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Questions related to importing/exporting? Contact Diaz Trade Law today at 305-456-3830 or info@diaztradelaw.com.  

FREE Webinar Series on Intellectual Property Rights

Do you want to learn more about intellectual property rights (IPR)? Do you want to understand how IPR and U.S. Customs mix (and don't mix)? Do you want to understand how to properly protect your brand internationally and domestically and what type of enforcement action U.S. Customs can take against infringers? If so, this 3 part FREE seminar series is especially for you. Act now, and reserve your FREE seat while they last. Did we mention it's FREE??

Date and Time:

Wednesday, January 29, 2020

12:00 PM EST to 1:00 PM EST

FREE Webinar!

Session Highlights:

BREAKING NEWS: U.S.-China Phase 1 Deal is Officially Signed

On January 15, 2020, U.S. President, Donald Trump, and Chinese Vice Premier, Liu He, signed the U.S.-China Phase 1 Deal in the White House. The partial trade deal is an eight-part agreement consisting of 94 pages.

   

Simultaneously, the Office of the United States Trade Representative (USTR) published a Federal Register Notice announcing tariff changes in accordance with the President’s direction (tweeted December 13, 2019) to modify the action taken pursuant to the Section 301 investigation.

China Trade War Intensifies

 

 Today, the Trump administration’s China trade war intensified as it announced plans to increase tariffs on Lists 1, 2, 3, and 4! The president connected the additional tariff hikes to China’s new retaliatory tariffs (as a result of US’s imposition of List 4 tariffs) on $75 billion-dollar in US products, mainly impacted the agricultural and auto industries, or President Trump’s base (as previously reported here). So what are the changes?

U.S. and China Reach ‘Phase 1 Deal’

 Today, President Trump and the Chinese government announced a “Phase 1 Deal” and suspended the proposed increase in tariffs for products (on Lists 1, 2, and 3) that were set to begin on October 15. The scheduled tariff was set to increase from 25 to 30 percent on $250 billion worth of Chinese imports. In exchange, the Chinese government will buy $40-50 billion worth of American agricultural goods, and the agreement will include terms on both intellectual property rights and financial services.

Trump to Impose Tariffs on All Imported Goods From Mexico

As a result of the immigration crisis intensifying at the border of the United States and Mexico, President Trump announced a five (5) percent tariff to be levied on all goods from Mexico starting June 10^th. 

The tariffs are set to continue to increase by five percent each month up to twenty-five percent. The tariffs will permanently remain at the 25 percent level unless and until Mexico substantially stops the illegal inflow of aliens coming through its territory.

The effective date of the imposition of the additional tariffs are as follows:

China Tariff Hike Postponed - USTR to Establish an Exclusion Process – Seminar on “China Tariffs/AD/CVD 101”

The on-going trade war continues as China and the US make progress to come to an agreement. For background information on past actions taken by the Trump Administration to protect American Intellectual Property, check out our previous blogs.

China Tariff Increase is Postponed

President Trump reported in a February 24th tweet that as a result of the “substantial progress” in trade negotiations with China on “important structural issues” he will be delaying the increase from 10 percent to 25 percent in the additional Section 301 tariffs on the List 3 goods (valued at about US$200 billion) that is scheduled to take place on  March 2nd. To formalize the extension, the administration will have to publish a Federal Register notice stating the Section 301 additional tariff on the so-called List 3 products will remain at ten percent for now and the notice will likely provide the new date for the tariff increase. To date no formal notice has been published.

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

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 in 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.

Ultimately a Device Manufacture has three options to choose from:

1. Do not use symbols
2. Use symbols with adjacent explanatory text, or
3. Use stand-alone symbols

What are “stand-alone symbols”?

• Symbols established in a standard developed by a standards development organization (SDO).
• FDA stress that “it’s critical that symbols on medical devices are understood by the individuals who use them.”
• FDA provides the example where manufacturers of sterile syringes could opt to use the symbol for “do not reuse” on a syringe package without adding the actual words “do not reuse” to the package.

