Tuesday, December 19, 2017
Your Data is NOT Your Own at the Border
On November 15, 2017, DTL’s very own Jennifer Diaz, along with other experts, spoke at the AILA CLE Luncheon on travelers’ rights when encountering U.S. Customs and Border Protection (CBP) at airports and other ports of entry. As international travel continues to grow, coupled with increase national security efforts, it is imperative travelers know their rights when entering or exiting the U.S. Travelers enjoy taking their electronic devices with them for pleasure and/or work. Electronic devices hold considerable amounts of our personal or privileged information.
What is CBP’s Policy?
Friday, December 15, 2017
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?
What is the U.S. Doing About It?
Thursday, November 9, 2017
Trump Administration Tightens Cuba’s Sanctions Program
Since June 2017, we have been anxiously awaiting changes to the Cuba sanctions program since President Trump signed an executive order and emphatically stated that his administration would tighten loose regulations established under the Obama Administration.
On November 8, 2017, the U.S. Department of the Treasury stated,
- “We have strengthened our Cuba policies to channel economic activity away from the Cuban military and to encourage the government to move toward greater political and economic freedom for the Cuban people”
Tuesday, November 7, 2017
AILA CLE Luncheon: Ports of Entry – Searches, Seizures and More!
Do you know rights (and your clients’ rights) when encountering law enforcement at airports and other ports of entry? Join us at The Rusty Pelican on Wednesday, November 15, 2017, at 11:45AM for an interactive discussion on various issues being encountered by travelers at ports of entry. Our panel of experts will discuss:
Labels:
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Event,
Ports of Entry,
Profiling,
Searches,
SEIZURES,
speaking
Friday, October 27, 2017
Peruvian Timber on the Hot Seat
In a press release, the Office of the United States Trade Representative (USTR) directed United States Customs and Border Protection (CBP) to block future timber imports from a Peruvian exporter, Inversiones Oroza SRL for three years or until it is determined that the company has complied with all applicable Peruvian laws, regulations, and other measures, whichever is shorter. This is the first enforcement action taken by the
Thursday, October 26, 2017
CBP's 2017 EAST COAST TRADE SYMPOSIUM
UPDATE – CBP JUST OPENED UP REGISTRATION TODAY for its EAST COAST Trade Symposium!
We always strive to keep you informed of the latest and greatest trade events. In this vain, U.S. Customs and Border Protection will be hosting the 2017 EAST Coast Trade Symposium on
Thursday, October 19, 2017
The UGG Boots Story: How Recording Your Registered Trademark Can Lead to a Jail Sentence
At the end of September 2017, Shi Wei Zheng, 42, plead guilty to one count of trafficking in counterfeit goods. During a five-month period, Zheng trafficked over 15,000 pairs of counterfeit UGG boots, with a total estimated retail value of over $2.5 million.
Friday, October 6, 2017
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
Monday, September 25, 2017
Essential Oils Company to Pay $760K for Lacey Act Violations
The Justice Department announced YOUNG LIVING ESSENTIAL OILS, L.C., (the Company), headquartered in Lehi, Utah, plead guilty in federal court to federal misdemeanor charges regarding its illegal trafficking of rosewood oil and spikenard oil in violation of the Lacey Act and the Endangered Species Act.
Despite the company voluntarily disclosing its violations and cooperating with government investigators, it entered into a plea agreement, and the Company was sentenced to a fine of $500,000, $135,000 in restitution, a community service payment of
Friday, September 1, 2017
CTPAT “Your Supply Chains Strongest Link”
I just attended the 2017 CTPAT conference in Detroit. After 2 days of CTPAT’ing, here a list of my top 10 takeaways including the changes I see coming to the CTPAT program.
- There is a new name. Notice the – is officially gone, no more C-TPAT (despite all of us conditioned to using the -, it is no more. CTPAT it is.
- There is a new slogan – CTPAT “Your Supply Chains Strongest Link”.
- There is a new woman at the helm. Elizabeth Schmelzinger is the Director of CTPAT.
The biggest take away is ....
Labels:
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CTPAT Conference,
events,
MSC,
Trusted Traders
Tuesday, August 29, 2017
Don’t Miss FDA’s Upcoming Webinar on ITACS
On September 5th, 7th, and 11th the U.S. Food & Drug Administration will hold three identical webinars, which will provide information on the evolution of FDA’s Import Trade Auxiliary Communications System or ITACS system “to ensure that trade users are familiar with and understand the new ITACS Account Management functionality.”
