Counterfeit 3M masks seized by CBP.

Fake Masks
Image of seized masks, source: CBP.gov

U.S. Customs and Border Protection (CBP) Officers at Chicago O’Hare International Mail Branch detained (and subsequently seized) a package from China manifested as containing contents as industrial masks on May 30.

The shipment contained in 24 boxes with each box containing 10 3M brand, 8822 Plus Masks. CBP suspected the masks as counterfeit due to low value, poor quality and poor packaging.

After CBP detained the masks, samples were sent to 3M where the shipment was selected for exam due to x-ray inconsistencies. Inside the parcel were 24 boxes each containing 10 counterfeit 3M 8822 Plus masks. Import Specialists noted the poor packaging, low value, and poor quality. A subsequent 3M authenticator (didn’t know they had those) confirmed the masks were counterfeit – if real, the masks would have an MSRP of $813.

Given the increase in COVID-19 cases, we will likely see more importations of counterfeit PPE, medicine and thermometers.

If you have had your goods seized by Customs, contact import seizure attorney David Hsu by phone/text at 832-896-6288 or by email at attorney.dave@yahoo.com, dh@gjatradelaw.com.

To combat these criminal activities, CBP is targeting imports and exports that may contain counterfeit or illicit goods. The products in targeted shipments often include false or misleading claims, lack required warnings or lack proper approvals.

CBP seizes counterfeit protective equipment and medications.

HAR COVID Rx6L 042120

Image of seized medication, source: CBP.gov

U.S. Customs and Border Protection (CBP) officers seize shipments of counterfeit personal protective equipment (PPE) and medications to treat the corona virus.

Since late March and the height of the corona virus panemdic, CBP has seized, including but not limited to:

-1,200 “Linhua Qingwen” capsules that are not approved by the FDA for medicine in treatment of COVID-19.
-1,350 counterfeit test kits
-400 counterfeit N95 masks
-2,500 possibly counterfeit medicine such as Hydroxychloroquine Sulfate, Chloroquine, Azithromycin, Lianhua Qingwen and Liushen Jiaonang; and
-67,000 counterfeit ACCU-CHEK test strips.

If you have questions about your shipment seized by Customs and you want a free, no cost or obligation consultation, contact by phone/text David Hsu at anytime: 832-896-6288 or by email at attorney.dave@yahoo.com, dh@gjatradelaw.com.

IAD 354 COVID Masks2L 040320

Image of seized masks, source: cbp.gov

New CSMS message about importing personal protective equipment during the COVID-19 public health emergency.

pexels-photo-3962293

Photo by Anna Shvets on Pexels.com

Due to the COVID-19 health crisis and to help facilitate the importation of personal protective equipment (PPE), the FDA issued new instructions for PPE and medical devices through the Cargo Systems Messaging Service. A copy and paste of the entire message is copied below:

 


CSMS #42124872 -Information for Filing Personal Protective Equipment and Medical Devices During COVID-19

The U.S. Food and Drug Administration is providing instruction to the import community regarding the submission of entry information for personal protective equipment and certain other devices. Following the instructions below will help facilitate the import process for all; especially for products related to the Coronavirus Disease-2019 (COVID-19) public health emergency. It is in the best interest of the U.S. to facilitate and expedite the importation of products into the U.S. market that address immediate, urgent public health needs.

For further information regarding entry submission requirements, see the FDA Supplemental Guidance for ACE at https://www.cbp.gov/sites/default/files/assets/documents/2020-Mar/FDA%20Supplemental%20Guide%20Release%202.5.1%202018%200410.pdf.

1. Non-FDA-regulated general purpose personal protective equipment (masks, respirators, gloves, etc.):

Personal protective equipment for general purpose or industrial use (that is, products that are not intended for use to prevent disease or illness) is not regulated by FDA.

For these types of products, entry information should not be transmitted to FDA. At the time of entry for these products, Importers should transmit entry information to US Customs and Border Protection (CBP) using an appropriate HTS code with no FD Flag; or using an appropriate HTS code with an FD1 flag and do a ‘disclaim’ for FDA.

2. Products authorized for emergency use pursuant to an Emergency Use Authorization (EUA)

When importing such products, entry information should be submitted to FDA; however reduced FDA information is required for review.

At the time of entry, Importers should transmit an Intended Use Code of 940.000: Compassionate Use/Emergency Use, and an appropriate FDA product code.

Below is a list of products and the appropriate product codes that are currently authorized by an EUA:

• Diagnostic tests: QPK, OTG, QKO, QJR
• Masks/Respirators: NZJ

Questions regarding appropriate product coding can be submitted to FDA at: COVID19FDAIMPORTINQUIRIES@fda.hhs.gov.

Requests for Emergency Use Authorization can be submitted to FDA at: CDRH-EUA-Templates@fda.hhs.gov (for diagnostic devices) and CDRH-NonDiagnosticEUA-Templates@fda.hhs.gov (for non-diagnostic devices)

3. Products regulated by FDA as a device, not authorized by an EUA, but where an enforcement discretion policy has been published in guidance.

When importing such devices, entry information should be submitted to FDA.

At the time of entry, Importers should transmit an Intended Use Code of 081.006: Enforcement discretion per final guidance, and an appropriate FDA product code.

Below is a listing of guidance documents that have been issued for specific products related to COVID-19, which contain product codes within the scope of each guidance:

• Non-Invasive Remote Monitoring Devices
• Ventilators and Accessories and Other Respiratory Devices

A full list of all guidance documents related to COVID-19 is also available on FDA’s website.

All questions regarding these instructions, or to resolve entry issues for shipments can be submitted to FDA at: COVID19FDAIMPORTINQUIRIES@fda.hhs.gov or 301-796-0356.


 

If you import PPE and have any questions, please do not hesitate to contact experienced trade attorney David Hsu by phone/text at 832-896-6288 or by email at attorney.dave@yahoo.com, dh@gjatradelaw.com.