Expert guide to GRAS Pathways: GRAS Notice vs. Self-Affirmed

A Comprehensive Guide to GRAS Pathways: GRAS Notice vs. Self-Affirmed Navigating the intricate landscape of food and food additive regulation in the United States involves understanding the GRAS concept – “Generally Recognized as Safe.” GRAS status is a pivotal determinant of whether a substance can be used in food without requiring formal approval from the U.S. Food and Drug Administration (FDA). This status relies on two primary pathways: the GRAS Notice and Self-Affirmed GRAS. In this article, we’ll explore these pathways in-depth, highlighting their differences, processes, and significance for businesses in the food industry.

Deciphering GRAS: What It Means

Before delving into the two GRAS pathways, it’s essential to grasp the essence of “Generally Recognized as Safe.” When a substance achieves GRAS status, qualified experts have reached a consensus that it is safe for its intended use in food based on rigorous scientific evaluations of its safety profile.

GRAS Notice: The Regulatory Route

1. Definition: The GRAS Notice pathway necessitates the submission of a formal notification to the FDA, accompanied by comprehensive scientific evidence and data substantiating the substance’s safety. The FDA meticulously reviews the compliance and affirms or disputes the GRAS status.

2. Scientific Evidence: Crafting a GRAS Notice mandates compiling substantial scientific evidence. This evidence encompasses toxicological studies, clinical trials, and historical data demonstrating the substance’s safety.

3. Independent Panel Review: A distinctive aspect of the GRAS Notice process is the engagement of an independent panel of experts. This panel meticulously evaluates the safety data and provides an impartial opinion on whether the substance qualifies as GRAS.

4. FDA’s Verdict: Following the company’s submission and the independent panel’s evaluation, the FDA conducts its independent review. If the FDA concurs with the GRAS determination, it issues a “no questions” letter, effectively confirming the substance’s GRAS status. Should the FDA have inquiries or concerns, it may release a response outlining the need for additional data or clarifications.

Self-Affirmed GRAS: The Internal Affirmation

1. Definition: The Self-Affirmed GRAS pathway empowers a company to establish a substance’s GRAS status without submitting a formal notification to the FDA. This method hinges on the company’s self-assessment and the consensus of qualified experts.

2. Scientific Evidence: In the Self-Affirmed GRAS route, companies must still compile extensive scientific evidence attesting to the substance’s safety. Experts within the company or external consultants usually evaluate and assess this evidence.

3. Internal Expert Consensus: A crucial distinction in Self-Affirmed GRAS is that the determination resides within the company. It is paramount that the company can provide evidence of consensus among qualified experts regarding the substance’s safety.

Key Differences and Strategic Insights

  • FDA Involvement: The most notable distinction between the two pathways lies in the level of FDA engagement. GRAS Notice mandates formal FDA review and approval, imparting a higher degree of FDA endorsement. In contrast, Self-Affirmed GRAS relies on the company’s internal evaluation.
  • Independent Panel: The GRAS Notice’s requirement for an independent expert panel can bolster the credibility of the GRAS determination. Self-affirmed GRAS does not require an independent panel but may involve external experts.
  • Transparency: GRAS Notice offers a more transparent process, which entails public access to information submitted to the FDA. Self-affirmed GRAS determinations are not compelled to be made public, though many companies voluntarily do so.
  • Legal Liability: Both pathways come with legal responsibility. Suppose a substance is later found to be unsafe. In that case, the FDA can take action against the company that made the GRAS determination, irrespective of the chosen pathway.


In summary, the GRAS pathways, GRAS Notice and Self-Affirmed GRAS, provide flexibility for companies seeking to establish the safety of substances in food products. Choosing the correct path hinges on several factors, including available resources, desired FDA involvement, and transparency preferences. Regardless of the pathway selected, ensuring the safety of food additives and substances’ safety is paramount, as it directly influences consumer health and trust in the food industry. Navigating these pathways with care and consideration is essential for the success of food businesses in the United States.

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 about GRAS, reach out to us today about GFSI certification requirements, GRAS Notifications, or GRAS self-affirmation!

Gras License Process


From A to Z: Everything You Need to Understand About GRAS Substances

Gras License Process Are you curious about GRAS substances? Look no further! This comprehensive guide takes you from A to Z, covering everything you need to know about GRAS substances. Whether you’re a novice or an expert, this article will provide a solid understanding of GRAS substances and their importance.

GRAS substances, also known as Generally Recognized as Safe Substances, have been tested and approved by regulatory authorities for their safety when used in food, drugs, cosmetics, or other applications. Understanding GRAS substances is crucial to ensuring the safety of the products we consume daily.

This article will explore the history and regulations surrounding GRAS substances, their uses and applications, and discuss the latest research and controversies. This article will equip you with the knowledge you need to navigate the world of GRAS substances. Let’s dive in!

What are the types of GRAS substances?

GRAS, also known as Generally Recognized as Safe Substances, encompasses a wide range of compounds thoroughly tested and approved for their safety. These substances are commonly used in various industries, including food, drugs, cosmetics, etc. There are several categories of GRAS substances, each serving a specific purpose.

