On January 4, 2013, FDA issued its long-announced proposed rule implementing Standards for Produce Safety mandated by Congress in the Food Safety Modernization Act. There has been much consternation about the exemptions and inclusions. For instance, produce commodities which are rarely consumed raw, e.g., asparagus, cranberries and potatoes, are “out”, but tree fruits, which never touch the ground and have never been associated with food-borne illness outbreaks, are “in”. Fruit tree growers are loudly opposing the broad jurisdiction of the proposed Standards, which would impose a costly burden of recordkeeping and implementation … READ MORE

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FDAImports.com recently attended and sponsored the Maryland China Business Council’s (MCBC) 18th Annual New Year Banquet at Hunan Manor restaurant in Columbia, MD.  The annual banquet provides valuable networking opportunities for many professionals, dignitaries and embassy personnel involved in US/China trade, including companies involved in FDA-regulated commodities. “It’s clear that there is significant opportunity here,” said Ben England, Founder and CEO of FDA consulting firm, FDAImports.com (ExportToUsa.com.cn in China).  Shelly Li, Regulatory Specialist in the firm’s Qingdao, China office, was also in attendance for the … READ MORE

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The U.S. Food and Drug Administration (FDA) recently released two important Proposed Rules related to the Food Safety Modernization Act (FSMA).  The two Proposed Rules, Hazard Analysis and Risk-Based Preventive Controls (HARPC) and Standards for Produce Safety, will impact Chinese food companies and manufacturers exporting products to the United States in many significant ways. Ben England, Founder and CEO of consulting firm ExportToUsa.com.cn (FDAImports.com in USA), explains the scope and impact of the Proposed Rules in a new short video.  “Chinese food companies must be aware of the emerging regulations within the Food Safety Modernization Act,” said England.  … READ MORE

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Benjamin England, Founder and CEO of Maryland-based FDA consulting firm, FDAImports.com, will present at the 2013 Boston Seafood Show as part of a Panel Discussion entitled, “Seafood Safety and Compliance with FDA and CBP Regulations as Implemented by the Food Safety Modernization Act.”  Mr. England will join other panelists, Peter Quinter of Gray Robinson, William Scopa of U.S. Customs and Border Protection (CBP), and John Verbeten of the U.S. Food and Drug Administration (FDA), in discussing specific concerns for the seafood industry within the Food Safety Modernization … READ MORE

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The U.S. Food and Drug Administration recently announced its Final Rule for the Administrative Detention of Foods under the Food Safety Modernization Act (FSMA).  The rule adopts the Interim Final Rule from May 2011 without change.  With this Final Rule, FDA now has the power to administratively detain any food simply because FDA claims it has reason to believe the food is adulterated or misbranded.  You may want to read that again: FDA may now administratively detain any food that it believes to be … 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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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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FDAImports.com Founder and CEO, Benjamin England, will present and moderate at the “FSVP and VQIP: Mandatory and Voluntary” panel discussion at the 2013 Food Week event put on by the Washington DC-based Food and Drug Law Institute (FDLI).  The session will examine the Foreign Supplier Verification Program and Voluntary Qualified Importer Program under the Food Safety Modernization Act and address:
Compliance with these two programs

The differences and overlap between the two programs

The relevance of facility certification by third parties

Impending tensions between importers and foreign suppliers

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Watch out dictionary lovers and English majors, the U.S. Food and Drug Administration (FDA) is about to make your head spin.  In its recent proposed rule for the Hazard Analysis and Risk-Based Preventive Control (HARPC) requirements under FSMA, FDA spent numerous pages defining “farm,” “harvesting,” “holding,” “manufacturing/processing,” and “packing” as they pertain to Food Facility Registration.  These words may seem trivial, however, the definition changes will have far reaching effects for some in the food industry concerning which safety and sanitary controls will apply to … READ MORE

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