GFSI Certification Requirements: How to get GFSI Certified?

GFSI Certifications: How to get your GFSI Certificate


The Global Food Safety Initiative (GFSI) is an international organization that sets standards for food safety and quality assurance. It was founded by the United Nations Food and Agriculture Organization (FAO), World Health Organization (WHO), and World Trade Organization (WTO).

The Global Food Safety Initiative (GFSI) is a collaboration between the world’s leading food safety experts from retailers, manufacturers, and food service providers. Founded in 2000 by CIES (The Consumer Goods Forum), GFSI brings together key actors of the food industry to collaboratively drive continuous improvement in food safety management systems around the world.

What is GFSI? It stands for Global Food Safety Initiative:

It is a voluntary initiative that was formed by CIES (The Consumer Goods Forum) in 2000. Since its inception, over 1 million companies have been certified through the program, including manufacturers like Nestle and Kellogg’s.  The Global Food Safety Initiative (GFSI) is a collaboration between the world’s leading food safety experts from retailers, manufacturers, and food service providers.

The GFSI brings together key actors of the food industry to collaboratively drive continuous improvement in food safety management systems around the world. The GFSI sets global standards for audits, certifications, and training that are used by more than 10,000 companies worldwide.

Global Food Safety Initiative Program Requirements Today:

Today, GFSI has more than 600 members worldwide in over 50 countries across the globe. Members include Walmart and Nestle and food safety stakeholders like NSF International and SQFI (Sqf Institute). Essentially, GFSI is creating a platform for open dialogue on all aspects of food safety which aims to harmonize standards for food certification schemes. In turn, this helps to certify bodies and raise their level of compliance.

1. Ensure that employees understand their responsibilities

Companies must make sure that their employees understand what their job duties entail. This includes ensuring that they have the necessary training and education to do their jobs safely. Employees should also be trained on how to handle emergencies and how to report any issues they encounter while at work.

2. Have an effective system for monitoring food production processes

A company’s food safety program should include a written policy that outlines the responsibilities of each employee. It should also include a plan for implementing new practices and procedures as well as a process for evaluating them. Finally, the company should establish a procedure for reporting any potential hazards or violations.

3. Train staff on how to handle emergencies

Food safety programs must address emergencies such as recalls, product contamination, and other incidents that could harm consumers. Companies should train employees on how to respond to these events and what steps to take when they occur. They should also develop an emergency response plan that includes contact information for local authorities and a list of emergency contacts.

4. Maintain records of all food products produced or processed

A company must maintain records of its food production and processing activities. These records should include documentation of the source materials used, the processes applied, and any changes made during the manufacturing process.

5. Implement a quality management system

Companies must implement a quality management system (QMS) to help them meet these requirements. This includes documenting how products are produced, testing samples before release, and monitoring product quality throughout the supply chain.

What does the GFSI Initiative promote?

The Global Food Safety Initiative (GFSI) was started by CIES (The Consumer Goods Forum), in 2000. It brings together key actors of the food industry to collaboratively drive continuous improvement in food safety management systems around the world.

The GFSI promotes global harmonization of standards for a wide range of food safety certification schemes. The objective is to build confidence in products by providing a common standard that can be used across countries and regions, regardless of if they are developed independently or by international organizations such as the Codex Alimentarius Commission (CAC) or the World Health Organization (WHO).

GFSI food safety platform for food certification:

Essentially, GFSI is creating a platform for open dialogue on all aspects of food safety which aims to harmonize standards for food certification schemes. In turn, this helps to certify bodies and raise their level of compliance.  The organization was founded in 1999 and it has over 600 members worldwide in over 50 countries across the globe.

GFSI’s main objective is to increase efficiency and effectiveness in food safety management systems by creating an environment where people can share information and learn from one another’s experiences. As such, they have established a network of professionals committed to raising global standards through continuous improvement within the industry’s supply chain – from farm to fork.

Since 2005, GFSI has been working on aligning standards with one another as well as recognizing each other so that every certification scheme meets a baseline of compliance:

Collaboration between GFSI Food Safety Experts:

The Global Food Safety Initiative (GFSI) is a collaboration between the world’s leading food safety experts from retailers, manufacturers, and food service providers. GFSI was launched in 2000 by CIES (The Consumer Goods Forum). Since 2005, GFSI has been working on aligning standards with one another as well as recognizing each other so that every certification scheme meets a baseline of compliance.

GFSI Certification makes sure that your company’s procedures meet international standards for good manufacturing practices (GMP), HACCP (Hazard Analysis and Critical Control Points), and International Food Standard Codex Alimentarius Commission recommendations and guidelines.


GFSI is an initiative that has been around for over 15 years now. The organization is continuously growing and expanding its reach across the globe, which makes it a great place to start if you’re looking for certifications or want to learn more about food safety management systems in general. If you want to make sure your company complies with international standards, then GFSI certification may be right up your alley!

How can Quality Smart Solutions serve you?

Firstly, QSS can help with formula review, food labeling, food importing, and nutrition facts creation (for Canada and the USA).

Secondly, we can also help with registering supplemented foods with TMALs (Temporary Market Authorization License) or reviewing when the new Supplemented Food Regulations are published. 

Thirdly, we help with Safe Foods for Canadians Regulations (HACCP, PCP, Import Licensing, and GRAS Notifications). Get help with your GFSI Certification, food facility registration, FSVP agent, and US Agent. 

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Need help obtaining your GFSI certification?


FDA to tighten regulatory process around CBD food & supplements

CBD Products food and supplements


The FDA may have turned a blind eye to companies like Bio Steel in the past who’ve been selling supplements containing CBD in the United States but they’re like to start issuing more warning letters when drug claims are made.  With the FDA enforcement of CBD supplements being like pet supplements the FDA is concluding that the existing regulatory framework isn’t appropriate for CBD supplements.

The cannabidiol (CBD) product market has seen accelerated growth in 2022, leading FDA to take a closer look at the regulatory pathways.  They’ve since concluded that a new pathway for CBD is required to balance risks and desire for CBD products.  While working with Congress to adjust regulations they’ve decided to deny petitions/rulemaking for marketing CBD products as dietary supplements.

The various usages of CBD (safety concerns):

Studies have shown that long-term usage of CBD has the potential to harm your liver, and the male reproductive system and interact negatively with various medications. CBD exposure can hurt young children and pregnant women.  The new impending regulatory pathway would aim to benefit consumers by providing safety measures to minimize risks.  This could be carried out by; CBD content limits, measures, minimum age requirements, prevention of contaminants, etc.  The current authorities have very limited tools for managing the risks of CBD products and health officials plan to change that.

CBD impact on animals (pet supplements)

CBD also poses risks to animals, and people could be unknowingly exposed to CBD through meat, milk, and eggs from animals fed CBD. Because it is not apparent how CBD products could meet the safety standard for substances in animal food, we also do not intend to pursue rulemaking allowing the use of CBD in animal food. A new regulatory pathway could provide access and oversight for certain CBD-containing products for animals.

What do the FDA officials have to say?

“We have not found adequate evidence to determine how much CBD can be consumed, and for how long, before causing harm,” FDA Principal Deputy Commissioner Janet Woodcock said.

“A new regulatory pathway for CBD is needed that balances individuals’ desire for access to CBD products with the regulatory oversight needed to manage risks,” the agency said.


Although as of January 26th, 2023, the FDA said that it doesn’t intend to make any new guidance related to CBD, they may have to depend on how effective the framework proves to be once it’s created.  Having mainly focused on unsubstantiated health claims of food/beverage and supplements in the past it will be interesting to see how they approach creating a regulatory framework for CBD.

The FDA has stated that the available data didn’t show how CBD products could meet the standards of safety for animal food substances and didn’t intend to provide new rules for its use in human or animal foods.

How Quality Smart Solutions can help:

Please contact our team for more information on food classification, ingredient feasibility questions, ingredient submissions, dietary supplement compliance, NHP compliance, and food labeling projects. Our specialists are here to help with the following services; Novel Food Notifications, SFCR License application, HACCP & PCP program, TMA License for Supplemented Foods, Nutrition Facts Table (NFT) Creation and label compliance!

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10 tips to Prepare for the Safe Food License Application Process

A safe food license is an essential part of any credible food business and understanding the application process is key. Learn how to prepare for it now!


There are many reasons that you might want to get licensed as a food processor or retail operator. You might be interested in expanding your business, or you might want to make sure that your food safety program is compliant with new regulations. Regardless of the reason, it’s important to know what you’re getting into and how much time it will take before you start applying for a license under Canada’s Safe Food for Canadians Regulations (SFCR).

A safe food for Canadians (SFC) license is essential for any credible food business. The process of obtaining a license can be complex and time-consuming, so it’s important to understand what steps you need to take to prepare for it and ensure your business meets all the necessary criteria.  In this blog, we’ll provide you with suggestions to help you prepare for the Safe Food for Canadians License application process.

1.     Set your goals.

The first step in the process of applying for a food license is to set goals. What are you trying to accomplish? What do you hope to achieve? How will this license help your business succeed, and what does that mean for you?

When thinking about your goals, it’s helpful to consider the end goal: what kind of restaurant do you want your establishment to be? Do you want it to be a place where people come in and get a quick bite before they run out the door again or are they going to sit down and enjoy their meal as part of an evening out with friends at one of the best restaurants in town? Your answers here will help guide how much time and energy should be spent on pursuing any number of different licenses.

