Categories
Blog FDA

GRAS Notice vs. Self-Affirmed GRAS: Which Is Best?

GRAS Notice vs Self-Affirmed GRAS

If you’re introducing a new ingredient or additive into food products, understanding the GRAS Notice vs. Self-Affirmed GRAS pathways is essential. In the U.S., substances that are Generally Recognized as Safe (GRAS) can be used in food without requiring a formal FDA approval.

But how do you determine which GRAS pathway is right for you?  

Keep reading to explore the key differences, regulatory requirements, and best practices for ensuring compliance. 

What is GRAS? 

GRAS, or generally recognized as safe, means a substance is deemed safe for its intended use based on expert consensus and scientific evaluation. The GRAS status of a substance is determined through two primary pathways, GRAS Notice (FDA-reviewed) and Self-affirmed GRAS (internally determined by the company). 

Both pathways have regulatory and business implications, so selecting the right one depends on your compliance needs, transparency preferences, and available resources. 

GRAS Notice: The FDA-reviewed pathway 

The GRAS Notice pathway involves submitting a formal notification to the U.S. Food and Drug Administration (FDA) for review. This process provides a higher level of regulatory validation. 

Key steps in the GRAS Notice process 

  1. Scientific evidence compilation: You must provide toxicology studies, clinical trials, and historical data demonstrating the substance’s safety. 
  2. Independent panel review: A third-party panel of experts evaluates the safety data before submission. 
  3. FDA review and response: The FDA assesses the submission and issues either a “no questions” letter, confirming the GRAS determination, or a request for more data if they need further clarification. 

Benefits of the GRAS Notice pathway 

  • The FDA reviews this process, enhancing regulatory credibility and reducing compliance risks. 
  • The process is transparent, as submissions are publicly available and referenced by regulators, industry professionals, and consumers. 
  • It assures consumers, investors, and partners, strengthening trust in the product’s safety and compliance. 

Self-affirmed GRAS: The internal pathway 

Self-affirmed GRAS allows a company to determine a substance’s safety without FDA review. Instead, the company conducts an internal scientific evaluation and expert review. 

Key steps in the Self-Affirmed GRAS process 

  1. Internal scientific review: The company compiles safety data similar to a GRAS Notice. 
  2. Expert consensus: A qualified panel (internal or external) confirms safety. 
  3. Documentation and record-keeping: The company maintains detailed records but does not submit to the FDA. 

Benefits of the Self-Affirmed GRAS pathway 

  • The process moves faster and reduces costs, making it an efficient option. 
  • Companies maintain confidentiality over business decisions and regulatory strategies. 
  • Organizations can voluntarily share the GRAS determination with customers or regulatory agencies if needed.
  • Once Self-Affirmed GRAS is obtained, it increases the probability of getting FDA GRAS Notice if submitted.  

GRAS Notice vs. Self-Affirmed GRAS: Key differences 

Feature 

GRAS Notice 

Self-Affirmed GRAS 

FDA involvement 

Yes, FDA reviews submission 

 Independent expert panel determines status

Independent panel 

Recommended but not mandatory

 Required

Transparency 

Publicly available 

Can be kept confidential 

Legal considerations 

Stronger FDA endorsement 

Higher liability if challenged 

Which pathway should you choose? 

If you want formal FDA recognition and transparency, the GRAS Notice pathway is best. However, if speed, cost savings, and confidentiality are priorities, Self-Affirmed GRAS may be the better option. Regardless of the pathway, ensuring food safety and compliance is critical. One can always go for FDA GRAS once self-affirmed GRAS is obtained.

Need help navigating GRAS compliance? 

Choosing the right GRAS pathway requires careful consideration of regulatory, financial, and business factors. Our experts at Quality Smart Solutions can help you navigate GRAS Notification, Self-Affirmation, and FDA compliance. 

Contact us today or fill out the form below to ensure your food additives and ingredients meet industry standards! 

 

Categories
Blog

What Are GRAS Substances? A Complete Guide

GRAS substances

GRAS substances, or “Generally Recognized as Safe” substances, are essential to product development in the food, pharmaceutical, and cosmetic industries. If you’re in any of these fields, it’s important to understand how GRAS substances work so your products stay compliant, safe, and ready for market. 

Maybe you’re working on a new formulation or reviewing an ingredient label. Either way, knowing the role and regulations of GRAS substances can make your life easier. In this guide, you’ll get a clear overview of what they are, how they’re used, and how to navigate the compliance process with confidence.  

