GRAS Consultants: NDIN or FDA GRAS Certification?

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)?

An Overview of ‘GRAS’ – General Recognized As Safe:

Wondering what GRAS stands for? Learn all about this FDA approval process and its implications for food & beverage products.  GRAS stands for Generally Recognized As Safe, the designation from the U.S. Food and Drug Administration that applies to ingredients used in food and beverage production. It indicates that an ingredient has been determined safe for its intended use and does not require pre-market approval.

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 is GRAS?

GRAS is a designation from the U.S. Food and Drug Administration (FDA) that applies to ingredients used in food and beverage production. This official designation indicates an ingredient has been determined safe for its intended use and does not require pre-market approval from the FDA. Generally, this means that if an independent panel of experts has deemed a food component or additive as safe to consume, then it is considered “generally recognized as safe” or “GRAS”.

How Does the GRAS Process Work?

The GRAS process consists of two different ways an ingredient can be approved as safe for use in food and beverages. First, a manufacturer can convene their own panel to review data from their research and determine if that specific ingredient is safe for its intended use. Alternatively, the FDA has established a list of recognized substances considered safe for use in different products without further testing. When those two processes have been completed, then the ingredient can be designated as GRAS or generally recognized as safe.

Who Gets to Decide Which Ingredients Receive GRAS Status?

The FDA has the final say on which ingredients and additives are designated as GRAS, but that authority may be delegated to certain expert panels or scientific bodies. When a manufacturer completes their own research and determines an ingredient is safe for use, it does not automatically receive GRAS status from the FDA until it has been thoroughly reviewed and approved according to existing criteria. This process allows for special consideration of ingredients believed to be safe that do not necessarily fit into pre-defined categories.

What Are the Benefits of GRAS Certification?

Having GRAS certification carries several benefits. It indicates that a product has met stringent FDA-approved criteria for safety, which makes it easier for manufacturers to get their products onto the market quickly and comply with regulatory requirements. Additionally, GRAS-certified ingredients tend to have higher prices due to their increased safety assurance and shorter waiting period before they can be used in food/beverage production. This can benefit manufacturers as well as retailers who need fewer delays in sourcing ingredients for their products.

What Risks are Associated with GRAS Certification?

Obtaining GRAS certification can be a long and tough process, and it can take months—or even years—to obtain. This is due to the fact that not all ingredients are immediately granted this status by the FDA, but must go through additional testing and review to prove they meet the requirements. Furthermore, there have been some issues in the past with products claiming GRAS status without going through all of these steps, which can lead to health issues if these products are not monitored prior to their release and ingestion by consumers.

What Does Generally Recognized as Safe (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-Affirmed GRASThe 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. 

GRAS 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 New Dietary Ingredient (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 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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What are (HACCP & PCP) Requirements for GFSI Certification?

HACCP, PCP, GMP, GFSI Certification

Since the publishing of the Safe Foods for Canadians Regulations in 2017, there is now a requirement for a Preventative Control Plan (PCP) for your food facility or food program. This blog aims to explain several different programs and certifications that a food facility may want to consider for your sites or products.

HACCP, PCP, or GFSI are GMP-related programs (Training) that can be used in your food processing or storage facility that will help to ensure high-quality and safe products are being made. Having programs like these in place can help protect your company from a food safety incident or issue.

Hazard Analysis Control Point (HACCP)

Hazard Analysis Critical Control Points (HACCP) is a program designed for the evaluation and oversight of biological, chemical, and physical hazards, throughout (from start to finish) the production and life cycle of your product. From the raw material to final human/consumer consumption. HACCP plans are tailored to the product and processes of the facility to ensure a high level of food safety for consumers. HACCP plans are broken into seven principles:

  1. Conduct a Hazard Analysis
  2. Identify Critical Control Points
  3. Establish Critical Limits
  4. Monitor Critical Control Points
  5. Establish Corrective Actions
  6. Establish Record Keeping Procedures
  7. Establish Verification Procedures

Auditing and review of the Food Safety Plan (HACCP) are keys to ensuring it is running properly and producing a safe and high-quality product. If your processes change, it will likely require a change to your HACCP plan as well.