2.     Do your research.

When you’re preparing to apply for safe food for Canadians license, it’s important to do your research. There are plenty of ways to find out more about the regulator and their guidelines:

  • Check their website. Every regulator will have information on their website regarding how to apply for a safe food license or how to become a member of the industry association in your province/territory. This will give you an idea of what is expected from you during the application process and where you can go for help if necessary.
  • Look through local papers and social media channels like LinkedIn or Facebook groups where other food businesses can share advice on how they got through this process successfully (or not).
  • Talk with other people working in your field who may have already applied for a safe food license with another government department or authority in another part of Canada—they may be able to offer valuable insights into what makes that jurisdiction so different from yours!

3.     Study the regulations.

You should start by learning about the regulations that govern your industry, which you can do by reading through the relevant sections of your provincial or local government’s website. Make sure to review all of the requirements for applying for a license and then check that you understand them before starting your application.

4.     Check if you need a Safe Food License.

You can also check if you need a Safe Food License by checking the list of requirements for your business. There are two ways to do this:

5.     Gather Your Documentation.

Before applying for safe food for Canadians license, it is important to gather all the documentation you will need as part of the application process. This includes information about your business and products, proof of insurance, and any other certifications or licenses that may be required. Additionally, make sure you have up-to-date food safety documentation on hand. Having all of this information at hand will help expedite the application process and ensure you are following the proper procedures.

6.     Make Sure Your Food Safety Plan Is Up to Date.

An integral part of the safe food for Canadians license application process is having an up-to-date food safety plan. This will help you demonstrate to regulators that your business is following current best practices in terms of food handling and preparation. Your food safety plan should outline steps taken to prevent contamination and set clear guidelines for employees when it comes to hygiene and sanitation.

7.     Have a Plan for Testing and Record Keeping.

Testing and record keeping are crucial parts of the food safety plan. This helps ensure that you have evidence to demonstrate to regulators that your business is taking proper precautions about food safety. Regularly test products during all stages of processing and handling, as well as any equipment for potential contamination. Record results in a log and have it available for review by regulators when requested.

8.     Prepare for the Inspector’s Visit.

An inspector may request to visit your site or review your food safety plan before a final license is approved. Before they come, make sure your facility is clean, organized, and up to health standards. Have all of the paperwork necessary for the inspection on hand, as well as relevant certificates from the government or your suppliers. Be prepared to answer any questions regarding your plan so you can show them why you should be approved for a safe food license.

9.     Complete these activities before applying for a Safe Food License:

Make a list of activities that need to be completed before you apply for a license under the Safe Food for Canadians Regulations (SFCR). These are the preliminary steps you must complete to ensure that your application is complete and compliant.


  • Reviewing food safety program requirements and completing an internal audit of systems to determine what areas need improvements or changes. You will also want to consider how much time it will take for staff members who are currently responsible for preparing food to learn about new processes, as well as those who will be responsible for conducting audits, inspections, and reviews.

10.  Show What You Know about Food Safety.

You will need to demonstrate you are knowledgeable about food safety regulations and that your establishment meets the requirements. Be sure to thoroughly research all applicable food safety requirements in your area, so you know the best practices for keeping food safe and healthy and how they should be applied to your premises. Understanding everything related to food safety not only helps with license approvals but also proves you are devoted to offering high-quality, safe products to customers.

How can we help?

Now that you know how important it is for someone else besides yourself to handle this process, what can our experts do exactly? The most important thing is that our consultants will look over all of your application materials thoroughly and make sure everything is up-to-date (guiding you on how to best update things). Then based on their expertise in food safety law, regulations, and standards set by governing bodies like the Canadian Food Inspection Agency (CFIA), etc., we’ll ensure everything looks good from both an internal perspective within your business as well as externally—from a regulatory standpoint.

How We Can Help

Our Experts at Quality Smart Solutions offer support with understanding the Safe Foods for Canadians Regulations and applying for the SFCR License.

Contact us today to learn more about how we can support your food compliance needs during and after licensing!  Our services include; label compliance, french translation, Nutrition Facts Table Creation, TMA License, Novel Food Notification, HACCP/PCP Setup, and FDA compliance services.

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Clearing Regulatory Hurdles with a 510K Premarket Notification

510K Premarket Notification


Submitting a 510K Premarket Notification is an essential step in the process of getting medical devices approved by the FDA. This notification includes detailed information about the device and its intended use and data regarding safety and efficacy. Learn more about the procedure for submitting a 510K Premarket Notification here.

What is the 510k process?

The 510k process is a regulatory pathway that medical device manufacturers must follow to gain clearance from the US Food and Drug Administration (FDA) to market their products. This process is named after the section of the Federal Food, Drug, and Cosmetic Act that outlines the requirements for clearance. The 510k process is designed to ensure that medical devices are safe and effective for their intended use. It requires manufacturers to demonstrate that their devices are substantially equivalent to devices that are already on the market and have been cleared by the FDA.

Who needs to submit a 510k application?

Any medical device manufacturer who wants to market a new device in the United States or make significant changes to an existing device must submit a 510k application to the FDA. This includes manufacturers of Class I, II, and III medical devices. Class I devices are considered low-risk and include items like bandages and tongue depressors. Class II devices are moderate-risk and include items like powered wheelchairs and pregnancy test kits. Class III devices are high-risk and include items like pacemakers and artificial heart valves.

What are the different types of 510k submissions?

There are three types of 510k submissions: traditional, abbreviated, and special. Traditional 510(k) submissions are for devices that have not been previously cleared by the FDA and require the most extensive documentation. Abbreviated 510k submissions are for devices that have already been cleared by the FDA and have a similar predicate device. Special 510(k) submissions are for devices that have minor changes to an existing device that do not affect its safety or effectiveness. It’s important to choose the right type of submission for your device to ensure a smooth and efficient process.

What are the key components of a successful 510k application?

A successful 510k application requires careful planning and attention to detail. Key components include a thorough description of the device and its intended use, a comparison to similar devices already on the market, detailed testing and validation data, and a comprehensive risk analysis. It’s also important to ensure that all documentation is complete and accurate, and that any questions or concerns raised by the FDA are addressed promptly and thoroughly. Working with experienced regulatory consultants can help ensure that your 510k application is successful and meets all necessary requirements.

How long does the 510k process take and what are the potential outcomes?

The length of the 510(k) process can vary depending on the complexity of the device and the completeness of the application. On average, the process can take anywhere from 3 to 12 months. The potential outcomes of a 510(k) submission include clearance, which allows the device to be marketed in the US, or a request for additional information or clarification from the FDA. In some cases, a device may be deemed not substantially equivalent to existing devices on the market and may require a more rigorous premarket approval process. It’s important to work closely with regulatory consultants and the FDA throughout the process to ensure the best possible outcome for your device.

What is a 510 K Premarket Notification?

A 510 K Premarket Notification is a type of federal regulatory filing that must be completed before the FDA will approve the marketing of any medical device in the United States. This notification must include extensive information about the device, its intended use, and how it works. Companies need to make sure their 510 K submission includes all the necessary components before submitting it to the FDA, as incomplete or incorrect filings can cause delays in the approval process.

When Should Companies File a 510k premarket notification?

Companies should submit the 510 K Premarket Notification as soon as they know that their product meets the criteria for medical device clearance. It’s important to note that some devices may require multiple filings or additional components like clinical studies. Companies should consider submitting their notification at least six months before marketing their product, allowing time for FDA review and approval.

How to Prepare and Submit the Notification?

A 510 K Premarket Notification consists of two parts: an Executive Summary and a Technical Document. The Executive Summary will provide the FDA with an overview of the medical device and will also include statements on how it meets the pre-defined criteria for submission. The Technical Document should include a detailed explanation of the design, performance, labeling, and quality of the device. Companies can work with regulatory consultants to ensure the submission is complete and accurate before submitting it to the FDA for review.

Benefits of Submitting a 510 K (PMN)?

Submitting a 510K Premarket Notification can help to reduce regulatory complexity and simplify the process of getting necessary FDA clearance for a medical device. It also helps speed up the timeline, as the FDA can review medical device applications more quickly with the information provided in the submission package. Submitting a 510K PMN allows organizations to gain an understanding of any potential risks associated with their product and make changes before launching it on the market.

Know the Time Frame for the submitted 510k PMN?

Most 510K submissions take 90-120 days for FDA approval. However, different factors can influence the speed of the process such as the complexity of the device, amount and quality of supporting information, type of product, and submission medium used. It is important to determine how long it typically takes before beginning the process to ensure that you work with realistic timelines and expectations.



Tips to Successfully Navigate Through the FDA’s Medical Device 510(k) Submissions:

Submitting a 510(k) application to the FDA for your medical device can be a stressful and complicated process. Luckily, there are a few tips and tricks you can use to make the submission process easier and increase the likelihood of your device being approved. Here are helpful steps to help you get your device cleared by the FDA.

Collect Device Information and Data:

Before you can prepare your application, you’ll need to collect all of the relevant device information and data. This includes technical documentation such as user manuals, drawings, Schematics, and specifications. You should also provide safety and performance testing results (if applicable) as well as supporting clinical research or studies that validate the use of your device. Make sure to submit up-to-date documents so that the FDA gets an accurate picture of your device.

Understand FDA Requirements for a 510(k):

Before you can submit your Medical Device 510(k) application to the FDA, it is important to understand the FDA’s requirements and guidelines. Applications must include detailed information about your device, such as its intended use and components so that the FDA can assess whether or not it meets all applicable safety and performance standards. Additionally, complete and accurate labeling with clear instructions for use should also be provided. This information will help the FDA evaluate your device before approving it.

