Amazon Seller Compliance

Andrew Parshad

Andrew Parshad is President, CEO and founder of Quality Smart Solutions, a North American compliance solutions provider offering regulatory and quality assurance services to comply with FDA & Health Canada brands and ingredients regulations in the categories of dietary supplements, foods, cosmetics, OTC drugs and medical devices. Andrew started Quality Smart Solutions in 2007. Since that time he and his firm has served thousands of clients worldwide . Andrew's affiliate company, Quality IMPORT Solutions that offers import agent services into the Canadian market as a government licensed importer for foods, dietary supplements and medical devices.

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Navigating HACCP Regulations: A Comprehensive Guide for Industry Compliance

HACCP Regulations: A Experts Guide for Industry Compliance

HACCP Regulations: A Experts Guide for Industry ComplianceIn today’s fast-paced and diverse industries, pursuing safety and quality isn’t just a goal; it’s a non-negotiable commitment. This is where HACCP – Hazard Analysis and Critical Control Points – takes center stage. It’s not just a buzzword; it’s a systematic approach that safeguards products and instills consumer trust. Let’s delve into the depths of HACCP regulations, understanding their significance, implementation, and how they empower industries across the board.

Understanding HACCP Regulations: Laying the Foundation

Deciphering HACCP Regulations HACCP regulations are the compass that guides businesses toward producing safe and consistent products. By identifying potential hazards and critical control points, industries can create robust protocols to mitigate risks. These regulations form the backbone of product integrity and consumer confidence.

The Weight of HACCP Compliance HACCP compliance isn’t a mere checkbox; it’s a commitment to delivering products that won’t compromise consumer safety. Whether in the food, pharmaceutical, cosmetic, or any other industry, adherence to HACCP guidelines is a testament to your dedication to quality assurance.

Unraveling the HACCP Guidelines: Step by Step

1. Assessment of Hazards begins with identifying hazards that could lurk within your production process. These hazards can range from microbiological contaminants to physical hazards. This step equips you with the knowledge needed to address potential risks.

2. Determining Critical Control Points (CCPs) CCPs are pivotal stages in your process where risks can be controlled or eliminated. For instance, CCPs could include cooking, chilling, or packaging in the food industry. By pinpointing these points, you’re proactively taking charge of product safety.

3. Setting Critical Limits Critical limits are the boundaries that ensure hazards are managed effectively. Whether it’s temperature, time, pH levels, or any other factor, staying within these limits guarantees that your products remain safe and consistent.

4. Implementing Monitoring Procedures Once you’ve set your critical limits, it’s time for vigilant monitoring. Regular checks and inspections ensure that CCPs are operating as intended. Monitoring is your safety net, preventing potential issues from escalating.

5. Corrective Actions and Verification: Even with meticulous planning, deviations can occur. Robust corrective actions are your toolkit for addressing these deviations promptly. Verification steps ensure that your HACCP plan is effective and reliable.

6. Documentation and Record-Keeping Documenting each phase of your HACCP plan isn’t just a formality; it’s a testament to your commitment. These records prove your due diligence and can be invaluable during audits.

Mastering HACCP Certification: The ultimate stamp of excellence

Embarking on the HACCP Certification Journey HACCP certification isn’t just a recognition; it’s a validation of your dedication to safety and quality. Achieving certification involves a thorough evaluation of your HACCP plan by authorized bodies. It’s a badge that signifies your commitment to meeting the highest standards.

The Ripple of Benefits HACCP certification ripples across your operations. It’s not just about compliance; it’s about operational efficiency, enhanced reputation, and access to new markets. Consumers, stakeholders, and regulators recognize and value the seal of HACCP certification.

Conclusion: Elevating Industries Through HACCP

HACCP regulations are more than just rules; they’re a mindset. They foster a culture where safety, quality, and excellence are non-negotiables. From assessing hazards to achieving certification, the journey is a testament to your commitment to consumer well-being. By embracing HACCP, you’re not just complying with regulations but pioneering a new standard of excellence across industries.

Learn about the cost of HACCP certification here or contact our team through the form below:

How can Quality Smart Solutions serve you?

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

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

Thirdly, we help with Safe Foods for Canadians Regulations (HACCP, PCP, Import Licensing, and GRAS Notifications). 

Help with facility registration, FSVP agent, and US Agent. 

Resources:

HACCP Process and CCP

The evolution of food safety standards

Why are HACCP consultants important?

7 principles of HACCP and how they impact food safety

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AAFCO Membership Approves New Pet Food Regulations for Enhanced Transparency and Consistency

Pet Food Regulations

VHP Notification Program, VHP Notification, VHP, VHP ConsultingIntroduction

In a groundbreaking move, the Association of American Feed Control Officials (AAFCO) has given the green light to an extensive overhaul of pet food and specialty pet food regulations. This decision is set to transform the way pet owners perceive and choose pet food products, marking a significant shift after more than four decades. With an emphasis on clarity and transparency, these changes aim to offer consumers standardized nutritional information, unequivocal ingredient details, and clear storage instructions.

The revisions come as a result of collaborative efforts between feed regulatory professionals, industry experts, and engaged pet owners from across the United States and Canada. The goal was to create a unified set of guidelines that would guide pet food manufacturers and distributors, ensuring that packaging and labels provide a comprehensive understanding of the product in question.

Austin Therrell, the executive director of AAFCO, emphasized the importance of feedback received during the collaborative process. “We sought public comment to learn more about how pet food label changes would enhance transparency and provide clearer information in a consumer-friendly format. New packaging and labels will be well-defined and easy to understand. And that’s good news for all of us, from pet owners and manufacturers to pets themselves,” said Therrell.

The AAFCO has recommended a period of enforcement discretion for states to adopt and enforce the revised Model Regulations for Pet Food and Specialty Pet Food. This approach encourages uniform adoption across states, ensuring consistency in the implementation of the new regulations.

Key highlights of the label changes include:

  1. Nutrition Facts Box: Resembling human-food labeling more closely for easier comprehension.
  2. Intended Use Statement: Relocated to the lower third of the front display panel to assist consumers in quickly understanding the purpose of the pet food.
  3. Ingredient Statement: Clarified with consistent terminology usage and the inclusion of parentheticals and common names for vitamins.
  4. Handling and Storage Instructions (Optional): Standardized and updated, including the incorporation of optional icons for enhanced consistency.

AAFCO’s Pet Food Committee will evaluate the enforcement discretion recommendation annually, addressing potential challenges that may arise during the transition. The ultimate goal is to ensure a seamless and uniform adoption process that benefits consumers, manufacturers, and pets.

The revisions are a result of the Pet Food Label Modernization (PFLM) initiative that began in 2015. The AAFCO collaborated with stakeholders and conducted multiple rounds of consumer research to create a set of regulations that better communicate essential information. This process highlights the power of collaboration between industry professionals and consumers, ultimately leading to improved pet food labels that empower pet owners to make informed decisions. For more information about PFLM, visit AAFCO’s official page.

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IOR Compliance USA: Navigating Regulations and Tax Responsibilities

USA IOR compliance

USA IOR complianceIntroduction: Navigating international trade regulations and the intricacies of Importer of Record (IOR) compliance and taxes can be complex. This comprehensive guide breaks down IOR compliance and its connection to tax obligations in the USA, offering a clear understanding for businesses engaged in global trade.

IOR Compliance USA: Connecting Regulations and Tax Responsibilities

What is IOR Compliance?

At the heart of successful international trade lies IOR compliance – the adherence to rules when bringing goods into the US. This guide demystifies IOR compliance and explains its crucial role in maintaining smooth import processes.

IOR Compliance and Taxes: A Balanced Approach

  1. Import Duties and Taxes: Learn how IOR compliance extends beyond import duties to include accurate tax calculations and payments.

  2. Customs Valuation and Tax Calculation: Discover how proper customs valuation impacts tax calculations and ensures accuracy in financial planning.

  3. Harmonized System Codes and Tax Alignment: Find out how aligning Harmonized System codes with tax categories prevents confusion and ensures correct tax application.

Handling Tax Obligations in IOR Compliance

  1. Understanding Tax Rates: Get insights into determining tax rates for various goods, ensuring accurate tax payments.

  2. Effective Tax Documentation: Learn about the importance of thorough documentation for transparent transactions and easy audits.

  3. Meeting Tax Deadlines: Explore the significance of timely tax payments to avoid penalties and disruptions in supply chains.

Strategic IOR Compliance and Tax Management

  1. Strategic Tax Planning: Understand how strategic tax planning within IOR compliance can positively impact your business’s financial outcomes.

  2. Managing Risks: Discover how adhering to tax obligations in IOR compliance reduces financial and legal risks, safeguarding your business’s reputation.

IOR Compliance for Different Business Models: Considering Taxes

  1. IOR Compliance for eCommerce: Find out how eCommerce businesses can ensure IOR compliance aligns with tax considerations for seamless cross-border transactions.

  2. IOR Compliance for International Shipping: Learn how IOR compliance simplifies tax challenges for businesses engaged in international shipping.

Conclusion: Navigating IOR Compliance and Tax Responsibilities

IOR compliance and tax obligations are essential aspects of thriving in international trade. This guide equips businesses with the knowledge to confidently handle IOR compliance, manage taxes, and operate seamlessly in the global marketplace.

Stay Tuned: In the ever-evolving world of regulations and taxes, staying informed and seeking professional advice ensures a positive business journey, navigating the complexities with confidence.

Need an Importer of Record? Then you should check out these blogs; 5 Benefits of Using an Importer of Record and How to Maximize Your Import Process with an Importer of Record.

Related Reading:

IOR Compliance and customs clearance

Medical Device Importer Benefits

FSVP Importer Food Importing

NHP Third-Party Importer Benefits

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Decoding Food Labeling Regulations: Unveiling Requirements on Food Labels

Food Labelling Food Regulations

Understanding Food Labels: A Simple Guide

Food Labelling Food Regulations Food labels are more than just ingredient stickers on packaging; they are a key tool that helps consumers make informed choices about what they eat. This guide simplifies the complex world of food labeling regulations, focusing on the rules set by Health Canada, the U.S. Food and Drug Administration (FDA), and the European Union (EU). From required elements to health claims and country-of-origin labeling, this article breaks down the essential information you need to know about food labels and their purpose.

Why Food Labels Are Important

Food labels serve several important functions:

  1. Informing Consumers: Labels show what’s in the food, including ingredients, nutritional information, and allergens. This helps people choose foods that fit their diet.
  2. Ensuring Safety: Labels warn about allergens or other health hazards, helping people avoid foods that might cause health problems.
  3. Promoting Healthy Eating: Nutritional information on labels encourages better food choices and supports dietary goals.
  4. Catering to Preferences: People with specific dietary needs or preferences can use labels to make informed choices.
  5. Building Trust: Accurate labels follow the rules set by regulatory authorities, promoting consumer confidence.
  6. Preventing Misleading Claims: Labels help prevent false advertising, ensuring consumers get what they expect.
  7. Making Recalls Easier: In the event of a recall, clear labeling makes it easier to identify and remove unsafe products from stores.
  8. Encouraging Comparisons: Uniform standards make it easier for consumers to compare products.
  9. Supporting Public Health: Accurate food labels are a key part of public health campaigns, helping reduce health risks like obesity and foodborne illnesses.

Key Elements of a Food Label

While food labeling rules vary by region, there are several basic elements that are usually required on labels:

  1. Product Name: A clear, accurate name that identifies what the product is.
  2. Ingredient List: All ingredients must be listed in order of weight, with allergens clearly marked.
  3. Nutrition Facts: This section includes serving size, calories, and information on key nutrients like fat, protein, vitamins, and minerals.
  4. Allergen Information: Labels must clearly state if the product contains common allergens, such as nuts, dairy, or gluten.
  5. Net Quantity: The total amount of food in the package, either by weight or volume.
  6. Dates: Labels often include a "best before" or "use by" date to ensure consumers know when the product is fresh.
  7. Country of Origin: This indicates where the food was grown, harvested, or produced.
  8. Usage Instructions: Guidelines for how to prepare or use the product properly.
  9. Storage Instructions: Tips on how to store the product to maintain its freshness and safety.
  10. Manufacturer Information: Contact details for the company that made, packed, or distributed the product.
  11. Food Additives: If any additives are used, they must be listed on the label.
  12. Health Claims: Some labels include claims about the health benefits of the food, but these must follow strict rules to prevent misinformation.

Health Claims on Labels

Health claims on food labels can be confusing, but they are divided into three main categories:

  1. Nutrient Content Claims: These claims describe the level of a nutrient in the food, like "low-fat," "high-fiber," or "good source of calcium." They must meet specific criteria set by regulatory authorities to ensure they are accurate.
  2. Structure-Function Claims: These claims talk about how a nutrient supports normal body functions, such as "calcium supports strong bones." These claims do not promise to cure or prevent any disease and usually include a disclaimer.
  3. Specific Health Claims: These claims link a particular food or ingredient to a specific health outcome, like "oats may reduce the risk of heart disease." These claims require scientific evidence and approval from regulatory authorities.

The Consequences of Misleading Health Claims

If a company makes false or unauthorized health claims, it can face serious consequences, including fines and legal action. That's why it's crucial for manufacturers to follow the rules and consult experts to ensure their claims are backed by science and comply with regulations.

What Isn’t Required on Food Labels?

Not everything that appears on a food label is legally required. Some things are optional and are added to enhance the consumer experience. These optional elements can include:

  1. Brand Names: While many products have fancy names, they are not required. The key is that the product name accurately reflects what it is.
  2. Marketing Language: Words like "delicious" or "tasty" are common on labels but not required.
  3. Recipes or Serving Suggestions: Some products offer ideas on how to use the food, but this is not a legal requirement.
  4. Retail Price: Prices usually vary by store and are not part of the label.
  5. Pictures or Graphics: Images can make a product more attractive but are not required by law.
  6. Contact Information for Consumers: While some companies provide a phone number or website for consumer questions, this is not always mandatory.
  7. Manufacturer’s Signature: Although a signature may appear on some products, it’s not a legal necessity.
  8. QR Codes or Smart Labels: QR codes that offer more information, such as sourcing or sustainability details, are optional.
  9. Cultural or Ethical Labels: Labels like "vegan" or "kosher" may be helpful for certain consumers, but they are not required unless the product is making a specific claim.
  10. Environmental Labels: Claims about sustainability or eco-friendly practices are often voluntary.
  11. Non-GMO Labeling: This is not always required by law, but many companies include it to inform consumers that their products do not contain genetically modified organisms.

Country-of-Origin Labeling

The rules for country-of-origin labeling differ depending on where you are. In the U.S., certain products like meat and fresh produce must display the country of origin. In the EU, origin labeling is required for fresh meat, fruits, and vegetables. Canada has similar rules, with certain foods like fish, seafood, and fresh produce requiring origin labels.

Food labels are essential for making informed choices and maintaining trust between consumers and manufacturers. Although complex, food label regulations are critical and full compliance is mandatory. Understanding the basic principles of food labeling can help both producers and consumers navigate this complex but crucial part of the food industry.

QSS is Your Essential Partner in Canadian Food Labelling Compliance

Food labelling laws can feel intimidating for many small and medium-sized businesses. However, when executed correctly, these regulations can become a competitive advantage, showcasing your brand’s commitment to transparency and consumer trust.

QSS brings decades of experience in helping brands navigate these complexities. We ensure that your packaging not only meets regulatory requirements across the U.S., Canada and Europe, but also resonates with today’s consumers. Our expertise in both compliance and design means that your product will stand out for all the right reasons.

If you have questions about food labelling, package design, or navigating the food-labelling market, QSS is here to help, contact us today.

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Del Health Canada: Roles & responsibilities in protecting Canadians

In this guide, we'll explore the responsibilities and functions of Del Health Canada in more detail.

In this guide, we'll explore the responsibilities and functions of Del Health Canada in more detail.Del Health Canada is a crucial regulatory body responsible for ensuring the safety and effectiveness of drugs and medical devices in Canada. This organization plays a vital role in protecting the health and well-being of Canadians by setting standards, conducting research, and enforcing regulations. In this guide, we’ll explore the responsibilities and functions of Del Health Canada in more detail.

What is Del Health Canada?

Del Health Canada is a federal agency that operates under the umbrella of Health Canada. Its primary role is to regulate drugs and medical devices in Canada, ensuring they are safe, effective, and high-quality. Del Health Canada is responsible for reviewing and approving new drugs and medical devices before they can be sold in Canada and monitoring their safety and effectiveness once they are on the market. The agency also works to prevent and address potential risks associated with drugs and medical devices and takes action when necessary to protect the health and safety of Canadians.

What are DEL Health Canada’s responsibilities?

DEL Health Canada regulates drugs and medical devices in Canada, ensuring they are safe, effective, and high-quality. This includes reviewing and approving new drugs and medical devices before they can be sold in Canada and monitoring their safety and effectiveness once they are on the market. The agency also works to prevent and address potential risks associated with drugs and medical devices and takes action when necessary to protect the health and safety of Canadians. Also, DEL Health Canada is responsible for enforcing compliance with regulations and standards related to drugs and medical devices and providing information and guidance to healthcare professionals and the public.

How does the DEL ensure the safety and efficacy of drugs and medical devices?

DEL Health Canada uses a rigorous review process to ensure the safety and efficacy of drugs and medical devices. This process includes evaluating clinical trial data, assessing the benefits and risks of the product, and reviewing the manufacturing process to ensure quality and consistency. The agency also monitors the safety and effectiveness of drugs and medical devices once on the market and takes action if any safety concerns arise. Additionally, DEL Health Canada works closely with international regulatory agencies to share information and collaborate on regulatory issues.

What is the drug approval process in Canada?

The drug approval process in Canada is a rigorous and multi-step process overseen by DEL Health Canada. It involves several stages, including pre-clinical testing, clinical trials, and a review of the data by DEL Health Canada. The agency evaluates the safety and efficacy of the drug and its manufacturing process before approving it. Once a drug is approved, DEL Health Canada continues to monitor its safety and effectiveness through post-market surveillance. This process ensures that Canadians have access to safe and effective medicines.

How can Canadian consumers access information about approved drugs and medical devices?

Canadian consumers can access approved drug and medical device information through the DEL Health Canada website. The website provides a searchable database of approved drugs and medical devices and information on drug recalls and safety alerts. Consumers can also report adverse reactions to medications or medical devices through the website. Additionally, healthcare professionals can access information on drug interactions, dosing, and prescribing through the website. Overall, the DEL Health Canada website is a valuable resource for Canadians seeking information on the safety and efficacy of drugs and medical devices.

We can help you with your USA compliance for Medical Devices, and Drug facilities or Canadian medical device and drug compliance.

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Everything you should know about Health Canada Controlled Substances

Health Canada Controlled Substances

Health Canada Controlled Substances

Health Canada, the Canadian federal health department, oversees the regulation of controlled substances in Canada. Controlled substances are regulated due to their potential for abuse, dependence, and public health and safety harm. They include drugs and substances that are categorized into different schedules based on their level of risk and potential for misuse.

In Canada, controlled substances are classified under the Controlled Drugs and Substances Act (CDSA). The CDSA categorizes controlled substances into various schedules, each with its regulations and restrictions that we’ll discuss in this blog.

What is a controlled substance in Canada?

Schedule I: Substances listed in Schedule I are considered the most tightly regulated and have a high potential for abuse. They are often prohibited for general use and may only be used for specific medical or scientific purposes. Examples of substances in Schedule I include heroin, cocaine, and LSD.

Schedule II: Substances listed in Schedule II have a high potential for abuse but may also have recognized medical uses. They are subject to strict controls, and their production, distribution, and service are tightly regulated. Examples of substances in Schedule II include cannabis, methamphetamine, and certain opioids.

Schedule III: Substances listed in Schedule III have a lower potential for abuse and may have recognized medical uses. They are subject to fewer restrictions compared to Schedule I and II substances. Examples of substances in Schedule III include certain anabolic steroids and some prescription drugs.

Schedule IV: Substances listed in Schedule IV have a lower potential for abuse than those in previous schedules and are often prescription medications. They are subject to less stringent controls. Examples of substances in Schedule IV include benzodiazepines and certain sedatives.

Schedule V: Substances listed in Schedule V have the lowest potential for abuse and are generally available over the counter or with a prescription. They are subject to minimal controls. Examples of substances in Schedule V include certain cough preparations containing small amounts of codeine.

It’s important to understand that the classification of substances into these schedules can change based on new research, evidence, and evolving public health concerns. Health Canada oversees the regulation and enforcement of controlled substances in Canada to ensure they are used safely and appropriately.

Suppose you have questions about a particular substance, its classification, legal status, or related regulations. In that case, I recommend referring to Health Canada’s official resources or consulting with our regulatory experts knowledgeable about Canadian drug regulations.

Health Canada Controlled Substances

How does Health Canada regulate controlled substances?

Health Canada regulates controlled substances in Canada through the Controlled Drugs and Substances Act (CDSA) and its associated regulations. The CDSA is the primary legislation that governs the legal framework for controlling and regulating drugs and substances with the potential for abuse, dependence, and harm to public health and safety. 

Here’s an overview of how controlled Health Canada regulates substances:

1. Classification and Scheduling: Health Canada categorizes controlled substances into different schedules (I to V) based on their potential for abuse, medical use, and overall risk. The schedules determine the level of control, restrictions, and regulations that apply to each substance. Substances with a higher potential for abuse and harm are placed in higher schedules with stricter rules.