1. Food Additives: Food additives are GRAS substances added to food products to enhance flavor, texture, appearance, or shelf life. These can include preservatives, sweeteners, coloring agents, and emulsifiers. Food additives are regulated to ensure they do not pose health risks when consumed within acceptable limits.
2. Pharmaceutical Excipients: Pharmaceutical excipients are GRAS substances that are used in the manufacturing of medications. These substances play a crucial role in drug formulation, helping to improve stability, solubility, and absorption. Examples of pharmaceutical excipients include fillers, binders, disintegrants, and lubricants.
3. Cosmetic Ingredients: Many cosmetic ingredients fall under the category of GRAS substances. These can include moisturizers, emollients, surfactants, and preservatives. The safety of these ingredients is carefully evaluated to ensure they do not cause any harm to the skin or overall health when used as directed.

Uses and applications of GRAS substances

Everything You Need to Understand About GRAS Substances

GRAS substances have a wide range of uses and applications across various industries. Let’s explore some of the most common areas where GRAS substances play a vital role.

1. Food Industry: In the food industry, GRAS substances are used to improve the taste, appearance, and safety of food products. Food additives, such as preservatives and antioxidants, help extend the shelf life of perishable items and prevent spoilage. Flavor enhancers and color additives enhance the sensory experience of food.
2. Pharmaceutical Industry: GRAS substances are essential in the pharmaceutical industry, where they are used as excipients to aid in the manufacturing and formulating medications. These substances ensure that drugs are stable, effective, and safe for consumption. Without GRAS substances, the production of many medications would not be possible.
3. Cosmetics Industry: In the cosmetics industry, GRAS substances are used to create safe products for the skin and hair. Moisturizers, emollients, and humectants help hydrate and nourish the skin, while preservatives prevent the growth of harmful bacteria and fungi. With GRAS substances, the cosmetic industry could create products that meet safety standards.

Research and studies on GRAS substances

GRAS substances have been extensively researched to ensure their safety and efficacy. Regulatory authorities, scientific organizations, and independent researchers continually evaluate GRAS substances’ potential risks and benefits. Here are a few notable research findings:

1. Long-Term Safety Studies: Many GRAS substances have undergone long-term safety studies to assess their potential risks when used over an extended period. These studies help ensure that GRAS implications remain safe for consumption or use.
2. Allergenicity Testing: Researchers have tested allergenicity on various GRAS substances to identify potential allergens and sensitizing agents. This research helps individuals with known allergies or sensitivities avoid exposure to GRAS substances that may trigger adverse reactions.
3. Efficacy Studies: Some GRAS substances, particularly those used in medications, have been subject to efficacy studies to determine their effectiveness in treating specific conditions. These studies help healthcare professionals make informed decisions when prescribing medications.

Are GRAS substances regulated?

GRAS substances are regulated by various regulatory authorities, such as the Food and Drug Administration (FDA) in the United States. These authorities evaluate the safety and efficacy of GRAS substances before they can be used in food, drugs, or cosmetics.

Additional Reading about GRAS:


Everything businesses should know about the Supplemented Foods Facts Table (SFFT)

Supplemented Foods Facts Table Introducing the Supplemented Foods Facts Table (SFFT), your go-to guide for navigating the ever-changing world of supplemented foods. With consumer demand skyrocketing for these products, grasping the SFFT is vital for businesses looking to excel in this booming market.

In this article, we’ll unravel everything you need to know about the SFFT, from its purpose to its must-follow rules. We’ll also explore how it can empower your business to effectively convey your supplemented food products’ benefits and nutritional value to consumers. Whether you’re a fresh-faced startup or a seasoned brand, consider this article your trusty companion for mastering the Supplemented Foods Facts Table.

Whether you’re a small startup or an established brand, this article is your go-to resource for understanding and complying with the SFFT. Stay ahead of the competition and enhance consumer trust by mastering the ins and outs of the Supplemented Foods Facts Table.

Why is the SFFT important for businesses?

The Supplemented Foods Facts Table (SFFT) is an essential tool for businesses operating in the supplemented foods industry. This table gives businesses a standardized format to communicate important product information to consumers. By including the SFFT on product labels, companies can ensure that consumers can access accurate and transparent information about their supplemented food products’ nutritional content and benefits.

The SFFT is crucial in building consumer trust and confidence in supplemented foods. With the increasing interest in health and wellness, consumers are becoming more conscious about the nutritional value of their products. By providing clear and comprehensive information through the SFFT, businesses can meet this demand and differentiate themselves in the market.

Furthermore, the SFFT helps businesses comply with regulatory requirements. Many countries have specific regulations that mandate the use of SFFT on product labels. By adhering to these regulations, companies can avoid potential legal issues and ensure that their products comply with industry standards.

In summary, the SFFT is essential for businesses because it allows them to communicate vital information to consumers, build trust, comply with regulations, and differentiate themselves in the competitive supplemented foods market.

What are the components of the Supplemented Foods Facts Table SFFT?

