Customs and International Trade Law Blog : International Trade Lawyer & Attorney : Becker & Poliakoff Law Firm : Customs Law, Border Protection

On 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

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At today's Food and Drug Law Institute's annual conference in Washington, D.C., FDA Commissioner Margaret Hamburg, M.D. said that one of her priorities is responding to the globalization of the food supply, and the increase in misbranded and adulterated food products imported into the United States.  Dr. Hamburg stated that the FDA "cannot wait until the food arrives at our borders," that "extending the FDA's global reach is key to our success," and that the FDA's new PREDICT system will focus FDA Inspectors to select, stop, and examine high-risk shipments being imported into the United States.

Ralph Tyler, FDA's new Chief Counsel, stated that the laws enforced by the FDA affect 25% of the American economy.  The crowd in attendance applauded when Ralph stated that "FDA lawyers are not doing their jobs when they simply say 'no'" to the food, drug, and cosmetic companies regulated by the FDA.

Michael Chappell, FDA's Associate Commissioner for the Office of Regulatory Affairs (ORA), is the person responsible for managing the import, inspections and enforcement policy of the FDA.   He stated that companies are now operating in "an age of heightened enforcement by the FDA."  He stated that "salmonella and listeria remain major problems in food manufacturing facilities."  He advised that there were 19 million customs entries in 2009, and the number is ever increasing.   He stated that the FDA had in 2010 already issued a record number of Warning Letters to importers, producers, and distributors of FDA regulated products, especially dietary supplements and cosmetics.

In summary, my take away after hearing from the top 3 people at FDA is that it is a much more aggressive agency under the leadership of Dr. Hamburg than previously.  Importers should be more careful than ever to understand and comply with the FDA regulations, or not be surprised to receive a Notice of Refusal, a Warning Letter, or even a civil penalty or subpoena.

For any questions about food and drug law, you may contact me at pquinter@becker-poliakoff.com or (954) 270-1864.

Peter Quinter, Partner, Becker & Poliakoff law firm, Miami, Florida.

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The U.S. Food and Drug Administration recently issued several warning letters to prominent food and drink companies regarding false claims displayed on their food and drink products, including those marketed to children.  Some food products brazenly claim to increase a person's immune system, reduce the chance of getting a cold, or even cure cancer.  Are they really believable?

The Obama Administration has taken a more aggressive posture to attempt to reduce the obesity of Americans, especially children.  There is a direct connection between what we eat and our health.  Remember the saying "You are what you eat"?   Dr. Margaret Hamburg, the new FDA Commissioner, announced in a March 3, 2010 letter to food companies:

I have made improving the scientific accuracy and usefulness of food labeling one of my priorities...It is clear to me as a working mother that the use of front of package nutrition symbols and other claims can be helpful to busy shoppers who are often pressed for time in making their food selections.

In a typical December 4, 2009 Warning Letter to one of the worlds' largest food companies, Nestle,  the FDA complained about Juicy Juice All Natural 100% Juice Grape products.  The FDA alleged that the product was misbranded because the labels were misleading in that the label was designed to imply that the producct was 100% grape juice when it truly was not.

The FDA regulations regarding food, including drinks, are complex.  True and accurate health claims are allowed on certain food products under specific circumstances, according to the FDA guidance.  Hopefully, the food industry will be more responsible, and if not, I encourage Commissioner Hamburg to pursue civil penalties against companies and the corporate officers of those companies who deceive the public. 

A seminar about health claims on food products and how to respond to FDA Warning Letters will take place on June 3, 2010 in Miami, at a seminar entitled "Importing Food Products in Compliance with FDA and U.S. Customs Rules". 

In solidarity with FDA Commissioner Hamburg, I am a working Dad, and I don't like to be lied to either!

Peter Quinter, Partner, Customs and International Trade Department.

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

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The United States Congress is considering legislation to make the food we eat, especially imported food, "safe and secure".  In my opinion, even if our food needs protecting, the proposed legislation only adds to the current Federal bureaucracy.  The U.S. Food and Drug Administration (FDA) already has a comprehensive regulatory procedure to stop, examine, and refuse imported food which it considers adulterated or misbranded, or otherwise not fit for human (or animal) consumption.  The current FDA system is working very well, and  the only achievement of the proposed legislation will be to increase the price of food.  We need enforcement of the current laws, not a bunch of new laws.