Formulate Your Submission Plan:

Creating a comprehensive plan will help you map out the steps required to successfully apply. This includes gathering all relevant device data, test results, and safety reports; determining any applicable FDA regulations and standards; and planning review and submission timelines. Additionally, if your device is being marketed internationally, it is important to familiarize yourself with the requirements in those countries so that you can ensure that your device meets all necessary criteria.

Create an FDA Regulatory Strategy:

When submitting a 510(k) application, it is important to create a regulatory strategy. This should include identifying any applicable FDA regulations and standards that your device needs to meet, as well as understanding the specific requirements for your type of product. Additionally, you will need to determine the most suitable submission process and pathway, such as traditional or abbreviated 510(k), Special 510(k), or notified body review/certification. Knowing which pathway works best for your device will ensure a successful and timely submission.

Compile your Test Results and Supporting Documentation:

Your 510(k) application will likely need to include a considerable amount of supporting documentation, such as full product specifications, results from preclinical testing, and comprehensive safety and performance data. These must be sourced, detailed, and organized into the submission package. This is one of the most important steps when submitting a 510(k) application as you must compile all relevant test results and device information that proves the safety and efficacy of your device before approval.

How Quality Smart Solutions can help

Our experts at Quality Smart Solutions are here to help and offer medical device-related regulatory advice and support on successfully securing your medical device license.  We can help you by responding to potential information requests, keeping your license updated, and reviewing your device labels (510k Medical Device Registration, Facility Registration & FURLS, IVD Device Registration, and SaMD Classification

Contact us today to learn more about how we can support your compliance needs during and after licensing! Please find our contact information: 

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How to Master the 12 Steps of HACCP Certification & 7 Principles

Are you looking to get certified in the Hazard Analysis and Critical Control Points (HACCP) system?  The purpose of a Hazard Analysis Critical Control Points (HACCP) plan is to identify and control any hazards that may arise during the process of manufacturing, storing, distributing, and consuming food products. HACCP plans are meant to reduce, eliminate, and avoid risks that may negatively impact the consumer and the organization. They will vary based on the product, process, and other factors that can occur in the facility. Developing a HACCP plan consists of 12 tasks with seven principles, which are further explained below.

Completing this certification program means completing seven important steps. In this guide, we’ll provide an overview of the 12 HACCP steps and 7 principles and help you get ahead on your certification process.

Understand HACCP Principles

The first step to getting certified in the HACCP system is to understand the seven principles that makeup HACCP guidelines.

These seven principles, developed by the Codex Alimentarius workgroup, were designed to ensure safe food production and handling. Knowing and understanding these principles will help you when it comes time to complete the certification steps.

Assign Responsibility & Authority

The fifth step of the HACCP certification process is to assign responsibility and authority. By doing this, it will enable all personnel involved in the HACCP system to adhere to the guidelines with a greater degree of consistency. This can be done by providing training to individuals assigned to positions related to HACCP and assigning personnel authority commensurate with their responsibilities within the system. Additionally, establish working relationships between groups of personnel who work together or provide oversight over any food safety process or part thereof.

Identify Critical Control Points (CCPs)

A critical control point (CCP) is a step of the process at which control can be applied to prevent or eliminate food safety hazards.

The seven principles for developing and managing a successful HACCP plan involve formally identifying CCPs, establishing critical limits for each CCP, monitoring these steps, ensuring corrective action is taken when necessary, verifying the system’s effectiveness, making sure all records are maintained, and conducting regular reviews. All of these steps contribute to the proper implementation of the HACCP plan.

Establish Critical Limits at CCPs

Establishing critical limits at CCPs is a hugely important step of your HACCP plan. These limits define the parameters which must be followed to ensure food safety. When determining the critical limits, it’s important to consider the type of hazard and its respective Severity of Consequence (SOC) should it occur. Upper and lower control points are sometimes established to describe the range in which an operation should work. For example, the time/temperature combination necessary for cooking a meat product may have an upper and lower limit that must be adhered to for the food to be considered safe.

Why are HACCP plans important for food businesses?

Food safety is a critical issue for any food business. Consumers expect that the food they consume is safe and of high quality. However, the food production process is complex, and many potential hazards, such as biological, chemical, and physical, can contaminate the food. These hazards can arise at any stage of food production, from receiving raw materials to shipping finished products. Therefore, food businesses need a systematic approach to identify and control these hazards.

This is where a HACCP plan comes in. A HACCP plan is a proactive approach to managing food safety hazards by identifying potential risks and implementing control measures to prevent or reduce them. A HACCP plan is a legal requirement in many countries, and failure to comply with these regulations can result in serious legal consequences for your business.

Implementing a HACCP plan can help your food business to minimize the risk of food safety hazards, thereby protecting your customers and your business. In addition, a HACCP plan can help you improve the quality of your products, reduce waste, and increase efficiency.

What food safety hazards should be considered in a HACCP plan?

Before developing a HACCP plan, it is essential to understand the different types of food safety hazards that can contaminate your food. There are three main types of food safety hazards: biological, chemical, and physical.

Biological hazards are microorganisms that can cause illness or disease, such as bacteria, viruses, and parasites. These hazards can arise from many sources, such as contaminated water, raw materials, or equipment.

Chemical hazards are substances that can cause illness or injury, such as pesticides, cleaning agents, or food additives. These hazards can arise from many sources, such as contaminated raw materials or the improper use of chemicals.

Physical hazards are foreign objects that can cause injury or illness, such as broken glass, metal fragments, or hair. These hazards can arise from many sources, such as equipment failure or poor handling practices.

Identifying potential hazards that can contaminate your food and developing control measures to prevent or reduce them is essential.

How do you develop a HACCP plan for your food business?

Developing a HACCP plan can be a complex process, but ensuring the safety and quality of your food products is essential. Conducting a hazard analysis is the first step in creating a HACCP plan. This involves identifying potential hazards at each stage of the food production process. Once you have identified the hazards, you can determine the CCPs and establish critical limits.

The next step is to develop monitoring procedures to ensure that the critical limits are met. Monitoring procedures can include visual inspections, measurements, or testing. You should also establish corrective actions to be taken if the required limits are not met. Disciplinary actions can include adjusting the process, stopping production, or disposing of contaminated products.

Once you have developed the monitoring and corrective action procedures, you should implement verification procedures to ensure the HACCP plan works correctly. Verification procedures can include testing, sampling, or reviewing records.

Finally, it would help if you established record-keeping and documentation procedures to document the HACCP plan. Records should be kept for a minimum of two years and should include hazard analysis, CCPs, critical limits, monitoring procedures, corrective actions, and verification procedures.

How do you implement a HACCP plan in your food business?

Implementing a HACCP plan can be challenging, but ensuring the safety and quality of your food products is essential. The first step in implementing a HACCP plan is to train your employees on the principles of HACCP and the procedures developed for your food business.

Establishing a HACCP team to oversee the plan’s implementation would be best. The HACCP team should include individuals with expertise in food safety, quality control, and production.

It is also essential to ensure that your equipment and facilities are designed and maintained to prevent contamination. It would help if you established cleaning and sanitation procedures to ensure that your equipment and facilities are free from contamination.
Finally, you should regularly audit your HACCP plan to ensure it works correctly. Audits can include reviewing records, testing, or observing the production process.

How do you maintain and update your HACCP plan?

Maintaining and updating your HACCP plan is essential to ensuring that it continues to meet the changing needs of your food business. You should regularly review your HACCP plan to ensure it effectively controls hazards.

You should also update your HACCP plan if there are any changes to your food production process, such as introducing new ingredients or equipment. You should also update your HACCP plan if there are any changes to food safety regulations.

Finally, you should ensure that your employees are trained on any updates to the HACCP plan.

What are the common HACCP process mistakes to avoid?

While implementing a HACCP plan can provide many benefits for your food business, there are also common mistakes that you should avoid. These mistakes include:
– Failing to conduct a thorough hazard analysis
– Failing to establish critical limits
– Failing to implement monitoring procedures
– Failing to establish corrective actions
– Failing to implement verification procedures
– Failing to keep accurate records
By avoiding these common mistakes, you can ensure that your HACCP plan effectively controls hazards and ensures the safety and quality of your food products.

Why are HACCP plan certification (12 steps and 7 principles) and training important?

HACCP plan certification and training can give your food business additional credibility and assurance that you are operating at the highest food safety and quality standards. Certification can also be a legal requirement in some countries.

HACCP plan certification involves an independent third-party verifying that your HACCP plan meets the required standards. Training can give employees the knowledge and skills to implement and maintain the HACCP plan effectively.

1. Establish a HACCP Team

The HACCP team consists of individuals possessing a wide range of disciplines and knowledge to contribute to the process of food safety. A typical team includes:

  • Team Leader: orchestrates and organizes the planning process; identifies the scope and specific problem(s) of the plan.
  • Specialist(s): provide consultation and formulation of the plan through their expertise and knowledge.
  • Front Line Staff: includes farmers, distributors, processors, etc.; have in-depth perspective on creating the food product.
  • Stakeholders: e.g. consumers, board of directors, departments, etc.

2. Describe the Product

A full description of the final product should have the following elements for the HACCP team to identify hazards in creating the product:

  • Ingredients, and their characteristics;
  • Formulation (aka “recipe”) of the product;
  • Process of packaging, storing, and transporting;
  • Shelf life.

3. Purpose of the Product

The team determines the main intent of how the product will be used. Will it be cooked, eaten directly, or require further processing? The team needs to identify its intended consumers and determine any vulnerabilities when using the product.  Lastly, the team should consider the effects of misuse or abuse of the product on the general population.

