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Best PracticesCBPEPAExportImport

New Executive Order…Will Small Businesses Benefit?

posted by Jennifer Diaz February 13, 2017 0 comments

cui-sealOn 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”.

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ExportFDA IssuesImportMedical Devices

Medical Device Registration Made Easy!

posted by Jennifer Diaz January 27, 2017 1 Comment

Screen Shot 2017-01-26 at 1.40.53 PMThis article is a continuation of: “What Do Dental Floss, Bedpans, and Pacemakers Have in Common?”, and discusses the three types of medical device classifications and how to register and list those devices with the FDA.

FDA’s classes of medical devices:

The Food and Drug Administration (FDA) has established classifications for approximately 1,700 different generic types of medical devices.” The device classification is broken up into three regulatory classes (Class I-III), which is “based on the level of control necessary to assure the safety and effectiveness of the device”. To determine the device classification, the FDA looks at “the intended use of the device and also the indications for use“. According to the FDA’s Guidance on Device Regulation, the intended use of a device “means the general purpose of the device or its function, and encompasses the indications for use”. Indications for use is “a general description of the disease or condition the device will diagnose, treat, prevent, cure, or mitigate, including a description of the patient population for which the device is intended”. (21 C.F.R. §814.20(b)(3)(i)). The class for which your medical device would belong to, determines the type of pre-market submission or application that is required for FDA clearance to sell the medical device in the United States.

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Best PracticesBISCBPCosmeticsCubaEventsExportFDA IssuesImportIPR, Trademarks and LogosSeizuresSpeakingU.S.Customs

Top Successes of Diaz Trade Law (DTL) & Diaz Trade Consulting (DTC) in 2016!

posted by Jennifer Diaz January 26, 2017 0 comments

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DTL saved clients MILLIONS of dollars in 2016, below we list a summary of some of our compliance successes!

U.S. Customs & Border Protection (CBP)

  • Assisted an importer in having $434,486.00 worth of goods seized returned to it in a RECORD 24 working days, with a signed settlement agreement with CBP in a record 17 working days!
  • Assisted an importer in having $324,466.00 worth of goods seized for an underlying AES violation returned.
  •  Assisted importers in filing prior disclosures that were accepted by CBP, advising of errors found, and avoiding substantial penalties.
  •  Assisted importers in successfully responding to CBP 28’s and 29’s resulting in close outs, and no further enforcement action by CBP!
  •  Assisted importers in creating and maintaining pre-compliance programs to evaluate intellectual property rights and pre-report merchandise to CBP resulting in expedited entry into the U.S. with no delays or examinations by CBP.

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CBPEPAImportInvestigationVehicles

VW to pay HIGHEST CBP PENALTY EVER, $1.45 Billion!

posted by Jennifer Diaz January 19, 2017 0 comments

Screen Shot 2017-01-18 at 11.48.28 AMOn 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”.

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FDA IssuesFoodFSMAImport

FSMA: Stay Compliant with DTL’s ‘PICTURE’!

posted by Jennifer Diaz January 12, 2017 1 Comment

FSMA todo listEach year, according to the findings of a Center for Disease Control and Prevention study, 48 million people (1 in 6 Americans) get sick, 128,000 people are hospitalized, and 3,000 people die as the result of food-related diseases. Instead of reacting to this news on a yearly basis, the U.S. Food and Drug Administration (FDA) decided to do something about it (although not fast enough, some would say) by enacting the Food Safety Modernization Act (“FSMA”). This law, which went into effect on January 4, 2011, aims to protect public health and ensure food safety by placing a greater emphasis on prevention, compliance, and enforcement.

We’ve summarized the seven foundational rules of FSMA for you below. The compliance elements which food facility owner/operators, growers, suppliers, importers, consignees, carriers, and/or accreditation/certification bodies should, at a minimum, incorporate into their 2017 actions plans are highlighted in red (information regarding compliance deadlines for different size-based categories of business can be viewed here). Diaz Trade Law has extensive advising clients on FDA matters and welcomes the opportunity to help your company get FSMA compliant.
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Best PracticesCBPEventsFTAImportIPR, Trademarks and LogosSpeakingU.S.Customs

Don’t Gamble with Compliance

posted by Jennifer Diaz January 6, 2017 0 comments

massconversions Are you interested in e-Commerce? Have a desire to go to Vegas?

Diaz Trade Law founder Jennifer Diaz will be speaking at the upcoming Massconversions Live e-Commerce conference in Las Vegas, Nevada. Jennifer’s presentation will focus on the TOP 10 Tips to Comply with Customs When Buying Online. Attendees will, by the end of her presentation, know and understand the importance of:

• Tariff classification
• Customs valuation
• Country of origin marking
• Intellectual Property Rights (IPR) Protection and CBP Enforcement
• Free Trade Agreements (FTAs)

Attendees will also learn basic customs concepts and terms like:

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AD/CVDCBPDepartment of Homeland SecurityExportImportInvestigation

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

posted by Jennifer Diaz December 22, 2016 0 comments

rob-articleU.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 Continue Reading

Best PracticesCBPCounterfeitsImportIPR, Trademarks and LogosSeizuresU.S.Customs

U.S. Customs – Your Personal Policeman at the Border

posted by Jennifer Diaz December 6, 2016 2 Comments

counterfeitMany companies mistakenly believe that registering a trademark or copyright with the U.S. Government provides sufficient protection and remedies, and, therefore, do not take the extra step to record those trademarks or copyrights with U.S. Customs and Border Protection (U.S. Customs).

The processes achieve two completely different goals.

Registering a trademark with the U.S. Patent and Trademark Office (USPTO) or copyright with the U.S. Copyright Office gives public notice of one’s ownership of the trademark or copyright. On the other hand, the purpose of recording a trademark or copyright with U.S. Customs is to partner with the agency in preventing the unauthorized importation of merchandise that bears a recorded trademark or copyright. U.S. Customs prevents counterfeit and otherwise infringing products from entering or exiting the United States for registered trademark or copyright holders who have recorded their trademarks or copyrights with Customs. Continue Reading

Best PracticesCBPImportU.S.Customs

CBP Launches New E-Commerce and Small Business Branch … Just in Time for the Holiday Shopping Season

posted by Jennifer Diaz December 1, 2016 0 comments

santaWith Thanksgiving in the rear view mirror and the Christmas holiday season kicking into high gear, now is the time to think of Pre-Compliance especially with the grave risks associated with shopping online and not knowing your supplier. As Small Business Saturday and Cyber Monday commercial activity spikes, CBP is, in specific connection with online sales, warns consumers and merchants alike to be on the lookout for holiday shopping scams and/or criminal trade practices. Red flags to watch for in this regard include offers designed to induce the purchase of counterfeit and/or unsafe goods, prices that are too good to be true, e-commerce sites that lack legitimate phone numbers and/or addresses, and sellers who lack good customer feedback.

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EventsExportImport

TPP: Dead or Alive?

posted by Jennifer Diaz November 22, 2016 0 comments

tppAre 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 with 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.

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