Update on Performance Standards for NHP Applications

Summary of Health Canada Licensing and Update Reports

Product Licensing

A combined 1390/5045 (28%) of NHP product license application submissions were refused from April to September 2021. 

  • Class I – 90% of product applications are meeting the 60-day performance timeline. Refusal rate for these is 14%. 
  • Class II – 90% of applications are meeting the 90-day performance timeline. Refusal rate for these is 36%.
  • Class III – 57% of applications are meeting the 210-day performance timeline. Refusal rate for these is 19%. There were about 200 Class III submissions that have not received an acknowledgement at the time of this posting. There is a Health Canada backlog of applications contributing to a delay in licensing timelines. 
  • Notifications – 99% of notifications received in 2020 have been completed. 46% of notifications received in 2021 have been completed. 

Product License Application Tips:

  • For a Class III application: be sure to include the reason for classification on the cover letter. 

Site Licensing

  • 213/362 (59%) site license submissions were refused during that time. (Apr to Sept 2021)
  • Stream 1 – 54% of applications are meeting the 35-day performance timeline. Refusal rate for these is 31%.
    Stream 2 – 87% of applications are meeting the 65-day performance timeline. Refusal rate for these is 36%.
  • Renewal – 162 complete renewals completed this year. Refusal rate for these is 36%.
  • Acknowledgement letter includes a built-in extension until a decision is reached. 
  • Health Canada expects to have site license renewals submitted in March 2021 to be completed by December 2021.

Risk based approach is still taken on Site Licence renewals.

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Site License Application Tips:

  • Designated Party Authorizations and new site licence application forms must be submitted via ePost to be considered. This is considered a secure portal. 
  • Applicants must use the most recent online Site License application form. 
  • Applicants must respond to all items in the Information Request Notice (IRN). Refer to each item by their number to organize your response for higher success rate. 
  • Risk 2 or 3 observations are expected to be addressed via corrective and preventative actions (CAPA). This will be monitored on the next renewal. 
  • Guidance documents are available to help with site licensing and product/site quality. 
  • All documents should be separated into their own files and named appropriately. Applicants are suggested to name documents less than 15 characters. 
  • All site licence applications should be screened and acknowledged within 10 days, a follow up may be warranted after 30 days without a posted acknowledgment. 

Common Issues:

  • Failure to submit 30 days prior to site licence expiry.
  • Failure to submit through the correct channel. ePost new applications tab. 
  • Failure to respond to an IRN on time. 
  • Failure to submit a complete and compliant application package. 
  • Addition of new sites during renewal. This should be done via amendment. Existing sites only in a renewal. 

Covid Site Licence Transition:

  • If a transition application was filed prior to the September 30th, 2021 deadline, sites can continue to operate until a decision has been reached. 
  • 107/174 sites submitted a transition application on time. Refusal rate of 35%
  • Reasons for refusal: No DPA, no GMP evidence, company code errors, missing application form. 
  • Companies that did not file for transition have been asked to confirm that activities have been ceased. 

Need Help Submitting Your Class III NHP Licence Application?

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NHP System Updates:

  • Web Product License application form V4.3: release in winter 2022. This will include all monograph validation, improved kit submissions, improved NMI filtering, improved error messages. 
  • The decommissioning of V3 PLA form will take place in winter 2022. You will no longer be able to finalize this form. You will be able to view and answer existing IRNs. 
  • There will be a short transition period to decommission the V3 form. Applicants are encouraged to use the V4 form now. This should result in fewer IRNs and a reduced refusal rate. 
  • Electronic site form: improvements are being made to assist in processing and screening for higher success rates and fewer IRNs. Improved in-form validation and a new notification table.

Consultation on a Secure Portal:

  • A questionnaire for industry and associations will go out. 
  • Seeking consultation on features a secure portal would need. 
  • Your feedback is important, two weeks will be allotted. 

Informatics and Automation:

  • Improved monitoring for files entering epost. 
  • Electronic forms reduce error rates. Allows for increased tracking and management of workload. 
  • Developing new automated tools. Enhancement of workload tracking and monitoring, identification of trends and forecasting, applying advanced analytics for optimization and efficiency. 
  • General Health, Traditional Chinese Medicine and Live Microorganism claims top the trend list over the last 3 years. 
  • Heart health, weight maintenance and Skin, hair nail, claims are trending lower over the past 3 years.

How Quality Smart Solutions can help

Please contact our team for more information on NHP classification, formula review, labelling projects or importing. Our specialists are here to help! If you would like to see a copy of the Health Canada bulletin or PowerPoint for this update, please reach out to our team!

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Greens and Proteins – Food or NHP?

The classification of Foods and Natural Health Products (NHPs) can be considered difficult, grey, and convoluted. Sometimes even comes down to preference of classification and labelling verbiage for certain ingredients. Foods are governed by the Food and Drug Regulations, however, NHPs fall under the Natural Health Product Regulations. Foods are thought to be consumed by ad-libitum consumption, whereas NHPs are consumed through regimented dosing. Health Canada has published an interface guidance document to assist in classification and understanding. 

Product Composition: It is important to consider each ingredient when classifying a product at the Food/NHP interface. Foods are thought to provide nourishment, satiety, flavour, etc. NHPs are thought to provide a medicinal benefit. NHP ingredients can be verified within the NHP Ingredients Database. This does not mean they cannot also be used in foods. 

Foods are intended to provide nourishment, nutrition or hydration, energy (for example by providing a source of Calories) or to satisfy hunger, thirst or a desire for taste, texture, or flavour. (Health Canada)

Conversely, if a product is or contains an added ingredient that has no known food purpose but does have a purpose as a Health Product, this may support classification as an NHP. 