4. Process Flow Diagram

A process flow diagram gives the HACCP team a broader view of the manufacturing process of the product. The diagram can also consist of a schematic of the facility, lending an easier understanding of the steps of each process.

5. On-Site Confirmation of Flow Diagram

The HACCP reviews the operating/manufacturing process to determine the quality of the flow diagram. Multiple reviews can be done and compared to iron out deficiencies in the process.  The site for which the HACCP plan is being designed should be visited as many times as possible to make sure all relevant information is collected.

6. Identify and analyze hazards (Principle # 1)

While identifying potential hazards, the HACCP team must do some background research on the following:

  • Ingredients and materials used in the product
  • Activities performed in each step of the manufacturing process
  • Method of storage and distribution
  • Use/consumption of the product

During analysis, the HACCP evaluates the product’s effects on human, environmental, and organizational interaction.

Control measures are considered once hazards are identified and analyzed during the manufacturing process. At times, organizations may have to hire external food safety consultants to offer different perspectives.

7. Determine the Critical Control Points (CCPs) (Principle # 2)

A critical control point is a step in the process flow diagram that involves reducing, eliminating, and preventing food safety hazards. If CCPs are not in place, production will stop and cannot continue further.

8. Establish Critical Limits for each CCP (Principle # 3)

A critical limit measures the maximum/minimum value of certain factors that have an impact on reducing, preventing, and eliminating food safety hazards. Factors such as temperature, time, moisture level, and visual appearance are considered.

9. Establish a Monitoring Procedure (Principle # 4)

A general monitoring procedure consists of:

  • Ensuring critical limits of each CCP are being met;
  • Detecting any inefficiencies of the control measures;
  • Corrective actions need to be taken as quickly as possible to avoid and minimize the loss of the product;
  • Observing or measuring samples using a statistically-based sampling plan;
  • Common measurements taken are time, temperature, moisture, and content.

10. Establish Corrective Actions (Principle # 5)

Corrective actions must be taken immediately if critical limits are not being met. Management and employees should be trained on how to perform and respond appropriately.

11. Verify the HACCP Plan (Principle # 6)

Once the plan is drafted and CCPs have been validated, the HACCP plan can then be verified. The team must evaluate if CCPs and control measures are effective. Internal auditing may be required to demonstrate an ongoing commitment to complying with and updating the HACCP plan. Asking questions, observing operational procedures, and collecting samples are just some of the ways to verify the plan.

12. Keep Records (Principle # 7)

Record keeping is an essential step of the HACCP plan due to the following:

  • Offers traceability and transparency
  • Ensures due diligence
  • Provides a record of complaints with critical limits set
  • Identifies potential problems

Record keeping can be carried out in several ways, such as checklists or control charts. Manual and computer records are acceptable, but the documentation method should be designed such that it is appropriate for the size and nature of the organization.

What are the benefits of implementing HACCP principles?

Implementing HACCP principles in food manufacturing has numerous benefits. Firstly, it helps to prevent foodborne illnesses by identifying potential hazards and implementing controls to prevent them. This not only protects consumers but also protects the reputation of the manufacturer. Additionally, implementing HACCP principles can improve efficiency and reduce waste by identifying areas where processes can be streamlined. It can also help manufacturers comply with regulatory requirements and improve overall food safety management. Overall, implementing HACCP principles is crucial for any food manufacturer looking to maintain consumer trust and ensure the safety and quality of their products.

What is the role of HACCP in food safety regulations?

HACCP plays a critical role in food safety regulations by providing a systematic approach to identifying and controlling potential hazards in the food production process. Many countries have regulations in place that require food manufacturers to implement HACCP principles as part of their food safety management systems. By doing so, manufacturers can ensure that their products are safe for consumption and comply with regulatory requirements. HACCP also helps to prevent foodborne illnesses, which is a major public health concern. Overall, HACCP is an essential tool for ensuring the safety and quality of food products and maintaining consumer trust.

If you or your company is seeking assistance in implementing a HACCP plan we’re ready to serve you.  Quality Smart Solutions has a team of experts who can implement a HACCP plan, coach, and train your staff. Get prepared now and contact us today to discuss how we can be your solution!

Common Challenges in Implementing HACCP and How to Overcome Them

Implementing HACCP can pose several challenges for businesses, including resistance to change, lack of resources, and complexity. However, these challenges can be overcome through careful planning, effective communication, and training.

Resistance to change can be addressed by creating awareness about the benefits of HACCP and involving employees in the decision-making process. Providing adequate resources, including training, equipment, and support, is crucial for successfully implementing HACCP. Moreover, simplifying the HACCP process and breaking it down into manageable steps can help overcome complexity-related challenges.

The Role of HACCP in Regulatory Compliance

HACCP plays a crucial role in regulatory compliance for businesses in the food industry. Many countries have regulatory requirements that mandate the implementation of HACCP for specific sectors, such as meat and poultry processing, seafood processing, and dairy production. By implementing HACCP, businesses can demonstrate compliance with these regulations and avoid penalties and legal consequences.

Moreover, HACCP provides a proactive approach to food safety and quality, which is highly regarded by regulatory authorities. By implementing HACCP, businesses can demonstrate their commitment to producing safe, high-quality food products and building trust with regulators and consumers.

HACCP Certification and Its Importance

HACCP certification is a voluntary process through which businesses can demonstrate their compliance with HACCP principles and standards. Certification is typically conducted by independent third-party organizations that assess the implementation and effectiveness of a company’s HACCP system.

HACCP certification provides several benefits for businesses. Firstly, it serves as a mark of credibility, demonstrating to consumers, regulators, and business partners that the company has implemented robust food safety and quality management systems. Secondly, certification can open doors to new markets and business opportunities, as many retailers and distributors require their suppliers to be HACCP-certified.

Overall, HACCP certification adds value to a company’s brand, enhances its reputation, and strengthens its position in the market. Below find a breakdown of the benefits of the HACCP process and plan.

Benefits of the HACCP Plan:

  1. What are the primary benefits of implementing a HACCP plan in my business?

    • Implementing an HACCP plan helps improve food safety, reduce the risk of foodborne illnesses, enhance product quality, and increase consumer confidence in your products.
  2. How can a HACCP plan benefit my business’s reputation and brand?

    • An effective HACCP plan demonstrates your commitment to food safety and quality, which can build trust with customers, retailers, and regulatory authorities, ultimately enhancing your brand reputation.
  3. Does an HACCP plan lead to cost savings for my business?

    • Yes, an HACCP plan can lead to cost savings by reducing product recalls, waste, and rework, as well as by minimizing the risk of legal and regulatory penalties associated with food safety violations.
  4. Will implementing HACCP help me meet regulatory requirements and compliance standards?

    • Yes, HACCP is a widely recognized and accepted food safety system that helps businesses meet regulatory requirements and comply with food safety standards such as those set by the FDA and USDA.
  5. How can a HACCP plan benefit my supply chain relationships?

    • Having an HACCP plan in place can improve relationships with suppliers and partners by ensuring consistency and quality throughout the supply chain.
  6. Does HACCP provide a framework for continuous improvement in my food safety processes?

    • Yes, HACCP emphasizes continuous monitoring and improvement, enabling your business to adapt to changing circumstances and improve food safety over time.

HACCP Process

  1. What is the HACCP process, and how does it work?

    • The HACCP process is a systematic approach to identifying, evaluating, and controlling food safety hazards. It involves seven principles, including hazard analysis, critical control point determination, and monitoring.
  2. What are the key steps in developing an HACCP plan for my business?

    • The key steps include conducting a hazard analysis, identifying critical control points, establishing critical limits, implementing monitoring procedures, taking corrective actions, verifying the system, and documenting the plan.
  3. How can I identify critical control points (CCPs) in my food production process?

    • Critical control points are identified through a thorough analysis of your process to determine where hazards can be prevented, eliminated, or reduced to an acceptable level.
  4. What role does monitoring play in the HACCP process?

    • Monitoring involves regularly checking and recording data at critical control points to ensure that the process is under control and that food safety hazards are being managed effectively.
  5. What should I do if a deviation or non-conformance is detected during monitoring?

    • If a deviation occurs, you must take corrective actions to bring the process back under control and prevent unsafe products from reaching consumers.
  6. How do I verify the effectiveness of my HACCP plan?

    • Verification involves reviewing and confirming that the HACCP plan is working as intended. This can include testing, reviewing records, and conducting audits.
  7. Is documentation a crucial aspect of the HACCP process?

    • Yes, thorough documentation is essential for HACCP compliance. It helps demonstrate that you have followed the process correctly and allows for traceability in case of issues.
  8. Where can I find resources or training on implementing the HACCP process in my business?

    • You can seek guidance from food safety consultants, industry associations, or take courses offered by reputable organizations and institutions specializing in food safety and HACCP.

Implementing an HACCP plan and following the HACCP process is critical for ensuring food safety, quality, and regulatory compliance in the food industry. It’s essential for business owners to understand the benefits and steps involved in HACCP to protect their customers and their business.

How We Can Help

Our Experts at Quality Smart Solutions also offer to support your needs for foods, cosmetics, OTC drugs, and medical devices for North America.

Contact us today to learn more about how we can support your HACCP process or any other compliance needs during and after licensing!

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What Should I know about the FDA GRAS Database & Notice

FDA GRAS Notice | FDA GRAS Database Unlocked


Like most food businesses, you probably spend a lot of time thinking about what’s in your food and how to ensure it’s safe. One of the ways you can do this is by checking the FDA GRAS (Generally Recognized as Safe) database.

