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* You are viewing the archive for June, 2012

How an FDA Inspection Can Fuel a Consumer Lawsuit

admin June 27, 2012 Food, Law & Regulatory 2 Comments

Tags: ben england, contamination, criminal investigations, detentions, Diamond Pet Food Processors, diamond pet foods, FDA, FDA detentions, inspections, lawsuit, pr, refusals, salmonella, warning letter

The following is a letter from FDAImports.com Founder and CEO, Benjamin England:
As you may know, Diamond Pet Food Processors issued multiple product recalls over the last two months.  On April 12, only six days after Diamond’s first recall, FDA conducted a weeklong inspection of Diamond’s facilities and found numerous violations.  Finally, a few weeks ago, a law firm filed what is believed to be the first lawsuit against Diamond.  The lawsuit, filed on behalf of an infant sickened by Salmonella, explicitly cites the results of FDA’s inspection as evidence of Diamond’s negligence.  Don’t let this happen to you.

If Diamond had … READ MORE

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FDA and Nanotech Regulation: The Smaller it is, the Longer it Takes

admin June 26, 2012 Cosmetics, Food, Law & Regulatory No Comments

Tags: cosmetics, Draft, FDA, food, GRAS, guidance, law, nanotech, nanotechnology, Nanotechnology Task Force Report, regulation

FDA Nanotech Regulations

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

Back in 2007, … READ MORE

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Rick Quinn & John Johnson Author FDLI Article, “FDA’s Illegal Treatment of Brazilian Orange Juice During the Carbendazim Incident”

admin June 25, 2012 Company News, Food, Law & Regulatory No Comments

Tags: article, Carbendazim, EPA, FDA, fdli, Food and Drug Law Institute, illegal, John Johnson, law, orange juice, Rick Quinn, treatment

FDLI Oj Article

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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Steven A. Johnson Joins the FDAImports.com Team

admin June 11, 2012 Company News, Drugs, Medical Devices No Comments

Tags: biotech, California, cGMP, device compliance, fdaimports.com, GCP, internet marketing claims, pharma, Principal, Steven Johnson, team

Steve  JohnsonThe FDAImports.com team is pleased to welcome Steven A. Johnson to our team!  Mr. Johnson joins the firm as Principal, bringing nearly 20 years of FDA, Pharmaceutical, Biotech and Medical Device experience to the firm.  He will be assisting clients with biotech and device compliance, cGMP and GCP issues, Internet and advertising marketing compliance and in other device and pharma-related regulatory areas.  Mr. Johnson will be assisting clients from FDAImports.com’s new office in Irvine, California.  Please join us as we welcome … 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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