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* You are viewing Posts Tagged ‘FDCA’

Talking About the Food Safety Modernization Act is a Mouthful. Here’s the Outtakes Reel to Prove it

admin February 04, 2013 Food, Food Safety Modernization Act, Humor, Law & Regulatory 2 Comments

Tags: ben england, FDA, fdaimports.com, FDCA, food, food and drug administration, food safety modernization act, FSMA, HARPC, hazard analysis, imports, law, legislation, Preventive Controls, produce, Proposed Rule, risk based, safety, united states

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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New Video: Impact of FSMA Proposed Rules on Importers and Foreign Suppliers

admin February 04, 2013 Food, Food Safety Modernization Act, Imports, Law & Regulatory No Comments

Tags: ben england, FDA, fdaimports.com, FDCA, food, food and drug administration, food safety modernization act, FSMA, HARPC, hazard analysis, imports, law, legislation, Preventive Controls, produce, Proposed Rule, risk based, safety, united states

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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New Video: What You Probably Missed in the Standards for Produce Safety Proposed Rule

admin February 04, 2013 Food, Food Safety Modernization Act, Law & Regulatory No Comments

Tags: ben england, FDA, fdaimports.com, FDCA, food, food and drug administration, food safety modernization act, FSMA, HARPC, hazard analysis, imports, law, legislation, Preventive Controls, produce, Proposed Rule, risk based, safety, united states

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 FSMA Proposed Rule

HARPC Proposed Rule

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New Video: Four Key Insights Into the New HARPC Proposed Rule (FSMA)

admin February 04, 2013 Food, Food Safety Modernization Act, Law & Regulatory No Comments

Tags: ben england, FDA, fdaimports.com, FDCA, food, food and drug administration, food safety modernization act, FSMA, HARPC, hazard analysis, imports, law, legislation, Preventive Controls, produce, Proposed Rule, risk based, safety, united states

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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Urgent! You Must Re-Register Your Food Facility With FDA By December 31st, 2012

admin November 28, 2012 Food, Food Safety Modernization Act, Imports No Comments

Tags: authority, bi-annual, deadline, FDA, FDCA, food facilities, food safety modernization act, FSMA, imports, producers, reasonable health risk, recall, register, registration, supply chain, suspension

Facility Registration Renewal

December 31st, 2012 is a crucial date for agents and owners of domestic and foreign food facilities.  It is the date by which all food facilities need to re-register with the U.S. Food and Drug Administration.  If you’re not aware of the history of this registration change or the implications of not re-registering, please read our first blog here.  The quick facts are:

  • Domestic and Foreign food facilities must be registered by December 31, 2012
  • Previous registrations are no longer valid.  Owners and agents must re-register
  • There are many new … READ MORE
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Countdown to October 1, 2012: New FSMA Biennial FDA Registration for All Food Facilities

admin August 27, 2012 Food, Food Safety Modernization Act, Imports, Law & Regulatory 1 Comment

Tags: authority, bi-annual, FDA, FDCA, food facilities, food safety modernization act, FSMA, imports, producers, reasonable health risk, recall, register, registration, supply chain, suspension

Food Facility Registration FSMA

It’s almost here.  The new biennial FDA registration requirement for foreign and domestic food facilities imposed by the Food Safety Modernization Act (FSMA) takes effect October 1, 2012.

FSMA amended Food, Drug and Cosmetic Act (FDCA) Section 415 by requiring foreign and domestic food producers to register their facility every two years with FDA, rather than just “one time for all time.”  What does this mean for foreign food producers that export food to the United States?  Turns out quite a lot.

Under the FDCA, … READ MORE

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Benjamin England Presents on FSMA Time Bombs: The Sleeper Provisions in FSVP, Bioterrorism, Import Alerts, HARPC and International Trade

admin June 06, 2012 Company News, Food, Food Safety Modernization Act, Law & Regulatory No Comments

Tags: amendments, ben england, bioterrorism, FDCA, food safety modernization act, Foreign Supplier Verification Program, FSMA, FSVP, FXConferences, hazards, law, national security, risks, time bombs, webinar

FSMA Time Bombs Webinar

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:

  • Appear at face value as if … READ MORE
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Recently Published FDA Import Refusal Report May Cause Complications for Foreign Manufacturers

admin March 02, 2011 Imports, Law & Regulatory 1 Comment

Tags: admission, china, CIQ, compliance, contents, declaration, facility, FDA, FDCA, federal, Food drug and Cosmetic act, foreign, GMP, good manufacturing practice, health, import refusal, inspection, labeling, manufacturer, net quantity, origin, Quarantine, regulatory, report, united states, violation

FDA recently made its Import Refusal Report available again on its website. The FDA Refusal Report lists products FDA refused admission into the United States because the product appeared to violate the Federal Food, Drug, and Cosmetic Act (FDCA), and FDA believes that the importer of record failed to present evidence sufficient to demonstrate compliance. Of course, FDA may refuse articles under the FDCA for many reasons unrelated to health or safety: for example, because the product label does not conform to all the technicalities of the FDCA. FDA says it provides the FDA Refusal Report page for the public … READ MORE

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