In today’s context, food safety plays a crucial role in safeguarding consumer health and maintaining the industry’s reputation. To address the increasingly complex challenges of the global food system, the Food Safety Modernization Act (FSMA) has become a significant step for the United States government. Let’s explore in this article with GOL an overview of the Food Safety Modernization Act, analyze its important components, and assess its impact on the modern food industry.

1. Introduction to FSMA

1.1 What is FSMA?

FSMA is an acronym for The Food Safety Modernization Act, representing a comprehensive reform in the issuance of food safety laws in the United States. On January 4, 2011, former President Obama signed the FDA’s FSMA into law, aiming to ensure a safe food supply for the American people by implementing monitoring mechanisms and preventive measures instead of relying solely on reactive risk mechanisms used in the past. Additionally, the law requires manufacturing businesses and distribution facilities to register a representative in the United States with the FDA.

In pursuit of better public health protection, the FDA also allows the strengthening of the food safety system and designates enforcement agencies for risk prevention, ensuring quick and responsive action when issues arise to achieve higher compliance with food hygiene standards.

Furthermore, FSMA addresses the introduction of new tools and resources under FDA ownership to contribute to elevating the standards of imported food to be on par with domestic standards. The act aims to establish an integrated national food safety system under the management of state and local agencies.

1.2 Why Was FSMA Enacted?

According to CNN citing statistics from the World Health Organization (WHO), an estimated 420,000 people die annually worldwide due to consuming contaminated food. In the United States alone, the Centers for Disease Control and Prevention (CDC) records over three thousand (3,000) deaths each year attributed to tainted and poor-quality food. Particularly in the summer of 2018, the CDC identified approximately thirteen (13) outbreaks caused by food-related illnesses in the U.S.

Based on these CDC figures, U.S. regulatory bodies and authorities believe that preventing diseases at the source is more effective than responding to illnesses caused by food later on. Therefore, to amend regulations related to food production processes, enhance import standards for goods facilities, adapt to significant changes, and ensure quality in the global food system, the Food Safety Modernization Act (FSMA) was enacted.

2. The target audience for FSMA regulations

The Food Safety Modernization Act (FSMA) is the latest legislation by the FDA applicable to all types of food managed by the FDA, except for specific cases outlined by the FDA (such as production, storage, and personal use) where FSMA rules do not apply. This means that facilities engaged in exporting food to the U.S. or those involved in the production, distribution, and storage of goods and food within the country, registered with the FDA, must strictly adhere to the regulations set forth by FSMA.

In some instances, the FDA will notify businesses about facility inspections, requiring them to have at least one (01) personnel thoroughly trained and certified in FSMA compliance.

Furthermore, FSMA will also apply to businesses implementing Hazard Analysis and Critical Control Points (HACCP) plans by updating and enhancing these plans to achieve full compliance with FSMA.

Within this legislation, both export and import businesses need to make adjustments and supplement their food safety management procedures to align with FSMA standards, ensuring they can continue to supply goods and products to penetrate the U.S. market.

Read more: Understanding risk assessment for food safety

3. The content of the FSMA regulations

Based on the provisions of the FSMA, domestic businesses are obligated to invest in the construction and management of their supply chains, ensuring a safe and quality-assured process right from within the country. Specifically, this supply chain must be monitored and managed, with regular risk prevention checks conducted by the FDA and other relevant U.S. regulatory agencies. Additionally, U.S. importers must have a plan to inspect their suppliers, ensuring that both the products and the manufacturing facilities comply with the food safety standards of the United States before issuing import certification. 

Here are the details of the seven (07) main rules when implementing FSMA that have been finalized by the FDA:

• Firstly, Food facilities registered with the FDA are required to implement preventive controls for human food by detailing written plans. These plans must specifically identify and delineate the strategies for addressing potential hazards, outlining appropriate measures and preventive control actions.
• Secondly, Food facilities registered with the FDA or those that have undergone FDA certification procedures are also required to implement preventive controls for animal food through written plans. These plans should clearly outline strategies for addressing potential hazards and provide preventive control measures to effectively manage and prevent hazards associated with the specified types of animal food.
• Thirdly, Food facilities need to establish minimum safety standards for production to ensure the safety of activities such as growing, harvesting, packaging, and storing various commodities and products.
• Fourthly, U.S. importers are required to verify full compliance with FDA procedures and regulations for their foreign suppliers through various verification programs.
• Fifthly, Food facilities recognize third-party certification bodies to manage assessments and voluntary consultations. This helps the manufacturing facilities better prepare for regulatory inspections and achieve the necessary certifications according to regulations.
• Sixthly, Food facilities registered with the FDA must develop one or more plans to assess vulnerabilities to contamination. This involves creating written strategies to minimize each identified vulnerability, aiming to protect food, including measures against intentional adulteration, fraud, intentional misbranding, etc.
• Seventhly, For companies engaged in the transportation of food, which includes shippers, receivers, loaders, and carriers, there will be increased requirements for ensuring hygiene.

In addition, the mentioned FSMA rules also contribute to enhancing the responsibility of U.S. importers regarding actions such as:

• Identifying foreseeable or known hazards associated with each food, including:

• Biological hazards, including parasites and disease-causing bacteria.
• Chemical hazards, including pesticides, natural toxins, substandard additives and colors, allergens in food, and radiation.
• Physical hazards, including contamination with metals and glass.
• Economically motivated adulteration hazards, such as substituting cheaper ingredients that may compromise quality.
• Risk assessment of food involves analyzing potential hazards and examining safety measures in the implementation processes of suppliers, specifically considering the following factors:

• Raw materials, food formulas, and other components.
• Conditions, functions, design models of equipment, and facilities within a typical food manufacturing company.
• Actual transportation processes.
• Harvesting, cultivation, production, processing, packaging, and labeling procedures.
• Storage and distribution activities.
• Sanitary assurance standards, especially occupational hygiene.
• Plans and preventive measures for foreseeable situations.

