FDA Prior Notice for Food Importers in 2023 when & how to submit


Prior notice is a requirement for all food manufactured, processed, packed, or held outside the United States that is imported into the United States. It ensures that the U.S. Food and Drug Administration (FDA) has the opportunity to evaluate the safety of a food shipment before it enters U.S. commerce and provides an opportunity for the FDA to inspect food products at their first port of arrival in the United States. In addition to protecting public health, prior notice allows FDA to reduce costs associated with detaining or refusing entry of potentially unsafe foods from entering U.S commerce

FDA prior notice food manufacturer importing

Submitting your FDA Prior Notice:

Prior Notice requires the submitter to provide certain information related to the food shipment to the FDA, including:

  • The name and address of the manufacturer, packer, or distributor
  • The name of the product
  • The quantity of each product being shipped
  • The anticipated arrival date of the shipment in the United States (or another applicable country)
  • Ports of entry through which the shipment will be imported into that country (e.g., “Port of Entry #1”) or another country relevant to a particular prior notice submission. This can be helpful if multiple countries are involved in your food importation process, and you wish to track your products as they move across borders—a very common situation for global brands selling products across continents!

Food Importers Submitting their FDA Prior Notice

The FDA has authority under section 801(a) of the Federal Food, Drug, and Cosmetic Act (FDCA) to require that importers provide prior notice before the food product is imported into the United States.

  • The FDCA ensures that foods are safe for consumers by prohibiting adulterated foods from entering or being sold in interstate commerce, and by requiring all foods shipped in interstate commerce be labeled accurately.
  • The FDCA also requires that FDA inspects imported food products at ports of entry to ensure they are free from filth, pesticide residues, and natural or artificial poisonous or deleterious substances added after harvest but before such entry into the United States; do not contain any substance which renders it injurious to health; their labeling bears no false or misleading statement as defined in section 403(a)(1); have been processed in compliance with section 404; bear labeling information required by specific provisions of law set forth in 21 CFR 101-40.

Looking for help submitting your FDA prior notice or importing your food products?

When to Submit your FDA Prior Notices

Prior Notice submissions must be submitted at least 24 hours before the shipment arrives in the United States. The FDA allows Prior Notice submissions to be submitted any time after a transaction has been agreed upon but no later than two hours before the shipment arrives at its first port of arrival in the United States.

The FDA also requires that each shipment must be accompanied by a valid Prior Notice submission or it will be refused entry. Any importer or shipper can submit a prior notice on behalf of an importer, but they must have authorization from the foreign manufacturer or distributor and have access to certain information about their products, such as ingredient lists and country of origin. A complete list of the required information can be found in FDA’s guidance document which provides detailed instructions on submitting Prior Notice Submissions online through ACES (Automated Commercial Environment) via an eManifest system used by Customs & Border Protection (CBP).

How to Submit Prior Notice:

  • To submit a prior notice electronically, a submitter must use FDA’s Prior Notice System Interface (PNSi), which is available online. We recommend that you verify your submission information before submitting it to the FDA.

Can my Prior Notice Submissions be Refused?

If the FDA is not able to receive the information required by Prior Notice before a particular shipment of food arrives at its first port of arrival, the FDA may refuse entry of the food into the United States. It is important to note that in order for a submission to be considered “on-time,” the submission must be received by the FDA within 30 calendar days from when the product enters into U.S. commerce (i.e., when it is entered into any port).

Need Help Submitting your FDA Prior Notice?

In addition to webinars and videos, the FDA also offers a series of e-learning modules on Prior Notice for Human Food. The most recent module, “ePrior Notice for Human Food,” was released in 2017. The video explains what happens when a Prior Notice is missing and gives step-by-step instructions on how to file an effective Prior Notice submission. This includes providing details on how to create an electronic submission using the FDA’s eSubmitter tool and submitting it to the FDA through certain portals.

The video also covers common problems that are encountered when submitting a Prior Notice submission as well as ways to avoid them during submissions by giving best practices advice such as providing all required information upfront instead of waiting until after submission has been submitted before finding out missing data needs adding or updating later on down the road – something that could delay approvals unnecessarily due delays caused by rework efforts needed afterward!


In summary, the FDA expects a prior notice submission to be complete and accurate, as well as timely. This means submitting an appropriate quantity of information at the right time and in an approved format. If your company is required to submit a prior notice for food imports or exports and is not doing so consistently or accurately, you may be subject to enforcement action. Contact us today for more information!

How Quality Smart Solutions can help:

We hope this post helped you understand food additives and preservatives a little better. There are many different kinds, and they can have a big impact on your health.

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

30 Minutes Free Consultation

GRAS, NDI, ODI Food Additives & Gras Notice Inventory in 2023

Food Classification NDI, ODI, GRAS Food AdditivesIntroduction

Food additives are chemicals added to food products to enhance flavor, texture, or color. Fortunately, there is a list of food additives that the Food and Drug Administration (FDA) has determined to be “generally recognized as safe” (GRAS). In this guide, you’ll find an updated and comprehensive list of GRAS food additives.

