FSMA Compliance and Food Fraud: How to Detect and Prevent Threats in Your Supply Chain
Kim Kowieski
Food fraud is a billion-dollar problem hiding in plain sight—and FSMA compliance is your first line of defense. From contaminated spices to counterfeit labels, today's supply chains face growing threats. This article explores how manufacturers can stay ahead with smart prevention, digital tools, and real-world examples.
The food and beverage industry is under constant pressure to meet evolving regulatory standards, and one of the most critical topics within FSMA (Food Safety Modernization Act) compliance is food fraud. Food fraud not only undermines consumer trust but also poses serious health risks and financial implications for businesses. While FSMA’s Intentional Adulteration (IA) rule focuses on preventing deliberate tampering aimed at causing public harm, the act also addresses food fraud through the Preventive Controls Rule for Human Food, which provides specific measures to mitigate this growing threat.
Understanding and addressing food fraud is essential for safeguarding the integrity of the supply chain and ensuring compliance with FSMA requirements. From detecting adulteration and mislabeling to implementing robust food defense strategies, manufacturers need to be proactive in their approach.
In this article, we’ll address:
What is Food Fraud?
Food fraud refers to the intentional deception or misrepresentation of food products for economic gain, often at the expense of public safety and product integrity. This practice, also known as economically motivated adulteration (EMA), undermines trust in the food supply chain and can lead to significant health risks for consumers.
Preventing food fraud is essential to FSMA compliance and avoiding serious legal ramifications. The FDA has made it clear that criminal prosecution will be pursued for both companies and individuals responsible for food fraud incidents. This underscores the need for food and beverage manufacturers to implement robust measures, such as supply chain transparency, thorough documentation, and regular risk assessments, to mitigate the risk of food fraud and ensure public safety.
Common Types of Food Fraud
While FSMA (Food Safety Modernization Act) does not explicitly define or list examples of economically motivated food hazards, it emphasizes the importance of identifying and mitigating risks associated with food fraud as part of broader compliance efforts. According to Food Safety Magazine, the general categories of food fraud include:
Theft: Unauthorized removal and resale of food products.
Tampering: Intentional alteration of food products, often impacting safety or quality.
Simulation: Manufacturing imitation products to resemble authentic brands.
Adulterant Substances: Adding unauthorized or harmful ingredients to products.
Diversion or Gray Market: Unauthorized distribution of legitimate products, often bypassing standard quality controls.
Intellectual Property Rights Counterfeiting: Copying branding, packaging, or trademarks to mislead consumers.
Digicomply from SGS finds such patterns and equips companies to create resilient strategies that mitigate risks and ensure compliance with food safety standards. They found that from 2020-2023, the distribution of food fraud incidents by hazard has Adulteration dominates the most common type of food fraud, reflecting widespread practices of unauthorized substance use to cut costs or alter quality:
They also found that the impact of food fraud varies significantly across different product categories, proving that the risk exists across all food sectors:
Recent Examples of Food Fraud
Food fraud cases continue to emerge across North America, shedding light on vulnerabilities in the food supply chain and the significant consequences for public health and safety.
In one of the most significant fraud cases in recent history, Aimee Bock, founder of the nonprofit Feeding Our Future, was convicted of orchestrating a $250 million scheme during the COVID-19 pandemic. Alongside her co-defendant, Salim Ahmed Said, former owner of Safari Restaurant in Minneapolis, Bock misappropriated federal funds intended to feed children in need. Prosecutors described the case as the nation's largest instance of fraud involving pandemic relief programs. Both Bock and Said were found guilty of conspiracy, wire fraud, and bribery, with allegations of witness tampering and attempted jury bribery further complicating the trial.
Another recent case involves Valley Processing Inc. (VPI), which pleaded guilty to distributing adulterated fruit juice. This case underscores the dangers of inadequate facility registration, poor storage practices, and falsified product quality. The incident highlights the necessity for food and beverage companies to maintain strict compliance and safety standards to avoid similar outcomes.
In a third high-profile investigation, lead-contaminated cinnamon applesauce pouches have raised alarms about economically motivated adulteration in the supply chain. The cinnamon, supplied by Negasmart in Ecuador, contained lead concentrations as high as 5,110 parts per million (ppm)—dramatically exceeding the proposed safety threshold of 2.5 ppm for bark spices. This contamination resulted in multiple recalls and FDA investigations, emphasizing the critical importance of robust supplier verification and preventive controls to mitigate risks and protect consumers.
These cases demonstrate the urgent need for food manufacturers and regulators to prioritize transparency, accountability, and rigorous quality control in every stage of the supply chain.
Building a Robust Food Defense Plan
To effectively reduce the risk of food fraud and ensure compliance with FSMA regulations, including the Intentional Adulteration (IA) Rule and the Preventive Controls Rule for Human Food, food and beverage manufacturers must develop and implement a comprehensive Food Defense Plan. Key steps include:
Perform a Vulnerability Assessment
Identify areas in your supply chain that are most susceptible to food fraud, such as economically motivated adulteration (EMA) or tampering.Implement Mitigation Strategies
Develop and execute targeted strategies to minimize the risk of identified vulnerabilities. For example, leveraging secure suppliers and conducting ingredient testing can reduce the risk of adulteration.Monitor Program Performance
Continuously evaluate your food defense program's effectiveness through regular audits and real-time monitoring tools.Take Corrective Actions
Address gaps or failures promptly by implementing corrective measures when vulnerabilities are discovered or incidents occur.Perform Routine Reanalysis
Regularly review and update your Food Defense Plan to address evolving threats and regulatory requirements.Document Everything
Maintain clear, accessible records of every step in your Food Defense Plan, from assessments to corrective actions. As FSMA guidelines emphasize: "If it isn’t documented, it didn’t happen."
High-Risk Types to Monitor
The FDA has identified the following activities as posing the greatest risk of food fraud:
Bulk Liquid Receiving and Loading
Liquid Storage and Handling
Secondary Ingredient Handling
Mixing and Similar Activities
Focusing on these high-risk areas, manufacturers can implement targeted safeguards to protect against intentional adulteration and fraud.
Leveraging Technology for Compliance
Modern solutions, such as SafetyChain Software’s digital plant management platform, can help automate and streamline your food defense efforts. From real-time data collection to comprehensive reporting tools, technology ensures compliance while reducing the administrative burden.
By following these steps and leveraging the right tools, manufacturers can safeguard their supply chains, protect consumers, and maintain regulatory compliance.
