Government activity – public health, criminology, supply chain resilience – is primarily judged on quantitative outcomes such as the number of illnesses or crime events. The most efficient preventive measure is to ensure that risk assessments and prevention plans are in place… including for food fraud prevention.
[NOTE: this blog post does not consider the USDA National Organic Program’s (NOP) Strengthening Organic Enforcement (SOE) guidance. The SOE is very prescriptive about what type of organic product fraud assessment and management plan is required, expected, and subject to audit.]
It is crucial for a government or regulatory agency to efficiently use scarce resources. To support this objective, it is often a challenge to shift from detection and prosecution to prevention. One reason that this is a difficult shift is because many of the legacy success metrics are tangible: seizure, arrest-related items such as number of arrests, quantity of product seized, or the length of criminal sentences. This was – and is – an ongoing challenge for public health improvement metrics.
There is a series of concepts to consider including: is the government doing enough for food fraud prevention, facing the reality of constrained resources, assessing the practical impact of actions, the role of a food public health agency, and then the optimal role of a food public health agency in food fraud prevention.
Following is a series of excerpts from the Food Fraud Prevention textbook (Spink, 2019):
Is the Government Doing ‘Enough for Food Fraud Prevention’?
In the past, food fraud was a known problem, but there was not enough information to really establish a common, practical, preventative approach. In a 2010 government public meeting, I was asked if I thought the “food industry was doing enough to address food fraud.” I responded with, “Based on the way we academics and the laws have defined food fraud and prevention, I think that industry and agencies are doing a fine job.” The key is how food fraud is defined and addressed in the laws and regulations. The focus should be on who is assigned the task. With the awareness of the enterprise-wide risk, the leadership is presented with a clear path forward. The leadership is “accountable” for this “inherent risk” and assuring that food fraud prevention is explicitly addressed. Great strides are being made considering how little is really known about food fraud prevention [Note from 2024: especially when considering this quote is from almost 15 years ago].
Be Realistic About Resource Allocation and Practical Impact:
- Law enforcement priority setting (what can food investigators expect from other agencies, prosecutors, the judiciary, and the legislators):
- The priorities that society expects are to address (in ranked order): public safety (drugs, guns, violence), public health (major harms), large-scale economic crimes that disrupt governments or markets (government bribery, sub-prime mortgage lending crisis), large economic crimes than impact many (billions across a market), and then more minor economic crimes that impact one or a few stakeholders.
- Conclusion: Most food fraud incidents would fall into the last category and lowest priority.
- Investigation and prosecution methods for results (the goal is not to catch bad guys and bad products but to prevent food fraud from occurring in the first place):
- Product fraud and counterfeiting are considered a ‘hybrid’ crime with aspects of ‘white collar’ crime and ‘traditional’ crime (Heinonen, Spink & Wilson, 2014). The planning and reward is a typical ‘white collar crime.’ At the same time, the violation is a ‘traditional crime’ where a victim has physical contact and impact of the action. A ‘traditional’ law enforcement investigation would focus on where the crime is conducted to either produce the illicit good or to work with the victim. For product fraud, it is very complex, difficult, or often approaching impossible to even find the origin of the product or the fraudster (Spink, 2011). Also, when considering some simple types of tampering instead of major production locations, there could be thousands of home-based fraudsters (Wheatley & Spink, 2013).
- Conclusion: Traditional food safety investigation methods may be impractical or inefficient in addressing food fraud prevention.
Food Law – A Public Health Agency Focus
While reviewing how an agency addresses unintentional or intentional acts, it is helpful to review details of how the FDA addressed the subject. While all hazards are a concern and focus for a public health agency such as the FDA, there was a need to define the scope of final rules to address the overall law.
There are a range of actions or responses available for a regulator such as the US Food and Drug Administration (FDA). Recalls are actions taken by a firm to remove a product from the market. Recalls may be conducted on a firm’s own initiative, by FDA request, or by FDA order under 21CFR7.3 statutory authority (21CFR7.3, 2014). [Note: from FDA: “Recall means a firm’s removal or correction of a marketed product that the FDA considers to be in violation of the laws it administers and against which the agency would initiate legal action, e.g., seizure.]
There are three types of product recalls:
- “Class I recall: a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.
- Class II recall: a situation in which the use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.
- Class III recall: a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.”
The above excerpts from the Food Fraud Prevention textbook help to provide some background and insight on priority-setting in a resource-constrained environment.
Fortunately, all types of food fraud are illegal under one law or another. Last week’s blog post reviewed the US Food Drug & Cosmetics Act section on “Adulterated Foods” and “Misbranded Foods.” Also see our 2023 blog post: REVIEW – Update of FDA’s ‘Economically Motivated Adulteration (Food Fraud)’ Webpage.
Food Fraud Prevention from a Food Regulatory Perspective (from the blog, 2023):
“The focus of food agencies is on food safety or a specific set of public health-related ‘hazards that require a preventive control.’
Also, food laws clearly state a requirement to conduct a ‘hazard analysis’ even if “the hazard may be intentionally introduced for purposes of economic gain.” This is required even if there is no health hazard since “the hazard analysis must be written regardless of its outcome.” Essentially, you cannot say you do not have a food fraud hazard unless you complete a ‘written assessment’ with this finding.
With all this in mind, an optimal role of a food agency in food fraud prevention is to confirm that all types of food fraud are clearly illegal. Also, it is essential to remember that a food fraud hazard analysis has been required since at least the start of the Food Drug & Cosmetics Act back in 1938. If a food fraud hazard analysis is not a part of regular audits/ inspections/ investigations, they could be part of a broader after-incident information gathering.”
Takeaway Points
- Overall, in food fraud prevention terms, a food fraud vulnerability assessment is a compliance requirement. Any food fraud violation could be subject to at least a Class III recall.
- All types of food fraud – even if there is no adulterant-substance or a health hazard – are illegal under the FDCA “Adulterated Foods” or “Misbranded Foods” sections.
- Fortunately, the holistic and all-encompassing food fraud prevention strategies seem to meet most of the world’s laws, regulations, standards, certifications, and commercial requirements. See our Food Fraud Gap Analysis to start your own review.