Preventive Control Plan (PCP)

The Preventative Control Plan (PCP) is like a HACCP Program as mentioned above. But with a greater focus on documentation and traceability. This is aimed at controlling and addressing any risk to food and food animals. This would explain how hazards to your products are identified, prevented, and eliminated to a level deemed acceptable. The main principles of PCP are:

  1. Explain biological, chemical, and physical hazards associated with the product/food.
  2. Document how you will handle each hazard identified.
  3. Provide plan information for development.
  4. Show how the plan is used and implemented.

Need help with your HACCP, PCP, or GFSI GMP-Related Programs?

This type of plan is required within and to meet the Safe Foods for Canadians Regulations and is required to hold a Food Import license. Health Canada has published several helpful guidance documents and policies to help you determine if you need a PCP plan and how to start creating it.  

GFSI Certification

The Global Food Safety Initiative Certification (GFSI) is a trusted process for confirming high standards in food safety. The concept is aiming to allow a holder to access multiple markets with this approval. You are required to undergo an audit by a certifying company of your internal practices, policies, and facility to obtain this type of certification.

In summary, a HACCP program will usually incorporate all elements of the PCP program, and you would use this plan in daily activities. This plan would be reviewed when applying for any certifications such as GFSI. Please reach out to our team of specialists to discuss a Food Safety Program that may suit your products or facilities.

Working with regulatory consultants such as Quality Smart Solutions and Quality Import Solutions will help bring your products into Canada in a safe and compliant manner. We hold a Safe Foods for Canadians Import License (SFCR) which allows us to provide quality sites for our clients. Please reach out to our team of specialists for all your Food Regulatory needs!



How can Quality Smart Solutions serve you?

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

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

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

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

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Unlock Food Regulations for Food Sales Health Canada & FDA

food regulations for food sales

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

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

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

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

Canadian Food Regulations & Food Labelling in Canada

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

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

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

TMAL and Supplemented Food Standards

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

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

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

Looking for help complying with food regulations?

Food Safety Requirements for Importing food into Canada

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

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

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

Why food regulations are important in the USA?

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

US Regulations for Food Label Requirements 

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

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

Food Facility Registration in the USA 

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

What is and why do I need an FSVP Agent?

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

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

Importer of Record!

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

Additional Information:

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

How Quality Smart Solutions can help you 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). 

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

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5 Common NHP Pitfalls | How to Improve Importing Natural Health Products

Health Canada import requirementsAs a license holder for Natural Health Products (NHPs), it is your responsibility to be aware of and educated on all requirements for Canada.

This blog will aim to highlight and summarize the common pitfalls of a company that manufactures NHPs outside of and imports them into Canada. Working with an importer such as Quality Import Solutions (QIS) and a consultant such as Quality Smart Solutions (QSS) will help guide you and bring your products to Canada in a safe and compliant manner.

Importing Natural Health Product Infographic

1. Not having an Importer of Record

For Natural Health Products that are manufactured outside of Canada. You are required to have and work with an Importer of Record. This party will act as a liaison within Canada for your NHPs. Health Canada inquiries will be sent to the Senior Official of the license holder as well as the listed Importer of Record.

This requirement aims to ensure there is a domestic contact person for all marketed products that can respond and act promptly.  If you do not have an importer of record, in place or marked on your label, your products may be held or refused at the time of import. This can lead to further enforcement action.

2. Not obtaining approval for Sites

Health Canada requires that all sites involved in the licensable activities (manufacturing, packaging, labeling, warehousing, and importing) hold a Site License.

Domestic/Canadian sites will hold a Site License themselves. For all foreign sites, this will mean that they are annexed/attached to the site of a licensed Importer. This licensing process aims to ensure the handling of NHPs before the sale is done so within an environment that is sanitary, well-controlled, and adheres to Good Manufacturing Practices (GMPs).