2. Licensing and Permits: Manufacturers, distributors, healthcare professionals, researchers, and other entities involved with controlled substances must obtain appropriate licenses, permits, or authorizations from Health Canada to handle, produce, distribute, prescribe, or research these substances. These licenses outline the specific permitted activities and the conditions that must be met.

3. Production and Distribution: Health Canada regulates controlled substances’ production, distribution, and import/export. Manufacturers and distributors of controlled substances must adhere to strict quality standards, record-keeping, and reporting requirements. They must also follow Good Manufacturing Practices (GMP) to produce controlled substances.

4. Prescription and Dispensing: Certain controlled substances are available only by prescription from authorized healthcare professionals. Prescribing, dispensing, and administering controlled substances must comply with specific regulations and guidelines to ensure patient safety and prevent misuse.

5. Monitoring and Reporting: Health Canada oversees the monitoring of controlled substances through various mechanisms, including collecting data on production, distribution, prescriptions, and adverse reactions. Manufacturers, distributors, healthcare professionals, and researchers must report certain activities and events related to controlled substances.

6. Inspections and Enforcement: Health Canada conducts inspections of facilities involved with controlled substances to ensure compliance with regulations, including Good Manufacturing Practices (GMP) and Good Distribution Practices (GDP). Non-compliance can result in enforcement actions, such as license suspension, revocation, or legal penalties.

7. Research and Clinical Trials: Researchers conducting studies involving controlled substances must obtain specific authorizations from Health Canada. These authorizations ensure the research is conducted ethically, safely, and in compliance with regulations.

8. Education and Public Awareness: Health Canada provides educational resources and information to healthcare professionals, patients, and the public about the risks, safe use, and regulations related to controlled substances. Public awareness campaigns help promote responsible use and prevent misuse.

It’s important to note that controlled substance regulations are subject to change. Health Canada may update or amend the rules based on new research, emerging trends, and public health considerations.

Individuals and organizations involved with controlled substances should stay informed about the latest regulations and guidelines provided by Health Canada to ensure compliance and the safe handling of these substances. Health Canada also forewarns about their roles and duties, responses to non-compliance, enforcement actions, and guiding principles. 

Other Frequently Asked Questions about Controlled Substances in Canada

1. What are controlled substances in Canada?

  • Controlled substances are drugs and substances regulated under the Controlled Drugs and Substances Act (CDSA). They include narcotics, controlled drugs, and precursor chemicals used to produce controlled substances.

2. Who regulates controlled substances in Canada?

  • The regulation of controlled substances in Canada falls under the jurisdiction of Health Canada and the Controlled Drugs and Substances Act (CDSA).

3. What is the purpose of regulating controlled substances in Canada?

  • The primary purpose is to ensure public safety and health by controlling the production, distribution, and use of substances with potential abuse and harm.

4. How are controlled substances classified in Canada?

  • Controlled substances are classified into schedules (Schedules I to IV) based on their potential for abuse, medical use, and safety. Schedule I substances are considered the most dangerous. In contrast, Schedule IV substances have the lowest potential for abuse.

5. What licenses or permits are required to handle controlled substances in Canada?

  • Depending on the activities involving controlled substances, individuals and organizations may require licenses, permits, or exemptions from Health Canada. These include charges for production, distribution, importation, and research.

6. How can I apply for a license to handle controlled substances in Canada?

  • The application process for controlled substance licenses involves submitting a detailed application to Health Canada, demonstrating compliance with regulatory requirements, security measures, and record-keeping protocols.

7. What security measures are required for handling controlled substances in Canada?

  • Security measures include physical security (e.g., secure storage), personnel security (background checks), and operational security (protocols to prevent theft or diversion).

8. Are there specific record-keeping requirements for controlled substances in Canada?

  • Individuals and organizations handling controlled substances must maintain detailed records of activities, including acquisitions, disposals, and inventories, as Health Canada outlines.

9. Can healthcare professionals prescribe controlled substances in Canada?

  • Healthcare professionals, such as physicians and dentists, can prescribe controlled substances in Canada. Still, they must follow strict guidelines and maintain accurate records.

10. What are the penalties for unauthorized possession or trafficking of controlled substances in Canada? 

  • Penalties for unauthorized possession or trafficking of controlled substances can be severe, including fines, imprisonment, and criminal charges.

11. Can controlled substances be imported or exported in Canada

  • Controlled substances can be imported or exported for legitimate purposes. Still, individuals or organizations must have the appropriate licenses and permits from Health Canada.

12. Where can I find comprehensive guidance on regulatory compliance for controlled substances in Canada?

  • Health Canada provides comprehensive guidance documents and resources on regulating controlled substances in Canada. Additionally, legal and regulatory experts can offer guidance and support for compliance.
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New CFIA regulatory responsibilities regarding caffeinated energy drinks

In response to an increasing number of consumer inquiries, the Canadian Food Inspection Agency (CFIA) would like to inform Canadians about regulatory responsibilities with respect to caffeinated alcoholic beverages.

In response to an increasing number of consumer inquiries, the Canadian Food Inspection Agency (CFIA) would like to inform Canadians about regulatory responsibilities with respect to caffeinated alcoholic beverages.The Canadian Food Inspection Agency (CFIA) has regulated food products for many years, with a particular focus on the safety of Canadians. This includes ensuring products are packaged, labeled, and advertised by government regulations and guidelines that set standards to protect the health and safety of consumers.

In response to an increasing number of consumer inquiries, the Canadian Food Inspection Agency (CFIA) would like to inform Canadians about regulatory responsibilities concerning caffeinated alcoholic beverages. in this news article, we’ll review the CFIA recall warnings, the impact of this news on vulnerable populations, CFIA inspection activities, and how our Supplemented Foods service can help you.

CFIA recall warnings:

Several brands of caffeinated energy drinks have received recall alerts from the Canadian Food Inspection Agency (CFIA). We know that many importers, merchants, and internet vendors are offering customers caffeinated energy drinks (CEDs) that must comply. This serves as a reminder that it is your responsibility to ensure that the CEDs you produce, import, or distribute comply with Canadian regulations, including the need that they do not contain more than 180 mg of caffeine per single-serving container, and display the necessary warnings required for Supplemented Foods.. Supplemented Foods (SFs) are prepackaged foods with 1 or more supplemental ingredients. Supplemental ingredients include things such as vitamins, minerals, amino acids, or caffeine.

Impact on vulnerable populations:

Drinking CED products may negatively impact vulnerable groups, including children, women who are breastfeeding or pregnant, and adults who are caffeine sensitive. Negative health impacts are also anticipated if other people consume these goods excessively. These groups rely on and have faith in the industry not to offer them goods that do not adhere to Canadian food safety regulations. If you market a product that falls short of these requirements, it may be ingested by a vulnerable consumer and cause harm to them.

CFIA inspection activities to locate non-compliance:

The CFIA is conducting inspections to determine who needs to comply. The CFIA may take legal action when non-compliance is discovered, including product seizure and detention, license suspension, administrative fines, or criminal prosecution.

License holders under the Safe Food for Canadians Regulations will still be obligated to inform the CFIA if their food threatens human health.

If you import CEDs:

  • Ensure you meet the requirements set out in your Temporary Marketing Authorization Letter (TMAL) from Health Canada or under the newly implemented Supplemented Foods Regulations
  • Ensure your products meet the needs of the regulations at the time of import If you distribute CEDs :
  • Ensure your product meets the requirements before distributing further.

How can our Supplemented Foods Service help you?

Quality Smart Solutions can help ensure your Supplemented Food products, including CEDs, comply with the newly implemented Supplemented Food Regulations. We will review your product formulation to check that caffeine levels are below the 180 mg limit (if applicable) and that the rest of the formulation complies with Health Canada’s list of permitted supplemented food categories as well as the list of permitted supplemental ingredients. After tailoring your formulation to meet the regulations, we can help bring your product label into compliance by making sure all the required labeling elements are present, including the supplemented food caution identifier and high caffeine content declaration. Quality Smart Solutions has recently helped several brands bring their energy drinks into compliance! Reach out to us today.

Helpful Information

To assist the industry in the interpretation of the SFs requirements and to ensure their SFs are compliant, the following resources are available:

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

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

Thirdly, we help with Safe Foods for Canadians Regulations (HACCP, PCP, Importer of Record Licensing, NDIN/GRAS Ingredients and GRAS Notifications). 

Help with facility registration, FSVP agent, and US Agent. 

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Quality Management Systems (QMS): Impact of Quality Assurance & Quality Control

Quality Management Systems (QMS): Impact of Quality Assurance & Quality Control

Quality Management Systems (QMS) are an essential part of the life sciences healthcare industry, and many people need clarification on what a Quality Assurance person is. The FDA and ISO 9000 mandate quality processes, including quality assurance (QA) and quality control (QC) in medical devices, pharmaceuticals, and other sectors. They are crucial to regulated businesses since they guarantee the quality and efficacy of their goods. 

Quality Management Systems (QMS): Impact of Quality Assurance & Quality Control

Although quality assurance and quality control are two distinct activities that coincide, they are frequently used interchangeably. Each has a unique role to play in life sciences organizations that is essential for efficient quality control. Your organization can master each function by clearly understanding it and producing the finest goods possible.

In our blog, we’ll cover everything you should know about quality assurance (QA) and quality control (QC) in terms of their impact on Quality Management Systems, starting with what they are: For adverse reaction reporting assistance or non-conformance reports ask us.

Quality Assurance (QA) Definition: Prevention by having rules, principles, and guidelines in place

Quality assurance (QA) refers to a systematic process or set of activities and practices to ensure that products, services, or processes consistently meet or exceed established standards, specifications, and customer expectations. The primary goal of quality assurance is to prevent defects, errors, or issues from occurring and to ensure that a high level of quality is consistently maintained throughout the entire lifecycle of a product or service.

Quality Control (QC) Definition: Reacting to errors in products

Quality control (QC) refers to systematically monitoring, testing, and inspecting products, services, or processes to ensure they meet or exceed established quality standards, specifications, and requirements. The primary goal of quality control is to identify and correct any defects, errors, or deviations from the desired level of quality before the final product or service is delivered to customers or users.

What is a Quality Management System (QMS)?

A Quality Management System (QMS) is a structured and systematic framework that an organization establishes and implements to manage and ensure the quality of its products, services, processes, and operations. The primary goal of a QMS is to achieve consistent quality, meet customer requirements, and continuously improve the organization’s overall performance.

Key components and principles of a Quality Management System include:

  1. Documentation and Procedures: QMS involves creating and maintaining comprehensive documentation that outlines standardized processes, procedures, work instructions, and guidelines. This documentation provides a clear roadmap for performing tasks to ensure consistency and quality.
  2. Quality Policies and Objectives: Organizations establish quality policies that reflect their commitment to delivering high-quality products and services. Quality objectives are set to align with these policies and provide measurable targets for improvement.
  3. Process Management: QMS focuses on the management and optimization of processes throughout the entire product lifecycle, from design and development to production, distribution, and customer support.
  4. Risk Management: Identifying and assessing potential risks affecting product quality or customer satisfaction is essential to QMS. Strategies are developed to mitigate these risks.
  5. Customer Focus: QMS strongly emphasizes understanding customer needs and expectations. By consistently meeting customer requirements, organizations can enhance customer satisfaction and loyalty.
  6. Continuous Improvement: A core principle of QMS is continuous improvement. Organizations monitor performance, collect data, analyze trends, and implement changes to enhance processes and outcomes.
  7. Measurement and Analysis: QMS involves collecting and analyzing data related to quality indicators, process performance, customer feedback, and other relevant metrics. This data-driven approach helps in making informed decisions and identifying areas for improvement.
  8. Employee Involvement and Training: Engaged and well-trained employees are essential to successful QMS implementation. Training programs are developed to ensure employees understand their roles and responsibilities in maintaining quality.
  9. Supplier and Partner Relationships: QMS extends to managing relationships with suppliers and partners. Effective communication and collaboration with external stakeholders contribute to the overall quality of products and services.
  10. Audit and Compliance: Regular internal audits and assessments ensure that processes adhere to established standards and regulations. External audits may also be performed to ensure compliance with industry-specific requirements.
  11. Certification and Recognition: Organizations can seek certification to internationally recognized QMS standards such as ISO 9001. Certification demonstrates a commitment to quality and can enhance credibility with customers and stakeholders.

A well-implemented Quality Management System helps organizations streamline operations, minimize defects, reduce waste, enhance customer satisfaction, and improve overall business performance. It is applicable across various industries and sectors, including manufacturing, healthcare, services, software development, and more.

What is the role of Quality Assurance and Quality Control within your quality management system (QMS)?

Quality Assurance (QA) and Quality Control (QC) play distinct but interconnected roles within a Quality Management System (QMS). They ensure that an organization’s products, services, and processes meet established quality standards, customer requirements, and regulatory compliance. Click here for the key similarities and differences between QA and QC by Cannabis License Experts. Let’s explore the roles of QA and QC within a QMS:

Quality Assurance (QA):

  1. Process Management: QA focuses on establishing and maintaining standardized processes, procedures, and workflows throughout the organization. It involves developing a systematic task performance approach to ensure consistency and reliability.
  2. Preventive Measures: QA is primarily concerned with preventing defects and issues from occurring in the first place. It involves identifying potential risks, vulnerabilities, and areas of improvement within processes and taking proactive measures to mitigate these risks.
  3. Documentation and Policies: QA includes creating and maintaining detailed documentation that outlines quality policies, objectives, and guidelines for various processes. These documents serve as a reference for employees to ensure that tasks are performed consistently and under established standards.
  4. Continuous Improvement: QA encourages a culture of continuous improvement by monitoring processes, analyzing data, and identifying opportunities for enhancement. QA teams work to optimize processes to achieve better outcomes and increased efficiency.
  5. Training and Education: QA ensures employees are adequately trained and equipped to follow established processes and best practices. Regular training programs help maintain a skilled and knowledgeable workforce, contributing to quality.

Quality Control (QC):

  1. Inspection and Testing: QC involves the systematic assessment, testing, and evaluation of products, services, and processes to identify defects, errors, or deviations from established standards. It is a reactive approach aimed at detecting and addressing issues after they occur.
  2. Conformance Checking: QC ensures that products and services meet the specified requirements and standards. It involves comparing actual results against predetermined criteria and taking corrective action if discrepancies are found.
  3. Data Collection and Analysis: QC relies on data collection and analysis to measure product and process performance. Statistical techniques are often used to assess variations and determine if the quality of products or services is within acceptable limits.
  4. Sampling: QC often involves selecting a representative sample of products or components for inspection and testing. The results obtained from the selection provide insights into the overall quality of the entire batch.
  5. Immediate Corrections: If defects or issues are identified during QC activities, quick corrective actions are taken to rectify the problems before products are released to customers.

In summary, QA focuses on establishing processes and practices that prevent quality issues from arising. At the same time, QC involves the active monitoring, testing, and inspection of products and services to identify and correct problems that have occurred. QA and QC are vital components of a comprehensive QMS, working together to ensure consistent quality, customer satisfaction, and continuous organizational improvement.

How do you determine if you have a great quality management system? 

A superb Quality Management System (QMS) is characterized by its ability to consistently deliver high-quality products, services, and processes that meet or exceed customer expectations. While there isn’t a one-size-fits-all checklist to determine the quality of a QMS, several key elements and indicators can help you assess the effectiveness of your QMS. Here’s a list to consider:

1. Clearly Defined Quality Policies and Objectives:

  • Are your organization’s quality policies and objectives documented and communicated to all employees?
  • Do these policies align with your organization’s overall mission and customer expectations?

2. Comprehensive Documentation:

  • Do you have well-documented processes, procedures, work instructions, and guidelines that guide employees in performing their tasks consistently?
  • Is documentation easily accessible to employees who need it?

3. Risk Management:

  • Have potential risks impacting product quality, safety, or customer satisfaction been identified and assessed?
  • Are risk mitigation strategies in place to address identified risks?

4. Customer Focus:

  • Is your organization actively gathering and incorporating customer feedback and requirements into your processes and products?
  • Are you consistently meeting customer expectations and addressing any issues promptly?

5. Process Management:

  • Are your processes standardized and well-defined to ensure consistency and repeatability?
  • Do you regularly monitor and measure process performance to identify areas for improvement?

6. Continuous Improvement:

  • Is there a culture of continuous improvement within your organization?
  • Are you actively collecting and analyzing data to identify trends and opportunities for enhancement?

7. Training and Competence:

  • Do you have a structured training program to ensure that employees are knowledgeable and skilled in their roles?
  • Are employees empowered to take ownership of quality and contribute to improvement initiatives?

8. Quality Control:

  • Have you established quality control measures to identify and correct defects or issues, including inspection, testing, and monitoring?
  • Is the frequency and scope of quality control activities appropriate for your products and processes?

9. Root Cause Analysis and Corrective Actions:

  • Are processes in place to identify the root causes of defects or non-conformities?
  • Are corrective actions taken to prevent the recurrence of issues and improve operations?

10. Supplier and Partner Relationships:

  • Do you collaborate closely with suppliers and partners to ensure their products or services meet your quality requirements?
  • Are supplier audits conducted to ensure their adherence to quality standards?

11. Metrics and Performance Indicators:

  • Are you using key performance indicators (KPIs) to measure the effectiveness of your QMS and overall quality performance?
  • Do you regularly review these metrics and take action based on the insights gained?

12. External Certification and Recognition:

  • Have you sought external certification for your QMS, such as ISO 9001?
  • Have you received positive feedback or recognition from customers, regulatory bodies, or industry peers?

13. Regulatory Compliance:

  • Are you consistently meeting regulatory requirements and industry standards that pertain to your products or services?

Remember that the effectiveness of a QMS can vary based on the unique characteristics of your organization, industry, and products. Regular audits, assessments, and feedback from employees, customers, and stakeholders can provide valuable insights into the strengths and areas for improvement within your QMS.

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. 

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Your comprehensive guide to GRAS Applications for peak efficiency and success

GRAS applications

GRAS applicationsAre you ready to take your business to new heights? Look no further. In this comprehensive guide, we will unlock the potential of GRAS applications to help you achieve peak efficiency and success. Whether you’re a small startup or an established enterprise, understanding the power of GRAS (Generally Recognized as Safe) applications is essential for reaching your business goals.

GRAS applications encompass various industries, from food and beverages to pharmaceuticals and cosmetics. By incorporating GRAS ingredients into your products, you can ensure consumer safety and gain a competitive edge in the market. This guide will provide a step-by-step approach to implementing GRAS applications, starting with a detailed overview of what GRAS means and how it is regulated. We’ll then dive into the different industries where GRAS applications are prevalent, exploring the benefits and challenges within each sector.

Understanding the importance of GRAS in various industries

GRAS applications encompass various industries, from food and beverages to pharmaceuticals and cosmetics. By incorporating GRAS ingredients into your products, you can ensure consumer safety and gain a competitive edge in the market. GRAS is crucial as it provides businesses with a framework to determine the ingredients’ safety in various applications. It allows manufacturers to use certain substances without seeking pre-market approval from regulatory bodies, saving time and resources.

In the food and beverage industry, GRAS applications are particularly significant. They ensure that the ingredients used in food products are safe for consumption and do not pose any health risks to consumers. By incorporating GRAS ingredients, food manufacturers can enhance their product offerings and meet the growing demand for safe and healthy food options. Furthermore, GRAS applications in the pharmaceutical, cosmetic, and personal care industries are equally important, as they ensure the safety and efficacy of products used by consumers.

The regulatory landscape for GRAS applications

To fully leverage the potential of GRAS applications, it is crucial to understand the regulatory landscape surrounding them. The United States Food and Drug Administration (FDA) is vital in regulating GRAS applications.

The FDA has established a rigorous process for determining the safety of GRAS ingredients, which involves evaluating scientific evidence and expert opinions. This process ensures that GRAS applications meet the highest security and quality standards. For businesses looking to incorporate GRAS ingredients into their products, navigating the regulatory requirements effectively is essential. Compliance with FDA regulations is crucial to avoid legal issues and maintain consumer trust. Working with regulatory experts and conducting thorough research can help businesses ensure that their GRAS applications are in full compliance with the FDA’s guidelines.

Gras License Process

Typical GRAS applications in the food and beverage industry

The food and beverage industry is a prime example of the widespread use of GRAS applications. Many commonly consumed food products contain GRAS ingredients deemed safe for consumption by regulatory authorities. Some examples of GRAS applications in the food industry include natural sweeteners like stevia, preservatives like citric acid, and food colorings like beta-carotene.

GRAS applications in the food and beverage industry offer numerous benefits. Firstly, it allows manufacturers to create products that meet consumer demands for healthier and more natural options. Secondly, GRAS applications provide a level of assurance to consumers, assuring them that the products they consume have undergone rigorous safety evaluations. Finally, incorporating GRAS ingredients can enhance food and beverage products’ flavor, texture, and overall quality.

GRAS applications in the pharmaceutical and healthcare industry

GRAS applications are critical in ensuring the safety and efficacy of medications and healthcare products in the pharmaceutical and healthcare industries. Many active pharmaceutical ingredients (APIs) used in remedies are classified as GRAS, reassuring healthcare professionals and patients. This classification allows pharmaceutical companies to focus on the development and production of medications without the need for extensive safety testing.

