• Review of FDA Presentation on Food Fraud and Economically Motivated Adulteration – FDA Deputy Commissioner for Foods Dr. Stephen Ostroff

    by John Spink • May 31, 2017 • Blog • 0 Comments

    FDA Deputy Commissioner for Foods and Veterinary Medicine, Dr. Stephen Ostroff, presented on Food Fraud at the April 4-5, 2017 Food Fraud Conference, Quebec City. FDA has been consistent in its direction and activities – all types of Food Fraud has been illegal since the adoption of the Food Drug & Cosmetics Act of 1938. FSMA just builds upon that Act and strengthens the agency enforcement.

    FDA Presentation on Food Fraud

    FDA Deputy Commissioner Ostroff opened the regulatory session where he defined the terms, discussed the scope, and provided a realistic perspective on the priority-setting by FDA.

    This presentation was significant since it appears to be the first time that an FDA presentation holistically addressed or mentioned Food Fraud. Before this conference a “Food Fraud” keyword search on FDA.gov had nine results which included comments from the FDA EMA meeting by USP (1) and MSU (3), a reference to the USP Food Fraud Database (3), a comment in the FSMA Intentional Adulteration final rule (1), and in a transcript of a public meeting (1).

    Review of Dr. Ostroff’s presentation contents and slides (Note: includes ADA-compliant descriptions of the figures):

    1. Food Fraud Risk Matrix: To define the terms, Dr. Ostroff used the Food Risk Matrix to explain the different types of food risks. The slide cited “Adapted from: Spink (2006), The Counterfeit Food and Beverage Threat, Association of Food and Drug Officials (AFDO), Annual Conference 2006.” He commented on the efficiency of separating the risks but also the challenge of the prevention versus the objectives or statutory boundaries of agencies. (Figure 1. The Food Continuum — citing Spink 2006, a presentation of the food risk matrix including food quality, food safety, food fraud and food defense.)









    1. FDA Working Definition of Economically Motivated Adulteration: To review the base concepts and boundaries he reviewed the FDA working definition that was originally in a Federal Register published meeting invitation for the FDA-wide public meeting on Economically Motivated Adulteration. His emphasis was on “intentional,” “a substance”, and “for economic gain.” [FFI NOTE: This working definition has not been updated and it is not explicitly cited in the FSMA law, regulations, or guidance documents. The Qualified Individual training documents use terms such as EMA, economically motivated hazard, and economically motivated food safety hazard.] (Figure 2. How does FDA Think of Economically Motivated Adulteration (EMA) – quoted the FDA working definition of EMA from the Federal Register published meeting invitation.)









    1. Consumer Perspective – All Issues: He noted that consumers were focused on both the Food Quality and Food Safety aspects of Food Fraud. (Figure 3. EMA- Consumer Perspective – a ven diagram demonstrating consumer concern of food fraud in terms of equal focus on food quality and food safety.)









    1. Consumer Perception: He noted there is “significant consumer anger” for a range of consumer issues, from being cheated to food safety concerns. The consumer concerns can lead to “industry harm/ reputation.” [FFI NOTE: as with comments from the other countries including China, the consumer concern can expand to loss of confidence in the food supply chain and government overseers.] (Figure 4. EMA- Consumer Perception – includes bulleted list of concerns.)









    1. Regulator Perspective: The FDA regulatory focus is on health hazards and specifically ‘hazards that require a preventive control.’ (Figure 5. EMA – Regulator Perspective – referring to the consumer perspective in Figure 3, this is a ven diagram demonstrating [food] regulator concern of food fraud in terms of low focus on food quality and 4x greater concern with food safety incidents.)









    1. Government Priority Setting: “In circumstances where no regulatory agency has unlimited resources, where and how does EMA [Food Fraud] fit onto a list of priorities?” This statement was a starting point for describing the FDA scope and focus. (Figure 6. Quote – content noted above)









    1. Regulator Activity – FSMA and FDCA: He noted the details of the Food Safety Modernization Act (FSMA) and also emphasized that the Food Drug & Cosmetics Act (FDCA or FD&C Act) has been in place since 1938. All types of Food Fraud have been illegal regardless of the actual health hazard.


