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Customs and International Trade Law Blog

News & updates on Customs and International Trade Law

MANDATORY BIENNIAL REGISTRATION RENEWAL TO TAKE PLACE OCTOBER-DECEMBER 2014

Posted in FDA Issues, Food, FSMA, Uncategorized

Manuf foodMandatory Biennial Registration Renewal for Food Facilities will soon be required, on October 1, 2014 until December 31, 2014. If your facility is not re-registered with the FDA by December 31, 2014, FDA will cancel your Bioterrorism Act registration and your importations will be delayed. A FDA Registration number is mandatory to import food products into the U.S.

Here’s what you need to know about FDA’s new FSMA requirement on Bioterrorism Act registrations. Owners, operators, or agents in charge of domestic or foreign facilities that manufacture/process, pack, or hold food for consumption in the U.S. are required to register the facility with the FDA.

Note that even facilities which are already registered with the FDA are still required to renew their registrations during the October– December 2014 registration renewal period.  

The Food Safety Modernization Act of 2011 (FSMA) has for the first time, specifically put the onus on importers to have a program to verify that the food products they are bringing into this country are safe. The idea behind FSMA is to change FDA regulatory enforcement and focus to more of a preventative approach, instead of reactionary. These new requirements include risk-based controls, foreign supplier verification program, certification, and audits. A brief overview of the requirements may be found here.

I’ve summarized the biennial registration requirements relevant to your Bioterrorism Act Registration below, so you can be sure your registration doesn’t lapse. 

New Biennial Registration Requirements

FSMA amended the Food, Drug & Cosmetic Act (FD&C Act) Section 415 to provide for biennial registration updates. Facilities which are required to register will have to re-register every 2 years, during the period beginning on October 1 and ending on December 31 in even numbered years. The first Biennial registration occurred October-December 2012, and the next is soon approaching from October-December, 2014.

Note that even facilities which are already registered with the FDA are still required to renew their registrations during the October – December registration renewal period.

U.S. Agent

 FDA requires that foreign facilities have a U.S. agent. The U.S. agent must:

  1. live or maintain a place of business in the U.S. and
  2. be physically present in the U.S.

The U.S. Agent is also responsible for the payment of “reinspection fees” of foreign facilities and failure to comply with recall orders. Reinspections are follow-up inspections conducted by the FDA after a previous inspection by the FDA where the FDA identified non-compliance issues materially related to food safety. The purpose of the reinspection is to assure the issue has been remedied and food is now safely produced. Fees are adjusted each fiscal year. For FY 2014 (October 1, 2014-December 30, 2014), the fees are steep, at $237 an hour if no foreign travel is required, and $302 an hour if foreign travel is required.

Need a U.S. Agent?

The law firm Becker & Poliakoff, P.A. provides registration services and will act as a U.S. agent with the FDA for a nominal fee, but, the foreign facilities are always responsible for the payment of any reinspection fee or fee for a failure to comply with a recall order. Please visit www.FDA-USA.com for more information about how to make Becker & Poliakoff, P.A. your U.S. agent with the FDA.

Contact me with any questions.

  • Jennifer Diaz, Esq.
  • Shareholder & Chair,
  • Customs and International Trade Department
  • 121 Alhambra Plaza, 10th Floor
  • Coral Gables, FL 33134
  • Office: (305) 260-1053
  • Cell: (305) 724-3281
  • Email: jdiaz@bplegal.com

Jennifer Diaz Teaches Two Medical Device Seminars at FIME

Posted in Best Practices, FDA Issues, Import Alert, Medical Devices, Speaking
FIME

I’m pleased to be back for my fourth year teaching at FIME! For those of you that don’t know, FIME was rated the #1 medical show in the USA by Successful Meetings Magazine. FIME runs from August 6-8, 2014 at the Miami Beach Convention Center.  You still have limited time to register to attend the conference and my seminars! Continue Reading

Time to Register – 2014 C-TPAT Conference

Posted in Best Practices, C-TPAT, CBP, Events, Import

forkliftIt’s officially time to register for the 2014  C-TPAT National Conference.

Despite substantial scrutiny and restriction due to Department of Homeland Security (DHS) guidelines for government sponsored conferences, a scaled back C-TPAT conference will go on.  This year’s theme will be “C-TPAT: Partnering in Supply Chain Security and Facilitation for the 21st Century.”

Here’s what you need to know:

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

Posted in Best Practices, CBP, Import, Seizures, U.S.Customs

made in ChinaOn 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.

