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04-2021-1236Administrative - FormalClosedFY 2021· Region 04

EPA v. 1616 HOLDINGS, INC. (COVID-19)

Unilateral Administrative Order Without Adjudication

Case summary

NOVEMBER 10, 2020 - NOTICE OF REFUSAL OF ADMISSION FIFRA 12(a)(1)(F) To sell or distribute a pesticide device that is misbranded. The device is not labelled in accordance with FIFRA Section 2(q)(1). Specifically, the label appears to contain false or misleading statements concerning the efficacy and safety of the device and did not contain directions for use that would be necessary for effecting the purpose for which the product is intended and if complied with are adequate to protect health and the environment. o Examples of false or misleading claims in the materials provided included: Use of a sanitization claim in conjunction with a claim to control viruses (this may be considered misleading as the EPA has no sanitizer-only products with approved virus claims); Unqualified claims related to the control of disease-causing bacteria and viruses; and Chemical-free. The directions for use did not include instructions specific for disinfection.

Defendants (1)

  • 1616 HOLDINGS, INC.Named in settlement

Facilities (1)

  • 1616 HOLDINGS, INC.

    701 MARKET STREET, SUITE 200, PHILADELPHIA, PA, 19106

    Registry ID: 110070864678

Statutes cited

  • FIFRA 12A1FDevice Misbranded

Enforcement conclusions (1)

  • 1616 HOLDINGS, INC.entered 2020-11-10

    Primary law: FIFRA

Timeline (3 milestones)

  • 2020-11-10Enforcement Action Closed
  • 2020-11-10Final Order Issued
  • 2021-01-05Enforcement Action Data Entered

Case metadata

EPA activity ID
3602370398
Case number
04-2021-1236
Lead agency
EPA
EPA region
04
Voluntary self-disclosure
No
Primary statute
Device Misbranded

Sourced verbatim from EPA ECHO Enforcement Case Report for case 04-2021-1236 . 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.