What is required to qualify for use of “stand-alone symbols”?

• Under the final rule there are two possibilities to permit a medical device label to carry “stand-alone symbols” without adjacent explanatory text.

1. As long as the standard symbol is recognized by FDA under its authority under section 514(c) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 360d(c)) and the symbol is used according to the specifications for use of the symbol set forth in FDA's section 514(c) recognition, OR

2. If the symbol is not included in a standard recognized by FDA under section 514(c) or the symbol is in a standard recognized by FDA but is not used according to the specifications for use of the symbol set out in the FDA section 514(c) recognition, the device manufacturer otherwise determines that the symbol is likely to be read and understood by the ordinary individual under customary conditions of purchase and use in compliance with section 502(c) of the FD&C Act (21 U.S.C. 352(c)) and uses the symbol according to the specifications for use of the symbol set forth in the SDO-developed standard.

• In either case, the symbol must be explained in a symbols glossary that is included in the labeling for the medical device and the use of symbols must also comply with other applicable labeling requirements in the FD&C Act.

Who benefits from the Use of Symbols in Labeling Final Rule?

• Device Manufacturers
• Importers
• International trade community

Manufacturers or Importers who have questions about implementing the Symbols final rule are encouraged to contact our office at info@diaztradelaw.com or 305-456-3830.

More information is available at:

Medical Device Registration Made Easy!

Frequently Asked Questions

World Trade Month Seminar Series for Compliance Professionals

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.

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? 

1. For a limited time, registration is FREE!
2. You have the ability to hear DIRECTLY from CBP and 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 the Centers of Excellence and Expertise (CEE) and Antidumping & Countervailing Duties (AD/CVD) for CBP, and food importation/FSMA related questions for the FDA. Please email your questions today to info@diaztradelaw.com!

Full details including registration information for BOTH seminars are below. 

May 10, 2017 ( 9 - 11 a.m.)

• ABC’s of AD/CVD & CBP Enforcement
• CLICK HERE for our draft agenda
  • Hear directly from CBP Import Specialists & an industry legal expert
  • TOP Tips when Importing to Ensure Compliance with AD/CVD
  • Valuable opportunity to speak direct with Supervisory Import Specialist with U.S. Customs and Border Protection and legal experts to address any concerns relating to CBP’s role in administering and enforcing imports subject to AD/CVD
  • *** CBP WOULD LIKE TO HEAR FROM ATTENDEES OF THE TRADE COMMUNITY ON WHAT ISSUES OR QUESTIONS THEY WOULD LIKE TO BE ADDRESSED DURING THE PRESENTATION. PLEASE SUBMIT QUESTIONS TO INFO@DIAZTRADELAW.COM ***
• RSVP HERE

May 18, 2017 ( 9 - 1 2 p.m.)

• FDA FSMA Compliance Seminar for Importers
• CLICK HERE for our draft agenda
  • Hear directly from FDA & an industry legal expert
  • Overview of FDA requirements for importing food products
  • A discussion of best practices when working with your broker to expedite shipments (ACE, ITACS, PREDICT)
  • Overview of the FSMA, including an overview of the FSVP requirement (which has a compliance date of 5/30/17)
  • Best practices for due diligence and responding to enforcement actions and FDA Notices of Action
  • *** FDA WOULD LIKE TO HEAR FROM ATTENDEES OF THE TRADE COMMUNITY ON WHAT ISSUES OR QUESTIONS THEY WOULD LIKE TO BE ADDRESSED DURING THE PRESENTATION. PLEASE SUBMIT QUESTIONS TO INFO@DIAZTRADELAW.COM ***
• RSVP HERE 

We look forward to seeing you at our World Trade Month events!

Now, More than Ever, Be Wary of and Responsive to a CBP Form 28!

U.S. Customs and Border Protection (“CBP”), having previously identified AD/CVD evasion as priority trade issue, is ramping up its efforts to further combat AD/CVD evasion. Effective August 22, 2016, interested parties can, in addition to pursuing either a civil False Claims Act/Qui Tam Action or a criminal trade violation, now report Enforce and Protect Act (“EAPA”) violations using CBP’s e-Allegation mechanism. 

