts the specific proviso in RA 9711 and existing tobacco-specific legislation. RA 9711 contains a proviso stating it shall not apply to products already regulated by special laws or other government agencies. Tobacco is specifically regulated by other laws such as RA 9211 (Tobacco Regulation Act) and RA 10643 (Graphic Health Warnings Law), and involves other agencies like the National Tobacco Administration. Allowing the FDA IRR to govern tobacco would create a conflict with these existing, specific regulatory schemes.
In conclusion, the dissenting opinion finds that the challenged provisions of the FDA IRR improperly expand the law, are inconsistent with its terms, and contravene other statutes, thereby constituting an excess of the administrative rule-making power.