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President Trump Outlines New U.S. Policy on Cuba

posted by Jennifer Diaz June 16, 2017 0 comments

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We’ve been patiently waiting for today’s announcement since President Trump took office on Friday, January 20, 2017. Some have speculated on whether President Trump’s stance on Cuba would further diplomatic relations following the steps of former President Barack Obama, while the majority have opined that Trump’s next steps could reverse some of the changes made by the former President. The speculation can now be put to the side as today President Trump delivered a speech in Miami (at the Manuel Artime Theater), a little over 90 miles away from the island of Cuba, outlining his new policy with the communist island. The announced changes do not take effect until the new OFAC regulations are issued. The forthcoming regulations will be prospective and will not affect existing contracts and licenses.  

Here is a summary of the MAIN changes, and background of why the President has signed an executive order making these changes in support of the Cuban people:

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Importing into the United States in Compliance with CBP

posted by Jennifer Diaz June 15, 2017 0 comments

If you import merchandise into the U.S., you may not realize, but, you are the responsible party!

In this presentation, noted speaker Jennifer Diaz will discuss how compliance with U.S. Customs and Border Protection’s (CBP) vast laws and regulations. By the end of the webinar you will know and understand the importance of tariff classification, customs valuation, country of origin marking, intellectual property rights and free trade agreements.

You will also learn basic customs concepts and terms like CBP Form 7501, protests, seizure cases, liquidated damage claims, penalties/fines, prior disclosures, and the FP&F process. Additionally, Jennifer will share with you the top 10 tips when importing to ensure compliance with CBP. This webinar will provide valuable assistance to all importers, customs brokers, and all trade professionals.

Session Highlights:

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Does Your Medical Device Have a Unique Device Identification (UDI)?

posted by Jennifer Diaz June 14, 2017 0 comments

We’ve previously kept you informed on how to determine whether your product is regulated as medical device by the U.S. Food and Drug Administration (FDA) and how to register your medical devices with the Agency. On June 2, 2017, FDA issued a letter to Device Labelers of certain classes informing of extended compliance dates for UDI requirements. Today we are providing more information on medical device labeling requirements – specifically the new Unique Device Identification (UDI) requirement. Continue Reading

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WHAT DO CONTACT LENSES, DENTAL FLOSS, AND PACEMAKERS HAVE IN COMMON?

posted by Jennifer Diaz June 12, 2017 0 comments

Medical DevicesOne might naturally think of a product like a defibrillator as a medical device, but in our business, we find many companies unsure if its products are, in fact, medical devices.

The following is the first of a two part series which you may use as a helpful guide to get you through the medical device maze. First is a description of what medical devices are, and helpful hints so that you may identify if your product is regulated as a medical device. Second is a brief overview of FDA’s regulation of medical devices. The second part of the series will discuss the classes of medical devices, and the FDA registration process.

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HELP! CBP Seized My Tobacco Products as Drug Paraphernalia, What Now?

posted by Jennifer Diaz May 30, 2017 0 comments

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Our office has increasingly received requests for guidance on importation of marijuana paraphernalia products to the U.S. where twenty-six (26) states have legalized the use of marijuana for medical purposes and/or personal consumption such as California, Massachusetts, Maine and Nevada. The purpose of this article is to dispel the confusion as to why paraphernalia products (grinders, storage containers, rolling paper, pipes, vape pens, etc.) are continuously being seized by U.S. Customs and Border Protection (CBP), even when such products may be used by tobacco smokers. It is important to address the realities between federal and state laws regulating drug paraphernalia products so importers can avoid CBP’s enforcement of U.S. Laws.

Why Does CBP Stop Drug Paraphernalia?

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Here’s a Recap of Part II of our #WorldTradeMonth Seminar Series for Compliance Professionals on FDA FSMA and FSVP

posted by Jennifer Diaz May 19, 2017 0 comments

Yesterday, we at DTL, had the pleasure of hosting Part II of our #WorldTradeMonth Seminar Series for Compliance Professionals. The second seminar focused on FDA FSMA (Food Safety Modernization Act) Compliance for Importers with expert speakers from the U.S. Food and Drug Administration (FDA) and industry. We had a packed house with an array of attendees such as importers of food, beverages, and medical devices, along with customs brokers, freight forwarders / NVOCCs, lawyers, consultants, and others. We received requests for a re-cap from those who attended and industry members who were not able to attend. You asked and we deliver. Here is our recap:

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Missed DTL’s seminar on AD/CVD with CBP? Here’s a re-cap.

posted by Jennifer Diaz May 11, 2017 0 comments

Yesterday we at DTL had the pleasure of hosting Part 1 of 2 of our Seminar Series for Compliance Professionals. In celebration of #WorldTradeMonth the first seminar concentrated on Antidumping Duties and Countervailing Duties (AD/CVD) with expert speakers from U.S. Customs and Border Protection (CBP). While we had a packed room, we have received requests from industry members who were not able to attend asking for a re-cap. You asked so we delivered!

 Here is our re-cap:

The morning kicked off with a networking breakfast where experienced and novice custom brokers, legal counsel, trade consultants, and others were able to engage in meaningful dialogue about overlapping issues they experience in their respective workplaces in dealing with the topic of AD/CVD.

JenThe seminar promptly began at 9:00 am with introductory remarks by our own President, Jennifer Diaz. We had all attendees introduce themselves and include why this seminar was important to attend. We were glad to hear from majority of attendees that their reason for participating was to further their trade education, and CBP wanted to ensure they performed “informed compliance” with the trade community.  One attendee commented with “I’m here to continue to learn as that’s what we [customer brokers] are required to do.” Continue Reading

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FDA Launches New Webpage to Promote Use of Symbols in Medical Device Labeling

posted by Jennifer Diaz April 28, 2017 0 comments

Today the U.S. Food and Drug Administration (FDA) launched a new webpage to assist the public understand the Use of Symbols in Labeling Final Rule. The final rule was issued by the FDA insigns June 2016 and became effective three months later.

FDA intends the final rule to be an attempt to “harmonize the U.S. device labeling requirements for symbols with international regulatory requirements. As the medical device industry has requested the ability to use stand-alone symbols on domestic device labeling, consistent with their current use on devices manufactured for European and other foreign markets.” This is exciting news for our clients who are Medical Device Manufacturers or Importers – as of September 2016 all medical device labeling may use stand-alone symbols!

What does the Use of Symbols in Labeling Final Rule provide for?

  • Permits the use of symbols in all medical device labeling without adjacent explanatory text. This means “stand-alone symbols” may be used, but only if certain requirements are met.
  • Stipulates the use of symbols, accompanied by adjacent explanatory text is still permitted. This means companies are not required to relabel their products, even if they meet the requirements for the use of “stand-alone symbols”.
  • Revises prescription device labeling regulations, now permitting to use the symbol statement “Rx only” or “℞ only” in the labeling for prescription devices.
  • The final rule does not apply to product graphics or pictograms, such as graphics showing the steps for using a device.

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Crash Course in the Harmonized Tariff Schedule of the United States

posted by Jennifer Diaz April 26, 2017 0 comments

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What is the HTSUS?

The HTSUS is the Harmonized Tariff Schedule of the United States.

This post will give a rundown of what the HTSUS is and why it is so important:

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