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

I authored "Recent Developments in Food and Drug Law, 2012 Edition" which was just published by Thomas Reuters.  It is part of a series called "Inside the Minds" written by attorney thought-leaders in food and drug law from the top law firms across the United States.  It analyzes the latest food and drug laws, regulations and policies that affect food and drug companies.  It also focuses on violations by persons and companies, and how to successfully defend any investigation by the U.S. Food and Drug Administration (FDA) without having to go to court.

The full title  of the 408 page publication is "Recent Developments in Food and Drug Law, 2012 Ed.: Leading Lawyers on Dealing with Increased Enforcement, Keeping Up-To-Date with FDA Requirements, and Developing Compliance Practices".  The book is written for C-level executives to learn the very latest trends about food and drug law enforcement and compliance requirements by the FDA.    According to the press release

This Aspatore legal title provides an authoritative, insider's perspective on complying with FDA regulations and staying up-to-date on the latest trends in food and drug law.

The Food Safety Modernization Act (FSMA) gave the FDA recall authority, so companies must know how and when to do a voluntary recall and when a product is safe and effective or, alternatively, defective.  The book will precisely explain the labeling requirements acceptable to the FDA and when the statements about the use of a product may be false and misleading so that the product is considered to be "mislabeled" by the FDA.   Readers should understand when is a violation handled administratively by the FDA' Office of Regulatory Affairs (ORA), and when a suspected violation is investigated by the FDA's Office of Criminal Investigations (OCI). Knowing the difference, and how to handle each of these types of inquiries, audits, or investigations may make the difference in avoiding a fine or being arrested. 

The book is available for only $90. Click here for a complete description or to purchase.   

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Comments or questions, click below, or contact me directly.

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

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

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The U.S. Food and Drug Administration ("FDA") has strict labeling requirements for cosmetic products.  One area that consistently causes confusion among companies that distribute cosmetic products to countries on different continents is the area of labeling. Different products have different labeling requirements depending on the application of the product, the type of ingredient being labeled, the size of the product, and the country to which the product will be shipped. For example, the rules regarding how to describe color additives for products entering the U.S. are different than those for Canada and Europe.

Fortunately, it is possible to comply with the labeling requirements for the U.S. as well as Canada and Europe using only one label. In fact, it can even be accomplished with a product bearing a label as small as that of mascara. Accomplishing this is greatly beneficial to these companies because they can take advantage of economies of scale and taper production costs by merely having one label printed to be distributed to several countries.  However, this is a delicate maneuver that, if not done properly, will likely result in seizure and detention by the FDA or a foreign country's equivalent agency. This will cause delays in the shipments, and may cause civil penalties and forfeiture of the products.

To avoid this common mistake and take advantage of the fact that one label may be used throughout the U.S., Canada, and Europe, you should contact an attorney well versed in the FDA regulations. Taking this precautionary measure is an investment in greater profits and peace of mind.

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The annual seminar "Practical Tools for Trade in the Food Industry" takes place at the Miami Seaport on September 7, 2011 from 8:30 a.m. to 12:30 p.m.  Sponsored by the Miami-Dade County Office of Economic Development & International Trade, and supported by the Port of Miami, this year we will again focus on what importers need to know about both U.S. Customs and Border Protection and U.S. Food and Drug Administration requirements.  There will  be special emphasis on the new Food Safety Modernization Act of 2011.

The seminar takes place at the beautiful Port of Miami Conference Room, 1015 N. America Way, Miami.  Registration may be done on-line.   Questions regarding REGISTRATION may be directed to Adam Peters, Trade Development Specialist at (305) 375-5420 or apeters@miamidade.gov.  Question regarding content of the seminar may be directed to me or Jennifer Diaz, Senior Attorney, Customs and International Trade Department, Becker & Poliakoff law firm (305) 260-1053.

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For questions or comments, please contact:

Peter Quinter, Partner, Customs and International Trade Department

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

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The U.S. Food and Drug Administration is increasingly stopping and examining imported shipments of food attempting to enter the United States.  Often, the FDA does not allow the food to enter the United States by declaring it to be misbranded or adulterated by filth or decomposition.  Virtually always, refused food is then either destroyed or exported from the United States. There is a little known, but valuable, option called "reconditioning".

Once reconditioned, food that was originally rejected by the FDA may legally enter the commerce of the United States.  How, when, and why to recondition food is the subject of a webinar on May 25, 2011, sponsored by the Journal of Commerce, and presented by attorney Peter Quinter and FDA manager John Verbeten.

