How much would you be willing to pay an attorney or paralegal to take care of all your FDA facility registration and product listing woes?  $500?  $750?  What about to have a reputable company serve as your US Agent, facilitating communications with FDA and making sure that your registrations and listings are up-to-date and compliant?   $1000?  Many companies are charging prices like these or higher for these services.  There seems to be a mindset in the industry that these services are hugely complex and take many hours, so they’re worth hundreds or … READ MORE

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Rick Quinn, Principal at Maryland based FDA consulting firm, FDAImports.com, will be serving as a panelist at the Natural Products Expo West Town Hall meeting for retailers, “Defining Natural Together” on Sunday, March 10th, 2013 at 9am Pacific Time.  The session, part of the Natural Products Expo West event in Anaheim, CA, is intended to provide an opportunity for attendees to work together to create a meaningful industry definition of “natural” in the absence of a functional definition from the U.S. Food and Drug Administration (FDA).  Rick Quinn will … 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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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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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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By now food manufacturers should be more than aware of the new Biennial Food Facility Registration requirement set forth under the Food Safety Modernization Act (If not, read this NOW).  Though registration is a relatively painless process, it can be time-consuming and frustrating, especially for those who registered several years ago and now must find or obtain their login credentials.

FDA has taken note of the food industry’s scramble to obtain their login credentials and complete their registrations.  FDA recently released a statement to the effect that officials may “exercise … READ MORE

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