The food industry in the United States is highly regulated to ensure the safety and quality of our nation’s food supply. In 2011, Congress passed the Food Safety Modernization Act (FSMA), which gave the FDA new authority to regulate how foods are grown, harvested, processed, and transported (FDA, 2025).

For businesses involved in producing or handling food products within the United States – from farms and manufacturers to distributors and retailers – compliance with the FSMA requirements is mandatory. Failure to comply can result in serious consequences such as product recalls, fines or even criminal charges.

As a food manufacturer operating within this heavily regulated industry, you must have a thorough understanding of your obligations under FSMA regulations. To help guide you through these complex requirements, we have created this step-by-step guide outlining key compliance aspects for U.S.-based food businesses.

Step 1: Determine if Your Business Falls Under the FSMA Regulations

The first step towards ensuring compliance with the FSMA is to determine whether your business falls under the jurisdiction of this law. Generally, any facility that manufactures, processes, packs or holds food for consumption in the United States must comply with the FSMA regulations. This includes both domestic and foreign facilities that produce food products intended for U.S. consumers.

Step 2: Understand Your Role Under the FSMA

Once you have determined that your business falls under the FSMA regulations, it is important to understand what specific requirements apply to your role within the food industry. For example, if you are a manufacturer or processor of human foods, there are different rules than those that handle animal feed or pet foods.

 Step 3: Implement Preventive Controls

One of the key aspects of complying with the FSMA is implementing preventive controls throughout all stages of production and handling. This means conducting a thorough hazard analysis to identify potential hazards in each stage, from farm to table. Based on this analysis, businesses must then implement risk-based preventative measures to minimize or prevent these hazards from occurring. These may include sanitation procedures, environmental monitoring and control, employee training programs, and equipment maintenance protocols.

The 4 Preventive Control in the US

Preventive controls (PCs) are an essential part of complying with FSMA regulations for U.S. food businesses. These measures help to prevent or minimize potential hazards in the production and handling of food products, ensuring that they are safe for consumption.

Allergen Preventive Controls:

One important preventive control is managing allergens in your facility’s operations. This includes identifying potential sources of allergenic ingredients and implementing procedures to prevent cross-contact during processing, packaging, labelling, and storage.

Process Preventive Controls:

Another key aspect of preventive controls is process control – monitoring critical points throughout the production process where hazards may occur or be introduced into the product. This can include temperature checks, pH levels testing, and other quality assurance measures.

Sanitation Preventive Controls:

Maintaining a clean environment is crucial for preventing contamination in food facilities. Implementing sanitation controls involves establishing cleaning protocols for equipment and surfaces used in production as well as employee hygiene practices such as handwashing requirements.

Supply Chain Preventive Controls:

The final PC requirement under FSMA involves supply chain management – ensuring that all suppliers involved in providing ingredients or materials have proper safety protocols in place to ensure their products do not pose a risk to consumers’ health when incorporated into finished goods.

This requires thorough documentation from each supplier regarding hazard analysis plans and preventative measures taken within their facilities.

As a food manufacturer, you need to document their preventive control plans as well as any corrective actions taken if an issue arises during production or distribution processes.

Additionally, under the FSMA regulations, food facilities must determine the control measure requirements and implement the control. This may include regularly testing products for contaminants such as bacteria or contaminants, allergens and keeping detailed records of these tests.

Step 4: Develop a Recall Plan

Another critical aspect of compliance with FSMA is having a recall plan in place should an issue arise with your product that could potentially harm consumers’ health. A recall plan outlines the steps your business will take if you need to remove products from circulation due to contamination concerns.

This plan should include clear communication strategies both internally within your organization and externally with customers who may have purchased affected products.

Step 5: Stay Up-To-Date on Changes

FSMA regulations are constantly evolving, so it’s crucial for businesses involved in food production or handling to stay informed about any changes made by the FDA regarding compliance requirements. Regularly checking updates on the FDA’s website can help ensure continued adherence to current standards.

What We Have Learned In This Blog?

Complying with the FSMA regulations requires dedication and attention at every level within U.S.-based food businesses -from top management to employees responsible for day-to-day operations. This step-by-step guide has provided an overview of key considerations for full compliance under this law.

Companies must understand their obligations under the Act and take appropriate actions to protect consumers and their businesses. By following these steps, U.S.-based food businesses can ensure the safety of the food supply chains while also avoiding potential penalties for non-compliance with FSMA regulations.

References

FDA. (2025, January 6). What’s new in FSMA. U.S. Food and Drug Administration. https://www.fda.gov/food/food-safety-modernization-act-fsma/whats-new-fsma