This database is a compilation of food substances/ingredients that are safe for human consumption. This means that when you see a food listed on the FDA GRAS Database, the Food and Drug Administration has determined that the food is generally considered safe for human consumption.

We will walk you through the process of accessing the FDA GRAS Database and show you some of the food substances that are currently listed.

What is an FDA GRAS Notice?

The FDA GRAS Notice is a formal notification from the FDA declaring that a food or food substance/ingredient is generally recognized as safe. The database of FDA GRAS Database can be accessed online here.

This database can be useful for scientists and researchers who are interested in determining if a particular food substance is safe to use in a food product or recipe during product development stages. It can also be used by manufacturers to determine which additives may be safely included in their products.

GRAS Notification Process:

The Food and Drug Administration (FDA) notifies the public of a food substance that has been determined to be Generally Recognized As Safe (GRAS). The GRAS notification dossier process follows a specific, standardized template that is published on the FDA’s website.

Food manufacturers must submit an application containing information about the food substance, as well as evidence that it is safe for use. Manufacturers can also request emergency approval if the substance is new and has not been previously tested by the FDA. After reviewing the application, the FDA will either issue a GRAS notification or determine that further safety testing is necessary.

If the substance is already listed in the FDA’s GRAS database, manufacturers do not need to submit an application or provide additional evidence. However, they must still follow all other applicable regulations when using this substance in food products.

FDA GRAS lists essential oils:

The FDA has updated its website to include a list of essential oils that are GRAS (Generally Recognized as Safe) according to the FDA. The essential oils on the list have been deemed safe by the FDA and they do not believe there to be any harmful effects associated with using these essential oils.

Some of the essential oils that are on the GRAS list are lavender, peppermint, thyme, rosemary, and chamomile. It is important to remember that these essential oils are only considered safe if used by the instructions on the bottle or package. If you are pregnant or breastfeeding, it is always best to speak with your doctor before using any type of essential oil.


Until recently, the identities of many food additives were a closely guarded trade secret. But with the passage of the Food Quality Protection Act (FQPA) in 1996, this policy changed. Now all food additives must be listed in the Federal Register and be subject to public review and comment. This open process allows consumers and other interested parties to learn about potential hazards and health concerns associated with these ingredients.

Foods that contain GRAS substances are not required to disclose their contents, but they are still subject to regulatory scrutiny. In March of this year, FDA released its GRAS Notice database, which provides detailed information on more than 1,500 GRAS substances currently used in foods. This expansive database will help ensure that foods containing these ingredients are safely consumed by Americans.

The release of this database is an important step in ensuring that Americans have access to safe and healthy foods. By publicly disclosing the ingredients used in American food products, FDA is ensuring that consumers can make informed choices about what they eat.

Navigating the GRAS Notice process for new food products:

If you’re a food product developer, you may have heard of the GRAS notice process. This process is used to determine whether a substance is Generally Recognized As Safe (GRAS) for use in food. However, the process can be complex and overwhelming for those who are new to it. In this guide, we’ll break down the steps of the GRAS notice process and provide helpful tips for success.

  • Understand the basics of GRAS

Before diving into the GRAS notice process, it’s important to understand the basics of what it means for a substance to be Generally Recognized As Safe. According to the FDA, a substance is considered GRAS if it is generally recognized by qualified experts as safe for its intended use in food. This determination is based on scientific evidence and the substance’s history of safe use in food. It’s important to note that GRAS status is not a formal FDA approval, but rather a determination made by the food industry.

  • Conduct a thorough safety assessment

The first step in navigating the GRAS notice process is to conduct a thorough safety assessment of the substance in question. This assessment should include a review of all available scientific literature and data on the substance, as well as any relevant safety studies or toxicology reports. It’s important to consider all potential routes of exposure to the substance, including ingestion, inhalation, and skin contact. Additionally, any potential risks to vulnerable populations, such as children or pregnant women, should be carefully evaluated. A comprehensive safety assessment will help ensure that the substance is safe for its intended use in food and will increase the likelihood of a successful GRAS notice submission.

  • Prepare and submit your GRAS notice

Once you have completed your safety assessment and are confident that your substance is safe for its intended use in food, it’s time to prepare and submit your GRAS notice to the FDA. The notice should include a detailed description of the substance, its intended use in food, and the basis for its safety. It should also include a summary of the safety assessment and any supporting data or literature. It’s important to follow the FDA’s guidance on formatting and content requirements for GRAS notices to ensure that your submission is complete and meets all necessary criteria. Once your notice is submitted, the FDA will review it and provide feedback or request additional information as needed. With careful preparation and attention to detail, you can increase your chances of a successful GRAS notice submission and bring your new food product to market.

  • Work with the FDA to address any concerns or questions

During the GRAS notice process, the FDA may have questions or concerns about your submission. It’s important to work with them to address these issues and provide any additional information they may need. This can include providing more data or literature to support the safety of your substance, r addressing any potential risks or uncertainties. By working collaboratively with the FDA, you can ensure that your submission meets all necessary criteria and increase your chances of a successful outcome. Remember, the ultimate goal is to bring a safe and innovative new food product to market, and working with the FDA is an important part of that process.

  • Keep up with ongoing monitoring and reporting requirements

Once your substance has been deemed GRAS, it’s important to continue monitoring its safety and any potential risks. This includes ongoing testing and research, as well as reporting any adverse events or concerns to the FDA. It’s also important to keep up with any changes in regulations or guidelines related to your substance or the food industry as a whole. By staying informed and proactive, you can ensure the continued safety and success of your new food product.

How Quality Smart Solutions can help:

We hope this post helped you understand food additives and preservatives a little better. There are many different kinds, and they can have a big impact on your health and the environment. If you want to learn even more, reach out to us today!

Please contact our team for more information on food classification, ingredient feasibility questions, ingredient submissions, and food labelling projects. Our specialists are here to help with the following services; Novel Food Notifications, SFCR License application, HACCP & PCP program, TMA License for Supplemented Foods, Nutrition Facts Table (NFT) Creation and label compliance!

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Dietary Supplement Labeling Guide: Everything you should know

FDA Dietary Supplements Labeling Requirements in the USA


The FDA offers an online dietary supplement labeling guide that provides labeling requirements for supplement manufacturers. The guide covers issues such as Supplement Facts Panel (SFP) labeling, ingredient labeling, and health claims.

In the USA, there are strict requirements for supplement labels. The FDA (Food and Drug Administration) requires all supplement labels to list the following: • Supplement name • Net quantity of contents • Direction for use • Warning statements if any • Supplement Facts Table • List of ingredients. All of this information must be displayed clearly and concisely.

You must comply with all the requirements if you want to do business in the USA, otherwise, the FDA may issue you a Warning Letter.

If you are unsure how to comply with these requirements, you can always consult a professional consultancy service, such as Quality Smart Solutions.

What is a dietary supplement?

A dietary supplement is a product that contains nutrients derived from food sources that are intended to supplement the diet. The most common type of dietary supplement is a vitamin or mineral supplement, which can be used to treat deficiencies or prevent health problems. Other types of dietary supplements include protein supplements, omega-3 fatty acid supplements, and herbal supplements.

Dietary supplements may be found in many forms, such as pills, tablets, capsules, gummies, soft gels, liquids, and powders. They can also be in the same form as a conventional food category, such as teas or bars, but only if the product is not represented as a conventional food or as a “sole item of a meal or the diet.” To be a dietary supplement, a product must also be labeled as a dietary supplement; that is, the product label must include the term “dietary supplement” or equivalent (e.g., “iron supplement” or “herbal supplement”).

Dietary supplements are not meant to replace food or medicine. They should be used as part of a healthy lifestyle.

Understanding Dietary Supplement Labeling

Dietary supplement labeling serves as an essential tool for both manufacturers and consumers. For manufacturers, it is an opportunity to provide accurate and informative information about their products. At the same time, it helps consumers make informed decisions. Understanding the importance of proper labeling is crucial in ensuring the safety and efficacy of dietary supplements.

Proper labeling helps consumers identify and select the right supplements for their needs and allows manufacturers to differentiate their products in a crowded market. Clear and concise labeling will enable consumers to understand the product’s purpose, ingredients, and recommended usage, allowing them to make informed choices.

FDA Regulations for Dietary Supplement Labeling

The Food and Drug Administration (FDA) is vital in regulating dietary supplement labeling in the United States. The FDA’s regulations ensure that supplement labels are accurate and transparent and do not mislead consumers. Compliance with these regulations is essential for manufacturers to avoid legal consequences and maintain consumer trust.

The FDA requires dietary supplement labels to include key components, such as a statement of identity, net quantity of contents, nutrition labeling, ingredient list, and manufacturer/distributor information. These requirements ensure that consumers have access to vital information about the product they are considering.

What are the labeling requirements for dietary supplements?

In order for a dietary supplement to be sold in the USA, it must comply with the FDA’s labeling requirements. These requirements are designed to ensure that consumers can make informed decisions about the supplements they purchase and to protect them from products that may be harmful.

Dietary supplements in the USA must be properly labeled according to the FDA’s requirements. The label must include the supplement’s name, net quantity of contents, list of ingredients, and the manufacturer’s or distributor’s name and address.

Additionally, the label must state any warnings or precautions associated with the supplement.

Need help with your dietary supplement labeling?

What are the key components of a Dietary Supplement Label?

