Product recalls are becoming more common in the United States. Did you know that the FDA has already issued recall notices for over 750 food and beverage products so far in 2024? This is alarming because the number has doubled compared to last year.  

This is why food manufacturers must be aware of the FDA FSMA regulations and compliance requirements; to impose a way more stringent set of rules and regulations to prevent foodborne illnesses and protect consumer safety.  

But what is FSMA, or its regulations?  

And how can you imply them?  

Read on to find out:  

• Why does FDA FSMA matter?

• How can you comply with it?

• What happens if you do not comply with it

• Why is it already late if you haven’t started implementing the new FSMA regulation?

• And how Artwork Flow can ease the process for you.

Also read: Understanding the FDA Food Labeling Guide: A Comprehensive Overview

What is FSMA?

The FDA Food Safety Modernization Act (FSMA), signed into the U.S. law in January 2011 is designed to protect public health by ensuring the safety of any food supply. It gives the FDA more power to regulate food production, from farm to table, shifting the focus from reacting to foodborne illnesses to preventing them.

The FSMA plays a critical role in overseeing manufacturers and ingredient suppliers in the United States, as well as those supplying imported goods. These ingredients make their way to restaurants, grocery chains like Costco, Whole Foods, and Walmart, along with commercial kitchens and delis.  

Who needs to comply with the FSMA?

The main reason to comply with FSMA is to ensure the distribution of safe food for the consumers which begins from its production.

FSMA regulations applies to the following groups:

• Food & Beverages companies under the FDA.

• Domestic and foreign food manufacturers and suppliers in the U.S.

• Food businesses with an established Hazard Analysis and Critical Control Points (HACCP) plan as HACCP updates fall under FSMA.

FSMA doesn’t apply to:

• For those businesses under the USDA, dealing with fresh produce, such as meat, dairy products, and poultry.  

• Farms and food producers handling raw agricultural commodities and domestic foods.

• Home-based gardeners, preservers, and processors.

FSMA regulations to note down

FSMA has laid down regulations to streamline a compliant food supply chain. Here are the main provisions under the act:

1. Preventive control rule for human and animal food

It is one of the most crucial rules here. It mandates that food facilities implement science-based preventive controls to minimize or prevent food safety hazards. For this, the food manufacturers need to have an extensive food safety plan. The key elements in the document include:

• Hazard Analysis and Risk-Based Preventive Controls (HARPC): Identifying potential hazards, assessing risks, and implementing controls to mitigate them.

• Current Good Manufacturing Practices (CGMPs): Following standard operating procedures for manufacturing, packaging, labeling, and storing food.

• Sanitation Standard Operating Procedures (SSOPs): Maintaining sanitary conditions in food facilities, including cleaning and sanitizing equipment and surfaces.

• Supply chain management: Verifying suppliers and implementing measures to ensure the safety of incoming ingredients.

• Recall plan: Developing and implementing a plan to effectively recall contaminated food products.

2. Foreign Supplier Verification Program (FSVP) Rule

This is the rule for importers. It states that the importers need to verify foreign suppliers are producing food in compliance with U.S. food safety standards. To remain FSMA compliant, the importers must perform risk-based verification activities. This could prevent high chances of adulteration in food, missing listing allergens, and mislabeling.  

3. Produce safety rule

This rule establishes science-based standards for growing, harvesting, packing, and holding produce (fruits and vegetables) to reduce the risk of contamination. Some practices stated by the FDA that needs to be carried include:

• Testing agricultural water: Ensuring the safety of water used for irrigation and washing produce. The FDA requires the samples of untreated ground water to be submitted for testing.  

• Worker hygiene: Implementing hygienic practices for workers through effective training.  

• Biological soil amendments: Following standards for application and microbial of soil amendments.  

• Use of animals: Preventing wildlife contamination of produce involves implementing specific guidelines when using domesticated and wild animals for purposes such as grazing or other agricultural activities.

• Postharvest handling and sanitation: Maintaining sanitary conditions during post-harvest handling, packing, and storage.  

4. Prevent intentional adulteration

This rule addresses intentional adulteration of food, such as the addition of harmful substances or contaminants. It requires food facilities to implement a food defense plan which involves assessment of vulnerability, establishment of mitigation strategies, monitoring, and verification systems.

From local to foreign food manufacturers, this rule applies to all, regardless of the business size.  

5. Accredited third-party certification

This rule allows the FDA to accredit third-party certification bodies to conduct inspections and certifications of food facilities. According to the FDA, the requirements for accreditation are competency, capacity, conflict-of-interest safeguards, and legal authority.

6. Sanitary transportation of human and animal food

This rule establishes standards for the sanitary transportation of human and animal food to prevent contamination or spoiling during transit. The food suppliers must cover these practices:

Vehicle and equipment cleanliness: Maintaining clean transportation vehicles and equipment.

Temperature control: Ensuring proper temperature control during transportation.

Training: Logisitics personnel must be trained regarding sanitary transport practices.  

Some other provisions include standards for food refrigeration, sanitation of vehicle and food contact surfaces in between loads, and proper recording of these conditions.