Wednesday, August 9, 2017
C-TPAT Conference 2017
U.S. Customs and Border Protection is proud to announce the 2017 C-TPAT Conference. The conference will be held in the Detroit Metropolitan Area. Two sessions will be offered: August 29 - 30, 2017 and August 30 - 31, 2017. Both sessions will include a day of workshops and a day of general session.
Labels:
C-TPAT,
C-TPAT Conference,
CBP,
Conference,
US Customs
Tuesday, June 20, 2017
6/22/17 EVENT - The Making of Global Cities: Can Miami Follow a Bold Strategy?
The Organization of Women in International Trade (OWIT South Florida) is hosting an event you don't want to miss: The Making of Global Cities: Can Miami Follow a Bold Strategy?
Friday, June 16, 2017
President Trump Outlines New U.S. Policy on Cuba
We’ve been patiently waiting for today’s announcement since President Trump took office on Friday, January 20, 2017. Some have speculated on whether President Trump’s stance on Cuba would further diplomatic relations following the steps of former President Barack Obama, while the majority have opined that Trump’s next steps could reverse some of the changes made by the former President. The speculation can now be put to the side as today President Trump delivered a speech in Miami (at the Manuel Artime Theater) today, a little over 90 miles away from the island of Cuba, outlining his new policy with the communist island. The announced changes do not take effect until the new OFAC regulations are issued. The forthcoming regulations will be prospective and will not affect existing contracts and licenses.
Here is a summary of the MAIN changes, and background of why the President has signed an executive order making these changes in support of the Cuban people:
Monday, June 12, 2017
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?
Labels:
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compliance,
FDA,
Import,
Importers,
International Law,
International Trade,
Medical Device,
reasonable care,
safety
Tuesday, May 30, 2017
HELP! CBP Seized My Tobacco Products as Drug Paraphernalia, What Now?
Our office has increasingly received requests for guidance
on importation of marijuana paraphernalia products to the U.S. where twenty-six
(26) states have legalized
the use of marijuana for medical purposes and/or personal consumption such
as California, Massachusetts, Maine and Nevada. The purpose of this article is
to dispel the confusion as to why paraphernalia products (grinders, storage
containers, rolling paper, pipes, vape pens, etc.) are continuously being
seized by U.S. Customs and Border Protection (CBP), even when such products may
be used by tobacco smokers. It is important to address the realities between
federal and state laws regulating drug paraphernalia products so importers can
avoid CBP’s enforcement of U.S. Laws.
Why Does CBP Stop Drug Paraphernalia?
-
CBP secures America’s borders at and between
ports of entry by stopping inadmissible people and illicit goods. The Tariff
Act of 1789 provides one of CBP’s core functions: to act as the leading
federal agency in determining the admissibility of goods that may enter the
Commerce of the United States. Even though each State has internally legalized
marijuana either for medical or recreational purposes, CBP still has the
express power to authorize or not
any merchandise that comes into the U.S. Thus, CBP can detain and seize “drug
paraphernalia” even if you did not intend to use the product that purpose
pursuant to 19
U.S.C. § 1595a(c) stating a violation of
21 U.S.C. § 863.
What Constitutes Drug Paraphernalia?
In 2014, a smoke shop owner imported different merchandise
from China described as “glass hookahs and parts”. The Central District of
California considered these products, which were valued at $82,933.64 as drug
paraphernalia and thus detained and seized the merchandise pursuant to 19
U.S.C. § 1595a(c) for violations of
21 U.S.C. § 863. The U.S. sued the shop owner and the Court concluded that
“despite…[the] erroneous characterization of the merchandise as ‘hookah
pipes’…they are bongs, and are therefore barred from entry into the United
States.”
To determine whether the product is drug paraphernalia, the
Court will not only consider the Code, but also other relevant factors such as
the existence and scope of legitimate uses of the product in the community and
expert testimony concerning its use. Under 21 U.S.C. Section 863(e), the
following items are used to determine if a product is drug paraphernalia:
(1) instructions, oral or written,
provided with the item concerning its use;
(2) descriptive materials accompanying
the item which explain or depict its use;
(3) national and local advertising
concerning its use;
(4) the manner in which the item is displayed
for sale;
(5) whether the owner, or anyone in
control of the item, is a legitimate supplier of like or related items to the
community, such as a licensed distributor or dealer of tobacco products;
(6) direct or circumstantial evidence
of the ratio of sales of the item(s) to the total sales of the business
enterprise;
(7) the existence and scope of
legitimate uses of the item in the community; and
(8) expert testimony concerning its use.