Peter Quinter is the Partner in Charge of the Customs and International Trade Department at the law firm of Becker & Poliakoff.  Mr. Quinter has extensive experience with FDA, U.S. Customs and Border Protection, and other Federal agencies involved in regulating international trade.  Mr. Quinter represents numerous international food companies, and has assisted companies to successfully recondition their food import shipments.  John Verbeten is the Director of Operations and Policy Branch, Division of Import Operations and Policy, at FDA Headquarters.  The discussion will cover detention without physical examination (DWPE), the Food Safety Modernization Act, the FDA Regulatory Procedures Manual, and the practical use of FDA Form 766.

Registration for the webinar is done on-line at the Journal of Commerce website.

Separately, a seminar for importers, customs brokers, and other persons involved in international trade is taking place in Tampa, Florida, on June 1, 2011. This will be a practical "how to" regarding the Food Safety Modernization Act of 2011, FDA's Detention Without Physical Examination (DWPE) and Notice of Refusal procedures, FDA Import Alerts, and U.S. Customs and Border Protection issuance of Liquidated Damages for failure to redelivery FDA refused merchandise. This event is sponsored by the Florida Customs Brokers and Forwarders Association, taught by attorney Peter Quinter and other prominent attorneys familiar with the importation of food, and registration may be done on-line.

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For questions or comments, please contact:

Peter Quinter, Partner, Customs and International Trade Department

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

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I am at the final day of the annual International Boston Seafood Show held at the Boston Convention Center. With record attendance and a record number of exhibitors filling the convention center floor with extravagant booths overflowing with shrimp, fish, crab, lobster, and other seafood delectables from all over the world, the Show is a success.   After all, this is the largest seafood show in North and South America.  Perennial exhibitors Pescanova, Inc. and Preferred Freezer Services had the largest and most memorable displays.  In addition to my speaking on the topic of "Food Safety", my law firm exhibited at the Show for the first time, and shared a booth with food testing laboratory, ABC Research Corp.

Serious topics for the educational seminars included "Rebuilding Consumer Confidence in Gulf Seafood," and "Food Safety".   There was significant discussion of aquaculture.  For pure fun, the Show included a new Game Lounge, the 5th Annual Oyster Shucking Competition, the 2nd Annual Tweet & Meet Tweetup, and a keynote address from Wayne Rogers, the actor from the hit series M*A*S*H. 

See you in Boston next year.

Peter Quinter, Partner, Customs and International Trade Law Department

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

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In 2010, Americans consumed almost 6 billions pounds of seafood.  The U.S. Food and Drug Administration (FDA) is responsible for ensuring that the nation's food supply, including seafood, is safe, wholesome, and properly labeled. That is a tough task considering 80% of the seafood we eat is imported from countries all over the world.  Unfortunately, the reality is that seafood fraud is common. Moreover, it can have not only economic, but food safety, consequences. 

According to a February 2009 GAO Report provided to the United States Congress which criticized the FDA for its lack of enforcement:

The most common types of seafood fraud are:

1.  shipping products through an intermediary country to avoid customs duties (transshipping),

2. adding excess amounts of water or ice to the seafood to increase its weight (over-treating),

3. substituting a different species of seafood for the species listed on the label (species substitution), and

4. including less seafood in a package than indicated by the label (short-weighting).

Read this typical January 20, 2011 Press Release from the U.S. Department of Justice regarding a company that pled guilty to false labeling of imported fish.  Read this typical Warning Letter from the FDA against a seafood company for misbranding its shrimp.

The Food Safety Modernization Act, signed into law in January 2011, is a step in the right direction to give the FDA the legal authority to prevent, not just respond to, seafood fraud. As FDA Commissioner Margaret Hamburg stated in a recent press release:

This law represents a sea change for food safety in America, bringing a new focus on prevention, and I expect that in the coming years it will have a dramatic and positive effect on the safety of the food supply.

The topics of seafood fraud and the Food Safety Modernization Act will be discussed in detail at the "Food Safety Reform Update" panel at the International Boston Seafood Show on Sunday, March 20, 1:30 to 3:00 p.m. Learn how to prevent seafood fraud, how to detect seafood fraud, and what to do if you or your company are under investigation by the FDA, U.S. Customs and Border Protection (CBP), or the National Marine Fisheries Service (NMFS) for seafood or other import fraud.

Please call or email me with any questions or comments.