To effectively create a compliant SFFT for your products, it is essential to understand the critical components of the table. The SFFT consists of several sections, each providing specific information about the supplemented food product. Let’s take a closer look at these components:

1. Serving Size: This section indicates the recommended serving size of the product. Determining an appropriate serving size that accurately reflects how consumers typically consume the product is vital.
2. Calories: The product’s calorie content is displayed in this section. It provides consumers with an understanding of the energy value of the product.
3. Total Fat: This section includes information about the total fat content of the product, including the amount of saturated and trans fats. It is essential to disclose this information as it helps consumers make informed choices about their dietary intake.
4. Cholesterol: The cholesterol content of the product is displayed in this section. High cholesterol levels can have adverse health effects, so providing this information to consumers is essential.
5. Sodium: This section indicates the sodium content of the product. High sodium intake can harm health, so disclosing this information allows consumers to manage their sodium intake effectively.
6. Total Carbohydrates: This section provides information about the total carbohydrate content of the product, including dietary fiber and sugars. It helps consumers understand the carbohydrate composition of the product, which is particularly important for individuals following specific diets.
7. Protein: The product’s protein content is displayed in this section. Protein is an essential nutrient, and disclosing this information helps consumers decide based on their dietary needs.
8. Vitamins and Minerals: This section lists the vitamins and minerals present in the product and their respective quantities. It is crucial to provide this information as it allows consumers to assess the product’s nutritional value.

By understanding these components, businesses can create a comprehensive and accurate SFFT for their supplemented food products.

How do you create a compliant SFFT for your products?

Creating a compliant SFFT for your products involves following specific guidelines and regulations. Here are the steps to ensure your SFFT meets the requirements:

1. Research Regulatory Requirements: Research the specific regulatory requirements for SFFT in your target market. Different countries may have varying guidelines and regulations, so it is crucial to understand and comply with the relevant standards.
2. Gather Accurate Nutritional Data: Collect accurate and up-to-date nutritional data for your supplemented food products. This includes information on serving sizes, calories, fats, cholesterol, sodium, carbohydrates, protein, vitamins, and minerals. Ensure that a reputable source or laboratory verifies the data.
3. Organize the SFFT: Use a standardized format to organize the SFFT. The table should be clear, readable, and prominently displayed on the product label. Use bold headings, appropriate font size, and spacing to enhance readability.
4. Calculate Percent Daily Values: The percent daily values (%DV) for each nutrient listed in the SFFT. %DV indicates the proportion of a specific nutrient in the product relative to the recommended daily intake. This information helps consumers understand the nutritional significance of the product.
5. Review for Accuracy and Compliance: Double-check the SFFT for accuracy and compliance with regulatory requirements. Ensure that all information is correctly displayed and that there are no misleading or false claims. It is advisable to consult with experts or regulatory bodies to verify the compliance of your SFFT.

By following these steps, businesses can create a compliant SFFT that provides accurate and transparent information to consumers.

Tips for optimizing your SFFT for consumer understanding

Creating a compliant SFFT is essential, but optimizing the table for consumer understanding is equally important. Here are some tips to help you achieve this:

1. Use Simple Language: Avoid technical jargon and use simple language that is easy for consumers to understand. Break down complex terms and provide explanations where necessary.
2. Provide Context: Supplement the SFFT with additional information or context to help consumers make informed decisions. For example, you can briefly describe the product’s benefits or usage instructions.
3. Consider Visual Aids: Incorporate visual aids, such as icons or symbols, to enhance the readability of the SFFT. These visual cues can help consumers quickly identify essential information, such as allergen warnings or nutritional highlights.
4. Highlight Key Nutrients: Use formatting techniques, such as bold or colored text, to highlight critical nutrients or beneficial ingredients. This can draw consumers’ attention to the nutritional value of the product.
5. Include Additional Information: Consider including additional information, such as allergen statements, dietary claims, or certifications, to further enhance consumer understanding and trust.
By optimizing the SFFT for consumer understanding, businesses can effectively communicate their supplemented food products’ benefits and nutritional value.

What are the common mistakes to avoid when creating an SFFT?

While creating an SFFT, businesses should be aware of common mistakes that can compromise the accuracy and compliance of the table. Here are some errors to avoid:

1. Inaccurate Nutritional Data: Ensure that the nutritional data used in the SFFT is accurate and current. Refrain from relying on outdated or incorrect information to mislead consumers and result in non-compliance with regulations.
2. Misleading Serving Sizes: Provide serving sizes that accurately reflect how consumers consume the product. Misleading serving sizes can misrepresent the product’s nutritional content and confuse consumers.
3. Omitting Key Nutrients: Include all relevant nutrients in the SFFT. Omitting vital nutrients can mislead consumers and result in non-compliance with regulations.
4. False or Misleading Claims: Avoid making false or misleading claims in the SFFT. All information should be accurate, transparent, and supported by scientific evidence.
5. Non-compliance with Regulations: Stay updated with the latest regulations and guidelines for SFFT. Non-compliance can lead to legal issues and damage the reputation of your business.

By avoiding these common mistakes, businesses can ensure the accuracy, compliance, and effectiveness of their SFFT.

What is the role of the SFFT in product labeling and marketing?

The Supplemented Foods Facts Table (SFFT) is vital in product labeling and marketing. Here’s how the SFFT contributes to these aspects:

1. Transparency and Consumer Trust: By including the SFFT on product labels, businesses demonstrate transparency and provide consumers with accurate and comprehensive information about their supplemented food products’ nutritional content and benefits. This builds trust and confidence in the brand.
2. Differentiation and Competitive Advantage: The SFFT allows businesses to differentiate by highlighting their products’ nutritional value and benefits. Companies can attract health-conscious consumers and gain a competitive advantage by effectively communicating this information.
3. Educating Consumers: The SFFT is an educational tool that helps consumers make informed choices about their dietary intake. By providing clear and understandable information, businesses empower consumers to make healthier and more conscious decisions.
4. Compliance with Regulations: The SFFT ensures compliance with regulations set by governing bodies. By adhering to these regulations, businesses avoid legal issues and maintain the integrity of their product labeling.

