Dep't of Health v. Philippine Tobacco Institute

In 2011, the Philippine Tobacco Institute (PTI) sued for declaratory relief, seeking to set aside the "Implementing Rules and Regulations of the Republic Act No. 9711" (otherwise known as the "Food and Drug Administration Act of 2009" or "IRR").  PTI sought to prohibit the Department of Health and the Food and Drug Administration of the Philippines from implementing the IRR "insofar as it relates to the regulation of Tobacco Products." The Court held the law constitutional and explained that the PTI "failed to establish an existing right that was violated" and that any "alleged damage or injury the subject IRR would cause is merely speculative and prospective in nature." 

On January 27, 2012, the Regional Trial Court ruled on the merits and granted PTI's petition, voiding the IRR insofar as it regulated tobacco products and the tobacco industry.  PTI argued that they should be principally regulated by the Inter-Agency Committee on Tobacco as provided for by the Tobacco Regulation Act of 2003 (IAC-Tobacco) and the court agreed that it was improper for the DOH or FDA to regulate tobacco products outside of IAC-Tobacco.

On March 29, 2012, the DOH and FDA filed a Petition for Review to the Supreme Court. On July 13, 2021, the Supreme Court granted the Petition, reversing and setting aside the 2012 decision which nullified certain provisions of the IRR insofar as it regulated tobacco products and the tobacco industry. The Supreme Court held that (1) Section 25 of the IRR does not exclude the regulation of the health aspects of tobacco products from the FDA's authority and (2) tobacco products are "health products" under the definition provided under Section 10(ff) of Republic Act No. 3720, as amended by Section 9 of the IRR. The Supreme Court stated that principal regulation by IAC-Tobacco would be contrary to law and the international obligations of the Philippines. The Supreme Court held the given IRR, the Constitution, and the WHO Framework Convention on Tobacco Control, petitioners have technical authority of matters of public health and therefore, regulation of the health aspects of tobacco products fall under the FDA's authority.


Dep't of Health v. Philippine Tobacco Institute, Inc., GR No. 200431, Republic of the Philippines Supreme Court (2021).

  • Philippines
  • Jul 13, 2021
  • Republic of the Philippines Supreme Court



  • Senator Frankline "Frank" M. Drilon
  • Senator Pilar Juliana "Pia" S. Cayetano
  • The Department of Health, represented by Sen. Enrique T. Ona The Food and Drug Administration, represented by Dir. Suzette Henares-Lazo


  • Philippine Tobacco Institute, Inc.
  • Representative Edcel C. Lagman

Legislation Cited

International/Regional Instruments Cited

Related Documents

Type of Litigation

Tobacco Control Topics

Substantive Issues

Type of Tobacco Product