If your sites are not approved your NPNs may be suspended until GMP evidence for each site is provided to, reviewed, and approved by Health Canada. This can also lead to further enforcement action.

3. Not being aware of Site License timelines

Please know that the posted Health Canada timelines for Site License applications and amendments are not currently being met by the regulator. It is difficult to give a clear timeline for approval since there are many variables such as Health Canada’s backlog/queue, the complexity of submission/sites, gaps in testing or GMP documentation, responding to Health Canada inquires, etc. We recommend building ample buffer time for your launch plan to account for expected delays in site licensing and annexation.

If you do not anticipate and plan for proper timing with Health Canada and begin making deals with retailers prior to approval, it is possible these deadlines may not be met. We suggest wherever possible, waiting for all approvals (labels, licenses, sites) to be in place prior to setting the deadlines to avoid potential conflict.

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            4. Not having testing results or labels that meet Health Canada requirements

All NHPs must undergo testing at the finished product stage and through shelf life (stability). This testing will show that your product meets Health Canada requirements for physical characteristics, purity, and potency. The Quality Guide is a great reference tool that shows all required testing. Product testing results or proof of future testing in the form of a template is required at the time of site annexation.

All NHPs must have a compliant and bilingual label. The Labelling Checklist is another great reference that shows elements for an NHP label. The importer of record and license holder address must be present on your label for imported products. For all products we import, we suggest a label review be conducted before print.

If you are not testing or labeling your products compliantly, you may not receive a release decision for your product at the time of import. You may also face a Health Canada audit or a trade complaint, which can lead to further enforcement action.

 5. Not knowing the above are legal requirements

Again, as a license holder (you can learn about registering here), it is your responsibility to know the requirements for Canada. The main requirements for Natural Health Products are an NPN (Natural Product Number), a compliant bilingual label, and ensuring all sites are either licensed or annexed. Review and knowledge of the regulations and associated guidance are imperative to success in the Canadian market.

Working with regulatory consultants such as Quality Smart Solutions and Quality Import Solutions will help bring your products into Canada in a safe and compliant manner. We hold an NHP Site License which allows us to import products and annex foreign sites for our clients. Please reach out to our team of specialists for all your NHP regulatory needs! 

How Quality Smart Solutions can help

At Quality Smart Solutions, we have a team of experts who are skilled in NHP compliance. We offer several solutions to meet your needs like NHPID, Health Claims Substantiation, Clinical Trial Application (CTA), etc. Please contact us today or call us at 1-800-396-5144 to learn about how we can help you.

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Insider scoop on Selling, Importing & Registering your VHPs in Canada

Veterinary Health Products in Canada


The market for animal and pet products is growing at a rapid pace. With that, there is also a constant need for compliance, with many Veterinary Health Products being rushed to market. This blog will aim to steer you toward compliance with your Veterinary Health Products (VHPs) or Animal Supplements in Canada. We will highlight key points on how to register, import, and sell your VHP products in Canada.

Registering your Veterinary Health Products in Canada:

Previously, the VHP notification program was voluntary, but as of November 2017, the new formal notification program was put in place. It is important to first classify the product properly as a VHP, as veterinary drugs and animal feed products are not regulated under the VHP framework.  

This is to be done by examining the dosage form, the proposed use, or claims being made and ensuring all ingredients are properly listed in the Permitted Substance List (PSL), amongst other criteria. Any ingredients that are not present or do not reflect the purpose as used in your product, within the PSL, can be added or amended via a PSL Notification. This must be done before filing the VHP notification.


It is required for a company that is located outside of Canada to arrange and provide the contact information for a Canadian Representative. QSS can act as your Canadian representative for VHP applications and throughout the product lifecycle.  It is also required that a company located outside of Canada lists the importer or product receiver on the notification form. 