Stick with us. This might just be the piece you need to move forward with clarity and confidence. 

What Does GRAS Mean? 

GRAS substances are ingredients that experts widely agree are safe under the conditions of their intended use. The U.S. Food and Drug Administration (FDA) oversees GRAS determinations and maintains a GRAS database, although companies can also self-affirm GRAS status with the proper documentation. There are two main pathways to GRAS status: 

  • FDA GRAS Notification: A voluntary submission to the FDA for review. 
  • Self-Affirmed GRAS: An internal scientific review by qualified experts, without FDA involvement. 

Regardless of the route, your documentation must support the ingredient’s safety, based on scientific data and public availability of information. 

Types of GRAS Substances 

GRAS substances fall into three main categories: 

1. Food additives

These include preservatives, flavor enhancers, emulsifiers, and colorants that improve shelf life, taste, and appearance. For example, ascorbic acid (Vitamin C) is a common GRAS additive in juice to prevent spoilage. 

2. Pharmaceutical excipients

GRAS substances also play a role in drug formulation. These “inactive” ingredients help with drug stability, absorption, and delivery. Think fillers, binders, and disintegrants. 

3. Cosmetic ingredients

In the cosmetics industry, GRAS substances are found in moisturizers, surfactants, and preservatives. Their safety must be demonstrated for topical use, ensuring they don’t harm the skin or body. 

Where GRAS Substances Are Used 

GRAS substances are everywhere. Here’s how different industries depend on them: 

  • Food industry: Extend shelf life, enhance flavour, and prevent spoilage. 
  • Pharmaceutical industry: Ensure drug consistency and performance. 
  • Cosmetics industry: Create safer, effective products that meet regulatory standards. 

Understanding the right category and application is crucial for compliance and consumer safety. 

Is Your GRAS Substance Compliant? 

GRAS substances may be recognized, but they still require scientific support and regulatory strategy. To ensure your GRAS substance complies with FDA requirements, consider: 

Staying compliant means documenting safety, evaluating exposure levels, and regularly reviewing ingredient data. 

Why GRAS Certification Matters 

Achieving GRAS status isn’t just a regulatory milestone. It builds trust with consumers, streamlines market entry, and protects your brand. 

Whether you’re launching a new dietary ingredient or expanding your food product line, a clear GRAS strategy reduces risk and gives you a competitive edge. If your team needs help preparing a GRAS dossier or navigating the notification process, our team at Quality Smart Solutions is here to help. 

Learn More About GRAS 

Want to dive deeper? Explore these helpful resources: 

Still have questions? Reach out to us about GRAS notifications, self-affirmation, or dossier preparation. Contact us today or fill out the form below for a free consultation with one of our regulatory experts. 

 
Categories
Blog

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

Supplemented Foods Facts TableIntroducing 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.

Categories
Blog

Medical Device Compliance in Canada: A Guide for Manufacturers


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.

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. 

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.

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.

Acing the labelling 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 labelling right? This is where another manufacturer found itself in a bind. Their labelling 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

Categories
Blog

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.

Categories
Blog

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:

Categories
Blog FDA

Drug Registration and NDC Number in the U.S.: A Complete Guide

drug registration and NDC number

Drug registration and NDC number might sound technical, but they play a big role in how medications make it to the U.S. market. If you’re in the pharmaceutical space, understanding how these systems work is key to getting your products approved, listed, and safely into the hands of patients. 

In this guide, we break it all down in a simple, accessible way. You’ll learn what’s involved in registering a drug, how the National Drug Code (NDC) number works, and why both matter for compliance, billing, and patient safety. So, if you’re looking for clarity, keep reading, and we’ll help you move forward with confidence.

What is the drug registration process? 

Before a medication can be sold in the U.S., it must go through a thorough registration process. This step is essential because it ensures the drug is safe, effective, and meets the U.S. Food and Drug Administration (FDA) standards. To give you a clearer picture, here’s a simplified overview of the main steps involved for a new drug product:

1. Preclinical Testing

At the start, the drug is tested in labs and on animals to evaluate safety and potential effectiveness. This foundational research helps determine if it’s ready for further testing on humans.

2. IND Application

Next, if the preclinical data is promising, the manufacturer submits an Investigational New Drug (IND) application to the FDA. This includes details about the drug’s composition, how it’s made, and how it will be tested in people.