For example, Green Tea (bagged) is classified as a traditional food. Green Tea extract (ingredient) is classified as an NHP.

Product Representation: Product Representation refers to the way the product is labelled and marketing materials appear to the consumer. The location it is sold in the grocery store near foods or near supplements may play a factor in classification. If the product displays a nutrition facts table and verbiage catered to servings it could be classified as a food. If the product shows health claims or therapeutic claims and medicinal ingredients it could be best classified as an NHP. 

For example, Whey protein for source of protein could be classified as a food. Whey protein for workout recovery could be classified as an NHP. 

Product Format: Product format is another primary factor in the determination of product classification. Traditional food formats such as beverages and bars could infer a food classification. Dosage formats such as tablet and capsule could be classified as an NHP. Powders are the in between case since there are some traditional foods in this format such as gelatin or beverage mixes. 

Protein, Collagen or Greens powders can also fall under both categories by dosage format. This is where other classification items/factors come into play. Such as ingredients within the powder, labelling elements, health claims and marketing verbiage on package, branding or images used, etc. 

Public Perception and History of Use: Historical patterns and how the average consumer views the product may also aid in classification. If the product has been consumed (safely) on the Canadian market for many years this may also alter the classification. 

Classification Review:

The specialists at Quality Smart Solutions can help classify and obtain registration for your products. We can provide options and directions for your products and labels if there is a classification that you prefer or reach out the regulator to assist in confirming the classification. Reach out to our team if you have any questions.

Safe Foods for Canadians Regulations Note:

All foods in Canada will be regulated by the Safe Foods for Canadians Regulations. Conventional and Supplemented foods now have additional requirements such as: Licensing, Traceability and Preventative Controls. Reach out to our team for assistance complying and importing within this new framework.

How can we help

Please contact our team for more information on food classification, formula review, labelling projects or importing. Our specialists are here to help!

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NHP/Food Interface Guidance:

NHP Ingredients Database:

Food and Drug Regulations:,_c._870/index.html


How Pet Food Labels Differ from Human Foods

Pet Foods and Human Food Labels are designed to look similar yet distinct. There are some similar label requirements and some that will appear different as they are product specific. Consumer packaging rules in Canada aim to ensure we know what we are buying at time of purchase, so that the consumer can make educated decisions. Considering common retail set-ups, products will likely be faced the same for both to show main information such as common name and net weight on the front panel and any additional information on the adjacent panels. 

Veterinary products are similar to foods by classification as well, in the sense that they are broken into similar-regulated subgroups of foods, drugs and health products

This blog will highlight several similarities and differences between Pet and Human Food Labels for Canada. 


All labels in Canada are required to be Bilingual. French and English are to be equal on all labels as they are both official languages. 

The statement or declaration of Net Weight is present on both label types. This allows the consumer to understand how much product is in the container. This can be reviewed against price and serving size at time of purchase. 

The Common Name of the product must be listed. This should provide a clear description of the product, be honest and not mislead the consumer with regards to ingredient quantity or effects. 

The List of Ingredients must be listed by common name of each component. It also must be listed in descending order by weight. To differentiate for pet foods AAFCO publishes a set of guidelines for the inclusion and list of pet food ingredients.

All Claims and statements are truthful and not misleading. All call outs and claims must be accurate and honest and supported by verifiable evidence. Deceptive awards and endorsements must not be used. Comparison to other products and companies is not suggested. 

All labels should clearly indicate the Company Name and Address. This allows the consumer to contact the product owner to report any side effects, leave a review or ask additional questions.


Rather than a nutrition facts table, pet foods employ and are required to list a table of Guaranteed Analysis. This explains the total crude protein, crude fat, crude fibre, and moisture within the product. Like NFTs on a human food, this can be compared to other pet foods when trying to decide between two or more products. 

Pet foods must list feeding instructions. This piece can also refer to the product being able to be used as a feed or a supplemental feed. This directional item must be called out on the label. If the product is intended for specific dietary use, the direction to use as recommended by a veterinarian may be required. Human foods often list preparation instructions but not directions as they are often thought of for ad-libitum consumption. 

Pet Foods must list the nutritional adequacy or intended life stage for the product. If the product has passed a feeding test or has specific nutrient values for a specific life stage. Then this can be explained on the label. Human foods are not usually labelled for a specific demographic, this may be part of the marketing campaign, but not overly apparent on the label. 

The Product Identity will need to be made clear. Whether the product is intended for Dogs or Cats. This should be depicted in writing. Often pet foods have graphics/images that show the intended animal.


In conclusion there are many differences and similarities between Pet and Human Food labels, most of which are apparent if you were to hold the two side by side. 

Please reach out to our team of specialists to further discuss your human or pet food products. We are happy to help discuss classification, labelling and registration for your products!



Benefits of Routine Inspection of your Licensed Food Facility

Inspection of your food facility will help identify and fix any quality or processing deviations found regarding food safety. Review of the processes and procedures will lead to higher quality products that are safe for Canadians. Internal/self-inspection is important in day-to-day operation to ensure all processes are flowing smoothly, however third-party inspections are important to get a fresh set of eyes and to obtain relevant accreditation. 

Why are inspections conducted?

CFIA and/or Health Canada inspections are important to ensure all processes are in alignment with the regulations (such as the Safe Food for Canadian Regulations). The goal is always turning out safe and high-quality products for Canadians to purchase and enjoy.

