Understanding the impact of food safety recalls, regulation

FDA vs. USDA oversight

The U.S. food safety system operates under a dual regulatory framework managed by the FDA and Food Safety and Inspection Service (FSIS) within the U.S. Department of Agriculture (USDA). While their overarching goal of ensuring food safety is the same, their areas of focus and methods differ.

The FDA oversees approximately 80% of the U.S. food supply, including produce, dairy, seafood, dietary supplements and processed foods. Its risk-based inspection model prioritizes high-risk products and facilities for periodic checks.

The USDA, on the other hand, focuses on high-risk categories such as meat, poultry and processed egg products. These categories demand continuous on-site inspections to ensure compliance with stringent safety standards.

Challenges of dual oversight

Businesses operating across FDA and USDA jurisdictions often face unique challenges, particularly with products that fall under the purview of both agencies. For example, a packaged sandwich containing USDA-regulated meat and FDA-regulated bread must adhere to the standards set by both regulators, requiring careful coordination to ensure compliance.

Labeling standards further complicate the food regulatory industry. For instance, USDA-regulated products typically emphasize origin, ingredients and certifications, such as "USDA Organic," while FDA-regulated products prioritize nutritional transparency, allergen warnings and ingredient lists.

These differences in regulatory focus demand tailored compliance strategies, which can significantly increase operational complexity and costs for businesses navigating dual oversight.

What are food recalls?

Food recalls are key to safeguarding public health by removing products that are unsafe or fail to comply with regulatory standards. The U.S. FDA defines food recalls as removing foods from the market due to violations of FDA regulations, which often involve contamination, mislabeling, or safety concerns. Similarly, the USDA explains that recalls of products regulated by the FSIS are voluntary actions taken by companies to withdraw adulterated or misbranded items from the market, aiming to protect consumers from unsafe or improperly labeled foods.

Types of recalls

The FDA and the USDA categorize food recalls into three classes based on the level of potential health risk.

• Class I. Class I recalls are the highest risk category, where a reasonable probability of severe health consequences or death exists. Examples include food contaminated with harmful bacteria such as Escherichia coli, Clostridium botulinum, Listeria monocytogenes and Salmonella spp.
• Class II. Class II recalls are a moderate-risk category, where adverse health effects are unlikely but remain possible. In rare instances, they may result in temporary or reversible health concerns that are generally not severe but still require attention. For example, a frozen meal with an undeclared milk or soy allergen would be classified in this category.
• Class III. Class III recalls are the least severe risk category, with unlikely or negligible adverse health effects. They can include labeling errors, missing nutritional information, packaging defects linked to product quality and cosmetic imperfections.

The cost of noncompliance

For businesses, food recalls impose significant financial and reputational burdens. The Grocery Manufacturers Association and the Food Marketing Institute estimate the average direct cost of a recall at $10 million, with some cases reaching hundreds of millions of dollars. For smaller businesses, these costs can be devastating and could lead to bankruptcy.

Reputational damage can have even longer-lasting effects. Consumers quickly lose trust in brands tied to unsafe products, and restoring confidence often requires years of effort and significant investment. The 2024 Boar's Head listeria outbreak, which resulted in at lease 59 hospitalizations and 10 fatalities, illustrates these consequences.

Beyond multimillion-dollar legal settlements, the company suffered a severe blow to its premium brand reputation. This incident echoed the 2022 nationwide listeria outbreak linked to deli meats and cheeses, which similarly caused significant public health impacts and amplified concerns about food safety across the industry.

Public trust in food safety systems has declined over the years because of recall cases like these high-profile incidents. A 2024 Gallup poll showed only 39% of Americans trusted the government to ensure food safety, down from 47% in 2019. This eroded consumer confidence highlights the need for businesses to prioritize food safety measures and transparency.

Recalls can also have ripple effects by reducing consumer demand for entire food categories, even among unaffected brands. In today's transparency-driven market, businesses must see food safety as an essential investment. Proactive measures and swift responses to risks are critical for mitigating noncompliance's financial and reputational damage, ensuring long-term viability and consumer trust.

Legislative backbones

Two pivotal legislative measures -- the Food Safety Modernization Act (FSMA) and the Farm Bill -- are at the core of U.S. food safety efforts. They work in tandem to enhance prevention, foster innovation and provide critical support for maintaining a safe and reliable food supply.

FSMA

Signed into law in 2011, the FSMA transformed U.S. food safety by prioritizing prevention over reaction. FSMA mandates that food facilities implement hazard analysis and risk-based preventive controls, requiring businesses to proactively identify, monitor and mitigate contamination risks. This prevention-first approach significantly reduces the likelihood of outbreaks and recalls by addressing hazards before they occur.