Food classification is a tricky topic. There are so many different names for additives and preservatives, and it can be hard to keep track of them all. But that’s okay! The goal of this post is to help you understand the different types of food ingredients, food additives, and preservatives and what they do in food. It’s an important topic to understand because there are so many terms and acronyms! However, it’s critical to know what each term means because these ingredients can have a big impact on your health and the environment. So, let’s dive right in!

What Do GRAS, NDI, and ODI mean?

These terms can sometimes be confusing because they all have similar-sounding names.

GRAS stands for “Generally Recognized as Safe”, NDI stands for “New Dietary Ingredient” and ODI stands for “Old Dietary Ingredient”. To be used in conventional foods, ingredients must be classified as either GRAS, NDI, or ODI.

In this post, we will focus on the different types of food additives and preservatives which can be considered GRAS, NDIs, or ODIs. We’ll also be discussing what they do in food and how they can impact your health, as well as the environment.

What are Food Additives and Food Preservatives?

Food additives are used to improve the quality, safety, and longevity of foods by changing their color, flavor, or consistency. They may also be used to prevent spoilage (oxidation), reduce the microbial load, or improve the nutritional value of food products such as cereals or dairy products that have been processed using heat treatment technology (pasteurization).

Here is a list of the most common food additives:

  • Artificial sweeteners such as sucralose (Splenda), aspartame (Equal), and saccharin (Sweet’N Low)
  • Artificial colours (e.g. Red 40 dye)
  • Food preservatives like sodium benzoate or potassium sorbate used in wine production

What are some of the Food Classification Complications?

You may have noticed that there are many different names for the same type of additive. For example, you might see “diglyceride” or “diglyceride esters” listed on a label and think they’re two different things when they’re the same thing. This is because FDA regulations allow manufacturers to use one name for an ingredient if it’s followed by another more specific type of name (e.g., shortening).

Another complication is that there are many types of food additives and preservatives, so knowing what each does can be confusing at first. Here’s a quick breakdown of some common categories:

  • Preservatives prevent spoilage from microorganisms such as bacteria and mold in foods like cheese or spices; examples include sodium nitrite/nitrate and calcium propionate/propionic acid.
  • Antioxidants help protect fats from going rancid (oxidizing) during storage; common ones include butylated hydroxyanisole (BHA), butylated hydroxytoluene (BHT), tertiary butylhydroquinone (TBHQ).
  • Stabilizers help keep ingredients mixed so they don’t separate over time; examples include carrageenan gum or xanthan gum.

How Are Additives and Preservatives Approved for Use in Foods?

Today, food and color additives are more strictly studied, regulated, and monitored than at any other time in history. FDA has the primary legal responsibility for determining their safe use. To market, a new food or color additive (or before using an additive already approved for one use in another manner not yet approved), a manufacturer or other sponsor must first petition FDA for its approval. These petitions must provide evidence that the substance is safe for how it will be used. As a result of recent legislation, since 1999, indirect additives have been approved via a premarket notification process requiring the same data as was previously required by petition.

When evaluating the safety of a substance and whether it should be approved, FDA considers:

  • The composition and properties of the substance,
  • The amount that would typically be consumed,
  • Immediate and long-term health effects,
  • Various safety factors.

The evaluation determines an appropriate level of use that includes a built-in safety margin – a factor that allows for uncertainty about the levels of consumption that are expected to be harmless. In other words, the levels of use that gain approval are much lower than what would be expected to have any adverse effect.

Does FDA have databases for GRAS ingredients and Food Additives?

YES! The FDA’s Food Additives Status List, formerly called Appendix A of the Investigations Operations Manual (IOM), organizes additives found in many parts of 21 CFR into one alphabetized list.

The Food Additives Status List includes short notations on use limitations for each additive.

The Food Additive Status List omits certain categories of additives, such as those that are considered GRAS and safe substances. You may find such substances in the GRAS Notice Inventory on the FDA website.

What is a GRAS List?

A GRAS list is a collection of substances, such as food additives, that have been evaluated by the Food and Drug Administration (FDA) and determined to be safe for use in food products. The FDA designates these substances as “generally recognized as safe” (GRAS) through an extensive review process. Once included on the GRAS list, the ingredient can be used in food products without requiring pre-market approval from the FDA.

What are the risks and benefits of each food additive?

When looking through the GRAS list of food additives, it’s important to remember that even though these ingredients are deemed safe for consumption, they may still have certain risks associated with them. For instance, some food additives contain preservatives or artificial sweeteners, which can potentially have adverse effects on long-term health. Therefore, it’s important to weigh the risks and benefits of each ingredient before you decide to use it in your food products.

What are the requirements for food additives in countries across the globe?

Before you use food additives in your products, it’s also important to check the regulatory information and requirements for various countries across the globe. Every country will have its list of accepted food additives, meaning it’s important that you double-check the safety status of each ingredient beyond just relying on the GRAS List. Take note of any regional differences and rules depending on where you are planning to export your food item – this will help to ensure compliance and safe usage.

Reference Documentation from Reputable Sources to Ensure the Accuracy of Safety Info:

To ensure the accuracy and safety of the ingredients in your product, it is essential to refer to reputable sources when sourcing information about food additives. Always look for documentation from reliable organizations such as the FDA or World Health Organization (WHO) when researching new ingredients. This way you can be sure that the safety data you have found is up-to-date and well-referenced, giving your product the best chance at success both domestically and internationally.

