Tag

registration

Export

Keep Your Eyes Peeled For The Single Export Licensing System!

posted by Jennifer Diaz February 6, 2017 0 comments

single export licensing picCurrently 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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ExportFDA IssuesImportMedical Devices

Medical Device Registration Made Easy!

posted by Jennifer Diaz January 27, 2017 1 Comment

Screen Shot 2017-01-26 at 1.40.53 PMThis article is a continuation of: “What Do Dental Floss, Bedpans, and Pacemakers Have in Common?”, and 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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Best PracticesCosmeticsFDA IssuesFoodFSMAImportMedical Devices

New FDA-USA Website for Importers

posted by Jennifer Diaz October 30, 2014 0 comments
FDA-USA

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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Best PracticesCBPImportSeizuresU.S.Customs

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

posted by Jennifer Diaz July 18, 2014 0 comments

made in ChinaOn 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.”  Both images are provided below for you to see for yourself – check out the extra space at the top, and the “u” in club.

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FoodFSMA

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

posted by Jennifer Diaz December 20, 2012 2 Comments

 Below are the latest and greatest updates  regarding compliance with the FDA’s Food Safety Modernization Act (FSMA). It includes 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.

FSMA Background

FSMA, enacted on January 4, 2011, amended section 415 of the Federal Food, Drug, and Cosmetic Act (FD&C Act) [21 U.S.C. § 350d]. The registration requirements in section 415 of the FD&C Act apples to domestic and foreign food facilities that manufacture, process, pack, or hold food for human or animal consumption in the United States. Section 102 of FSMA amended section 415 of the FD&C Act in relevant part to provide that food facilities required to register with FDA must renew their registrations with FDA every other year, during the period beginning on October 1 and ending on December 31 of each even-numbered year, otherwise, their registration will be cancelled by the FDA.

Reinspection Fees

Importantly, please note that facilities will be charged reinspection fees by the FDA. Reinspections are follow-up inspections conducted by the FDA after a previous inspection by the FDA where the FDA identified non-compliance issues materially related to food safety. The purpose of the reinspection is to assure the issue has been remedied and food is now safely produced. Fees are adjusted each fiscal year. For FY 2013 (October 1, 2012-September 30, 2013), the fees are $221 an hour if no foreign travel is required, and $289 an hour if foreign travel is required. U.S. Agents will be responsible to assure these fees are collected.

FDA Extension

Because there was a delay in FDA’s implementation of biennial registration renewal for the 2012 cycle, and registration renewal did not become available until October 22, 2012, FDA’s guidance document advised that FDA intends to exercise enforcement discretion with respect to registration renewals submitted to FDA after December 31, 2012 for a period of 31 days, until January 31, 2013.

FDA Published 2 Guidance Documents:

Guidance for Industry: Questions and Answers Regarding Food Facility Registration (Fifth Edition). This guidance document contains helpful questions and answers regarding food facility registration.

Guidance for Industry: What You Need To Know About Registration of Food Facilities; Small Entity Compliance Guide. Thus guide was updated to reflect FSMA amendments to the FD&C Act, and discusses: who is required to register pursuant to the Bioterrorism

Suspension of Registration

FSMA also amended section 415 of the FD&C Act to provide FDA with the authority to suspend a food facility’s registration in certain circumstances involving food that has a reasonable probability of causing serious adverse health consequences or death to humans or animals. FDA already used this power and suspended the registration of Sunland, a producer of nuts. The full story may be read here.

IPR, Trademarks and Logos

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

posted by Jennifer Diaz July 9, 2012 0 comments

Jennifer DiazThe 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, I am thrilled to be part of a new series of "How to Source from China" conferences at the China Sourcing Fair (July 10-12, Miami)!

The conferences are led by industry experts, and reveal real-life sourcing risks in China.  We will share actionable knowledge at every step as the project moves from concept to delivery, and the conference will offer in-depth insights and practical tips on do’s and don’ts of China sourcing. Whether you’re a beginner or veteran buying professional, the FREE conference program is your chance to learn how to source efficiently and effectively from the "world’s factory".

Register now to enhance your importing skills and knowledge today! Conference seats are limited and are on a first-come, first-served basis.

I will be speaking on "How to Solve U.S. Customs Issues When Importing From China".

Intellectual property rights (IPRs) are a priority trade initiative for U.S. Customs. Most confiscated China imports violated US Customs’ IPR laws, which should serve as a reminder when buying from China.