The use of GRAS applications in the pharmaceutical industry offers several advantages. Firstly, it streamlines the drug development process, allowing for faster and more cost-effective production of medications. Secondly, it ensures that healthcare products are safe for consumption and do not pose unnecessary patient risks. Finally, GRAS applications in the pharmaceutical industry foster innovation, as researchers can focus on developing new treatments and therapies rather than repeating safety evaluations for existing ingredients.

GRAS applications in the cosmetics and personal care industry

The cosmetics and personal care industry heavily relies on GRAS applications to ensure the safety and effectiveness of their products. Many ingredients used in cosmetics and unique care products, such as moisturizers, shampoos, and makeup, are classified as GRAS. This classification gives manufacturers the confidence to use these ingredients in their formulations without compromising consumer safety.
The use of GRAS applications in the cosmetics and personal care industry has several benefits.

Firstly, it allows manufacturers to create safe skin, hair, and body products. This reassures consumers that their products will not cause harm or adverse reactions. Secondly, GRAS applications in this industry enable the development of innovative and effective products that cater to various consumer needs and preferences. Lastly, incorporating GRAS ingredients can enhance the overall quality and performance of cosmetics and personal care products.

GRAS applications in the agricultural and farming industry

The agricultural and farming industries also benefit from GRAS applications, particularly crop protection and enhancement. Many substances used in agriculture, such as biopesticides and growth enhancers, are classified as GRAS. This classification ensures that these substances do not harm human health or the environment while helping farmers improve crop yields and protect their harvests.

GRAS applications in the agricultural industry offer several advantages. Firstly, they provide farmers with effective and environmentally friendly alternatives to traditional pesticides and fertilizers. This promotes sustainable farming practices and reduces the potential negative impact on ecosystems. Secondly, GRAS applications help farmers meet consumer demands for organic and pesticide-free produce, enhancing market competitiveness. Lastly, they contribute to agricultural products’ safety and quality, ensuring consumers enjoy safe and nutritious food.

Case studies of successful GRAS applications

To further understand the potential of GRAS applications, let’s explore some case studies of successful implementation. One notable example is the use of GRAS ingredients in plant-based meat alternatives. Companies like Beyond Meat and Impossible Foods have successfully developed meat substitutes that taste delicious and provide a safe and sustainable protein source. By using GRAS ingredients, these companies have gained widespread consumer acceptance and disrupted the traditional meat industry.

Another case study is the use of GRAS applications in skincare products. Brands like The Ordinary and Drunk Elephant have created highly effective, popular skincare formulations using GRAS ingredients. These products have garnered a loyal following due to their safety, affordability, and visible results. By leveraging GRAS applications, these brands have revolutionized the skincare industry and set new standards for quality and transparency.

Challenges and considerations in implementing GRAS applications

While the potential of GRAS applications is vast, there are challenges and considerations that businesses must be aware of when implementing them. Firstly, staying up-to-date with regulatory changes and ensuring compliance with evolving guidelines is crucial. The FDA regularly updates its regulations, and businesses must adapt their practices to maintain GRAS status.

Secondly, businesses must invest in research and development to ensure the safety and efficacy of their GRAS applications. Thorough testing and evaluation are necessary to provide scientific evidence supporting the protection of GRAS ingredients. This requires resources and expertise to conduct comprehensive studies and gather relevant data.

Lastly, businesses must effectively communicate the benefits and safety of their GRAS applications to consumers. Transparency and education are vital in building consumer trust and confidence in these products. Clear labeling and marketing efforts that emphasize the safety and quality of GRAS ingredients can help businesses overcome potential skepticism and gain consumer acceptance.

Best practices for maximizing the efficiency and success of GRAS applications

To maximize the efficiency and success of GRAS applications, businesses should follow certain best practices. Firstly, it is crucial to establish strong relationships with regulatory experts who can provide guidance and support in navigating the regulatory landscape. These experts can help businesses understand the requirements and ensure compliance with relevant regulations.

Secondly, investing in research and development is vital to developing innovative GRAS applications. By staying at the forefront of scientific advancements and conducting thorough testing, businesses can create products that meet consumer demands and provide a competitive edge.

Additionally, businesses should prioritize transparency and communication with consumers. Clearly labeling products and providing accurate information about the safety and benefits of GRAS ingredients can build trust and credibility with consumers. Engaging in educational initiatives and sharing scientific research can enhance consumer confidence in GRAS applications.

Resources and tools for navigating GRAS applications

Navigating the world of GRAS applications can be complex, but resources and tools are available to assist businesses. The FDA website provides detailed information on GRAS regulations, guidelines, and the submission process. It is a valuable resource for companies looking to understand the requirements and stay updated on regulatory changes.

Working with regulatory consultants and industry associations can also provide businesses with expert guidance and support. These professionals have in-depth knowledge of GRAS applications and can help enterprises to navigate the regulatory landscape effectively.

Conclusion:

In conclusion, GRAS applications allow businesses to unlock their full potential and achieve peak efficiency and success. By incorporating GRAS ingredients into products, companies can ensure consumer safety, gain a competitive edge, and meet the growing demand for safe and healthy options. Understanding the regulatory landscape, exploring typical applications in various industries, and implementing best practices are crucial for maximizing the benefits of GRAS applications. With the right approach and resources, businesses can harness the power of GRAS and propel themselves forward in their respective industries. Unlock the potential of GRAS applications and unlock a world of possibilities for your business.

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!

Additional Reading about GRAS:

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Everything you should i know about Health Canada product monographs

Health Canada product monographs

Health Canada product monographsHealth Canada publishes product monographs to describe a product’s health risks, benefits, and performance. Product monographs are for health products licensed by Health Canada and those approved by the Natural Health Products Directorate (NHPD). A product may appear on the market without a product monograph being written. A manufacturer is responsible for ensuring that the information provided on labels and in marketing submissions is accurate.

They contain comprehensive safety, efficacy, and quality information on human health products sold in Canada. They include information on how the products should be used and stored, a description of the ingredients, and how they were manufactured. This blog answers the what, why, when, who, and more questions about Health Canada product monographs.

What is a product monograph?

Health Canada product monographs are essential documents that provide comprehensive and detailed information about regulated health products, including prescription drugs, over-the-counter medications, natural health products, and medical devices. 

What is commonly found in a product monograph?

Here are the key components typically found in a product monograph:

  1. Product Identification: This section includes the brand, generic, and other product trade names. It may also include information about the dosage form, strength, and route of administration.
  2. Indications and Clinical Use: This section outlines the approved therapeutic uses for the product, including specific medical conditions it is intended to treat or prevent.
  3. Dosage and Administration: Information about the recommended dosing regimen, including instructions for how the product should be taken, administered, or applied. This section may include details about dosing adjustments for different patient populations (e.g., children, elderly patients).
  4. Contraindications: A list of circumstances or medical conditions under which the product should not be used due to potential risks or adverse effects.
  5. Warnings and Precautions: Important safety information, including potential risks, interactions with other substances, and specific precautions to take when using the product.
  6. Adverse Reactions: A comprehensive list of known side effects and adverse reactions associated with the product, along with their frequencies and severity.
  7. Clinical Pharmacology: Information about how the product works in the body, including its mechanism of action, pharmacokinetics (absorption, distribution, metabolism, and excretion), and pharmacodynamics (effects on the body).
  8. Nonclinical Toxicology: Data from preclinical studies provide insights into the product’s potential toxicity and safety profile.
  9. Clinical Studies: Summaries of vital clinical trials and studies conducted to demonstrate the product’s safety and efficacy. This may include information on patient populations, study designs, endpoints, and results.
  10. Storage and Handling: Instructions for proper storage conditions to ensure the product’s stability and effectiveness.
  11. Date of Revision: The date on which the monograph was last updated or revised.
  12. How Supplied: Details about packaging, available sizes, and any additional materials or accessories that come with the product.

What is the role of these product monographs?

Product monographs are critical in ensuring healthcare professionals and consumers access accurate, evidence-based information about health products. They help guide these products to safe and effective use, facilitate informed decision-making, and contribute to patient safety.

These monographs serve as a valuable resource for healthcare professionals, regulators, and the general public to understand a specific health product’s characteristics, indications, contraindications, dosing, safety, and efficacy. 

What you should know about Health Canada product monographs:

  1. Purpose and Content: Product monographs are created by the health product manufacturer and reviewed and approved by Health Canada. They contain essential information about the product, including its active ingredients, therapeutic indications, recommended dosage, administration guidelines, contraindications, warnings, precautions, adverse reactions, and clinical trial data.
  2. Regulatory Approval: Health Canada reviews and evaluates the information provided in the product monograph to ensure that the health product is safe, effective, and of high quality before it can be authorized for sale in Canada.
  3. Accessibility: Product monographs are typically available to the public on Health Canada’s Drug Product Database (DPD) or Natural Health Products Database (NHPD) websites. Healthcare professionals and consumers can access these monographs to make informed decisions about using health products.
  4. Updates and Revisions: Health Canada requires manufacturers to keep their product monographs updated with new information, including any changes to indications, dosing, safety information, or manufacturing processes. This helps ensure the most current and accurate information is available to healthcare professionals and patients.
  5. Comparison to Other Countries: Health Canada product monographs may be similar in purpose and content to documents like the United States FDA-approved product labeling (package inserts) and the European Summary of Product Characteristics (SmPC). However, specific requirements and formats may vary among different regulatory agencies.
  6. Patient Information: Some product monographs also include patient-friendly sections that provide essential information about the health product in language that is easy to understand. This helps patients make informed decisions about their treatment.
  7. Off-Label Use: While product monographs provide information about authorized uses of a health product, healthcare professionals sometimes prescribe medications for off-label uses that are not explicitly listed in the monograph. This practice is based on their clinical judgment and the available evidence.
  8. Importance for Healthcare Professionals: Healthcare professionals, including doctors, pharmacists, and nurses, rely on product monographs to make informed decisions about prescribing, dispensing, and administering health products. They use this information to ensure patient safety and optimal therapeutic outcomes.

When using Health Canada product monographs, it’s essential to refer to the most current version available on official government websites and to consider the specific context and patient needs. These monographs are crucial tools for promoting safe and effective healthcare practices.

How can I check for Health Canada monograph updates?

To check for updates to Health Canada product monographs, you can follow these steps:

  1. Health Canada’s Drug Product Database (DPD):
  2. The Drug Product Database (DPD) is a comprehensive source of information about approved drugs in Canada. It provides access to product monographs, including updates and revisions. Here’s how you can use the DPD to check for updates:
  3. a. Visit the Health Canada Drug Product Database website: 
  4. b. Use the search function to find your desired drug or product. You can search by brand name, generic name, or active ingredient.
  5. c. Once the product is located, click on its name to access the detailed product monograph.
  6. d. Look for the “Date of Revision” or a similar section in the monograph. This information indicates when the monograph was last updated.
  7. Health Canada’s Natural Health Products Database (NHPD):
  8. For natural health products, you can use the Natural Health Products Database (NHPD) to check for updates to product monographs:
  9. a. Visit the Health Canada Natural Health Products Database website:
  10. b. Use the search function to find the specific natural health product you want.
  11. c. Once the product is located, click on its name to access the detailed product monograph.
  12. d. Look for the “Date of Revision” or a similar section in the monograph to determine the latest update.
  13. Subscriptions and Notifications:
  14. Health Canada may offer subscription or notification services that allow you to receive updates when product monographs are revised or new information is added. These services can help you stay informed about changes without actively checking the databases.
  15. a. Check the Health Canada website or contact Health Canada’s regulatory information service for subscription or notification options.

It’s important to note that product monographs are regularly updated as new information becomes available, such as changes in dosing recommendations, safety warnings, or indications. Keeping track of these updates is crucial for healthcare professionals, patients, and consumers to ensure health products’ safe and effective use. Always refer to official Health Canada sources for the most accurate and up-to-date information.

How do I use the Health Canada product Monograph database?

To use the Health Canada Product Monograph Database, which includes both the Drug Product Database (DPD) and the Natural Health Products Database (NHPD), follow these steps:

  1. Access the Database:
  2. a. For drug products, visit the Drug Product Database (DPD) website: 
  3. b. For natural health products, visit the Natural Health Products Database (NHPD) website: 
  4. Search for a Product:
  5. a. You’ll find a search bar on the DPD or NHPD homepage. Enter the name of the drug or natural health product you want to search for. You can search by brand name, generic name, active ingredient, or other relevant information.
  6. b. Click on the “Search” button to initiate the search.
  7. View Product Information:
  8. a. Browse the search results to find the specific product you want.
  9. b. Click on the product name to access its detailed product monograph.
  10. Explore the Monograph:
  11. a. The product monograph provides comprehensive information about the product, including its indications, dosing, contraindications, warnings, adverse reactions, and more.
  12. b. Navigate through the monograph using the table of contents or scroll through the document to find the specific information you want.
  13. c. Pay attention to important sections such as “Indications and Clinical Use,” “Dosage and Administration,” “Warnings and Precautions,” and “Adverse Reactions.”
  14. Check for Updates:
  15. a. Look for information about the “Date of Revision” or a similar section within the monograph. This will indicate when the monograph was last updated.
  16. b. If you’re concerned about the currency of the information, you can contact Health Canada or refer to other reliable sources to verify any recent updates.
  17. Print or Save the Monograph:
  18. a. You can print or save the monograph for your reference. This can be useful for healthcare professionals and individuals who want to keep a record of the information.
  19. Additional Features:
  20. a. The databases may offer additional features, such as advanced search options, viewing product labels or packaging, and links to related resources.

Remember that the Health Canada Product Monograph Database is valuable for accessing accurate and up-to-date information about regulated health products. It’s crucial to rely on official sources like this database when making decisions about the use of health products. If you have questions or need further assistance, contact Health Canada’s regulatory information service for guidance.

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How to Get a Medical Device Establishment License in Canada

Canada medical device establishment licence form application

Canada medical device establishment licence form application

If you’re planning to sell or distribute medical devices in Canada, obtaining a medical device establishment licence (MDEL) is one of the first and most important steps. Health Canada requires this licence to ensure companies meet national safety, quality, and post-market surveillance standards. 

Whether you’re a new business or expanding into the Canadian market, navigating Health Canada’s requirements can be challenging. This MDEL guidance explains who needs a licence, how to apply, common mistakes to avoid, and what to expect after you’re approved. Let’s explore how to stay compliant and accelerate your path to market. 

What is a Medical Device Establishment Licence? 

A medical device establishment licence is issued by Health Canada to authorize companies that import, distribute, or manufacture medical devices for human use in Canada. It verifies that your establishment follows the requirements set out under the Medical Devices Regulations. 

Importantly, the MDEL is different from a Medical Device Licence (MDL), which applies to the device itself. If you’re unsure how to begin, having the right MDEL guidance can make the process more manageable. 

Who needs a medical device establishment licence? 

You need an MDEL if your business imports medical devices into Canada for resale, sells or distributes medical devices that fall under Class I, II, III, or IV, or manufactures Class I medical devices. 

However, you are exempt from requiring an MDEL if you only manufacture Class II, III, or IV devices under your own name and already hold a valid MDL, if you operate as a healthcare facility purchasing devices for internal use, or if you’re a retailer selling directly to individual consumers for personal use. 

If you’re unsure which class your device falls into, Health Canada provides a classification guidance document available on their official site. 

How to apply for an MDEL 

Applying for a medical device establishment licence involves more than just filling out a form. The following steps offer practical MDEL guidance to help you avoid delays and meet all Health Canada requirements efficiently: 

1. Establish documented procedures

Before applying, make sure your business has a few key procedures in place. These include maintaining distribution records, having a basic process for handling complaints, a system for reporting serious issues to Health Canada, and a clear recall plan. These steps show that your company is ready to meet regulatory expectations. 

2. Submit your application package

To apply, complete the Medical Device Establishment Licence application form and prepare the required documentation. Then, submit your full application package to Health Canada as outlined in their current guidance. Ensure all forms are completed accurately and that your company’s details and role are clearly indicated. 

3. Pay the required fees

Health Canada charges a fee for processing MDEL applications, and small businesses may be eligible for a reduced rate. Make sure to review the current fee structure and eligibility criteria before submitting. 

4. Health Canada review

Once submitted, Health Canada reviews the application and supporting documentation. Timelines can vary, but the average processing time is up to 120 calendar days, depending on the completeness of your application. During this period, Health Canada may request clarifications or additional information. 

5. Receive your MDEL and maintain compliance

Upon approval, you’ll receive a licence number and be listed in Health Canada’s public MDEL database. Keep in mind that MDELs must be renewed annually by April 1, and any change in business operations must be reported. 

Common pitfalls that delay MDEL approval 

Many companies underestimate the importance of submitting a complete and compliant application. Common mistakes include missing or incomplete SOPs, outdated forms, submitting through the wrong portal, or not responding to Health Canada’s requests in time. These errors can result in costly delays. Working with regulatory experts helps avoid these issues. 

What happens after you get your MDEL? 

Your responsibilities don’t end once you’ve received your licence. Holding an MDEL means committing to continuous compliance. You’ll need to renew annually, manage complaints and recalls properly, and be prepared for on-site inspections. Keeping your procedures up to date and your records well organized is essential. 

How Quality Smart Solutions can help 

At Quality Smart Solutions, we guide you through the full process of obtaining and maintaining your medical device establishment licence. We help you review and draft SOPs that align with Health Canada’s expectations, manage the application process from start to finish, support your annual renewals, and assist during any Health Canada audits or inspections. This way, you can stay focused on your operations while we take care of the regulatory details. 

Whether you’re applying for the first time or need help navigating a renewal, our experienced regulatory team is here to help. Contact us today to get started. 

FAQs

Do I need an MDEL if I only distribute medical devices made by other companies?

Yes. Even if you don’t manufacture the product, you need a valid MDEL to distribute or import it in Canada. 

You don’t need a Medical Device Licence (MDL), but you must have an MDEL to legally manufacture or distribute Class I devices. 

Your licence may be suspended or cancelled. You would then need to stop operations and reapply, which can delay business activities significantly. 

It can be complex depending on your internal procedures. Working with a regulatory partner reduces the risk of errors and speeds up approval. 

You can apply independently, but many companies prefer to work with experienced consultants to reduce delays and compliance risks. 

Ready to apply for your MDEL? 

Whether you’re a distributor, importer, or Class I manufacturer, we’re here to help. Partner with Quality Smart Solutions to follow the right MDEL guidance, streamline your licensing, and stay compliant. Reach out to our team or explore our Medical Device services to learn more. 

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Ultimate FDA Establishment Registration guide for your business

FDA Establishment Registration for Your Business

FDA Establishment Registration for Your BusinessAre you running a business that deals with food, drugs, medical devices, cosmetics, or dietary supplements? If so, you must know the FDA establishment registration requirements to ensure your products meet legal standards and are safe for public consumption. The process of FDA establishment registration may seem daunting, but with the proper guidance, it can be a straightforward and manageable process.

This ultimate guide will walk you through the necessary steps for FDA establishment registration, including the definition of an establishment, the benefits of registration, and the requirements for different types of businesses. You’ll also learn how to renew your registration, update your information, and avoid common pitfalls. Whether you’re starting a new business or looking to expand your existing one, this guide will provide you with essential knowledge and resources to stay compliant with FDA regulations and keep your customers safe. So, let’s dive in and explore the world of FDA establishment registration together.  We also have a FDA FURLS and Establishment Registration page that you’ll definitely want to check out.

Why is FDA Establishment Registration important?

FDA establishment registration is crucial for businesses that deal with food, drugs, medical devices, cosmetics, or dietary supplements. The FDA uses this registration process to track products and monitor their safety. By registering your establishment with the FDA, you demonstrate your commitment to quality and safety. It also shows that your business complies with FDA regulations, which helps build trust with your customers and suppliers. Furthermore, registration is a prerequisite for importing and exporting products to and from the United States.

FDA establishment registration is also essential because it enables the FDA to respond quickly to public health emergencies. In the event of a product recall or outbreak, the FDA can use the establishment registration information to identify the source of the problem and take appropriate action. It also allows the FDA to conduct inspections and audits to ensure your business complies with the regulations.

What are the FDA Establishment Registration requirements?

The FDA defines an establishment as any place of business where food or medical products are manufactured, processed, packed, or held. FDA establishment registration requirements vary depending on the type of business and the products you are dealing with. Generally, companies manufacturing, processing, packing, or holding food or medical products must register with the FDA. If you are a foreign business that exports products to the United States, you must also register with the FDA. The FDA requires you to appoint a US agent to liaison with the FDA. The US agent should be located in the United States and be available to communicate with the FDA on behalf of your business.

Some businesses are exempt from FDA establishment registration. For example, companies that only hold or distribute products but do not manufacture or process them are not required to register. Similarly, businesses that produce low-risk products, such as handcrafted soap or homemade jam, may not require registration. However, checking with the FDA to determine whether your business is exempt from registration requirements is essential.

How to register your establishment with the FDA?

FDA Establishment Registration for Your Business

For the process of FDA establishment registration, you’ll need to provide information about your business, including the name, address, and contact details. You must also give details on the products you manufacture, process, pack, or hold. The FDA requires that you provide a unique facility identifier (UFI) for each establishment.

