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:

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

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

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!

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!

New Executive Order...Will Small Businesses Benefit?

On January 30th, the Office of the Press Secretary released the Executive Order (EO) on reducing federal regulations and controlling regulatory costs. This latest EO requires that all federal agencies "cut two existing regulations for every new regulation they implement". According to President Trump, this EO is meant to help small businesses by easing "the opening and expansion of small businesses" and the "incremental costs for the new regulations in 2017 will be zero dollars". The EO requires “for every one new regulation issued, at least two prior regulations be identified for elimination, and that the cost of planned regulations be prudently managed and controlled through a budgeting process.” There will also be "certain categories of regulations that will be exempt from this new policy, including those dealing with the military and national security".

Catch up on DTL's TOP Blogs from 2016!

We want to make sure you stay up to date with the hottest trade topics from 2016. Below is a summary of what you missed by category. Enjoy!

CBP

1. Why Pre-Compliance is a Must
2. Ongoing Hoverboard Concerns
3. Yet Another Reason to Record your Trademark or Copyright with U.S. Customs and Border Protection (CBP)
4. U.S. Customs - Your Personal Policeman at the Border
5. Learn About "The ABC's of Customs Seizures - Plus Top 10 Tips to Ensure Import Compliance" From the Expert!
6. ISF Penalties Have Officially Arrived: Self File and Self Police

On January 11, 2017, the U.S. Customs and Border Protection (CBP) and the Attorney General announced the largest criminal and civil settlement ever against Volkswagen (VW) that totaled $4.3 billion. The breakdown of the settlement was $2.8 billion for the criminal penalty and $1.45 billion for a combined civil penalty for both the CBP and the Environmental Protection Agency (EPA). Volkswagen agreed to plead guilty to three felony criminal counts and pay the $2.8 billion dollar penalty. The $1.45 billion combined settlement was for EPA's "claim for civil penalties against VW in connection with VW's importation and sale of these cars" as well as CBP's claim for customs fraud.

CBP’s part of the $1.45 billion settlement dealt with a violation of 19 U.S.C. §1952, which "prohibits persons, by fraud, gross negligence or negligence, from entering or introducing, attempting to introduce, or aiding and abetting the entry or introduction of merchandise into the commerce of the United States, by means of statements or acts that are material and false, or by means of omissions which are material".

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

Learn About "The ABC’S of Customs Seizures - PLUS Top 10 Tips to Ensure Import Compliance" From the Expert!

The DTL Team wants to ensure you are a compliant with U.S. federal regulations and laws when importing your goods from abroad! Here is your chance to learn directly from our Founder, Jennifer Diaz, about the "dos" and "don'ts" of importing. 

On Wednesday, September 14th, 2016 from 1:00 pm to 2:00 pm, The Organization for Women in International Trade (OWIT) invites you to a Trade Talk Webinar Program on International Trade Compliance-Register NOW! 

 Did you know that In FY 2015, 28,865 seizures were for underlying Intellectual Property Rights (IPR) violations? The MSRP of the goods seized was $1,352,495,341! IPR enforcement is a priority trade initiative for U.S. Customs and Border Protection (CBP) and the detention and seizure process is a complicated one. If your merchandise is detained and/or seized, you have options. But more  Learn exactly how you should respond and more importantly how to avoid future problems with CBP.

This event is particularly important for:

HOVERBOARD RECALLS DUE TO EXPLOSIONS

Back in January, we addressed Ongoing Hoverboard concerns and numerous CBP seizure cases. Now, the Consumer Product Safety Commission (CPSC) announced ten companies have recalled about half a million self-balancing scooters/hoverboards made in China. However, the recall isn’t because of the countless risks hoverboards pose to unwary riders, instead it is because the lithium-ion battery packs in these products can overheat, creating a risk that the hoverboards will start to smoke, catch fire and/or explode. The list of the ten firms is here. Below are the models impacted:

ISF PENALTIES HAVE OFFICIALLY ARRIVED: SELF FILE AND SELF POLICE

Back in July, 2013, we warned CBP would start enforcement efforts for Importer Security Filing (ISF) violations. What’s ISF Again? The ISF rules require importers and vessel-operating carriers to provide additional advance trade data on cargo shipments to CBP 24 hours prior to vessel lading, pursuant to Section 203 of the Security and Accountability for Every Port (SAFE Port Act) of 2006. (Practitioners Tip – This ONLY applies to goods arriving to the U.S. by Sea, not air). Now, CBP advised:

SOLAS (Weigh or Pay) - Enforcement as of July 1, 2016

If you are involved in international trade, then you’ve recently heard the buzzword SOLAS and an enforcement date of July 1, 2016. Below contains a summary of SOLAS and what to be prepared for.

What is SOLAS?

• “SOLAS,” an acronym made from The International Convention for the “Safety of Life at Sea,” is an international treaty that governs the safe operation of all ships engaged in international maritime trade. The SOLAS Convention specifies the minimum standards for the construction, equipment, and operation of merchant ships. The United States is a signatory to SOLAS.

Who is responsible?

Why Pre-Compliance is a MUST

If the thought of monetary penalties, shipment delays, detentions or seizures of merchandise keep you up at night, then this article is for you.  First, it’s quite easy to establish a U.S. company, pick (what you hope is) a terrific customs broker, file Form 5106 with U.S. Customs and Border Protection (CBP) to request your importer number, pick a surety (there are many, your broker will likely sway you to their favorite) and WALLAH! Right? Wrong. No one sits you down during this process to say, wait, importing can be great, but, this is also a LOT of responsibility. Your company (and SOMETIMES even YOU) have liability and a burden when importing. This article will walk you through YOUR burden as an importer, how CBP can question your imports, and how penalties can ensue and what you should be doing about it, in advance! 

Food Importers - FDA Issues New Guidance Aimed at Expediting Your Importations

The FDA Food Safety Modernization Act (FSMA) is the most sweeping reform of our food safety laws in more than 70 years and was signed into law by President Obama on January 4, 2011. FSMA aims to ensure the U.S. food supply is safe by shifting the focus from responding to contamination to preventing it. FSMA requires FDA to establish a voluntary, fee-based program, named the “Voluntary Qualified Importer Program” (VQIP) which promises expedited review and importation of foods from importers who achieve and maintain a high level of control over the safety and security of their supply chains.

 On June 4^th, 2015 the FDA published a draft version of “Guidance for Industry: FDA’s Voluntary Qualified Importer Program (VQIP)”.  According to FDA’s website, VQIP will also benefit consumers by enabling the FDA to focus its resources on high risk foods, further protecting consumers from the potential health hazards associated with those foods. In order for a food importer to be eligible for the VQIP program, the importer should:

1. Have at least a 3 year history of importing foods
2. Have a Data Universal Numbering System (DUNS) number
3. Use a paperless filer/broker who received a passing rating during their last FDA evaluation
4. Import food that is not subject to an import alert or Class 1 recall
5. Not be, nor any non-applicant entity associated with the VQIP food be, subject to an FDA administrative or judicial action, have a history of significant non-compliance with food safety, or have one or more voluntary food recalls
6. Assure compliance with several FSMA regulations
7. Possess a current facility certification
8. Have a clear 3 year history with U.S. Customs and Border Protection (CBP), meaning no CBP penalties, forfeitures, or sanctions.
9. Pay the annual VQIP user fee before October 1^st of the intended year of participation (FDA estimated flat fee of $16,400 annually), and
10. Develop and implement a Quality Assurance Program (QAP)

Having a robust QAP program is one of the most vital components to have in place to qualify for VQIP and will be one of the largest hurdles for eligibility for those that do not have a QAP program in place. QAP is a compilation of the written polices and procedures a food importer will need in order to ensure adequate control over the safety and security of the foods to be imported. The QAP portion of the VQIP application will be time consuming and difficult to navigate, but with expert help, it can be manageable. FDA believes financial benefits of VQIP will outweigh the efforts in the application process.

FDA estimates that the VQIP program will officially commence in January, 2018.

