• Review: GAO Report on FDA and Economically Motivated Adulteration

    by John Spink • January 11, 2014 • Blog • 0 Comments

    ffi blog V2 No1 capitolFood-related Economically Motivated Adulteration (EMA) is a complex topic that has been discussed widely here in the US and now globally.  There are a range of industry and government regulations and reports that are beginning to address the topic.  It is one thing to try to interpret the text and the intent of a law, and another to understand the direction provided in government reports such as the Government Accountability Office (GAO) and the Congressional Research Service (CRS).  It is clear that Congress – and the American people – are expecting FDA to address EMA and to focus on prevention.

    Food-related EMA has not been specifically mentioned or addressed in government regulations, though it has been mentioned in several draft  rulemaking documents.  The January 2011 Food  Safety Modernization Act (FSMA) mentions “intentional adulteration, including acts of terrorism” eleven times. The grammar of this sentence clearly identifies terrorist acts or attacks on the food supply as only a part of the “intentional adulteration” scope.  While the FSMA only covers food products, the overall EMA product is clearly defined as an FDA responsibility. This was reiterated in the October 2011 GAO report “Better Coordination Could Enhance Efforts to Address Economic Adulteration and Protect the Public Health ”.  The report confirmed that FDA is responsible for products including: food, food ingredients, dietary supplements, prescription drugs, over-the-counter-drugs, generic drugs, medical device equipment-durables, medical device equipment-nondurables, medical device products, and veterinary products.

    GAO Report on FDA and EMA

    The report addressed EMA for all FDA products, not just food.

    Direct Recommendations and Suggestion. Regarding all FDA-regulated EMA, for all products beyond just food, the GAO FDA/EMA report identified three direct “recommendations” and one “suggestion”:

    • Create a more formal definition of EMA (Note: the GAO meant a definition beyond the 2009 Federal Register notice, so FDA did confirm the definitions through their Workgroup on Economically Motivated Adulteration [WEMA].)
    • Provide guidance on how the FDA Centers are to address EMA (Note: FDA did this in creating WEMA.)
    • Increase inter-agency communication  (Note: also conducted through WEMA.)
    • One more suggestion was to create an industry-reporting clearinghouse.

    FDA Expertise Limitations of Product Fraud Specialists. Other statements focused attention in several other areas including: the FDA’s lack of expertise in intelligence gathering and law enforcement; traceability; and exploring a public-private forum. The GAO FDA/EMA report specifically quotes an FDA official who stated they “do not have the range of expertise… with a background in intelligence gathering or law enforcement.”

    Prevention.  There is a continuing focus on prevention.  FSMA included over 70 mentions of “prevent” or “prevention”, and the GAO report included 8 mentions of “detecting and preventing.”

    Reviewing EMA in the Food Safety Modernization Act

    In January 2011 Congress passed the Food Safety Modernization Act (FSMA). The FSMA states that companies should “…ensure their plans account for all reasonably foreseeable hazards…” but the act does not explicitly define “intentional adulteration ”.  FSMA doesn’t even mention EMA or “intentional contamination ”. FSMA is focused on prevention and there are eleven mentions of “intentional adulteration” that technically covers Food Fraud, counterfeiting, smuggling, tampering and terrorism. In support of the Food Fraud focus and a shift to prevention, the important FSMA points emphasize: public health and protection, public-private partnerships, inter- and intra-country collaborations, prevention, and defining the key terms (which would eventually include EMA and Food Fraud).

    Through the GAO and new laws, the US Congress is defining that agencies – specifically FDA – are responsible for protecting consumers from danger.  They emphasize not only detecting but preventing danger.  The regulatory and statutory boundaries are not clearly defined yet for EMA, Product Fraud, and Food Fraud… but the GAO-type reports will clarify that vision.  There is no doubt that citizens hold the FDA responsible for the safety of all food and drug products. The GAO FDA/EMA report and FSMA have mandated that the FDA is also responsible for prevention.  JWS.

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