FSMA also expanded the FDA's authority by enabling it to mandate recalls, a shift from the prior voluntary system. To address the complexities of a globalized food supply, FSMA introduced the Foreign Supplier Verification Program, ensuring imported foods meet U.S. safety standards. Additionally, the Produce Safety Rule established rigorous, science-based standards for the safe growing, harvesting and handling of fruits and vegetables.

While FSMA has significantly strengthened the U.S. food safety system, it also requires substantial effort and resources from food producers, particularly smaller businesses. By emphasizing prevention and accountability, FSMA has improved food safety and fostered innovation in identifying and managing risks across supply chains.

The Farm Bill

The Farm Bill complements FSMA by providing vital funding and resources to support compliance and innovation. Though primarily focused on agriculture, the Farm Bill plays a critical role in food safety by offering financial assistance to smaller producers and rural operations, enabling them to adopt the technologies and practices needed to meet FSMA standards.

The Farm Bill also drives advancements in food safety technologies, such as blockchain traceability systems and rapid pathogen detection, which reduce contamination risks and increase supply chain transparency.

Collaboration between the USDA and FDA is a cornerstone of the Farm Bill. Joint programs funded under this legislation promote integrated approaches to combat foodborne illnesses. For example, farmer education and training initiatives help producers meet both USDA guidelines for high-risk products like meat and poultry and FSMA's preventive requirements.

The Farm Bill ensures that U.S. food safety efforts remain strong and adaptable to emerging challenges by providing the infrastructure to complement FSMA's prevention-focused mandate.

Together, FSMA and the Farm Bill create a comprehensive strategy to protect public health and sustain a safe food supply. FSMA enforces strict standards and preventive measures, while the Farm Bill provides the tools and support businesses need to innovate and comply within the dynamic food safety environment.

Using technology to enhance food safety

Advances in technology are transforming the food safety industry, offering businesses innovative tools to improve compliance and operational efficiency.

Blockchain for traceability

Blockchain technology is transforming the food safety landscape by enabling real-time traceability of products throughout the supply chain. Each transaction or step in the supply chain is recorded immutably, creating a transparent and easily auditable trail. This capability allows businesses to quickly identify contamination sources during recalls, reducing response times and limiting the scope of affected products. Beyond compliance, blockchain builds consumer trust by offering transparency about the origin and handling of food products.

Predictive analytics for risk prevention

Predictive analytics is another game-changing tool in food safety. By analyzing historical and real-time data, businesses can identify patterns and vulnerabilities that signal potential risks. These insights enable companies to take proactive measures, such as adjusting production processes or tightening safety protocols, to prevent contamination before it occurs. This proactive approach enhances operational efficiency and minimizes the likelihood of costly recalls.

Advancements in pathogen detection

Rapid pathogen detection technologies are critical for identifying contaminants in food products faster and more accurately. These advancements allow businesses to detect contamination earlier in the production process, enabling swift corrective actions to mitigate risks. The ability to respond to emerging threats quickly not only protects public health but also strengthens businesses' reputations as safety-conscious and reliable industry players.

Industry implications

The globalized nature of today's food systems presents significant regulatory challenges. For instance, different countries have varying standards for food safety, requiring businesses to adapt their operations to meet diverse requirements. Navigating these differences demands thorough documentation and meticulous compliance practices, as companies must ensure that their products meet the expectations of multiple jurisdictions. Failure to do so can lead to costly delays, recalls, or even import bans.

For example, in 2021, the Food Allergy Safety, Treatment, Education and Research Act identified sesame as a major food allergen, requiring clear labeling on all packaged foods sold in the U.S. These new regulations, which took effect on Jan. 1, 2023, posed significant challenges for global food companies exporting to the U.S., as sesame allergen labeling was not a standard requirement in many other countries. Companies were forced to adapt rapidly to comply with these rules, highlighting the complexities of navigating diverse regulatory frameworks.

Restoring consumer confidence

Earning back public trust in food safety systems is an urgent priority for the industry. High-profile outbreaks and recalls have exposed vulnerabilities, leading to declining consumer confidence. Transparency is key to rebuilding trust, and businesses must embrace strategies that demonstrate accountability and commitment to safety.

Adopting advanced technologies highlights a proactive stance on food safety. Transparent labeling practices and open communication with stakeholders also reinforce consumer confidence by showcasing a business's dedication to protecting public health.

Importance of food safety

Food safety is more than a regulatory requirement -- it is a strategic priority with far-reaching implications for public health, operational resilience and consumer trust. Companies prioritizing safety are better positioned to navigate regulatory complexities, foster stakeholder trust and gain a competitive advantage. As food supply chains grow increasingly complex, businesses must remain vigilant and proactive, ensuring their operations align with the highest standards of safety and integrity.

Alivia Kaylor is a scientist and the senior site editor of Pharma Life Sciences.