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

Partner, Customs and International Trade Department

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The Customs and International Trade Department of the law firm of Becker & Poliakoff* regularly holds workshops. Attendees learn the most recent information regarding compliance with the import and export requirements of the various Federal agencies of the United States Government.  Our next workshops will focus on one of my favorite subjects - FOOD, and its increasing regulation by the FDA.  The workshops take place in both Miami and Ft. Lauderdale, Florida.

The 2010 Import/Export Fall Workshop Series hosted in cooperation with the Office of Economic Development  & International Trade of Miami-Dade County  (OEDIT) is entitled "Importing Food into the United States for International Trade Professionals".  The speakers are from the U.S. Food and Drug Administration's Miami Imports Branch and ABC Research Corp., a food testing laboratory, and the Customs and International Trade Department.  The presentation will be from 8 a.m. to 11:30 a.m. on Thursday, November 4, at the Miami Free Zone. The workshop will focus on food, but also include cosmetics, medical devices, and dietary supplements, all of which are also regulated by the FDA.  For more information, you may contact me or the OEDIT at 305-375-1254 or e-mail oedit@miamidade.gov.  The seminar is open only to Miami-Dade County companies.

On Tuesday, November 16, 2010, from 8 a.m. to 11 a.m., at the Port Everglades Administration Building, Ft. Lauderdale, Florida, my law firm, in cooperation with Broward County's Office of Economic and Small Business Development, and the City of Hollywood, will host "Importing Food Products in Compliance with FDA and U.S. Customs Rules".  The seminar is open to all persons and companies.  Registration for the seminar may be easily done on-line.  The seminar is interactive, and focuses on practical "what you need to know" information.  Handouts and real-life scenarios will be discussed regarding detentions by the FDA, liquidated damage claims by CBP, refusals by the FDA because a company is on an Import Alert, Nutrition Facts labeling and medical claims,  Bioterrorism Act registration of food facilities, etc.

I look forward to seeing you at both excellent seminars above.  Importers, customs brokers, attorneys, consultants, and anyone involved in the importation and logistics businesses will benefit.

*Becker & Poliakoff was honored to be listed in the 2010 U.S. News & World Report review of law firms in the area of FDA Law.  Peter Quinter was honored to be included in the "Best Lawyers in America" for 2009 in the area of FDA Law.

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Peter Quinter, Partner, Customs and International Trade Department

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

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On December 12, 2003, the U.S. Food and Drug Administration (FDA) implemented the Bioterrorism Act of 2002.  That Act basically required that companies shipping food to the United States must first be registered with the FDA, and that importers of food must provide "prior notice" to the FDA of any particular shipment before it physically arrives in the United States.  Over the past 7 years, has the Bioterrorism Act lived up to its expectations to protect the American consumer from eating dangerously contaminated food?

In an article entitled "Scrap the Bioterrorism Act" published in February 2004, I criticized the Act as not going far enough because it did not require (1) FDA Inspectors to be located in foreign countries sending us food,  (2) cooperation with foreign food inspection governmental authorities, and (3) mandatory recall authority to the FDA for contaminated foods.  In a May 6, 2010 report by the U.S. Government Accountability Office (GAO) entitled "Food Safety:  FDA Could Strengthen Oversight of Imported Food," it came to exactly the same conclusions. 

As stated in the GAO report:

The FDA physically examines approximately 1 percent of imported food.

Imported fish and other seafood is of particular interest to the FDA.  Obviously, FDA Inspectors cannot physically inspect every shipment of imported seafood, but every shipment that contains FDA-regulated products that enters the United States is electronically reviewed by the FDA  to determine if the shipment should be physically examined or a sample laboratory tested.   Hence, the prior notice information enables FDA, working closely with U.S. Customs and Border Protection, to more effectively target inspections at the border to ensure the safety of imported foods before the food enters the commerce of the United States.

Registration of food facilities that manufacture, process, pack, or hold food is suppose to help provide FDA with information on the origin and distribution of food.  The objective is that the registration will aid in the detection and quick response to actual or potential threats to the U.S. food supply, usually by microbiological contamination such as listeria.

If  an importer is attempting to import food from a foreign facility which has not been registered with the FDA, the food will be held at the port of arrival until the registration violation is corrected.  Registration by the foreign food producer and shipper may be easily accomplished, in multiple languages, at www.FDA-USA.com.  

My conclusion is that the FDA is doing a much better job at protecting the international food supply chain, but it needs the U.S. Congress to now pass the Food Safety bill, pending there for over a year, to really do an effective job. Coincidentally, the Sunday New York Times front page article "Senate Bill on Food Safety is Stalled," makes the same argument.