Analyze Data to Make Informed Decisions About Adding Food Additives to Products:

When researching food additives, it is important to do some data analysis to understand the safety implications of introducing a particular additive into your product. Look beyond the “GRAS” designation by evaluating scientific studies and reports regarding overall safety and potential health risks that may be brought on by consuming the additive. This will help you make an informed decision as to whether or not you want to proceed with using that ingredient in your product.

What is the Gras Notice Inventory System?

The Gras Notice Inventory System is an online resource administered by the USFDA that allows manufacturers and processors to submit their products for review before they are put on the market. It contains a listing of GRAS (Generally Recognized as Safe) substances and notifications submitted to the USFDA, which users can search by product category, active ingredients, date, or designation type. This system provides an efficient way for manufacturers and processors to understand and comply with regulatory requirements for their products.

Why should you stay up to date with the USFDA regulations?

Manufacturers and processors need to stay up to date with the USFDA regulations and the Gras Notice Inventory System. Failure to adequately comply with these regulations can result in costly fines or product recalls, which could negatively affect a business’s reputation and financial health. Additionally, Staying up to date on the latest changes ensures that products remain safe for consumption and are not inadvertently introduced into the market without proper testing or review.

How do you interpret and implement USFDA regulations in your business?

Once manufacturers or processors have obtained information about the Gras Notice Inventory System, it is important to understand how to interpret and implement these regulations promptly. Manufacturers should ensure that all processes, products, and ingredients comply with all relevant USFDA regulations. Additionally, they should conduct regular reviews of all procedures to ensure they remain compliant and address any changes that may occur to maintain safety standards.

What are the benefits of being compliant with the Gras Notice Inventory system?

Staying compliant with the Gras Notice Inventory system offers many benefits to manufacturers. This includes being able to confidently produce safe food and ingredients by USFDA standards, as well as having peace of mind that no shortcuts were taken which could potentially result in a major recall. Additionally, following these regulations will allow the manufacturer or processor to stay ahead of potential issues and decrease any risks associated with them.

Where can you access all the relevant information related to the Gras Notice Inventory system?

All the relevant information regarding the Gras Notice Inventory system can be found on the FDA’s website. You can search for specific notices and regulations related to the Gras Notice Inventory System through the “Search for GRAS Notices” option. Additionally, FDA posts updates and changes related to the system which are readily available on their site too. It is important to regularly review these updates as they can help you make sure that your processes remain compliant with USFDA standards.

What is a GRAS Notice Inventory System?

A GRAS Notice Inventory System is a database that stores and organizes information on Generally Recognized as Safe (GRAS) notices. A GRAS Notice is an evaluation carried out by the Food and Drug Administration to determine the safety of certain food ingredients, additives, and processing aids. The system allows users to quickly search for relevant GRAS notices, providing easy access to previously submitted notices. This makes it easier to stay compliant with industry regulations while ensuring quick access to relevant information.

How to manage multiple Gras Notices with one system?

A GRAS Notice Inventory System can help you manage multiple GRAS notices at once. With the system, users can combine different filters and search criteria to quickly scan a database of submitted notices. This allows them to easily find relevant GRAS notices within seconds, enabling them to easily keep track of all the GRAS notices they need. The system also comes with an intuitive user interface designed to make navigation easy, so users can take advantage of its powerful features without spending time learning how it works.

How to streamline your GRAS Inventory system regulatory compliance?

Streamlining your GRAS inventory system for regulatory compliance is easy and efficient when using the right systems. The GRAS Notice Inventory System allows you to quickly and easily search for relevant GRAS notices, filter them according to your needs, and monitor them for any updates or changes. It also generates automated reports for all of your notices, so that you can identify trends in compliance and have a full view of all your GRAS items at a glance. This simplifies the process and makes compliance easier than ever.

How to track your GRAS Notices, documents and regulations?

With the GRAS Notice Inventory System, you can easily track all your GRAS notices, documents, and regulations. The system allows you to filter and search for the relevant notices according to your needs and requirements. It also supports automated reporting so that you have a more comprehensive view of your records at all times. This makes compliance much easier, as you will have a central record of any changes or updates to the regulations governing GRAS notices.

How Quality Smart Solutions can help:

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

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

30 Minutes Free Consultation

FDA Food Safety Requirements FSMA Traceability BRC Standards

GFSI BRC FDA Food Safety


Meeting FSMA compliance requirements is one of the most important things a manufacturer can do to protect their business. The Food Safety Modernization Act (FSMA) was passed by Congress in 2011, and it places new regulations on food producers and manufacturers.  While there are many ways to meet FSMA regulations, one way is through implementing data collection for your supply chain and production processes. 

Achieving GFSI BCBS239 certification demonstrates that your company has met the highest safety standards.  Certification assures consumers that products meet high-quality standards. This helps them make informed choices when buying food and drink products. In addition, it also gives companies a competitive advantage as it shows customers that they take food safety seriously. This article will discuss the key components of an effective FSMA traceability solution and how it can help bring your organization into compliance with this important regulation.