The Notification Form is completed online on the Health Canada portal and is submitted there as well. Companies are required to notify their VHPs to Health Canada: At least 30 days before selling a VHP in Canada, at least 30 days before making a change to a VHP that is already notified in Canada, and before importing a VHP into Canada. We recommend waiting for approval before finalizing the label or going to market.

There are fees payable to Health Canada associated with the notification. The current fee is $503 (subject to an annual increase). Please know that your company may qualify for a reduction or fee waiver based on the first application or company size.

The current standard Health Canada timeline for review of ingredient and product notifications is ~2 months, based on recent submissions.

During the review, Health Canada will review your VHP claims and ingredients. They may ask for revisions to ensure the product is safe, efficacious, and of high quality for the Canadian market. After their review, they will issue a licensing decision and if approved, issue a Notification Number (NN).

VHP Selling in Canada:

The product owner or notifier must ensure the product is properly labeled. This includes bilingual label text, adding the NN to the label, and calling out ‘Veterinary Health Product’ on the front panel, amongst other requirements. It is important that your product is not labeled in a way that is misleading or false. The best way to avoid this is to only use verbiage that is approved within your notification.

Also, while on market, it is required that companies report any serious adverse drug reactions to Health Canada.

Furthermore, should you wish to make a post-notification change to your product, you would need to determine whether the change requires a new NN or if a revision can be made to the existing NN.

Looking for assistance with your VHP?

VHP Importing (CFIA Requirements):

All animal products and tissues being imported must be notified and adhere to CFIA import requirements. This can be confirmed, researched, and verified on the AIRS webpage for animal/commodity-specific requirements. You may require documentation such as veterinary health product certificates or import permits for specific materials/ingredients.

All commercial shipments must be handled properly to ensure all duties and taxes are paid to Canada Revenue Agency (CRA) and/or Canada Border Services Agency (CBSA). This can be handled through a customs broker.

The product owner must ensure the import documentation shows the VHP Notification Number. The sites/contacts that are involved in processing, importing, and storing your products as per your VHP application. The Canadian Representative should also be listed here. You should be prepared to answer questions from the CBSA at the time of import.


It is important to ensure compliance during the whole product lifecycle to reduce enforcement action from any regulatory body. Working with a regulatory consultant such as Quality Smart Solutions can help get your product notified, labeled, and launched into the Canadian Market. We can also consult Health Canada on your behalf for any unique questions you may have.

Please reach out to our team of specialists for any questions regarding your VHPs in Canada. Such as ingredient and formula review, Canadian representative solutions, notification submission, labeling, bilingual translation, and post-licensing changes. We are happy to help!

How Quality Smart Solutions can help

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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Learn how to differentiate Dietary Supplement vs NHP Labeling


Dietary supplements in the USA are very similar to natural health products (NHP regulations) in Canada and many products can be classified as both. But not all dietary supplements are natural health products and vice-versa. There are some distinct classification factors for each. Generally, dietary supplements are labeled comparably to food products in the USA. Whereas natural health products are labeled more like drug products in Canada. This blog will provide an overview of some labeling requirements for both NHPs and dietary supplements, to compare the two product types.

Principal Display Panel Aka the Front Panel

Dietary Supplements – Must list a statement of identity and net quantity on the front panel.

Natural Health Products – Must list primary brand name, Natural Product Number (NPN label requirements), the net amount of product, specify if the product is sterile and if not already apparent, list the dosage form.

Nutrition Facts and Ingredients Listing

Dietary Supplements Labeling – Dietary Supplements must list a Supplement Facts panel hosting all nutritional information including daily value as well as the list of active ingredients. The listing of ingredients should be in descending order by weight.

Natural Health Products labeling– To best align with the regulations for Natural Health Products, we recommend a line listing for each of your medicinal ingredients. This would list common name and proper name, source material, label claim amount, extract information, and any potencies. Also, a list of all other ingredients preceded by a title of “non-medicinal ingredients” must be included.

Health Claims

Need help bringing your dietary supplement or NHP labels into compliance?

