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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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 in 2023

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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FDA Proposes New Rule for Investigational New Drug Applications (IND)

Introduction:Investigational New Drug Applications (IND)

The FDA recently announced a proposal to change the current regulations for Investigational New Drug (IND) applications. The proposal includes two exemptions from IND requirements for clinical trials involving lawfully marketed foods (including functional foods and dietary supplements) and cosmetics when they are being studied for use as drugs.

In this blog, we will aim to unpack the key highlights of the FDA’s proposal on IND applications but if you wish to read the full proposal to learn about the clinical investigations, exemptions, and more click here.  If you want to submit a comment to the FDA after reading this proposal you can make comments until March 9th, 2023.

IND Application Background:

The purpose of an IND application is to help ensure the safety and rights of clinical trial participants are protected, as well as to ensure the quality of data is adequate to allow evaluation of the safety and effectiveness of a drug seeking marketing approval.

What is the proposal’s purpose?

  1. Firstly, to help speed up clinical trials involving legally marketed foods and cosmetics by removing them from the IND pathway.
  2. Additionally, to help incur cost-saving benefits by reducing the number of IND applications filed with the FDA.

Looking for Investigational New Drug Applications regulatory assistance?

There were 2 exemptions proposed:

  1. Self-determined exemption: Food or cosmetics would be exempt from IND requirements if the following requirements were met:
  • The investigation is not intended to support a drug development plan, including a future IND or application for marketing approval.
  • The investigation is conducted in compliance with an institutional review, informed consent, and commercial distribution of investigational drugs:
    • Meeting with the requirements for institutional review in 21 CFR Part 56and the requirements for informed consent in 21 CFR Part 50; and
    • Meeting with the requirements of 7.
  • The route of administration is the same as that of the lawfully marketed product.
  • The investigation meets the following participant health, safety, and welfare requirements:
    • No participants below 12 months.
    • No pregnant or lactating mothers.
    • No participants with compromised immune systems.
    • Does not restrict participants from taking a prescribed therapeutic.
    • Does not increase risk beyond routine physical or psychological evaluations or standard of care procedures.
    • The product is being used in a way that is consistent with its labelled conditions of use.
    • No other product taken by or used to treat subjects during the investigation would significantly increase the risks (or decrease acceptability of the risks) encountered in the investigation.
    • There were no participants with weakened immune systems.
    • Participants are not prohibited from taking a prescribed therapeutic.
    • Increases risk in addition to routine physical or psychological evaluations or standard of care procedures.
    • The product is being used in accordance with its labelled conditions of use.
    • No other product taken by or used to treat subjects during the investigation would significantly increase (or decrease acceptability of) the risks encountered.
  1. FDA-determined exemption: While some products may not meet all the safety-related eligibility requirements for the self-determined exemption, the FDA may conclude that the study does not pose a significant risk to participants’ health, safety, or welfare. To qualify for the FDA-approved exemption, products must meet the following criteria:

*The product must be legally marketed as a Food or Cosmetic in the United States.

  • The FDA would require a copy of the study protocol, which would include the following information: design and duration.
  • Endpoints that have been proposed.
  • The study population, as well as the inclusion and exclusion criteria.
  • Description of the investigational product, including all ingredients, formulation, and labelling information.
  • The dosage form and regimen.
  • Administration path.
  • Examine the procedures.
  • In the event of an adverse/serious adverse event, the protocol is altered.
  • Provide evidence that the investigational product does not pose a significant risk to:
  • Participants must be less than 12 months old, pregnant, or lactating.
  • Participants with weakened immune systems or who suffer from serious or life-threatening diseases or conditions.
  • If participation necessitates the discontinuation of therapy or treatment prescribed by a healthcare provider.
  • If the study procedures put participants in greater danger than they would normally face during routine physical or psychological evaluations or standard-of-care procedures.
  • If the proposed conditions of use of the product in the investigation differ from the labelled or usual conditions of use of the product.
  • If the investigational product is used in conjunction with other medications or treatments that a subject is taking or receiving,
  • If the investigational product is being used concurrently with other products that a subject is taking or being treated with, either as part of the study or as prescribed or recommended by a healthcare provider outside the study.

How Quality Smart Solutions can help

The experts at Quality Smart Solutions can support your compliance needs with National Drug Code Labeler Registration, drug label compliance, US agent service, facility registration/renewal, and US Drug Listing (DRLS) in North America. Contact Quality Smart Solutions today! We can help.

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Clearing Regulatory Hurdles with a 510K Premarket Notification

510K Premarket Notification


Submitting a 510 K 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 510 K Premarket Notification here.

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 in 2023

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 make up 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 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 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 in order 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 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 in order 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 in order for the food to be considered safe.

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 in order 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 to the general population.

4. Process Flow Diagram

A process flow diagram gives the HACCP team a broader view on 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 performs a review of 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 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, the 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 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 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 ongoing commitment to complying 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 record of complaints with critical limits set
  • Identifies potential problems

Record keeping can be carried out in a number of 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.