The SFFT is crucial in product labeling and marketing by promoting transparency, differentiation, consumer education, and regulation compliance.

What are the regulatory considerations for the SFFT?

When creating an SFFT, businesses must consider the specific regulatory requirements in their target market. Here are some regulatory considerations to keep in mind:

1. Country-specific Guidelines: Different countries may have specific guidelines and regulations for SFFT. Research and understand the requirements of your target market to ensure compliance.
2. Language Requirements: Some countries may have language requirements for the SFFT. Ensure that the table is presented in the appropriate language(s) for your target market.
3. Formatting and Placement: Regulatory bodies may have specific requirements for the formatting and placement of the SFFT on product labels. Familiarize yourself with these guidelines to ensure compliance.
4. Health Claims and Disclaimers: Some countries have strict regulations regarding health claims and disclaimers on product labels. Ensure that any claims made in the SFFT are supported by scientific evidence and comply with these regulations.
5. Updates and Changes: Stay updated with any changes or updates to the regulatory requirements for SFFT in your target market. Regularly review and revise your SFFT to ensure continued compliance.
By considering these regulatory aspects, businesses can create an SFFT that meets the specific requirements of their target market.

Resources for businesses to learn more about the SFFT

As businesses navigate the world of supplemented foods and the requirements of the Supplemented Foods Facts Table (SFFT), it is essential to have access to reliable resources. Here are some valuable resources to learn more about the SFFT:

1. Regulatory Bodies: Consult the websites and publications of regulatory bodies in your target market. These organizations often provide detailed guidelines and resources related to SFFT.
2. Industry Associations: Join industry associations or organizations specializing in the supplemented foods sector. These associations often provide resources, webinars, and workshops to help businesses understand and comply with SFFT requirements.
3. Professional Consultants like Quality Smart Solutions: Seek guidance from professional consultants who specialize in food labeling and compliance. These experts can provide personalized advice and assistance tailored to your business needs.
4. Online Research: Conduct online research to access articles, studies, and publications related to the SFFT. Many reputable sources provide free information and resources to help businesses better understand the topic.

Remember to verify the credibility and relevance of the resources you consult to ensure accurate and up-to-date information.

Conclusion: The future of the SFFT in the food industry.

The Supplemented Foods Facts Table (SFFT) is an essential tool for businesses operating in the supplemented foods industry. As consumer demand for transparent and nutritious products continues to rise, the SFFT plays a crucial role in providing accurate and comprehensive information to consumers. By understanding the components of the SFFT, following regulatory guidelines, and optimizing the table for consumer understanding, businesses can effectively communicate the benefits and nutritional value of their supplemented food products. Compliance with regulations ensures transparency, builds consumer trust, and enhances the competitiveness of businesses in the market.

As the food industry evolves, the SFFT will likely play a significant role in product labeling and marketing. By staying updated with regulatory changes and industry trends, businesses can adapt and thrive in the dynamic landscape of supplemented foods. Remember, the Supplemented Foods Facts Table is not just a regulatory requirement but an opportunity for businesses to showcase their commitment to transparency, health, and consumer satisfaction. Mastering the ins and outs of the SFFT will position your business for success in the ever-growing market of supplemented foods.

Click here to learn about the Supplemented Facts Table Regulations.

Quality Smart Solutions has a team of professionals to offer support from day one of starting your business, including formulation and label reviews, Veterinary Health Product notifications and more.


Medical Device Compliance in Canada: A Guide for Manufacturers

Navigating Canadian Medical Device Compliance with Regulatory Experts: Real-Life Success Stories

So, you’re a medical device manufacturer eyeing the Canadian market? Great choice! But before you dive in, let’s talk about the regulatory hoops you’ll need to jump through. Selling medical devices in Canada comes with its own set of rules, and trust me, you want to be on the right side of these regulations. This article will discuss the key steps and considerations for ensuring your medical devices meet Canadian compliance standards.

1. Who’s the regulatory boss in Canada?

First, Health Canada is the big cheese, specifically the Medical Devices Directorate (MDD). They’re the folks overseeing all things medical devices. Their rulebook is called the Canadian Medical Devices Regulations (CMDR) and is your go-to guide.

2. Know your device

Before anything else, you must determine where your device fits into Canada’s risk-based classification system. There are four classes (Class I to IV), each with its own rules. Knowing where your device falls is like the North Star guiding you through the compliance maze.

3. Get yourself a partner in Canada

You’ll need a friend there if you’re not based in Canada. Specifically, a Canadian Medical Device License (MDL) holder or agent. This person or entity will be your point person for Canadian regulations and keep you in the loop with Health Canada.

4. Register your Facility

Your manufacturing facilities must be registered with Health Canada through the Establishment Licensing and Medical Device Establishment Registration (MDEL) system. Expect questions about your facility, its activities, and other nitty-gritty details.

5. Quality is Key

Implement a Quality Management System (QMS) that follows the ISO 13485 standard. It’s the international gold standard for medical devices. Your QMS should cover everything from the design phase to distribution.

6. License to Thrill

You’ll need a Medical Device License (MDL) from Health Canada for most medical devices. Think of it as your golden ticket to sell legally in Canada. Your application should be detailed and backed up with proof of CMDR compliance.

