Posted on July 18, 2010 by Peter Quinter

Pills That Will Make You Smarter, Lose Weight, and Cure Cancer

Peter A. Quinter, Florida Customs LawyerAll those dietary supplements advertised on television and readily available on the Internet claim to do one thing or another.  Taking certain pills allegedly will make you smarter, give you a burst of energy, end problems with erectile dysfunction, or even cure cancer. The United States Food and Drug Administration (FDA) is the primary Federal agency responsible for protecting the American consumer from such false claims.  The FDA does this through its Office of Regulatory Affairs (ORA), and pursues criminal investigations through its Office of Criminal Investigations (OCI). 

The mission of the Office of Criminal Investigations (OCI) is to conduct and coordinate investigations of suspected criminal violations of the Federal Food, Drug, and Cosmetic Act (FDCA). OCI has an office at FDA Headquarters in Rockville, Maryland, and field offices around the United States.  For example, the Miami Field Office is located in Ft. Lauderdale, Florida, and covers 8 Southeastern States, plus Puerto Rico and the U.S. Virgin Islands.  Special Agents of the OCI investigate street level distribution of counterfeit, unapproved, and designer drugs, major organized illicit diversion of prescription drugs, fraudulent schemes involving ineffective AIDS, cancer, and Alzheimer cures, large scale product substitution conspiracies, application and clinical investigator fraud, and health frauds involving harmful FDA-regulated drugs and medical devices.

In Miami, Florida, two importers were recently arrested for importing cheese contaminated with Staphylococcus aureus, making the food adulterated.  A conviction for introducing contaminated food into the United States may result in 3 years in prison and a fine of $250,000.

Whenever contacted by a Special Agent of the FDA's OCI, be sure to contact an attorney knowledgeable in FDA laws, regulations, policies, and procedures.

---------------------------------------

Peter Quinter, Partner in Charge, Customs and International Trade Department

pquinter@becker-poliakoff.com or (954) 270-1864

 

Tags: , ,
Posted on June 18, 2010 by Peter Quinter

Pep Boys Paid $5 Million to Settle Case with EPA for Illegal Importation of Motor Vehicles and Generators

Peter A. Quinter, Florida Customs LawyerNow that summer is here, air conditioners and generators are on our minds.  It is likely the AC unit or generator that was installed in your home or office was imported into the United States, and made in China.  The EPA has very specific requirements regarding the importation of generators and  motor vehicle engines, including ATVs, snowmobiles, motorcycles, and anything else with a non-road spark ignition engine.  EPA is concerned about enforcing emissions standards under the Clean Air Act, and so should you.

EPA regulations regarding the importation of motor vehicles are enforced by U.S. Customs and Border Protection, which will stop, examine, and seize any engine not exactly complying with detailed EPA requirements, including proper labels displayed on the engine part.  All such importers should be aware of, and timely, accurately and completely submit EPA Form 3520-21 (EPA Declaration Form for Vehicles and Equipment Subject to Federal Air Pollution Regulations).  Failure to do so will result in the seizure of the imported merchandise by U.S. Customs, and penalties against the importer up to $37,500 per vehicle/engine in violation.  Seizures are resolved by filing a Petition with the appropriate U.S. Customs' Fines, Penalties, and Forfeitures Office, and by negotiating and then signing an Administrative Settlement Agreement with the Air Enforcement Division of the EPA.

The aggressive enforcement of EPA's regulations of 40 CFR Parts 86 and 90 were demonstrated in the recent settlement by Pep Boys which has agreed to pay the EPA $5 million, implement a corporate compliance program, and export over 15,000 non compliant vehicles and generators.

Please provide your comments below. For any questions regarding EPA's requirements, please contact me at pquinter@becker-poliakoff.com or (954) 270-1864.

Peter Quinter, Partner, Customs and International Trade Department

Tags: , , ,
Posted on June 9, 2010 by Peter Quinter

U.S. Customs Commissioner Bersin Gave a Great Speech at AAEI

Peter A. Quinter, Florida Customs LawyerAlan Bersin, Commissioner, U.S. Customs and Border Protection, gave a rousing speech to the international trade community attending the AAEI Annual Conference on  June 7, 2010 in New York City.  Instead of focusing on the typical law enforcement concepts of counter-terrorism and national security, Commissioner Bersin enthralled the audience with more business savvy concepts such as "risk management" and "improved trade facilitation."