FDA FSMA Food Safety Requirements:

FSMA is a new set of rules that will change how food companies operate. It’s a law that was passed by Congress in 2011 and signed by the President in January 2011. BRC Global Standards (BRC) is a product certification program used by over 29,000 certificated suppliers in 123 countries, with certification issued through a worldwide network of accredited certification bodies.

BRC has recently revamped its standards, and the new BRC 9.0 standard was released in September 2018. The revised standard provides food safety assurance and quality management requirements aligned with FSMA requirements while addressing environmental protection, sustainability, and brand protection issues as well as modernizing food processing technologies like robotics and technology-enabled traceability systems to meet consumer needs for authenticity and trustworthiness across global supply chains.

Benefits of being certified: Demonstrate Compliance with International Regulations, Insurance, training & brand awareness:

Certification helps companies meet global requirements and maintain high levels of customer confidence. It also helps them to attract new customers by demonstrating their commitment to safety and quality.

Certification assures consumers that products meet high-quality standards. This helps them make informed choices when buying food and drink products. In addition, it also gives companies a competitive advantage as it shows customers that they take food safety seriously.

Certification assures consumers that products meet high-quality standards. This helps them make informed choices when buying food and drink products. In addition, it also gives companies a competitive advantage as it shows customers that they take food safety seriously.

Consumers trust certified brands more than non-certified ones. They believe that certified products are safer and of better quality. As a result, they are more likely to buy these products.

Reassurance for your Employee and Clients:

Employees who work with food products need to feel confident that the products they are using are safe. They also need to trust that the companies they buy from are trustworthy. By being certified, you demonstrate that your company meets these high standards.

In addition to meeting international standards, achieving GFSI BCBS 239 certification demonstrates that your company meets the highest safety standards. This means that your products and services are safe for use by consumers.

FSMA Traceability:

FSMA traceability is mandated by the Food Safety Modernization Act (FSMA). The final rule, called Current Good Manufacturing Practice and Hazard Analysis and Risk-based Preventive Controls for Human Food, also known as FSMA Preventive Controls, was published on September 17, 2015.

The objective of this law is to reduce foodborne illness by improving the safety of all foods imported into the US and reducing contamination at domestic facilities that produce processed or packed foods. It also requires food producers to identify which facilities they do business with and track their products throughout each facility’s supply chain.

For your company to meet FSMA requirements you need an effective way to manage food safety data from the field through the distribution center (DC) back down through production lines until it reaches consumers’ plates at restaurants or grocery stores across America.”

BRC Global Standards 9.0:

The BRC Global Standards 9.0 is the most current version of BRC Standards, a global standard for food safety and quality management. It includes requirements for hygiene and sanitation, employee hygiene practices, hazard analysis critical control point systems, record keeping, and traceability.

BRC 9.0 has increased requirements for hygiene and sanitation—particularly regarding cleaning protocols that must be adhered to when an establishment has received a non-compliance rating on its HACCP plan during a USDA inspection (which can affect an establishment’s ability to sell products). In addition, it now requires that employees are well trained in food safety procedures; this includes regular refresher training sessions that address food safety topics such as temperature monitoring during storage or transportation of products among other things.

One aspect of the FSMA Traceability Rule that impacts businesses at all stages of handling raw materials or ingredients used in manufacturing processes is its requirement that facilities maintain records detailing how each product was sourced from its origin through any subsequent processing steps before arriving at their destination (i.e., retailers’ shelves).

BRC 9 Non-Conformity Management:

BRC 9 Non-Conformity Management is a key component of BRC Global Standards 9.0.

BRC 9 Non-Conformity Management provides a framework for identifying and managing non-conformities in the food supply chain. BRC 9 Non-Conformity Management covers the full spectrum of food safety and quality requirements, from preoperational to post-operational.

The module for the identification of non-conforming products in the supply chain includes:

  • A detailed breakdown of critical control points (CCPs) with an explanation of why they are critical.
  • How these CCPs interact with one another.
  • How these CCPs relate to prerequisite programs.
  • The importance of effective record keeping for compliance with regulations such as HACCP (Hazard Analysis Critical Control Point), FSMA (Food Safety Modernization Act), GMP (Good Manufacturing Practices), GLP (Good Laboratory Practices), GHP (Good Hygienic Practice) and OIE (Office International des Epizooties).

HACCP Compliance Solutions:

HACCP is a system that helps you identify and control hazards in your production process. Developed by the National Advisory Committee on Microbiological Criteria for Foods (NACMCF), HACCP is a systematic approach to food safety. It requires you to analyze your production processes and identify potential hazards, then develops controls for those hazards.

HACCP can be used to meet FDA FSMA requirements for traceability and if you have some degree of FDA-mandated third-party verification, like BRC certification, it’s especially useful because it will ensure that the appropriate records are being kept supporting claims about ingredient sources as well as product origins.

However, HACCP isn’t a “one size fits all” solution; every company needs its own unique plan tailored specifically for its operations, facilities, and products. And while many manufacturers have voluntarily adopted HACCP systems to ensure compliance with regulations such as FSMA or FSSC 22000:2007—the international standard on food safety management systems—not everyone has done so yet (though this trend may have changed now that the NLEA rules have been finalized).