You can register your establishment with the FDA through the FDA Unified Registration and Listing System (FURLS). FURLS is an online portal allowing you to submit your registration and listing information securely. You must create an account on FURLS and obtain a digital certificate to access the system.

Once you have submitted your registration information, the FDA will review your application and assign a registration number. The registration number is valid for one year and must be renewed annually. The FDA will also assign a DUNS number, which is used to track federal funding and procurement activities.

What are some common mistakes to avoid during FDA Establishment Registration?

The process of FDA establishment registration can be complicated, and it is essential to avoid common mistakes that may delay or reject your application. Here are some common mistakes to avoid:
– Providing inaccurate or incomplete information: Ensure you provide accurate and complete information about your establishment and products. Providing incorrect or incomplete information may delay or reject your application.
– Failure to renew your registration: FDA establishment registration is valid for one year and must be renewed annually. You’ll need to renew your registration to avoid the cancellation of your registration.
– Failure to update your information: If there are any changes to your establishment or products, you must update your registration information with the FDA. Please update your information to ensure compliance with FDA regulations.
– Failure to appoint a US agent: If you are a foreign business, you must establish a US agent to act as a liaison with the FDA. Please, select a US agent to avoid delays or rejection of your application.

FDA Establishment Registration for Your Business

What happens during an FDA inspection?

The FDA conducts inspections and audits to ensure businesses comply with the regulations. During an inspection, the FDA may review your establishment’s records, processes, and procedures to determine whether you meet the FDA standards. The FDA may also collect samples of your products and test them for safety and efficacy.

If the FDA finds any violations during the inspection, you may receive a warning letter or a notice of a breach. The FDA may also take enforcement action, such as product seizure or injunction. It is essential to comply with the FDA regulations to avoid penalties and legal actions.

When does FDA Establishment Registration need to be Renewed?

FDA establishment registration is valid for one year and must be renewed annually. The FDA sends a renewal notice to registered establishments approximately 60 days before expiration. You can restore your registration through FURLS and provide updated information about your establishment and products.

It is essential to renew your registration on time to avoid any interruptions in your business operations. Please continue your registration to prevent the cancellation of your registration, and you may not be able to import or export products to and from the United States.

How to update your FDA Establishment Registration?

You must update your registration information with the FDA if there are any changes to your establishment or products. You can update your information through FURLS, and you will need to provide updated details about your establishment and products.

It is essential to update your registration information promptly to ensure that you are complying with the FDA regulations. Failure to update your information may result in non-compliance and may lead to legal action.

Tips for a Successful FDA Establishment Registration Process:

– Understand the FDA regulations: It is essential to understand the FDA regulations and how they apply to your business. Ensure you are familiar with your products’ FDA guidelines and requirements.
– Provide accurate and complete information: Ensure you provide accurate information about your establishment and products. Providing incorrect or incomplete information may delay or reject your application.
– Keep your information up to date: If there are any changes to your establishment or products, update your registration information promptly. Please update your information to ensure compliance with FDA regulations.
– Work with an FDA consultant: If you need clarification on the FDA regulations or the registration process, consider working with an FDA consultant. An FDA consultant can provide guidance and support to ensure that you comply with the FDA rules.

What are the roles of an FDA Consultant in FDA Establishment Registration?

An FDA consultant can help you navigate the complex FDA regulations and registration process. An FDA consultant can provide guidance and support to ensure you comply with the FDA regulations. They can help you prepare your registration application, assist with FDA inspections, and help you develop and implement quality systems.

Working with an FDA consultant can help you save time and money by avoiding common mistakes and ensuring that your business complies with the FDA regulations.

Conclusion:

FDA establishment registration is essential for food, drugs, medical devices, cosmetics, or dietary supplements businesses. It is a legal requirement that demonstrates your commitment to quality and safety and helps to build trust with your customers and suppliers. The process of FDA establishment registration can be straightforward if you understand the requirements and follow the guidelines.

By avoiding common mistakes, renewing your registration on time, and updating your information promptly, you can ensure that your business complies with the FDA regulations. If you need clarification on the FDA regulations or the registration process, consider working with an FDA consultant to ensure your business is compliant and successful.

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Top 6 questions to ask about FDA Food Facility Registration

FDA food facility registration

Quality Smart Solutions offers the best FDA Facility Renewal & Registration services in North America for Medical Devices, Food, and Drug FDA domestic and foreign facilities!

The process of food facility registration can be complex, but knowing what is required and following the instructions carefully helps ensure a successful registration. In this guide, you will find the answers to your questions about the steps you need to take for proper food facility registration with the US Food and Drug Administration (FDA).

FDA food facility registration

Why is Food Facility Registration & Renewal Important?

Individuals such as owners, operators, or agents that oversee domestic or foreign facilities that manufacture, process, or package food for consumption in the United States are required to register their food facility with the FDA. This requirement along with the FDA being given advance notice on shipments of imported food (Prior Notice of Imported Foods) became effective by the Bioterrorism Act on December 12th, 2003, as a protective to protect the U.S. food supply.

What is FDA food facility registration?

A food facility registration is the process of registering a business to legally operate as a provider of food products in the United States. Section 415 of the Federal Food, Drug, and Cosmetic Act (FD&C Act), as amended by the FDA Food Safety Modernization Act (FSMA), requires food facilities to register with the FDA and to renew such registrations every other year.

Who needs to register their FDA facility?

Any facility, business, or organization that is engaged in manufacturing, processing, packing, or holding food for consumption in the United States is required to register its facility with the FDA. Food facility registrations must also be renewed on a biennial basis.

What information needs to be submitted for FDA facility registration?

For a successful food facility registration, several pieces of information are typically required including the facility location, the contact person for the facility, and US agent information (if the facility is located outside of the United States). It is also a requirement to submit information on the activities and types of food products that will be handled at the facility location.

What other requirements should I consider before registering my FDA facility?

When registering your food facility, other considerations should include the type of business, the type and quantity of products you will be producing, and any health department regulations relating to your food items or manufacturing processes. Additionally, when handling food products that are susceptible to contamination or spoilage, it’s essential to identify potential risks and design a Food Safety Plan to meet safety standards set by regulatory agencies such as the U.S. Food and Drug Administration (FDA) and the Department of Agriculture (USDA).

How will I know when my FDA facility registration is approved?

Once the registration has been drafted and submitted to the FDA, a confirmation email will be sent to the contact person for the facility. Furthermore, a food facility registration number will be issued to the facility. This number is important to keep on file, as it confirms that the facility is successfully registered with the FDA.

We can provide FDA food label compliance, Nutrition Facts Panel creation and act as your FSVP Import Agent. We can also guide you through the entire FDA Facility Registration or FDA Facility Renewal process for domestic and foreign Food facilities.

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Unlocking the FDA Guidelines for NAC Supplements

NAC Supplements labeling Requirements

NAC Supplements labeling Requirements

Introduction:

On August 1, 2022, the FDA announced the final guidance on FDA’s policy regarding products labeled as dietary supplements that contain N-acetyl-L-cysteine (NAC). NAC is a supplement form of cysteine, a semi-essential amino acid, which was approved by the FDA as a drug in 1963 to treat liver side effects from an overdose of Tylenol (acetaminophen) and to loosen the thick mucus in the lungs of people with cystic fibrosis or chronic obstructive pulmonary disease.

The new guidance explains the FDA’s intent to exercise enforcement discretion concerning the sale and distribution of certain NAC-containing products that are labeled as dietary supplements. This enforcement discretion policy applies to products that would be lawfully marketed dietary supplements if NAC were not excluded from the definition of “dietary supplement” and are not otherwise in violation of the Federal Food, Drug, and Cosmetic Act (FD&C Act).

To learn about the FDA’s enforcement discretion for NAC supplements click here:

Know the requirements for marketing NAC Supplements:

The FDA requires that the manufacturer or distributor of an NAC supplement follows certain guidelines for labeling and safety. Make sure to read all labels carefully, as the label should detail everything you need to know about the product, including any warnings about potential side effects and contaminants. Additionally, ask your provider questions about NAC supplements before including them in your health regimen. This can help ensure you’re making informed decisions about what products are safe and beneficial for you.

Be aware of NAC Supplement labeling requirements:

When purchasing an NAC supplement, it’s important to be aware of certain labeling requirements as put forth by the FDA. These include both general and product-specific labeling, such as itemized ingredients, a description of what the product does, information about nutraceuticals, usage instructions and dosage information, safety warnings about potential side effects or adverse reactions due to drug interactions, and expiration date. Additionally, all NAC supplements must clearly state if they are dietary supplements.

Understand safety guidelines for NAC supplement products:

As with any supplement, it’s important to make sure that the NAC product you purchase meets safety guidelines. Look for reliable suppliers of high-quality NAC supplements and pay attention to any warning labels about potential drug interactions or side effects when taking them. Be sure to read the information carefully before taking a NAC supplement so that you can accurately understand the benefits, risks, and dosing instructions. Additionally, look for products that have been third-party tested for quality and purity.

Pay attention to current NAC Supplement updates:

Be sure to pay attention to current updates about NAC supplement regulations to ensure that you are fully aware of all FDA requirements. The FDA regularly evaluates supplements and issues updated guidelines or product recalls as necessary. Understanding and following the latest instructions related to dosing, labeling, ingredients, and manufacturing standards can help you stay informed.

Utilize FDA resources for guidance and advice:

Make sure you understand all relevant safety, labeling, and manufacturing standards for NAC supplements by taking advantage of FDA resources. The FDA provides helpful tips and guidance on its website as well as regulatory update alerts about any changes that have been made to the regulatory requirements. Additionally, you can contact the FDA directly with questions or comments regarding your products.

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Unlock 7 Steps to Verifying Your FSVP in 2023

FDA FSVP Certification

FDA FSVP Certification

Foreign Supplier Verification Program (FSVP)

Due to the increasingly global nature of today’s industry, an increasing number of businesses are searching for their suppliers overseas. Even though foreign sourcing has traditionally been difficult, the Foreign Supplier Verification Program (FSVP) established under the FSMA does not make the process any less difficult.

The obligation for guaranteeing that imported food items are safe has been transferred from the government to the corporations in accordance with the FSVP rule. In addition, the Food and Drug Administration (FDA) holds importers responsible for ensuring that food brought into the United States and Canada meets the requirements set out by the agency.

We have listed the following seven steps for businesses that want to get their FSVP certification.

What is FSVP?

Importers put in place a program known as an FSVP Plan in order to ensure that their international suppliers produce food in a way that is safe for the general public’s health. These plans demonstrate that foreign suppliers export food that has not been adulterated, that allergies are properly identified, and that U.S. preventative controls or safety laws are met.

All food and drinks, food and color additives introduced during processing, nutritional supplements, packaging, and food contact substances are considered part of an FSVP Plan’s definition of “food.”

Follow the FSVP checklist to ensure timely results.

Step 1: Review Compliance Status

The Quality Inspector will initially make contact with a foreign supplier to investigate the latter’s present level of compliance. Additionally, the compliance history of the supplier is taken into consideration by the QI.

This is done by looking at warning letters from Customs, import warnings, and requirements for certification issued by the FDA in accordance with section 801(q) of the Food, Drug, and Cosmetic Act (FD&C Act).

Step 2: Perform Hazard Analysis

Importers are obligated to do a risk assessment on each and every food they bring into the country, evaluating not just the possible dangers but also the likelihood and severity of such dangers. The majority of the time, a danger analysis has already been carried out by a foreign provider. The QI will analyze the pre-existing hazard assessment and write their findings in these circumstances.

If a supplier does not have a hazard analysis, it is the obligation of importers to investigate the firm’s activities and seek for dangers that need to be controlled. If the investigation does not uncover any potential hazards, there will be no need for further product verification. Nevertheless, an importer is required to preserve a copy of the hazard study in their records as verification.

Step 3: Verify Suppliers     

Importers can check suppliers in several ways. On-site audits, frequent sampling, testing, and reviewing of food safety records and documentation are examples of verification procedures. Importers can do their own on-site audits or employ a third-party auditor to verify a foreign supplier’s activities. According to CFR Title 21, importers don’t need on-site audits unless a danger may cause significant health repercussions or death.

Importers who rely on product sampling and testing for verification must keep detailed records.

  • Sample kinds and numbers
  • Sample lot numbers
  • Tests
  • Corrective measures for dangers
  • Laboratory information
  • QI test documentation

FSVP importers can check food safety records. If so, they must keep track of the documents they evaluated, when they reviewed them, and what they were. They must also document their findings and remedial measures.

Step 4: Take Corrective Action

When necessary, importers have the authority to demand remedial steps from their suppliers. During verification efforts, it is possible to discover that a firm is not storing a product at the required temperature to prevent it from going wrong or that a company is picking lettuce after applying organic manure.

Both of these violations are considered fraudulent. It is possible that the investigation will determine that a corporation needs to provide bathrooms for its field personnel. Each of these cases calls for a unique course of action to be taken, illustrating how solutions will be unique to both individual businesses and individual products.

Step 5: Provide Importer Identification Upon Entry

A Data Universal Numbering System, or DUNS, the number is required for every business that deals in international trade. When submitting an entry form with Customs and Border Protection, importers are required to supply both their name and their DUNS number.  For an update on the DUNS requirement for 2022 Food Facility Registrations click here:

Step 6: Maintain accurate records over time

Additionally essential is the maintenance of extensive records. Importers are required by the FDA to keep documents relating to compliance status, foreign supplier verification efforts, hazard analyses, investigations, and remedial measures in accordance with the FSVP regulation.

Additionally, importers are required to undergo FSVP reassessments. Unless otherwise instructed, importers must preserve their records in either their original form, a photocopy, or digital format for at least two years. Additionally, the records must be made available to the FDA whenever they request them.

Step 7:  Reassess the FSVP plan consistently

After the verification process, an importer is free to purchase items from a supplier who has been approved. Nevertheless, a continuous focus on assessment and upkeep is necessary for an effective FSVP plan. According to the law, importers are required to conduct a reevaluation of their FSVP Plans every three years. An earlier evaluation is required to take place in the event that an importer becomes aware of new dangers associated with imported goods, such as a changed product formulation or a different source of raw materials.

FSVP Importers are required to take corrective measures if the evaluation determines that an imported food no longer satisfies the standards of the FSVP. Their actions may consist of deciding to update their FSVP Plan to guarantee that they screen suppliers in a more comprehensive manner or refraining from engaging with a supplier until that party has addressed any identified risks.

Before bringing food into the United States, importers must perform their own research as part of the Food Safety and Voluntary Program (FSVP). When it comes to compliance, taking a preventative stance is the best way to avoid difficulties in the future. Even if the food is safe and the overseas supplier is complying with regulations, the FDA has the authority to prevent shipments from entering the nation if it determines that a company’s FSVP efforts are deficient. Importers may better protect themselves and the food supply of the United States at the same time by following the FSVP checklist.

Conclusion

Due to the increasingly global nature of today’s industry, an increasing number of businesses are searching for their suppliers overseas. Even though foreign sourcing has traditionally been difficult, the Foreign Supplier Verification Program (FSVP) established under the FSMA does not make the process any less difficult.

The obligation for guaranteeing that imported food items are safe has been transferred from the government to the corporations in accordance with the FSVP rule. FSVP certification is essential to operate your business. If you are an FSVP importer, follow the above-mentioned FSVP checklist to get the desired results.

If you are busy, you can contact an expert to guide you further and make these steps of getting FSVP certification easier for you.

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Top 6 Things to Know About NHPID and NPN

Screenshot of Health Canada's NHPID and NPN search pages

Screenshot of Health Canada's NHPID and NPN search pages

If you’re selling natural health products in Canada, understanding NHPID and NPN is essential. These tools from Health Canada determine whether your ingredients are acceptable and whether your product is eligible to be sold legally. Without proper licensing, your product cannot be legally marketed or distributed in Canada. 

Both the NHPID and NPN processes require detailed information, careful documentation, and regulatory know-how. That’s why we’ve outlined the top six things you need to know to stay compliant, save time, and avoid costly mistakes. Keep reading to learn how to use them properly and where to get support. 

1. NHPID is your first step in product formulation

The Natural Health Products Ingredients Database (NHPID) is Health Canada’s searchable list of acceptable medicinal and non-medicinal ingredients. It helps ensure your formulation is permitted and follows proper terminology, dosage forms, and ingredient purposes. 

You can access it through the NHPID portal. Key search features include: 

  • Ingredient search: Find ingredients by name, CAS number, or taxonomy 
  • Controlled vocabulary search: Look up standard terms for test methods, purposes, and dosage forms 

Before you prepare your application, verify that all your ingredients are listed in the NHPID, and confirm whether they’re supported by pre-cleared information (PCI), like monographs. 

2. NPN confirms your product is approved

An NPN (Natural Product Number) is an eight-digit number assigned by Health Canada once your product has been licensed. It’s a legal requirement for marketing natural health products in Canada. 

You must submit a detailed Product Licence Application (PLA) to the Natural and Non-Prescription Health Products Directorate (NNHPD). Your application needs to include: 

  • Medicinal and non-medicinal ingredients 
  • Source, dosage, and potency 
  • Recommended use(s) 
  • Evidence supporting safety and efficacy 

Once approved, you’ll receive an NPN. This number must appear on your product label to indicate compliance and allow consumers to verify it through the Licensed Natural Health Products Database. 

3. Your label must follow strict rules

To stay compliant, your NHP label must include all mandatory elements under the Natural Health Products Regulations, including: 

  • Product name and NPN 
  • List of ingredients 
  • Recommended use and dosage 
  • Warnings and directions 
  • Manufacturer’s contact details 

Labeling errors are one of the top reasons for compliance issues. Working with a regulatory consultant helps ensure your label meets Health Canada’s expectations. 

4. Post-licensing changes matter

Getting your NPN isn’t the end of the process. Any changes to your product must follow Health Canada’s post-licensing rules. These include: 

  • Fundamental changes (e.g., dosage form or route of administration): Require a new application and NPN 
  • Amendments (e.g., new recommended dose): Require approval 
  • Notifications (e.g., brand name change): Must be submitted within 60 days 

Use the Amendment and Notification Form (ANF) for all updates, and make sure to keep your NPN listing current. 

5. Avoid misleading claims at all costs

One of the most common mistakes with NHPID and NPN compliance is making unapproved or misleading claims. Under the Food and Drugs Act, all claims must be: 

  • Supported by proper evidence 
  • Truthful, not exaggerated 
  • Appropriate for the product category 

Avoid promising disease treatment, cures, or unproven benefits. Not only is this non-compliant, it can also lead to warning letters, product recalls, or fines. Learn more through Health Canada’s compliance policies. 

6. Regulatory support makes a big difference

Staying compliant with NHPID and NPN requirements can be challenging, especially if you’re managing multiple products or launching a new brand. Delays in the application process, missing documentation, or incorrect ingredient classifications can hold you back. 

That’s why many companies partner with experienced regulatory consultants to streamline the process. From formulation reviews and NHPID checks to preparing PLA submissions and managing post-licensing updates, expert guidance helps you stay ahead of Health Canada’s evolving standards. 

Bonus tip: What if your ingredient isn’t listed in the NHPID?

If you can’t find a specific ingredient in the NHPID, that doesn’t mean your product is automatically disqualified. You can submit an NHPID Issue Form to the NNHPD, along with supporting evidence, to request its inclusion.

Alternatively, if the ingredient is proprietary or confidential, you may consider filing a Master File (MF) submission with Health Canada. This ensures the ingredient details are protected while allowing regulators to review the necessary information.

NHPID and NPN: frequently asked questions

What is the purpose of the NHPID?

The Natural Health Products Ingredients Database (NHPID) is a regulatory tool used by Health Canada to assess the acceptability of medicinal and non-medicinal ingredients in natural health product submissions.

If your ingredient is not listed, you can submit an NHPID Issue Form to the NNHPD with supporting safety and quality data. For proprietary ingredients, a Master File (MF) submission may be appropriate.

Yes. Without an NPN issued by Health Canada, a natural health product cannot be legally marketed or sold in Canada.

Yes. Changes to your product after licensing fall into three categories: notifications, amendments, or fundamental changes. Some updates require Health Canada’s approval, while others only need to be reported.

Need help with your NHPID or NPN? 

At Quality Smart Solutions, we help businesses navigate the complexities of Health Canada compliance, from ingredient reviews to full NPN licensing. Whether you’re launching your first product or scaling up your portfolio, we’re here to guide you at every step. For a full overview of our natural health product licensing services, visit our NHP licensing page. Talk to our regulatory experts today and get the support you need to succeed. 

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Unlock Food Regulations for Food Sales Health Canada & FDA

food regulations for food sales

food regulations for food sales

Do you want to learn about the food regulations for food sales in North America?  This could include food facility registration, food safety regulation standards, TMAL, food label requirements, FSVP agents, and more. Then your wish is about to be granted.

If you import, export, manufacture, or trade food products in North America you may have had trouble with the complex Food & Beverage Regulatory Requirements.

The food & beverage industry is growing fast, especially with the growing demand for Non-GMO, Vegan/Vegetarian, and other alternatives.

In this blog, we will be discussing the Canadian and US requirements for food importation to Canada & the U.S.  

Canadian Food Regulations & Food Labelling in Canada

Canadian Foods are regulated by Health Canada, the Canadian Food Inspection Agency, and the Canada Border Services Agency. Some applicable regulations for foods and imports in Canada are the Food and Drug Regulations, the Safe Foods for Canadians Regulations, and the Customs Act.

