How CBP Protects Your Intellectual Property Rights at the Border / ¿Derechos de propiedad intelectual en la frontera?

IPR ---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:

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Keep Your Eyes Peeled For The Single Export Licensing System!

Currently the U.S. government has three different agencies that have been given the authority to issue export licenses. Those three agencies are: the Departments of Commerce, State, and the Treasury. In 2009, President Obama ordered an interagency review of the current export control system. The review found that the current system was “overly complicated, contained too many redundancies, and, in trying to protect too much, diminished the ability to focus their efforts on the most critical national security priorities”. The review also found that many companies had to apply for multiple export licenses with each of the departments. Due to the findings of the review, the Administration created the Export Control Reform initiative to help establish a single export licensing system.

“The goal of the (ECR) initiative is to create a Single Licensing Agency (SLA), which would act as a ‘one stop shop’ for businesses seeking export license and for the US government to coordinate review of license applications.” The ultimate goal of this new licensing process would be to make the process predictable, timely, and transparent.

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By |2021-11-09T13:55:45-05:00February 6, 2017|Export|Comments Off on Keep Your Eyes Peeled For The Single Export Licensing System!

Medical Device Registration Made Easy!

This article discusses the three types of medical device classifications and how to register and list those devices with the FDA.

FDA’s classes of medical devices:

The Food and Drug Administration (FDA) has established classifications for approximately 1,700 different generic types of medical devices.” The device classification is broken up into three regulatory classes (Class I-III), which is “based on the level of control necessary to assure the safety and effectiveness of the device”. To determine the device classification, the FDA looks at “the intended use of the device and also the indications for use“. According to the FDA’s Guidance on Device Regulation, the intended use of a device “means the general purpose of the device or its function, and encompasses the indications for use”. Indications for use is “a general description of the disease or condition the device will diagnose, treat, prevent, cure, or mitigate, including a description of the patient population for which the device is intended”. (21 C.F.R. §814.20(b)(3)(i)). The class for which your medical device would belong to, determines the type of pre-market submission or application that is required for FDA clearance to sell the medical device in the United States.

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New FDA-USA Website for Importers

Do you import food products (or any FDA regulated product) into the U.S.? I’ve launched a new website (www.FDA-USA.com) to assist you in learning the basic requirements for FDA regulated products. The website features information for importers of food, drugs, cosmetics, medical devices, dietary supplements and alcoholic beverages.

Don’t forget, if you are a registered food facility with the FDA and don’t comply with FDA’s mandatory biennial registration, FDA can cancel your FDA Food Facility Registration. Learn more about the Biennial Registration requirement in my previous post here.

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By |2021-11-09T14:55:31-05:00October 30, 2014|Best Practices, Cosmetics, Food, FSMA, Import, Medical Devices, U.S. Food and Drug Administration (FDA)|Comments Off on New FDA-USA Website for Importers

Exports from China are on the Rise – What is your IPR Plan?

On April 11, amid a high demand for soccer apparel in preparation for FIFA World Cup, U.S. Customs and Border Protection (CBP) seized counterfeit soccer apparel shipped from China to the Port of Savannah. The value of the seized goods exceeded $1 million in manufacturer’s suggested retail price (MSRP). The apparel seized contained counterfeit trademarks of the following professional soccer clubs: Arsenal, Barcelona, Celtic, Chelsea, Mexican Federation, Paris Saint-Germain, and Real Madrid.  Little did they know they should have tried to import Germany’s soccer club’s apparel.

“You look at that Chelsea patch, and it just looks off,” said Steve Sapp, a spokesman for U.S. Customs and Border Protection. “The last B is smaller than the rest, and that’s the kind of thing you often see with these counterfeit goods. Our investigators know the signs that these goods aren’t real.”

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By |2022-07-06T14:11:09-04:00July 18, 2014|Best Practices, China, China Trade War, Customs Expert, Export, Import, International Business, International Law, International Trade, Seizures, Supply Chain, U.S. Customs and Border Protection (CBP)|Comments Off on Exports from China are on the Rise – What is your IPR Plan?

FDA Extends Until January 31 for Food Facilities to Re-Register

Are you a manufacturer, processor, packer or holder of food products? If you are, or know someone who is, you need to keep up with the latest and greatest updates regarding compliance with the FDA's Food Safety Modernization Act (FSMA). This post includes a background on FSMA, an update from FDA with 2 new guidance documents, FDA's extension to file biennial registrations, and an update on FDA using its enforcement power to suspend a facilities registration - meaning they can NOT import into the U.S.

By |2021-11-10T14:30:26-05:00December 20, 2012|Food, FSMA|2 Comments

China Sourcing Fair – How to Solve U.S. Customs Issues When Importing From China

The rewards of sourcing from China are well known, but succeeding at it is far from simple. With a sluggish global economy resulting in unpredictable market changes, cost-effective sourcing is important. To help you build or sharpen your China sourcing strategies, a new series of "How to Source from China" conferences are back at the China Sourcing Fair (July 10-12, Miami)!

By |2019-10-22T01:48:39-04:00July 9, 2012|China, China Trade War, International Trade, IPR, Trademarks and Logos, Supply Chain|Comments Off on China Sourcing Fair – How to Solve U.S. Customs Issues When Importing From China

Food Facility Registration Mandatory With The U.S. FDA

On December 12, 2003, the U.S. Food and Drug Administration (FDA) implemented the Bioterrorism Act of 2002. That Act basically required that companies shipping food to the United States must first be registered with the FDA, and that importers of food must provide "prior notice" to the FDA of any particular shipment before it physically arrives in the United States. Over the past 7 years, has the Bioterrorism Act lived up to its expectations to protect the American consumer from eating dangeously contaminated food?

By |2010-09-18T13:15:26-04:00September 18, 2010|Food, U.S. Food and Drug Administration (FDA)|Comments Off on Food Facility Registration Mandatory With The U.S. FDA
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