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For questions or comments, please complete the form below, or contact me directly.

Peter Quinter, Partner, Customs and International Trade Department

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

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Americans are constantly bombarded with warnings that the seafood we eat is contaminated with salmonella, listeria, or some other antibiotic, fungicide, or microorganism that will make us sick.  The U.S. Food and Drug Administration (FDA) is taking more samples of imported seafood, holding more seafood for laboratory analysis, and rejecting more seafood than in past years. That is true of basa from Vietnam, crabmeat from Indonesia, and a variety of seafood from countries as far away as China, or as close to the United States as the Bahamas.

The FDA issues 'Import Alerts' to attempt to prevent  contaminated seafood (or specific products) from certain overseas suppliers from entering the food supply chain in the United States.  Seafood importers should be very familiar with Import Alert 16-81 - "Detention Without Physical Examination of Seafood Products Due to the Presence of Salmonella". 

The Obama Administration's Import Safety Working Group Food Protection Plan encourages the FDA to issue more Import Alerts.  An Import Alert is an order to all FDA district officials to detain and examine imported seafood that is identified on an Import Alert, or to detain and examine any seafood shipped by an overseas company  that is listed on the Import Alert (i.e. the "Red List"). 

Import Alerts are issued on an almost daily basis by the FDA.  For Import Alert 16-81, the "Charge" reads as follows:

The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the product appears to contain salmonella, a poisonous and deleterious substance, which may render it injurious to heath. [Adulteration, Section 402(a)(1).]

The explanation for such a food safety procedure was explained in a 2004 report to Congress by the U.S. General Accountability Office in Report 04-426 with a scathing criticism of the FDA's "Food Safety" program.

More than 80% of the seafood that Americans consume is imported from an estimated 13,000 foreign suppliers in about 160 nations. If contaminated, imported and domestic seafood can cause foodborne illnesses with problems ranging from mild gastrointestinal discomfort to neurological damage.

Next year, when Congress passes, and the President signs, a new food safety law, suppliers, importers, warehouses, and transportation companies should all expect a lot more changes from the FDA.  The U.S. House of Representatives already approved H.R. 2749 entitled "Food Safety Enhancement Act of 2009," and the Senate is now debating S.B. 510 entitled "Food Safety Modernization Act of 2010." With reports that now 90% of our seafood is from overseas, the increased use of aquaculture, and the continuing threat of contaminated seafood, companies which are manufacturing, shipping, warehousing, and transporting seafood will have to face the reality of more government regulation.

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For comments or questions, please complete the form below or contact me directly at:

Peter Quinter, Partner, Customs and International Trade Department

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

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The U.S. Food and Drug Administration has issued notices to all foreign food facilities registered with the FDA that it will conduct an inspection of those facilities between October 1, 2010 and September 30, 2011.  Foreign food facilities that manufacturer, process, pack, hold, and ship food to the United States must have registered with the FDA pursuant to the Bioterrorism Act.  Foreign food facilities that do not properly respond to the FDA notices may have their registrations automatically terminated. In effect, that will result in a detention of any food that arrives in the United States from those canceled facilities.

It is no secret why the FDA is visiting foreign food facilities shipping food to the United States.  See blog post "The FDA is Flexing Its Enforcement Muscles".  The Foreign Food Inspection Team at the FDA's Center for Food Safety and Applied Nutrition (CFSAN) based in College Park, Maryland, is responsible for coordinating the foreign food inspections.  The recent FDA notices state, in part:

The inspection will be conducted by an investigator of the FDA to determine if your facility is operating in accordance with U.S. Food, Drug, and Cosmetic Act and its regulations, including Title 21 CFR Part 110, Good Manufacturing Practices (GMP) regulations.

Any foreign food facilities not yet registered may register with the FDA using a website www.FDA-USA.com established and operated by my law firm for a fee.  It is very easy to register on-line in English, Spanish, Portuguese, or German.  Companies should properly prepare prior to the FDA inspection.

For any questions or comments, e-mail me or complete the form below.

P.S. If you have not read my 2004 article "Scrap the Bioterrorism Act" then now is the time.

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Peter Quinter, Partner, Customs and International Trade Department

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

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All 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.

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

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

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FDA 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.

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Co-authored with Dean Leaman, Director of Business Development

Import/Export - Miami, FL, ABC Research Corporation

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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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The 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

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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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