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04-2025-3134Administrative - FormalClosedFY 2025· Region 04

EPA v. Puraclenz, LLC

Unilateral Administrative Order Without Adjudication

Case summary

FIFRA NORA: 9/2/2025 Notice of Recommendation to Refuse Admission Consignee: Puraclenz, LLC Entry Number: 791-55316495 Product(s): Puraclenz C750 By this memorandum, the U.S. Environmental Protection Agency is notifying the U.S. Customs and Border Protection (CBP) that it is the opinion of the EPA that one or more of the pesticidal products in the shipment 791-55316495 described below, is in violation of the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA, or the Act), as amended, 7 U.S.C. ? 136o(c), and should be refused entry into the United States pursuant to the authority of Section 17(c) of FIFRA as more fully detailed below. The following information pertains to this shipment: Entry Number: 791-55316495 Product Name(s): Puraclenz C750 Shipper/Manufacturer: Comefresh (Xiamen) Electronic Co., Ltd (EPA est. no. 91680-CHN-1) Consignee: Puraclenz, LLC Date of Importation: August 18, 2025 Port of Entry: Port of Memphis, Tennessee It appears that the product is not in compliance with the Act and is subject to refusal of entry into the United States due to the following violation(s): ? FIFRA ? 12(a)(1)(F): To sell or distribute a pesticide device that is misbranded. Specifically, the device does not appear to be labeled in accordance with FIFRA ? 2(q)(1) in that the product label appears to include claims that are false or misleading in relation to the efficacy of the product. See the below resources additional information in regards to making pesticidal claims. Specifically, the product makes claims like, ?Germicidal UV to help deactivate pathogens that enter the device? and ?Actively treats indoor spaces with PCO ionization to deactivate mold spores, bacteria and viruses in the environment.? Claims such as ?germicidal? must be both numerical and qualified as to the specific microorganisms which a device is tested against. Unqualified claims are considered false or misleading pursuant to 40 C.F.R. 156.10(a)(5)(ii) and/or (vii). Please note: each claim of microbial efficacy (e.g., disinfection) by a pesticide device should always be 1) limited to the specific pests which a device is tested against, and 2) accompanied by scientific studies showing evidence that the device in question has accomplished said claim.

Defendants (1)

  • Puraclenz, LLCNamed in settlement

Facilities (1)

  • PURACLENZ LLC

    P.O. BOX 733, OLD GREENWICH, CT, 06870

    Registry ID: 110072071735

Statutes cited

  • FIFRA 12A1FDevice Misbranded

Enforcement conclusions (1)

  • Puraclenz, LLCentered 2025-09-02

    Primary law: FIFRA

Timeline (3 milestones)

  • 2025-09-02Enforcement Action Closed
  • 2025-09-02Final Order Issued
  • 2025-09-14Enforcement Action Data Entered

Case metadata

EPA activity ID
3604524741
Case number
04-2025-3134
Lead agency
EPA
EPA region
04
Voluntary self-disclosure
No
Primary statute
Device Misbranded

Sourced verbatim from EPA ECHO Enforcement Case Report for case 04-2025-3134 . Bulk data: ICIS-FEC download summary.

This is legal information, not legal advice. Laws vary by jurisdiction and change frequently. Always verify current law with official sources and consult a licensed attorney in your jurisdiction for advice on your specific situation.