What processes are checked during an inspection?

Common activities for foods are manufacturing, processing, treating, preserving, grading, packaging, labelling. CFIA will inspect your site based on the risk involved with the products you produce and the activities you undertake. For example: if you slaughter animals, you will likely have more frequent inspections. 

What are the benefits of routine inspection?

Identifying risks and the hazards that may arise is crucial to food manufacturing. Audits are a great tool to identify and reduce these risks. Self-inspection should be built into your SOPs to ensure staff members internally self-reflect on their assigned tasks. Third-party inspections allow a fresh set of unbiased eyes to review your practices and policies. All three are very important to your business. 

Some of the many benefits of Inspection are:

  • Inspections help identify health risks for your consumers and employees. Pointing out process errors may be able to correct a future safety issue. A health risk or recall may be detrimental to your business’ public perception and marketability. Avoiding issues that may arise from a quality violation is reason enough to schedule an inspection. 
  • Inspections are a great learning tool. Any items noticed during the inspection will lead to facility and staff improvement. Constant and ongoing improvement is key to product quality and to your business. Any time there is room for learning opportunities, it can provide growth and skill development for your company. 
  • Inspections can keep your business open. High risk deviations that are found may lead to facility closure until the issue can be corrected. Minimizing these issues will mitigate potential reasons for closures. Preventing these types of issues of any size will reduce financial obligation to correct the issue, if it were to become a larger problem. 
  • Passing an important inspection is a great accomplishment! Practicing for governmental audits and inspections with an in-house or with a third-party review can help prepare your site and staff to ace an inspection in the future. Accreditation that results from some audits will help grow consumer trust and can even be advertised in some cases. 
  • Improving the preparedness and cleanliness of your site. Sometimes even preparing for an audit is reason enough to do a more thorough tidy of the facility. Impressing an inspector is important to a successful review. This is a clear reason to schedule an audit. 


Running through and reviewing the quality processes and documentation for your site will always lead to company improvement. Being able to identify issues and correct them is a main pillar of food safety and quality. Inspections offer a thorough look into the operations of your company.

If you have any questions regarding food facilities, licensing/registration, and inspections/audits, please reach out to one of our specialists! We are always happy to help!



CFIA and Health Canada Joint Policy Statement on Food Labelling Coordination

Health Canada and the CFIA (Canadian Food Inspection Agency) are teaming up to plan advancements and improvements for the timing of food labelling changes in Canada. This is in accordance with the most recent 2019 Agri-food and aquaculture sector regulatory review roadmap. Changes of this nature may be required based on aligning with Canadian and International standards, for scientific improvements or to keep Canadians safe and healthy. 

The goal is to enhance coordination between the departments and make the food labelling change process more predictable. Implementing these changes would reduce the cost needed to make multiple changes required by each governing body at separate intervals. The alignment of requirements will make things more efficient and cost-effective for industry to implement. 

The essential components of this project are:

  1. Establishing a process for interdepartmental food labelling changes
  2. Establishing predictable (2-year) compliance dates.


Based on a consultation from February to April 2021, comments were received from 32 parties. The summary is available for the public at the official website of Health Canada.


The USA currently uses a 2-year (1-3 year) transition period for these types of changes. The US FDA and USDA align and publish new rules that culminate in a two-year compliance window. This timeline allows industry to make changes and use up current inventory. Currently the USA is the only country with a published labelling cycle for foods. 


Regulatory amendments that do not initiate a label change would be considered out of scope for this programme. Business decisions to update labels vs. government required updates would be the deciding factor here. 

Compliance Dates

The compliance date would be the date of registration. Two-year intervals for label changes will start January 2026. This will align with US rules.  Product owners are responsible for ensuring their food products meet regulatory requirements including labelling. Health Canada and the CFIA will continue using their risk-based approach to product oversight. 

Transition Period

Transition periods will range from 1-3 years and will be individually tailored based on the extent of the change required with any new regulatory requirement. This piece will be built into the consultation period of any new/proposed regulation that requires food labelling changes. 

For predictability purposes, the minimum transition time will be 2 years, unless there is a safety concern. Any complicated or multi level changes brought on by regulatory requirements/updates may have multiple deadlines, these will be communicated within the proposal/consultation for each regulatory revision.  


Areas or items that are detrimental to human risk will be assigned a different timeline. As these label updates are of greater concern it is likely that shorter update timelines would be assigned to allow shift revisions and prevent injury/harm. 

Regulatory Development

Updates to new policies and guidance documents will follow this new clear approach. This establishes an open path for aligned label changes on predictable intervals. Scope, complexity, and cost are all factored into new consultations. Long intervals limit flexibility for factors like scope and complexity. 

Further Assistance

For any questions regarding this policy, any food labelling needs or help with product registration/classification that you may have, please reach out to our team of specialists!


GRAS or NDI? Factors to Consider

Say you have a new ingredient and are ready to enter the US food market. To ensure this ingredient is considered approved (and the product will not be considered adulterated upon formulation) for use, you have a decision to make: Do you wish to obtain ingredient approval through GRAS (Generally Recognized As Safe) or via NDI (New Dietary Ingredient)?

This blog will explore the concepts and requirements surrounding both GRAS and NDI to help you navigate your ingredients into the US food supply. We will discuss each pathway and reasons why your company may want to favour one over the other.

What Does GRAS stand for?

GRAS stands for “Generally Recognized As Safe”. GRAS is the more flexible option as these decisions allow use in foods and dietary supplements no additional processing is applied to the ingredient. 

How Do I Classify my Ingredient as GRAS?

