EPA v. 3B MEDICAL, INC (COVID-19)

Case summary

9/25/2020 - STOP SALE, USE, OR REMOVAL ORDER ISSUED. ON OR AROUND JULY 9, 2020 TO ON OR AROUND JULY 14, 2020, UNIT INTERNATIONAL, INC. (HEREINAFTER UNIT INTERNATIONAL), THE LICENSED CUSTOMS BROKER FOR 3B, FILED AN ENTRY IN THE CBP ACE SYSTEM FOR THE IMPORTATION OF 2,200 UNITS OF THE PESTICIDE DEVICE LUMIN LM3000, WHICH ARRIVED AT THE PORT OF ATLANTA, GEORGIA ON OR AROUND JULY 6, 2020. NEITHER AN NOA, NOR AN ALTERNATIVE FILING THROUGH THE CBP ACE SYSTEM, WAS SUBMITTED WITH THE ENTRY. EPA CONTACTED UNIT INTERNATIONAL AND 3B TO REQUEST ADDITIONAL INFORMATIONAL AS THE PRODUCT SHIPMENT APPEARED TO BE A PESTICIDE DEVICE. 3B EMAILED A COPY OF THE PRODUCT LABEL FOR RETAIL BOX OF THE DEVICE LUMIN LM3000. EPA DETERMINED THE PRODUCT WAS MISBRANDED IN THAT THE LABEL INCLUDED FALSE AND MISLEADING CLAIMS AND DID NOT INCLUDE THE EPA ESTABLISHMENT NUMBER OF THE MANUFACTURER. ON OR AROUND JULY 15, 2020 TO ON OR AROUND JULY 29, 2020, UNIT INTERNATIONAL CANCELLED THE ENTRY AND SUBMITTED THE ELECTRONIC ALTERNATIVE TO THE NOA IN THE CBP ACE SYSTEM. UPON INSPECTION OF THE SECOND SET OF LABELS SUBMITTED BY 3B, THE EPA DETERMINED THE PRODUCT WAS MISBRANDED IN THAT THE LABELING ON THE RETAIL BOXES OF THE PRODUCT DID NOT INCLUDE AN EPA ESTABLISHMENT NUMBER, THE SHIPPING BOX LABEL INCLUDED AN EPA ESTABLISHMENT NUMBER FOR A DOMESTIC FACILITY INSTEAD OF THE FOREIGN MANUFACTURING FACILITY, AND CONTAINED THE FALSE AND MISLEADING CLAIM ?NO OZONE?. ADDITIONALLY, 3B MEDICAL?S WEBSITE FOR THE PRODUCT WHICH WAS INCLUDED ON THE RETAIL BOXES AND ADVERTISEMENT ON ANOTHER WEBSITE CONTAINED MULTIPLE FALSE AND MISLEADING CLAIMS FOR THE LUMIN LM3000 PRODUCT. ON OR AROUND AUGUST 27, 2020 TO SEPTEMBER 24, 2020, THE EPA NOTIFIED 3B THAT THE PRODUCT WAS MISBRANDED. 3B REQUESTED TO HAVE THE PRODUCTS RELABELED. THE EPA APPROVED THE REQUEST TO RELABEL AT AN EPA-REGISTERED PRODUCER ESTABLISHMENT IN BRASELTON, GEORIGA PURSUANT TO THE ISSUANCE OF A SSURO BY THE EPA ALSO REQUIRING 3B TO REMOVE FALSE AND MISLEADING CLAIMS FROM PRODUCT WEBSITES.

Defendants (1)

• 3B MEDICAL, INCNamed in settlement

Facilities (2)

• COMPASS HEALTH BRAND

  699 BRASELTON PARKWAY, BRASELTON, GA, 30517

  Registry ID: 110070835655

• 3B MEDICAL INC

  203 AVENUE A NW, SUITE 300, WINTER HAVEN, FL, 33881

  Registry ID: 110070836544

Statutes cited

• FIFRA 12A1F — Device Misbranded

Enforcement conclusions (1)

• 3B MEDICAL, INCentered 2020-09-25

  Primary law: FIFRA

Timeline (3 milestones)

• 2020-09-25Final Order Issued
• 2020-09-28Enforcement Action Data Entered
• 2020-12-08Enforcement Action Closed