Question 1: Is food fraud addressed in the FDA’s Intentional Adulteration rule (“Mitigation Strategies to Protect Food Against Intentional Adulteration”)?
Karen Everstine: Food fraud, or what the FDA calls “economically motivated adulteration” (EMA), is certainly an intentional act. However, recent U.S. regulations for food fraud/EMA are outlined in the Preventive Controls (PC) rules (“Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food” and “Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Food for Animals”) and not in the Intentional Adulteration (IA) Rule. FDA indicated that the IA rule was intended to “prevent acts intended to cause wide-scale harm.” Therefore, new requirements related to food fraud/EMA are included in the hazard analysis requirements in the PC rules. FDA indicated they anticipate EMA preventive controls to be needed only in rare circumstances and “usually in cases where there has been a pattern of EMA in the past.” It is important to note that these requirements are specific to hazards that may be introduced for the purposes of economic gain. EMA that only affects product quality is outside the scope of the PC rules. However, there are misbranding and adulteration provisions of the Food Drug and Cosmetic Act that apply to EMA more broadly (whether or not the substance used may be a hazard).
Question 2: If my facility includes food fraud/EMA in our hazard analysis, will we be compliant with global food fraud requirements?
Everstine: Addressing food fraud/EMA only in your hazard analysis is not sufficient for GFSI compliance. Therefore, if your facility needs to be GFSI compliant, you will need to implement a food fraud vulnerability assessment and mitigation plan that covers all types of fraud. This includes fraud that only affects quality and it includes counterfeiting, theft, diversion, and gray market production. While FDA has indicated they are primarily focused on food fraud/EMA that has a known pattern of occurrence and could be a hazard, GFSI requires that industry evaluate vulnerability more broadly. This includes identifying fraud opportunities (such as complex supply chains), individual capability, and “weak signals” of fraud that could include indicators such as price changes for commodities.