FDA Compliance Management Solutions:

FDA Compliance Management Solutions is a comprehensive suite of solutions that help food and beverage manufacturers meet the requirements of the Food Safety Modernization Act (FSMA) and other food safety regulations. The FSMA requires food companies to take steps to prevent contamination, or at least detect it when it occurs. Preventative Controls are one-way companies can achieve this goal. They focus on preventing problems rather than reacting to them after they occur.

Preventative Solutions help users develop plans for identifying hazards and implementing effective corrective action practices through process hazard analysis (PHA). This tool also allows users to generate corrective actions plans (CAPs), monitor critical control points (CCPs), monitor HACCP systems, and track complaints and product withdrawals associated with a CAP/HACCP plan or CCPs/PCPs in real time using an enterprise-wide Quality Management System (QMS) with built-in integration features that connect disparate systems into a single platform for continuous improvement initiatives across all departments within an organization’s supply chain network infrastructure

Integrating Supply Chain Data:

Integrating data from your supply chain, production, and packaging areas will allow you to manage your food safety and quality processes with ease and efficiency. You can use a single system to manage food safety, quality and traceability. This allows you to have better visibility across the entire organization, which results in more effective management of your suppliers’ performance. It also helps you respond faster if there’s an issue with one of their products – for example if an ingredient has been recalled.

How to sell to larger retailers – typically by meeting third-party certifications required by supplier programs. Managing multiple certifications effectively adapting your processes as requirements change.

How Quality Smart Solutions can help:

We’re here to help. If you have questions about food safety or need help with your supply chain, contact us today.

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). 

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VHP Consulting 5 things about the VHP Notification Program

VHP Notification Program, VHP Notification, VHP, VHP ConsultingIntroduction

Health Canada oversees the importation and sale of Veterinary health products (VHPs) in Canada through the VHP Notification Program. This program replaces the previous voluntary Interim Notification Pilot Program (INPP). The VHP Notification Program is a tool that allows manufacturers to notify Health Canada about the sale of their VHPs and changes in their products which may affect their eligibility for marketing as a VHP.  In this blog, we’ll also touch upon VHP Registration, VHP package compliance, and VHP Canadian Representative.

1. When does Health Canada need to be notified?

  • VHPs must be notified to Health Canada:
  • At least 30 days before selling a VHP for the first time in Canada
  • At least 30 days before making a change to a VHP that is already notified in Canada
  • Before importing a VHP into Canada
  • VHP Notifications are submitted to Health Canada’s VHP Customer Service Unit (CSU) in order to process and respond to inquiries, as well as to maintain the accuracy of the information on the Health Canada website.

2. What rules/requirements are needed for the VHP Notification Program?

Companies who manufacture, package, label, import, distribute and/or store VHPs are required to follow Part 3 – Good Manufacturing Practices (GMPs) in the Natural Health Products Regulations.

Product labels must:

  • Include the statement “Veterinary Health Product / Produit de santé animale”
  • Follow the labelling rules of the Food and Drug Regulations
  • Include any applicable mandatory label statements as described in List C
  • Companies are required to report any serious adverse drug reactions to Health Canada

Need help with the VHP Notification program, VHP Registration & Package compliance?

3. What is the process for submitting a VHP Notification?

  • Health Canada’s Notification Program (web application) for VHPs provides a user-friendly tool to help notifiers meet the rules for importing and selling VHPs in Canada. After a Notification Form is submitted to Health Canada, received through the VHP Notification Program, and acknowledged, it undergoes an administrative screening stage followed by an info verification stage.
  • Notification Forms are screened against all of the required elements of the program. After a positive Admin Screening stage when the required information has been submitted, the Notification Form is considered to be administratively complete and moves to the Info Verification stage. If the Notification Form is administratively incomplete, Health Canada will inform the notifier of all administrative deficiencies via e-mail and ask to resubmit the form with the necessary changes or by providing any missing information via the web application within 10 calendar days. There is a limit of two admin requests per notification at this stage. If the revised form is still deficient or not received within 10 calendar days, it will be rejected, and a new Notification Form will need to be submitted. This type of rejection is referred to as “Rejection (Incomplete Form)”.
  • Once a Notification Form is considered to be administratively complete, Health Canada will conduct an assessment of the submitted information to confirm that the VHP is compliant with the applicable rules and regulations. Health Canada will consider the proposed health claim(s), dosing information, and brand name during this stage of the process.
  • If the info verification decision is positive, the notifier is informed of the outcome via e-mail, and the issuance of the NN follows. When a VHP is notified, it is added to the List of Notified Products.
  • If there are deficiencies identified, the notifier is informed via e-mail and given a maximum of 7 calendar days to resubmit the form using the VHP web application. Health Canada will only issue one info request per notification. If the revised form is not received within 7 days or is deficient, it will be rejected, and a new Notification Form will need to be submitted. This type of rejection is referred to as “Rejection (No Response to Request)” or “Rejection (Deficient Response to Request)”, respectively. Health Canada informs the notifier of this by e-mail.