7. Labeling Love

Make sure your device’s labeling and packaging are up to snuff with Canadian requirements. It’s bilingual, baby! English and French, please. You must include device details, manufacturing info, and usage instructions.

8. Watch and Learn

Please set up a system for keeping tabs on your devices after they hit the market. If anything goes south, you need to be ready to report it to Health Canada. Safety first, always!

9. Money Talks

Remember fees. There are application fees for licensing and annual fees for keeping that MDL shining. Approval times vary, so budget and plan accordingly.

10. Stay in the Know

Canadian regulations can change, just like anywhere else. Keep your ear to the ground for updates because compliance is a journey, not a destination.

Examples of medical device manufacturers relying on Regulatory Experts

Making your mark in the Canadian medical device market can be daunting. The labyrinth of regulations, registrations, and quality standards can leave even the savviest manufacturers scratching their heads. That’s where regulatory consultants come to the rescue. 

1. The case of swift Registration

Imagine this: You’re a medical device manufacturer based outside Canada and eager to tap into the lucrative Canadian market. You’ve done your homework, but the paperwork for registering your manufacturing facility with Health Canada is overwhelming. Enter the regulatory consultant. They help you understand the complex requirements and streamline the process. With their guidance, your facility gets registered swiftly, giving you the green light to start the licensing process.

2. The license to sell

Once your manufacturing facility is cleared, the next hurdle is obtaining a Medical Device License (MDL). Here’s where another manufacturer’s story comes into play. They had tried navigating the application process independently. Still, they were met with delays and confusion. Frustrated, they turned to a regulatory consultant with in-depth knowledge of the Canadian system. With their expert guidance, the application was error-free and supported by a robust quality management system (QMS), significantly expediting the license approval.

3. Acing the labeling game

Picture this: You’ve secured your MDL and are all set to launch your medical device in Canada. But wait, have you got the bilingual labeling right? This is where another manufacturer found itself in a bind. Their labeling didn’t meet Canadian requirements, risking their entire launch. Thankfully, their regulatory consultant was quick to spot the issue. They helped redesign the labeling and ensure it complied with Canadian regulations, saving the day and their product launch.

4. The long-term partnership

These success stories aren’t just about one-off solutions. They highlight the lasting partnerships manufacturers develop with regulatory consultants. These experts assist with immediate compliance needs and keep a watchful eye on regulatory updates. This vigilance ensures that manufacturers stay ahead of the curve, making necessary adjustments to their processes and products to remain compliant.

Why do Medical Device Manufacturers trust experts like Quality Smart Solutions?

So, why do medical device manufacturers rely so heavily on regulatory consultants? It’s simple: expertise and peace of mind. Professionals like ours bring years of experience and an in-depth understanding of the ever-evolving medical device regulations. We’ve seen it all and know how to navigate the complexities.

Our consultants are proactive. They anticipate changes in regulations, helping manufacturers adapt before issues arise. This forward-thinking approach saves time and resources in the long run. Having an expert by your side is a strategic advantage in medical device compliance, where the stakes are high. It’s not just about meeting regulations; it’s about ensuring your products are safe, effective, and ready to serve the Canadian market without hiccups. Manufacturers trust experts like ours to forge partnerships that lead to success stories and smooth market entry.

In Conclusion

Getting your medical devices into the Canadian market is brilliant but challenging. Registering your facilities, securing the correct licenses, and maintaining quality standards are all part of the game. Consider teaming up with a regulatory consultant who knows the Canadian ropes—they’ll be your best friend through this process. With a bit of patience and diligence, you can conquer the world of medical device compliance in Canada and offer your products to a whole new audience, all while ensuring they’re safe and effective.

Our experts at Quality Smart Solutions are here to help and offer medical device-related regulatory advice in Canada 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


Selling Food in Canada: Navigating the Requirements for Conventional and Supplemented Products

This article will explore what it takes to sell food in Canada, from staple products to those with added supplements. Canada is known for its diverse culinary landscape. If you’re considering selling food products in this country, you’re in for a rewarding venture. However, it’s essential to understand the specific requirements and regulations governing the sale of conventional and supplemented food items. This article will explore what it takes to sell food in Canada, from staple products to those with added supplements.

1. Regulatory Framework: Understanding the Basics

First, let’s delve into the regulatory framework shaping the Canadian food industry. The Canadian Food Inspection Agency (CFIA) and Health Canada jointly oversee food regulations, with the CFIA primarily responsible for enforcing these rules. This agency ensures that food products meet safety and labeling standards, regardless of type.

2. Conventional Food Products: Compliance Essentials

Selling conventional food items in Canada comes with specific requirements. Here are some key aspects to consider:

  • Labeling and Packaging: Food labels must display essential information such as the product name, ingredient list, nutrition facts, allergen declarations, and the manufacturer’s contact details. Ensuring accuracy and compliance with labeling regulations is paramount.
  • Safety Standards: Conventional foods must meet safety standards to prevent contamination and ensure they are fit for consumption. This includes adherence to good manufacturing practices (GMPs) and maintaining sanitary conditions throughout production.
  • Product Classification: Different categories of food may be subject to distinct regulations. Understanding how your product is classified is crucial in ensuring compliance.

