Recent FDA Developments Handbook

Peter Quinter, Esq.

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 peter.quinter@gray-robinson.com

Can I bring in more than $10,000 to the United States when travelling?

Melissa Groisman Steinfeld, Esq.

I’m coming back into the United States and I need to bring in more than $10,000. I heard that it is illegal to bring that much money into the U.S. when you travel. Am I allowed to bring in more than $10,000 to the U.S. when I travel?

The simple answer to this question is: YES. 

Many people are under the impression that you are not allowed to carry more than $10,000 into the United States; this is nothing more than an urban legend. The fact is that you may legally carry any amount of money you want into or out of the United States, but there is a catch. When transporting more than $10,000, you must file a report declaring the exact amount of funds you are transporting to U.S. Customs and Border Protection. To be clear, there are no customs duties, taxes or other fees paid to U.S. Customs for the international transportation of the money; it is merely a reporting requirement to U.S. Customs.

If persons traveling together have $10,000 or more, they cannot divide the currency between each other to avoid declaring the currency. For example, if one person is carrying $5,000 and the other has $6,000, they have a total of $11, 000 in their possession and must report it.

What happens if you don’t declare your money? The penalties and repercussions can be severe. If you are stopped by a U.S. Customs and Border Protection officer and more than $10,000 is found on your person or in your belongings and this money was not declared, you run the very real risk of CBP taking all of the money you were carrying… and keeping it.

Failure to report the international transportation of money is serious business. Not only could you lose your money forever, you may be subject to civil and criminal penalties.

On a side note, reporting requirements are not limited to cash dollars. The same requirements apply for various monetary instruments, including foreign currency, traveler’s checks, domestic or foreign bank notes, securities or stocks in bearer form. To learn more about the requirements of the Currency and Foreign Transaction Reporting Act, click here.

And if you are reading this blog post because you failed to report your funds and CBP has seized your money, your best bet is to contact an attorney who is knowledgeable and experienced with these matters. There is an administrative process by which you can attempt to recuperate your funds and having the assistance of a skilled attorney is key to maximizing your chance of getting your money back and minimizing your chances of exposing yourself to civil and criminal fines.

My firm and I are greatly experienced with these matters, having handled hundreds of these types of cases nationwide. This is a Federal process most often done through email, telephone and snail mail correspondence with the Federal Government and so we can help no matter where in the country you are located or your monies were seized. Although we are located in South Florida, we handle cases all over the country. 

Customs Broker License Denial for Poor Credit History

Peter Quinter, Esq.

Hundreds of people apply every year to become a customs broker. Customs brokers are licensed by U.S. Customs and Border Protection (CBP). The process requires passing a rigorous multiple choice examination, and then passing a background investigation.  For many applicants who successfully pass the examination, they are denied a license because the background investigation revealed a poor credit history and rating.

Although the application to be a customs broker is submitted to the local port, the decision letter granting or denying a broker license is issued by Allen Gina, Assistant Commissioner, Office of International Trade, CBP Headquarters in Washington, D.C.  A typical denial letter would state:

After careful evaluation of the information obtained from the background investigation, we must deny your application due to your financial history.

The denial letter always cites the CBP regulation at 19 CFR 111.16 - a failure to establish the business integrity and good character of the applicant.  Fortunately, the letter also cites 19 CFR 111.17 which provides the right of appeal of the denial of the customs broker license.

The appeal must be filed, in writing, and submitted to Mr. Gina no later than 60 days from the date of the denial letter. The appeal must persuasively argue why the applicant has business integrity and good character.  For example, if the applicant went through a divorce, and the former spouse failed to pay certain bills which negatively affected the applicant's credit history and rating, that is an important fact that must be argued, and documented, in the appeal.

There are numerous reasons why CBP may legitimately deny a customs broker license to an applicant who has a spotty financial history. Similarly, there are numerous reasons to explain to CBP that despite what appears to be a questionable financial history, the applicant has business integrity and good character, and should still receive the customs broker license.
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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 peter.quinter@gray-robinson.com