There is no requirement that the violator had specific knowledge
that the merchandise constituted drug paraphernalia. United
States v. 160 Cartons of Glass Water Pipes, Case No. CV 12-8965- BRO (VBKx)
(C.D. Cal. Mar. 10, 2014).
What Must You Refrain From Doing?
- Sell or offer to sell drug paraphernalia
- Mail drug paraphernalia or transport it through interstate commerce
- Import or Export drug paraphernalia
REMEMBER: CBP is the federal agency that has control over
everything that is imported and exported to/from the U.S. and therefore, they
have the power to detain and seize your products when it constitutes drug
paraphernalia. This will continue to happen until Congress decides to enact a
Federal Law that allows marijuana consumption on a federal level or drug
paraphernalia within the U.S.
What Do You Do if CBP Detains and/or Seizes Your Merchandise?
CBP has the power
to detain persons or merchandise and make admissibility decisions. If CBP
believes merchandise should be detained, it is required to send a Notice
of Detention no later than five (5) business days from the day of
examination. Often, the Notice of Detention does not specify the circumstances
of the detention or is not even issued. It is important during this detention
phase to communicate with CBP to discuss why your merchandise should not
constitute drug paraphernalia and should be released.
CBP also has the ability to seize your merchandise if it is
contrary to law and CBP will send a Seizure
Notice, which you will have 30 days to respond, and typically we respond in
the form of a Petition. Seizure cases are complicated, it is best to hire an
expert who knows the policies, internal procedures and practices of U.S.
Customs. Most importantly, getting involved early in the detention process is
the best way to tackle this issue.
Want to Know if Your Product Will be Considered Drug Paraphernalia
Prior to Importing?
Prior to importing your product, we recommend you
review your product with an expert and determine whether to request a Binding Ruling from CBP. In
CBP Ruling HQ
H150766, an importer inquired on whether
its hookah and hookah components constituted drug paraphernalia. The major
issue CBP decided was whether the hookahs are “primarily intended” for use with
drugs since it is considered a multiple-use item. CBP ruled that hookahs are admissible merchandise into the United
States and held that they are not considered drug paraphernalia based on
the weight of the evidence addressing the 8 criteria as set forth in 21 U.S.C.
§ 863, specifically its intended use for tobacco and not drugs.
If you have questions on whether or not your product
constitutes drug paraphernalia and are interested in requesting a binding
ruling, or if CBP has detained or seized your product, contact our office at info@diaztradelaw.com or (305) 456-3830
for assistance.
Friday, May 26, 2017
Crash Course in the Harmonized Tariff Schedule of the United States
What is the HTSUS?
The HTSUS is the Harmonized Tariff Schedule of the United States.
This post will give a rundown of what the HTSUS is and why it is so important:
- The HTSUS was established in 1989 through an act of Congress. This new tariff classification replaced the old Tariff Schedule of the United States.
- The “HTS comprises a hierarchical structure for describing all goods in trade for duty, quota, and statistical purposes.”
- The hierarchical structure is based on the international Harmonized Commodity Description and Coding System (HS). This system was created by the World Customs Organization, which is based out of Brussels, Belgium.
- The HTSUS contains 10 numbers, grouped by chapter, heading and subheadings.
- The first 6 digits of the HTS are universal throughout the world.
- The HTSUS is the primary source for determining the proper tariff classification for goods that are imported into the United States.
- The HTSUS assists importers in deciphering what duties are owed for imported goods.
- It is an importers obligation to utilize “reasonable care” in ascertaining the correct HTSUS.
- Experts use the HTS, in conjunction with explanatory notes, general notes, general rules of interpretation and Customs Binding Rulings to determine the correct HTS.
- Penalties for non-compliance with the HTSUS (i.e., randomly picking the HTSUS with the lowest duty rate) can be severe! 19 U.S.C. 1592 is the statute CBP references when issuing penalties for negligence, gross negligence or fraud – depending on the degree of culpability CBP believes you had at the time of your non-compliance.
How is the classification determined?
- The classification for the HTSUS is done in accordance with the General and Additional U.S. Rules of Interpretation. There are two columns for rates of duties. The first column is broken down into two subcolumns. Those subcolumns are “General” and “Special” rates of duties. The General subcolumn “sets forth the general or normal trade relations (NTR) rates”. The “Special” subcolumn “reflects rates of duty under one or more special tariff treatment programs”. Column two is “duty rates for products from” countries that do not have NTR with the United States. Currently there are only two countries on that list and those are Cuba and North Korea.