Ingredients can be self-affirmed GRAS or submitted via notification to the FDA for approval

Self-AffirmedThe ingredient must be widely used in the food supply to meet the self-affirmed criteria. GRAS assessments require the substantiation/evidence to be made available to the public upon approval, thus limiting discretion. The requirement for proof is use in conventional foods for a long period of time and/or the food is considered safe by experts. Essentially you need to prove safe historical use. 

Notification to the FDA – FDA reserves the right to take 180 days or longer to evaluate a GRAS notification. Once an ingredient is approved via the GRAS route, it can be used in both food and dietary supplements. GRAS ingredients must meet the safety standard: reasonable certainty of no harm under the intended use conditions. GRAS ingredients must meet the lower GMP standards set out in 21 CFR 110. To summarize, this notification process takes longer to obtain, but allows for use of the ingredient in food and dietary supplements.

What Does NDI Stand For?

NDI stands for “New Dietary Ingredient”. Unless considered an ‘old dietary ingredient’ (used in dietary supplement products prior to October 15, 1994), an NDIN (New Dietary Ingredient Notification) must be sent to and approved by the FDA. NDI approved ingredients are only approved for use within Dietary Supplements, thus limiting applications and uses of your ingredient. 

The NDI notification process will keep your submitted documentation largely between you and the regulator and is a good option for proprietary research/documentation. The NDI review standard is within 75 days, a considerably shorter timeline. NDI ingredients must meet the safety standard: does not present a significant or unreasonable risk of illness or injury. NDI ingredients must meet the higher GMP standards set out in 21 CFR 111. To summarize, this notification process is shorter in overall length, but only allows your ingredient to be used in dietary supplements. 


In conclusion, although the GRAS notification process takes longer on average it allows the most flexibility for end use (ie. use in dietary supplements and in food). NDI allows you to keep your documentation private, has a shorter review period but only allows you to market your ingredient within Dietary Supplements. There are pros and cons to each. Ultimately, how you wish to position your finished goods is the best deciding factor to choose GRAS or NDIN. The self-affirmed pathway allows for the quickest pathway to market, but you are still required to have significant evidence/proof. 

How Quality Smart Solutions can help:

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!

30 Minutes Free Consultation

Supplemented Foods Proposed Regulatory Framework

Health Canada has been working on creating/revising the regulations with regards to Supplemented Foods for some time now. A recent Health Canada webinar indicated new proposals/consultation could be on the horizon. Health Canada anticipates publishing a new draft regarding the Supplemented Foods Regulations shortly (June 2021) in Canada Gazette Part I. Until now, supplemented foods have been regulated under a Temporary Market Authorization Licence (TMAL) in Canada.

What They Heard

Industry indicated that new regulations and guidelines must/should be able to capture the following: allow for innovation, limit pre-market burden, consider existing TMAL formulas and their ingredients, and allow health claims. 

Limiting Innovation: 12 categories of supplemented foods would be available to start. Additional categories could/would be added/considered upon safe review. 

Pre-Market Burden: Majority of existing TMALs could go straight to market under this new framework. Required information to proceed would be published in regulations or guidance. 

Permitted ingredients: Majority of TMALs would be able to remain the same/unchanged under the new framework. Some changes would be required based on upper limits to specific ingredients. Approximately 6.5% would require reformulation.  

Health Claims: Limiting claims that contradict required risk statements is a priority. Such as liver benefits when a liver caution is required. Some claims would not require notification. Some higher risk claims would require review prior to marketing.

Canada Gazette Part I, Prepublication:

Upon publication, the documentation will include Regulatory Impact Analysis Statement, List of Permitted Supplemented Food Categories, List of permitted supplemental ingredients, Directory of Supplemented Food Facts Table Formats, Directory of Supplemented food caution identifier specifications, Supplemented food guidance document. 

Established 12 Categories Proposed Upfront:

  1. Carbonated and non-carbonated water-based beverages including concentrates and mixes 
  2. Caffeinated energy drinks including mixes
  3. Fruit and vegetable drinks from fruit and vegetable concentrates
  4. Fruit and vegetable based smoothies
  5. Juices
  6. Protein beverages including mixes other than workout supplements
  7. Single serving prepackaged tea, coffee, and herbal infusions
  8. Bars
  9. Hard, soft and semi-soft candies
  10. Chocolate confectionery
  11. Chewing gums
  12. Ice pops

Supplemental Ingredients:

Charts are being proposed for each ingredient allowable in Supplemented foods, based on the category of product to be used. 

For example: Vitamin A: limit of 745 mcg per serving size.

For example: Magnesium as a List 1 category up to 175 mg, and up to 23 mg for a List 2 category product allowed per serving size.

Amounts/limits for amino acids will be published for supplementation in specific categories as well. 

For example: up to 1537 mg Leucine per serving size. 

Cautionary statements may be required per category, should an ingredient surpass a certain threshold. 


150 ppm would be regulated under the food additive framework, not as a supplemented food.

Over 150 ppm would be considered a caffeinated energy drink. Where any new uses would require a pre-market review. 

Other ingredients would have set limits when formulated with caffeine as well. 

Not recommended for those under 14 years old, would be a required risk statement. 

List Modification:

Modifications will be able to be made to the List of Permitted Food Categories and List of Permitted Supplemental Ingredients by request. (Additions, removals, changes, etc.)

Changes would require sound rationale and support, The process to make updates will be explained in the regulations and guidance documents. 

Supplemented Food Facts Table:

The table Would include various formats such as: standard, narrow, horizontal, simplified, linear, aggregate, dual, etc. Like the Nutrition Facts Tables. 