    From his slide on “Regulator Response” he reiterated sections of FDCA that clarified all types of fraud – for both raw materials and finished goods – are illegal, unfit for commerce, and subject to a recall. [FFI NOTE: Knowledge of illegal products allowed to enter commerce is a crime.]:

    • “Adulterated foods
      • Section 402 (a) of the FD&C Act [FDCA] (21 USC 342): “If it bears or contains any poisonous or deleterious substance which may render it injurious to health.
      • Section 402 (b): “if any valuable constituent has been in whole or in part omitted or abstracted therefrom; or if any substances has been substituted wholly or in part…; or if damage or inferiority has been concealed… or if any substance has been added thereto or mixed or packed therewith, so as to increase its bulk or weight, or reduce its quality or strength, or make it appear better or of greater value than it is.”
    • “Misbranding
      • Section 403(b) of the FD&C Act (21 USC 343 (B)): “offered for sale under the name of another food.”
      • Section 403(a): “labelling is false or misleading”
      • Section 403(i): ingredient labeling”
    1. Strategy for Identifying the “Next Melamine”: He addressed the ultimate goal, which is to predict the next Food Fraud incident… or to identify “the next Melamine.” Very broadly he presented the Criminology and Situation Crime Prevention concepts where the expected reward is greater than the expected risk or penalty. This is the starting point to prioritize prevention countermeasures. (Figure 7. Strategy for Identifying the ‘Next Melamine’ – content noted above.)









    1. EMA Risk Factors: Specifically, he expanded the risk factors to include: inherent vulnerabilities, difficulties in detection (both “inadequate to detect” and “inappropriate methods may give spurious evidence”), supply disruptions increase arbitrage benefits, and the expanding fraud opportunity based on globalization (complex supply chains with products that are moving farther and faster around the world). (Figure 8. EMA Risk Factors & Figure 9. (Continued) – content noted above.)


















    1. Recommendations by the US Government Accountability Office (2011): He reviewed how FDA responded to the GAO recommendations by: adopting a working definition (uses the Federal Register published definition from the meeting invitation), providing written direction on how the FDA centers should address the issue, and then increasing communication. (Figure 10. Review of GAO report on EMA – content noted above.)









    1. GAO Recommendation – Workgroup on Economically Motivated Adulteration (WEMA): He noted that this group was created in response to the GAO report. The group is ongoing. (Figure 11. Workgroup on Economically Motivated Adulteration (WEMA) – summary of activities.)









    1. FDA Focus on Collaboration: The FDA focus for addressing this issue is to collaborate not only within the US but also globally. [FF NOTE: Countries around the world are challenged by the interdisciplinary and international nature of the fraud and that the prevention is fundamentally different than for the traditional food safety hazards.] (Figure 12. Greater Collaboration is Essential – content noted above.)









    1. FDA Focus on Collaboration – Role of Industry: The presentation emphasized the importance of industry leadership. He also specifically noted the work of the US Pharmacopeia. The FDA presentation closed with another emphasis that collaboration was key for success. (Figure 13. Role of Industry, and Figure 14. Collaboration Essential for Success – content noted above.)

















    Whether for the US FDA, UK National Food Crime Unit [Food Fraud], the EU Food Fraud Network, the Chinese CFSA or CFDA, INTERPOL, or Codex Alimentarius, addressing and preventing Food Fraud is a unique and complex challenge. The US FDA presented their thinking on the topic, and while it focuses on addressing health hazards, there is an awareness of the broader consumer concerns. Dr. Ostroff repeated and emphasized a need for international collaboration across the public-private partnership. It will be interesting to follow the FDA presentations on Food Fraud, clarifications provided in training on FSMA implementation, as well as the US government compliance and enforcement actions.

    Addressing and preventing Food Fraud is very complex but if there is a focus on a sound theoretical Criminology-based approach – as well as global collaboration across industry, agencies, and associations – the first steps are not too difficult and they can vastly reduce the ‘fraud opportunity.’ We will continue to monitor the global trends and participate where we can provide value.  FFI

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