3. Supplemented Food Products: Extra Considerations

When it comes to selling supplemented food products in Canada, additional requirements come into play:

  • Health Claims: If your product makes health claims related to supplements or functional ingredients, you must ensure these claims are substantiated by scientific evidence and approved by Health Canada. Unverified claims can lead to regulatory issues.
  • Natural Health Products: If your supplemented food product falls into the category of natural health products, it may be subject to separate regulations. Compliance with the Natural Health Products Regulations is necessary in such cases.
  • Ingredient Approval: Ingredients added to supplemented foods must be approved in Canada. Health Canada maintains a list of permitted food additives and supplements; any new ingredients must undergo a rigorous assessment.

4. Licensing and Registration: The Basics

Whether you’re selling conventional or supplemented food products, certain businesses may need to register or obtain a license with the CFIA. Factors such as the type of product and its intended use can impact whether these requirements apply to your operation.

5. Import and Export Considerations

If you’re importing food into Canada or exporting Canadian food products abroad, additional regulations and documentation may come into play. This includes compliance with international standards and trade agreements.

6. Staying Informed and Compliant

The regulatory landscape for selling food in Canada is dynamic, and it’s crucial to stay informed about updates and changes. Engaging with regulatory experts, conducting thorough research, and seeking guidance from the CFIA and Health Canada can help you navigate the requirements successfully.

In conclusion, selling food in Canada involves adherence to specific regulations and standards, whether conventional or supplemented. Understanding and complying with these requirements ensures your products are safe, accurately labeled, and ready to delight Canadian consumers and meet their dietary needs.

Check out our 10 tips for preparing for the SFCR License Application process.

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


FDA 510(k) Clearance: Unveiling the Medical Device Regulations.

This article will break down the regulatory complexities of FDA 510(k) clearance, including submission requirements, classification, and more.

Navigating the intricate world of medical devices can be daunting, especially when it comes to ensuring their safety and effectiveness. In the United States, the FDA 510(k) clearance process is the critical checkpoint manufacturers must pass before introducing medical devices. This article will break down the regulatory complexities of FDA 510(k) clearance, including submission requirements, classification, and more.

1. Decoding the FDA 510(k) Clearance: What Does It Mean?

At its core, FDA 510(k) clearance is the pathway through which manufacturers gain approval to sell their medical devices in the U.S. This regulatory process is named after Section 510(k) of the Food, Drug, and Cosmetic Act, which outlines the requirements that must be met to obtain this clearance. Essentially, it’s the FDA’s way of ensuring that new or modified medical devices are safe and effective.

2. What’s Needed for Submission?

Manufacturers must embark on a detailed journey when submitting a 510(k) premarket notification to the FDA. This submission is a comprehensive dossier that provides evidence that the device is substantially similar to an already legally marketed device, known as a “predicate device.” The submission includes information about the device, labeling, and any proposed changes.

3. Understanding Device Classification: How Risk Plays a Role

One of the first crucial steps in this process is determining the classification of the medical device. The FDA classifies devices into three categories—Class I, II, and III—based on their complexity and level of risk. This classification dictates the level of regulatory scrutiny and the type of evidence required for clearance.

4. Substantial Equivalence: The Heart of the Matter

Substantial equivalence is the linchpin of the 510(k) clearance process. Manufacturers must present compelling evidence showcasing how their device is akin to the predicate device, including aspects like safety, performance, and technological distinctions.

5. Quality Matters: Embracing Quality System Regulations (QSR)

Ensuring the quality of medical devices is paramount. The FDA’s Quality System Regulations (QSR), outlined in 21 CFR Part 820, dictate manufacturers’ standards. These standards encompass everything from design and manufacturing practices to labeling and post-market surveillance.

6. Clinical Data and Testing: Ensuring Safety and Effectiveness

Clinical data may be required depending on the device’s classification and any variances from the predicate device. This data includes bench testing, animal studies, or clinical trials. It’s the bedrock upon which safety and effectiveness claims are built.

7. The FDA Review Journey: A Dialogue with Experts

After the submission, the FDA performs a thorough review, examining the device’s scientific, technical, and clinical aspects. This is also when manufacturers discuss with the FDA to address any questions or concerns.

8. Beyond Clearance: Your Health in Focus

When the FDA issues a 510(k) clearance letter, it signifies the device’s green light for the U.S. market. However, the story doesn’t end there. Manufacturers uphold post-market surveillance and reporting requirements to ensure your safety and the device’s ongoing effectiveness. Manufacturers should know the steps or partner with a regulatory consultant to provide medical devices that have a real and positive impact on their target consumers.

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

To learn when and how to file your 510k submissions click here:


Everything to know about Drug Registration & NDC drug number

drug registration, NDC number

The pharmaceutical industry ensures public health by developing, manufacturing, and distributing safe and effective medications. For any drug to be legally marketed in the United States, it must undergo a rigorous drug registration process and receive a National Drug Code (NDC) number. This article will delve into the essential aspects of drug registration and the significance of the NDC drug number in healthcare.

Understanding Drug Registration

Drug registration is a crucial step in the pharmaceutical industry that involves obtaining regulatory approval from government agencies to market a drug product. This process ensures that all medications meet strict safety and efficacy standards before making them available. Here’s a breakdown of critical components and steps involved in drug registration:

1. Preclinical Development: Before a drug can even be considered for registration, extensive preclinical research is conducted. This requires laboratory testing and animal studies to assess the drug’s safety, toxicity, and potential effectiveness.

