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Best PracticesFDA IssuesImportMedical Devices

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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CBPExportImport

Crash Course in the Harmonized Tariff Schedule of the United States

posted by Jennifer Diaz April 26, 2017 0 comments

tariff

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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Best PracticesCustoms BrokerEventsFDA IssuesFoodFSMAImportSpeaking

FREE World Trade Month Seminar on FDA/FSMA COMPLIANCE for Importers

posted by Jennifer Diaz April 24, 2017 4 Comments

Flyer

In celebration of World Trade Month, Diaz Trade Law is hosting a World Trade Month Seminar Series for Compliance Professionals featuring U.S. Customs and Border Protection (CBP) and U.S. Food and Drug Administration (FDA) speakers.

Food Importers, here is your chance to learn practical tools for trade! We are providing the trade community a valuable opportunity to speak direct with FDA, Brokers, and legal experts to address any concerns relating to food importations and discuss the upcoming Foreign Supplier Verification Program (FSVP) requirement under the Food Safety Modernization Act (FSMA).

The TOP reasons you should attend? 

  1. For a limited time, registration is FREE!
  2. You have the ability to hear DIRECTLY from FDA.
  3. We want the seminars to be informative and all of your questions answered. In that vain, we are currently taking ANY questions you have related to food importation/FSMA for the FDA. Please email your questions today to info@diaztradelaw.com!

You have a limited time to RSVP to this event for FREE!!! Yes, for FREE. We find this information to be invaluable so Diaz Trade Law is sponsoring this event, to bring it to you for FREE. RSVP today! Our full event agenda including the who, what, when, and where is below. Don’t miss it!

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AD/CVDCustoms BrokerImportU.S.Customs

FREE World Trade Month Seminar on AD/CVD & CBP ENFORCEMENT

posted by Jennifer Diaz April 21, 2017 0 comments

Flyer.Importers, here is your chance to learn all about the hot topic of AD/CVD. In celebration of World Trade Month, Diaz Trade Law is providing the trade community a valuable opportunity to speak direct with Supervisory Import Specialists with U.S. Customs and Border Protection (CBP) and a legal expert to address your questions and concerns relating to CBP’s role in administering and enforcing imports subject to AD/CVD.

In Fiscal Year 2016, CBP Processed $14 billion of imported goods subject to AD/CVD, and collected $1.5 billion in cash deposits. By the end of the fiscal year, $2.8 billion in AD/CVD duties were still owed to the U.S. (dating back to 2001). From fiscal year 2015 to 2016, AD/CVD cash deposits increased over 25
percent. Learn directly from CBP on AD/CVD Compliance and Enforcement! With President Trumps new Executive Order mandating a plan by June 29 “to require importers deemed a risk to U.S. revenue to provide security for AD and CVD liability through bonds and other legal measures”- many questions arise! Now’s your time to ask them!!

You have a limited time to RSVP to this event for FREE!!! Yes, for FREE. We find this information to be invaluable so Diaz Trade Law is sponsoring this event, to bring it to you for FREE. RSVP today! Our full event agenda including the who, what, when, and where is below. Don’t miss it!

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AD/CVDBest PracticesCBPCustoms BrokerEventsFDA IssuesFoodFSMAImportU.S.Customs

World Trade Month Seminar Series for Compliance Professionals

posted by Jennifer Diaz April 20, 2017 0 comments

WORLD TRADE MONTH Seminar Series FlyerIn celebration of World Trade Month, Diaz Trade Law is hosting a World Trade Month Seminar Series for Compliance Professionals featuring U.S. Customs and Border Protection (CBP) and U.S. Food and Drug Administration (FDA) speakers.
In the first seminar, attendees will learn the ABC’s of Antidumping & Countervailing Duties (AD/CVD) compliance and CBP Enforcement.

In the second seminar, FDA will focus on food importations and discuss the upcoming Foreign Supplier Verification Program (FSVP) requirement under the Food Safety Modernization Act (FSMA).

The TOP reasons you should attend?  Continue Reading

AD/CVDCBPImportU.S.Customs

President Trump & CBP Aim to Collect Unpaid AD/CVD Duties

posted by Jennifer Diaz April 18, 2017 2 Comments

ad cvd picOn March 31, 2017, President Trump signed an Executive Order (EO) that addressed unpaid anti-dumping and countervailing duties. This new EO, “promotes the efficient and effective administration of U.S. customs and trade laws by establishing enhanced measures to collect duties”.

What are anti-dumping and countervailing duties (AD/CVD)?

