The opinions expressed are those of David Hsu and do not necessarily reflect the views of the firm, its partners, or its clients. The information in this blog is for general information purposes only and is not intended to be and should not be taken as legal advice on any subject. No recipient of content from this site, clients or otherwise, should act on the basis of any content in this site without seeking the appropriate legal or professional advice based on the particular facts and circumstances at issue from an attorney licensed in the recipient's state.
According to the Food and Drug Administration (FDA) announcement today (Thursday, February 2, 2023); imports of products made by Indian healthcare company, Global Pharma Healthcare Private Limited and sold under the brand names “EzriCare” or “Delsam Pharma” are restricted from importation to the US.
The import ban is a result of a recall of the eye drops due to violations of manufacturing regulations by the manufacturer, lack of microbial testing and concerns over tamper-evident packaging. The violations have led to a potential bacterial contamination that increases the risk of eye infections that may result in blindness or even death.
The U.S. Centers for Disease Control and Prevention claims at least 55 people around the US have been impacted by the bacterial contamination. So far one person has died from the infection and 5 of 11 patients with infections in their eyes have lost their vision.
The eye drops are top sellers on Amazon and also available through Walmart. If you or your company are on the FDA “red list”, contact attorney David Hsu by phone/text at anytime, 832-896-6288 or by email at attorney.dave@yahoo.com; dh@gjatradelaw.com.
Since the start of 2022, U.S. Customs and Border Protection (CBP) officers have seized 21 shipments of improperly imported erectile dysfunction medicine such Viagra, Cialis, and Levitra through the Port of Cincinnati. For the month of January, Officers seized approximately 32,556 pills of the prescription drugs in shipments of vitamins, supplements, watches, and other medications. In addition to being in pill form, seized shipments also contained over 1,000 packets of various jellies and honey containing sildenafil – the active ingredient in Viagra.
CBP seized the goods even though they were sold as “dietary supplements”. Additionally, only 3 percent of pharmacies overseas reviewed by the National Association of Boards of Pharmacy are in compliance with U.S. pharmacy laws and practice standards – highlighting the risk of purchasing drugs online.
CBP recommends people think with their mind and not their wallet when purchasing prescription medications overseas because many are made in facilities that do not meet good manufacturing practices. Also, CBP says there are few measures in place to ensure the goods are manufactured correctly and may be potentially dangerous when consumed.
If you want to import medication from overseas, contact our office before you begin shipments. Contact David Hsu by phone/text at all times to: 832-896-6288 or by email at attorney.dave@yahoo.com.
In late October, U.S. Customs and Border Protection (CBP) officers along with the U.S. Food and Drug Administration (FDA) Office of Criminal Investigation special agents and FDA consumer safety officers seized nearly half a million dollars worth of nearly 26,000 pairs of counterfeit contact lenses. Contact lenses are regulated by the FDA and CBP is the enforcement mechanism.
The CBP media release further highlighted the dangers of purchasing counterfeit goods to the American consumer. If you have had your goods seized on suspicion of being counterfeit, contact seizure attorney David Hsu by phone/text at 832-896-6288 or by email at attorney.dave@yahoo.com
According to a U.S. Customs and Border Protections media release, officers in Indianapolis over 10,000 Juul Pods shipped from Ontario, Canada to New York and New Jersey. The shipments were seized because they were misbranded consumer goods imported by an unauthorized agent.
The Federal Food, Drug, and Cosmetic Act (FD&C Act) governs the importation of e-cigarettes and other tobacco products. However, the basis of this seizure was likely under 19 USC 1499(a)(3)(a) unspecified articles and 19 USC 1595(c)(1) merchandise introduced contrary to law because the packages were labeled as an “electrical apparatus”.
If you have had your goods seized and you received a seizure notice alleging violations of 19 USC 1499 and 19 USC 1595, contact David Hsu by phone/text at 832-896-6288 or by email at attorney.dave@yahoo.com.
According to a U.S. Customs and Border Protection (CBP) media release, CBP officers at Chicago O’Hare seized 50,000 vaping pens from Hong Kong.
The “dragster Mountain Vape Pens” were seized because they violate the Federal Food, Drug, and Cosmetic Act (FD&C Act) regarding the importation of tobacco products – specifically for being misbranded and for being imported by an unauthorized agent. Typically this means an importer is not authorized to import goods (that may be counterfeit).
According to the Customs media release, Customs believes the shipment was intentionally and improperly mislabeled as “lithium ion batteries” to avoid seizure.
While not reported in the Customs media release – shipments that are mislabeled are typically seized under statute 19USC1499(a)(3)(A), copied below:
(3)Unspecified articles If any package contains any article not specified in the invoice or entry and, in the opinion of the Customs Service, the article was omitted from the invoice or entry—(A) with fraudulent intent on the part of the seller, shipper, owner, agent, importer of record, or entry filer, the contents of the entire package in which such article is found shall be subject to seizure; or
19USC1499(a)(3)(A) is a catch all statute Customs frequently uses to seize any goods that are not included in paperwork. Omissions or mis-representations on the paperwork (regardless of goods being imported) is the easiest way for Customs to seize shipments. If you are in the import business – be sure the exporter is correctly declaring the shipment and are following your import compliance manual and procedures.
If you import and don’t have a compliance manual or procedures – contact me, you need one, 832-896-6288.
Going back to the vape pens – Customs will likely not release these goods as the FDA has increasingly cracked down on the importation of these vape pens and other nicotine delivery systems. The alleged counterfeit nature of the pens and the mislabeling of the shipment will likely mean these vape pens will not be released.