If you have comments about the draft VQIP, especially the estimated annual fee of $16,400, FDA wants to hear from you by August 19, 2015. FDA will review all comments and publish the final fee in a future Federal Register notice at least 60 days prior to the start of the program. All food importers that want a faster, streamlined supply chain should consider participation in VQIP.

For more information on VQIP, or assistance in developing your QAP program, or want to make sure your voice is heard during the comment period, contact me anytime at jdiaz@bplegal.com.

NEW CBP Pilot Program Focuses on IPR Pre-Compliance

CBP is currently taking volunteers for a brand new Intellectual Property Rights (IPR) voluntary pre-compliance program.  The Journal of Commerce reported on the new pilot program here. Do you agree with my comments?

Jen Diaz to Speak on Import Regulations

The 11th Annual International Business Trade Expo (IBTE), “Expanding Beyond Our Borders,” will be held Thursday, October 16, 2014 at the Broward Center for the Performing Arts. The event promotes international trade and highlights the significant impact that bilateral trade has in South Florida’s economy. IBTE is hosted by the Lauderhill Regional Chamber of Commerce (LRCC) in partnership with: Florida Chamber of Commerce; Enterprise Florida; City of Lauderhill; Broward Center for the Performing Arts; Unique Production International, and MD Marketing Network.

Business leaders from across the globe will convene to strategize on how to promote and expand bilateral trade between Florida the Caribbean and Latin America. Attendees will hear from experts on trade issues and regulations affecting Florida’s international business economy, and more.

Featured Speakers, Panels and Workshops are listed below:

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

On 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.

Export Penalties Already Total $184 MILLION in 2014 – Want to Learn Who, What, Why & How to Stay Compliant?

Within just the first nine weeks of 2014, almost $182 million dollars in penalties have been assessed against companies for OFAC and ITAR export violations.  Within those same nine weeks alone, companies have been ordered to pay the Department of Treasury almost $25 million dollars more than was ordered in all of 2013. Simply put, compliance is critical, and non-compliance is costly!

Don’t miss this update on export enforcement actions stemming from a busy 2013 and start of 2014.

BEWARE - Liquidated Damages WILL be Imposed for 10+2 Violations

For those who thoughts CBP's “measured and commonsense” approach for those that weren’t fully complying with the Importer Security Filing (ISF or 10+2) rules would last forever, think again!

Effective, July 9, 2013, CBP advised it would start the liquidated damages phase of the Importer Security Filing (ISF) enforcement process. CBP will now make use of the newly activated cargo holds in the Automated Cargo Environment (ACE) system to address non-compliance with the ISF rule. CBP may also withhold the release or transfer of non-compliant ISF shipments at the terminal until the required ISF is filed. For carrier violations of the vessel stow plan requirement, CBP may refuse to grant a permit to unlade the merchandise. Once the ISF data is received and a security assessment is made, additional enforcement actions including a Non-Intrusive Inspection (NII) and/or intrusive exams may be initiated.

Liquidated Damages

CBP may also assess liquidated damages of up to $5,000 per violation for the submission of an inaccurate, incomplete or untimely filing. CBP Dec. 09-26 discusses "Guidelines for the Assessment and Cancellation of Claims for Liquidated Damages for Failure to Comply with the Vessel Stow Plan, Container Status Message, and Importer Security Filing Requirements."  First violations may be mitigated to $1,000-$2,000 - depending on the presence of aggravating or mitigating factors.  Some mitigating factors for the failure to file a complete, accurate and timely ISF include evidence of progress in the implementation of ISF during the "flexible enforcement period," small number of violations compared to number of shipments, Tier 2 and 3 C-TPAT status, remedial action....  CBP has advised that "no relief will be granted if CBP determines that law enforcement goals were compromised by the violation."  Aggravating factors include multiple errors on your ISF!  If you do receive a Liquidated Damages claim, it is important you consult with an expert to file a timely, persuasive Petition to CBP and address all relevant mitigating factors to assure you receive the maximum reduction possible.

What's ISF Again?