Granted, there are numerous instances of imported food making people sick, and even causing death.  15% of the food we eat is imported. Nevertheless, the overwhelming number of Americans who get sick or die from consuming food had nothing to do with imported food.  You may get sick at your local restaurant with food poisoning because of the poor handling of the food at the restaurant, not because the food came from overseas.

Currently, for any food to enter the United States, the importer must submit an electronic entry to both U.S. Customs and Border Protection and the FDA.  The entry information includes the name of the importer, a description of the imported food, the name of its manufacturer, the country of origin, the value, the buyer of the food, and where the food is to be delivered.  The requirements of the Bio-terrorism Act of 2002 require "prior notice" which means that the importer must advise U.S. Customs and the FDA far in advance of the arrival of the food at a border crossing of the United States. The U.S. General Accountability Office just issued a thorough Food Safety Report which has an excellent graphic at page 58-59 describing the imported food procedures.  The Report did state that our food supply is safe, but that U.S. Customs and FDA could do better. 

The Government made significant changes already regarding the traceability of food in the Bioterrorism Act which went into effect in December 2003. It required all foreign companies involved in the manufacturing, processing, packing, or holding food that enters the United States to first register with the FDA so that the food may be traced all the way back from the retailer to its source overseas.  Companies may register on-line at www.FDA-USA.com.   

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On August 14, 2009, Jennifer Diaz and I will speak at the annual FIME Conference taking place at the Miami Beach Convention Center, Miami Beach, Florida. The FIME Conference is one of the largest trade shows in the United Stated attended by medical device manufacturers, importers, and distributors from throughout the United States and Latin America.

The seminar topic is “How to Effectively Resolve Typical U.S. Food and Drug Administration and U.S. Customs and Border Protection Issues for Medical Devices.”

Medical devices are strictly regulated by the FDA.  We will discuss how to handle everyday examples of difficult issues with he U.S. Food and Drug Administration (FDA).  FDA issues include what to do if you receive a "Notice of FDA Action" or a "Warning Letter" that could potentially state you must stop producing or importing certain medical devices.  FDA may allege that the device is adulterated because you do not have an approved Premarket Approval Application (PMA) to demonstrate that the device is safe and effective for the new intended uses for which you are marketing it. In addition, the FDA may allege that a device is misbranded because you have not submitted a section 510(k) premarket notification to notify the FDA of your intent to introduce the device into commercial distribution for these new intended uses. Your company may have its imported merchandise authomatically detained by the FDA because it is on the "detention without physical examination" list.  Fortunately, there is a procedure to get off that list.

Effectively resolving U.S. Customs and Border Protection (CBP) issues includes appropriately responding when CBP says your medical devices are under "detention," or will be "seized" and "forfeited".   You will also learn the appropriate response after you receive a "liquidated damages claim" up to $75,000 from CBP.    

If you are interested in attending this informative seminar, you may register here!

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What is the FDA 'Black List'?

The United States Food and Drug Administration (FDA) has authority to put an importer, manufacturer, shipper, grower, geographic area of a country, or an entire country on a “detention without physical examination” (DWPE) list  (a/k/a the FDA’s 'Black List').  To check if a company you are doing business with is on such a list, check FDA’s Import Alert page.   You can search by country, company, etc.  If your company is on this list, any merchandise you attempt to import into the United States may be detained by the FDA as soon as it is offered for entry into the United States.  An importer will have to prove to the FDA that the merchandise should be allowed to enter the U.S., otherwise, it will be refused entry and must be exported or destroyed within 90 days.  The company/country, etc. will remain on this 'Black List' until sufficient information is presented to the FDA that proves the merchandise complies with the FDA requirement.

How to Get Off the Black List

FDA’s Regulatory Procedures Manual provides guidance to those who wish to get off the 'Black List'.  The specific method to use to get off the 'Black List' is directly related to why you were placed on the 'Black List' in the first place.  For example, if a food product was placed on the 'Black List' because it was deemed “adulterated” or “misbranded” by the FDA, a minimum of five consecutive non-violative commercial shipments must thereafter enter the U.S., and at least one of the five non-violative entries should be audited by the FDA to ensure compliance.  The five shipments must be over a reasonable time period, not one day.  Separately, a Petition must be filed with the FDA requesting that the importer be removed from the 'Black List'.  The Petition must include the specific products being automatically detained, the Entry Numbers, and any other relevant documentation to detail steps taken to prevent entry into the U.S. of merchandise that violates the FDA's many requirements. 

It is wise to know whether you or your company are on the FDA 'Black List', to know the FDA requirements to get off the list as soon as possible, and to take action, so that you too, can get off the FDA 'Black List'.

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