Mr. Bersin was appointed on March 27, 2010, by President Obama, as Commissioner for one year under a recess appointment. His former position was as the U.S. Department of Homeland Security’s “Border Czar”. Commissioner Bersin is still awaiting confirmation by the Senate Finance Committee.

As stated in the Journal of Commerce regarding Commissioner Bersin's speech:

If 10 percent of shippers cause 90 percent of the security threats, Bersin said, 'We should not be spending 90 percent of our time on the 90 percent of the trade in which we have confidence .... It is only by expediting the movement of the trusted shipper and the trusted traveler that we can actually attack and find the needle in the haystack.'

Commissioner Bersin stated that CBP needs to “stop acting first and listening second,” and he renewed his pledge of increasing the sense of partnership between CBP and the private sector. 

As summarized best in Global Trade News, the Commissioner outlined 3 specific points he has for advancing CBP's objective to improve trade facilitation:

  • Increase participation in C-TPAT, Global Entry, and other trusted trade and traveler programs to, as he put it, “perform segmentation of customers” and focus on high risk “needle in the hay stack;”;
  • Stop looking at borders as lines of demarcation or barriers and start treating them like dynamic flow of goods and people; and
  • Improve targeting to not only provide security but also to offer the benefit of improved trade facilitation and show value to the trade for their effort in providing more data earlier in the supply chain.

I'm not yet ready to say Commissioner Bersin is my hero, however, I am saying welcome to our new leader at U.S. Customs.

Provide your comments below or contact me at or 954 270-1864.

Peter Quinter, Partner, Customs and International Trade Department

pquinter@becker-poliakoff.com

Tags: , ,
Posted on June 8, 2010 by Peter Quinter

Webinar Invitation: Trademarks & Digital Advertising

 
Using Trademarks in Digital Advertising & Online Marketing
 
 
  Join us for a Webinar on June 9
 
 
   
 
 
Digital advertising is one of the most cost-effective ways to develop brand recognition and create goodwill on a worldwide basis.

From Google Adwords to blogging to pop-up advertising, companies have many marketing options available to them.  However, these options are fraught with risk.  Trademark infringement, unfair trade practices, and secondary liability are just a few of the areas that await the unwary when it comes to digital advertising and online marketing.

In this webinar, we will explore recent cases in the area of keyword purchasing and use, as well as the latest decisions impacting blogging and pop-up advertising strategies, and related marketing paradigms.

We will also discuss best practices for registering and protecting your company's trademarks, and answer questions from participants (time permitting).

Space is limited, so register now!

Presented by:  Bradley Gross, Esq.

Bradley Gross is a partner in the law firm of Becker & Poliakoff, P.A., and directs the Firm's Business Technology Law Group. Positioned at the crossroads of technology and intellectual property law, Brad's practice is devoted to protecting his client's IP, and structuring transactions and creating business solutions in cutting-edge areas of intellectual property, technology and online media law.
 
Title:   Using Trademarks in Digital Advertising & Online Marketing
 
Date:   Wednesday, June 9, 2010
 
Time:   11:00 AM - 12:00 PM EDT
 
After registering you will receive a confirmation email containing information about joining the Webinar.
 
System Requirements
PC-based attendees
Required: Windows® 7, Vista, XP, 2003 Server or 2000
 
Macintosh®-based attendees
Required: Mac OS® X 10.4.11 (Tiger®) or newer
 
Space is limited.
Reserve your Webinar seat now at:
https://www1.gotomeeting.com/register/741288225

Tags: , , , ,
Posted on May 26, 2010 by Peter Quinter

FDA Transparency Task Force

Peter A. Quinter, Florida Customs LawyerFDA is proposing to expand disclosure of certain information which is currently not openly shared with the general public.  The twenty-one draft proposals are in response to comments received by FDA’s Transparency Task Force as a way to make the decision-making of the FDA more apparent to consumers and regulated industries.  The proposals are available on-line as a complete report or by specific topic area. 

The report divides the draft proposal into the following eight general topic areas:

 

  • Adverse Event Reports
  • Docket Management Process
  • Enforcement Priorities and Actions
  • Import Procedures
  • Inspections
  • Product Applications (including Investigational applications)
  • Recalls
  • Warning and Untitled Letters

Ten of the twenty-one draft proposals are applicable to the food industry.  They are listed below with links provided to background information, summary of public comments, agency considerations and reasoning for the draft proposal.

Draft Proposal 2 [Docket Management Process]

FDA is accepting comments on the proposals through July 20, 2010.