Who is an Interested Party?

Interested parties qualified to use this violation reporting mechanism include:

• Foreign manufacturers, producers, exporters, or importers of covered merchandise or a trade or business association a majority of the members of which are producers, exporters, or importers of such merchandise
• Manufacturers, producers, exporters, or importers in the U.S. of a domestic like product 
• A certified union or recognized union group of workers that is representative of an industry engaged in the manufacture, production or wholesale of a domestic like product in the U.S. 
• A trade or business association a majority of the members of which manufacture, produce, or wholesale a domestic like product in the U.S. 
• If covered merchandise is a processed agricultural product, a coalition or trade union that is representative of processors, processors and producers, or processors and growers

CBP EAST COAST Trade Symposium (#ECTS2016) Dec 1-2, 2016!

The CBP East Coast Trade Symposium theme is "Trade’s Impact on American Health, Safety and Economic Prosperity” and will take place from December 1-2, 2016, at the Hyatt Regency Crystal City in, Arlington, Virginia.

Our top 5 reasons to attend including an invite to a premier networking event are below!

Travel to the U.S. with an Unlimited Number of Cuban Cigars and Rum - Courtesy of New Revised OFAC and BIS Regulations

On October 14, 2016, President Obama issued a Presidential Policy Directive on United States-Cuba Normalization to further ease travel and trade restrictions with Cuba. As a result, Monday, October 17, 2016, amendments to both OFAC and BIS regulations will take effect.

Below are the top changes from both OFAC and BIS:

OFAC is making additional amendments to the Regulations with respect to health, trade and commerce, civil aviation safety, travel and related transactions, humanitarian-related activities, and certain other activities. Below is a recap:

• Health
  • Persons subject to U.S. jurisdiction are now permitted to engage in commercial and non-commercial joint medical research projects with Cuban nationals. (Section 515.547).

• Travel and Related Transactions
  • Importation of Cuban merchandise: Not too long ago we alerted our readers that CBP was targeting Cuban Cigars at American Ports. We haveBIG news for cigar and rum lovers… As of Monday, October 17, 2016, persons subject to U.S. jurisdiction are now able to return home from Cuba (or any other country where Cuban rum and cigars can legally be purchased) with an unlimited amount of rum and cigars. However, the number of cigars and amount rum must be for personal use and such merchandise must be imported as accompanied baggage and are subject to the normal limits on duty and tax exemptions. This is a huge step forward from OFAC’s initial limit of $400 or less (with no more than $100 of such merchandise consisting of alcohol or tobacco products). (Section 515.560(c)(3)).

Register NOW: Trade Day Hosted by CBP

Have you wanted a better relationship with U.S. Customs and Border Protection (CBP)? Wanted to meet key personnel within numerous departments of CBP and different PGA's? Here's the time to take advantage: Trade Day is coming to Miami, courtesy of CBP, on August 4, 2016. Did we mention it's FREE?! Calling all importers, exporters, customhouse brokers, freight forwarders and all other interested parties in the international trade community – if you have been looking for an opportunity to meet with government officials that are responsible for processing and facilitating trade related import transactions and to get educated and ask more questions about ACE and CEE's, this is your chance.

If you missed the previous Trade Day don’t miss this opportunity to:

Build Your Own 'People to People' Mission & More Cuba Changes

If you have been following our Cuba updates, you'll note we've been busy. A full listing of all of our posts to get you caught up are all the way at the bottom. Here's the Cliff Notes version:

• On December 17, 2014, President Obama made a historic announcement: “Today, the United States is taking historic steps to chart a new course in our relations with Cuba and to further engage and empower the Cuban people.”
• By January 16, 2015, both the U.S. Treasury Department, Office of Foreign Assets Control (OFAC) amended its Cuban Assets Control Regulations, and the U.S. Department of Commerce’s, Bureau of Industry and Security (BIS) amended the Export Administration Regulations with a “Support for the Cuban People” license exception. Both OFAC and BIS’s new rules were effective as of January 16, 2015.
• OFAC and BIS issued additional new rules on June 15, 2015, September 21, 2015, January 27, 2016 and again today!