4. Is there a fee required as part of the VHP Notification Program?

  • As of April 1, 2020, VHP notifications are subject to cost recovery. The fee for submitting a VHP notification is $503. Fees will apply to all new VHP notifications received after this date and when changes to an already-notified VHP require the issuance of a new NN.
  • An invoice for the applicable fee will be issued by Health Canada once verification is completed for a VHP notification. The notifier (i.e Principal Contact for the Notifier) will receive an invoice by e-mail, along with instructions on how to make payment to the Receiver General for Canada.
  • Fees will apply regardless of the outcome of the info verification (positive or negative); therefore, notifiers should ensure that Notification Forms are complete, meet all regulatory requirements and that requests for additional information made by Health Canada are answered completely and within the allotted time.

5. Does Health Canada perform Compliance and Enforcement measures as part of the VHP Notification Program?

  • As with all health products (including VHPs), our compliance and enforcement approach is proportional to the risk of the product. VHPs are required to be in compliance with the Food and Drugs Act and Regulations when sold or imported in Canada. Commercial importation requires that VHPs are notified before import. Personal importation (also known as own-use importation) of a VHP for a food-producing animal or animal intended as food that is not notified is only permitted if it is on List B: List of Certain Veterinary Drugs Which May Be Imported But Not Sold.
  • When Health Canada identifies or is notified of potential non-compliance with the Food and Drugs Act and/or its Regulations, it takes steps to verify that non-compliance has occurred. Incidents of non-compliance are prioritized, and action is taken based on the risk they may pose to the general public. Several compliance and enforcement options are available, if necessary, to correct a non-compliant situation or mitigate risk to Canadians including, for example, on-site visits, recalls, public communications, or product seizures. The primary objective of Health Canada’s compliance and enforcement approach is to manage the risks to Canadians using the most appropriate level of intervention.

How Quality Smart Solutions can help

We hope that this information has been helpful, and we encourage you to reach out with any further questions.

Quality Smart Solutions offers regulatory solutions for getting your Veterinary Health Products ready for sale in Canada.  Our experts are here to help and offer any VHP regulatory advice!

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Health Canada Medical Device Regulations (MDL, MDEL, SaMD)



Medical devices are an important part of healthcare and play a critical role in the treatment of patients. Medical devices are used to diagnose, monitor, or treat medical conditions in Canada and around the world.

The Canadian Medical Devices Regulations provide a framework for regulating medical devices that meet Health Canada’s standards. The regulations authorize the sale of safe and effective medical devices, help protect consumers by preventing unsafe products from being sold and ensure that manufacturers comply with good manufacturing practices (GMP).

Health Canada Medical Device Regulations (MDL, MDEL, SaMD)

What are the Medical Device Regulations in Canada?

The Medical Device Regulations is a set of rules that govern how medical devices are manufactured and sold in Canada. The MDL was enacted in 1993 and required manufacturers to notify Health Canada when they wanted to sell a new medical device in Canada. It also regulated marketing claims made by manufacturers about their products, including what information had to be provided on product labels and how well those labels were designed. In addition, it required manufacturers to provide information about their facilities for inspection by Health Canada before their products could be marketed or imported into Canada.

Since then, there have been two significant changes: one implemented in 2002 with the passage of Bill C-8; another enacted as recently as 2008 with Bill C-51 (you may have seen this referred to as legislation regarding “safe use”).

What are the Medical Device Regulations in Canada?

Health Canada Medical Device Licenses (MDL, MDEL). As a manufacturer or importer of medical devices in Canada, you must apply for a Medical Device Licence (MDL). If you wish to sell your device in Canada and import it into Canada, then you must also apply for a Medical Device Establishment Licence (MDEL). The MDEL is not required if only manufacturing is taking place in Canada or if only importing is taking place in Canada.

Who is subject to the Canadian Medical Device Licenses and Regulations (MDL, MDEL, SaMD)?

MDL, MDEL, and Software as a Medical Device (SaMD) apply to all manufacturers, importers and distributors of medical devices in Canada. Below are the descriptions of each type of licence:

Medical Device Licence (MDL) – a licence issued to manufacturers authorizing them to import or sell their Class II, III or IV medical devices in Canada.

Medical Device Establishment Licence (MDEL) – a licence issued to Class I manufacturers as well as importers or distributors of all device classes to permit them to import or distribute a medical device in Canada.

Software as a Medical Device” (SaMD) – software intended to be used for one or more medical purposes that perform these purposes without being part of a hardware medical device.

Do you need MDL, MDEL, or SaMD Assistance?


How Do I Get My Medical Device on the market in Canada?

To get your medical device on the market in Canada, you will need to:

– apply for an MDL for Class II, III or IV medical devices.

– apply for an MDEL if you manufacture Class I devices or import/distribute any device classes.

What is a medical device establishment license (MDEL)?

A medical device establishment license (MDEL) is a license issued to Class I medical device manufacturers as well as importers or distributors of all device classes (Class I, II, III, IV) to permit them to import or distribute a medical device in Canada.

What is a medical device license (MDL)?

An MDL is a license issued to manufacturers of medical devices authorizing them to import or sell their Class II, III, or IVD medical devices in Canada.

What are the different medical device classes in Canada?