Dumping happens when a foreign company exports goods into the U.S. and sells those goods at less than fair market value. This in turn causes “injury to the U.S. industry”. Due to this, U.S. manufacturers or businesses can file a petition with the International Trade Commission (ITC), claiming that it has suffered an injury. Once the ITC finds that evidence of an injury exists, then the Department of Commerce (DOC or the Department) will investigate the claim. If the DOC determines that dumping occurred, then Customs and Border Protection (CBP) can withhold “liquidation of entries” and collect anti-dumping (AD) duties. AD “duties are calculated to bridge the gap back to a fair market value.” Continue Reading

FDA IssuesFoodFSMAImport

Import Food Products? Deadline to Comply with FSVP is May 30, 2017!

posted by Jennifer Diaz April 13, 2017 2 Comments

FSVPWhat is the FSVP Rule?

The Foreign Supplier Verification Program (FSVP) was created on November 27, 2015, as “a significant provision of the Food Safety Modernization Act (FSMA)”. The FSVP “shifts the burden of certifying the safety of food imports from [the] FDA to the importers themselves”. This means that importers must set up a program that verifies that both the foreign supplier of the food and the food itself will comply with United States (U.S.) laws.

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CBPCounterfeitsDepartment of Homeland SecurityImportIPR, Trademarks and LogosSeizuresU.S.Customs

31,560 Shipments Were Seized by CBP in 2016 for ONE Reason

posted by Jennifer Diaz March 23, 2017 0 comments

ipr

Last year, on a typical day the U.S. Customs and Border Protections (CBP) seized about $3.8 million worth of products because of Intellectual Property Rights (IPR) Violations. CBP reported that the total number of IPR seizures has increased nine (9) percent since last year, from 28,865 in 2015 to 31,560 in 2016. With the manufacturer’s suggested retail price (MSRP) exceeding $1.3 trillion.

What is Causing the Increase in Seizures?

Recordation of Trademark And Copyright With The CBP

In addition to registration of IPR with the U.S. Patent and Trademark Office (USPTO for trademarks), or the U.S. Copyright Office (for copyrights), owners can record said trademark or copyright with CBP. This additional step grants CBP additional enforcement power in both seizing counterfeit and piratical goods as well as thereafter issuing penalties for the MSRP value of the goods. In previous blog posts, we explained benefits of taking the extra step of recording your registered trademark or copyright with CBP, and CBP’s additional enforcement powers as a result of the recordations. Continue Reading

CBPImport

The Centers For Excellence and Expertise Have Arrived!

posted by Jennifer Diaz March 17, 2017 1 Comment

Screen Shot 2017-03-16 at 8.33.06 PMWhat are the Centers for Excellence and Expertise?

CBP is changing how it does business. CBP envisions an end to port shopping and uniform decision making throughout all ports of entry via use of the Centers of Excellence and Expertise (CEE). We previously advised our readers that a CEE was arriving in Miami!

By way of background, in 2012, Customs and Border Protection (CBP) published a Federal Register notice (77 FR 52048) that “developed a test to incrementally transition the operational trade functions that traditionally reside with port directors to the CEE.” The purpose of the test was to expand the CEEs’ ability to make decisions, by allowing the directors of the CEE to make decisions that were normally reserved for port directors. CBP’s goal for the CEEs is to “facilitate trade, reduce transaction costs, increase compliance with applicable port laws, and to achieve uniformity of treatment at the ports of entry for the identified industries (77 FR 52048).”

CBP discussed the application process, and urged importers to apply to a CEE to begin receiving the benefits of being a participating account early.

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Best PracticesCBPCustoms BrokerDepartment of Homeland SecurityEventsImportInternational TravelU.S.Customs

CBP’s 2017 West Coast Trade Symposium…Don’t Miss It!

posted by Jennifer Diaz February 20, 2017 4 Comments

west coast trade symposium

UPDATE – CBP JUST ANNOUNCED TODAY that registration will OFFICIALLY open on Wednesday, March 22, 2017, 12:00 pm Eastern. Keep your eyes peeled for more information from CBP!

We always strive to keep you informed of the latest and greatest trade events. In this vain, U.S. Customs and Border Protection will be hosting the 2017 West Coast Trade Symposium from May 24-25 in Scottsdale, Arizona.

More information about the event, including where to register, will be provided at a later date (and will be posted here). You can be sure we’ll keep you in the loop as we hear more.

If you need reasons to attend (or to get your employer to foot the bill), check out these top 5 reasons!