November 2013

Did You Know…? 2013 FDA FSMA Report Facts

FDA has just released the 2013 Annual Report on Food Facilities, Food Imports, and FDA Foreign Offices.

Section 1003(h)(2)(A) – Number of import lines examined/sampled

FDA physically examined (conducted field exams or analyzed samples) 207,839 food and feed import lines in FY 2012.

Section 1003(h)(2)(B) – Number of import lines not examined/sampled

The total number of food import lines for FY 2012 was 11,136,599. FDA physically examined 1.9 percent, or 207,839, of the food import lines. It is important to note that while FDA is not able to physically inspect a large percentage of food entries, all import entries are electronically screened using an automated system, which helps field inspectors determine which products pose the greatest risk and, therefore, should be physically examined. FDA recently enhanced screening capability by implementing the Predictive Risk-based Evaluation for Dynamic Import Compliance Targeting (PREDICT) information technology system. PREDICT uses data analytics from the entire life cycle of a product to better identify and target high-risk products before they enter the country. In addition, when necessary, FDA can issue import bulletins which signal FDA inspectors to pay special attention to a particular product, or a range of products from a particular producer, shipper, or importer. Under import alerts, products that appear to be subject to refusal based on existing evidence (such as a history of violations) can be detained […]

By Jennifer Diaz|2022-07-07T10:08:14-04:00November 25, 2013|FDA Issues, FSMA, U.S. Food and Drug Administration (FDA)|0 Comments

PortMiami and CBP Join Forces to Bring Back (and Expedite) Transshipment

PortMiami has been working feverishly to bring back transshipment to Miami.

Step one was PortMiami’s outreach to U.S. Customs and Border Protection (CBP). PortMiami Director Bill Johnson wrote a letter to Acting CBP Commissioner, Thomas Winkowski, dated June 26, 2013, asking CBP to develop a pilot program, “with a transshipment inspection protocol pilot for PortMiami.”

According to PortMiami’s letter to CBP Commission Winkowski, prior to 9-11, “transhipment made up over 22% of the cargo trade at PortMiami.” Now, that transshipment cargo goes through Panama, Freeport, and Kingston.

You may be asking, what’s the rationale for the move to other ports away from PortMiami? The answer, CBP’s increased inspections of transshipment goods, resulting in cargo delays and added expenses. A specific example is CBP’s intensive examination of goods checking for intellectual property rights violations, and seizing goods that are non-compliant, when alternative ports are not as proactive. CBP confirmed that after 9-11, almost all transshipment cargo was inspected, now, CBP is down to under 5% (a much more reasonable number).

CBP confirmed that its mission is to protect the nations borders, but, also to “PROMOTE AND EXPEDITE TRADE AND COMMERCE,” which is wonderful to hear from CBP!!

CBP leaders are active on this committee and CBP has 4 lofty goals:

As a result of PortMiami’s efforts, a new task-force has formed, and CBP is actively partnering with PortMiami to ensure its success. It is called the “Transshipment Committee” and will meet quarterly at PortMiami. Terminal Operators and ALL other […]

By Jennifer Diaz|2022-07-08T16:15:20-04:00November 19, 2013|Detention, Seizure, U.S. Customs and Border Protection (CBP)|0 Comments

Large Seizure by CBP Highlights High Margins of Counterfeiting, and Necessity of Recordation

Co Authored by Michael De Biase

One of CBP’s latest news releases, dated September 27, 2013, noted that more than 16,000 counterfeit Hermes handbags were seized by Customs and Border Protection (“CBP”) because Hermes took the extra step of recording their intellectual property with CBP. Not surprisingly, when you analyze the difference between the alleged value of the counterfeit products (reported to CBP) as compared to the suggested retail price of the genuine goods, you have a grave difference. In this case, $295,665 (value of counterfeit goods) compared to $210,785,475 (value of genuine goods). That’s over $210 million worth of potential profits for the counterfeiters, at the expense of Hermes – a crime in every sense. Because Hermes recorded its intellectual property with CBP, CBP seized this infringing merchandise, and will also have the ability to issue a penalty for the MSRP of the merchandise. Yes, that means a penalty in the amount of $210,785,475 will be coming to the counterfeiters!

Most often, counterfeiters target large luxury brands whose goodwill and name recognition has a certain element of exclusivity. While some may not sympathize with profitable companies, what they fail to realize is that counterfeiting hurts in a variety of other ways. Counterfeiting hurts consumers who buy products under the false impression that they are genuine, companies whose goodwill is tarnished by the inferior quality of the counterfeit products bearing their brands, and it hurts those who worked hard to build something of substantial value. In this case, Hermes lost out on, potentially, more than $210 million dollars […]

By Jennifer Diaz|2022-07-08T16:15:20-04:00November 4, 2013|Import, Intellectual Property Rights, Seizure, U.S. Customs and Border Protection (CBP)|0 Comments

Did You Know…? 2013 FDA FSMA Report Facts

PortMiami and CBP Join Forces to Bring Back (and Expedite) Transshipment

Large Seizure by CBP Highlights High Margins of Counterfeiting, and Necessity of Recordation

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