CBP seizes counterfeit protective equipment and medications.

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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.

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Image of seized masks, source: cbp.gov

CSMS – info for importing PPE and medical devices during COVID-19.

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Photo by cottonbro on Pexels.com

According to Cargo Systems Messaging Service (CSMS #42448725) titled: Information for Filing Personal Protective Equipment and Medical Devices During COVID-19.

Today the FDA provided an update for instructions to importers of personal protective equipment and certain other devices.

General purpose (non-FDA-regulated) personal protective equipment such as masks, respirators, gloves, etc or for industrial use (ie not to prevent disease or illness) is not regulated by the FDA, and as such entry information does not need to be transmitted to the FDA. The entry paperwork only needs to include the correct HTS code and the importer or customs broker should include the FD1 flag and “disclaim” for FDA.

On the other hand, products authorized for emergency use pursuant to an Emergency Use Authorization (EUA) do need to have the entry information submitted to the FDA. During the time of the coronavirus pandemic, however, the FDA information is less than prior to the pandemic.

Goods that are authorized by the EUA include:

· Non-NIOSH-Approved Respirators: 80QKU

· NIOSH-Approved Respirators

· Face Masks (Non-Surgical)

· Diagnostic Tests Kits

· Ventilators

· Face Shields

· Respirator Decontamination Systems

· Extracorporeal Blood Purification Devices

· Infusion Pumps

· Ventilators

· Diaphragmatic Pacing Simulator Systems

The full text of the CSMS can be found here.

If you  have any questions about your upcoming PPE or medical device import or want to ensure you are in compliance, contact experienced trade attorney David Hsu by phone/text at 832-896-62988 or by email at attorney.dave@yahoo.com, dh@gjatradelaw.com.

Unlabeled hand sanitizer seized by Customs.

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Actual image of the seized hand sanitizer, source: CBP.gov

U.S. Customs and Border Protection Officers at the Bridge of the Americas international crossing seized a shipment of unlabeled gel product April 15 that was claimed to be hand sanitizer.

The U.S. citizen was driving a car from Mexico and declared they had personal use quantity of hand sanitizer. During a secondary evaluation, CBP offers found 2,205 unlabeled bottles in the vehicle along with 1,000 unmarked masks. CBP officers declared the shipment a “commercial quantity”.

If you have had a shipment of personal protective equipment or hand sanitizing products seized by CBP during the coronavirus pandemic, contact experienced seizure attorney David Hsu by phone/text at 832-896-6288 or by email attorney.dave@yahoo.com, dh@gjatradelaw.com.

CBP revoke withhold release order (WRO) on disposable rubber gloves.

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Photo by ELEVATE on Pexels.com

According to a U.S. Customs and Border Protection media release, yesterday, CBP revoked a Withhold Release Order (WRO) for rubber gloves imported by WRP Asia Pacific Sdn. Bhd.

Briefly, a WRO is issued by CBP and intended to prevent goods suspected to have been made with forced labor or in violation of labor standards from entering the US.

The WRO, which was initially put in place last September and revoked recently because CBP obtained information demonstrating the company no longer produces rubber gloves under forced labor conditions. The process to revoke a WRO required CBP becoming involved with the manufacturing and labor practices to ensure WRP complied with international and US labor standards.

While the media release made no mention of the corona virus, it is unusual to see a media release singling out a revocation of a withhold release order, especially a WRO on PPE goods  such as disposable rubber gloves.

If you are subject to a WRO and want to explore your options, contact experienced customs attorney David Hsu by phone/text at 832-896-6288 or by email at attorney.dave@yahoo.com, dh@gjatradelaw.com.

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

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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.