--------

Co-authored with Dean Leaman, Director of Business Development

Import/Export - Miami, FL, ABC Research Corporation

Tags: , , , , ,
Posted on May 24, 2010 by Peter Quinter

U.S. Congressional Trade Committee Questions CBP and ICE

Peter A. Quinter, Florida Customs LawyerOn May 20, 2010, the top management of both U.S. Customs and Border Protection (CBP) and the U.S. Immigration and Customs Enforcement (ICE) testified before the U.S. House of Representatives' Committee on Ways and Means Subcommittee on Trade.   Chairman Tanner said the hearing was "to strike the right balance" between trade facilitation and security.  Unfortunately, the Committee heard all about the enforcement success of both ICE and CBP without hearing about the difficulties faced daily by importers and customs brokers.

Chairman Tanner accurately stated:

There has been a growing concern that, in particular, CBP's modernization of trade functions, facilitation of trade, and enforcement of traditional customs laws have appeared to lag while the agency tightened security screening of passengers and cargo.

ICE was particularly proud of its accomplishments by its National Intellectual Property Rights Coordination Center.  In ongoing Operation Guardian, ICE has interdicted substandard, tainted, or counterfeit products, including food and medicine that pose health and safety risks to American consumers.  $26 million of such condoms, circuit breakers, toys, extension cords, honey, and shrimp were seized by ICE and CBP.

What was not revealed was how many unnecessary delays and expenses were caused by ICE and CBP for the legitimate merchandise that entered or transited the United States.  In order to determine the effectiveness of the targeting programs used by CBP, Congress needs to inquire about the number of detentions and examinations by CBP, and the consequential financial costs to importers.  The U.S. Government Accountability Office (GAO) is also concerned with properly targeted imported food shipments, as indicated in its May 6, 2010 report on "Food Safety".

Does CBP do a good job at targeting imported shipments?

Peter Quinter, Partner in Charge, Customs and International Trade Department

pquinter@becker-poliakoff.com or (954) 985-4101

Tags: , , , ,
Posted on May 21, 2010 by Peter Quinter

See You at the Boston Seafood Show in 2011!

Peter A. Quinter, Florida Customs LawyerThe largest North American seafood event is the annual International Boston Seafood Show which next takes place March 20-22, 2011, in Boston, Massachusetts.  Not only will I be there, I welcome everyone to visit our exhibition booth!  This reflects the growth of our focus on FDA issues within the Customs and International Trade Department of my law firm.

With the U.S. Food and Drug Administration (FDA) holding, detaining, examining, testing, and refusing more imported food than ever before, our attorneys are constantly interacting with FDA Inspectors, Compliance Officers, and Investigators.  We typically represent the U.S. importer who has received a Notice of FDA Action, and is given 10 days to explain to the FDA that the food product  should enter the United States rather than be refused.  We also represent overseas suppliers who unfortunately find themselves listed on an FDA Import Alert, and want to get off that list. 

For example, on May 20, 2010, the FDA issued Import Alert #16-18, which is "Detention Without Physical Examination of Fresh  and Frozen Shrimp from Bangladesh, Hong Kong, Indonesia, Taiwan, and Thailand" for filth, decomposition and Salmonella.  Shrimp from those countries will automatically be detained by the FDA until a United States laboratory provides sufficient documentation to the FDA that the product meets U.S. standards.  The secret is getting on what the FDA calls the "Green List" of approved shrimp suppliers from these countries so that the product proceeds through the FDA entry process without delay.

Please comment on form below to let me know your experiences from attending or exhibiting at the Boston Seafood Show in prior years.  Remember, it's all the seafood you can eat!

Peter Quinter, Partner in Charge, Customs and International Trade Department

pquinter@becker-poliakoff.com or (954) 985-4101

Tags: , , ,
Posted on May 16, 2010 by Peter Quinter

Frequent Flyer Miles Getting Harder to Use

Peter A. Quinter, Florida Customs LawyerAre you also having a tough time turning in frequent flyer miles to travel internationally?  My wife and I will travel to the beautiful area of Tuscany, Italy, this summer. I wanted to fly non-stop on Delta or Continental, or their code-share partners, but their roundtrip frequent flyer mile minimum requirements were very high - 90,000 and 100,000 miles, respectively!   Instead, I turned in 60,00 frequent flier miles  on American Airlines to get each of the tickets, paid $80 in "taxes" for each, and am flying on American Airlines' code-share partner, Iberia Airlines, through Madrid. 