In my seminar, we will look at ways of preventing and dealing with these issues. In particular, we will cover: 

  • Trademark / copyright violations (What U.S. Customs looks for)
  • Top compliance tips in advance of importation (What you need to know before your goods go!)
  • Statistics of seizure cases (concentrating on China statistics)
  • How cases progress with U.S. Customs

Join this session and you’ll leave with a better understanding!

Register now to confirm your seat!

U.S.Customs

How I Helped Release $2.5 Million Stuck in Customs

posted by Jennifer Diaz May 3, 2012 0 comments

Jennifer DiazBefore beginning a career in international trade, I did not ever stop to think that the t-shirt I was wearing or dishes I was using were likely made elsewhere, and went through a long complicated logistics supply chain in order to reach my local store. Little did I know that when anything goes wrong in that complicated supply chain, it would be my job to help. Recently, a client had over 2.5 million dollars worth of electronic merchandise on hold by U.S. Customs and Border Protection (Customs) for alleged intellectual property rights violations. In plain English, Customs was under the impression my client was trying to import goods with trademarks or logos they did not have the authorization to import.

When you see the symbols below, make sure you think about LICENSES to use them!!

For this client, this was a lot of money at stake, and it could have put them out of business if we did not come up with a quick solution. Instead of thinking of the band aid type solution, to solely fix this issue, we came up with a compliance plan for the client to use going forward, that would also help solve the current issue.

The compliance plan involved both a short term and long term solution. In the short term, the goal was to have the 2.5 million dollars worth of merchandise released ASAP. To accomplish this goal, we had to prove to Customs that our client had the appropriate authorization from the relevant trademark holders. (Good time for you to check over your trademark licenses, are they all in place?  Do you have easy access to them if Customs comes a knockin’?)

For the long term solution, we began to work with Customs to prove that the client was a reputable importer. In this case, actions spoke much louder than words. Instead of telling Customs our client was compliant, we were able to produce documentation, and develop a relationship with the appropriately picked personnel in Customs. Through this relationship, we started a new process where the client utilized a pre-compliance program with Customs for all new products the client would import. This pre-compliance program included Customs review and internal track keeping of the client’s new products and relevant license agreements. This way, Customs had a first hand sneak peak at the new products and any potential issues would be addressed before, not after importation.

I am happy to report that all of my clients 2.5 million dollars worth of merchandise was released, and in a relatively short period of time. To date, all products that were pre-approved by Customs are typically immediately released by Customs and do not go through additional timely intensive exams.

Have you ever had a shipment on hold? What type of compliance programs do you have in place? I’d love to hear your stories, email me!

FDA IssuesFood

Food Facility Registration Mandatory With The U.S. FDA

posted by Customs & International Trade Law Blog September 18, 2010 0 comments

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 dangerously contaminated food?

In an article entitled "Scrap the Bioterrorism Act" published in February 2004, I criticized the Act as not going far enough because it did not require (1) FDA Inspectors to be located in foreign countries sending us food,  (2) cooperation with foreign food inspection governmental authorities, and (3) mandatory recall authority to the FDA for contaminated foods.  In a May 6, 2010 report by the U.S. Government Accountability Office (GAO) entitled "Food Safety:  FDA Could Strengthen Oversight of Imported Food," it came to exactly the same conclusions. 

As stated in the GAO report:

The FDA physically examines approximately 1 percent of imported food.

Imported fish and other seafood is of particular interest to the FDA.  Obviously, FDA Inspectors cannot physically inspect every shipment of imported seafood, but every shipment that contains FDA-regulated products that enters the United States is electronically reviewed by the FDA  to determine if the shipment should be physically examined or a sample laboratory tested.   Hence, the prior notice information enables FDA, working closely with U.S. Customs and Border Protection, to more effectively target inspections at the border to ensure the safety of imported foods before the food enters the commerce of the United States.

Registration of food facilities that manufacture, process, pack, or hold food is suppose to help provide FDA with information on the origin and distribution of food.  The objective is that the registration will aid in the detection and quick response to actual or potential threats to the U.S. food supply, usually by microbiological contamination such as listeria.

If  an importer is attempting to import food from a foreign facility which has not been registered with the FDA, the food will be held at the port of arrival until the registration violation is corrected.  Registration by the foreign food producer and shipper may be easily accomplished, in multiple languages, at www.FDA-USA.com.  

My conclusion is that the FDA is doing a much better job at protecting the international food supply chain, but it needs the U.S. Congress to now pass the Food Safety bill, pending there for over a year, to really do an effective job. Coincidentally, the Sunday New York Times front page article "Senate Bill on Food Safety is Stalled," makes the same argument.