Food labels must be bilingual, and common names, countries of origin, expiry dates, and storage instructions must be included. Any label claims being made must be reviewed against the permitted lists to ensure they are compliant.

All statements must be truthful and not misleading on your label.  At Quality Smart Solutions our team of specialists can help review your labels for compliance.  

TMAL and Supplemented Food Standards

Traditional foods are those that have been consumed for a long time, such as bread, milk, and eggs. Supplemented foods are those that have had new ingredients or manufacturing processes added to them, such as caffeine in an energy drink.

A traditional food must have a compliant label, and a supplemented food must also be approved through a review process called a TMAL or Temporary Market Authorization Letter.

New regulations are set to be published in the spring of 2022 to allow and set out several categories of foods for which certain ingredients can be supplemented.

Food Safety Requirements for Importing food into Canada

When shipping food from another country into Canada you must have or use a Safe Foods for Canadians Food Import License (SFCR).  

A Preventative Control Plan (PCP) and a HACCP (Hazard Analysis Critical Control Points) must be set up for your food manufacturing site. Quality Import Solutions can help with this and with bringing your products into Canada.

U.S Labels must be bilingual and there must be enough product testing (for example, for allergens, microorganisms, and heavy metals). Please note that there are also customs and duties required for importing that must be arranged with a broker or freight partner.

Why food regulations are important in the USA?

USA foods are regulated by the US Food and Drugs Administration, the US Department of Agriculture, and Customs and Border Protection. Some applicable regulations are the Food Safety and Modernization Act, and the Bioterrorism Act. These set out requirements for food in the USA.

US Regulations for Food Label Requirements 

It is important to make sure your label meets US standards. This includes the common name, net quantity, ingredients, and nutritional information. The US Department of Health and Human Services has published a labeling guide to help with this.

One tip is to avoid intervening material, which is any text that is not required by regulation. An example of this could be a gluten-free claim between the nutrition facts table and the ingredients list. This can divert the consumers’ attention.

Food Facility Registration in the USA 

FSMA (Food Safety Modernization Act) and the Bioterrorism Act require that all food production facilities must be registered with the FDA and renewed every other year, which allows the agency to track and regulate them. Registration can be revoked if there is a risk to human health. Facilities can submit their registration package online, by mail, or by fax. A US agent is required to communicate with the FDA on behalf of the facility and must be a resident of or located in the USA. 

What is and why do I need an FSVP Agent?

An FSVP Agent is a representative located in the USA who is responsible for reviewing and holding food safety-related documentation that proves a company/food facility meets or exceeds US food requirements.

The goal is to ensure products are not adulterated or misbranded by exceeding the US food requirements for all important documentation. The FSVP agent will assist with compliance reviews and audits, or questions issued by the regulator. 

Importer of Record!

Finally, our sister company Quality Import Solutions can help with the importation and market entry for Canadian and US foods by acting as your Importer of Record.

Additional Information:

For more information on the FDA & Health Canada Food Regulations and how to ensure your Food Products are compliant visit the government websites.

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4 Tips on How to Complete Your Cosmetic Notification Form

Cosmetic Notification Form

Are you a cosmetics manufacturer or distributor looking to navigate the complex world of regulatory compliance? Look no further than cosmetic notification forms—your roadmap to observation and success. In the ever-evolving cosmetics industry, staying on top of regulations and ensuring product safety is crucial. Understanding and adequately completing cosmetics notification forms allows you to meet legal requirements and build trust with your customers and stakeholders. This comprehensive guide will take you through everything you need to know about cosmetic notification forms, from what they are and why they are essential to how to fill them out correctly. Whether you are a seasoned player in the cosmetics industry or just starting, this guide will equip you with the knowledge and tools to stay compliant, drive growth, and set yourself apart from the competition. Don’t let regulatory hurdles hinder your success; let cosmetics notification forms be your guide to compliance and prosperity.

What is a Cosmetic?

Under Section 2 of the Food and Drugs Act, a cosmetic is defined as “any substance or mixture of substances manufactured, sold or represented for use in cleaning, improving or altering the complexion, skin, hair or teeth, and includes deodorants and perfumes.” This is different than drugs and natural health products even though they are all regulated under the Food and Drug Act. The classification of the product depends on its function, purpose, and representation for use (such as claims or recommended purposes). Ingredients in the formula may also help determine the classification. For example, in Canada, ingredients like corticosteroids can only be licensed as drugs whereas Green Tea Leaf Extract may be licensed as a cosmetic product or a natural health product.

What are cosmetic notification forms?

Cosmetics notification forms are vital to the regulatory landscape for cosmetics manufacturers and distributors. These forms serve as a means of communication between the industry and regulatory authorities, allowing for the monitoring and regulating of cosmetic products. Cosmetics notification forms provide essential information about the products being placed on the market, including the ingredients used, manufacturing processes, and labeling. By submitting these forms, manufacturers and distributors demonstrate their commitment to transparency and compliance with regulations.

Why are cosmetic notification forms vital for compliance in the cosmetics industry?

Compliance with regulatory requirements is not just a legal obligation; it is also crucial for the success and reputation of cosmetics businesses. Non-compliance can result in fines, product recalls, and damage to brand reputation.

In an industry where consumer trust is paramount, demonstrating compliance through properly completing cosmetics notification forms is a powerful way to build credibility. By proactively meeting regulatory requirements, cosmetics businesses can assure customers that their products are safe, reliable, and in line with industry standards.

Types of Cosmetic Notification Form

This form can be used for new products, amendments, and discontinuation of sales. For new products, you must notify Health Canada within 10 days after you first sell the cosmetic product in Canada. For amendments, you must notify Health Canada of this within 10 days of the change and include the Cosmetic Number in the notification form. For discontinuation of sale, you must notify Health Canada of this within 10 days of the discontinuation and include the Cosmetic Number in the notification form. This notification form must be completed and submitted at the latest 10 days after it is first sold in Canada.

How do I complete a cosmetic notification form?

Completing cosmetic notification forms may seem daunting, but it can be straightforward with the right approach. Here’s a step-by-step guide to help you navigate the requirements and ensure accurate and timely submissions:

  1. Familiarize yourself with the regulations: Start by understanding the specific rules for your cosmetic products. This will help you identify the relevant forms and the information you need to provide.
  2.  Gather the necessary information: Collect all the information needed for each form, including product composition, manufacturing processes, and safety data. This may involve liaising with suppliers, conducting lab tests, and reviewing existing documentation.
  3. Fill out the forms accurately: Take your time to complete the forms accurately, ensuring that all information is correct and up to date. Pay close attention to details such as ingredient names, concentrations, and units of measurement.
  4. Include supporting documentation: Attach any required supporting documents, such as safety assessment reports, test results, or compliance certificates. These documents will strengthen your submission and provide additional evidence of compliance.
  5. Review and double-check: Before submitting the forms, thoroughly review them to ensure accuracy and completeness. Check for any errors, missing information, or inconsistencies. It may also be helpful to have a colleague or compliance expert review the forms.
  6. Submit the forms as required: Follow the submission process outlined by the regulatory authorities. This may involve electronic submissions, physical copies, or online portals. Be aware of any deadlines or additional requirements for compliance.

By following these steps, you can streamline the process of completing cosmetics notification forms and ensure compliance with regulatory requirements.

What are the common mistakes to avoid when filling out cosmetic notification forms?

While completing cosmetics notification forms, one must be aware of common mistakes that can lead to delays, rejections, or non-compliance. Avoid these pitfalls by keeping the following in mind:

  1. Inaccurate or incomplete information: Ensure that all information provided is accurate, complete, and current. Double-check ingredient names, concentrations, and any other relevant details.
  2. Missing or incorrect supporting documentation: Include all required supporting documents, such as safety assessments, test reports, or certificates. Make sure these documents are valid, properly labeled, and relevant to the product being notified.
  3. Failure to meet labeling requirements: Pay close attention to labeling requirements and ensure all mandatory information is included in the product packaging. This includes ingredient lists, warnings, claims, and proper language translations where applicable.
  4. Not keeping up with regulatory changes: Stay informed about any changes or updates to cosmetic regulations that may affect your notification forms. Regularly check for updates from regulatory authorities and adjust your processes accordingly.
    By avoiding these common mistakes, you can save time, reduce non-compliance risk, and ensure a smooth notification process.

Cosmetic Notification Form

In Canada, it is the Food and Drugs Act and Cosmetics Regulations that require a Cosmetic Notification Form to be submitted by the manufacturer or importer for all cosmetic products. This notification form must be completed and submitted at the latest 10 days after it is first sold in Canada. This form is also used for amendments and discontinuation of sales. This form must include the following information:

  • Name and address of the manufacturer of the cosmetic product
  • Name of the cosmetic product
  • Function of the cosmetic product (i.e. moisturizer, shampoo, conditioner)
  • Ingredient list that includes each ingredient’s name and its concentration percentage or concentration range
  • Form of the cosmetic product (i.e. foam, liquid oil, semi-solid lotion)
  • Name and address Canadian manufacturer, importer or distributor
  • Name and address of individual who manufactures or formulates the cosmetic product
  • Name and title of individual who signs the notification form

Tips on How to Complete a Cosmetic Notification Form

To complete the Cosmetic Notification Form efficiently, it is recommended to:

  • Have a complete list of ingredients ready, including composition information of the formula
  • Have a copy of the bilingual product label prepared
  • Know who your manufacturer/importer/distributor is and have their contact information on file
  • Work with a third-party consulting firm like Quality Smart Solutions, that is familiar with the Canadian Cosmetics Regulations. This way you can have your cosmetic formulas and labels reviewed before submission to minimize any pushback from Health Canada
  • Have a copy of the previously submitted notification form and cosmetic number ready if this is an amendment or discontinuation of the sale

CNF Infographic

cosmetic notification form

What is the role of cosmetic notification forms in ensuring product safety?

Cosmetic notification forms play a crucial role in ensuring the safety of cosmetic products. By providing detailed information on product composition, manufacturing processes, and safety assessments, these forms enable regulatory authorities to assess the potential risks associated with cosmetic products.

By submitting cosmetic notification forms, manufacturers and distributors demonstrate their commitment to product safety and compliance. This helps protect consumers from potential harm and ensures that cosmetic products meet the necessary safety standards.

How do cosmetic notification forms contribute to business success?

Compliance with cosmetics notification forms is not just a regulatory obligation; it can also contribute to the overall success of cosmetics businesses. Here’s how:

  1. Building trust and credibility: By demonstrating compliance with regulatory requirements by properly completing notification forms, cosmetics businesses can build trust and credibility with customers, stakeholders, and regulatory authorities. This can increase customer loyalty, positive brand reputation, and better relationships with regulatory bodies.
  2. Market access and expansion: Many countries and regions require cosmetics products to be notified before they can be placed on the market. By completing notification forms, businesses gain access to new markets. They can expand their reach, driving growth and increasing sales opportunities.
  3. Risk mitigation: Compliance with cosmetics notification forms helps businesses mitigate the risk of non-compliance penalties, product recalls, and damage to brand reputation. By proactively meeting regulatory requirements, companies can avoid costly legal issues and maintain a positive image in the market.
  4. Competitive advantage: Compliance with regulatory requirements sets businesses apart. By demonstrating a commitment to product safety and compliance, cosmetics businesses can differentiate themselves in the market and attract customers who prioritize safety and quality.

Resources and tools to help with cosmetics notification form compliance

Navigating the world of cosmetic notification forms can be complex. Still, there are resources and tools available to help businesses stay compliant. Here are some useful resources:

  1. Regulatory authorities: Consult the websites and guidelines provided by regulatory authorities in your country or region. They often provide detailed information on the requirements for cosmetic notification forms and offer guidance on accurately completing them.
  2. Industry associations: Join associations or organizations dedicated to cosmetics and personal care products. These associations often provide resources, training, and networking opportunities that can help businesses navigate the regulatory landscape.
  3. Compliance consultants: Consider working with compliance consultants specializing in cosmetics regulations. These experts can provide valuable insights, guidance, and support throughout the notification process.
  4. Technology tools: Explore software solutions to streamline the cosmetics notification process. These tools can automate data management, document generation, and submission tracking, saving time and reducing the risk of errors.

By leveraging these resources and tools, businesses can stay informed, navigate the compliance landscape, and ensure accurate and timely completion of cosmetics notification forms.

Conclusion: The key to compliance and success in the cosmetics industry

Cosmetics notification forms are more than just paperwork – they are a roadmap to compliance and success in the cosmetics industry. By understanding the importance of obedience, familiarizing yourself with the different types of notification forms, and following a step-by-step guide, you can confidently navigate the regulatory landscape.
Businesses can build trust with customers, stakeholders, and regulatory authorities by properly completing cosmetics notification forms.

Compliance ensures the safety and reliability of cosmetic products. It contributes to business success by opening new markets, mitigating risks, and differentiating from competitors.

Utilizing Consultants to Ensure You Fully Comply with Regulations:

It’s always important to seek out professional advice when completing any complex regulatory process, and this includes the completion of cosmetic notification forms. Consulting with an expert in the cosmetics field can help ensure the process runs as smoothly as possible by avoiding any incorrect information or compliance mistakes that could lead to sanctions or fines for your business. Utilizing their expertise will give you complete peace of mind that all aspects are being taken care of correctly and legally, helping you to avoid any unwanted regulation-related problems.

References

https://www.canada.ca/en/health-canada/services/consumer-product-safety/cosmetics/regulatory-information.html

https://www.canada.ca/en/health-canada/services/consumer-product-safety/cosmetics/notification-cosmetics/guidance-document-complete-cosmetic-notification-form.html

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News

Health Canada Marketing Authorization Update – Increased Vitamin D

On January 19, 2022, Health Canada announced a marketing authorization (MA) to permit manufacturers to voluntarily increase the amount of Vitamin D in cow’s milk, goat’s milk and margarine.  This was decided in order to facilitate alignment and compliance with the Regulations Amending the Food and Drug Regulations (Nutrition Labelling, other Labelling Provisions and Food Colours).

Background

Vitamin D is a key nutrient that helps the body use calcium and phosphorus to maintain strong bones and teeth. Vitamin D can be obtained from food and supplements and can be made by the body after exposure to sunlight. Vitamin D deficiency can lead to rickets in children and Osteomalacia (softening of the bones) in adults.

The Food and Drug Regulations (FDR) set out the daily value (DV) for vitamin D (i.e. a value that would meet the vitamin D requirements of almost all Canadians) as well as the amount of vitamin D required in cow’s milk and margarine, and permitted in goat’s milk. Manufacturers cannot increase the amount of vitamin D in foods beyond what is currently set out in the FDR.

However, Health Canada has made plans to increase Vitamin D intake with the public health objective of promoting adequate bone health among Canadians without excessive Vitamin D intake. As a first step, Health Canada proposed increases to the amount of Vitamin D required in cow’s milk and margarine and permitted in goat’s milk, as these are the biggest contributors of Vitamin D in the Canadian diet.

Benefits of this change

This marketing authorization will have the following benefits:

  • Helping to promote adequate bone health among Canadians by permitting an increased amount of vitamin D in cow’s milk, goat’s milk and margarine;
  • Allowing for the possibility of financial savings for manufacturers who have not already updated their product labels to comply with the 2016 nutrition labelling regulations. For these manufacturers, the MA enables a single label change (rather than multiple changes) to account for an increase to vitamin D amounts and meeting the requirements set out in the 2016 nutrition labelling regulations
  • Allowing manufacturers to continue to market cow’s milks and goat’s milks as an “excellent source” of vitamin D, thus providing a marketing benefit to manufacturers and
  • Helping to reduce the risk of illness related to certain bone diseases and therefore potentially reduce health care spending on the treatment of these diet-related diseases

 Implementation

Public education efforts to help Canadians understand how best to use nutrition labelling to make informed food choices is ongoing. In addition, Health Canada will post information about the marketing authorization on its website and will notify stakeholders. Industry is not required to submit a premarket notification or a Temporary Marketing Authorization application in order to apply the increased vitamin D levels for cow’s milk, goat’s milk or margarine. Therefore, action can be taken immediately, but must follow the applicable rules and regulations.

Compliance and Enforcement

Compliance and enforcement of the marketing authorization will be incorporated into existing activities carried out by the Canadian Food Inspection Agency (CFIA). The CFIA is responsible for the enforcement of the Food and Drugs Act as it relates to food. While it is the responsibility of the industry to comply with regulatory requirements, compliance will be monitored as part of ongoing domestic and import inspection programs. Appropriate enforcement action will be taken based on risk.

Resources:

https://www.canada.ca/en/health-canada/services/consumer-product-safety/cosmetics/regulatory-information.html

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Blog

MDSAP: What Is It and How Does It Apply to my Medical Device?

Who Needs an MDSAP Certificate?

Anyone looking to manufacture a Class II, III or IV medical device in Canada requires a Medical Device Licence (MDL) for each product they sell. In order to obtain an MDL you need an ISO 13485 certificate that has been issued through the Medical Device Single Audit Program (MDSAP). These certificates are evidence that your company has an appropriate quality management system in place to ensure that only safe and effective medical devices are made available for sale.

How do I obtain an MDSAP certificate?

First you must implement a quality management system within your company that meets the requirements of ISO 13485. The areas covered by these practices include design and development, production, storage and distribution, installation, and servicing of medical devices. Once all applicable procedures are in place you must contact an auditor that has been authorized to issue MDSAP certificates. Only certificates issued by approved auditors will be recognized by Health Canada.

Note that these certificates include a scope of the types of products that your company is authorized to manufacture. For example, if you obtain an MDSAP certificate for the manufacture of medical gloves you can get an MDL for medical gloves but not for home pregnancy tests. The scope of the certificate must match the type of product being sold. If you need to expand the scope of your certificate you must contact your auditor.

Why is it called a single audit program?

Historically every country would require their own audit of medical device manufacturer’s quality management system. This led to a situation where a company looking to sell in 5 different countries would often require 5 different audits of the quality management system. In order to reduce the burdens associated with multiple audits, several countries banded together to form the Medical Device Single Audit Program. Certificates issued through MDSAP will satisfy the audit requirements for all participating countries.

Countries that currently recognize MDSAP certificates include:

  • Australia
  • Brazil
  • Canada
  • Japan
  • USA

Are there any exemptions? What if I have an ISO 13485 certificate but it’s not MDSAP?

Health Canada won’t accept any other ISO 13485 certificate even if it’s from a major market such as the European Union. The only exception that has ever been granted is for devices related to the COVID-19 pandemic. Health Canada created a special approval pathway for these devices that would allow non-MDSAP certified companies to obtain authorization to sell their products.

I don’t have an MDSAP certificate and I’m not interested in obtaining one. What are my options?

The only option in this case is to enter into a private label agreement with a company that has one. The company you partner with must already have an MDSAP certificate and an MDL for the product they will be making. You will need to submit a Private Label Licence Application to Health Canada that states that your business partner will be conducting all manufacturing work and the product is identical to the already licenced product in every way except brand name and the company name listed on the label.

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News

Public Consultation on Medical Devices Clinical Trials Modernization Initiative

Health Canada has published a consultation paper on proposed changes to the regulation and oversight of clinical trials for drug, medical devices and natural health products (NHPs). The purpose of these changes is to improve the speed at which these trials are approved, to avoid stifling medical advances that could help improve the health of Canadians, and to improve transparency and regulatory oversight.

The proposed changes would integrate all health products into the same framework and feature:

  1. Proportional risk-based oversight 
  2. New regulatory agilities over the lifecycle of the trial 
  3. Greater transparency through registration and public disclosure of results
  4. A modernized compliance and enforcement regime (see figure 1)

Health Canada is accepting feedback on the proposed changes until 4 July 2021.

Agile Life Cycle

With the adoption of a more agile life cycle approach, Health Canada is looking to be able to give themselves the tools to oversee clinical trials in their entirety while better enabling sponsors to conduct innovative types of trials. As part of these changes, Health Canada will be able to authorize a trial rather than just the sale or importation of an investigational product, authorize a trial with multiple product types through a single authorization, and streamline the application requirements across all product lines for greater efficiency, while maintaining the protection of the health and safety of participants.

Under this scheme Health Canada will allow for the authorization of Master protocols that include multiple sub-studies for different therapies or indications for use. Types of proposed Master protocols include:

  • Basket trials, which investigate the safety/efficacy/effect of an investigational product across a variety of indications
  • Umbrella trials, which investigate the safety/efficacy/effects of several investigational products in a single indication
  • Platform trials, which investigate several investigational products in one or multiple indications in a highly dynamic design

By integrating all health products into a common framework, products from multiple categories can be approved under the same protocol. For medical devices this would result in an expansion of who can sponsor a clinical trial. It will now include independent investigators (such as a researcher, clinician or health care facility) in addition to the manufacturers and importers of medical devices. These changes will also result in any medical device trial being required to adhere to Good Clinical Practices (GCP).

Health Canada is also seeking to improve safety monitoring of clinical trials through improved clarity and increased authority to request information relating to adverse events including the ability to request an analysis of safety data while the trial is ongoing. This may include an assessment of safety signals to determine if the benefit/risk balance has changed during the conduct of the trial.

