January 2012

Recent FDA Developments Handbook

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 […]

By |2015-12-01T06:49:05-05:00January 22, 2012|FDA Issues, Food|0 Comments

Importing into the United States in Compliance with U.S. Customs & Border Protection (CBP)

Do you want to learn the Top 10 Tips When Importing to Ensure Compliance?  What about the Importance of CBP Rulings for Classification, Valuation and Country of Origin?

How about Cost Savings practices like utilizing Free Trade Agreements?

Well you can learn this and hot topics like:

– Importance of protecting Intellectual Property Rights

– Basic customs concepts and terms

– What to do if you encounter a CBP detention and/or seizure case

– Learn when to submit a Prior Disclosure to CBP

Join my webinar with Compliance Online, January 27, 2012, at 1:00 pm eastern. 

You can join the live session and ask questions! 

If you import merchandise into the U.S., you may not realize, but, you are the responsible party! In this presentation, we will discuss how to comply with U.S. Customs and Border Protection’s (CBP) vast laws and regulations. By the end of the Seminar you will know and understand the importance of tariff classification, Customs valuation, Country of origin marking, intellectual property rights and Free Trade Agreements. You will also learn basic customs concepts and terms like CBP Form 3461 & CBP 7501, Protests, Seizure cases, Liquidated damage claims, Penalties/Fines, Prior disclosure, and FP&F Petition Process.

Can I Bring in More Than $10,000 to the United States When Travelling? / ¿Puedo Viajar Con Más De 10,000 Dólares A Los Estados Unidos?

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 (CBP). 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 […]

By |2022-07-06T13:37:35-04:00January 10, 2012|Currency Seizure|0 Comments

Customs Broker License Denial for Poor Credit History

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 […]

By |2015-12-01T06:47:15-05:00January 8, 2012|Customs Broker|0 Comments

Global Entry Program of U.S. Customs and Border Protection

U.S. Customs and Border Protection’s Global Entry program is a smashing success. I have been a member for a few years, and have personally experienced its principal benefit of rapidly and easily clearing Customs upon arrival in the United States.  Global Entry allows expedited clearance for pre-approved, low-risk travelers upon arrival in the United States.   Applicants must first pass a comprehensive background investigation  Not everyone gets accepted, however, and for those people who have applied and been denied, there is an appeal process.

To apply, simply answer some questions on-line at www.globalentry.gov, then schedule an appointment at one of the many CBP enrollment centers. Bring with you a few required documents such as a passport, answer a few simple questions about your international travels, and you will soon be notified of your acceptance or disapproval into Global Entry.

If disapproved, you will be notified electronically and the CBP disapproval letter will be from “Supervisor, Global Entry Enrollment Center, U.S. Customs and Border Protection,” located in Williston, Vermont.  A typical disapproval letter will say.

We regret to inform you that your membership in Global Entry has been disapproved for the following reason(s):

You have been found to have violated CBP laws, regulations, or other related laws.

CBP has never set forth any specific guidelines for disapproving an applicant except “other circumstances that indicate to CBP that you have not qualified as ‘low risk’ – whatever that means.

Fortunately, there is an administrative appeal process which the applicant should pursue.  There is no court, no judge, no meeting with CBP, and […]


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