FSMA compliance checklist

If you want to run your food and beverage business successfully in the U.S., you must comply with the FDA's FSMA requirements. Here is an FSMA compliance checklist to help you get started on the process which covers various aspects of food safety, including:  

1. Food Safety Plan  

A Food Safety Plan (FSP) is a comprehensive document that outlines the steps a food facility takes to prevent foodborne illness. It includes:

• Hazard identification: Identifying potential hazards in the food production process such as the result of management of raw materials, manufacturing practices, and sanitation controls.  

• Specifications: Specifications are detailed guidelines that must be met to ensure food safety. They help maintain consistency and quality throughout the food production process such as ingredients, purchase, process specifications, etc.  

          Also read: The ONLY Spec Sheet Guide You Need [+ free template]

• Critical control points: A critical control point is any stage in the manufacturing process designed to eliminate food safety hazards or prevent them from occurring. Examples: Chilling, chemical testing, testing any food item for any physical hazard, and more.

2. Monitoring and verification procedures  

These procedures ensure that the food safety plan is effective. Keep reports, records, and forms of tracking the progress and the efficiency of application of the Food Safety Plan. This could come in handy in case of an audit.

3. Preventive and corrective control

The FSMA requires science-based preventive controls across the food supply for the identified hazards. The preventive controls are proper sanitation practices, temperature control, allergen control, and Good Manufacturing Practices (GMPs).  

These plans must be revised periodically to see if any improvements are needed. This proactiveness can help tackle more complicated situations in such cases.

4. Recall plan

A recall plan is a detailed document outlining the steps a food facility will take during a food recall. Steps include:

• Identifying key personnel responsible for the recall.

• To initiate and manage a recall.

• Methods for notifying customers of a recall.

• Discarding or returning contaminated food.

• Ability to track and trace products to identify and contain the affected product.

Also read: Product Recall: How to Save Yourself from the Mess

5. Supply chain program

Establishing a supply chain program can ensure that the suppliers also meet the FSMA requirements, leading to the distribution of safe and quality food ingredients. Here, the suppliers must present the documents confirming they have conducted hazard analysis and provide supplier approval documents from external manufacturers.  

6. Traceability system

A traceability system allows a food facility to track and trace food products from the farm to the consumer. This system helps to derive information on the product, including the formulation used, lots and batches, and maximum shelf-life.

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This information is crucial for product recalls and investigations of foodborne illness outbreaks.

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What do you need to know about FDA’s Traceability Rule?

Also known as the Food Safety Modernization Act (FSMA) Rule 204, is introduced to fast-track the tracing of food to ensure a safer and effective food supply chain.  

Not only does the new rule protect the consumers but also bring transparency to the business, preventing the chances of unethical distribution of food.

Even though the rule came into effect on January 20, 2023, the evaluation of the implementation will begin only by January 20, 2026, giving manufacturers three years to prepare.  

Note: The Traceability Rule only applies to certain types of food mentioned in this list by the FDA.

Consequences of FSMA non-compliance

FDA FSMA was introduced to regulate F&B compliance. Non-compliance with FSMA can lead to a range of grave consequences for food businesses, including:

• Product recalls: Recalls can be costly, involving product disposal, customer notification, and potential loss of consumer trust.

• Foodborne illness outbreaks: Non-compliance can lead to foodborne illness outbreaks, which can have serious health consequences for consumers.

• Import detainment: Imported food products may be detained at the border if they do not comply with FSMA regulations.

• Civil penalties: The FDA can impose significant civil penalties for violations.

• Legal Fees: Legal fees associated with defending against regulatory actions or lawsuits can be substantial.

• Negative publicity: Public health scares and negative media coverage can severely damage a company's reputation.

• Loss of consumer trust: Consumers may avoid products from non-compliant companies.

• Difficulty in market access: Retailers and distributors may be hesitant to work with non-compliant suppliers.

To mitigate these risks, food businesses must prioritize FSMA compliance by:

• Understanding the regulations.  

• Developing and implementing a robust Food Safety Plan.

• Training employees.

• Conducting regular audits and inspections.

• Maintaining accurate records.

• Responding promptly to issues.

• Integrate compliance software into the system.

Time for your Food & Beverages brand to comply

Now that you have learnt the FSMA regulations and know that you need to comply with every detail on your F&B packaging label, adopting an AI-powered compliance solution is essential in this rapidly evolving market.  

From managing product specs to streamlining your Food & Beverage product’s label compliance, Artwork Flow’s ComplyAI can do it all while ensuring accuracy.

1. Automated label compliance: Meet complex FDA regulatory requirements with our intelligent compliance. Fact-check nutrition values, ingredient and allergen information, claims, recycle logos, and more by simply running your artwork on the ComplyAI engine. It will share insights on where the information deviation occurred.

2. AI-led spec sheets: Avoid mislabeling and confusion by adding product specifications and packaging copy in a centralized space where everyone can access. You can integrate this information with ComplyAI and create rulesets directly to run checks on your labels.

3. Smart proofing: Prevent costly recalls by catching typos, missing images and wrong fonts (on nutrient panel).

4. Robust barcode scanner: Spread accurate product information by ensuring you have the right code with every single detail on your F&B product label.  

And there’s more!  

Schedule a demo with us to save your product from uncalled recalls!

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