In this approach, Health Canada will have the ability to suspend or cancel either the whole trial or only a part of the trial if there’s a lack of efficacy or a safety concern.

Risk-Based Approach

All health products will follow a common risk-based approach to authorization. To do this they will create risk-based categories with differing levels of oversight and regulatory requirements for drugs and NHPs. The pre-existing risk-based device classification scheme for medical devices will be maintained and integrated into the new scheme. See figure below:

Source: www.canada.ca

Health Canada will be granted the authority to impose terms and conditions on a clinical trial authorization before and during the trial to address significant uncertainties or mitigate risks related to the product(s) being tested, or to the conduct of the trial. These terms and conditions may include:

  • More frequent safety reporting
  • Monitoring of specific populations because of potential increased risk (e.g. children, pregnancy)
  • Additional information to characterize and mitigate newly identified risks

To allow for greater trial participation from volunteers outside of major urban areas, changes will be made to allow for studies to take place remotely, without a physical visit to a trial site. Monitoring will be allowed using videoconferences with investigators, visits at home by study personnel, internet-based tools for data collection and reporting, and mobile technology such as biosensor devices.

Transparency

Health Canada is looking to expand on its current  Clinical Trials Database and is exploring new ways to publish clinical trial information. This may include mandatory registration of any trial conducted in Canada on an existing international registry of Health Canada’s choosing. Sponsors may be required to make the results of their trials available to all members of the public by publishing the information in this database. Health Canada is also proposing making this information available on its website to ensure it’s easy to find and available in both official languages.

Modernization of Compliance and Enforcement

Although Health Canada already has the authority to conduct inspections on clinical trial activities under Section 23 of the Food and Drugs Act, its activities have been limited to drugs. As part of the modernization, Health Canada will extend its compliance and enforcement to NHPs and medical devices. Inspections will be conducted using a risk-based and pro-active approach based on trial design, the medical condition under study, target population, and the risk classification of the investigational product. Health Canada will also implement a cyclical risk-based inspection approach that considers the compliance history and the volume of activities. Highly compliant entities would be inspected less frequently while less compliant ones would be inspected more frequently.

At present Health Canada only has direct oversight over the sponsors of the trials. Health Canada is proposing regulatory changes that would ensure that all third parties conducting trials on behalf of a sponsor are legally responsible for any activities they conduct. This would result in an increased regulatory burden for these third parties but will increase the safety of clinical trial participants by allowing Health Canada to require them to take corrective action instead of directing the sponsor to take the action against the third party.

Anticipated Outcomes for Stakeholders

Health Canada believes these changes will help encourage clinical trials in Canada by providing greater agility in oversight of the development of healthcare products, ensuring that regulatory requirements are proportional to risks, improving access to clinical trial information, creating a more streamlined approach that is better aligned internationally and leverage partnerships and provide leadership in Canada’s health ecosystem to further facilitate clinical trials in Canada.

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News

Cancellation of MDELs for Non-Compliance with Annual Licence Review Requirements

Cancellation of Medical Device Establishment Licence for A Non-compliance With Annual Licence Review Requirements

On May 27, 2021 Health Canada issued a bulletin about cancellation of Medical Device Establishment Licence (MDELs) for the sites that are not compliant with the annual licence review requirements. About 700 MDEL holders have not submitted an annual licence review application for the 2020/2021 fiscal year, and as a result Health Canada cancelled their MDELs. This means that these sites are not able to conduct their activities and must re-apply for a new establishment licence and pay the applicable fees. 

Annual Licence Review

An annual licence review (ALR) ensures that medical device establishment licence (MDEL) holders are complying with regulatory requirements associated with the Medical Devices Regulations. An ALR also ensures that their licence information is up-to-date.

As a courtesy, Health Canada sends an ALR application package to all active MDEL holders at the end of each calendar year. Health Canada also sends out 2 reminder notices to the licence contact person on file.

MDEL Holder Responsibilities

To continue doing business, active MDEL holders must submit an ALR application before April 1 of each year as per section 46.1 of the Medical Devices Regulations. Licence holders with a suspended MDEL do not need to apply.

Health Canada will cancel the MDEL for those licence holders who do not submit their ALR application within the required timeline. This authority is set out in section 51.1(b).

Under section 48, active MDEL holders must also notify Health Canada within 15 calendar days if they change their contact information. This includes changing the name or address of their establishment or the information of the establishment representative associated with their MDEL.

Cancellation of MDELs

Since the ALR deadline of April 1, 2021, about 700 MDEL holders have not submitted an ALR application for the 2020/2021 fiscal year. As this violates section 46.1, Health Canada have cancelled their MDELs and removed them from the active MDEL live listing.

MDEL holders whose establishment licence is cancelled are no longer authorized to conduct licensable activities (such as manufacturing, distributing or importing medical devices). They must cease their activities immediately once they receive their cancellation notice.

Resuming Licensable Activities

To resume licensable activities, companies whose MDEL has been cancelled must re-apply for a new establishment licence and pay the applicable fees. In line with the compliance and enforcement policy for health products (POL-0001), Health Canada carries out compliance monitoring activities. Cancelled MDEL holders may be subject to compliance and enforcement actions if Health Canada finds they are conducting non-compliant activities.

For more information on how to re-apply for a MDEL or if you need assistance filling your ALR please visit our website. Our Experts at Quality Smart Solutions continue to support your needs for medical devices, natural health products, foods, cosmetics and OTC drugs for North America. Contact us today to learn more about how we can support your compliance for Medical Device Establishment licence.

References:

Cancellation of MDELs for non-compliance with annual licence review requirements – Health Canada.

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News

Interim Order No. 2 Respecting the Importation and Sale of Medical Devices for Use in Relation to COVID-19

Interim Order

As of March 1, 2021, Interim Order No. 2 replaces Interim Order No. 1 Respecting the importation and sale of medical devices for use in relation to COVID-19. Interm Order No. 2 will continue to issue expedited authorizations for the sale or import of medical devices to deal with the current significant risk of COVID-19 to the health and safety of Canadians.

The Interim Order provides an expedited authorization pathway for:

  • new COVID-19 medical devices that are not yet licensed in Canada,
  • COVID-19 related uses for existing devices licensed under the Medical Devices Regulations or Interim Order No. 2 and
  • COVID-19 medical devices that leverage an authorization of a device from a trusted foreign regulatory authority, whereby the Minister would maintain the ability to request additional information on a case-by-case basis.

Interim Order No. 2 introduces new requirements for importers and distributors of COVID-19 medical devices to hold an MDEL, and for manufacturers to comply with bilingual labelling requirements. Both of these changes align with requirements in the Medical Devices Regulations.

Authorization for importation or sale by the manufacturer

Interim Order No. 2 provides COVID-19 medical device manufacturers an exemption from certain requirements of the Medical Devices Regulations, provided they have received an authorization for the importation or sale of their device(s) from Health Canada.

A manufacturer may submit an application for authorization under Interim Order No. 2. If an authorization is granted, the manufacturer may import or sell the COVID-19 medical device for which they hold an IO authorization in Canada. The manufacturer’s information and device information on the device label can then be cross-referenced against the IO authorization during importation and distribution, which is required to accompany the product during import.

Fees related to the submission of an application for a COVID-19 medical device authorization

Health Canada will waive all application fees for COVID-19 medical device authorizations subject to Interim Order No. 2 Respecting the Importation and Sale of Medical Devices for Use in Relation to COVID-19.

Quality Management System requirements related to the submission of an application for a COVID-19 medical device

Health Canada does not require manufacturers to provide a Medical Device Single Audit Program (MDSAP) certificate with their application for a COVID-19 medical device subject to Interim Order No. 2. Manufacturers will be required to share information to demonstrate that their products are of consistent quality and effectiveness. This can be demonstrated by either providing a copy of the manufacturer’s Quality Management System certificate to ISO 13485:2016, or by submitting evidence of Good Manufacturing Practices and its proper implementation.

Documentation required for importation

Under Interim Order No. 2, each shipment of a COVID-19 medical device that is imported into Canada must be accompanied by a copy of the Interim Order authorization. This document will be issued to the applicant upon authorization and will facilitate transport of the COVID-19 medical device(s) across the border, as it will be used as a signal that the device has been authorized under the Interim Order. Importers should rely on this mechanism to demonstrate to Health Canada that a shipment containing COVID-19 medical devices should be allowed access into Canada. References to Interim Order No. 1 on the authorizations can be read to be references to Interim Order No. 2.

Incident reporting 

Interim Order No. 2 requires that the holder of the COVID-19 medical device authorization for the importation or sale of the device report to Health Canada to comply with incident reporting requirements. 

Importers and distributors also must comply with mandatory reporting as outlined in the Medical Devices Regulations. Importers and distributors should also note that new regulations on mandatory reporting under the Medical Devices Regulations will come into effect on June 23, 2021, at which point importers will be expected to comply with the new regulations.

Requirement for importers and distributors to hold a Medical Device Establishment Licence (MDEL)

Under Interim Order No. 1, importers and distributors were not required to hold an active Medical Device Establishment Licence (MDEL) to import or distribute COVID-19 medical devices authorized under the IO. To enable risk-based regulatory oversight on the medical device supply chain and facilitate complete and rapid recalls of problematic devices when necessary, Health Canada has added this requirement to Interim Order No. 2.

Requirement to hold an MDEL

Interim Order No. 2 requires importers and distributors of COVID-19 medical devices to hold an MDEL and comply with certain requirements set out in the Medical Devices Regulations.

COVID-19 medical device importers and distributors:

  • have six months from the date that Interim Order No. 2 takes effect to obtain an MDEL and comply with relevant parts of the Medical Devices Regulations as defined in section 2(2)(a) of the Order (by September 1, 2021)
  • must submit applications for an MDEL within sufficient time to accommodate the service standard of 120 calendar days
  • are required to pay application fees, as well as annual fees, for as long as they hold an MDEL

MDEL holders are subject to other regulatory requirements, including record-keeping, reporting and inspections. Health Canada inspectors verify that the MDEL holder has the ability to conduct rapid, effective recalls of problematic devices when necessary.

Consult the existing Guidance Document for Mandatory Problem Reporting for Medical Devices for information on how to comply with those sections. Importers and distributors should also note that new regulations on mandatory reporting under the Medical Devices Regulations will come into effect on June 23, 2021, at which point importers will be expected to comply with the new regulations.

MDEL fees

Importers and distributors of any medical devices (including COVID-19 medical devices) who are required to hold an MDEL, must pay the associated MDEL fee, and comply with requirements set out in the Medical Devices Regulations.

For more information pertaining to MDEL fees, please review the Fees for the Review of Medical Device Establishment Licence Applications at the official website of Health Canada.

References

www.canada.ca 

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News

FDA’s Addition of the 9th Allergen (Sesame)

Sesame will become the 9th major food allergen officially recognized by the United States (FDA) on January 1st, 2023. The industry will have roughly two years to incorporate labeling changes to accommodate this new requirement. This clear labeling initiative is warranted to improve transparency, reduce allergic reactions, and protect this vulnerable population. 

Prevalence:

Sesame allergies are more common than one would think. Approximately 0.1% or 350,000 Americans experience allergic reactions or sensitivity to the ingredient sesame, thus justifying this major change and the addition to the Priority Allergen List (PAL). Symptoms from sesame reactions can range anywhere from hives to anaphylaxis and can even be potentially fatal to some individuals. 

How to disclose allergens:

Mislabelling or misrepresentation of an allergy is a serious issue and can lead to enforcement action for your product. The proper format(s) to disclose a major allergen on food labeling in the United States is as follows:

In parentheses following the name of the ingredient. Examples: “lecithin (soy),” “flour (wheat),” and “whey (milk)”
or
Immediately after or next to the list of ingredients in a “contains” statement. Example: “Contains wheat, milk, and soy.”

Exceptions:

When this new change comes into force, sesame must appear clearly in the ingredients listing. However, sesame will not be required to be listed if it is within a spice or flavoring. It will also not need to be listed when sesame is assumed within the common or usual name of a food (e.g. Tahini is made from sesame seed). It is important that consumers are aware of any allergens within their foods at the time of purchase. Taking precautions and clearly labeling your ingredient can help save lives. The industry is urged to transparently disclose sesame wherever possible. Taking an honest approach is always suggested when it comes to allergens. 

Other names for sesame are Benne, gingelly, seeds, sesamol, sesamum indicum, sim, tahini, and til. It is important that these ingredients will now be called out clearly as providing sesame to avoid where possible, any confusion, allergic reactions, and potential hospitalizations. 

Enforcement:

The FDA can enforce incorrect allergen labeling similarly to an adulterated or misbranded product. They can take actions such as warning letters, recalls, import refusals, or product seizures. In most cases where incorrect labeling has been identified the company can and will recall the product voluntarily. The seriousness of incorrect labeling can be fatal and should be taken very seriously.  

International Recognition:

Sesame is a recognized priority allergen in many major markets such as Canada, the EU, and now the USA. Sesame is the largest food allergy in Israel and its commonality is spreading. 

Allergens:

The original/other eight major US allergens are Milk, Tree Nuts, Eggs, Peanuts, Fish, Wheat, Shellfish, and Soybeans.

How Quality Smart Solutions can help:

Please contact our team for more information on labeling of allergens, or other food labeling projects. Our specialists are here to help!  

Resources:

www.fda.gov

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Blog

Why You Should Consider a Third-Party NHP Importer of Record?

NHP Impoter Record

Natural Health Products (NHPs) are regulated by Health Canada under the authority of the Food and Drugs Act and the Natural Health Products Regulations (NHPR) and must be licensed prior to marketing in Canada. Licensed NHPs are assigned an eight (8) digit Natural Product Number (NPN) or Homeopathic Medicine Number (DIN-HM). To be classified as an NHP, all of the medicinal ingredients in the product must be in Schedule 1 of the NHPR, not include any substances listed in Schedule 2 of the NHPR and be marketed for health reasons.

NHPs include traditional medicines; health supplements/vitamins; minerals; and bulk raw materials manufactured, sold or represented for use as NHPs. Cosmetics containing NHP ingredients and that meet both the function and substance components of the NHP definition are regulated as NHPs. 

Health Canada has an easy-to-follow policy on the importation of health products for commercial use. The Guidance Document on the Import Requirements for Health Products under the Food and Drugs Act and its Regulations (GUI-0117) outlines the requirements related to the importation of health products as defined by the Food and Drugs Act.

Health products commercially imported into Canada must meet all applicable requirements of the Food and Drugs Act and its Regulations including proper labelling, market authorization and establishment licenses. Here’s a summary of the licensing requirements for natural health products that are intended to be shipped to Canada for commercial purposes.

License Requirements for Natural Health Products:

Product license (NPN or DIN-HM) for each product.

All products, whether manufactured domestically or in a foreign site, must first undergo a pre-market review where it will be assessed for safety, efficacy, and quality. Evidence demonstrating this must be submitted to Health Canada by means of a product licence application (one for each product). Products, which meet the required criteria, will be authorized for sale and each issued a Natural Product Number (NPN) or Homeopathic Medicine Number (DIN-HM). Further information on this process is available in the Product Licensing Guidance Document.

Site license for each importer located in Canada.

The Natural Health Products Regulations require any Canadian site where natural health products are manufactured, imported, labelled, packaged, distributed, and/or stored to have a site licence. Businesses can choose to have a single site licence for all their operations (i.e. multiple sites) or an individual licence for each site. Site licences are obtained by demonstrating that the above-mentioned activities are conducted in a manner that is congruent with the requirements of the Canadian Good Manufacturing Practices (GMPs) for NHPs.

Quality Import Solutions (QIS) has a valid Site License to import Natural Health Products and can act as an importer of record into the Canadian market. We have collaboration with fist-class third-party warehouses annexed to our site license that can provides storage services of NHPs in compliance with Canadians GMPs if needed.

The foreign manufacturer must be listed on the importer’s site license.

While site licences are only issued to Canadian sites (none are issued to foreign sites). Foreign manufacturers as well as packagers, labellers of NHPs must be annexed to a Canadian importer’s site licence. In order to annex a foreign site to importer’s site licence, each foreign site must provide GMP evidence to demonstrate compliance with Part 3, GMP, of the Natural Health Products Regulations in full.  

Why Use Quality IMPORT Solutions (QIS) as a Third-Party NHPs Importer of Record 

Using QIS as a third-party NHPs Importer of Record will give you the benefits outlined below:

  1. Flexibility to use multiple distributors and/or brokers or sell direct in Canada
  2. Acting as a neutral third party which helps eliminating packaging liability (Our Importer’s name is required on your NHP label) if you were to use a distributor as your NHP importer and if down the line the relationship doesn’t work or if you decide to switch to a new distributor, you would be required to either over-sticker or destroy packaging 
  3. Multiple geographical choices as we have warehouse and fulfillment partners (annexed to Quality IMPORT Solutions site licence) located across Canada improving speed to market based on your preferred destination point 
  4. Having the option to either sell to traditional retail outlet or to online venues like Amazon, Well.ca and others 
  5. Low resource cost as we have an experienced team of quality assurance who provide full product disposition to the Canadian market and manage your quality assurance obligations

More than 80% of Canadians consume natural health products (NHPs), so it’s a ripe market for brands that are willing to navigate the product registration and importation requirements outlined by Health Canada. Our team will help you navigate through the process of registration and importation of your NHPs. 

Our Experts at Quality Smart Solutions continue to support your needs for natural health products, foods, cosmetics, OTC drugs and medical devices for North America. Contact us today to learn more about how we can support your compliance for NHPs registration and NHP importation.

Related Reading:

IOR Compliance and customs clearance

Medical Device Importer Benefits

FSVP Importer Food Importing

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Validation of the Safe Food for Canadians Licence to Import

cfia fresh fruit and vegetable licence number

cfia fresh fruit and vegetable licence number | safe food for canadians licenceIn order for food that is regulated under the Safe Food for Canadians Regulations, to be imported into Canada, the importer must hold a valid Safe Food for Canadians (SFC) license.

This license is issued by the Canadian Food Inspection Agency (CFIA) and must be presented with the shipment at the border in order for importation to be approved. Please note that this licensing may not be obtained at the border and all documentation must be in order when the shipment arrives at the border for it to be eligible for import.

The CFIA has announced that as of March 15th, 2021 certain commodities may be rejected by the CFIA unless a valid SFC license is entered in the Integrated Import Declaration (IID). The following food commodities are included.

  • Meat
  • Fish
  • Dairy
  • Eggs
  • Processed Eggs
  • Processed Fruits or Vegetables
  • Honey
  • Maple
  • Fresh Fruits or Vegetables

The Safe Food for Canadians license number should be entered into the appropriate field exactly as it was issued. This field is entitled “Registration Number” and the format for the license number an 8-digit alpha-numeric code.

The provided SFC license number will be reviewed to ensure that the license is valid, covers the activity of importing food, and covers the specific commodity being imported.

If the license number is not valid, a reject message will be received in the importer or custom broker’s IID system. See the below chart for an explanation of reject messages that could be received. If you have multiple licenses, verify that you are entering the correct license number on the import declaration.

Reject MessageReason for RejectCorrective Actions
AIRS registration number is required. (893 – Safe Food License).When the registration number field is left blank.Enter your SFC license number in the registration number field.
License number must be 8-digit alpha numeric (A12B3CD4). Verify license in My CFIA.When a Y or N is entered, or the number provided is not in the CFIA database. (Check for typos)

Ensure your license number is entered correctly.

License number is either suspended, cancelled, or expired. Verify status in My CFIA.When the license number entered has been suspended, cancelled, or expired.If your license is suspended or cancelled, you will have to contact your local CFIA office. If your license has expired, you will have to apply for a new one using the My CFIA Portal.
License number is not valid for importing. Verify activity in My CFIA.When the license number entered is not issued for importing food.You can amend your license in your My CFIA portal to include “importing food” to your license profile.
License number entered does not cover food being imported. Verify license in My CFIA.When the license number entered is not issued for the food commodity that is being declared.You can amend your license in your My CFIA portal to include the commodity in your profile.

Please note you can amend your SFC license at any time utilizing the My CFIA Portal without incurring an additional fee.

Obtaining a Safe Food for Canadians License:

The first step involved in obtaining a Safe Food for Canadians license is to create a My CFIA Account. It is through the use of the My CFIA account that you can request license and export certifications as well as set up electronic payment methods. While enrolling, you can create one or more profiles for your business. This way if your company involves multiple site locations, you can have a profile for each site.

Once your My CFIA Account is created, you will need to then determine your license structure. Since the Safe Food for Canadians Regulations do not limit the number of licenses a person can hold, you can operate under a single license or multiple licenses. It all depends on what works best for your business!

In order to decide how many licenses you will request, you should take the following points into consideration.

  • There is a fee for each license requested.
  • A Preventative Control Plan must be implemented and maintained for each license you hold.
  • Since many foreign trading partners require unique identifiers for each location or establishment, you may want to ensure that each license you hold is only associated with one establishment is you deal with exportation.
  • If there is more than one license for a particular physical location, there cannot be any overlap in the food categories and activities covered by the license.

After you know which license(s) you wish to apply for, you should collect all the necessary details of your business that are required during the application process. The following must be entered into the Safe Food for Canadians License Application,

  • The activities being conducted.
  • The location of the establishment(s) where the activities will be conducted.
  • The category of food.
  • Attestations regarding the requirements of holding an SFCR License such as having a preventative control plan implemented within the facility and that the information provided within the application is complete and not misleading.