What is My Obligation as an Importer as it Relates to the HTSUS?
- CBP published a terrific guide titled “Importing into the U.S.” “A Guide for Commercial Importers”. The guide discusses the Trade Act of 2002 and the Customs Modernization Act (the “Mod Act”) and the responsibilities that came to fruition for importers as a result. A key feature of the Mod Act is a “relationship between CBP and importers that is characterized by informed compliance”. What this means is now there is ashared responsibility between CBP and the import community, wherein CBP communicates its requirements to the importer, and the importer, in turn, uses “reasonable care” to assure that CBP is provided with accurate and timely data. Bottom line, no “reasonable care” = BIG problem.
How Do I Prove I Used Reasonable Care?
If you have an answer for these 10 questions (from CBP’s Reasonable Care Checklist), then you can prove you used “reasonable care” as it relates to your HTSUS:
- “Have you provided or established reliable procedures to ensure you provide a complete and accurate description of your merchandise to U.S. Customs and Border Protection in accordance with 19 U.S.C. 1481? (Also, see 19 CFR 141.87 and 19 CFR 141.89 for special merchandise description requirements.)
- Have you provided or established reliable procedures to ensure you provide a correct tariff classification of your merchandise to U.S. Customs and Border Protection in accordance with 19 U.S.C. 1484?
- Have you obtained a Customs "ruling" regarding the description of the merchandise or its tariff classification (See 19 CFR Part 177), and if so, have you established reliable procedures to ensure that you have followed the ruling and brought it to U.S. Customs and Border Protection’s attention?
- Where merchandise description or tariff classification information is not immediately available, have you established a reliable procedure for providing that information, and is the procedure being followed?
- Have you participated in a Customs pre-classification of your merchandise relating to proper merchandise description and classification?
- Have you consulted the tariff schedules, Customs informed compliance publications, court cases and/or Customs rulings to assist you in describing and classifying the merchandise?
- Have you consulted with a Customs "expert" (e.g., lawyer, Customs broker, accountant, or Customs consultant) to assist in the description and/or classification of the merchandise?
- If you are claiming a conditionally free or special tariff classification/provision for your merchandise (e.g., GSP, HTS Item 9802, NAFTA, etc.), How have you verified that the merchandise qualifies for such status? Have you obtained or developed reliable procedures to obtain any required or necessary documentation to support the claim? If making a NAFTA preference claim, do you already have a NAFTA certificate of origin in your possession?
- Is the nature of your merchandise such that a laboratory analysis or other specialized procedure is suggested to assist in proper description and classification?
- Have you developed a reliable program or procedure to maintain and produce any required Customs entry documentation and supporting information?”
What is a Customs Binding Ruling and Do I need One?
- Considering an importer of record has a responsibility to use “reasonable care” when declaring the classification for merchandise upon entry to the U.S., CBP has a binding ruling program in place where importers can receive a binding determination from CBP on issues relating to classification prior to importation.
- A binding ruling can only be given by the National Commodity Specialist Division (NCSD) of the Office of Regulations and Rulings. We routinely advise importers to research the HTSUS first, and ask CBP for the HTSUS you believe best fits your product when requesting a binding ruling. It’s important to remember, the decision is BINDING. Not following it is not an option. There is a reconsideration process, but, it takes a considerable amount of time, whereas binding ruling requests for an HTSUS are generally issued within 30 days.
How Would CBP Know I’m NOT Using the Correct HTSUS?
- CBP has the right to check up on importers and ensure you are using “reasonable care” in regard to the classification of merchandise entered into the U.S. CBP often verifies that an importer is declaring merchandise entered into the U.S. properly by sending an importer a Request for Information, also known as Customs Form (CBP Form) 28. Upon receipt of a Request for Information, if an importer determines an inadvertent error took place, and an investigation by CBP has not yet commenced, filing a perfected Prior Disclosure may assist in drastically reducing potential penalties from CBP. A CBP Form 28 is NOT friendly. It can (and often does lead to enforcement by CBP). This is where you get counsel involved to ensure you respond adequately to the CBP Form 28, and if advised by counsel, submit a Prior Disclosure as a response.
Need help with complying with the proper HTSUS so you do not receive a penalty? Then contact Diaz Trade Law at info@diaztradelaw.com to make sure you have the correct HTSUS.
Labels:
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Export,
HTSUS,
Import,
reasonable care
Thursday, May 25, 2017
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:
- Do not use symbols
- Use symbols with adjacent explanatory text, or
- 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.