In years past, I had used only 50,000 frequent flyer miles on AA, Delta, and Continental to fly roundtrip from the United States to many countries in Europe.  Now, airlines want me to use double the miles, and charge me $20 per ticket for having to bother them by telephone to book the trip.  Since I live in South Florida, where American Airlines is the dominant carrier at Miami International Airport, I still have the AA Mastercard, of course, but charge on American Express whenever I can.

Fortunately, I have long had the Starwood American Express card, which allows me (for free) to move 20,000 Starpoints to get 25,000 frequent flyer miles on most airlines.  This is by far the best credit card I have ever used (yes, even better than the AMEX Platinum credit card).  After all,  I need to start saving for next year's trip to Vienna, Austria.

P.S. Any recommendations for places to stay in Siena, Italy? Let me know.

Peter Quinter, Partner in Charge, Customs and International Trade Department

pquinter@becker-poliakoff.com 

Tags: ,
Posted on May 14, 2010 by Peter Quinter

U.S. Consumer Product Safety Commission: Not Just Toys and Games

Peter A. Quinter, Florida Customs LawyerU.S. Consumer Product Safety Commission  (CPSC) officers will target more imported merchandise for safety risk assessments using information filed with U.S. Customs and Border Protection by importers or their customs brokers. The CPSC is an independent health and safety regulatory agency that is responsible for protecting the American public from unreasonable risks of injury and death from about 15,000 types of consumer products. Since the passage of the Consumer Product Safety Improvement Act (CPSIA) of 2008, CPSC increased the number of staff co-located with U.S. Customs at U.S. ports of entry.  Recently, U.S. Customs Commissioner Alan Bersin and CPSC Chairman Inez Tenenbaum signed a memorandum of understanding to create an Import Safety Commercial Targeting and Analysis Center (CTAC). 

CTAC is the culmination of President Obama's Food Safety Working Group  focused on (1) prevention, (2) surveillance, and (3) responding to the attempted importation into the United States of unsafe products.  The authority of CPSC officers is modeled after the authority and actions by the U.S. Food and Drug Administration (FDA), and the U.S. Department of Agriculture's Food Safety and Inspection Service (FSIS). 

CPSC will soon issue its own Detention Notices, rather than having U.S. Customs do it, for imported cargo that is suspected of being unsafe.  CPSC will not only target and detain toys, games, and other children's' products, but also products previously screened only the FDA - food, cosmetic, medical devices, and dietary supplements. 

The $600,000 penalty that Target Corp., of Minneapolis, Minn. has agreed to pay to CPSC for allegedly violating the federal lead paint ban on toys is merely a prelude to the type of civil penalties to be assessed against importers for attempting to import and sell unsafe products.

Is the CPSC doing enough to keep unsafe products out of the United States, or being too aggressive and bureaucratic? Sound off with a comment below. 

Tags: , , , , ,
Posted on April 30, 2010 by Peter Quinter

Do You Have A Legal Problem Outside the United States?

Peter A. Quinter, Florida Customs LawyerI am attending the Spring Conference of Consulegis in the city of Funchal, on the beautiful island of Madeira, Portugal.  Consulegis is one of of the world's largest professional networks of international law firms.  Clients benefit by our ready access to 1,600 lawyers in 42 countries in 150 cities. My law firm has been a member for 10 years.    

The specialist groups of Consulegis include: (1) cross-border litigation and arbitration, (2) intellectual property rights, (3) taxes, (4) debt collection, and, of course, (5) customs and international trade law, for which I am the Chair.  

For those of you who enjoy using Facebook, Consulegis has a new page as of today! Click here to join. Our recent growth in law firm membership has been in Asia, especially China. While it can be challenging to find a dependable law firm in, for example, China, to assist a European or American company, the Consulegis network makes it easy.  

Through regular attendance at Consulegis meetings over many years, strong and personal relationships with senior partners at member law firms around the world have already been developed, so it's not like just finding a law firm on the Internet or getting referred to a stranger. Some of my successes in cooperating with overseas law firms include registering and enforcing a trademark in China, knowing the anti-dumping laws in Mexico, arbitrating a case in Prague, and collecting on a judgment in Germany.  

For any questions about solving legal problems around the world, or about Consulegis generally, feel free to contact me.

Peter Quinter, Partner in Charge, Customs and International Trade Department, Miami, USA

pquinter@becker-poliakoff.com or (954) 270-1864.

 

Tags: , , , ,