Kratom contaminated with salmonella seized by CBP.

Image of kratom powder, source: CBP.gov

According to a U.S. Customs and Border Protection’s (CBP) media release, CBP officers in Detroit seized more than a half ton of “salmonella-laced Kratom” at the Fort Street Cargo Facility.

Author’s comment: the original headline was “CBP Seizes Half Ton of Salmonella-Laced Kratom“. Not sure why they used the word “laced” in the headline as lacing something is typically used to mean adding an ingredient to bulk up a drug. I am unsure how a kratom exporter can “lace” kratom with salmonella on purpose or if there would be a benefit to doing so. Additionally, the use of the word “lace” to describe kratom may also be an effort to associate kratom as dangerous as other illegal drugs that are frequently laced such as crack, heroin, PCP, etc.

The media release reports 1,200 pounds of contaminated powder (valued according to CBP at $405,000) was selected for further inspection due to an unusual description and classification discrepancies.

CBP said the kratom “which originated from China, were manifested as botanical soils from Canada, though Officers and specialists believed it to be consistent in appearance to bulk green tea”.

Author’s comment: this is the first time I have heard of kratom from China, maybe it was transhipped from Indonesia? CBP did not indicate the “classification discrepancy” or point out what HTSUS code was used to enter the kratom.

CBP took a sample of the power and sent it to the Food and Drug Administration for lab tests – which confirmed the shipment was kratom but also saw it was contaminated with salmonella. As a result, CBP seized the shipment “due to significant risk to public health and safety”.

Author’s comment: CBP does not specify the import alert on kratom as the basis for seizure. I have not seen the seizure notice (it will only be sent to the importer of record), but it was likely seized for not being described as kratom on the shipping documents.

In the last paragraph of the CBP media release, they write:

Kratom is a tropical tree native to Southeast Asia, and its leaves are often ingested in the form of tea. Depending on dosage, Kratom can produce both stimulant and sedative effects. Kratom is not a scheduled substance under the Controlled Substances Act, though the Drug Enforcement Administration currently lists it as a Drug or Chemical of Concern.

It is interesting they do not mention the 2016 import alert regarding kratom. If you have had your shipment of kratom (mitragyna speciosa) seized by CBP, contact David Hsu, 24/7 by phone/text at 832-896-6288 or by email at attorney.dave@yahoo.com, dh@gjatradelaw.com.

Birmingham CBP seizes unapproved thermometers.

Image of seized thermometers, source: CBP.gov

CBP officers in Birmmingham seized 500 unregistered non-contact and infrared thermometers with country of origin as Malaysia or China. If genuine articles, the value of the shipment would have totaled $21,400.

The thermometers did contain the Food and Drug Administration (FDA) markings on the packaging and the devices, but the shipment was still seized as the shipping company was not registered with the FDA when the thermometers were imported. The registration of the shipping company is required as part of the pre-market notification process under section 510(k) of the Food, Drug and Cosmetic Act.

According to CBP, so far this year they have seized 107,000 illegal COVID-19 test kits, 11,000 doses of chloroquine and more than 750,000 counterfeit masks. Given the current increase in COVID-19 hospitalizations, CBP will likely be seizing more thermometers, face masks and chloroquine in the near future.

If you have had your goods seized by Customs, contact seizure attorney David Hsu to discuss your options anytime by mobile phone at 832-896-6288 or by email at attorney.dave@yahoo.com, dh@gjatradelaw.com.

Unauthorized COVID-19 medicine seized.

Seized COVID-19 medicine, source: CBP.gov

U.S. Customs and Border Protection (CBP) officers seized 360 pills of medicine marketed to treating COVID-19. The medicine was a violation of U.S. Food and Drug Administration (FDA) rules preventing unauthorized medical treatments that may mislead consumers by making false claims to prevent or treat diseases or may in fact harm the consumer.

The FDA is especially concerned with unauthorized COVID-19 treatments that are marketed towards curing, treating or preventing serious illnesses.