Once the application for licensure has been submitted you will receive an electronic message indicating whether your license was approved or if the CFIA must first inspect the business before the license can be issued.

If your license is approved, it can be found within your My CFIA account.

If the CFIA has indicated that an inspection is required first, this could be for several reasons. The CFIA utilizes a risk-based approach for inspecting new business with a variety of risk factors being selected to prioritize and manage the inspection activities. If you are requesting an export certificate or other permissions, this inspection may be a requirement of the importing country.

References:

Validation of the Safe Food for Canadians licence to import

Health Canada – Safe Food for Canadians Licence

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Ensuring Predictability for Interim Orders Relating to COVID-19

Health Canada recently published an additional notice regarding all interim orders relating to COVID-19 and Medical Devices. This notice is showing the understanding from Health Canada that stakeholders require predictability for applicable regulatory aspects in respect to the interim orders.

The notice will be updated with links to notices regarding any consultations, and any related measures, as they are occurring/released.

The following outlines key information and updates that were delivered through this notice.

  • The flexibilities and regulatory oversight that has been provided through the use of these IOs will be maintained until at least the fall of 2021.
  • After the fall of 2021, regulatory amendments will be introduced that will allow for many of these temporary flexibilities to continue.
  • In the coming months, interested industry stakeholders, health system partners and other government departments will be consulted by Health Canada on the proposed regulations.

Interim Orders (IOs)

An IO is one of the fastest options for change available to the federal government to help make health products available to address larger-scale public health emergencies.

The objective of the Interim Orders is to expedite any necessary authorization for the importation, sale, and advertising of drugs used in relation to COVID-19 while taking into consideration urgent public health needs.

It allows for Medical Device Establishment Licences to be issued in relation to COVID-19 drugs in a manner that ensures pandemic related medical supplies remain accessible to all Canadians.

These Interim Orders further provide the Chief Public Health Officer of PHAC the ability to notify the Minister of a need to pre-position a promising COVID-19 drug in Canada. In order for a drug to be pre-positioned, the Government of Canada must have entered into a contract for its procurement and the manufacturer must have filed an application for the drug’s authorization in Canada, or abroad with a foreign reference regulator. Together, these measures help ensure Canadians have timely access to COVID-19 drugs.

A total of 5 interim orders have been issued in response to the COVID-19 pandemic since March 2020. These IOs have focused on making changes necessary to ensure that necessary Medical Device Licenses can be issued quicker in response to the current pandemic while also ensuring that the products and licenses continue to have sufficient oversight.

The following will summarize some important information from the currently issued IOs.

Importation and Sale of Medical Devices

Part 1 of the Regulations, with the exception of sections 52 to 56 and 63 to 65.1, no longer apply to the importation or sale of a COVID-19 medical device if the following conditions are met:

  1. the Minister determines that there is an urgent public health need for the importation or sale of the device;
  2. the manufacturer of the device has filed with the Minister an application for the authorization of importation or sale of the device in a form established by the Minister;
  3. the Minister has issued the authorization; and
  4. the authorization has not been cancelled.

All shipments of COVID-19 medical devices that are imported in Canada must be accompanied by a copy of the proper authorization for importation.

Permitting Exceptional Importation of Key Products

If a shortage of a specified medical device — or of its components, accessories, parts or consumable materials — has been reported or is likely to occur, the manufacturer and the importer of the device must each submit the following information to the Minister in both English and French in the form and manner determined by the Minister:

(a) the name and contact information of the manufacturer and of the importer;

(b) in the case of a Class II, III or IV device, the medical device licence number;

(c) the identifier of the device, including the identifier of any medical device that is part of a system, test kit, medical device group, medical device family or medical device group family;

(d) the name of the device and of any component or accessory of the device, including, if applicable, the model name;

(e) a description of the device;

(f) the date when the shortage began or is anticipated to begin; and

(g) the anticipated date when the manufacturer will be able to meet the demand for the device if that date can be anticipated.

This information must be submitted within 5 days after the manufacturer or importer becomes aware of a shortage. This also applies to any anticipated shortages

If any information previously submitted by the manufacturer or importer changes, the new information must be submitted to the Minister within 2 days after the change is made or 2 days after becoming aware of the change.

Once the shortage has been resolved and the manufacturer is once again able to meet the full demand for the medical device – or for its components, accessories, consumable material or parts – the manufacturer or importer will have 2 days to notify the Minister in writing to that effect.

Specified medical devices involved in the COVID-19 interim measures can be located on the Health Canada website within the COVID-19 Health Product Industry page. (https://www.canada.ca/en/health-canada/services/drugs-health-products/covid19-industry.html)

Prevention and Alleviation of Drug Shortages

As previously noted, the COVID-19 pandemic has caused an unprecedented demand for certain drugs and medical devices. As such, an interim order was issued in order to properly manage the subsequent drug shortages.

Under certain conditions;

  • Anyone who sells a drug may now be required to provide information that is relevant to a (potential) shortage of that drug relating to COVID-19.
  • The Minister of Health may also impose or amend terms and conditions placed on authorizations for selling drugs.

This Interim Order will assist with trending the usage of certain drugs in order to ensure all Canadians have uninterrupted access to the necessary COVID-19 related drugs.

How we can help

Quality Smart Solutions offers many avenues of support including full support for obtaining any Medical Device License. Our team is equipped with professionals who have extensive experience in the Canna, Pharmaceutical, Natural Health Product, Food and Medical Device industries

References

https://www.canada.ca/en/health-canada/services/drugs-health-products/covid19-industry/ensuring-predictability-interim-orders-notice.html

https://www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/announcements/interim-order-importation-sale-medical-devices-covid-19.html

https://www.canada.ca/en/health-canada/services/drugs-health-products/compliance-enforcement/covid19-interim-order-drugs-medical-devices-special-foods.html

https://www.canada.ca/en/health-canada/services/drugs-health-products/covid19-industry/drugs-vaccines-treatments/interim-order-drug-shortages/notice.html

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Q&A: Selling Hand Sanitizers in Canada

With the need for hand sanitizers significantly increasing for healthcare personnel and individuals during the current COVID-19 pandemic do help prevent and reduce the spread of the coronavirus Health Canada is taking action with interim measures to increase the supply of these products. This post is to help answer questions related to these actions and help you make an informed decision as it relates to licensing and marketing your hand sanitizer.

1. What action is Health Canada taking to increase the supply of disinfectants and hand sanitizers?

On March 17, 2020 Health Canada announced actions they take as an interim measure to increase the supply of hand sanitizers and disinfectants.  A summary of these actions can be found here:

https://healthycanadians.gc.ca/recall-alert-rappel-avis/hc-sc/2020/72623a-eng.php

On February 16, 2023 Health Canada announced the interim measure for hand sanitizers has expired.

2. I am a distiller of alcoholic beverages in Canada. Do I need any special license to make hand sanitizers?

There are 3 requirements to manufacture and sell hand sanitizers. You must obtain a Natural Product NPN license (if the hand sanitizer is ethanol or isopropyl alcohol based).  Licensing timelines can take 60 to 90 days for this class of natural health products.  Second, you will require a site license to manufacture, package and/or label hand sanitizers.  Third, you will need to obtain a Specially Denatured Alcohol (SDA) registration. This is issued by the Canada Customs and Revenue Agency (CCRA).  Quality Smart Solutions can help you with all 3 of these requirements.

3. Which countries does Health Canada recognize as being licensed and approved hand sanitizers?

As of February 216, 2023 the interim program has expired. As such, Health Canada will not accept authorization in other PIC/S countries as equivalent to sell hand sanitizers in Canada.  Hand sanitizers from those countries must obtain a NPN license.  However, GMP from manufacturers of those countries may help in equivalency to Canada’s GMP requirements.  Countries that are part of the PIC/S scheme are as follows:

Argentina
Australia
Austria
Belgium
Canada
Taiwan
Croatia
Cyprus
Czech Republic
Denmark
Estonia
Finland
France
Germany
Greece
Hong Kong
Hungary
Iceland
Indonesia
Iran
Ireland
Israel
Italy
Japan
Latvia
Lichetenstein
Lithuania
Malaysia
Malta
Mexico
Netherlands
New Zealand
Norway
Poland
Portugal
Romania
Singapore
Slovak Republic
Slovenia
South Africa
South Korea
Spain
Sweden
Switzerland
Thailand
Turkey
Ukraine
United Kingdom
USA

These countries are members of the Pharmaceutical Inspection Co-operation Scheme (PIC/S).

4. If I have a hand sanitizer license and/or authorization from one of these countries does this mean I can sell hand sanitizers in Canada?

No, as of February 16, 2023.   A Natural Health Product Number (NPN) or Drug Identification Number (DIN) is required.   You will also need to partner with a Health Canada licensed importer.  Quality Smart Solutions can file your NPN or DIN application.  

5. My hand sanitizer is registered in the United States but my label is based on  FDA regulations. Can I sell this in Canada?

You must obtain a NPN or DIN to sell your hand sanitizer in Canada. We can register your hand sanitizer whether it requires a NPN or DIN.   If your hand sanitizer is a NHP that requires a NPN we can act as your Health Canada importer through our sister company, Quality IMPORT Solutions. 

6. How can Quality Smart Solutions help me?

We can assist you with licensing your hand sanitizer. We have extensive experience having registered over 8000 Natural Health Products successfully obtaining Natural Product Number (NPN) licenses for hundreds of companies worldwide including many hand sanitizer companies.  Our sister company, Quality IMPORT Solutions, is a Health Canada licensed importer of Natural Health Products.  We currently import several hand sanitizer brands.  If you are planning to manufacture your hand sanitizer in Canada we will complete your SDA registration of your facility with CCRA.

Quality Smart Solutions is an end-to-end compliance solutions expert which has been assisting clients for 11 years in the areas of Dietary Supplements/NHPs, Foods, Cosmetics, Medical Devices, OTC drugs in Canada and the United States. Ask us for details or visit our website at www.qualitysmartsolutions.com.

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Foreign Supplier Verification Program – USA & Canada agreement?

Under the Food Safety Modernization Act (FSMA), the United States (U.S.) started graduated enforcement of the Foreign Supplier Verification Program (FSVP) in May 2017.

FSVP (Foreign Supplier Verification program) requires U.S. importers (regulated by US FDA) to verify that food imported into the United States has been produced in a manner that meets applicable U.S. safety standards. Similar to the Safe Food for Canadian Regulations, Canadian importers will soon have to verify and prove to CFIA the food they are importing meets the regulations and standards.

What does this mean for US Importers of Canadian foods?

Canada and the U.S. have a Food Safety Systems Recognition Arrangement (FSSRA). The FSVP provides modified requirements to U.S. importers when they import food that is covered under the FSSRA from Canadian manufacturers that are in good regulatory standing with the Canadian Food Inspection Agency (CFIA).

Does this mean we can finally see an alliance between the US FDA and CFIA?? That is the intention of the FSSRA and, fingers crossed, this will make it easier for US and Canadian imports and exports.

The FSSRA applies to foods regulated by the US FDA including:

  • fruit and vegetables
  • shelled eggs
  • dairy (except “Grade A” milk and milk products)
  • fish (except farmed catfish, catfish products and molluscan shellfish
  • maple
  • honey
  • processed products; and
  • manufactured foods

What does this mean for the Canadian food industry?

Canadian food manufacturers who process food for export will require a licence under the Safe Food for Canadians Regulations (SFCR). When the SFCR comes into force, the CFIA will publish a listing of SFCR licensed food manufacturers as the method to certify that they are operating in good regulatory standing if they comply with SFCR requirements. To be considered to be operating in good regulatory standing under the SFCR, the federally licensed establishments will need to operate with an acceptable Preventive Control Plan (PCP) and maintain acceptable traceability documents in order to be placed on the listing of SFCR licensed food manufacturers.

If you are currently federally registered and/or licensed with CFIA:

If you operate an establishment that is currently registered with the CFIA, you will need to have an acceptable Preventive Control Plan (PCP) and traceability documentation process in place in order to obtain a license when the SFCR comes into force. Your registration and the federally registered lists currently available may be used by U.S. importers to indicate your good standing until all food manufacturers are licensed and the new list of SFCR licence holders comes into effect.

If your business is already federally registered or licensed at the time that the SFCR comes into force, you can maintain your exporting activities while you make the necessary changes to transition to the SFCR licensing system.

If you are NOT currently federally registered and/or licensed with CFIA:

Businesses in certain food sectors (i.e. manufactured foods, non-federally registered sector, etc.), which have traditionally NOT required federal registration and/or licensing, will now need to be licensed to demonstrate that your company is in good regulatory standing. Like a registered facility, you will need to have an acceptable a PCP and a traceability documentation process in place in order to obtain a licence when the SFCR comes into force.

Food businesses seeking to begin or continue exports to the U.S. will need to be licensed when the SFCR comes into force if they want to be on the Canadian list of licence holders in ‘good standing’ in order for US importers to apply the modified FSVP requirements.

The CFIA encourages all Canadian food businesses exporting to the U.S. to prepare for the SFCR as it comes into force. Being federally licensed and listed with the CFIA will eliminate the burden of documentation for importers and exporters of US FDA regulated foods. Businesses do not need to apply for an SFCR licence at this time, but as the transition to the new regulations takes place, you will be able to apply for the new licence online or access information about the licence and regulations through your My CFIA account.

If you want to be sure your food safety practises are in line with the new SFCR and export requirements, Quality Smart Solutions has a team of specialists who can assist with preparing and implementing a PCP or reviewing your documents and conducting an audit of your facility. Get prepared now and contact us today to discuss how we can be your food safety solution!

Quality Smart Solutions is an end-to-end compliance solutions expert which has been assisting clients for 11 years in the areas of Dietary Supplements/NHPs, Foods, Cosmetics, Canna, Medical Devices, OTC drugs in Canada and the United States. Ask us for details or visit our website at www.qualitysmartsolutions.com.

Resources Canadian Food Inspection Agency. Inspection modernization. 2018-01-03. http://inspection.gc.ca/food/sfcr/exports/requirements-library/fsvp/eng/1521203122812/1521203165440
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Natural Health Product Brand Name Guidance

Natural Health Product Brand Name Guidance

Brand names are an important part of your marketing strategy, but as many of us know firsthand there is a difference between what the marketing team wants to say and what the regulatory authorities will let you get away with. Consideration needs to be taken to ensure your brand name is as compliant as your health claims since a brand name is essentially an extension of your health claims.

As part of the review process, the Natural and Non-precription Health Products Directorate reviews your brand name in addition to your health claims. They expect that the name you choose for your product reflects the approved product claims. For example, if you want to market a product containing vitamin B12 which is licensed for the claim “Helps to maintain the body’s ability to metabolize nutrients” you will not be permitted to use any reference to weight management as part of the brand name. Other brand name challenges we have come across is the use of the term ‘detox’. This term is reserved exclusively for products which support liver function or the elimination of waste from the body.

Another challenge is having a brand name which implies treatment of a condition but only being able to receive a licence for an antioxidant claim. For example, the marketing team wants to call the product “Low Dose Lutein for Eye Health” and market the product to support eye health in conditions such as cataracts and age-related macular degeneration.  However, when we review Health Canada’s monograph for Marigold extracts and isolates (including lutein) we see this eye health claim is based on quantities of at least 6 mg lutein per day.  If the ‘low dose lutein’ product provides less than 6 mg lutein per day, Health Canada will only permit the use of the product for antioxidant purposes. In which case, using a brand name which speaks to the products efficacy for eye health would be considered non-compliant.

If you are looking to appease your marketing department while keeping the product brand name fully compliant, Quality Smart Solutions has a team of specialists who can assist in achieving innovative brand name compliance for your products.  Contact us today to discuss how we can be your solution!

Quality Smart Solutions is an end-to-end compliance solutions expert which has been assisting clients for 11 years in the areas of Dietary Supplements/NHPs, Foods, Cosmetics, Medical Devices, OTC drugs and Canna for Canada and the United States. Ask us for details or visit our website at www.qualitysmartsolutions.com.

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Amazon.ca removing non-compliant Natural Health Products in October

In September  Amazon.ca notified every Natural Health Product vendor (whether they had an NPN or not) that, effective in October 2018 they will be removing all products that don’t have a Natural Health Product Number.   Here’s the email they sent to sellers:

AMAZON NOTICE TO SELLERS OF NATURAL HEALTH PRODUCTS

Dear Seller,

Pursuant to Canadian laws and regulations, all non-prescription drugs, supplements, and natural health products (“NHPs“) that are sold in Canada must be assigned a registration number by Health Canada.

We are updating our product registration templates to require either a Natural Product Number, Drug Identification Number or a Homeopathic Medicine Number to list these products on our site.

From October 2018, Amazon will remove drugs, supplements, and NHPs that do not have registration numbers associated with them in the catalog from the site. If your product is impacted, you can identify the ASINs and contact Seller Support.

To back-fill the required compliance information for your existing products, you can do so through the single item setup in Seller Central or through an Inventory Template file. More information about listing drugs, supplements and NHPs can be found here: https://sellercentral.amazon.ca/gp/help/external/200164490

Amazon.ca, in recent months, had been taking a proactive approach for new products listed on their site whereby if a brand didn’t have an NPN they couldn’t be listed. However, prior to this policy implementation many products were listed without an NPN.  Clearly there was significant pressure on Amazon from border officials, Health Canada and likely shareholders to tighten up their policy.

For international (ie. outside Canada) companies shipping dietary supplements to Canada there are 3 requirements as summarized on  NHPLicenseExperts.com which includes:

  1. A Natural Product Number
  2. A compliant Natural Health Product label
  3. An importer of record if you are shipping a finished product into Canada.

Some of the biggest brands like Amazing Grass, Dr. Bronner’s Barlean’s, Goddess Garden, SmartyPants and many more rely on our end-to-end NHP License solution.

The good news is that we are your one-stop shop solution for all three of these requirements.  Working with hundreds of clients and brands we offer competitive rates having prepared thousands of NPNs over the last 12 years.   Ask about our new client NPN registration offer to help you continue your business on Amazon.ca and your business in the Canadian marketplace.

Quality Smart Solutions is an end-to-end ompliance solutions expert which has been assisting clients for 11 years in the areas of Dietary Supplements/NHPs, Foods, Cosmetics, Medical Devices, OTC drugs and Canna for Canada and the United States. Ask us for details or visit our website at www.qualitysmartsolutions.com.

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Business considerations: Natural Product Number Application NPN

MDEL medical device establishment licence listing

mdel license application canadaJust a little background information first before I talk about the business aspect of capitalizing on your NPN.  NPN stands for Natural Product Number. It is a license that is issued by Health Canada and required for a dietary supplement (the term used in Canada is Natural Health Product) to legally be sold in Canada.  The NPN is required to have at least one health claim associated with the license. Obtaining a license can take 10 days to 210 days depending on the product ingredients and whether they are within the scope of Natural Health Product (NHP) Monographs (class 1 or 2 NHPs) or not (Class 3).

Timing is crucial to get the highest ROI and timely return for your NPN. This will depend on when your business generates the most revenue for the desired NPN.  For example, sunscreen products would typically generate most of their revenue between the summer months, May to September. Retail stores (particularly food, drug, mass stores) set their planograms and orders much earlier to ensure on-shelf presence in advance of the season start so preplanning is important, starting with a timeline when to apply for an NPN.  In this example of natural sunscreen products (those with titanium dioxide and zinc oxide) these are class 1 NPNs so license is issued in 10 days. Based on lead times of various other factors (label print run, manufacturing) a reasonable time should be considered to start the process to deliver on time and not miss those key selling months. Why is this so important? If an NPN were prepared late, packaging completed mid season and delivery of packaged goods late in the summer, in this example, there could be inventory sitting that becomes short dated (in this sunscreens example, shelf life is1 to 2 years) or worse, doesn’t sell, possibly delisting or repeat orders not placed for the next season thereby depreciating your ROI for your NPN!

In the case with a class 3 NPN, that could take up to 210 days (7 months) after submission acknowledgement, a more long term planning launch strategy is needed. Some retailers, for example,  won’t begin dialogue with a branded company until they have an NPN.   Most natural health products see most of their sales between September to February. Diet and Sports Nutrition companies see a significant portion of new business in the “new years resolution period” between December to February. Let’s look at a hypothetical example, of a class 3 NHP that would start in 2016. Here’s how a Canadian launch planning could be mapped out to gain the most revenue and the soonest to NPN issuance:

  • August 2016 – begin on a class 3 NHP application
  • Mid August/early September 2016 – submit class 3 NHP application
  • mid September/Early October 2016 – acknowledgement letter of class 3 NHP submission indicating that it will take up to 180 days, 30 days after the date of the letter (total 210 days) to meet the performance target to obtain an NPN
  • April 2017 – if you are a foreign company and manufacturing, shipping finished product from outside of Canada your manufacturer, labeller and packager have to be annexed to a Canadian importer. This process can take 30 to 90 days for approval
  • May 2017 – latest when the class 3 NHP will be issued an NPN (based on an October acknowledgement letter receipt). Safe now to schedule the manufacturing of approved NPN product.
  • Mid May/early June 2017 – bilingual compliant NHP label ready to print
  • Late June/early July 2017 – printed packaging ready
  • June to August 2017 – manufacturing of approved NPN product (based on manufacturer lead time which is dependent on raw material availability, seasonality peaks, line time queue from other manufacturer clients). Typical lead time of manufacturers is 4 to 12 weeks.
  • Mid August – ship to retail or warehouse
  • September 2017  – Product launch

This scenario is a best case situation.   There are many factors that come into play upstream such as ingredient safety and efficacy substantiation, formula feasibility, researching substitute ingredients if one or more ingredient in the original formula aren’t meeting safety parameters and other considerations (these are some areas we look at with our clients applying for NPNs).