As far as travel goes, the NY Times posted their travel tips, but, here are MY travel tips to you:

Five Day TRADE Conference in Fort Lauderdale

Whether you’re a new business that wants to connect with import and export experts, or an existing business that wants to expand its activity across the globe, you do not want to miss the Florida International Trade & Cultural Expo (“FITCE”).

FITCE is a five-day event that is held October 12^th to 16^th at the Greater Fort Lauderdale Broward County Convention Center. World leaders, high level networking, business opportunities and expert panelists are just some of the reasons to attend FITCE.

TOP 11 NEW Business Opportunities with Cuba as a Result of NEW OFAC and BIS Laws

In December, 2014, we updated you on the president’s historic announcement in regards to doing business in Cuba, and in January we updated you on both the Office of Foreign Assets Control (“OFAC”) amendments to the Cuban Assets Controls Regulations (“CACR”) and the amendments to the Export Administration Regulations (“EAR”) administered by the United States Department of Commerce. As of September 21, 2015, both OFAC and the BIS have amended their regulations again, and below details the top 11 changes as a result of the new laws.

We'll be discussing these new changes on October 8th, at our Export Compliance Seminar at the Miami Free Zone. Blog subscribers get to take advantage of the discount code! Email me at jdiaz@bplegal.com for it. You can RSVP here. 

PortMiami Tunnel Opening Celebration!

Today was the historic PortMiami Tunnel Opening (where you can watch my video of the first 3 trucks that officially entered the port tunnel)!  A better video can be found here, courtesy of Local 10.

As the Miami Herald reported today, four long years and $915 million dollars went into this tunnel that will now allow both cruise traffic and trucks to bypass downtown Miami and instead, head straight to the highway.

Much needed relief for residents. And... No Tolls!

REGISTRATION OPENS for CBP's 2013 East Coast Trade Symposium in D.C.

Mark your calendars for the CBP 2013 East Coast Trade Symposium, scheduled for October 24 – 25, 2013, at the Washington Hilton Hotel in Washington, D.C. This year’s theme is “Increasing Economic Competitiveness Through Global Partnerships and Innovation”.

Based on the overwhelming interest received by CBP for participation at the Symposium, CBP is limiting attendance to three (3) participants per company to afford equal representation from all members of the international trade community. If a company exceeds the limitation, subsequent registrations will automatically be placed on the waiting list.

Registration for onsite participation is $108, and is open as of September 18, 2013 at 12:00 p.m. EST. Act fast, this event sells out quickly!

Attendance at the Symposium is an excellent opportunity to meet with all levels at CBP, so take advantage of this opportunity! For a sneak peak at what to expect in DC, see the agenda here. See you at the CBP Symposium!

An added bonus:

• As a special opportunity for U.S. citizens participating in this year’s CBP 2013 East Coast Trade Symposium, U.S. Customs and Border Protection (CBP) will be on-site to conduct interviews for those interested in enrolling in the Global Entry program. Act within the next week, in order to be eligible for on-site enrollment. This offer is only available to those who have completed the online application, paid the $100 application fee, and are pre-approved through the Global Online Enrollment System.
• Interested attendees must apply for Global Entry by Friday, October 10.
• When applying, be sure to only select the Global Entry option. Global Entry is extremely popular with frequent international travelers because approved travelers use a kiosk to enter the U.S. rather than waiting in line to see an officer. For U.S. travelers, Global Entry approval also allows you to enroll in the Transportation Security Administration’s (TSA) PreCheck trusted traveler program, which expedites screening through TSA checkpoints at participating airports.

This is a terrific benefit I hope you will take advantage of.  I am a HUGE advocate of the TSA PreCheck program, check out my blog post regarding this wonderful program here.