CBP Now Issuing Penalties for Wood Packaging Material Violations

Due to the increase in penalties for wood packaging material (WPM) violations – we thought it important to remind the importing community that CBP is issuing WPM penalties and the background as to why.

On September 25, 2017, CBP issued Cargo Systems Messaging Service (CSMS) #17-000609 informing importers of CBP’s intent to issue penalties for wood packaging material violations. In the message, CBP states all wood packaging material (WPM) imported into the United States must have been treated at the place of origin, and contain the appropriate marking upon importation.  CBP is trying to “prevent the introduction of exotic timber pests,” and is encouraging the importing community to look towards alternatives to WPM and to educate your supply chains about ISPM 15 requirements.

On the Brink of a Trade War: Trump’s New Tariff Plan on Chinese Imports

The Trump administration has engaged in a trade showdown with China, targeting more than $50 billion worth of products.  The administration’s actions are the result of investigations under Section 301 of the Trade Act of 1974 (“Section 301”) and Section 232 of the Trade Expansion Act of 1962 (“Section 232”). 

Section 301 

OWIT International President to Host OWIT South Florida Breakfast

Our very own Diaz Trade Law President, Jennifer Diaz, is also the newly elected President of the Organization of Women in International Trade (OWIT). OWIT International was established in 1989 and is a global association for women in international trade and business. Our 2,000-plus members impact hundreds of millions of dollars in trade and business transactions annually. OWIT’s focus is on adding value to our corporate, mid-sized, small business and individual members around the world. OWIT serves as the unifying body of a network of chapters spanning the globe in the Americas, Western Europe, and Africa.

OWIT South Florida (the premier networking organization in South Florida for women and men involved in international trade and business) is one of 22 chapters of OWIT around the globe. OWIT South Florida has numerous events throughout the year. Diaz Trade Law is proud to host the next breakfast event at our office. Don't miss it!

Importers: If you Can’t Answer These 12 Questions on Forced Labor You’re In Trouble!

An estimated 40.3 million people were living in modern slavery at any moment in time in 2016. This amounts to 5.4 victims of modern slavery for every thousand people in the world. Seventy three per cent of the victims of forced labor were female, and one in four victims were children. Forced labor accounted for 24.9 million people, while 15.4 million were in forced marriage.

What is the U.S. Doing About It?

UPDATE: FDA Delays Compliance Dates for the New Nutrition Facts Label Rule

In an earlier article, we detailed some of the new changes that would be implemented with the new Nutrition Facts Label rule. That article also provided the compliance dates for the rule. On September 29,2017, however, the FDA proposed yet another deadline extension for

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

One 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.

What is a Medical Device?

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!

TPP: Dead or Alive?

Are you wondering whether, given President-elect Trump’s recent promise to abandon the agreement on his first day in office, the Trans-Pacific Partnership (“TPP”) is even going to happen? Are you interested in knowing what all the buzz is about the TPP? Would the TPP open up new business opportunities for your small- to medium-sized business in Australia, Brunei, Canada, Chile, Japan, Malaysia, Mexico, New Zealand, Peru, Singapore, and Vietnam? If you want to know more, then this FREE webinar is for you!

Top Five Reasons to Participate:

1. Gain insight into the nuts and bolts of how goods and services are exported from the U.S. into TPP countries.
2. Discover which elements of the TPP can help small- to medium sized U.S. companies save time, reduce costs, and improve certainty in TPP markets.
3. Hear from government officials what lies ahead with respect to the approval and entry into force of the TPP.
4. Take advantage of the opportunity to ask questions to and receive answers from TPP experts in real time (including whether or not they believe the TPP has a fighting chance).
5. Develop new contacts within the U.S. Commercial Service.

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!

Top Impacts of Cuba Being Removed From "Terrorism List"

As you know, the President made a big announcement back in December, 2014 that the US would take historic steps to chart a new course in our diplomatic relations with Cuba. One specific action item was instructing the Secretary of State to immediately launch a review of Cuba’s designation as a State Sponsor of Terrorism, and provide a report to the President within six months regarding Cuba’s support for international terrorism.

Within four months of the President's announcement, on April 8, 2015 (2 months early!), the Secretary of State finalized their review and recommended that Cuba no longer be designated as a State Sponsor of Terrorism.  Thereafter, on April 14, the President sent Congress the statutorily required report indicating the Administration’s intent to rescind Cuba’s State Sponsor of Terrorism designation, including the certification that "Cuba has not provided any support for international terrorism during the previous six-months; and that Cuba has provided assurances that it will not support acts of international terrorism in the future." Members of Congress, initially vowing to block the removal of Cuba from the "terrorism list" had no legal outlet to voice their opposition, and as of today, the 45-day Congressional pre-notification period has expired. As a result, the Secretary of State has officially made the final decision to rescind Cuba’s designation as a State Sponsor of Terrorism, effective today, May 29, 2015.

