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).
Tobacco companies or front groups may challenge any legislative or regulatory measure that affects their business interests. Unlike public interest litigation, these cases seek to weaken health measures. These cases frequently involve the industry proceeding against the government. For example, a group of restaurant owners challenging a smoke free law as unconstitutional.
Subsequent regulations exceed the scope of the originating law.
Type of Tobacco Product
None
Limitations regarding the use of quotes The quotes provided here reflect statements from a specific decision. Accordingly, the International Legal Consortium (ILC) cannot guarantee that an appellate court has not reversed a lower court decision which may influence the applicability or influence of a given quote. All quotes have been selected based on the subjective evaluations undertaken by the ILC meaning that quotes provided here may not accurately or comprehensively represent a given court’s opinion or conclusion, as such quotes may have originally appeared alongside other negative opinions or accompanying facts. Further, some quotes are derived from unofficial English translations, which may alter their original meaning. We emphasize the need to review the original decision and related decisions before authoritatively relying on quotes. Using quotes provided here should not be construed as legal advice and is not intended to be a substitute for legal counsel on any subject matter in any jurisdiction. Please see the full limitations at https://www.tobaccocontrollaws.org/about.
"Accordingly, as national health authority, the Department of Health, along with the Food and Drug Administration, must consider the country's commitments under the WHO FCTC in exercising their regulatory powers over health products. From the standpoint of Republic Act No. 9711, the Constitution, and the WHO FCTC, petitioners acted within their powers in including Book II, Article III (Tobacco Products) in the Implementing Rules. There is no overlap of functions, as it is clear that petitioners have technical authority over matters of public health. At any rate, the Implementing Rules explicitly state that the rules and regulations and other issuances to be promulgated by the Food and Drug Administration will refer to policy areas that are not covered by specialized agencies and special laws."
Limitations regarding the use of quotes The quotes provided here reflect statements from a specific decision. Accordingly, the International Legal Consortium (ILC) cannot guarantee that an appellate court has not reversed a lower court decision which may influence the applicability or influence of a given quote. All quotes have been selected based on the subjective evaluations undertaken by the ILC meaning that quotes provided here may not accurately or comprehensively represent a given court’s opinion or conclusion, as such quotes may have originally appeared alongside other negative opinions or accompanying facts. Further, some quotes are derived from unofficial English translations, which may alter their original meaning. We emphasize the need to review the original decision and related decisions before authoritatively relying on quotes. Using quotes provided here should not be construed as legal advice and is not intended to be a substitute for legal counsel on any subject matter in any jurisdiction. Please see the full limitations at https://www.tobaccocontrollaws.org/about.
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.