Occasionally, incidents make you scratch your head when considering, “Is it food fraud?” Does it matter what you call it? If you’re the food fraud prevention manager, do you need to take action?
During one of my regular calls with a colleague, Jason Bashura, a question arose: “Is this food fraud?” That sounds like a TV game show, but it is a fundamental question for food fraud prevention managers. It is not just important to put incidents in a category, it is also helpful to sort out the vulnerability and motivation components. If we understand the vulnerability, we can assess how dangerous this is for consumers or companies. If we understand the motivation, then we can try to prevent the event from occurring. Remember, we’re not trying to catch food fraud, we’re trying to prevent it from occurring in the first place.
Incident: illegal drugs smuggled in food packages
On March 3, 2022, the US Customs and Border Protection (CBP) released a statement that they had found counterfeit pharmaceuticals smuggled inside food packages (reference link below). Specifically, they found 10,000 packaged tablets of a morphine-like opioid inside cookie packages. This was seized one week after CBP found 11 liters of liquid ecstasy – also known as molly or MDMA, an unregulated hallucinogenic stimulant – in cans of soup. The product was being sent from one individual criminal to another individual. The product did not enter food commerce and was never intended to enter it.
Coincidently, a week before, my colleague Marco Musumeci from UNICRI (United Nations Interregional Crime and Justice Research Institute) mentioned drugs shipped inside soup cans during his presentation at the World Trade Organization webinar on “Food Fraud and Counterfeits” (see this previous blog post).
Question: “Is it food fraud?” = illegal drugs transported in cookie packages or cans of soup
To review this question, we should start by considering definitions and specific regulatory requirements:
- Food Fraud definition – short version: “intentional deception for economic gain using food”
- Answer: Well, yes and no.
- “Yes” — there was “intentional deception” and “for economic gain,” and this was using “food” by using the “food packaging.”
- “No” – the fraud wasn’t passing off the food as some type of food that it is not. The food packaging was used to slip by any peering eyes and not to deceive a consumer.
- Answer: Well, yes and no.
- Food Fraud definition – extended version: “Food fraud is a collective term used to encompass the deliberate and intentional substitution, addition, tampering, or misrepresentation of food, food ingredients, or food packaging; or false or misleading statements made about a product, for economic gain. […]. Food fraud may not include “adulteration” or “misbranding,” as defined in the Food, Drug, and Cosmetic Act (FD&C Act) when it involves acts such as tax avoidance and smuggling.”
- Answer: No, maybe?
- “No” – The deception was not to trick the buyer or to have the product enter commerce.
- “Maybe” – what if the product had been misplaced and unintentionally entered commerce? That could have led to a recall.
- Answer: No, maybe?
- FSMA-Preventive Controls: “The hazard analysis must be written regardless of its outcome” [21CFR507.33 (a)(2)]. “The hazard may be intentionally introduced for purposes of economic gain.” (iii)
- Answer: Well, maybe.
- “Maybe” – There was a “hazard” that was “intentionally introduced,” and it was “for purposes of economic gain.” Then again, whether this does or doesn’t fall under US food laws is debatable. That said, it is not recommended to guess when it comes to compliance with regulations. It would be wise to go ahead and conduct a “hazard analysis,” even if it is only rapid and simple.
- Answer: Well, maybe.
So, considering those three data points, if it is not food fraud, then where does it fit into the food risk matrix categories of food quality, food safety, food fraud, and food defense? The first key factor is that the product was not intended to enter commerce since it was sent between individuals. Then, the drugs in the food packaging would not lead to a public health threat because it is logical to assume no one would accidentally eat a cookie box full of packaged medicine. This was not an attack to cause economic harm or terror to consumers or companies. The identification and seizure of this product did not lead to a food recall.
All food incidents need to be categorized in one of the four areas of food quality, food safety, food fraud and food defense (See “Defining the Public Health Threat of Food Fraud,” Journal of Food Science, 2011).
The drugs in soup cans don’t seem like a food quality issue since it didn’t relate to the manufacturing process. This is a one-off incident that was controlled outside the commercial supply chain so it is definitely not a food safety or food defense problem. This is an intentional act of deception, it does use food, so it is a de facto food fraud incident.
Question: Where would this rank on a Food Fraud Vulnerability Assessment?
If this has been categorized as a food fraud incident, we would then consider the incident in a Food Fraud Vulnerability Assessment. A key is to define the fraud act narrowly.
- Fraud act: one criminal replacing food with a packaged illegal drug or counterfeit medicine to transport or smuggle the individual packages to another criminal.
- Likelihood of the incident occurring – Very Low: we now are aware that smuggling drugs in packaged goods does occur, but, compared to other food production and manufacturing, the likelihood of occurrence would be “very low” (on a qualitative scale of very low, low, medium, high, and very high).
- Consequence if the event did occur – Very Low: the product was sent person-to-person and was never intended to enter commerce. Also, a consumer would most likely not ingest the drugs (e.g., if a consumer opened a bag of cookies and there were medicine tablets, they would probably not eat them).
- Overall Vulnerability – Very Low: the combined very low likelihood and the very low consequence would lead the overall vulnerability to be very low. Probably no countermeasure or control system would be required regarding the food fraud prevention strategy.
- Conclusion – a corporate security review: Since every incident is a concern, there should be a review to see if there are overall system weaknesses or vulnerabilities that led to this incident, or if this product was a random target (e.g., the cookie bag or soup can just happened to be what was convenient for the criminal). The critical corporate security consideration is if this becomes a more frequent incident (or you find that your product is constantly being used by criminals to conduct their acts), it might require more countermeasures.
- For this crazy incident, was it necessary to classify it as a food fraud incident and conduct a food fraud vulnerability assessment? No, but it wasn’t crazy to run it through the vulnerability assessment. Most likely, conducting a hazard analysis for this incident is a requirement in the US food law. Also, note that we did conduct a “written hazard analysis” in the previous section – but consult your regulatory attorney for a final review.
- There will be incidents that fall outside what we typically see, AND the most important value of the Food Fraud Prevention Strategy is a system to review each incident.
- The drugs in soup cans incident could possibly be classified as “smuggling” rather than as one of the normal types of food fraud. The food product was not the target of the fraud act – the food product was the vehicle to enable the smuggling.