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

In 2009, Republic Act No. 9711 , the Food and Drug Administration (FDA) Act, was enacted, reinforcing the regulatory capacity of the Bureau of Food and Drugs, which was renamed the FDA. In 2011, the Department of Health (DOH), in coordination with the FDA, promulgated the Implementing Rules and Regulations (IRR) of RA 9711. The Philippine Tobacco Institute, Inc. (PTI) filed a Petition for Declaratory Relief before the Regional Trial Court (RTC) seeking to prohibit the enforcement of the IRR and to declare it void for allegedly disregarding RA 9711 and RA 9211 (Tobacco Regulation Act of 2003). PTI argued that under RA 9211, the Inter-Agency Committee on Tobacco (IAC-Tobacco) had exclusive jurisdiction over tobacco products, including their health aspect, and that Section 25 of RA 9711 prohibited the FDA from regulating health products already under other agencies. PTI specifically contested Book II, Article III of the IRR, which classified tobacco products as “health products” and placed them under FDA authority, and provisions on licensing, labeling, and advertisements. The DOH and FDA insisted on their regulatory authority, arguing tobacco products are “health products” under RA 9711 due to their harmful effects and that the FDA retains jurisdiction over matters not covered by special laws. The RTC granted PTI’s petition, ruling that tobacco products were excluded from RA 9711’s coverage and that the DOH and FDA improperly included them in the IRR, encroaching on the IAC-Tobacco’s exclusive authority under RA 9211.

ISSUE

Whether the Food and Drug Administration, under Republic Act No. 9711 , has regulatory authority over tobacco products, particularly concerning their health aspects, or if such authority resides exclusively with the Inter-Agency Committee on Tobacco under Republic Act No. 9211 .

RULING

The Supreme Court ruled that tobacco products are “health products” under RA 9711 due to their harmful effects on health and, as to their health aspect, fall under the regulatory authority of the FDA. The Court held that Section 25 of RA 9711 does not grant exclusive jurisdiction to other agencies over all aspects of a product; it only prohibits the FDA from modifying the jurisdiction of other agencies “insofar as the acts covered by these specialized agencies and laws.” The FDA retains authority over the health aspects of products, even those regulated by other laws like RA 9211. The Court found that the DOH and FDA validly exercised their rule-making power in promulgating the IRR. The provisions on protection against tobacco industry interference were deemed consistent with the state’s constitutional mandate to protect public health and the Philippines’ commitments under the WHO Framework Convention on Tobacco Control. The RTC decision was reversed.