If you have had your goods seized by Customs, contact seizure attorney David Hsu immediately by phone or text at 832-896-6288 or by email at attorney.dave@yahoo.com.
As the year ends, the 2020 COVID lockdowns has resulted in increased seizure by U.S. Customs and Border Protection (CBP) of face masks, un approved testing kits, unlabeled medicine, non-FDA approved treatments, etc.
Image of non-FDA approved COVID-19 test kits, source CBP.gov
In the past month, CBP has seized:
6,080 counterfeit 3M masks in Cincinnati labeled as “3M Disposable Respirators Model 8210”. The shipment from Hong Kong was scrutinized by CBP because the country of origin marking on the outside of the box was labeled as “Made in the USA”. CBP officers determined the 3M masks were counterfeit and seized the goods before they were to be sent to Kingston, Jamaica.
CBP officers in San Diego seized a shipment containing 251 non-FDA approved COVID-19 test kits from Mexico. The shipment caught the attention of CBP because the kits were manifested as plastic cards. Over 251 test kits divided among two packages were seized and likely to be destroyed.
In another shipment, CBP officers in El Paso seized more than 100,000 counterfeit 3M N95 surgical masks for use by hospital workers. If authentic, the N95 surgical masks carried an MSRP of $600,480.
If you have had your COVID-related goods seized by Customs, contact customs seizure attorney David Hsu by phone/text at 832-896-6288 or by email at attorney.dave@yahoo.com.
“The seizure of these counterfeit surgical masks not only ensures the health and safety of our frontline health care workers by preventing them from receiving inferior personal protective equipment, it also protects the integrity of the American economy. We will continue to aggressively investigate, arrest and prosecute criminal counterfeiters who show a total disregard for human life and take advantage of a relentless world pandemic for economic gain.” said Erik P. Breitzke, acting special agent in charge of ICE HSI El Paso.
“HSI and CBP will continue to collaborate to prevent unauthorized and counterfeit products from getting to U.S. consumers to protect the health and safety of the American public and the American economy,” said Ysleta Port Director Arnoldo Gomez. “This large seizure of counterfeit surgical masks, destined for frontline medical workers, demonstrates the great collaborative effort between CBP and HSI. Counterfeit surgical masks pose a great risk to our medical community, and any individual who may use them.”
This shipment is in violation of Importation, Removal and Contrary to Law (19 U.S.C. 1595a(c)(2)(A)) and the Federal Food, Drug and Cosmetic Act. ICE HSI El Paso is investigating the seizure with assistance from CBP.
ICE HSI launched Operation Stolen Promise in April 2020 to protect U.S. consumers from the increasing and evolving threat posed by the pandemic. The operation involves various federal agencies, including CBP, the U.S. Department of Justice, U.S. Postal Inspection Service, U.S. Food and Drug Administration, the Internal Revenue Service, and multiple private sector partners, including Pfizer, 3M, Amazon and others.
Operation Stolen Promise combines ICE HSI’s expertise in global trade, financial fraud, international operations and cybercrime to investigate financial fraud schemes, the importation of prohibited pharmaceuticals and medical supplies, offending e-commerce schemes, and any other illicit criminal activities associated with the COVID-19 virus that may compromise legitimate trade, financial systems and/or endangers the public.
According to a U.S. Customs and Border Protection media release – officers seized a shipment of pre-filled syringes containing 200 Sodium Hyaluronate from Seoul, South Korea. Sodium Hyaluronate is used to treat osteoarthritis and seized for violation of the Food, Drug and Cosmetic Act (FDCA) prohibiting the importation of any food, drug, device, tobacco product, or cosmetic that is adulterated or misbranded.
The FDA Office of Criminal Investigation seized the shipment that would be worth $10,666 if authentic. Typical FDA seizures are due to unapproved prescriptions containing manufactured using incorrect or harmful ingredients.
If you have had your shipment seized by Customs for FDA violations, contact seizure attorney David Hsu by email at attorney.dave@yahoo.com or anytime by phone/text at 832-896-6288.
U.S. Customs and Border Protection (CBP) officers in Philadelphia seized 48 shipments of either counterfeit or unapproved e-cigarette pods since June with the 58,538 individual pods worth a combined $500,000 if authentic or if approved for sale.
The U.S. Food and Drug Administration (FDA) regulates the importation of tobacco products imported into the US and all products must comply with the Federal Food, Drug, and Cosmetic Act (FD&C Act) along with the Family Smoking Prevention and Tobacco Control Act.
This past April, in response to the increase rise in teenage tobacco usage, the FDA issued new measures to regulate the unauthorized importation of flavored cartridge e-cigarettes. Besides unauthorized goods, the seized products also included counterfeit of brand names such as Pop, Puff, Eonsmoke, etc.
If you have had your good seized by Customs on behalf of the FDA, contact David Hsu by phone/text at 832-896-6288, or by email at attorney.dave@yahoo.com.
Since July, U.S. Customs and Border Protection (CBP) Officers in Seattle have seized 8 shipments totaling over 2,400 pills of unauthorized influenza treatments for COVID-19. Working with the FDA, CBP prevents unauthorized medicines that may mislead consumers by falsely claiming to treat or prevent diseases.
If you have had your goods seized by Customs and want to explore your options contact David Hsu by phone/text at 832-896-6288 or by email at attorney.dave@yahoo.com.
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.