Dietary Supplements – All health claims should be structure-function based. Claims can be notified/approved for use through the FDA’s dietary supplement notification process. Many allowable claims can be found online through FDA resources and are like food claims in that way. We recommend the product owner hold a dossier of research to support the safety of the product and efficacy for any health claim made on a supplement label. We recommend you only use approved claims on product labels.

Natural Health Products – All health claims published on natural health product labeling must be in accordance with your product license. These come from Health Canada monographs or the class 3 application process where additional research can be submitted to support the efficacy of the product or an ingredient. We recommend you only use approved claims on product labels.

Caution and Risk Statements

Dietary Supplements – The general FDA caution statement must be listed when a structure/function claim is used. Other caution statements are voluntary to protect the consumer and certain subpopulations.

Natural Health Products – All risk statements for natural health product labeling must be as per your product license. These may come from Health Canada published monographs or through the class 3 application process where they can be added voluntarily or by the regulator.

Company Information

Dietary Supplements – For dietary supplement labeling, you must list the name and place of business for the manufacturer, packer, or distributor. You must list the street address if the company is not listed in a city directory or telephone book.

Natural Health Products – For natural health product NHP labeling you must list the name and address of the product license holder. You must also list the name and address of the importer if the product is made outside of Canada.

Other Information/Tips

Dietary Supplements – These products must specify on the front panel that they are dietary supplements. Font size for dietary supplements is 1/16 inch in height as measured by lowercase ‘o’. You may not place any non-required label content between required label content, this is known as intervening material.

Natural Health Products – All required content that is pertinent to the consumer must be printed in both official languages, English and French. Font size for natural health products is such that the average consumer can read the label (is legible). No minimum font sizes are prescribed/limited at this time.


In conclusion, there are many differences and similarities between natural health products and dietary supplement labels, most of which are apparent if you were to hold the two side by side. It would be difficult to prepare a label that is acceptable for both Canadian and US requirements, as each label type has its own intricacies. We recommend having separate labels for these markets based on many of the above requirements.

Please reach out to our team of specialists to further discuss your dietary supplements or natural health products. We are happy to help discuss the classification, labeling, and registration for your products in North America!


FDA Qualified Health Claim for Magnesium 2022

The U.S. Food and Drug Administration (FDA) has communicated via Letter of Enforcement Discretion that it will not oppose or object to some qualified health claims regarding magnesium and the reduced risk of high blood pressure (hypertension), so long that the claims are worded properly to avoid misleading the consumer. The claims are essentially accompanied by a disclaimer to convey the available scientific evidence that supports the claim. 

The Center for Magnesium Education and Research LLC. has sent a petition to the FDA to allow a health claim regarding the consumption of magnesium and a reduced risk of high blood pressure. Thus, confirming and characterizing a relationship between the ingredient and a disease or health condition. In this case magnesium and blood pressure.  

Upon review of the submitted evidence, FDA has decided that there is a valid support for such a claim to be made for conventional foods and dietary supplements. FDA has released a guide for how they will enforce this new claim. 

The following health claims for conventional foods and dietary supplements are included in the FDA’s letter:

  • “Inconsistent and inconclusive scientific evidence suggests that diets with adequate magnesium may reduce the risk of high blood pressure (hypertension), a condition associated with many factors.”
  • “Consuming diets with adequate magnesium may reduce the risk of high blood pressure (hypertension). However, the FDA has concluded that the evidence is inconsistent and inconclusive.”
  • “Some scientific evidence suggests that diets with adequate magnesium may reduce the risk of high blood pressure (hypertension), a condition associated with many factors. The FDA has concluded that the scientific evidence supporting this claim is inconsistent and not conclusive.”

Looking for Dietary Supplement Help?

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Need an expert to help ensure your food or dietary supplement is compliant for sale in the USA?

Quality Smart Solutions can help.