The Department of State issued a Press Statement today advising that:

The rescission of Cuba’s designation as a State Sponsor of Terrorism reflects our assessment that Cuba meets the statutory criteria for rescission. While the United States has significant concerns and disagreements with a wide range of Cuba’s policies and actions, these fall outside the criteria relevant to the rescission of a State Sponsor of Terrorism designation

Below are the top 4 impacts I foresee as a result of Cuba being removed from the State Sponsor of Terrorism List (leaving only Iran, Sudan, and Syria now on the list):

Jen Diaz Honored as Rising Star by DBR

On July 18, 2013, the Daily Business Review (DBR) announced the 40 young Florida lawyers chosen as 2013 Rising Stars by a panel of DBR judges. I'm proud to announce I have been selected as one of the 40 Rising Stars!
The article stated:

Our panel carefully reviewed more than 125 nominations of attorneys 40 years old and under who have established themselves as top contributors to the practice of law and their communities, and are in a position to become tomorrow's top lawyers and leaders.

See the list of the 40 Rising Star honorees.

Profiles of all the Rising Stars will appear in a DBR special section on Wednesday, Sept. 18, and an event honoring their accomplishments will be held that night from 6 p.m. to 9 p.m., at the Bankers Club in downtown Miami, One Biscayne Tower, Biscayne Room, 14th Floor.
For those who wish to attend the event to honor the Rising Stars, please contact Andre Sutton at asutton@alm.com or (757) 721-9020. The event's main sponsor is Ice Legal.

Congratulations to the 2013 Rising Stars.

-David Lyons, Editor in Chief
-Chris Mobley, Publisher

I'm honored to have been selected and invite you to join me as we celebrate on September 18th at the Bankers Club.

Free Trade Zones Expanding in Miami-Dade County

PortMiami wants free trade zones (FTZ’s) throughout Miami-Dade county.

As we know, PortMiami is currently dredging to 50 feet in pursuit of the post Panamax ships, and wants to prepare for the massive amounts of cargo PortMiami looks forward to receiving as a result of the dredging project.  In preparation, PortMiami is looking to the South Florida business community to get engaged and prepared as well.

Under PortMiami's plan, any business north of Southwest Eighth Street could apply for free-trade status (under FTZ 281) and be exempt from import duties (for example, for cargo heading abroad). There are many benefits to an FTZ, ultimately resulting in duty savings.

The Miami Herald reported that PortMiami’s application is expected to receive approval by the summer (UPDATE - PortMiami has officially been approved and operates FTZ 281), which will allow local businesses the opportunity to apply for foreign-trade zone status, enabling them to utilize their FTZ for duty savings, as goods shipped into a FTZ that are destined for export are exempt from paying CBP duties.  Many companies use South Florida as a transhipment hub, purchasing goods from China, using South Florida as a distribution center, and then selling those goods to customers in South America.  Using a FTZ saves the importer from having to pay customs duties on imports for exports.

The Beacon Council – Miami-Dade County's official economic development partnership – has coined trade/logistics and aviation as two of the ‘seven pillars’ of Miami-Dade County in the One Community, One Goal (OCOG) initiative. The others include International Banking & Finance, Education, Creative Design, Hospitality & Tourism, Information Technology, and Life Sciences & Health Care.

In 2010, Miami-Dade County had $95,380,550,601 in International Trade revenue (both import and export). Wholesale trade alone accounts for 9,383 businesses in Miami-Dade County, employing 62,407 people with an average salary of $64,984. With these proposed FTZ expansions, these numbers are only going to grow... If you want to take advantage and get your application in for your FTZ, please contact Jen Diaz at (305) 260-1053 or by email at JDiaz@bplegal.com.

Do You Know the TOP 10 COMPLIANCE TIPS?

If you import, you need to!

On behalf of the Organization of Women in International Trade (OWIT-South Florida), I am hosting an informal round table where members OWIT will have the opportunity to get to know one another and learn all about compliance with U.S. Customs and Border Protection (CBP)!

Yes, men are welcome!

This session is especially important for importers and brokers and those in involved in international trade.

Attendees will receive a special "cheat sheet" providing great resources to utilize when importing, including the top 10 compliance tips.

Space is limited to OWIT members! Become a member of OWIT here (it is only $100 for a YEAR of benefits including these FREE IBR's), and assure your spot by sending in your RSVP today!

Please email Jennifer Diaz with any questions!