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

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

Fake Cialis and Viagra Pills Seized by CBP.

Counterfiet Cialis 1

Counterfeit medication from Turkey; source: CBP.gov

U.S. Customs and Border Protection (CBP) officers in Kentucky seized counterfeit Cialis and Viagra pills in Kentucky. The shipment from Turkey was destined to a city in California and labeled as “throat lozenges and candies”. However, CBP’s experienced officers looked at the totality of the circumstances and determined the route of the shipment and the packaging of the pills were indicative of being counterfeit pills.

Customs warns consumers of the dangers of buying counter medicines – which may have the incorrect or harmful ingredients.

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

More counterfeit COVID-19 test kits seized.

Test Kit 1

Image of seized COVID-19 test kit, source: CBP.gov

U.S. Customs and Border Protection (CBP) officers in New Jersey seized another shipment containing counterfeit COVID-19 test kits. A secondary inspection of the shipment discovered 25 COVID-19 test kits not approved by the U.S. Food and Drug Administration (FDA). This seizure was just 25 out of the 600 COVID test kits seized at the Rochester airport.

All imported test kits are presumed to lack FDA approval as the FDA has only allowed 50 companies to develop and distribute the COVID test kits and the companies that manufactured the seized test kits have not been approved.

*****

My guess for the large number of imports and seizures of the test kits are due to family members overseas sending kits to their family in the US who want to be sure they do not have the virus and pass on to older family members.

If you have had your good seized by customs and want to know what you can do next, contact experienced seizure attorney David Hsu by phone at 832-896-6288 or by email at attorney.dave@yahoo.com, dh@gjatradelaw.com.

35 pounds of counterfeit Xanax seized by Customs.

Xanax 2

Image of seized Xanax, source: CBP.gov

Last week, U.S. Customs and Border Protection (CBP) officers in the Champlain Port of Entry seized 35 pounds of counterfeit Xanax among 27 shipments.

The shipments were unlabeled pills but resembled the anxiety drug. Afterwards, CBP sent the pills for testing and were determined to contain the properties of Xanax. As Xanax is a schedule 4 controlled substance and cannot be shipped to the US without a prescription.

If you have had your shipment seized, contact David Hsu for a free consultation by phone/text at 832-896-6288 or by email at attorney.dave@yahoo.com or dh@gjatradelaw.com.

CBP seizes non-FDA compliant thermometers.

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Photo by Anna Shvets on Pexels.com

According to a U.S. Customs and Border Protection media release, CBP officers in El Paso’s Bridge of the America’s facility seized a shipment of “pyrometers” (infrared forehead thermometers) with a value of over $7,000.

Upon examination, the CBP officers found the pyrometers to be non-compliant with FDA regulations. It is important for FDA compliance on these types of thermometers because they can give false readings if they do not meet strict FDA requirements.

If you have had your goods seized for non-FDA compliance, or if you have any questions about ensuring FDA compliance BEFORE you import, contact experienced import and export attorney David Hsu at 832-896-6288 or by email at attorney.dave@yahoo.com or 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.

Costco approved as FDA’s first Voluntary Qualified Importer Program (VQIP) company.

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Photo by Alexander Isreb on Pexels.com

Costco Wholesale was approved by the U.S. Food and Drug Administration (FDA) as the first company in the FDA’s Voluntary Qualified Importer Program (VQIP).

The VQIP is a voluntary fee-based program ($16,681 FY2020) that helps expedite the review and importation of foods into the US. One main requirement is for importers to demonstrate they maintain control over the safety and security of the supply chain. As the supply chain reaches overseas, most food importers such as Costco need to ensure the locations of their foreign suppliers are certified by the FDA’s third-party certification program.

If you are a food importer and want to take advantage of benefits offered by being a VQIP, contact experienced customs and trade law attorney David Hsu by phone/text at 832-896-6288 or by email at attorney.dave@yahoo.com, dh@gjatradelaw.com.