Title
Venus Commercial Co., Inc. vs. Department of Health
Case
G.R. No. 240764
Decision Date
Nov 18, 2021
Venus challenged FDA's seizure of its product for high lead content, alleging constitutional violations. SC upheld FDA's authority, ruling actions valid under police power for public health.

Case Digest (G.R. No. 240764)
Expanded Legal Reasoning

Facts:

  • Parties; Law and Regulatory Context
    • Petitioner: Venus Commercial Co., Inc. (Venus), manufacturer/distributor of Artex Fine Water Colors.
    • Respondents: Department of Health (DOH) and Food and Drug Administration (FDA).
    • Statutes: RA 3720 (Food, Drug, and Cosmetic Act) as amended by RA 9711 (FDA Act of 2009). Key provisions:
1) Section 4(j): FDA power to issue cease and desist orders (CDOs) motu proprio or upon complaint. 2) Section 10(ff): Definition of “health products.” 3) Section 12(a): Penalties; authority to seize and hold in custody health products pending proceedings without hearing or court order upon reasonable cause. 4) Section 30(4): Authority of the FDA Director-General to issue orders of seizure and hold in custody adulterated, misbranded, unregistered health products pending authorized hearing. 5) Section 30(6): Catch-all power to exercise functions necessary to implement the Act.
  • IRR: DOH Department Circular No. 2011-0101. Key provisions:
1) Article III, Section 2(b)(5): Mirrors Sec. 30(4) authority to seize/hold in custody pending hearing. 2) Article VII, Sec. 3(b)(2): With prior DG approval, Regional Field Director may order padlocking as a temporary/preventive measure.
  • Factual Antecedents; FDA Action
    • April 7, 2014: EcoWaste Coalition informs FDA of alleged high lead content in Artex Fine Water Colors, supposedly sold without FDA approval.
    • FDA conducts post-market surveillance; purchases samples from Merriam-Webster Bookstore (Binondo) and VMZ Guadalupe Shopping Center; laboratory analysis shows lead content exceeds FDA limits by 3,700% and 5,600%.
    • FDA verifies Venus has no license to operate (LTO) as a manufacturer of household/urban hazardous substances; product unregistered with FDA.
    • May 28, 2014: FDA Acting Director-General issues Personnel Order No. 2014-220 authorizing designated officers to:
1) Enter Venus’ premises (10 University Ave., Malabon City). 2) Inspect and, if confirmed manufacturing/distributing Artex watercolors, seize the same. 3) Padlock the establishment.
  • May 29, 2014: FDA agents attempt to implement the Order but are denied entry by security; they serve a Notice of Violation Report and advise return.
  • Proceedings in RTC and CA
    • June 4, 2014: Venus files petition for certiorari and prohibition (SCA 14-010-MN, RTC Branch 74, Malabon) with prayer for TRO/PI, challenging:
1) Constitutionality of Sec. 30(4) and IRR Art. III, Sec. 2(b)(5) as violative of warrant requirement. 2) Constitutionality of Sec. 10(ff) as undue delegation. 3) Validity of FDA Personnel Order No. 2014-220 as violative of due process.
  • PI hearing:
1) Venus’ Operations Manager testifies FDA agents only had Personnel Order No. 2014-220, with no confirmatory test documents; Venus had not been charged administratively. 2) Respondents present no counter-evidence during PI.
  • July 25, 2014: RTC grants writ of preliminary injunction, finding probable due process and search/seizure violations; maintains status quo.
  • Trial:
1) Venus adopts prior testimony; presents no further evidence. 2) FDA presents its biochemist who confirms lab results exceeding allowable lead limits by 3,700% and 5,600%.
  • September 23, 2015: RTC renders decision avoiding constitutional issues; annuls Personnel Order No. 2014-220 for lack of factual showing tying tested samples to Venus’ products and for due process violations; makes injunction permanent insofar as seizure/padlocking.
  • December 4, 2015: RTC denies respondents’ partial MR.
  • CA appeal (CA-G.R. SP No. 144844):
1) February 23, 2018: CA reverses RTC, upholds Sec. 30(4) as police power measure, sustains validity of administrative warrantless search/seizure based on lab findings, upholds Sec. 10(ff) against delegation challenge, and recognizes implied authority to padlock. 2) July 11, 2018: CA denies Venus’ MR.
  • Petition in the Supreme Court (Rule 45)
    • Venus seeks reversal; declaration of unconstitutionality of:
1) Sec. 30(4) and IRR Art. III, Sec. 2(b)(5) for unreasonable searches/seizures. 2) Sec. 10(ff) for undue delegation. 3) FDA Personnel Order No. 2014-220 for violating due process and right against self-incrimination.
  • Additionally challenges Sec. 12(a) for the first time, arguing seizure without warrant will procure evidence for criminal prosecution and supplants neutral magistrate’s warrant function.
  • Respondents (OSG) counter that:
1) Searches are administrative/regulatory, not criminal; benchmark is reasonableness, not traditional probable cause. 2) FDA acted within police power to protect public health; temporary closure is a preventive measure akin to “close now, hear later.”

Issues:

  • Judicial Review Gatekeeping
    • Whether the constitutional challenges, particularly to Sec. 12(a) (raised for the first time on appeal), are cognizable under the requisites of judicial review (earliest opportunity; lis mota).
  • Constitutional Validity of Search/Seizure Scheme
    • Whether Secs. 12(a) and 30(4) of RA 3720, as amended by RA 9711, and IRR Art. III, Sec. 2(b)(5), authorizing seizure/holding in custody and administrative inspection without prior court order, violate the constitutional proscription against unreasonable searches and seizures.
  • Delegation
    • Whether Sec. 10(ff) constitutes an undue delegation of legislative power by allowing FDA to determine products requiring regulation because they “may have an effect on health.”
  • Due Process; Self-Incrimination; Padlocking
    • Whether FDA Personnel Order No. 2014-220 violates procedural/substantive due process or the right against self-incrimination.
    • Whether FDA has authority to padlock establishments pending hearing despite no express “padlock” clause in the statute.

Ruling:

  • (Subscriber-Only)

Ratio:

  • (Subscriber-Only)
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