A well-designed dietary supplement label contains several key components that provide essential information to consumers. These components include a statement of identity, net quantity of contents, nutrition labeling, ingredient list, and manufacturer/distributor information.
The statement of identity identifies the product and its intended purpose. It should concisely reflect the product’s nature, such as “Calcium Supplement” or “Herbal Sleep Aid.” The net quantity of contents indicates the amount of the product contained within the package. This information is crucial for consumers to determine the value and duration of use.

Nutrition labeling provides consumers with information about the product’s nutritional content. It includes serving size, calories, macronutrients, vitamins, and minerals. This information helps consumers understand the nutritional benefits of the supplement and make informed choices based on their dietary needs.

Nutritional Information and Serving Size Requirements

When it comes to dietary supplement labeling, providing accurate and comprehensive nutritional information is essential. The FDA requires supplement labels to include a serving size and the number of servings per container. This information helps consumers understand the appropriate dosage and duration of use.

The nutritional information should also include the total calories per serving and the amounts of macronutrients, such as carbohydrates, proteins, and fats. This applies to vitamins, minerals, and other essential nutrients and is also crucial to inform consumers about the product’s nutritional value.

Manufacturers must ensure that the nutritional information is accurate and based on reliable testing methods. Any claims made regarding nutritional benefits should be supported by scientific evidence.

Health Claims and Structure-Function Claims on Dietary Supplement Labels

Health claims and structure-function claims are two types of claims that can be made on dietary supplement labels. Health claims describe a relationship between a nutrient or ingredient and a disease or health condition. In contrast, structure-function claims describe the role of a nutrient or ingredient in maintaining normal bodily functions.

Certain health claims require FDA approval before they can be used on supplement labels. These claims must be supported by significant scientific evidence. On the other hand, structure-function claims do not require FDA approval. Still, they must be accompanied by a disclaimer stating that the FDA has not evaluated the claim.

Manufacturers must understand health and structure-function claims regulations to ensure compliance and avoid misleading consumers.

What are the requirements for dietary supplement Ingredient Lists and Allergen Declarations?

The ingredient list is one of the most important components of a dietary supplement label. It provides consumers with information about the ingredients used in the product, helping them identify potential allergens and make informed choices based on their dietary restrictions.
The FDA requires supplement labels to list all ingredients in descending order of predominance by weight. This means that the ingredient with the highest amount should be listed first, followed by the next highest amount, and so on.

In addition to listing the ingredients, manufacturers must declare any major food allergens. These allergens include common ingredients such as milk, eggs, fish, shellfish, tree nuts, peanuts, wheat, and soybeans. Clear allergen declarations help consumers with food allergies or sensitivities avoid products that may cause adverse reactions.

Additional Labeling Requirements for Specific Types of Dietary Supplements

Different dietary supplements may have specific labeling requirements based on their nature and intended use. For example, dietary supplements containing botanical ingredients may require additional labeling to provide detailed plant part information or extraction methods.

Manufacturers need to familiarize themselves with the specific regulations on their product type to ensure compliance and avoid any potential legal issues.

Designing an effective and visually appealing supplement label

In addition to meeting regulatory requirements, designing an effective and visually appealing supplement label is crucial for attracting consumers and standing out in a competitive market. A well-designed label should accurately represent the brand, clearly communicate the product’s benefits, and engage the target audience.

Consider font choice, color scheme, and layout to create a visually appealing label. It’s important to balance aesthetics and readability to ensure the information is easily accessible to consumers.

Including high-quality product images, relevant icons, and clear call-to-action statements can further enhance the label’s appeal and encourage consumers to purchase.

What are the common mistakes to avoid in Dietary Supplement Labeling?

While understanding the regulations and requirements for dietary supplement labeling is crucial, it is equally important to be aware of common mistakes that should be avoided. These mistakes can lead to regulatory non-compliance, legal consequences, and damage to brand reputation.

Some common mistakes in dietary supplement labeling include inaccurate ingredient listings, misleading health claims, incorrect serving size information, and failure to declare allergens. Poor design choices, such as illegible fonts or cluttered layouts, can negatively impact consumer perception and trust.

By being aware of these mistakes and taking proactive measures to avoid them, manufacturers can ensure that their supplement labels are accurate, compliant, and effective in attracting consumers.

What information must be included on the supplement label?

All dietary supplements must be labeled with the following information:

  • The product’s name/identity and contact information for the manufacturer or distributor
  • The term “dietary supplement” or equivalent on the principal display panel
  • A list of all ingredients
  • The recommended dosage
  • Net quantity of contents
  • Nutrition labeling/Supplement Facts Panel
  • Any warnings or precautions associated with the product
  • The expiration date or “best before” date

Who is responsible for ensuring that dietary supplements are labeled correctly?

It is the responsibility of the supplement manufacturer to ensure that their products are properly labeled by American law. The Dietary Supplement Health and Education Act of 1994 (the DSHEA) defines what a “dietary supplement” is, and includes specific labeling requirements for dietary supplements, as well as optional labeling statements.

The FDA recommends that consumers consult a healthcare professional before taking any dietary supplements, especially if they have pre-existing health conditions.

What do I need to do before selling dietary supplements in Canada?

  1. You need to obtain a Natural Product Number (NPN). This is a license issued by Health Canada for Dietary Supplements. The process to obtain a license can take 10 to 210 days depending on the ingredients in the formula.  There is currently a pilot program that is trying to ensure that 95% of applications receive a license in 30 days. This program concludes at the end of February and initiatives, technology and processes will be improved to hit this target.
  2. You must have a compliant label, both in terms of content and layout as well as a bilingual label that is in both English and French.
  3. Your manufacturing facility has to be annexed to a Natural Health Product site licensed importer (these licenses are only issued to Canadian businesses).  Often distributors hold an import site license but it is not necessary or a requirement that the distributor also be your importer on record.  Depending on your needs and strategy for Canada, it may be preferable to work with a third-party importer that is separate from the distributor. 

Supplement Facts Panel (SFP):

The nutrition label for a dietary supplement is called a “Supplement Facts” panel. The major differences between the “Supplement Facts” panel and the “Nutrition Facts” panel are as follows:

  • You must list dietary ingredients without Recommended Daily Intake (RDIs) or Daily Reference Values (DRVs) in the “Supplement Facts” panel for dietary supplements. You are not permitted to list these ingredients in the “Nutrition Facts” panel for foods.
  • You may list the source of a dietary ingredient in the “Supplement Facts” panel for dietary supplements. You cannot list the source of a dietary ingredient in the “Nutrition Facts” panel for foods.
  • You are not required to list the source of a dietary ingredient in the ingredient statement for dietary supplements if it is listed in the “Supplement Facts” panel.
  • You must include the part of the plant from which a dietary ingredient is derived in the “Supplement Facts” panel for dietary supplements. You are not permitted to list the part of a plant in the “Nutrition Facts” panel for foods.
  • You are not permitted to list “zero” amounts of nutrients in the “Supplement Facts” panel for dietary supplements. You are required to list “zero” amounts of nutrients in the “Nutrition Facts” panel for food.

You must list the names and quantities of dietary ingredients present in your product, the “Serving Size” and the “Servings Per Container.” However, the listing of “Servings Per Container” is not required when it is the same information as in the net quantity of contents statement.

What are the penalties for mislabeling dietary supplements?

The penalties for mislabeling dietary supplements in the USA can be severe. The FDA generally issues warning letters if companies are illegally marketing dietary supplements. If the warning letter is not addressed or acknowledged, more severe compliance and enforcement steps can be taken.

Prohibited Health Claims:

There are a few prohibited health claims that you cannot make when labeling your dietary supplement products in the USA. These claims are:

  • Claims that the product can cure, treat, or prevent any disease
  • Claims that the product can have an immediate or dramatic effect on the structure or function of the body
  • Claims that the product is completely safe and has no side effects

In addition, all health claims made on dietary supplement labels must be supported by scientific evidence. It means that you will need to do your research and have studies to back up any claims you make about your product.

What is the role of the FDA in regulating dietary supplements?

The Food and Drug Administration (FDA) is a federal agency responsible for regulating the safety and efficacy of food, drugs, and medical devices in the United States. The FDA also has jurisdiction over dietary supplements, defined as products containing one or more nutritional ingredients such as vitamins, minerals, herbs, or amino acids. However, unlike drugs, dietary supplements do not require FDA approval before being marketed to consumers. Instead, the FDA regulates dietary supplements under the Dietary Supplement Health and Education Act (DSHEA) of 1994. Under this law, dietary supplement manufacturers must ensure their products are safe, properly labeled, and free from contaminants.

Despite these regulations, the FDA needs more resources to monitor the dietary supplement industry. As a result, it relies heavily on manufacturers to comply with laws and report any adverse events associated with its products. This creates a potential for inaccurate labeling, which can seriously affect consumer health.

Risks of inaccurate labeling

Inaccurate labeling is a significant risk for consumers who rely on dietary supplements to maintain their health and wellness. When supplements are mislabeled, consumers may not get the intended amount of the active ingredient or may be exposed to harmful contaminants. This can lead to adverse reactions, including allergic reactions, toxicity, or drug interactions. Sometimes, inaccurate labeling can lead to serious health complications, such as liver damage or kidney failure.

Moreover, inaccurate labeling can lead to false claims of effectiveness, which can be misleading to consumers. For example, a supplement may claim to cure a disease or condition without any scientific evidence to support such claims. This can lead consumers to delay or forego medical treatment, which can have serious consequences.

What are the common types of inaccurate dietary supplement labeling?

