Port of Anchorage (3126) closed Thursday and Friday due to the coronavirus.

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According to the CBP Cargo Systems Messaging Service (#42243866), the Port of Anchorage, Alaska (port code 3126) located at 604 West Avenue, Anchorage, Alaska will close for the rest of the week due to an employee testing positive for COVID-19. The CSMS says the port may close for a total of 14 days.

Customs, trade, import/export or compliance question? Contact 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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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.

No FDA import alert updates for kratom.

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The FDA frequently modifies alerts for food imports on their website here. For the most recent update on June 18, 2019, the entry for “DIETARY SUPPLEMENTS AND BULK DIETARY INGREDIENTS THAT ARE OR CONTAIN MITRAGYNA SPECIOSA OR KRATOM” remains unchanged.

Will update if/when the FDA modifies their import alert for kratom. If you have any kratom related import questions, contact experienced import attorney David Hsu by text/call on David’s mobile, 832-896-6288 or by email at his personal email: attorney.dave@yahoo.com or work address: dh@gjatradelaw.com.

FDA OKs Import of Genetically Engineered Salmon.

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As reported from WebMD, I know, not exactly the authoritative source on import law. However, I checked and they are correct. On March 8th, the FDA issued a press announcement “deactiviting” an import alert from 2016. Full link to the press announcement can be found here.

Import alerts are bulletins that notify U.S. Customs and Border Protection (CBP) of potentially dangerous foods and drugs that are prohibited from entering the US.

The 2016 import alert on genetically engineered salmon became active until the FDA finalized labeling guidelines to inform consumers the product they were consuming was genetically engineered. At that time in 2016, Congress passed a law directing the U.S. Department of Agriculture (USDA) to create a labeling standard for bioengineered food. As the USDA issued their food labeling standards in December of 2018, the FDA determined they did not have the labeling authority and as such, there is no need for the import alert.

Ironically, genetically engineered salmon is now safe for import to the US but kratom is not.