Case Digest (G.R. No. 200431)
Facts:
On July 13, 2021, the Supreme Court, En Banc, promulgated its decision in G.R. No. 200431, resolving a petition by the Department of Health (DOH), represented by Secretary Enrique T. Ona, and the Food and Drug Administration (FDA), represented by Director Suzette Henares-Lazo. In 2009, Congress enacted Republic Act No. 9711 (the FDA Act of 2009), strengthening the FDA’s regulatory capacity over “health products.” In 2011, the DOH and FDA jointly promulgated the Implementing Rules and Regulations (IRR) of RA 9711, classifying tobacco products as “health products” under Book II, Article III. The Philippine Tobacco Institute (PTI) promptly filed for declaratory relief and a temporary restraining order in the Regional Trial Court (RTC) of Las Piñas City to void those provisions, arguing that under the Tobacco Regulation Act of 2003 (RA 9211) and by virtue of Section 25 of RA 9711, the FDA lacked jurisdiction over tobacco. After denying injunctive relief, the RTC ruled on January 27,Case Digest (G.R. No. 200431)
Facts:
- Evolution of the FDA and IRR
- 1963: RA 3720 creates Food and Drug Administration under DOH.
- 1982–1987: Bureau abolished, functions transferred; EO 175 amends RA 3720.
- 2009: RA 9711 renames Bureau as FDA, expands to all health products; Sec. 22 directs DOH-FDA to issue IRR within 120 days.
- 2011: DOH-FDA issues Implementing Rules including classification of tobacco as “health products.”
- Litigation over tobacco regulation
- PTI files declaratory-injunction petition in RTC, challenging IRR as beyond RA 9711 and contrary to RA 9211 (Tobacco Regulation Act) and IAC-Tobacco’s exclusive jurisdiction.
- RTC (Branch 255, Jan 27 2012) voids IRR provisions on tobacco, ruling RA 9711 excludes tobacco and defers to IAC-Tobacco under RA 9211.
- DOH-FDA petitions SC for certiorari; PTI, Senators Cayetano/Drilon, and Rep. Lagman intervene.
- Legislative and treaty context: WHO FCTC ratified (2005), various DOH memos and AO’s on tobacco industry interference, RA 10351 (Sin Tax), RA 10643 (Graphic Health Warnings).
Issues:
- Whether Sec. 25 of RA 9711 excludes regulation of health aspects of tobacco products from FDA authority.
- Whether tobacco products qualify as “health products” under Sec. 10(ff) of RA 3720, as amended by RA 9711.
Ruling:
- (Subscriber-Only)
Ratio:
- (Subscriber-Only)
Doctrine:
- (Subscriber-Only)