Consumers should be aware of several common types of inaccurate labeling when purchasing dietary supplements. One is the mislabeling of the active ingredient. For example, a supplement may claim to contain a certain amount of a particular vitamin or mineral. Still, in reality, it contains less than the advertised amount. This can lead to a deficiency in the nutrient, which can have serious health consequences.
Another type of inaccurate labeling is misidentifying the plant species used in herbal supplements. Some supplements may claim to contain a specific herb, but a different, potentially harmful plant species was used. This can lead to toxicity or other adverse reactions.

Finally, some supplements may contain harmful contaminants, such as heavy metals or pesticides, not listed on the label. This can lead to serious health complications, especially if the supplement takes a long time.

The impact of inaccurate labeling on the supplement industry

Inaccurate labeling can have a significant impact on the dietary supplement industry as a whole. When consumers experience adverse reactions or do not get the expected results from a supplement, they may lose confidence in the industry. This can lead to decreased sales and negatively impact the industry’s reputation.

Moreover, inaccurate labeling can lead to increased regulation and oversight by the FDA. This can be costly and time-consuming for manufacturers and may limit consumer choice in the marketplace.

Legal consequences of misleading labeling

Misleading labeling can have serious legal consequences for dietary supplement manufacturers. Under the DSHEA, manufacturers must ensure that their products are safe, properly labeled, and free from contaminants. Failure to comply with these regulations can result in fines, recalls, and criminal charges.

Moreover, consumers who experience adverse reactions or are misled by false claims may be able to file lawsuits against the manufacturer. This can result in significant financial damages and damage the manufacturer’s reputation.

Resources and Tools for Creating Compliant Supplement Labels

Creating compliant supplement labels can be a complex task. Still, several resources and tools are available to help manufacturers navigate the process. The FDA’s website provides detailed guidance on dietary supplement labeling requirements, including downloadable resources and examples.

Additionally, there are software solutions and online platforms specifically designed to assist in creating compliant supplement labels. These tools often provide templates, label design options, and regulatory compliance checks to ensure that labels meet all requirements. By leveraging these resources and tools, manufacturers can streamline the labeling process and ensure accuracy and compliance.


In conclusion, the FDA dietary supplement labeling regulations are very important to follow. They help ensure that your dietary supplement is safe for use. The FDA’s dietary supplement labeling guide provides clear and concise requirements for supplement labels in the USA.

These requirements ensure that consumers can easily understand the key information about a supplement, including its benefits, risks, and how to use it safely. By following these guidelines, manufacturers can provide consumers with the information they need to make informed decisions about their health and well-being.

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Global Food Safety Initiative (GFSI Certification) How to get GFSI Certified?

GFSI Certification Benchmarking Audit

The Global Food Safety Initiative: What You Need to Know:

The Global Food Safety Initiative (GFSI), founded in 2000, is an international collaboration among the world’s leading food safety experts and organizations. To ensure safe food worldwide, GFSI has developed a holistic approach to building consumer trust in the global food system by setting strict standards for food production, manufacturing, and distribution. Here, find out all you need to know about the initiative including its purpose, key principles, and how to become a member.

The Global Food Safety Initiative (GFSI) is a comprehensive food safety initiative that helps to ensure that only the safest and most high-quality products are being imported into the local market. It is also used to verify that these products are meeting the standards set by national laws and regulations. GFSI was established to ensure confidence in the delivery of safer food to consumers while continuing to improve food safety throughout the supply chain.

These global standards address food, packaging, packaging materials, storage, and distribution for primary producers, manufacturers, and distributors. GFSI Certification allows companies to gain access to new markets, improve their reputation, and add value through better quality assurance programs.

What is GFSI certification?

GFSI stands for Global Food Safety Initiative, which is a collaboration between some of the world’s leading food safety experts. GFSI certification is a voluntary program that helps ensure food safety and quality throughout the entire supply chain. It involves a rigorous process of auditing and certification and is recognized by many major retailers and food service companies around the world. GFSI certification is not mandatory, but it can provide a competitive advantage for businesses in the food industry.

What is Global Food Safety Initiative?

The Global Food Safety Initiative (GFSI) is a global collaboration of food safety experts from the retail, manufacturing, and food service industries. GFSI’s primary mission is to provide a single, comprehensive approach for ensuring that internationally recognized food safety standards are consistently applied across all parts of the global food supply chain.

How does GFSI Certification Work?

GFSI certification is a process carried out by certified organizations and specific auditors to ensure that proper safety measures are in place and followed at steps throughout the food supply chain. Companies that have achieved GFSI certification are required to submit their operations, quality systems, and production environments to third-party audits regularly to remain certified. The GFSI audit seeks to identify non-conformance of standards set by recognized industry sectors such as the Global Retailer Produce Group (GRPG)and Codex Alimentarius.

What are the benefits of GFSI Certified Standards?

GFSI Certified Standards are among the most rigorous and comprehensive food safety requirements available, helping businesses ensure that their products meet safety and quality standards. Learn more about the benefits of GFSI Certification and how it can help your business maintain food safety.

Not only is GFSI recognition and certification beneficial to the supplier, but it also allows retailers and other food business owners to assure their customers that the food products purchased from them are safe for consumption. Additionally, GFSI certification reduces the chances of food product recalls due to safety concerns, which can cause significant financial costs to businesses in terms of lost sales and reputational impacts. Furthermore, obtaining GFSI certification helps businesses qualify for certain government contracts.

What are the requirements to achieve Global Food Safety Initiative Certification?

To be recognized as a GFSI-certified supplier, businesses must demonstrate that their food safety measures are compliant with GFSI’s seven principles and regularly undergo assessment and auditing. The principles include food safety management procedures that should be implemented in production, pest management, product labeling, logistical control systems, sanitation operations, and recalls/withdrawals. Additionally, suppliers must have a comprehensive system of traceability in place to ensure easy one-step forward and one-step back tracing capabilities should a problem arise.

What are the GFSI Certified Standards?

GFSI Certified Standards provide a comprehensive set of requirements and procedures for companies looking to demonstrate their commitment to food safety excellence. By demonstrating a commitment to these standards, businesses can improve operational efficiency, reduce product recalls and mitigate legal issues associated with food safety violations. Additionally, GFSI Certified Standards can attract new customers and open up new markets by showcasing that the company is serious about its food safety efforts.

Do i need GFSI Certification?

It is not a legal requirement to have GSFI certification (ie. it is not required by the regulations) however it does have many benefits for the food industry and its consumers.

The following are some of them:

  • GFSI certification ensures that your product is safe to eat as it meets international standards of quality and safety, which is important for you as a manufacturer or seller in the global market;
  • For consumers, you can assure them that their food will be safe to eat because you have been certified according to international standards;
  • This also helps protect against counterfeiting since they know they are buying original products from reputable companies;

Is GFSI Certification mandatory?

  • GFSI Certification is not a law.
  • There are no regulations that require GFSI certification.
  • GFSI is a voluntary food safety initiative and there are no legal or regulatory requirements for complying with the standard.

Why do some companies seek GFSI Certification?

GFSI Certification is a means for companies to demonstrate how they manage food safety. To become GFSI certified, a company must first have a food safety management system in place and then seek certification by one of the recognized bodies that offer the accreditation (e.g., BRC or IFS). Once certified, companies assure their customers that they are doing what is necessary to ensure the manufacturing of safe food products. In addition, they show their suppliers that they know what is needed to be globally competitive and efficient with multiple buyers.

Need help obtaining your GFSI certification or doing an audit.

Which Audits are considered Global Food Safety Initiative (GFSI) Recognized?

GFSI-recognized standards include:

  • FSSC 22000
  • SQF Code Edition 8
  • BRC Global Standard for Food Safety
  • BRC-IOP Global Standard for Packaging and Packaging Materials
  • IFS Version 6
  • CanadaGAP
  • Global Red Meat Standard (GRMS)
  • PrimusGFS Standard
  • IFS PACsecure Version 1
  • IFS Logistics Version 2.1

What is a GFSI Benchmarking Audit Scheme?

The GFSI Benchmarking Audit Scheme is a program that allows you to compare your food safety management system with other companies. You can then benchmark your food safety management system against the best practices of other companies and use this information to improve your food safety management system.

What are the key differences between GFSI certification and CFIA compliance?

The main difference between GFSI certification and CFIA compliance is that GFSI certification is a voluntary program that focuses on food safety management systems, while CFIA compliance is a legal requirement for Canadian businesses in the food industry. GFSI certification is recognized globally and can help businesses improve their food safety practices, while CFIA compliance ensures that businesses are following all relevant regulations and guidelines in Canada. GFSI certification can also be a helpful tool for businesses looking to expand their market reach and demonstrate their commitment to food safety.

Achieving Global Food Safety Initiative (GFSI) Certification:

GFSI Certification is not mandatory. It is not the only way to achieve food safety, nor is it required by any government agency anywhere in the world. The Global Food Safety Initiative (GFSI) certification process requires you to meet a series of requirements that are specific to your company while demonstrating your commitment to quality management systems.

To become GFSI certified, companies need to:

  1. Select a standard to become certified to
  2. Get trained on the requirements
  3. Implement a food safety management system and document your processes.
  4. Be audited by a certification body to receive your certification

What are the benefits of GFSI certification for food industry businesses?

GFSI certification offers numerous benefits for food industry businesses. Firstly, it helps to ensure the safety and quality of their products, which is essential for maintaining customer trust and loyalty. It also helps businesses to comply with regulatory requirements and reduce the risk of food safety incidents, which can be costly in terms of both financial and reputational damage. Additionally, GFSI certification can improve supply chain efficiency and reduce costs by streamlining processes and reducing waste. Finally, it can provide a competitive advantage by demonstrating a commitment to food safety and quality that sets businesses apart from their competitors.