The ISF rules require importers and vessel-operating carriers to provide additional advance trade data on cargo shipments to CBP 24 hours prior to vessel lading, pursuant to Section 203 of the Security and Accountability for Every Port (SAFE Port Act) of 2006.

Importers must report the following 10 data elements on each ISF:

1. Manufacturer (or supplier) name and address
2. Seller (or owner) name and address
3. Buyer (or owner) name and address
4. Ship-to name and address
5. Container stuffing location
6. Consolidator (stuffer) name and address
7. Importer of record number/foreign trade zone applicant identification number
8. Consignee number(s)
9. Country of origin
10. Commodity Harmonized Tariff Schedule (HTS) number

From the carrier, 2 data elements are required:

1. Vessel stow plan – required for arriving vessels with containers.
2. Container status messages – required for containers arriving via vessel.

Hence, 10+2!

For shipments consisting entirely of freight remaining on board (FROB) cargo or goods intended to be transported in-bond as an immediate entry or transportation and exportation entry, the following 5 data elements are required:

1. Booking party name and address
2. Ship-to name and address
3. Commodity Harmonized Tariff Schedule (HTS) number
4. Foreign Port of Unlading
5. Place of delivery

In order to avoid liquidated damages and untimely delays with your cargo, full ISF compliance is now required.  Since we're talking compliance, do you have your pre-compliance plan established?  If not... Let's talk!


If you have any questions on the listed requirements or need assistance with cargo detained as a result of this new enforcement phase, please feel free to contact me, and I'm happy to assist you with any ISF or CBP related question!  

Florida Companies Convicted and Sentenced

Co Authored by Robert Becerra

In another example of the government’s continuing use of the criminal justice system to enforce international trade laws, three Florida companies and their management were recently convicted and sentenced for importing smuggled toys from China containing lead and containing counterfeit trademarks.

LM Import-Export, Inc., Lam’s Investment Corp., and LK Toys Corp., Hung Lam and Isabella Kit Yeung plead guilty to charges of conspiracy to traffic and smuggle toys containing hazardous substances such as lead, and one count of trafficking in counterfeit goods, in violation of 18 U.S.C. Secs. 371 and 2320, respectively. Co-defendant Yeung plead guilty to one misdemeanor count of submitting a false country of origin label, in violation of 19 U.S.C. Sec. 1304(a). The information, or charging document filed in court, against all defendants, as well as the plea agreements for each defendant can be found on the website of the District Court for the Southern District of Florida. (If you have trouble getting these documents, email me and I'd be happy to share them with you).
The facts underlying the charges, as stated in court documents, are that from April, 2000, until May 2011, a span of 11 years, the corporate defendants conspired to sell children’s products imported from China in violation of the Consumer Product Safety Act 15 U.S.C. Sec. 2068, and the Federal Hazardous Substances Act, 15 U.S.C. Sec. 1263. Some of the toys contained lead, while others presented various hazards such as choking, aspiration or ingestion. The products were imported using false statements on Customs declaration forms and with false country of origin labeling.

Hung Lam was sentenced to 22 months incarceration, 3 years of supervised release and a $10,000 fine. The corporations were sentenced to 5 years of probation. Yeung was sentenced to 1 year probation and a $1,000 fine. An order was entered mandating the forfeiture to the government of $862,500 and all products imported by the defendants that were seized by the government. The press release from the Consumer Products Safety Commission and Department of Justice discussing the case can be found here and here respectively.

This case is extremely important for importers to be familiar with and understand that:

1. It is vital for importers to retain counsel to assist with pre-compliance before you import.
2. When you receive any violation notice from the federal government, retain counsel immediately and be sure to address all violations with remedial action and enhanced compliance procedures in an attempt to keep administrative penalties or forfeiture cases from turning into potential criminal matters.
3. Resolving a civil action through a consent decree with the government does not absolve you of criminal liability.
4. Once contacted by government officials, retain counsel immediately. Any evidence you provide or any statements you make will be used against you in court.
5. Repeated misconduct and federal regulatory law violations over a period of years will often result in criminal prosecution of both companies and their individual employees, resulting in federal prison sentences and substantial fines and forfeitures.