- 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
- 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:
Wednesday, May 24, 2017
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
- Examples: PFR is the code used to designate a Manufacturer Food Facility Registration Number and it’s used with a 11 digit qualifier.
- 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
- Labeling Issues:
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
- To provide adequate assurances that:
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.******
Thursday, May 11, 2017
Missed DTL's seminar on AD/CVD with CBP? Here's a re-cap.
Yesterday we at DTL had the pleasure of hosting Part 1 of 2 of our Seminar Series for Compliance Professionals. In celebration of #WorldTradeMonth the first seminar concentrated on Antidumping Duties and Countervailing Duties (AD/CVD) with expert speakers from U.S. Customs and Border Protection (CBP). While we had a packed room, we have received requests from industry members who were not able to attend asking for a re-cap. You asked so we delivered!
Here is our re-cap:
Monday, April 24, 2017
FREE World Trade Month Seminar on FDA/FSMA COMPLIANCE for Importers
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.
Food Importers, here is your chance to learn practical tools for trade! We are providing the trade community a valuable opportunity to speak direct with FDA, Brokers, and legal experts to address any concerns relating to 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?
- For a limited time, registration is FREE! UPDATE - FREE TICKETS ARE OFFICIALLY SOLD OUT! Limited $20 tickets remain.
- You have the ability to hear DIRECTLY from FDA.
- 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 food importation/FSMA for the FDA. Please email your questions today to info@diaztradelaw.com!
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!
Friday, April 21, 2017
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!!
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!!
Labels:
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pre-compliance,
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speaking
Thursday, April 20, 2017
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?
- For a limited time, registration is FREE!
- You have the ability to hear DIRECTLY from CBP and FDA.
- 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!
Labels:
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Apparel,
Bioterrorism Act,
CBP,
CBP 28,
CBP 29,
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events,
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fda issues,
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trade,
U.S.CUSTOMS
Tuesday, April 18, 2017
President Trump & CBP Aim to Collect Unpaid AD/CVD Duties
On March 31, 2017, President
Trump signed an Executive Order (EO) that addressed unpaid anti-dumping and
countervailing duties. This new EO, “promotes the
efficient and effective administration of U.S. customs and trade laws by
establishing enhanced measures to collect duties”.
What are anti-dumping and
countervailing duties (AD/CVD)?
Dumping happens when a foreign
company exports goods into the U.S. and sells those goods at less than fair
market value. This in turn causes “injury to the U.S. industry”. Due to this, U.S. manufacturers
or businesses can file a petition with the International
Trade Commission (ITC),
claiming that it has suffered an injury. Once the ITC finds that evidence of an
injury exists, then the Department of Commerce (DOC or the Department) will investigate the claim. If
the DOC determines that dumping occurred, then Customs and Border Protection
(CBP) can withhold “liquidation of entries” and collect anti-dumping (AD)
duties. AD “duties are calculated to bridge the gap back to a fair market
value.”
Thursday, April 13, 2017
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.
Labels:
DUNS number,
FDA,
food importation,
FSMA,
FSMA compliant,
FSVP,
Importers,
UFI
Tuesday, April 4, 2017
Is “Made in the USA” Really Made in the USA?
Which Federal Agency Regulates the “Made in the USA” Claim?
The Federal Trade Commission (“FTC” or “the Commission”) “is charged with preventing deception and unfairness in the marketplace. The FTC created an Act that would allow the Commission to bring legal action “against false or misleading claims that a product is of U.S. origin”.
When Can I Say Made in the USA?
- For a product to be considered as “Made in the USA” without qualification, that product must be “all or virtually all” made in the U.S. How the Commission determines whether a product is “all or virtually all” made in the U.S., by looking at whether there was “a ‘reasonable basis’ to support the claim at the time it is made”. To prove the “reasonable basis” standard, a manufacturer or marketer must provide “competent and reliable evidence” to the FTC.
- A qualified Made in the USA claim must describe “the extent, amount or type of [its] domestic content or processing”. This allows the consumer to know “that the product isn’t entirely of domestic origin”. The FTC warns that qualified claims can be tricky, so it is best to “avoid qualified claims unless the product has a significant amount of U.S. content or U.S. processing”.
- Ex: “60% U.S. content. Made in USA of U.S. and imported parts. Couch assembled in USA from Italian Leather and Mexican Frame.
- For a complete understanding of the FTC’s Made in the USA standard, take a look at “Complying with the MADE IN USA STANDARD”.
Labels:
All or virtually all,
Best Practices,
compliance,
FTC,
Made in USA
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