There are four classes of medical devices in Canada:

  • Class I devices are low risk and include simple equipment like bandages, or something like a tongue depressor.
  • Class II devices are at moderate risk and include items such as blood pressure cuffs, stethoscopes, or thermometers.
  • Class III devices are high-risk, but not life-sustaining or life-supporting (i.e., they don’t keep you alive). These include things like pacemakers and bone screws.
  • Class IV devices are very high risk and usually must be implanted into patients’ bodies – things like breast implants fall into this category too!

Health Canada has a unique process for getting medical devices to market compared to regulations outside of Canada:

Health Canada has a unique process for getting medical devices to market compared to regulations outside of Canada. The Canadian medical device regulatory framework is a combination of the Medical Devices Regulations and licenses (MDL, MDEL, SaMD) and the Food and Drug Regulations (FDR). Health Canada is the regulatory authority that is responsible for the oversight of medical devices in Canada.

The Canadian medical device regulations have recently been updated to include rules for software as a medical device. This article provides an overview of what you need to know about medical devices so you can get your product on the market faster!


We hope that this post has helped you better understand the Canadian Medical Device Regulations and the licenses required to sell in Canada. If you want to learn more about our services and how we can help you get your product to market, please contact us today!

How Quality Smart Solutions can help

Our experts at Quality Smart Solutions are here to help and offer medical device-related regulatory advice and support on successfully securing your medical device license.  We can help you by responding to potential information requests, keeping your license updated, and reviewing your device labels. 

Learn more about MDEL Registration, License Class Determination, In Vitro Diagnostic Devices (IVD) Registration, SaMD Classification and Registration, or our MDEL Import Agent service.

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

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GRAS vs NDI Clarification: Everything you should know in 2023!

GRAS vs NDIN Clarification Ingredient compliance FDA

Introduction to GRAS & NDI

An ingredient can get into the diet by being a food, food additive, drug, dietary supplement, or GRAS ingredient. The way that ingredient is used and what the finished product marketer says about it determines which category it goes into. Depending on product use and marketing claims, one ingredient could go into many buckets.

GRAS Ingredients & GRAS Determination:

GRAS ingredients are intended to become a component of food. They must have general recognition of safety based only on the views of experts qualified by scientific training and experience to evaluate the safety of substances directly or indirectly added to food. GRAS ingredients are supported by either scientific procedures or everyday use in food before January 1, 1958. GRAS is a summary of all available evidence, positive or negative. 

GRAS requires the same safety standard as food additives, i.e., reasonable certainty of no harm. However, unlike a food additive, the Information must be publicly available. For GRAS determination, a history of consumer exposure is required, and the product labeling can’t limit intake by amount or population. A GRAS determination must also outline the intended effect or practical use.

GRAS Status:

GRAS status was a carve-out of the food additives group created in the Food Additives Amendment of 1958. In 1997, legislation allowed GRAS status to be self-determined, taking it out of the premarket-approval process. Before this, a company needed to petition FDA; however, this process caused GRAS petitions to backlog in FDA offices. Companies would sometimes have to wait years to get approval. Post-1997, companies can still petition FDA, but it is not an approval process. Once a company self-affirms an ingredient as GRAS, it can send it to FDA for review. FDA can then issue a “no-objection or an objection” to the GRAS status of an ingredient.

Food Additives & Dietary Ingredients:

Food Additives also become a food component, but they require premarket approval. The research on food additives doesn’t have to be publicly available or acceptable. Like GRAS, food additives cannot exclude sub-populations or limit intake.

Dietary Ingredients supplemented the diet and were legally created with the Dietary Supplement and Health Education Act of 1994 (DSHEA). Dietary supplements are not subject to premarket approval but require premarket notification with a 75-day review period. Dietary ingredients can limit intake by amount and population on the label. The safety data on nutritional ingredients don’t need to be publicly available or accepted. Still, DSHEA said the safety needs to be reasonably expected to be safe under the conditions used in the labeling.

FDA Draft Guidance GRAS or NDIN Clarification:

According to the Draft Guidance, the categories can seem straightforward, but some ingredients, such as probiotics, that industry considered dietary ingredients that may fall into the food additive category. Regarding probiotics, it’s up to product manufacturers to prove they were in man’s diet before they were isolated as an ingredient and used in a dietary supplement or as a GRAS ingredient. If not, they are considered food additives.

Novel strains will typically require regulatory approval to lawfully enter the U.S. market, even if some strains within the species have regulatory approval or have a history of use. The most common pathways to achieve regulatory compliance are through Generally Recognized as Safe (GRAS) or a New Dietary Ingredient Notification (NDIN). Determining the best way is specific to the individual probiotic and product goals. This installment of our probiotic series will walk through some primary considerations to help you decide the best path to regulatory compliance for a novel probiotic ingredient. To help determine the best path, we can start by answering the following questions:

What is the intended use (GRAS vs NDI)?

If the goal is to add the ingredient to conventional foods, the GRAS pathway is best. Once you have the ingredient GRAS for use in conventional foods, the ingredient is placed in the food supply. The ingredient (must be the same as what was GRAS and in the food supply) can be used as a new dietary ingredient (NDI) in dietary supplements as well, and in this case, the NDIN to FDA is not required. Suppose the goal is to add the ingredient into dietary supplements only. In that case, either the GRAS or NDIN pathway may be available, and the best path could depend on the answers to the additional questions below.