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!

Quality Smart Solutions is an end-to-end compliance solutions expert which has been assisting clients for 14 years in the areas of compliance and quality assurance for Dietary Supplements/NHPs, Foods, Cosmetics, Canna, Medical Devices, OTC drugs in Canada and the United States. Ask us for details or visit our website at

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 compliance needs during and after licensing!

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FTC guidance for sellers & marketers of Health Products Unlocked

FTC Health Products


In this blog, we’ll aim to summarize the principles that help advertisers comply with FTC laws (deceptive claims/facts) for OTC drugs, food, homeopathic products, supplements, health equipment, and more.

Overview of Regulatory Framework: FTC Authority over Advertising Health Products:

The responsibility of the Federal Trade Commission (FTC) is to prevent unfair/deceptive acts and practices in marketing or selling health-related products.  To summarize:

  1. Advertising must be truthful and not misleading; and
  2. Before disseminating an ad, advertisers must have adequate substantiation for all objective product claims conveyed, expressly or by implication, to consumers acting reasonably.
  3. “Advertising” refers to a wide variety of marketing techniques (social media, digital content, brochures, influencer marketing, etc).
  4. Anyone participating in deceptive marketing is potentially liable under FTC law.
  5. The FTC can seek a variety of remedies for deceptive advertising up to legally bringing courts in to ban companies from certain activities.

Coordination between the FTC and FDA:

The FTC and the Food and Drug Administration (FDA) share jurisdiction over the marketing of dietary supplements, foods, drugs, devices, and other health-related products. The agencies coordinate their enforcement and regulatory efforts under a Memorandum of Understanding – often called the “FDA-FTC Liaison Agreement” – that governs the basic division of responsibilities between them. The FDA has primary responsibility for claims that appear in labeling, including the package, product inserts, and other promotional materials available at the point of sale. The FTC has primary responsibility for claims in all forms of advertising. Due to the shared jurisdiction, the two agencies work closely to ensure that their enforcement efforts are fully consistent and feasible.

What are the differences between the FTC and FDA Laws?

While both the FTC and the FDA require truthful and accurate marketing of dietary supplements and other health-related products, there are some key differences in the agencies’ legal frameworks and approaches that marketers should be aware of.

  • FTC advertising law applies to all products and claims
  • The FTC doesn’t pre-approve “health” claims, as that term is defined by FDA labeling laws
  • The FTC doesn’t require notification for “structure/function” claims

How to apply FTC law to advertising Health-Related Products:

To determine whether advertising complies with FTC law, it is necessary to first identify all claims communicated to reasonable consumers through advertising materials. Once the claims are identified, the FTC evaluates the scientific evidence on which the company relies to determine whether the claims are adequately supported. We can assist you by helping you;

  1. Identify Claims and Interpreting Ad Meaning Express and Implied Claims
  2. When to disclose qualifying information
  3. How to disclose clearly

How to substantiate health-related product claims?

Marketers must ensure that their claims are adequately supported in addition to conveying them clearly and accurately. Advertisers must have a reasonable basis for their product claims under FTC law before running an ad. What constitutes a reasonable basis is highly dependent on the claims made, how they are presented in the context of the entire advertisement, and how they are qualified. The FTC’s substantiation standard is stringent, especially when it comes to health claims. It is intended to give consumers confidence in the accuracy of information presented in advertisements. A variety of factors influence the amount and type of substantiation required, including:        

Need help with NHP or Dietary Supplement FTC-FDA compliance of Health Products

  1. The type of product
  2. The type of claim
  3. The benefits of a truthful & cost or feasibility of developing substantiation for the claim
  4. The consequences of a false claim
  5. The amount of substantiation that experts suggest is reasonable

Claims based on traditional use:

Several health-related products, such as botanical supplements, homeopathic medicines, and other alternative products, have a long history of use as traditional medicine in the United States or elsewhere to treat specific conditions or symptoms. Under FTC law, claims for products based on traditional use must be substantiated with competent and reliable scientific evidence, just like any other product.

At the same time, FTC law does not prohibit advertising that is sufficiently qualified to be truthful and not misleading. Advertising that merely describes the traditional or historic use of a product and is carefully qualified to avoid any misleading implications about the product’s efficacy or health benefits may be permissible.

Avoid Misleading Messages in your Health Product labeling:

To avoid communicating a misleading message about the product’s efficacy or the scientific basis for any health benefit, an advertiser who wants to describe a product’s historic or traditional use should take the following steps: Guidance for Health Product Compliance

⊲ The advertiser should identify the historic or traditional use and make sure that its product is consistent with that use – for example, that it contains the same ingredients and formulation, the same strength or dose, the same form of administration, and the same indications for use. If there is a significant difference between the traditional use of the product and the marketed product, a “traditional use” claim isn’t appropriate. ⊲ A claim that suggests a health-related benefit for which there isn’t competent and reliable scientific evidence must communicate the lack of scientific evidence. To avoid any deceptive implication, a disclosure that there is no scientific basis for the traditional use should stand out and be near the claim. To be effective, it may need to be incorporated into the claim.

