33,810 IPR Seizures in 2018!

U.S. Customs and Border Protection (CBP) is tasked with the monitoring of and enforcement of intellectual property rights (IPR). In CBP's FY 2018 Seizure Statistics, CBP advised that it enforced trademarks and copyrights pertaining to over 17,641 active recordations, including 2,289 new recordations and 812 renewals of expiring recordations.

In fiscal year 2018, 381 individuals were arrested by CBP or ICE for violations related to IPR violations and 260 convictions related to intellectual property crimes proceeded. The total number of IPR seizures decreased by 333 seizures from the previous year. Surprisingly, while the number of seizures decreased from 34,143  in 2017 to 33,810 in 2018, the total estimated manufacturer’s suggested retail price (MSRP) of seized goods, had they been genuine, increased $1.4 billion.

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.

UPDATE: USTR Increases Section 301 Tariffs to 25% Duty for Products on List 3

Since September 17, 2018, the trade industry has been bracing themselves for the increase of China tariffs from 10% to 25%. The trade community has enjoyed a few months of postponements – January 1st, 2019 to March 1st, 2019. The postponements led many to believe the increase was unlikely, until May 6, when the President emphatically stated that “the 10% will go up to 25% on Friday [May 10, 2019].” via twitter. Only three days later and USTR has officially announced the anticipated 25% increase is effective on 12:01 am, May 10, 2019.

Voice Your Comments about CTPAT & the Trusted Trader Program!

U.S. Customs and Border Protection (CBP) provided a 60-day extension as part of their “Agency Information Collection Activities” requesting comments on the CTPAT and Trusted Program.

CBP will be submitting the information collection request to the Office of Management and Budget (OMB) for review and approval in accordance with the Paperwork Reduction Act of 1995 (PRA). The PRA changed many aspects of Information Collection by the Federal government. requiring agencies to plan for the development of new collections of information and the extension of ongoing collections well in advance of sending proposals to OMB. Agencies must:

Using a Middleman? Learn How to Lower Your Customs Value Using First Sale!

Pursuant to the Customs Modernization Act, the importer of record (IOR) must use “reasonable care” when providing the value of the goods to Customs and Border Protection (CBP). All merchandise imported into the United States is subject to valuation or appraisement. The Trade Agreements Act of 1979, codified at 19 U.S.C. § 1401a, sets forth a hierarchy of methods for the appraisement of imported merchandise. Under the Trade Agreements Act of 1979, the transaction value of imported merchandise is the primary or preferred method for determining the value of imported merchandise. Generally, transaction value is the price actually paid or payable for merchandise when sold for exportation to the United States, plus certain statutorily enumerated additions.

Deadline Approaching - A Snapshot of Section 301 Duties & Your Options!

The trade war has kept members in the trade industry on their toes – here is a recap.

Effective Dates: 

For importers being hit by additional duties it is crucial to know when the additional duties are effective and must be paid. USTR has now issued three lists under 301 Section Trade Remedies. We urge importers to clearly understand which list their products are subject to and develop a business plan on how to prepare for additional import costs.

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?

Here's a Recap of Part II of our #WorldTradeMonth Seminar Series for Compliance Professionals on FDA FSMA and FSVP

Yesterday, we at DTL, had the pleasure of hosting Part II of our #WorldTradeMonth Seminar Series for Compliance Professionals. The second seminar focused on FDA FSMA (Food Safety Modernization Act) Compliance for Importers with expert speakers from the U.S. Food and Drug Administration (FDA) and industry. We had a packed house with an array of attendees such as importers of food, beverages, and medical devices, along with customs brokers, freight forwarders / NVOCCs, lawyers, consultants, and others. We received requests for a re-cap from those who attended and industry members who were not able to attend. You asked and we deliver. Here is our recap:

The morning kicked off with a networking breakfast where experienced and novice industry members were able to engage in meaningful dialogue about overlapping issues they experience in their respective workplaces in dealing with the topic of FSMA. We heard comments from small to large business on their current implementation strategies in place to ensure they meet FSMA requirements by FDA’s compliance dates.