Does the ingredient qualify as a dietary ingredient under DSHEA?

To utilize the NDIN pathway, the substance must meet the definition of “dietary ingredient.” DSHEA defines a “dietary ingredient” as a vitamin; a mineral; an herb or other botanical; an amino acid; a dietary substance for use by man to supplement the diet by increasing total dietary intake; or a concentrate, metabolite, constituent, extract, or combination of any of the above dietary ingredients.

Is there a population that should be excluded from using the ingredient? 

The NDI pathway provides more freedom to exclude specific populations or age groups. For example, if the ingredient does not have any clinical studies in pregnant or nursing women or children under 2, these groups could be excluded from an NDIN.

Is the GRAS or NDI safety information publicly available?

All information that is pivotal to showing the safety of an ingredient in the GRAS process must be publicly available. This is not the case for the NDIN pathway. In an NDIN, safety studies do not have to be published, and more information in the notification is permitted to be redacted compared to the GRAS pathway. Because of this, the NDIN pathway allows for more proprietary data.

Does the client need to notify the FDA for GRAS notification?

For the NDI pathway, notification to FDA is mandatory, whereas notification to FDA on a GRAS conclusion is voluntary (some exceptions apply).


The NDI pathway is a possible pathway for a probiotic ingredient found in the food supply. The NDI pathway is only applicable to dietary supplement usage and does not extend to regulatory compliance for use in conventional food products. The NDI pathway allows for more protection of proprietary information.

The GRAS pathway is a possible pathway for a probiotic ingredient found in the food supply and one derived from non-food sources. The GRAS pathway requires pivotal safety data to be publicly available. A conclusion of GRAS may or may not be notified to FDA. Suppose a probiotic is GRAS and placed into the food supply. In that case, the probiotic may be used in a dietary supplement as a new dietary ingredient without the required NDI notification, provided the dietary supplement does not contain significantly higher levels of the NDI than is used in already established conventional foods or does not exceed the levels established as safe in a GRAS conclusion.

Determining the best pathway to regulatory compliance can seem overwhelming but considering the above factors can direct you to the most appropriate path for your specific novel probiotic. RNI is also available to help you determine the best path forward based on your ingredient needs and goals and can support the development of your GRAS and NDIN dossiers for regulatory compliance.  Learn more about self-affirmed GRAS here:

How Quality Smart Solutions can help:

We hope this post helped you understand food additives and preservatives a little better. There are many different kinds, and they can have a big impact on your health.

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

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FDA Determines Nicotinamide Mononucleotide (NMN) Not Permitted in Dietary Supplements for Sale


The U.S. Food and Drug Administration (FDA) recently published responses to several new dietary ingredient (NDI) notifications submitted for nicotinamide mononucleotide (NMN). The FDA concluded that NMN is “an article authorized for investigation as a new drug by the FDA”. Therefore, if the ingredient is considered a drug by the FDA, it is concluded that the ingredient is NOT permitted in dietary supplement products for sale in the USA, per the “Drug Preclusion Clause”.

Dietary Supplements

The “Drug Preclusion Clause” states that ingredients first approved or clinically studied as a drug, are not permitted for use as a food ingredient in dietary supplements.

What is Nicotinamide Mononucleotide?

NMN is short for nicotinamide mononucleotide, a naturally occurring molecule present in all species. NMN is a precursor of nicotinamide adenine dinucleotide (NAD+), a molecule that may be useful in slowing down some aspects of aging. NAD+ serves many critical functions in our cells, such as electron transport, cell signaling, and DNA repair. NMN can be found naturally in foods such as avocado, broccoli, cabbage, cucumber, and edamame.

Regulation of NMN by FDA.

As stated above, the “Drug Preclusion Clause” states that ingredients first approved or clinically studied as a drug, are not permitted for use as a food ingredient in dietary supplements. Because NMN is an article authorized for investigation as a new drug by the FDA, it does not currently qualify for use in dietary supplements.

NMN and the Future.

NMN is currently considered a drug ingredient and therefore cannot be sold in dietary supplements in the USA.

Research shows that NMN may help to prevent cardiovascular disease by reversing oxidative stress damage on blood vessels that can lead to high blood pressure and heart attacks. NMN may also help treat diabetes by helping insulin work better in people who have type 2 diabetes. There are limited studies that firmly conclude that NMN supplements actually work to slow down aging. Fortunately, there are more human trials underway that will hopefully tell us just how useful NMN is in this respect.

Need help bringing your dietary supplement or NHP labels to market in North America?


It seems that NMN, the main ingredient in many supplements, is not yet ready for use in the USA. Until we find out more about this ingredient and how it interacts with other drugs in our bodies, we won’t know what the future holds for us all when it comes to taking NMN supplements.

If either you or your ingredient supplier has recently filed an NDI Notification for NMN or want to learn more about this topic contact Quality Smart Solutions at

How We Can Help

Our Experts at Quality Smart Solutions can offer support to your needs for dietary supplements, foods, cosmetics, OTC drugs, and medical devices in the United States.

Contact us today to learn more about how we can support your compliance needs during and after licensing!

30 Minutes Free Consultation

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