It is strongly encouraged that your conventional food and/or dietary supplement labels capture the full statements issued by the FDA. We recommend using the statement verbatim to avoid misleading the consumer.  

The amount of magnesium required to justify such a claim is 84 mg. Please ensure your conventional food or dietary supplement product does not also contain high levels of total fat, saturated fat, cholesterol, or sodium as these ingredients may disqualify your claim. 

The full petition and FDA response reports are available online and in the resource links below. Please reach out if you have any questions about blood pressure or magnesium claims.

How Quality Smart Solutions can help

Please contact our team for more information on FDA compliance, formula review, health claims, labelling projects or food imports. Our specialists are here to help! If you would like to see a copy of the FDA bulletin for this update, please see the below links or reach out to our team.

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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. The refusal rate for these is 14%. 
  • Class II – 90% of applications are meeting the 90-day performance timeline. The refusal rate for these is 36%.
  • Class III – 57% of applications are meeting the 210-day performance timeline. The refusal rate for these is 19%. There were about 200 Class III submissions that have not received an acknowledgment 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. The refusal rate for these is 31%.
    Stream 2 – 87% of applications are meeting the 65-day performance timeline. The refusal rate for these is 36%.
  • Renewal – 162 complete renewals completed this year. The 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.

A risk-based approach is still taken on Site Licence renewals.

Looking for NHP Compliance Guidance?

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Site License Application Tips:

  • Designated Party Authorizations and new site license 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 a 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 license 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 before site license 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?

Quality Smart Solutions can help.


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 the 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 post
  • 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 claim to 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!

30 Minutes Free Consultation

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!

30 Minutes Free Consultation

How Pet Food VHP Labels Differ from Human Food Labels in 2022

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 & Health Canada Policy on Food Labelling

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 the 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 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 the 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 program. 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 in 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 shorter update timelines would likely 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 at 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!


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)” or 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 Products). 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, labeled, and classified properly can help protect the population from unwanted side effects. Additional regulatory requirements aim to ensure this added protection.

What is Conventional Food?

Conventional food is a term used to describe food that is produced, processed, and sold in accordance with traditional agricultural practices. It includes items found in supermarkets as well as organic foods grown and processed according to approved standards.  Conventional food is commonly defined as food that is grown, processed, and sold in accordance with traditional agricultural practices. This includes GMO (genetically modified organism) products, conventional breeding of crops, production using chemical fertilizers, pesticides, and growth hormones; livestock being routinely fed antibiotics and other animal health care products; and the use of synthetic preservatives, dyes, and flavor enhancers.

Why is Conventional Food Important?

Conventional food production is important because it allows us to meet the needs of a growing global population. Conventional farming methods are used to maximize crop yield and quality in a spectrum of diverse environments, avoiding wastage and preserving precious resources. Additionally, conventional food has been found to increase shelf life and reduce post-harvest losses as well as provide consumers with a greater variety of choices.

What are the Different Types of Conventional Foods?

Conventional food production encompasses a wide variety of products. These include fruits, vegetables, grains, dairy, processed foods, canned goods, and more. Conventional farmers also specialize in a particular type of food growing or processing method to maximize efficiency and profits. For example, some use industrial-scale greenhouses or chemical-based pest control methods to increase crop yields. Others utilize automated robots and other technology to significantly reduce labor costs associated with certain tasks like harvesting.

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, and 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 Products. Usually, these are 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 food), would shift the classification into the 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 flavor, 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: this 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: 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 the 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 some ingredients 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 labeling items are often required on the label for supplemented foods, depending on the number of ingredients within the formula. This is explained in the application 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 labeling 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 requirements 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.

How Does the Industrialization of Food Impact Quality?

The industrialization of food can significantly impact the quality of what ends up on our dinner plates. In conventional production, farmers use genetically modified (GM) crops, as well as artificial fertilizers and pesticides to produce higher yields. These methods are often less expensive and faster than organic ones, but they may contain more synthetic ingredients which can reduce nutritional value and change the flavor profile of foods.

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

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