2. Investigational New Drug (IND) Application: If the preclinical data is promising, the manufacturer submits an IND application to the U.S. Food and Drug Administration (FDA) or the relevant regulatory agency in other countries. The IND application includes information about the drug’s composition, manufacturing process, proposed clinical trials, and preclinical data.

3. Clinical Trials: Clinical trials are conducted in multiple phases to evaluate the drug’s safety and efficacy in humans. Phase I focuses on security and dosage, and Phase II involves larger groups to assess effectiveness and side effects. Phase III confirms effectiveness and monitors side effects in a larger population.

4. New Drug Application (NDA) or Biologics License Application (BLA): The drug manufacturer submits an NDA or BLA to the FDA after successful clinical trials. This application contains comprehensive data on the drug’s safety, efficacy, manufacturing processes, labeling, and proposed use.

5. FDA Review: The FDA reviews the NDA or BLA to determine whether the drug should be approved for marketing. This review process includes evaluating data from clinical trials, chemistry, manufacturing, labeling, and inspections of manufacturing facilities.

6. Approval: If the FDA approves the drug, it can be marketed and sold in the United States. The approval process may include labeling requirements, warnings, and restrictions.

7. Post-Marketing Surveillance: After approval, the drug continues to be monitored for safety and efficacy through post-marketing surveillance. Adverse events are reported and investigated, and the drug’s label may be updated.

The Role of the National Drug Code (NDC)

The National Drug Code (NDC) is a unique identifier assigned to each medication product in the United States. It plays a pivotal role in drug registration, distribution, and billing. The NDC number consists of three segments: the labeler code, product code, and package code, each separated by hyphens. Let’s break down the significance of each segment:

1. Labeler Code: The first segment, also known as the manufacturer code, is assigned by the FDA to the drug manufacturer, repackager, or distributor. It identifies the entity responsible for bringing the drug to market.

2. Product Code: The product code segment identifies the specific drug, strength, and dosage form. It differentiates between various drug formulations made by the same manufacturer.

3. Package Code: The package code segment indicates the packaging size and type, such as bottle, box, or vial. It helps differentiate between different package configurations of the same drug product.

The NDC number serves several critical purposes:

A. Drug Identification: The NDC number uniquely identifies and tracks drugs in the marketplace, facilitating accurate record-keeping and drug recalls when necessary.

B. Billing and Reimbursement: Healthcare providers use the NDC number when submitting claims to insurance companies and government programs like Medicare and Medicaid. It ensures that medications are accurately billed and reimbursed.

C. Drug Listing and Registration: Manufacturers and distributors use the NDC number to list their drug products with the FDA and meet regulatory requirements. This is an essential step in the drug registration process.

D. Drug Labeling: The NDC number is typically printed on a drug’s packaging and label. It provides essential information for healthcare professionals, pharmacists, and patients, helping them verify the correct medication.

The NDC Drug Number Format

The NDC number is structured in a 10-digit format, divided into three segments. Here’s a breakdown of the format:

  • The first segment contains 4 or 5 digits, representing the labeler code.
  • The second segment includes 3 or 4 numbers indicating the product code.
  • The third segment has two digits, meaning the package code.

For example, let’s consider the NDC number for a hypothetical medication:

  • Labeler Code: 12345
  • Product Code: 6789
  • Package Code: 01

The NDC number would be written as 12345-6789-01

This format allows for many unique combinations, accommodating various medications available.

The Role of the Labeler Code

The labeler code, the first segment of the NDC number, is assigned by the FDA to drug manufacturers, repackagers, or distributors. This code is a critical identifier; each entity involved in drug production or distribution must have a unique labeler code. Here’s how it functions:

1. Manufacturer Identification: The labeler code identifies the entity responsible for manufacturing or distributing the drug. This ensures transparency and accountability in the pharmaceutical supply chain.

2. Drug Listing: Manufacturers, re-packagers, and distributors use their assigned labeler code when listing their drug products with the FDA. This step is essential for regulatory compliance.

3. Billing and Reimbursement: The labeler code is used in the billing and reimbursement. When healthcare providers submit medication claims, the labeler code helps ensure that the correct entity is billed.

4. Tracking and Traceability: The labeler code is crucial in tracking and tracing drugs throughout the supply chain. It helps identify the source of medication and facilitates recalls when necessary.

The Role of the Product Code

The product code, the second segment of the NDC number, is a numeric identifier that specifies the specific drug product, its strength, and its dosage form. The labeler assigns this code and serves the following purposes:

1. Product Differentiation: Manufacturers use the product code to differentiate between various formulations of the same drug. For example, different medication strengths or separate dosage forms (tablets, capsules, liquid, etc.) will have unique product codes.

2. Accurate Identification: Healthcare professionals, pharmacists, and patients rely on the product code to accurately identify and prescribe the correct medication. It ensures that the right drug product is dispensed.

3. Regulatory Compliance: The product code is essential for regulatory compliance. When manufacturers list their drug products with the FDA, they include the product code to provide detailed information about the specific medications they offer.

4. Drug Labeling: The product code is typically printed on the drug’s packaging and label. It assists with accurately identifying the drug, its strength, and its dosage form.

The Role of the Package Code

The package code, the third and final segment of the NDC number, is a two-digit identifier that specifies a drug product’s packaging configuration and size. This code is crucial for several reasons:

1. Package Differentiation: The package code allows manufacturers to differentiate between various package sizes and types for the same drug product. For example, a medication may be available in different quantities, such as 30 tablets, 60 tablets, or 100 tablets, and each package size will have a unique package code.

