FDA “Request for Comment” on FSMA Hazard Disclosure (or Not) – Regarding Food Fraud and EMA

Earlier this week FDA released “Describing a Hazard That Needs Control in Documents Accompanying the Food, as Required by Four Rules Implementing the FDA Food Safety Modernization Act: Guidance for Industry.” This was officially published in the Federal Register on October 31, 2016. Food Fraud (or EMA) was not directly addressed. This only defines how …

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Review – Final Rule for FSMA Intentional Adulteration (Food Defense) Regarding Food Fraud and EMA

This is a detailed, 22-page review of the Food Fraud aspects or requirements of the recently published Food Safety Modernization Act Intentional Adulteration (Food Defense) Final Rule (FSMA-IA). In addition to regular contributors Spink & Moyer, we are pleased to add MSU’s Dr. Andrew Huff (College of Veterinary Medicine) and University of Auckland’s (NZ) Bradley …

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Survey Preliminary Results – What is a ‘Reasonably Foreseeable Hazard’? What is a “Pattern”?

by John Spink • January 25, 2016 • Blog • 0 Comments What will FDA consider a Food Fraud “Known or Reasonably Foreseeable Hazard” and a “Pattern”? Is it one (1) known incident, one in a million or billion transactions? This is a—THE—critical compliance question for the Preventative Controls section of the Food Safety Modernization Act (FSMA-PC). At what point is …

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Some Fishy News

Here is a post for those Thornapple Blog readers who rely on me to keep them informed of all the doings in the murky world of food regulatory policy. Of course I have to caution any other innocent soul who happens to have stumbled onto the Blog that the readers who rely on me to …

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Review: Final Rule for FSMA Preventative Controls Regarding Food Fraud and EMA – Preliminary MSU FFI Report

SUMMARY (150-word-brief): This is the MSU FFI review of the Food Safety Modernization Act Preventive Controls (FSMA-PC) Final Rule for Human Food and for Animal Food that was published yesterday. The Final Rule confirms that Food Fraud/Economically Motivated Adulteration (FF/EMA) must be addressed. FF/EMA is under Preventative Controls (Food Safety) and not Intentional Adulteration (Food …

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Publication – Selection of Strategic Authentication and Tracing Programs

Authentication is a key to Food Fraud prevention and a critical part of the “detect-deter-prevent” continuum. Selecting authentication countermeasures that contribute to prevention is often complex and challenging. This challenge was the subject of my chapter on “The Selection of Strategic Authentication and Tracing Programs ” in the book Counterfeit Medicines : Volume I. Policy, Economics, and …

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USP’s Comments to FDA on ‘Intentional Adulteration’ and ‘Economically Motivated Adulteration’

US Pharmacopeia (USP) recommends the US Food and Drug Administration (FDA) adopt a ‘hybrid’ framework to address combating Economically Motivated Adulteration (EMA) – a sub-category of Food Fraud – separate from preventative controls (Food Safety) or catastrophic events (Food Defense). USP, and their Food Chemicals Codex, is an important stakeholder in protecting the global food …

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Question Authority?

So here is one of those occasions where I couldn’t get everything off my chest last week so I just have to follow up with another blog entry on food sovereignty. We’ve raised this subject at least once some time back in the Thornapple blog, but maybe it’s time to come around again and think …

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Our Vast Influenza

Last week’s page 4 news from Washington demonstrated the vast influence of the Thornapple blog on the nation’s elite decision makers. Just six weeks after blogging on the problems associated with the sub-therpeutic use of antibiotics in meat production, the U.S. Food and Drug Administration (that’s FDA to the policy geeks among my readership) announced …

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