The seminar promptly began at 9:00 am with introductory remarks by our own President, Jennifer Diaz. We had all attendees introduce themselves and include why this seminar was important to attend. We were glad to hear from majority of attendees that their reason for participating was to further their education on FSMA. One attendee commented, “Excited to hear from FDA about FSVP requirements and what the broker’s role is in the process.”

Next Representatives of Miami Free Zone explained their role in international business solutions as it provides users and visitors with convenient international business resources including turnkey FTZ solutions for distribution; a wholesale marketplace; an international business center environment; and premium showroom, office, and warehouse spaces. As well as providing FTZ users with flexible control over their domestic and foreign inventory, duty elimination and deferment, and high security standards for their businesses and valuable merchandise.

The first speaker was Elena O. Asturias, is a licensed U.S. Customs Broker, and Certified Customs Specialist providing customs brokerage services for imports. Elena provided top tips for custom brokers as she has been involved in logistics for over fifteen years, and has experience handling a broad range of commodities. Some helpful tips from here presentation include:

• Make sure food facilities that must be registered with the FDA pursuant to the Bioterrorism act are registered to avoid delays upon entry into the U.S.
• A major issue causing FDA to detain food products are product labeling violations
• Ensure you use correct Affirmation of Compliance (AofC) Codes
  • When the entry is filed with FDA, use AofC codes to affirm the products meets specific import requirements.
  • Depending on the product type, many AofC’s are required, and must be submitted upon time of entry.
  • The AofC is a 3 letter indicator, then the qualifier which will vary in format. In some cases no qualifier is required.
    • Examples: PFR is the code used to designate a Manufacturer Food Facility Registration Number and it’s used with a 11 digit qualifier.
      • PFR 12345678901
      • FDA Affirmation of Compliance (AofC) Code Quick Reference
• FSVP – Unique facility identifier (UFI)
  • As of May 30th, you will need to add the UFI (Unique Facility Identifier) when you transmit the entry.
  • The AofC code being added is FSV, which will require the following:
    • DUNS number (as acceptable UFI)
    • Importer name & address
    • Email address
    • If the importer doesn’t have a DUNS number yet, you can transmit UNK “unknown” temporarily.
  • ENTRY DATA TRANSMISSION PROCESS:

• ITACS
  • ITACS – Import Trade Auxiliary Communications System
  • Importers are able to see the current FDA status (as long as they have the entry number), using the ITACS system (you have the ability to monitor your shipments without having to call your broker!).

Lundy Patrick followed Mrs. Asturias’ presentation and echoed the significance of being familiar with the importation process. Mr. Patrick is Lieutenant Commander serves as a U.S. Public Health Officer assigned to the Florida District Office of the FDA as an Imports Compliance Officer.  There were questions and answers during his presentation as the attendees had submitted questions prior to the seminar.  Here are highlights from the discussion:

• Articles are expected to be in compliance AT THE TIME OF ENTRY. Therefore, you need to exercise due diligence to make sure the products you intend to import are in compliance PRIOR to the importation of the goods.
• The following food imports require Prior Notice:
  • Food imported for use, storage, or distribution in the U.S. (including gifts and trade and quality assurance/quality control and market research samples)
  • Food transshipped through the U.S. to another country
  • Food imported for future export, or food for use in a Foreign Trade Zone, unless it is on the list of exemptions
• If you fail to provide Prior Notice, the food shipment is subject to refusal and, if refused, must be held at the port of entry unless directed to another location. The importing or offering for import into the U.S. of an article of food in violation of Prior Notice requirements is a "Prohibited Act" under the laws FDA administers.
• If a food product is assigned for examination/sampling, FDA will examine and will collect samples. Historically between 1-2% get examined/sampled.
• Lieutenant Commander Patrick echoed the importance of product label compliance and stressed FDA does not pre-approve labels for food products.
• He stated that the State of Florida, the third busiest district, has had over 8,000+ detention and 2200+ Refusals and provided the top reasons for food product detentions:
  • Labeling Issues:
    • Incorrect or missing statement of identity/name of the food
    • Failure to List potential allergens
    • Failure to declare ingredients
    • Failure to bear nutrition labeling or the nutrition label is in incorrect format.
  • Most common Import Alerts the FDA sees in Florida:
    • IA 16-81 - "Detention Without Physical Examination of Seafood Products Due to the Presence of Salmonella“
    • IA 99-05 - "Detention Without Physical Examination Of Raw Agricultural Products for Pesticides"
  • If Refused Goods are sold and Cannot be Redelivered for Export / Destruction, you may face:
    • Liquidated Damages and/or 19 USC 1592 Penalties