They are also proposing a front of package text box to signify this is a supplemented food.

The size of the SFCI would be dependent on the label and principal display surface size. There also would be an additional smaller/boxier version available. 

Post Market Monitoring:

Based on TMAL data reviewed by Health Canada, Supplemented Foods were generally found to be safe. However, Incident reporting and post market requirements still showed some gaps to be addressed.  Health Canada is recommending the CFIA be a single window for post market monitoring for follow ups and recalls. Collaboration between HC, CFIA and Poison Control are important to ensure these products are properly overseen. 

Proposed Transition:

There is a 3-year proposed transition once the regulations are published. Current TMAL products would still be exempt from the Food and Drug Regulations during this period until the coming into force date. These products can remain on market with an existing and compliant Nutrition Facts Table and ingredient listing. Anything submitted prior to the coming into force would also qualify for the transition up until the deadline.  After the label coordinator policy is finalized a compliance date would be set that likely aligns with the transition period.  

Proposed Timelines:

April – May 2021: Stakeholder engagement sessions

June 2021: Canada Gazette Part 1 Publication. (Target)

Summer 2021: 60-day consultation period, technical briefings for stakeholders

*All current TMALS will be extended until the regulations come into force. *

How Quality Smart Solutions can help:

If you would like to be involved in the consultation period (Summer 2021) or have any questions once the draft regulations are released, reach out to our team!

Please also contact our team for more information on food safety, food classification, formula review, labelling projects or for your importing needs. Our specialists are here to help!


Health Canada Webinar 2021

How We Can Help

At Quality Smart Solutions, we provide you with the guidance to plan your Veterinary Health Products business, navigate the legal requirements, and acquire the appropriate license for your operations.

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

30 Minutes Free Consultation

Proposed Food Safety Guidance for Novel Food Regulations Focused on Plant Breeding

CFIA and Health Canada have been working on new Food Safety guidance documents pertaining to Novel foods focused on plant breeding. Two new guidance documents are available to aid in your company’s plant breeding compliance, these are:

  • Guidance on foods derived from products of plant breeding.
  • Guidance on the pre-market assessment of food products derived from retransformants of previously assessed genetically modified (GM) plants.

Health Canada’s approach is to:

  • allow for modernization while maintaining the health and safety of our food supply
  • keep the system product focused
  • align with other nations
  • ensure the oversight is risk-based
  • narrow the regulatory interpretation and support safe innovative foods

These documents will be added as an appendix to the existing 2006 Guidelines for the Safety Assessment of Novel Foods and will refer to the Novel Food Regulations (Division 28, Part B of the Food and Drug Regulations)

Based on Health Canada’s thorough review of DNA inserted plants and those traditionally bred, there has been no noticeable safety concerns. Health Canada has become familiar with several species/techniques and have drafted these proposed guidance documents. The guidance is intended to be risk-based in nature and refer to mainly pre-assessed species. Novel product will still require a standard (410 calendar day premarket review)

Guidance on foods derived from products of plant breeding:

Health Canada has taken time to review historical and current methods of plant breeding. This article explains their understanding of current practices and how methods and modifications result in characteristics for GM plants.

Certain plant species will not require pre-market assessment as novel foods based on plant breeding. This will also list requirements for plant characterization explained based on any breeding methods used.  Breeding has been used safely within our food supply for hundreds of years. Gene editing is becoming more common, and Health Canada has developed a ‘primer’ on gene editing within this new guidance. This primer is a summary of Health Canada’s understanding and stance of current gene-editing technology. Health Canada has reinforced their stance that altered plants are not likely to impact safety. 

It would always be the responsibility of the applicant to prove and ensure the product is safe for consumption. As always, Health Canada will review each situation under a risk-based approach. Novelty requests can be submitted to the Food Directorate to obtain a written opinion from the regulator prior to market or prior to filing a premarket submission.

Guidance on the pre-market assessment of food products derived from retransformants of previously assessed genetically modified (GM) plants:

Should the parent plant have already undergone premarket assessment as a retransformant plant, this guidance will help industry use that plant to make future generations. This will help industry compare their plants to already approved variants with a new premarket process that is more straightforward and expedited. This review will again be risk-based in nature. 

Consultation was available from March 25 to May 24, 2021 and focused on how product will be separated into tiers (1 and 2), what information is required to be provided, and how to enter the expedited pre-market review (with a 120-day service standard)

Tier 1 – plants with identical modifications using the same methods resulting in the same characteristics as a GM plant that has undergone review. (Health Canada has already reviewed this combination).

Tier 2 – plants with identical modifications using the different methods resulting in the same characteristics as a GM plant that has undergone review.

Plants that fit the above criteria, submitted in a complete package, would be turned around by Health Canada in 120 calendar days. If any items require further questioning, an additional 45 days would be added to allow the applicant to respond to the request. Pre-submission requests are suggested for any plant that may sit on the fringe of this programme.

A successful submission would be issued a letter of No Objection. An unsuccessful submission can be issued a refusal without prejudice to resubmit. 

Labelling Note:

Health Canada and industry are interested in potentially expanding the current voluntary transparency initiative for ingredients that have undergone gene-editing. We always recommend clearly declaring your ingredients/foods. 

How Quality Smart Solutions can help:

Please contact our team for more information on ingredient review, food classification, formula review, labelling projects or importing. Our specialists are here to help! 


How We Can Help

At Quality Smart Solutions, we provide you with the guidance to plan your Veterinary Health Products business, navigate the legal requirements, and acquire the appropriate license for your operations.