Here are general rules of thumb when to begin the NPN license process prior to launch date:

Class 1 – at least 6 months

Class 2 – at least 7 months

Class 3 – at least 13 months

In each of these cases, if annexing your manufacturer to a Canadian importer site license is required, this should start at least 5 months before product launch.

If you have any questions we are happy to help. Feel free to contact us.

Quality Smart Solutions is an end-to-end compliance solutions expert helping clients for 10 years in the areas of Dietary Supplements/NHPs, Foods, Cosmetics, Medical Devices and OTC drugs. 

Our business development solution division, Quality IMPORT Solutions, can act as your Dietary Supplement Importer into the Canadian market and connect you with reputable brokers and distributors that cover the Canadian market from coast-to-coast. Ask us for details or visit our website at www.qualitysmartsolutions.com

FAQs

What is a Natural Product Number (NPN)?

An NPN is an 8-digit license number issued by Health Canada for approved natural health products (NHPs) that confirms the product’s safety, efficacy, and quality.

An NPN is legally required to market and sell natural health products in Canada, ensuring compliance with federal regulations and consumer safety.

Important factors include regulatory compliance, cost of submission, product formulation, target market, manufacturing practices, and long-term business strategy.

Timelines vary, but it can typically take between 60 to 210 days depending on the class of submission and the completeness of your application.

Health Canada categorizes submissions as Class I, II, or III, based on product complexity, risk, and the amount of supporting evidence required.

Required documents include a product license application form, evidence for safety and efficacy, label text, and site license information (if applicable).

Yes, but they must have a Canadian representative or importer and comply with Health Canada’s regulations for market authorization.

A site license is mandatory for manufacturers, packagers, labelers, and importers of NHPs and must be in place before the product is sold.

Costs may include regulatory consulting fees, preparation of safety/efficacy data, product testing, and post-licensing compliance costs.

They offer end-to-end regulatory consulting, including application preparation, submission, strategic planning, and ongoing compliance support.

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Summary of the Proposed Approach to the Regulation of Canna

Large Indoor Marijuana Commercial Growing Operation With Fans, Greenhouse, Equipment For Growing High Quality Herb. Cannabis Field Growing For Legal Recreational Use in Washington State

On November 21, 2017 the Canadian Minister of Health announced the Proposed Approach to the Regulation of Canna.  The public consultation 60-day period has begun for feedback on the proposed rules which are primarily to layout the framework and regulations around recreational marijuana with medical marijuana rules, for the most part, being status quo.  The consultation paper covers 8 areas including Licenses, permits and authorizations, security clearances, canna tracking system, canna products, packaging and labelling, canna for medical purposes, health products and cosmetics containing canna and miscellaneous issues.  The government’s intent is to have the Canna Act be approved before July 2018.  Here are the main takeaways from the proposed Canna Act :

Expansion of License categories

Currently the license categories include cultivation, processing and selling of medicinal marijuana. The new proposal will allow for an expansion of the cultivation license including micro cultivation, microprocessing and nursery licenses.   Also, outdoor cultivation would be permitted (as opposed to the current regulations that allow for indoor cultivation that is only allowed) though a dwelling house would be prohibited from conducting any licensed activity.  Import and Export of medical canna and industrial hemp would be allowed.

Security Clearances

The current system has a strict security clearance of individuals with any previous criminal record not being permitted to obtain clearance for producing or distributing canna.  Under the proposed regulations, this will be determined on a case-by-case basis whereby individuals who are considered low risk may be granted clearance.

Canna Tracking System

A National tracking system (likely through a public online platform) would be created with the intent to prevent unauthorized activities and/or deter organized crime from conducting activities.  This system would likely be similar to the Establishment License system for drugs and medical devices.  There is currently a monthly tracking system in place for medical canna licensed producers. This new proposed system would expand on this platform.

Canna Products and Forms

Five classes of canna would be permitted for sale including dried canna, canna oil, fresh canna, canna plants and canna seeds.   Edibles such as foods or beverages would be permitted. Currently capsules and creams are not allowed under the ACMPR framework.  However, with the proposal various forms such as capsules, topical application creams and oils would be permitted and likely licensed similar to the NHP and DIN regulations.  There would be limits set on the amount of THC allowed per dosage unit set at 10 mg.

Packaging and Labelling

Adopting the labelling standards of tobacco products, the proposed labelling requirements would limit graphics, colours and other packaging aesthetics to deter youths from purchasing recreational canna products.  Tamper evident, child-resistant packaging. Limits of 30 grams of dried canna per single package and 2.1 Litres for canna oil would be set.  Labelling requirements would include such items as product name, description, THC/CBD content and warnings to KEEP OUT OF REACH OF CHILDREN. Health warning statements would be mandatory similar to tobacco products. A Standardized canna symbol will be created to prevent accidental ingestion for products with more than 10 ppm of THC.

Medical Canna

The regulations for medical canna, as outlined in the ACMPR, would remain mostly the same with the access for patients being modified to allow for greater than a 30 day supply if a licensed seller cannot fill multiple orders within a 30-day period.

Health Products and Cosmetics with Canna

Health products such as prescription, non-prescription (OTC) drugs, natural health products (NHP), veterinary drugs, veterinary health products (VHP) and medical devices with canna may be permitted based on scientific evidence that demonstrate safety and efficacy of these combination products.  Furthermore, cosmetics (which currently prohibit canna derived ingredients) may be allowed under the proposed Canna  Act.

Miscellaneous Issues

Amendments to the current ACMPR and NCR based on this proposed Canna Act would be implemented. Qualifications for designated analysts of suspected seized controlled substances would be determined. Amendments to the practitioners to prescribe, administer and provide based on respective provincial regulations.

The complete proposed document can be found here:

 Proposed Approach To the Regulation of Canna

Quality Smart Solutions is ready to assist companies seeking expert Canada Canna regulatory and quality assurance assistance under the current ACMPR framework for license applications and we will be prepared to assist companies on the forthcoming Canna Act framework.  Contact us today how we can be your solution!

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Canada Natural Health Product (NHP) Labelling Revision Update for Products Containing Green Tea Extract (GTE)

On November 14, 2017 the Natural and Non-prescription Health Products Directorate (NNHPD) announced that there are several updates to the NHP Monograph for Green Tea Extract based on reports from Canada and worldwide that there may be a link, albeit the risk is rare, of the use between green tea extract and risk of a rare and unpredictable liver injury.  The risk statement is already required with products falling within the scope of the current Green Tea Extract monograph. The updated monograph will elaborate on these warnings and risk statements.  As well, the subpopulation of children and adolescents will be excluded from the monograph and will be restricted to adults 18 years and older.

The following changes to and additional risk statements will be required (with new verbiage in bold):

  • “If you have a liver disorder, consult a healthcare practitioner prior to use. Stop use if you develop symptoms of liver trouble such as yellowing of the skin/eyes (jaundice), stomach pain, dark urine, sweating, nausea, unusual tiredness and/or loss of appetite and consult a healthcare practitioner”
  • “Rare, unpredictable cases of liver injury associated with green tea extract-containing products have been reported (in Canada and internationally)”

Products that contain Green Tea Extract as a non-medicinal ingredient are required to report the amount of EGCG in the green tea and required to add the above stated risk statements.

As Health Canada must be notified stating companies containing GTE either as medicinal or non-medicinal ingredient the dates are as follows:

GTE as a non-medicinal ingredient and quantity of EGCG  – December 14, 2017

GTE as a medicinal ingredient attestation – November 14, 2018

If you have a NPN licensed product containing Green Tea extract either as a medicinal ingredient or non-medicinal ingredient please contact Quality Smart Solutions today to assist you in notifying Health Canada about this important label update.

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FDA proposes extended dates for Nutrition Facts and Supplement Facts labels compliance

This past June 2017 the Food and Drug Administration (FDA) put a hold on the compliance dates for Nutrition Facts and Supplement facts compliance dates.  The compliance dates were scheduled for July 26, 2018 for companies with annual sales over $10 million and July 26, 2019 for companies with sales over $10 million.   Scott Gotlieb sent a tweet out in mid-September that FDA would propose a 18 month delay on the compliance dates so we knew this was coming soon.

The new dates are as follows:

January 1, 2020 – companies with annual sales over $10 million

January 1, 2021 – companies with annual sales under $10 million

The details of these changes to the Nutrition Facts tables can be found here.

Quality Smart Solutions has been implementing the new Nutrition Facts and Supplement Facts table regulations for our clients for the last 12 months so they are future-proofed.  We are experts in US Food and Dietary Supplement label compliance. Contact us today if you are seeking affordable US label review assistance.

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Changes to Regulation of Veterinary Health Products (VHP) in Canada

Cat with Green Eyes takes a Pill

As discussed in an earlier post (PLL – Plain Language Labeling: What it means and how it affects you), the Food and Drugs Act (F&DA) underwent drastic revision after the thalidomide crisis of the 1960s. While some amendments have been introduced since then, the F&DA has remained mostly untouched. In 2014, the Regulations Amending the Food and Drug Regulations were passed in order to address several issues that were identified over the previous 50 years. One set of these amendment impacts the registration of veterinary health products, defined as low-risk products such as vitamins, minerals, traditional and homeopathic medicines for companion and food-producing animals. These products promote the health and wellbeing of animals but do not diagnose or treat disease.

On May 17, 2017, the final publication in the Canada Gazette, Part II of the Regulations Amending the Food and Drug Regulations (Veterinary Drugs – Antimicrobial Resistance) formalizes the existing voluntary Interim Notification Pilot Program (INPP).  The regulations are scheduled to come into effect on November 13, 2017.

Background

Health Canada’s INPP for veterinary health products (VHPs) has been in place since 2012. Health Canada leveraged a third-party organization North American Compendiums (NAC – www.lrvhp.ca) and the Canadian Animal Health Institute, launched a voluntary pilot program to launch a pilot as a mechanism to assess how well a risk-based, streamlined process would work to register such products and all learnings were to inform a more permanent program. Nearly 1000 products have been successfully notified by Canadian manufacturers and importers for sale in Canada.

The Veterinary Drugs Directorate of Health Canada will administer the Notification Program that will build on the current pilot’s process structure. The notification of VHPs, the requirements for VHP substances or ingredients as included on List C: Veterinary Health Products, and the reporting of adverse events remains intact.

Rules For VHPs

The risk-based notification program for VHPs will require:

  • companies to notify Health Canada 30 days before selling a VHP or making a change to a marketed VHP
  • All active, homeopathic and traditional medicine substances permitted in VHPs are listed in List C: Veterinary Health Products and must be labeled accordingly
  • labels to state “Veterinary Health Product”
  • mandatory reporting of serious adverse drug reactions to Health Canada
  • adherence to the Good Manufacturing Practices (GMPs) in the Natural Health Products Regulations

How Does This Impact You?

For companies with existing valid notifications, their labels will be transferred over to the new system and companies must update their labels within 18 months, or sooner at the next labeling cycle. New registrants can notify according to the old rules until October 13, 2017, and all VHPs will be required to comply with the new rules as of November 13, 2017.

How QSS Can Help

Our Quality Smart Solutions (QSS) team takes great pride in our client-focused, solutions-oriented approach to resolving your issues and challenges.  Not only will we review your labels to assess your compliance with the new regulations, but we will also submit the registrations and work with the regulator on your behalf. Further to this, we will work with you to make sure you and your supply chain meet GMP. QSS is your solution to ensuring you are compliant with Health Canada’s VHP requirements. Contact Quality Smart Solutions today at 1-800-396-5144 ext. 4 or fill out our online page by clicking here.   To see all we have to offer in regulatory compliance and quality assurance solutions, visit us at www.qualitysmartsolutions.com.

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Import Solutions for Natural Health Products – Our New Website!

Our sister company, Quality IMPORT Solutions has a new website with all the information you need to make an informed decision when choosing an importer for your natural health products and what makes Quality IMPORT Solutions different than other providers.  You visit the site at www.qualityIMPORTsolutions.com.

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PLL – Plain Language Labeling: What it means and how it affects you

BACKGROUND

Originally implemented in 1920 after the inception of the Federal department of Health in 1919, the Food and Drugs Act (F&DA) underwent drastic revision after the thalidomide crisis of the 1960s. While some amendments have been introduced since then, the F&DA has remained mostly untouched. In 2014, the Regulations Amending the Food and Drug Regulations were passed in order to address several issues that were identified over the previous 50 years.

Many of the 2014 changes allocated to the Minister more power to demand action in the face of identified risk, i.e. the power to request recalls products affected by emergent safety issues, or request immediate package label revisions to include warnings in reaction to newly identified risks in a mandate called Vanessa’s Law. Along with this and other sets of changes, amendments were passed in order to promote consumers’ understanding of drug labels at the point of purchase.

The new Canada Plain Language Labeling (PLL) requirements apply these amendments to the regulations. The intention was seemingly simple: to provide important information to consumers in plain language in an easy to read format, so product names are not confusing and it is clear how to report harms caused by the purchased drug.

IMPACT TO INDUSTRY

These PLL requirements for prescription and non-prescription pharmaceutical drugs, biologic drugs, and radiopharmaceuticals were phased in per drug product type. The Health Canada Labeling Guidance Regulations took effect for prescription products as of June 13, 2015, and for non-prescription products, more recently as of June 13, 2017.

Overall, much more work must be done upfront before submitting application packages to the regulator for pre-market approval. As such, graphic design work must be done in parallel to submission preparation. Health Canada will no longer accept unformatted label text; however, it will accept annotated written text, in lieu of mock-ups, to reflect proposed changes to the inner/outer labels as part of Notifiable Change (NC) submissions or Post-Authorization Division 1 Change submissions (PDCs).

If you plan to submit a new or amend a DIN, NDS, SNDS, or to amend your existing drug product license, you are affected by this.

CANADA LABELING REQUIREMENTS

Information on the label must be expressed in plain language in a way that does not impede the user’s understanding. Health Canada’s expectation is for all existing labels to be updated with PLL labels over time and for all new drug applications to consider the following aspects of their labeling:

Brand name: Your product’s brand name cannot resemble any other DIN product, a kit, or a radiopharmaceutical. HC may request evidence. Look-alike sound-alike (LASA) drug product names refer to names of different drug products that are similar when written or spoken. Such similarities may cause confusion and result in errors when self-selecting, prescribing, transcribing, dispensing, or administering a drug product, introducing a risk of harming the user/patient/consumer if the wrong medication is prescribed or improperly dosed/administered.

Contact information: Inner and outer labels must display information that allows the consumer to contact the party responsible for the product in Canada for guidance if any problems occur. At least one method of contact should be listed, such as a toll-free number, email address, or website. The licensee can decide who can be the initial contact. Note that biologic drugs and radiopharmaceuticals are exempt from this requirement.

Mock-up requirement: Mock-up labels of every label to be used for the drug must be provided to Health Canada upfront with the product license application submissions instead of at the DIN activation stage (i.e. as part of market notification). These labels are market-ready and fully bilingual, in full color and actual size. This includes package inserts. Health Canada  Labeling reviewers will review font size and type, color; and placement (including proximity, overlap, and panel location) of key elements of an inner/outer label. Only editable labels (i.e. not locked PDF files) are accepted, meaning those which enable reviewers to verify the font type and sizes. A locked file impedes reviewers from making annotations to the labels. Provide the font size and typestyle upfront in the Certification doc, required to accompany the submission. When Health Canada label reviewers know the font size and typestyle of labels at the beginning of a review, they are able to review labels more efficiently. Specific labeling requirements exist for product monographs and various package insert/pamphlet/leaflet formats. Mock-ups must also be submitted with administrative for changes to manufacturer or product name.

Canadian Drug Facts Table (CDFT): A formatted table of the required information is mandatory only for non-prescription drugs only so that consumers are fully informed at the point of sale. Good Label and Package Practices must be applied, and all formatting rules must be followed.

PLL applies to prescription and non-prescription pharmaceutical drugs, biologic drugs, and radiopharmaceuticals.

TIPS

To facilitate your adherence to PLL and Health Canada’s review and approval of your drug submissions, consider the following points:

  • Research Brand names to ensure they do not resemble other brand names, common names, or proper names of products/chemical entities that are currently available for sale in Canada.
  • Wording for contact information most often seen is “For questions or to report problems, please contact…” or “Questions or concerns?”, followed by the contact information.
  • Provide only editable labels (i.e. not locked PDF files) to the QSS reviewer and as part of the submission.
  • Provide the font size and typestyle used in the label upfront in the accompanying Certification document
  • Review the specific formatting requirements for product monographs and package insert/pamphlet/leaflet. Leverage QSS’s expertise for strategic advice in your unique circumstance. We believe in a no-nonsense approach to help you navigate regulatory hurdles without sacrificing your business goals.

HOW WE CAN HELP

Our Quality Smart Solutions (QSS) team takes great pride in our client-focused, solutions-oriented approach to resolving issues and challenges.  With expertise in OTC, ANDS drug submissions, label review, and French translation, we provide Health Canada Labeling Guidance to ensuring you are compliant with Health Canada’s Drug Regulations.   Contact Quality Smart Solutions today at 1-800-396-5144 ext. 4 or fill out our online page by clicking here.   To see all we have to offer in regulatory compliance and quality assurance solutions, visit us at www.qualitysmartsolutions.com.

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Top 3 things to consider when planning to sell your Dietary Supplement in CANADA

Some companies make the assumption that selling a dietary supplement product in Canada is no different than selling in the United States.   There are, in fact, several distinct differences.  As you plan to enter the Canadian market there are several points to consider.  

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

Quality Smart Solutions can assist you in these three areas.  In addition, we have a national network of distributors and brokers in Canada to fit your distribution and channel needs.  We are more than just a consulting firm. We are YOUR end-to-end solution for a compliant and successful Canadian launch. Contact us today or call us at 1-800-396-5144.

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A New NHPD Ingredient Database Monograph Coming Soon?

Health Canada recently announced their initiative to modernize the regulatory framework for health products and foods. This is required due to a variety of factors, such as new and emerging science breakthroughs and public health threats worldwide. The modernization is also based on public input regarding the need for greater transparency. The Canadian federal government published a Red Tape Reduction program in January 2012, and some of the reasons for change also stem from this report.

The NHPD recently released a Standards of Evidence document that is currently under consultation review by stakeholders. This consultation review is set to end August 21, 2012. The document takes a risk based approach to health claims and may allow lower risk claims to be made based on non-human studies (e.g. In vitro animal studies) as long as safety data in humans is available. Essentially this review and licensing will be based on three class levels, each having a level of risk. In addition to this license evaluation approach there are new timelines proposed. The chart below illustrated the current and future timelines:

ClassCurrent TimeframeFuture timeframe
1 – High level of certainty
– (eg. Monographs, AbLs, Category IV/TPD labeling		60 days10 days
2 – Medium level of certainty – a combination of pre-cleared information and high quality data from peer reviewed published journals180 days30 days
3 – Low level of certainty – clinical trial evidence and full pre-market assessment180 days180 days

Based on the amount of information that the NHPD has gathered over the last 8 years and pre-cleared information through NHPD monographs, the anticipation is that 99% of all product license applications would be reviewed in 30 days or less. With the Exemption number program set to expire in February, the NHPD is under the gun to clear the backlog and introduce a new process. After UPLAR expires in February, the mandate will be in place so that products will not be allowed for sale unless an NPN is issued.

These new target review timelines are a major requirement forcing companies to set dates for products on shelf with their retail partners. The new framework will hopefully prevent any future backlogs. Based on the rapid response that Quality Smart Solutions has seen in the past year, from license submission to license issuance for our clients, it is encouraging that the NHPD will meet their target of clearing the backlog and repeal UPLAR without further extension of the regulations past the due date. We also anticipate many more monographs to be published between now and next February. Quality Smart Solutions will keep you updated as this new approach develops and becomes reality.

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Keeping An Eye On The Global Health Products Landscape

Significant changes are occurring in the global regulatory landscape as of late, and this is just another example of how the world is evolving into a single global marketplace. Products marketed in the United States may be in Brazil after having cleared the regulatory hurdles of that country. Products made in Korea may be in Canada after receiving an acknowledgment letter or NPN. With globalization, various regulatory hurdles must be overcome for each country or region where entry is desired. Quality Smart Solutions is involved in this global market, and our clients span the globe. We will keep you informed through news feeds which we regularly update on our website.

Other ways to follow Quality Smart Solutions are:

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Thank you for visiting us at the NATURAL PRODUCTS EXPO WEST in Anaheim, California in March!

NPEW

We hope you found it as successful as we did. Feel free to email us at

info@qualitysmartsolutions.com or give us a call at 1-800-396-5144.

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Quality Smart Solutions is a global consulting firm, engaged in providing strategic support for products including NHPs, pharmaceuticals, and medical devices, in areas such as Regulatory Support, Site Licensing, Clinical Development and more.

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