Philippine Tobacco Institute v. Dep't of Health

The Philippine Tobacco Institute 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") seeking 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."

Petitioners argued that the new law would cause "grave and irreparable injury" if the IRR went into effect, because it "invalidly expands and modifies the Food and Drug Administration Act as well as the Tobacco Regulation Act by placing the regulation and supervision of tobacco products under the FDA.  The Tobacco Institute further argued that it would "be exposed to an invalid and baseless regulation by government agencies, particularly the DOH and the FDA, which were deprived of any authority and jurisdiction over tobacco products and will consequently entail additional regulatory costs that are neither contemplated under the Food and Drug Administration Act nor the Tobacco Regulation Act."  They also argued that it would be exposed to hefty administrative penalties for possible violations of the IRR even though FDA has no jurisdiction over tobacco products. 

In rejecting Petitioners' application for a Writ of Preliminary Injunction, the Court found that the Tobacco Institute "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."  Because there was no definite or immediate harm to rectify, the Court stated that the law would be presumed constitutional until "otherwise declared by judicial interpretation."


Philippine Tobacco Institute, Inc. v. Dept't of Health, SCA No. 11-0013, Philippines Regional Trial Court Branch 225 Las Pinas City (2011).

  • Philippines
  • Sep 28, 2011
  • Republic of the Philippines National Capital Judicial Region Regional Trial Court Branch 255 Pinas City


Plaintiff The Philippine Tobacco Institute


  • Department of Health
  • Food and Drug Administration

Legislation Cited

International/Regional Instruments Cited

Related Documents

Type of Litigation

Tobacco Control Topics

Substantive Issues

Type of Tobacco Product