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

    by John Spink • June 4, 2014 • Blog • 0 Comments

    USP headquarters

    USP headquarters

    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 supply.  Their insight is valuable since they have expertise beyond just the food to dietary supplements, medicines, and herbal products.

    Unique Hybrid Framework

    Consistent with the conclusions from others, including quotes in a US Government Accountability Office report on Economically Motivated Adulteration, USP stated in their comments to FDA: “Of specific concern to USP is FDA’s decision to address Economically-Motivated Adulteration (EMA) of food through preventative controls [section of the US Food Safety Modernization Act].  While USP agrees with the Agency that it is far from ideal to handle EMA under typical food-defense/ vulnerability approach, we believe EMA would be equally misplaced under preventative controls – EMA should be addressed as its own unique category of food adulteration.”  USP mentioned the adulteration focus on dilution, substitution, concealment, mislabeling (“e.g., toxic Japanese star anise labeled as Chinese star anise, mislabeled/ recycled cooking oil”), and unapproved enhancements.

    When discussing the implementation, USP comments to FDA included: “USP recommends FDA consider a ‘hybrid’ framework tailored to the specific nature of EMA that draws on elements of other approaches as the basis for a regulatory regime.” The USP standards and test methods and reference samples primarily focus on defining product integrity and quality rather than identifying contaminants or adulterants – though USP has been very proactive in creating new Expert Panels to responding to FDA requests to expand to identifying adulterants. For Food Fraud, the scope of the USP focus is naturally on how adulteration compromises food integrity rather than vulnerabilities from tampering, stolen goods, diversion, counterfeiting, unauthorized re-packaging, or unauthorized re-filling.  Thus, there is an efficiency to their statement that: “Given risk points external to the facility, the review should focus on raw ingredients (as opposed to the facility itself or final food product).”

    Reasonably Likely to Occur

    USP brought up a key point – maybe THE key point when considering a legal challenge of the application of this regulation – with the use of the term ‘reasonably likely to occur.’  USP stated: “A traditional hazards analysis [in the context of HACCP] and preventative controls approach assumes the successful identification of specific potential hazard(s) that is ‘reasonably likely to occur’ as a basis for characterizing public health risks in a food supply or system.  This assumption is not compatible with EMA since its associated hazards are difficult to predict, often involving novel and unanticipated means of deception.”  For stolen or diverted goods or date code tampering, there wouldn’t even be an adulterant since the product is genuine.

    The Role of Standards

    Through USP, International Organization for Standardization (ISO), the Global Food Safety Initiative (GFSI) and others (though not yet Codex Alimentarius), there has been active engagement in pursuing public standards or certifications.  USP stated: “Publically available standards for food ingredients – including tests for identity, purity, and impurities, establish verifiable specifications that can help define a good ingredient. A number of well-respected and globally-recognized food ingredients standards exist that can be used directly by a manufacturer or as a component of a third party certification system.” (There’s that ‘third-party certification’ term again.  This is an industry action that is again identified as a key aspect of combating Food Fraud.)
    I’ve personally experienced the value of the USP efforts.  The USP impact is supported and amplified by broad engagement by volunteers from across the food industry.  I volunteer on three of their Expert Panels including Food Ingredient Intentional Adulteration (food ingredients), Dietary Supplement Adulteration with Drugs (dietary supplements), and Povidones Adulteration (drug).  I’ve also been fortunate to be able to attend and present at several of their workshops or conferences.  USP has a unique set of experiences since they are involved in many products beyond food.  These broader activities include several product counterfeiting initiatives, including a USAID-USP cooperative agreement (http://us.vocuspr.com/Newsroom/ViewAttachment.aspx?SiteName=USPharm&Entity=PRAsset&AttachmentType=F&EntityID=107934&AttachmentID=4348e150-bc6a-4f83-a1c3-8e89da27694d ) led by Dr. Patrick Lukulay (an MSU alumni, I might add).

    As has been stated in our previous blog posts, Food Fraud prevention is an emerging concept that is experiencing efficiency due to so many groups and people being involved from the very start.  The US Food Safety Modernization Act is just starting to address Food Fraud, and there is so much engagement and focus on establishing a firm, science-based foundation.  This effort is mirrored collaboratively and independently around the world in the UK (Elliott Review of Food Crime/ Food Fraud), the EU referendum on Food Fraud, the Interpol Operation Opson IV (food crimes), the Global Food Safety Initiative (GFSI), and others. We are all getting on the same page.  For more information on the US Pharmacopeia work in this area please see their website at www.usp.org/food-ingredients/food-fraud-database . JWS.

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