EPA v. Anesta LLC (0040)

Case summary

The H13 HEPA Filters are misbranded pursuant to FIFRA section 2(q)(1), 7 U.S.C. ? 136(q)(1) because there is no EPA Establishment Number, there are no directions for use, and no caution or warning statements on their label. Therefore, these products are misbranded pursuant to 7 U.S.C. ? 136(q)(1). Importing these products in the shipment referenced above is a violation of FIFRA section 12(a)(1)(F), 7 .S.C. ? 136j(a)(1)(F), as a distribution or sale of a misbranded device. The shipment that arrived at the border for import is also in violation of FIFRA section 12(a)(2)(N), 7 U.S.C. ? 136j(a)(2)(N), because a registrant, wholesaler, dealer, retailer, or other distributor failed to correctly file reports required by the Act. As required by 19 C.F.R. section 12.114, a Notice of Arrival of Pesticides and Devices, EPA form 3540-1, and a copy of one product label must be submitted.

Defendants (1)

• Anesta LLCNamed in complaintNamed in settlement

Facilities (1)

• ANESTA LLC

  4745 WILEY POST WAY, SALT LAKE CITY, UT, 84116

  Registry ID: 110009508461

Statutes cited

• FIFRA 12A2N — Failure to File Reports
• FIFRA 12A1F — Device Misbranded

Enforcement conclusions (1)

• Anesta LLC (0040)entered 2022-07-12

  Primary law: FIFRA

Timeline (3 milestones)

• 2022-07-12Final Order Issued
• 2022-07-12Enforcement Action Closed
• 2022-07-29Enforcement Action Data Entered