3. Clinical Trials

Then come the clinical trials, which take place in three main phases:

  • Phase I: Small group to test safety and dosage. 
  • Phase II: Larger group to test how well it works and any side effects. 
  • Phase III: Even bigger group to confirm effectiveness and monitor long-term side effects. 

4. NDA or BLA Submission

After successful clinical trials, the next step is submitting a New Drug Application (NDA) for new small molecules or Biologics License Application (BLA) for new large molecules. This submission includes all the collected data from previous steps, including the results of non-clinical studies, clinical studies, and the Chemistry, Manufacturing, and Controls (CMC) section.

5. FDA Review and Approval

From there, the FDA conducts a comprehensive review. If the drug meets all requirements, it’s approved for sale in the U.S., often with specific labeling and safety conditions.

6. Post-Market Monitoring

Finally, even after approval, the drug continues to be closely monitored for safety. As new side effects are identified, updates to the labeling may follow. Ongoing post-market monitoring also helps evaluate the drug’s long-term safety and effectiveness.

What is the National Drug Code (NDC) and why the NDC number matters 

Drug products are identified and reported using a unique, three-segment number, called the National Drug Code (NDC), which is a universal product identifier for human drugs.

The National Drug Code (NDC) works like a barcode for medications in the U.S., making it easier to identify, track, and manage drug products throughout their life cycle. As a result, it plays a central role in helping manufacturers, healthcare providers, and regulatory bodies maintain accuracy and transparency. 

Specifically, the NDC is made up of three parts: 1. the labeler code, assigned by the FDA to identify the manufacturer or distributor; 2. the product code, which defines the specific drug, its strength, and dosage form; and 3. the package code, which reflects the packaging type and size. For example, a full NDC might look like this: 12345-678-09 or 12345-0678-9, depending on the firm’s configuration

Together, these segments ensure that the right drug is listed, billed, dispensed, and monitored correctly across the healthcare system. In turn, this structure helps reduce errors, streamline inventory, and improve patient safety.

Breaking down the NDC segments 

The National Drug Code is made up of three main segments: the labeler code, product code, and package code. Together, they provide a full picture of a drug product’s origin, formulation, and packaging. To make it easier to understand, here’s a quick summary of each component in table format for easier reference: 

Segment 

Assigned by 

What it identifies 

Labeler code 

FDA 

Identifies the manufacturer or distributor. Also used in FDA listings and billing. 

Product code 

Firm

Indicates the drug’s strength, dosage form and formulations. Appears on labels and listings. 

Package code 

Firm

Details of package type and size.

As a result, this structured format not only helps with accurate product identification but also improves compliance and traceability throughout the entire pharmaceutical supply chain.

Key tips for drug manufacturers 

If you’re a manufacturer, here’s what else you should know: 

  • Know your NDC format: The standard NDC format is limited to 10 digits. Therefore, when a firm is assigned a 5-digit labeler code, it must choose between using a 3-digit product code with a 2-digit package code, or a 4-digit product code with a 1-digit package code. 
  • Use unique NDCs: Different strengths or forms (like a tablet vs. syrup) need separate NDCs, even if it’s the same drug. 
  • Private labeling: If you sell to private labels, those versions also need their own NDCs. 
  • Repackaging needs a new NDC: If you change the packaging, assign a new NDC to reflect that. 
  • Keep your info updated: Always notify the FDA if your codes change or a product is discontinued. 
  • Stay compliant with other countries: The NDC is U.S.-specific. If you’re exporting, be aware of global regulations too. 

Final thoughts 

Drug registration and the NDC number are more than just paperwork. In fact, they are essential tools for maintaining safety, transparency, and regulatory compliance in the pharmaceutical industry. By staying informed and keeping documentation current, you set your products up for long-term success.

At Quality Smart Solutions, we specialize in helping companies register their drug products with Health Canada. From DIN applications to Drug Establishment License (DEL) support, our team of experts is here to guide you every step of the way. 

Ready to get started? Contact us or fill out the form below for a free consultation. We’re here to make the process smoother and help you meet your regulatory goals with confidence. Explore our FDA OTC drug compliance solutions to learn more about how we can support your U.S. drug compliance strategy.

Visit the FDA’s official NDC Directory to look up or verify drug listings. Learn about Canadian drug registration on the Health Canada website. 

Subscribe to global regulatory updates

We use cookies to display personalized content, analyze site traffic, provide recommendations, and ensure you have a great browsing experience. By continuing to use our site, you consent to our use of cookies. Privacy Policy.