In response to the COVID-19 Pandemic, the FDA took unprecedented action in transforming its enforcement because of the declaration of a Public Health Emergency while also issuing, and continuing, Emergency Use Authorizations. These governmental actions facilitated and increased the importation of necessary medical devices needed to combat the pandemic here in the United States. And now as the U.S. relaxes its pandemic protocol, the FDA is exploring the best way to have medical devices transition back to pre-pandemic regulations and protocol. On December 23, 2021, the FDA issued two draft guidance documents in the Federal Register detailing its proposed medical device transition plans for all medical devices previously imported under the two aforementioned government declarations. And to provide further assistance, the FDA hosted a webinar “Draft Guidances on Transition Plans for COVID-19 Related Medical Devices” providing further explanations to the trade community on what can be expected from the proposed transition plans.
Diaz Trade Law’s President, Jennifer Diaz and Associate Attorney, Denise Calle are enthusiastic to announce that our article “USDA & CBP Combat Non-Compliant WPM“ was published by Bloomberg Law! Below is the article reproduced with permission for your reading pleasure. We’d love to hear your feedback! […]
DTL saved clients MILLIONS of dollars in 2019. It is with great joy that we finish off 2019 celebrating our fourth anniversary! We would like to thank each of you for being an integral part of making DTL a success.
This year has been filled with numerous achievements and accomplishments. We are grateful for the clients who have entrusted their trade and customs issues to us, and we look forward to assisting you in 2020!
Below we share some of our 2019 success stories with you.
How CBP Protects Your Intellectual Property Rights at the Border / ¿Derechos de propiedad intelectual en la frontera?
As an intellectual property right (IPR) owner, you have the right to work with CBP to prevent the unauthorized importation of infringing goods into the U.S. Registered trademarks, trade names, and copyrights can all be recorded with the with U.S. Customs and Border Protection (CBP). CBP helps trademark and copyright owners prevent the unauthorized importation of infringing products. CBP has the ability to detain, seize, and issue penalties to those who import goods which violate intellectual property rights.
This article will discuss:
CBP proposes a new rule to formalize the process used by Customs Brokers of verifying the identity of their clients, specifically importers and nonresident importers. CBP believes the broker is uniquely situated to collect the information necessary to authenticate an importer’s identity at the time a Power of Attorney is obtained. The purpose of placing a verification burden on brokers is to ensure that importers are conducting legitimate trade transactions. The Federal Register Notice announcing the proposed rule clearly states brokers are subject to hefty monetary penalty for failure to collect the required information. If you have comments or concerns, now is the time to speak up! Brokers, importers, and the general public, have until October 15 to submit comments on the proposed rule.
DTL saved clients MILLIONS of dollars in 2018, below we share some of success stories with you. We look forward to assisting you in 2019!
U.S. Customs & Border Protection (CBP)
- Successfully assisted numerous importers in various seizure cases to assist in getting property returned, despite CBP claims merchandise was drug paraphernalia, counterfeit, etc.
In our previous post, we discussed ZTE’s record penalty for selling technology with US-origin chips to North Korea and Iran, in violation of US trade laws. The company initially received a $1.19 billion in penalties and was ordered to reprimand the executives responsible for the malfeasance’s as a condition to re-enter the United States (US) market after a three-year suspension. Despite telling the US government that the guilty executives had been properly punished, it became clear that they were instead rewarded with bonuses. This violation triggered an automatic ban of ZTE from the US market for seven (7) years. As the 4th largest seller of cell phones to the US, the ban on ZTE serves as a means of protecting American production.
After the announcement, the ensuing backlash from Beijing, as well as trade talks in China, President Trump stated that he and Chinese president Xi Jiping are working together to bring ZTE “back into business”.
Now, the Trump administration threw a metaphorical lifeline to this tech giant, seemingly easing tensions with Beijing. Secretary Ross announced a $1.4 Billion dollar settlement with ZTE. […]
The Justice Department announced YOUNG LIVING ESSENTIAL OILS, L.C., (the Company), headquartered in Lehi, Utah, plead guilty in federal court to federal misdemeanor charges regarding its illegal trafficking of rosewood oil and spikenard oil in violation of the Lacey Act and the Endangered Species Act. […]
Aramex Emirates, LLC, located in Dubai, United Arab Emirates (U.A.E.), agreed to pay a $125,000 civil penalty to the U.S. Department of Commerce’s (DOC) Bureau of Industry and Security (BIS) for the unlicensed export and reexport to Syria, via the U.A.E., of network devices and software without the required BIS licenses.
The Under Secretary of Commerce Eric L. Hirschhorn commented:
Today’s settlement shows the importance of compliance with U.S. law by foreign freight forwarders handling items subject to U.S. export controls.
The items in question could be used by the Syrian government to monitor Internet activity and block pro-democracy websites as part of its brutal crackdown against the Syrian people.