Case Summary (G.R. No. 240764)
Key Dates
• Enactment of RA 9711 (FDA Act of 2009): August 18, 2009
• Issuance of IRR (Dept. Circular 2011-0101): March 22, 2011
• FDA Personnel Order No. 2014-220: May 28, 2014
• Petition for Certiorari (RTC, Malabon): June 4, 2014
• RTC Order granting preliminary injunction: July 25, 2014
• RTC Decision voiding Order No. 2014-220: September 23, 2015
• CA Decision reversing RTC: February 23, 2018
• CA Resolution denying reconsideration: July 11, 2018
• SC Decision denying petition: November 18, 2021
Applicable Law
• 1987 Philippine Constitution, Art. III, Sec. 2 (unreasonable searches and seizures)
• RA 3720 (Food, Drugs and Cosmetics Act of 1963), as amended by RA 9711 (FDA Act of 2009)
– Sec. 3 (State policy to protect public health)
– Sec. 4(j) (cease-and-desist orders)
– Sec. 10(ff) (definition of “health products”)
– Sec. 12(a) (penalties; ex parte seizure)
– Sec. 30(4) (power to seize hazardous products pending hearing)
• IRR (Dept. Circular 2011-0101)
– Art. III, Sec. 2(b)(5) (quasi-judicial power to seize and hold health products pending hearing)
– Art. VII, Sec. 3 (temporary/preventive measure order; padlocking procedures)
Procedural History
Venus challenged FDA Personnel Order No. 2014-220—which authorized RFO-NCR officers to enter its premises, seize alleged violative watercolors and padlock its establishment—on constitutional grounds (illegal search and seizure, undue delegation, due process). The RTC granted and later made permanent a writ of preliminary injunction, voiding the Order for grave abuse of discretion and lack of due process, citing absence of proof of actual tests. The CA reversed, upholding the FDA’s authority under Sec. 30(4), Sec. 10(ff), and IRR provisions, and impliedly to padlock, as valid exercises of police power and not an undue delegation. SC review ensued.
Issues Presented
- Whether Secs. 12(a) and 30(4) of RA 3720, as amended, and Sec. 2(b)(5), Art. III of the IRR violate the Constitution’s prohibition against unreasonable searches and seizures.
- Whether Sec. 10(ff) constitutes an undue delegation of legislative power.
- Whether FDA Personnel Order No. 2014-220 violated Venus’s rights to due process and against self-incrimination.
- Whether the FDA has implied power to padlock establishments pending hearing.
Unreasonable Search and Seizure (Art. III, Sec. 2)
Warrantless administrative searches are generally invalid unless falling within recognized exceptions. Administrative inspections under police power (“special needs”) are permissible when reasonably related to a regulatory scheme. RA 9711’s Sec. 30(4) and Sec. 12(a)’s seizure-pending-hearing clause authorize warrantless seizure of health products that are adulterated, misbranded, counterfeited or unregistered, provided post-seizure hearings. The FDA acted on laboratory confirmation of lead content far exceeding tolerable limits and verified absence of a manufacturing license and product registration. Given the compelling public health interest—especially to protect children—and the impracticability of securing judicial warrants for urgent public-health threats, these provisions are a reasonable exercise of police power and do not violate the constitutional proscription.
Delegation of Legislative Power (Sec. 10(ff))
Valid delegations require (1) a complete statute expressing legislative policy and (2) sufficient standards to bound the delegate’s discretion. RA 3720 as amended sets forth State policy (Sec. 3), defines “health products” with detailed categories (Sec. 10(ff)), and creates specialized FDA Centers corresponding to those categories. Section 25 explicitly excludes products under other agencies’ jurisdiction. Thus, the law’s terms leave nothing to the FDA except implementation, and sufficiently guide its rule-making. Sec. 10(ff) does not vest unbridled discretion but operates within a comprehensive regulatory structure.
Due Process and Self-Incrimination
Procedural due process is satisfied where post-seizure hearings and prescribed IRR procedures (service of summons/notices; preliminary conferences; position papers) ensure fair opportunity to be heard. Venus was served a Notice of Violation Report and is entitled to the hearings outlined in Art. VII and VIII of the IRR. Self-inc
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Facts of the Case
- EcoWaste Coalition wrote the FDA on April 7, 2014, alleging high lead content in Artex Fine Water Colors manufactured by Venus Commercial Co., Inc. without FDA approval.
- The FDA purchased samples from two branches, laboratory tests confirmed lead levels above permissible limits.
- On May 28, 2014, the Acting Director-General of the FDA issued Personnel Order No. 2014-220 authorizing Regional Field Office–NCR officers to enter Venus’s Malabon premises, inspect, seize the violative products, and padlock the establishment.
- On May 29, 2014, FDA agents attempted to implement the Order, but security guards barred entry; they served a Notice of Violation Report and informed Venus of a future return.
- Venus filed on June 4, 2014 a petition for certiorari and prohibition with application for TRO and preliminary injunction in RTC Malabon (SCA 14-010-MN), challenging:
• The constitutionality of Sections 30(4) and 10(ff) of R.A. 3720 as amended by R.A. 9711, and Section 2(b)(5), Article III of the IRR, as unlawful warrantless search and seizure or undue legislative delegation.
• The validity of FDA Personnel Order No. 2014-220 for violating due process.
Legal Framework / Antecedents
- R.A. 9711 (FDA Act of 2009) amends R.A. 3720 (Food, Drugs and Cosmetics Act of 1963), renaming BFAD to FDA and expanding its police-power functions.
- Key amended provisions:
• Section 10(ff): Defines “health products” to include food, drugs, cosmetics, devices, biologicals, vaccines, in-vitro diagnostic reagents, household/urban hazardous substances, and any product “that may have an effect on health which require regulations as determined by the FDA.”
• Section 12(a): Penalizes prohibited acts; authorizes seizure and custody of violative health products “without hearing or court order” upon reasonable cause.
• Section 30(4): Grants the FDA Director-General authority to issue seizure orders, seize, hold in custody, and padlock facilities pending administrative hearing. - DOH Department Circular 2011-0101 (IRR of R.A. 9711) mirrors and details these powers, including procedures for notice, hearing, and preventive measures.
Procedural History
- RTC Malabon (Branch 74) denied Venus’s TRO, then granted its writ of preliminary injunction by Order of July 25, 2014, finding the FDA Order issued without due process and based on hearsay.
- By