The U.S. Food and Drug Administration (FDA) has been court ordered to set firm dates for FSMA's implementation. Details of the court case forcing FDA to set these dates, and the organization that sued the FDA to make this happen follow.
Do you sell products in multiple countries? How are you assuring your intellectual property is protected? Do you know about "Foreign Patent Applications" or "PCT's"? If not, you may not be adequately protecting your intellectual property abroad!
I am pleased to share with you a new periodical, "World Export Controls Review - the journal of export controls and compliance," published by Brightlaw Media Ltd., London, England. The first issue published in March 2011 is free. The April 2011 publication contains my article entitled "Responding to an Administrative Subpoena Issued by the Office of Foreign Assets Control (OFAC), U.S. Department of the Treasury."
Please make plans to attend the Forbidden Places -- Tourism and Trade seminar on September 24, 2010. This seminar will take place at the J.W. Marriott Hotel, Miami, Florida. This half-day seminar will address a variety of recent regulations administered by the Office of Foreign Assets Control (OFAC) of the U.S. Department of the Treasury. Topics to be addressed include travel to and trade with restricted countries, immigration aspects of tourism to sanctioned countries, and representing a client who is the subject of an investigation or penalty by the OFAC.
Maerk Line, Ltd. paid the U.S. Office of Foreign Assets Control (OFAC) $3 million to settle allegations of violations of the U.S. trade embargo with Sudan and Iran that Maersk committed between 2003 and 2007. How the world's largest ocean transportation company committed such violations is a good story. How Maersk's lawyer was able to limit the payment to $3 million is also important to understand.
The U.S. Food and Drug Administration has issued notices to 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 will result in a detention of any food that arrives in the United States from those canceled facilities.
In the next few weeks, I am giving lectures and doing a webinar on the general topic of export compliance. In my legal practice over the past 20 years as a Customs and International Trade attorney, I am increasingly involved with clients on export compliance and penalty matters, especially with the BIS and OFAC. The laws and regulations have changed dramatically over the past few years, as has the name and number of Federal agencies enforcing them, plus the penalties for non-compliance are much higher now.