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

30 Minutes Free Consultation

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. 


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)”
Immediately after or next to the list of ingredients in a “contains” statement. Example: “Contains wheat, milk, and soy.”


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. 


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. 


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!  


How We Can Help

At Quality Smart Solutions, we provide you with the guidance to plan your Veterinary Health Products business, navigate the legal requirements, and acquire the appropriate license for your operations.

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

30 Minutes Free Consultation

Coming into Force: Human Milk Fortifiers Regulations

After consultation with stakeholders and based on a noticeable lack of current regulations and need for availability and innovation for these types of products, Health Canada has released new Directives/Guidance Documents and Publications in Canada Gazette part II. These articles pave the way for new regulatory requirements and now list Human Milk Fortifiers (HMFs) within the Food and Drugs Regulations

This framework will enhance the ability of industry to add vitamins, minerals, and amino acids to human milk, in turn, providing infants with these important nutrients. These types of products are commonly administered to premature and low birthweight infants, bolstering the benefits of human milk to aid in growth and development.

A clear pathway to market will increase efficiency and accessibility for these products in medical and prescribed home care settings, thus benefiting medical practice and the individual infants.  There are currently 10 approved HMFs. Many more are expected to be approved with the implementation of this programme.  

Safety of infants is of utmost priority. This framework lays out clear guidance for the regulation and oversight of safe and innovative products.  A risk-based approach will be taken to implement and enforce these products.

Quick Definitions:

Human milk fortifier means a food that: (a) includes at least one added vitamin, mineral nutrient or amino acid, and (b) is labelled or advertised as intended to be added to human milk to increase its nutritional value in order to meet the particular requirements of an infant in whom a physical or physiological condition exists as a result of a disease, disorder or abnormal physical state.

Infant means an individual who is under the age of one year.

New (Draft) Guidance Documents:

Health Canada is currently drafting 8 new guidance documents regarding HMFs. If you would like access to any specific draft guidance document such as: Guide on the Sale of Human Milk Fortifiers please reach out to our team. 

Premarket Submission:

HMFs were previously marketed under the Temporary Market Authorization Framework, like caffeinated energy drinks and supplemented foods. Now, HMFs are required to be submitted to the regulator and reviewed prior to sale on their own. Applications are to be submitted to allow sufficient time for review prior to April 30, 2022. Applications shall include the following components:

  • Brand name
  • Manufacturer’s name and address
  • Name and address of other manufacturing establishments
  • Quantitative list of ingredients
  • Formulation rationale
  • Product specifications, Including nutrients, microbiological and physical quality
  • QC details for product and ingredient testing
  • Details of manufacturing process and QC procedures
  • Stability results, to determine expiry
  • Nutritional adequacy support, when consumed under the proposed directions
  • Description of packaging
  • Directions for use
  • Copy of all labels to be used
  • Name and time of applicant who signed and dated the application

Authorization and Application Review:

Should the application be deemed complete and sufficient the product would be authorized. The regulator may also request changes or conditions prior to approval. Additional information or confirmations may be requested during the submission process. Resubmissions and new approval would be required if your formula undergoes a major change, unless otherwise authorized by the regulator. If any information submitted is missing, considered false, misleading, or deceptive the application may be refused.

Legal Sale:

HMFs will only be sold to hospitals directly or to individuals for home use with a written order (prescription) from an authorized physician, nurse practitioner, or dietitian (Health Care Practitioner). Industry will not be able to sell these products direct to consumer.  

Label Requirements:

Labels of HMFs are required to carry the following information on the outer label:

  • List by quantity the amount of protein, fat, carbs, and fibre (in grams)
  • Statement of energy value/calories 
  • Statement of quantity (in mg or mcg) of all vitamins, minerals, or amino acids
  • Statement of quantity (in mg or mcg) of any other nutritive substance
  • Storage instructions for both opened and unopened containers 
  • Directions of use including preparation and storage instructions
  • Statement to only use this product under medical supervision
  • Expiration date
  • Lot number
  • Any other statements or content required to be added during review. 

Information can be displayed on outer label, inner label, or on an affixed leaflet. 

You are not permitted to list the following on any labelling or any advertising materials to percent daily value amounts. 

Health Claims:

It is suggested to remove/limit all health claims regarding these products, as it would be the health care practitioner’s discretion when and why they are dispensing the product. Marketing verbiage and imagery should also be minimal.


Ingredients used in HMFs may include Amino acids, Minerals and Vitamins.

Item 6 of tablet in section D.03.002

Also, based on recent safety assessments, several new food additives will be permitted for use in Human Milk Fortifiers. These include carrageenan, gellan gum, lecithin, monoglycerides, potassium citrate, potassium hydroxide and sodium citrate. Please keep in mind each of these may have specifically approved purposes and required cautionary statements. Otherwise, Infant foods are currently prohibited from containing food additives, but some can be granted. There currently are no limits set for these ingredients for HMFs the responsibility will be on the applicant to prove each ingredient is safe and effective. 

Safe Foods for Canadians Regulations Note:

All foods in Canada will be regulated by the Safe Foods for Canadians Regulations. Conventional and supplemented foods now have additional requirements such as: Licensing, Traceability and Preventative Controls. Reach out to our team for assistance complying and importing within this new framework.

How We Can Help

At Quality Smart Solutions, we provide you with the guidance to plan your Veterinary Health Products business, navigate the legal requirements, and acquire the appropriate license for your operations.