2. Inventory Management: Pharmaceutical manufacturers, distributors, and pharmacies use the package code to manage inventory effectively. It helps them keep track of the quantity of each package size in stock and reorder as needed.

3. Dispensing Accuracy: Pharmacists and healthcare providers rely on the package code to ensure they dispense the correct quantity of medication to patients. This helps prevent errors and ensures that patients receive the prescribed dosage.

4. Regulatory Compliance: When listing a drug product with the FDA, manufacturers include the package code as part of the NDC number. This step is essential for regulatory compliance and provides detailed information about the various packaging options available for the medication.

5. Prescription Labeling: The package code is often included on prescription labels to help patients and healthcare professionals verify that they receive the correct medication quantity. It adds an extra layer of accuracy to the prescription and dispensing process.

6. Reordering and Procurement: Hospitals, pharmacies, and healthcare facilities use the package code when reordering medications from wholesalers or manufacturers. It ensures that the correct package size is ordered to meet patient needs.

7. Supply Chain Efficiency: The package code is crucial in maintaining efficiency in the pharmaceutical supply chain. It helps with tracking and traceability, allowing for the rapid identification of specific package sizes during distribution and delivery.

8. Patient Education: The package code can also serve as a reference for patient education. It helps patients understand the quantity of medication they should take and facilitates communication with healthcare providers about prescription refills and dosing instructions.

In summary, the package code is a vital component of the NDC number, providing essential information about the packaging configuration of a drug product. It serves multiple purposes, from accurate dispensing to inventory management and regulatory compliance. Healthcare professionals, pharmaceutical manufacturers, and regulatory authorities rely on the NDC number, with its package code segment, to ensure the safe and efficient distribution of medications to patients across the United States.

Is there anything else I should know as a drug manufacturer?

Yes, there are several additional essential considerations and aspects that drug manufacturers should be aware of regarding drug registration and the National Drug Code (NDC) system:

  1. NDC Variations: While the standard NDC format consists of 10 digits (in a 5-4-2 layout), there are variations, such as the 11-digit format (5-4-2 with a check digit) and the 5-3-2 format for over-the-counter (OTC) drugs. Manufacturers must be aware of the specific form applicable to their products.
  2. Unique NDCs for Different Dosage Forms: If a manufacturer produces the same drug in multiple dosage forms (e.g., tablets, capsules, and liquid), each dosage form typically requires a unique NDC. This allows for precise identification of each form.
  3. NDC for Private Labeling: Manufacturers who produce drugs for private labels (generic or store-brand medications) must assign NDCs to these products. Private-label NDCs should be distinguishable from the NDCs of the original manufacturer.
  4. Repackaging and Relabeling: Manufacturers involved in repackaging or relabeling activities, where drugs are removed from their original packaging and placed into new containers, must assign new NDCs for the repackaged products. These NDCs should reflect the new packaging configuration.
  5. NDC Updates: Manufacturers should keep their NDC information updated with the FDA. Any labeler, product, or package code changes, including discontinuations or updates, should be reported to the FDA.
  6. International Considerations: For manufacturers exporting drugs to global markets, it’s essential to understand that the NDC system is specific to the United States. Other countries may have unique product identification systems, and compliance with international regulatory requirements is crucial.
  7. FDA Registration and Listings: Drug manufacturers must register their facilities with the FDA and list their drug products and corresponding NDCs with the FDA’s National Drug Code Directory. This information should be kept accurate and updated regularly.
  8. Supply Chain Traceability: The NDC system facilitates traceability throughout the pharmaceutical supply chain. Manufacturers, distributors, and pharmacies rely on NDCs to track products, verify authenticity, and ensure accurate dispensing.
  9. Regulatory Compliance: Compliance with NDC requirements is a legal obligation. Manufacturers must adhere to FDA regulations governing drug registration, labeling, and reporting. Failure to comply can result in regulatory actions and legal consequences.
  10. Patient Safety: Accurate NDC labeling and tracking contribute to patient safety. Ensuring patients receive the correct medication, dosage form, and packaging configuration is critical in preventing medication errors.
  11. Serialization and Track-and-Trace: Besides NDCs, some jurisdictions and regulatory initiatives require drug serialization and track-and-trace systems for enhanced product security and supply chain transparency. Manufacturers should stay informed about relevant serialization requirements.
  12. Regulatory Changes: Regulations related to drug registration, labeling, and NDCs can change over time. Manufacturers should stay informed about updates and revisions to FDA requirements and adapt their processes accordingly.
  13. Consultation with Regulatory Experts: Given the complexity of drug registration and compliance with NDC requirements, manufacturers may benefit from consulting with regulatory experts or professionals experienced in pharmaceutical regulatory affairs to ensure full compliance and avoid potential pitfalls.

In summary, drug manufacturers must navigate the intricate drug registration process and the NDC system to bring safe and effective medications to the market. Staying informed about regulatory requirements, adhering to NDC standards, and maintaining accurate records are essential for regulatory compliance and ensuring the well-being of patients.

Are you looking to have your drug product registered with Health Canada? Quality Smart Solutions has a team of experts who are skilled with DIN applications. If you need help with your Drug Establishment License (DEL) Registration we can help with that as well. 

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