By David Isaacson

It seems that food and beverage product recalls are occurring almost weekly, despite a rise in federal and industry regulations. In fact, according to a recent article, the U.S. Food & Drug Administration (FDA) reported 30 recalls of food and beverage products, pet products and drugs/medical devices in the month of January 2024 alone. This is an ongoing problem that not only impacts a company financially but also causes severe damage to brand reputation.  

While recalls continue to rise, the U.S. government and industry groups continue to expand their compliance regulations to ensure the health and safety of consumers in the food and beverage sector. 

On the federal government level, three groups oversee the safety of food and beverages in the U.S. These include the Food Safety and Inspection Service (FSIS) of the U.S. Department of Agriculture, the FDA and the Centers for Disease Control and Prevention (CDC).

• Food Safety and Inspection Service. Under the Federal Meat Protection Act, the Poultry Products Inspection Act and the Egg Products Inspection Act, the FSIS is responsible for ensuring that the nation’s commercial supply of meat, poultry, and egg products is safe, wholesome, and properly labeled and packaged. 
• US Food and Drug Administration. The FDA is responsible for protecting public health by ensuring that foods (except those protected under the FSIS) are safe, wholesome, sanitary and properly labeled. 
• Centers for Disease Control and Prevention. This organization leads federal efforts to gather data and investigate foodborne illnesses and outbreaks, and monitor the effectiveness of prevention and control efforts to reduce foodborne illnesses. 

U.S. Regulations

The U.S. government continues to establish regulations and guidance to boost the quality and safety of products. The food and beverage compliance regulations have undergone significant changes in recent years to align with modern consumer demands, environmental concerns and advances in the food industry. 

Under the guidance of the FDA, the Food Safety Modernization Act (FSMA) originated in 2011 to improve the nation’s food safety system by shifting the focus from responding to foodborne illness to preventing it. Congress enacted FSMA in response to dramatic changes in the global food system and in an understanding of foodborne illness and its consequences, including the realization that preventable foodborne illness is both a significant public health problem and a threat to the economic well-being of the food system.

Key components of the FSMA include:

Preventive Controls for Human and Animal Food. Requires food facilities to implement preventive controls to minimize the risk of contamination.

Produce Safety Rule. Establishes science-based standards for the safe growing, harvesting, packing and holding of fruits and vegetables.

Foreign Supplier Verification Program (FSVP). Requires importers to verify that their foreign suppliers are producing food in a manner that meets U.S. safety standards.

Hazard Analysis and Critical Control Points (HACCP). The HACCP system is a science-based approach to identifying and preventing hazards in food production. While not a specific law, the FDA requires seafood processors and others to implement HACCP plans.

FDA Food Code. The FDA Food Code provides model food safety regulations for restaurants and retail food establishments. While it is not a federal law, many states adopt it or modify it to suit their specific needs.

Good Manufacturing Practice (GMP). Both the FDA and the USDA have established GMP to ensure that food is processed, manufactured, and held in a sanitary and safe manner.

National Environmental Health Association (NEHA) Standards. These standards are used by local health departments and agencies to regulate and inspect food establishments.

As the U.S. continues to prioritize health, sustainability and consumer protection in the creation, manufacture and distribution of food and beverage items, we can expect to see more oversight and the need for manufacturers to adhere to strict compliance controls. 

Quality Management Holds the Key to Compliance

Remaining compliant with changing regulations and guidance is not easy. Food and beverage manufacturers are tasked with standardizing quality practices on the factory floor, as well as ensuring quality in its suppliers. These tasks are combined with the need to document all operations to prove compliance, and conduct root cause analysis when problems occur.  

Below are key considerations for achieving quality and subsequently ensuring compliance to changing regulations. 

1. Automate your Processes.  Developing and implementing a robust quality management system and data analytics enable manufacturers to identify potential issues in real-time.
2. Implement HACCP (Hazard Analysis and Critical Control Points). The HACCP system is a preventive approach to identify and control potential hazards in the food production process. This system helps to prevent contamination and ensures that critical points are monitored and controlled.
3. Establish Strict Supplier Quality Management. Implementing strict criteria for selecting and evaluating suppliers is the first step in avoiding product issues.  It’s important to standardize and communicate requirements, conduct regular audits and monitor suppliers on an ongoing basis.  
4. Document Procedures. Develop and maintain detailed and well-documented procedures for all aspects of production. This includes ingredients, processing methods, quality checks and sanitation procedures. Documentation helps in traceability and root cause analysis in case of issues.
5. Conduct Employee Training. It’s important to provide comprehensive training programs for employees on food safety practices, hygiene protocols, quality control processes and any updated procedures. Regularly update training to keep employees informed about the latest standards and best practices.
6. Conduct Regular Audits and Inspections. Regular internal and external audits can assess compliance with quality and safety standards, and help you implement corrective actions based on audit findings to continuously improve processes.
7. Utilize Traceability Systems. Implement robust traceability systems that allow quick identification and removal of any contaminated or compromised products from the market. This is essential for targeted recalls to minimize the impact on consumers.

As the pace of food and beverage recalls continues to accelerate, maintaining compliance to regulatory requirements can do more than keep you in favor with the federal government. Making quality the mantra of your operations can reduce costs, boost brand reputation and ensure safe and effective food and beverages for all consumers. 

About the author: David Isaacson is Vice President of Product Marketing at ETQ.