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

30 Minutes Free Consultation


Canada Gazette Part II Listing

List of Human Milk Fortifiers

List of Guidance Documents

Food and Drug Regulations


Conventional Foods vs. Supplemented Foods

Conventional Foods vs. Supplemented Foods

The easiest way to know the difference between these categories are that Conventional foods are older-common foods and Supplemented foods are newer-unique foods. 

The category of supplemented foods( originated from the struggle of classifying and regulating the first handful of novel Energy Drinks in Canada. Companies originally held NPNs (Natural Product Numbers) for their Energy Drink products, but the dosage format (ready-to-drink beverage) does not lend itself to dosing as is required for NHPs (Natural Health Product). Thus, a new category was born. 

Originally intended to be a short-term bridge for safety and market data collection, Temporary Market Authorization Letters (TMAL) were granted to supplemented foods. Years later, this is still the practice for obtaining regulatory approval for a Novel/Supplemented food. Since NHPs are closely related to these products, it is necessary to consider this as a third option when classifying foods and supplemented foods. 

Regulators want to ensure consumers are well educated and prepared to make decisions regarding nutrition and food selection. With safety in mind, ensuring all products are regulated, formulated, labelled, and classified properly can help protect the population from unwanted side effects. Additional regulatory requirements aim to ensure this added protection.

How These Categories Are Defined:

Food: It includes any article manufactured, sold, or represented for use as food or drink for human beings, chewing gum, and any ingredient that may be mixed with food for any purpose.

Supplemented Food: A supplemented food is broadly defined as a pre-packaged product that is manufactured, sold, or represented as a food, which contains added vitamins, minerals, amino acids, herbal or bioactive ingredients. These ingredients may perform a physiological role beyond the provision of nutritive requirements. 

Other novel foods are: Products and ingredients that do not have a history of safe use as a food, Foods resulting from a process not previously used for food, causing the food to undergo a major change, or Foods that have been modified by genetic manipulation, also known as genetically modified foods, genetically engineered foods, or biotechnology-derived foods. Foods meeting this classification are submitted for premarket assessment and assigned a Temporary Market Authorization Letter (TMAL). 

Natural Health Product (NHP): It is a substance or combination of substances in which all the medicinal ingredients are manufactured, sold, or represented for use in: 

(a)  the diagnosis, treatment, mitigation or prevention of a disease, disorder or abnormal physical state or its symptoms in humans; 

(b)  restoring or correcting organic functions in humans; or 

(c)  modifying organic functions in humans, such as modifying those functions in a manner that maintains or promotes health. 

Products meeting this classification are submitted for premarket assessment and are assigned a Natural Product Number (NPN).

In summary, and in most cases, a supplemented food usually sits between the classification of Traditional food and Natural Health Product. Usually, these are a traditional food that has added ‘active’ ingredient(s) or attribute(s). This alteration/fortification would be considered novel. 

Classification Considerations:

Product Composition: Any fortification of ingredients or novel preparation as per the definition (of a supplemented food when a vitamin, mineral, amino acid, herbal or bioactive ingredient is added to a food), would shift the classification into territory of Supplemented Food. 

Product Representation: Any marketing verbiage, label claims, images, etc. suggested on traditional foods are very regulated and regimented. Wording for foods is intended to speak more to flavour, texture and satiety. Health claims by way of nutrient function can be available for use, so long that your ingredient/food meets any specific criteria. How you represent or speak about your product may shift the classification.

Product Format: is a key indicator for classifications on the Food vs. NHP interface. Ready to drink beverage and snack bar formats are commonly thought of and classified as foods. Foods are generally linked to the concept of ad libitum consumption. Tablet and capsule formats are thought of as NHPs. NHPs are thought to be delivered more by dose. 

Public Perception: of food plays a big role in classification. Questions you may ask yourself are: Have I eaten this before? Am I able to purchase this at the local grocer? Is there any historic or traditional use?  Has another country been eating this food for centuries? Etc. 

Since there are many overlapping-complicated concepts involved in classification of foods, supplemented foods and NHPs, we highly suggest a formula feasibility review for all supplemented foods. And, in some cases, we suggest reaching out and receiving written confirmation from the regulator. 

The Experts at Quality Smart Solutions can review your formulation to determine product classification.

Supplemented Foods Formulation:

It should be noted there are ingredients that are not permitted in supplemented foods. There are also specific ingredient limits set out for these types of products. Health Canada has posted several guidance documents that refer to specific types of supplemented foods (such as: caffeinated energy drinks). 

Labelling Differences:

Risk statements, directions of use and other labelling items are often required on the label for supplemented foods, depending on the amount of ingredients within the formula. This is explained in the applicable guidance document to which your product best fits or can be assigned by Health Canada during their review of the application. Similarly, both products will require a Nutrition Facts Panel and will follow general food labelling regulations.

The Experts at Quality Smart Solutions can conduct a review of labels or marketing materials for your food products.  

Simplification of Pathway to Market:

Conventional Food – Compliant/bilingual label, adhering to food specific requirements/standards, arranging importation and distribution, meeting SFCR requirements.

Supplemented Food – All of the above plus licensing requirement which entails: a TMAL Application (may include: a label, label text, application form and other administrative documents). During the review of your application, Health Canada will likely issue several rounds of Request Notices. Health Canada reserves the right to suggest/make changes to your formula, application form and label content to ensure your product is compliant. 

Natural Health ProductNPN (review timeline 60-210 days, depending on product class), Compliant/bilingual label, Manufacturing site annexed to a Canadian Site License. 