⊲As with all claims, marketers shouldn’t undercut a disclosure about the lack of science with additional positive statements, consumer endorsements, images, or other elements of the ad suggesting the product is effective.

⊲ Given the inherent difficulty of discussing the traditional use of a product while also effectively communicating that there is no scientific basis for its efficacy, an advertiser should consider conducting a copy test or other consumer research to confirm that consumers understand the limited nature of the claim. The FTC will look closely at how consumers perceive a traditional use claim and whether they assume the claim means the product is effective and backed by more evidence than the marketers have. An ad that, despite a disclosure, conveys more substantiation than a marketer has, is deceptive.

The Quality of the Evidence:

The scientific community has generally accepted several basic principles as enhancing the validity of test results. Whether designing and conducting their research or relying on research conducted by third parties, marketers should ensure that the research upon which they rely for any health-related claim complies with these basic principles.

  1. Control Group
  2. Randomization
  3. Double Blinding
  4. Statistically Significant Results
  5. Clinically Meaningful Results

Other Advertising Issues:

In addition to the principles of ad meaning and substantiation discussed above, several other issues commonly arise in the context of health-related advertising. These include the use of consumer testimonials and expert endorsements; claims based on alternative medicine or traditional use; the effect of DSHEA disclaimers in advertising; claims about FDA approval or compliance; and the relevance to FTC advertising law of the FDA’s “third-party literature” exemption.

  • Claims based on consumer testimonials or expert endorsements
  • Claims based on traditional use
  • Use of the DSHEA Disclaimer in advertising
  • Mischaracterizations of FDA Approval
  • Third-party literature


Marketers of health-related products, including dietary supplements, should be familiar with FDA and FTC requirements that labeling and advertising claims be truthful, not misleading, and substantiated. In general, the FTC requires that health-related claims be supported by competent and reliable scientific evidence proving that the representations are true. Marketers of any health-related product should take two important steps to ensure FTC compliance:

1) Consider what explicit and implied messages your advertisements are likely to convey to consumers.

2) Carefully review the support for each claim to ensure it is scientifically sound, adequate, and relevant, and qualify your claims as needed.

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FDA GRAS Notice | FDA GRAS Database What to know in 2023

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 have been found to be 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.

How to use the FDA GRAS Database?

The Food and Drug Administration (FDA) GRAS Database is a searchable database that lists all of the food ingredients that have been determined to be GRAS by the FDA. This database can be used to determine if an ingredient is safe for use in your food products. The database can also be used to find out if an ingredient has been recalled or is under investigation by the FDA.

To access the GRAS Database, visit the FDA website. On the main page, click on “Searching For Information” in the left-hand navigation bar. In the search field, type “GRAS” and click on the “Search” button. The GRAS Database will appear at the top of the results page.

To learn more about how to use the GRAS Database, please review our blog post entitled “How to Use the FDA GRAS Database.”

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 in accordance with 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.


The FDA GRAS Database is a compilation of food substances/ingredients that have been found to be safe for human consumption. This means that when you see a food substance or ingredient listed on the FDA GRAS Database, the Food and Drug Administration has determined that the food is generally considered safe for human consumption.

The FDA GRAS Database is a useful tool that can be used by industry and consumers to determine the safety of food and food substances.

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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FDA Dietary Supplements Labeling Requirements in 2023

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.

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 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.

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.


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 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.

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.

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.

Understanding 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.

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

Compliance and Market Advantages:

GFSI Certified Standards not only help ensure that a company is compliant with applicable food safety regulations and requirements but also provide many market advantages. By demonstrating a commitment to GFSI Certified Standards, businesses can attract new customers and open up new markets due to the reputation associated with certification. Additionally, certification can result in fewer product recalls, quicker responses to customer complaints, and lower costs associated with premium freight rates or insurance premiums.

Improved Manufacturing Procedures:

GFSI Certified Standards are in place to ensure that food safety meets the highest possible standards. As such, they require companies to adhere to improved manufacturing procedures, employ protocols like HACCP plans, and ensure that their facilities are constantly monitored to meet any updates or changes in industry standards. This helps to prevent potential breaches in protocol and ensures that all parties involved remain compliant.

Increased Consumer Confidence:

By securing GFSI certification, food producers can demonstrate their adherence to the highest safety standards possible. This increased level of trust helps to build consumer confidence and also gives retailers peace of mind knowing that they are providing safe and healthy products to their customers. Furthermore, certifications can help producers differentiate themselves in the marketplace, making it simpler for buyers to differentiate between certified-aligned or non-certified companies.


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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