How to obtain GFSI certification?

To obtain GFSI certification, food industry businesses must first choose a recognized certification program that meets their specific needs and requirements. They must then undergo an audit by an accredited certification body to assess their compliance with the program’s standards. The audit will typically involve a review of the business’s food safety management system, including its policies, procedures, and documentation. Once the audit is complete, the certification body will issue a certificate of compliance if the business meets the program’s requirements. The certification must be renewed periodically to ensure ongoing compliance with the standards.

What are GFSI-recognized schemes?

GFSI-recognized schemes are certification programs that have been approved by the Global Food Safety Initiative as meeting their standards for food safety and quality. These schemes include well-known programs such as BRCGS, SQF, and FSSC 22000, among others. By choosing a GFSI-recognized scheme, food industry businesses can ensure that their products meet the highest standards for safety and quality, and that they are in compliance with international regulations and best practices.

How to maintain GFSI certification?

Maintaining GFSI certification requires ongoing commitment and effort from food industry businesses. This includes regular audits and inspections to ensure compliance with GFSI standards, as well as continuous improvement efforts to identify and address any potential risks or areas for improvement. It is also important to stay up-to-date with any changes or updates to GFSI standards and regulations, and to communicate effectively with suppliers, customers, and other stakeholders to ensure that everyone is aligned on food safety and quality goals.

Why is GFSI certification important for food businesses?

In today’s interconnected global marketplace, ensuring food safety has become more crucial than ever before. Foodborne illnesses and product recalls pose a significant risk to public health and can have severe financial and reputational consequences for businesses. GFSI certification serves as a globally recognized benchmark for food safety, providing businesses with a framework to assess and mitigate risks throughout the entire food supply chain. By achieving GFSI certification, companies demonstrate their commitment to maintaining the highest food safety standards, enhancing consumer trust and confidence in their products.

GFSI certification is significant for businesses that operate in multiple countries or supply their products to international markets. It helps streamline compliance with various food safety regulations and standards, reducing the need for duplicative audits and assessments. Moreover, GFSI certification enables companies to identify and address potential food safety hazards proactively, preventing costly product recalls and protecting their brand reputation. In today’s competitive landscape, having a GFSI certification can be a differentiating factor that sets businesses apart from their competitors and opens doors to new market opportunities.

What are the GFSI standards?

The Global Food Safety Initiative (GFSI) is a collaborative platform that gathers food safety experts worldwide to develop and maintain internationally recognized food safety standards. These standards provide a framework for managing food safety risks and help businesses establish effective food safety management systems. GFSI-recognized measures include the British Retail Consortium (BRC) Global Standard for Food Safety, International Featured Standards (IFS), Safe Quality Food (SQF), and FSSC 22000, among others.

While each GFSI-recognized standard has its unique requirements, they all aim to ensure the highest level of food safety throughout the supply chain. These standards cover various aspects such as food safety management systems, hazard analysis and critical control points (HACCP), traceability, supplier management, and product quality control. Businesses need to select the most appropriate GFSI-recognized standard based on their specific industry, market requirements, and organizational goals.

What are the steps to achieving GFSI certification?

Achieving GFSI certification requires careful planning, implementation, and continuous improvement. Let’s explore the critical steps involved in the journey toward GFSI certification.
1. Conducting a gap analysis
Before GFSI certification, businesses must assess their food safety management systems and practices. This involves conducting a thorough gap analysis to identify areas where the company falls short of the GFSI standards. The gap analysis helps businesses understand the scope of work required to meet the certification requirements and serves as a roadmap for the implementation phase.
During the gap analysis, key stakeholders, such as quality assurance teams, production managers, and senior executives, must be involved. This ensures that all relevant aspects of the business are considered and that there is a shared understanding of the gaps that need to be addressed.
2. Developing a food safety management system
Once the gaps have been identified, the next step is to develop a robust food safety management system (FSMS) that aligns with the chosen GFSI-recognized standard. The FSMS outlines the policies, procedures, and controls the business will implement to ensure food safety throughout the supply chain.
The development of an FSMS involves several key elements, including:
– Establishing food safety objectives and targets
– Identifying and assessing food safety hazards
– Implementing preventive controls and critical control points (CCPs) based on the principles of HACCP
– Defining procedures for monitoring, verification, and corrective actions
– Establishing a traceability system to track and recall products if necessary
– Implementing a supplier approval and management process
– Developing a robust internal audit program
The FSMS should be documented, communicated, regularly reviewed, and updated to ensure effectiveness. It is essential to involve employees at all levels of the organization in developing and implementing the FSMS to foster a culture of food safety.
3. Implementing GFSI standards and requirements
With the FSMS in place, the next step is implementing the specific requirements of the chosen GFSI-recognized standard. This involves aligning business processes, practices, and documentation with the standard’s requirements. It may require changes in the company’s operations, training programs, supplier management practices, and product specifications, among other areas.
Implementing GFSI standards requires a collaborative effort across different departments and organizational functions. Training and awareness programs should be conducted to ensure that employees understand the requirements and their roles in maintaining food safety. Clear communication channels should be established to address any concerns or questions during the implementation process.
4. Preparing for the GFSI audit
Once the implementation phase is complete, businesses need to prepare for the GFSI audit. The audit is conducted by an accredited certification body, which assesses the company’s compliance with the chosen GFSI-recognized standard. The audit involves a comprehensive review of the FSMS, documentation, records, and processes to ensure that they meet the standard’s requirements.
To prepare for the audit, businesses should conduct internal and mock audits to identify gaps or areas for improvement. This helps ensure that the company is ready to undergo the official certification audit without significant issues. It is also essential to gather all necessary documentation, records, and evidence to demonstrate compliance with the standard’s requirements.

During the audit, providing the auditor with full access to the company’s facilities, records, and employees is crucial. Open and transparent communication with the auditor enhances the audit process and facilitates a smooth certification outcome.

Common challenges in the GFSI certification process

While GFSI certification brings numerous benefits, it has its challenges. Let’s explore some common obstacles businesses may encounter during certification and strategies to overcome them.

1. Resource constraints
Implementing GFSI standards and preparing for certification can be resource-intensive, requiring time, staffing, and financial investment. Many businesses, tiny and medium-sized enterprises, may need help with resource constraints that make the certification process more challenging. To overcome this challenge, companies can consider leveraging external expertise and resources, such as hiring consultants or partnering with certification bodies that provide support and guidance throughout the certification journey.
2. Cultural change
Implementing GFSI standards often requires a cultural shift within the organization. It may involve changing long-established practices, improving communication and collaboration, and fostering employees’ strong commitment to food safety. Overcoming resistance to change and building a culture of food safety requires strong leadership, effective communication, and ongoing training and awareness programs.
3. Maintaining compliance
Achieving GFSI certification is a significant milestone, but it is crucial to maintain compliance with the standards on an ongoing basis. Businesses must continuously monitor and improve their food safety management systems, conduct regular internal audits, and stay updated with any changes in the GFSI standards. This requires continuous improvement and a proactive approach to identifying and addressing potential risks and non-compliance.

The competitive edge of GFSI certification

A GFSI certification can give businesses a significant competitive edge in the increasingly competitive food industry. Let’s explore how GFSI certification sets companies apart from their competitors.

1. Market Access
GFSI certification opens doors to new markets and customers, particularly in regions where retailers and buyers prioritize certified suppliers. With GFSI certification, businesses can access a broader range of distribution channels, secure lucrative contracts, and expand their customer base.
2. Brand reputation and consumer trust
GFSI certification is a testament to a company’s food safety and quality commitment. It enhances brand reputation and instills confidence in consumers increasingly demanding safe and high-quality food products. GFSI certification is a powerful marketing tool that differentiates businesses from their competitors and drives customer loyalty and acquisition.
3. Supplier partnerships
GFSI certification encourages collaboration and cooperation among stakeholders in the food supply chain. Certified businesses are preferred partners for retailers, distributors, and other suppliers, who value the assurance of a robust food safety management system. This collaboration strengthens the entire supply chain, consistently delivering safe and high-quality food products.
4. Risk mitigation
Businesses can proactively identify and mitigate potential risks by implementing GFSI standards and continuously monitoring and improving their food safety management systems. This reduces the likelihood of foodborne illnesses, product recalls, and other costly incidents that can damage a company’s reputation and financial stability.
5. Operational efficiency
Implementing GFSI standards involves streamlining processes, reducing waste, and optimizing resource utilization. This drives operational efficiency, improves productivity, and reduces costs. By adhering to GFSI standards, businesses can create leaner, more sustainable operations that deliver value to the company and its customers.


At the end of the day, it all comes down to food safety. If you are interested in starting a new business or expanding an existing one, then we can help you achieve GFSI certification. It will give your business an edge over others by proving its commitment to quality control and ensuring that all products meet international standards for both safety and quality assurance.

How can Quality Smart Solutions serve you?

Firstly, QSS can help with formula review, food labeling, food importing, and nutrition facts creation (for Canada and the USA).

Secondly, we can also help with registering supplemented foods with TMALs (Temporary Market Authorization License) or reviewing when the new Supplemented Food Regulations are published. 

Thirdly, we help with Safe Foods for Canadians Regulations (HACCP, PCP, Import Licensing, and GRAS Notifications). Get help with your GFSI Certification, food facility registration, FSVP agent, and US Agent. 

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