Post Licensing Requirements for TMALs:

To help Health Canada draft appropriate regulations for supplemented foods, there are additional requirements throughout the lifecycle of your product. This data/research protocol will be agreed upon with Health Canada during their review. Adverse events are also required to be recorded and submitted to the regulator annually. These pieces of data will help Health Canada understand consumer trends and provide support for any ingredients being used.

Safe Foods for Canadians Regulations Note:

All foods in Canada are regulated by the Safe Foods for Canadians Regulations (SFCR). Conventional and Supplemented foods now have additional requirements such as licensing, traceability and preventative controls. 

Reach out to our team for assistance complying and importing within this new framework.

How Quality Smart Solutions can help:

At Quality Smart Solutions, we provide you with the guidance to plan your food business, navigate the legal requirements, and acquire the appropriate license for your operations. 

Quality Smart Solutions has a team of professionals to offer support from day one of starting your business, including Hazard Analysis, SOPs, Preventative Control Plans (PCPs) and more.

How We Can Help

At Quality Smart Solutions, we provide you with the guidance to plan your Veterinary Health Products business, navigate the legal requirements, and acquire the appropriate license for your operations.

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

30 Minutes Free Consultation

Veterinary Health Products to be allowed in Livestock Feed

Health Canada and the Canadian Food Inspection Agency have joined forces to evaluate the incorporation of Veterinary Health Products (VHPs) into Livestock Feeds (Food).

This Project originated from an expressed interest by the industry to allow active VHP ingredients into Livestock feeds. Since the successful roll-out of the more recent VHP Notification Program, many Health Products have been approved for use. But more work is still needed to ensure these beneficial ingredients can be safely and legally added to foods for our animals. The marriage of these two product classifications may be on the horizon and your company can be part of the regulatory decision-making process!

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.

Within the current framework, VHPs and Livestock Feeds are sorted into distinct categories requiring a separate regulatory pathway to market. Livestock feeds are currently regulated based on two published ingredient lists, requiring notification when for example, ingredients are listed in Part II of the regulations, when ingredients are considered novel or when other languages (besides English and French) are used on the label. VHP Notifications must be submitted for all products, a Notification Number is assigned upon approval.

Under this new investigative project, several common and low risk Organic Acids and Essential Oils are being explored. Industry will be able to make label claims for these ingredients relating to maintaining general health for approved products. Only these types of general health claims are allowed currently allowed for VHPs. [Veterinary Health Products: used to maintain or promote the health and wellness of companion and food-producing animals. VHPs are not for use to treat, prevent, or cure a disease or condition.] Products with more specific: therapeutic, antiparasitic or antimicrobial claims would better meet the classification of a Veterinary Drug and not be allowed within the scope of this Project.

This Project will help regulators gather important data for use in law/decision making and the future of both Veterinary Health Products and Livestock feeds. Ultimately, leading to improved access to Health Products and a wider range of ‘active’ ingredients for livestock. Thus, easing the path to market for VHPs, enabling broader aspects to these types of products and reducing the use of drugs and other antimicrobials for animals. A compendium of ingredients will be published at the conclusion of this program to allow newly approved ingredients to be used in Livestock Feeds.

For this specific project, industry has been provided with a List of Ingredients that will be permitted. This will allow Health Canada to control the project and gather specific evidence on ingredients they have deemed as potentially acceptable. Under the current proposal allowable ingredients may include:

  • Organic Acid, such as Acetic acid and Malic acid.
  • Essential Oils, such as Peppermint and Rosemary.
  • Common Non-medicinal ingredients such as Coconut oil and Silicon dioxide.

Each ingredient may have specific inclusion limits as explained within the Notice or the currently published Permitted Substances List. Please reach out to our team to determine the admissibility of your ingredients.

The following formula criteria must also be met to be eligible for the program:

  • Contain at least 1 approved active/medicinal ingredient.
  • Contain only approved inactive/non-medicinal ingredients.
  • Make only approved general health (VHP style) claims.

The company representative will need to attest that the product is safe and supported by convincing evidence and that the product is effective when used properly per the directions. Under this project, please ensure that all manufacturing processes are evaluated to ensure the final availability or stability is not impacted when any new ingredients are added to your food.

The recommended use of the product is to be marked specifically on the application and you will need to confirm the formula has been sufficiently tested. Products currently marketed as either Food or VHPs will need to be re-submitted to be eligible for this new project. When a VHP product or ingredient is being added to livestock feed, the new label will also be required to carry the VHP Notification number.

The sequence of steps for this proposal, as laid out in the notice are:

  1. Pre-screening Process (begins March 2021)
  2. Notification Process (begins May 2021)
  3. Publication of Compendium (July 2021)

To register, prescreening templates with product information must be submitted to Health Canada between March 15th and April 2nd, 2021. Once approved for eligibility by Health Canada a subsequent Notification will need to be sent.

Please contact our team for more information on Veterinary Health Products, Livestock Feeds or to have one of our specialists determine if your formulas are eligible and to enroll in this exciting project!

How We Can Help

At Quality Smart Solutions, we provide you with the guidance to plan your Veterinary Health Products business, navigate the legal requirements, and acquire the appropriate license for your operations.

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

30 Minutes Free Consultation


Health Canada and the Canadian Food Inspection Agency to launch a pilot project to allow veterinary health products in livestock feed, Inspection Canada

Veterinary Health Products – Notification Program, Government of Canada

Rules for VHPs, Government of Canada

Update on the pilot project to allow veterinary health products in livestock feed, Inspection Canada

Introduction – Regulation of Livestock Feed in Canada, Inspection Canada