Rick Quinn, Partner at Maryland-based FDA consulting firm, FDAImports.com, will be presenting at the third annual conference of Affiliated Lawyers of the Americas (ALTA), discussing the intersections of regulatory compliance and business law.  The conference will be held from February 28 to March 2, 2013, in Long Beach, California, and is entitled “Cross Border Business in Mexico and the Americas.”  Mr. Quinn will be discussing the unique opportunities for attorneys representing South American food, drug, cosmetic, supplement and medical device firms looking … READ MORE

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Talking about the Food Safety Modernization Act is hard work.  It’s hard to understand, hard to pronounce, hard to summarize and even harder to have some fun with.  But it’s what we do at FDAImports.com all the time.  Although our final videos appear poignant and polished it’s not always an easy road to get there.  In this short video please enjoy a hilarious outtakes reel from our latest FSMA video shoot starring Founder and CEO, Ben England.

Outtakes: FSMA Video Shoot, January 2013

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In this new FSMA training video, Ben England, Founder and CEO of FDAImports.com, shares his unique insights into the recently released Proposed Rules for HARPC and Standards for Produce Safety under FSMA with an eye toward their impact on importers and foreign suppliers, specifically.  This video discusses some key areas of concern for importers and foreign suppliers and how to prepare for coming changes in the food import landscape.

Just for Importers and Foreign Suppliers: FSMA January 2013 Update

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As part of a new FSMA video series, Ben England, Founder and CEO of FDAImports.com, makes some valuable observations on the Proposed Rule for Standards for Produce Safety and explores some ways that industry can begin aligning themselves with FDA’s thinking.

Food Safety Modernization Act: Standards for Produce Safety Update, January 2013

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Watch our other January 2013 FSMA video updates:

HARPC Proposed Rule

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By now the food industry should have a general grasp of the new Proposed Rules for HARPC and Standards for Produce Safety released by FDA this January 4th under FSMA.  If you are looking for an overview please read these blogs on HARPC, Produce Safety and cGMP changes first.  As part of a new FSMA video series, this new video on the Hazard Analysis and Risk-Based Preventive Controls Proposed Rule, explores some key areas of impact that may not be immediately apparent.  Ben England, Founder and CEO of FDAImports.com, discusses HARPC as well as Standards … READ MORE

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The FDAImports.com team has added two new attorneys to its staff, expanding its team of affiliated regulatory attorneys.

Ryan M. Fournier, Esq., Associate Attorney

Mr. Fournier practices in the area of Food and Drug Law.  He previously completed a summer position with the firm before joining as Associate Attorney.  While in law school, Mr. Fournier served as a Senior Editor on the International Law Review and participated on the Willem C. Vis International Commercial Arbitration Moot Court Team, receiving an Honorable Mention in Hong Kong, China. Additionally, he … READ MORE

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If you distribute or import radiation-emitting electronic products, you may have already heard of FDA’s accession number system.  However, we have found that many importers are perplexed when they are required complete Customs Form 2877 which, in part, asks the importer to supply an accession number if the imported product is subject to FDA performance standards.  “Where can I look up the accession numbers for my products?” is a very common question we receive at this point in the importation process.  The answer is … READ MORE

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The U.S. Food and Drug Administration recently released a proposed rule that will require that most medical devices distributed in the United States carry a unique device identifier (“UDI”). A UDI is a unique code that is designed to allow anyone to identify the model number, lot or batch number, the serial number and/or expiration date for any given medical device. The FDA is also creating a database that will include a standard set of basic identifying elements for each UDI, and will make most of it available to … READ MORE

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Apparently, the smaller something is, the longer it takes to talk about.  This is the axiom currently employed by FDA, illustrated by the agency’s recently published guidance on nanomaterials in cosmetics and foods (5 years in the making).   While the European Union already requires companies to prove a product containing any nanotech materials is safe before the product can be sold to consumers, FDA has sat on the sidelines, forcing many industries to wait for some kind of guidance from FDA on how to proceed.

Slow to Speak

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Did the U.S. Food and Drug Administration act illegally, capriciously and arbitrarily in its treatment of imported orange juice during the carbendazim incident? 

This is the question that FDAImports.com Principal, Rick Quinn, and Associate Attorney, John Johnson, answer in their recent article published in the Food and Drug Law Institute’s Update magazine.  The article, “Imported Orange Juice Gets the Squeeze: FDA’s Illegal Treatment of Brazilian Orange Juice During the Carbendazim Incident,” clearly outlines the history of the carbendazim issue, the FDA’s inconsistent response to both domestic and foreign juices, … READ MORE

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FDAImports.com Founder and CEO, Benjamin England, recently presented a webinar with FXConferences entitled “FSMA Time Bombs: The Sleeper Provisions and How to Prepare.”  This webinar addressed numerous provisions within the Food Safety Modernization Act that are not being widely discussed due to their comparative obscurity to the “big items.”  These “time bombs” will eventually “go off” as FSMA is implemented, regardless of whether the press or industry is ready for them.  According to Mr. England, FSMA time bombs are items within FSMA that:

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