• Applying risk assessments in the imported food production process to review approval for suppliers involved.
• Verification of suitability for the supplier.
• Implementation of corrective actions and measures.

In addition to the mentioned contents, FSMA also empowers the FDA to take preventive actions against the entry of blended or misbranded foods that pose risks to the U.S. market for several reasons:

• Blended foods may include those containing substandard additives, being spoiled, decayed, contaminated by bacteria or chemicals, packaged and stored in unsanitary environments and conditions, or having components and ingredients replaced with lower-quality substitutes.
• Misbranded foods may involve packaging that does not accurately disclose and fully list the ingredients, main allergens, or nutritional information present in the product.

Therefore, FSMA is considered an effective tool that enables the FDA to successfully eliminate substandard and non-compliant foods from distribution channels through lawful actions.

Read more: 12 Frequently Asked Questions on FSMA regulations

4. How does FSMA differ from other food safety regulations?

FDA focuses on preventive plans for food spoilage rather than just product handling procedures when issues arise.

Therefore, food establishments need to supplement their food safety profiles with:

Analysis of biological, chemical, and physical hazards associated with the products. These hazards can occur naturally, inadvertently, or intentionally.

Preventive methods for these hazards, including preventive measures within:

• Production Process: Methods to prevent damages occurring during the production process.
• Allergens: Prevention of allergic reactions due to cross-contamination, ensuring allergenic substances are clearly stated in consumer product packaging.
• Hygiene: Environmental hygiene methods to prevent damages during food processing.
• Others: Other preventive methods for risks beyond those listed above.

Managing Preventive Methods: After identifying preventive methods, the facility needs to establish a management approach to ensure these processes are implemented adequately.

• Monitoring: Monitoring procedures for personnel and machinery to ensure the correct implementation of preventive methods against damages.
• Correction: Steps to be taken when errors or issues occur.
• Preventive Correction: Measures to prevent the recurrence of errors.
• Verification: Steps to verify the effectiveness of preventive methods, such as testing the accuracy of machinery. Verification steps should be documented and stored

Supply Chain Management Program: Manufacturers must establish a supply chain management program based on potential risks associated with raw materials. This program should outline preventive methods and establish preventive regulations with the raw material suppliers.

• Manufacturers need to ensure that raw material suppliers meet quality standards and undertake quality checks for raw material sources.

Product Recall Plan: Applies to cases where products have already been released to the market and face severe damage issues, requiring a specific and detailed product recall plan and execution method.

Read more: What is ultra-processed food? How does it affect health?

5. Penalties for businesses not complying with FSMA

Manufacturing facilities play a crucial role in preventing foodborne illnesses through the responsibilities outlined in the FDA Food Safety Modernization Act (FSMA). So, what happens if a business does not comply with this law?

• First and foremost, FSMA is a law, meaning it is a mandatory regulation that must be adhered to. Non-compliance can be considered a criminal offense. If such violations are discovered by the Food and Drug Administration (FDA), they will issue warning letters and publicly disclose the information on their website. Subsequently, the FDA will conduct inspections of these manufacturing facilities to ensure compliance with the FSMA.
• The FDA also has the authority to issue food recall orders if contamination is widespread and persistent. In cases where the hazards are significant, the FDA may seize contaminated food products, detain responsible parties, and even conduct broader business operations inspections or suspend registrations for food facilities (potentially leading to temporary or permanent closure of the manufacturing facility).
• In cases where consumers have used contaminated food products resulting in illnesses or fatalities, affected individuals and their families may file lawsuits against the food manufacturing businesses.
• Beyond the legal implications, manufacturing and food businesses that fail to comply with FSMA face a decline in market share, loss of consumer trust, and severe impacts on their competitive advantage in the market.

6. How to achieve quick and convenient compliance with FSMA

The Food Safety Modernization Act (FSMA) is a complex law with numerous new regulations. Compliance with FSMA can be challenging for food manufacturing facilities, especially small and medium-sized ones. Therefore, delegating the responsibilities of FSMA compliance for manufacturers and importers can be done through agents.

GOL is a company that provides FDA registration services and acts as a consulting and support agent for businesses in the field of import and export, including food safety. GOL has an experienced team of experts in food safety who can assist businesses by:

• Explaining FSMA regulations in an understandable manner.
• Developing FSMA compliance plans tailored to each business.
• Advising and supporting businesses in implementing food safety preventive measures.
• Inspecting and evaluating a business’s compliance with FSMA.

With the support of GOL, businesses can achieve FSMA compliance more quickly, conveniently, and effectively.

Here are our insights on some information about the FSMA law. We hope that the details provided in this article can assist food businesses and those interested in food safety in gaining a better understanding of the Food Safety Modernization Act. Additionally, to support global businesses in easily exporting their products to the U.S. market, GOL offers services related to the FDA:

• FDA registration services for food, cosmetics, and medical devices.
• Consulting services for packaging and labeling according to FDA standards.
• Training services, applying FSMA standards to factories (for food).
• Pre-audit services, assisting in FDA inspections.
• Representation services in the U.S. for exporters and importers.
• FSMA compliance services for importers/exporters.

For more detailed information or further consultation regarding the FDA, please feel free to contact us here!

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Exporting food to the United States – Things to keep in mind