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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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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A recently published FDA Warning Letter to a cantaloupe farm reveals FDA’s use of the principles found in its new Proposed Rule for Standards of Produce Safety, recently issued on January 4, 2013 under the Food Safety Modernization Act (FSMA).  The Warning Letter, addressed to Chamberlain Farms, Inc., looks normal enough in the opening remarks. However, it gets interesting once FDA states that the agency “documented the following conditions and practices that may have contributed to the contamination of your products with Salmonella.”  That … READ MORE

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On Friday, January 4, 2013, the U.S. Food and Drug Administration (“FDA”) issued a Proposed Rule which proposed revisions to the current Good Manufacturing Practices (“cGMPs”) requirements for foods along with proposing the regulation for Hazard Analysis and Risk-Based Preventive Controls (“HARPC”) under the Food Safety Modernization Act (“FSMA”).  This is noteworthy because FDA has not substantively revised the Food cGMP regulations since their establishment in 1986. The Proposed Rule makes several important proposed revisions to the regulatory requirements.

FDA Proposal: Food Sanitation “Shoulds” to Become … READ MORE

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The U.S. Food and Drug Administration (“FDA”), for the first time in its history, formally entered into regulating how food is grown and harvested by proposing standards for the safe growing, harvesting, packing, and holding of produce on farms. The Food Safety Modernization Act required FDA to establish minimum standards for minimizing the risk of serious adverse health consequences or death for producing and harvesting raw agricultural food products.  The proposed rules have a comment period deadline of May 16th, 2013.  What exactly … READ MORE

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On January 4, 2013, FDA published its proposed Hazard Analysis and Risk-Based Preventive Controls (“HARPC”) regulations for food facilities, exactly one year after it was required to under the Food Safety Modernization Act (“FSMA”).  HARPC is a new set of food safety regulations that essentially copies existing food safety principles previously only applicable to seafood and juices (HACCP Principles) and applies them to the production of almost all other food types.  FDA posted the proposed regulations today with a comment deadline of May 16th, … READ MORE

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