Thereafter, Giselle Jordan took the floor to discuss the hot topic of FSMA Compliance and Foreign Supplier Verification Program. Giselle is a Consumer Safety Officer at the Division of Import Operations of FDA. In August 2016, she joined the newly established Food Safety Verification Program Team. Here are highlights from her presentation:

• Resources:
  • FDA/FSMA   ß SIGN UP (there is a subscription feature available)
• FSMA Sec. 301 requires importers to have FSVPs and FDA to issue regulations.
  • The goal for FSMA is FOOD SAFETY
• Key Principles of FSVP Rule
  • Establishes explicit responsibility for importers to ensure the safety of imported food
  • Risk-based (according to types of hazards, importers, and suppliers)
  • Alignment with PC supply-chain provisions
  • Flexibility in meeting requirements (assessing activities conducted by others)

• Purpose of an FSVP
  • To provide adequate assurances that:
    • Foreign suppliers produce food using processes and procedures providing same level of public health protection as FSMA preventive controls or produce safety provisions
    • Food is not adulterated or misbranded (as it relates to allergen labeling)
  • Who Must Comply?
    • “Importer” is U.S. owner or consignee of a food at time of U.S. entry.
    • If no U.S. owner or consignee at entry, importer is U.S. agent or representative of the foreign owner or consignee, as confirmed in signed statement of consent to serve as the importer under FSVP (“FSVP Importer”).
    • Note that the responsibility for FSVP compliance lies with the FSVP Importer and the FSVP Importer can be different from the Importer of Record.
  • FSVP Exemptions
    • Firms subject to juice or seafood HACCP regulations
    • Food for research or evaluation
    • Food for personal consumption
    • Alcoholic beverages and alcoholic beverage ingredients (7%)
    • Food transshipped through U.S.
    • Food imported for processing and export
    • “U.S. foods returned”
    • Meat, poultry, and egg products subject to USDA regulation at time of importation
    • Low acid canned food facilities (microbiological hazards only)
  • Appropriate Verification Activities
    • Must document determination, performance, conduct, review and assessment of results
    • Verification activities include:
    • Onsite audits (qualified auditor), sampling and testing of the food, a review of foreign supplier relevant food safety records, other appropriate activities
  • To qualify as a “Very Small Importer”:
    • Must meet definition of a very small importer
    • Less than $1 million/yr. in human food sales
    • Less than $2.5 million/yr. in animal food sales
    • Annually documentation of eligibility
  • Compliance Dates
    • The final FSVP rule was published on November 27, 2015
    • First compliance date: May 30, 2017
    • Last compliance date: July 27, 2020
    • FSMA Food Guidance Regulation

Jennifer Diaz concluded the seminar with best practices for due diligence and best practices for responding to enforcement actions and FDA Notice of Action. Check out DTL’s TOP 10 TIPS for importing food products into the U.S.

For more information on how we can help you through the maze of importing and FSVP email us at info@diaztradelaw.com.

A special thanks to all our prize winner for participating during the seminar. We appreciate your involvement and interest! For pictures of the event LIKE us on Facebook.

Subscribe Today to keep up with the latest Customs and International Trade Law News.

Our next Live Broadcast webinar will be held on Wednesday, May 24, 2017 to discuss Intellectual Property Rights Violations and the U.S. Customs & Border Protections Enforcement. More information is available here.

DTL will also be at the NEI will be hosting the 3rd annual Global Trade Educational Conference held on August 7-8. NEI is bringing customs brokers, freight forwarders, NVOCCs, OTI, service providers, importers, exporters and all global logistics professionals an opportunity to update themselves on industry developments and connect with colleagues old and new. To RSVP - Read more. . .

*****This document is provided for informational purposes only and does not constitute legal advice nor does use of this constitute the formation of an attorney-client relationship.******

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!

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

What 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.

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

Each 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.