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FDA Helps Small Businesses Get Ready for New “Gluten-Free” Labeling Requirements

Posted in Best Practices, FDA Issues, Food, FSMA, Gluten Free, Import, Uncategorized

GFAccording to the FDA, approximately 3 million people (or 1 in 133 people) in the United States have celiac disease (CD), including me. While there is currently no cure for CD, unfortunately, individuals who have the disease are advised to follow a strict gluten-free diet. Over time, the continued ingestion of gluten by Celiacs triggers the production of antibodies that attack and damage the lining of the small intestine. Such damage hinders the absorption of nutrients, which leads to an array of severe health issues. This makes truthful gluten-free labeling essential for a Celiac’s survival, and celiac’s like me ecstatic that the “gluten-free” claim will be enforced, come August 5, 2014. If you manufacturer a food product, and are not ready to comply, read on.

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White House’s OMB Intervenes to Weaken FDA’s Proposed Regulation of E-Cigs

Posted in E-Cigarette, FDA Issues, Import, Tobacco

e-cig smokeOn April 24, 2014, the U.S. Food and Drug Administration’s (FDA) issued a proposed regulation which would subject the currently unregulated e-cigarette industry to FDA regulation under the authority of the Federal Food, Drug and Cosmetic Act (FD&C Act). The proposed rule put e-cigarettes with a list of products FDA “deemed” tobacco products, and as such, subject to the FD&C Act. OMB intervened to weaken FDA’s original proposal.

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Do You Want to be a “Trusted Trader”? C-TPAT is No Longer Enough

Posted in Best Practices, C-TPAT, CBP, CPSC, FDA Issues, Import

Trust

U.S. Customs and Border Protection (CBP) recently published the long awaited Federal Register Notice, dated June 16, 2014, discussing the “Announcement of Trusted Trader Program Test.”

This new “Trusted Trader” program is big news for U.S. and non-resident Canadian importers, and if implemented will combine the Customs-Trade Partnership Against Terrorism (C-TPAT) and Importer Self Assessment (ISA) programs, making ISA extinct.  CBP is currently recruiting test companies that have to be willing to go through an 18 month program test. Continue Reading

Freight Forwarder Pays $125,000 Mitigated Penalty – Avoid This & Learn 11 Steps to Exporting

Posted in Best Practices, BIS, Events, Export, Freight Forwarding, OFAC, Uncategorized

Aramex Emirates, LLC, located in Dubai, United Arab Emirates (U.A.E.), agreed to pay a $125,000 civil penalty to the U.S. Department of Commerce’s (DOC) Bureau of Industry and Security (BIS) for the unlicensed export and reexport to Syria, via the U.A.E., of network devices and software without the required BIS licenses.

The Under Secretary of Commerce Eric L. Hirschhorn commented:

Today’s settlement shows the importance of compliance with U.S. law by foreign freight forwarders handling items subject to U.S. export controls.

The items in question could be used by the Syrian government to monitor Internet activity and block pro-democracy websites as part of its brutal crackdown against the Syrian people.

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Port Miami Tunnel Opening Celebration!

Posted in CBP, Department of Homeland Security, Events, Import

photoToday was the historic PortMiami Tunnel Opening (where you can watch my video of the first 3 trucks that officially entered the port tunnel)!  A better video can be found here, courtesy of Local 10.

As the Miami Herald reported today, four long years and $915 million dollars went into this tunnel that will now allow both cruise traffic and trucks to bypass downtown Miami and instead, head straight to the highway.

Much needed relief for residents. And… No Tolls!

Perhaps one of the more touching moments was when all of the 900+ workers were celebrated and extremely proud exiting the tunnel.

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CBP Updates Trade Community on GSP Expiration

Posted in CBP, Customs Broker, FTA, Import, Uncategorized

For those of you that relied on the Generalized System of Preferences (GSP) and are now subject to duties, CBP sent a notice today that directly impacts you.

A previous post discussed the expiration of GSP and need for congressional action to renew it. GSP expired July 31, 2013. Importers were advised to continue to use the Special Program Indicator (SPI) “A” when importing into the U.S., which would signify a valid claim for GSP but to pay duty subsequent to that date, so that in the event of a retroactive renewal, CBP could process refunds automatically.

Unfortunately, the picture above is still correct – the trade community is in limbo – will we get our duties refunded if we are entitled to GSP?  The answer… Yes, Maybe, No.  Not comforting or reassuring.

Today, CBP advised the trade community that:

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