Amazon Seller Compliance

Andrew Lau

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SFCR License and Preventive Control Plans (PCP) Unlocked

SFCR License and Preventive Control Plans

SFCR License and Preventive Control Plans

In this blog, we’ll focus on answering your questions about the SFCR License and Preventive Control Plans, including why they are important and how they go together.

What is a Safe Food for Canadians Regulations License (SFCR)?

The Safe Food for Canadians Regulations (SFCR) and the Safe Food for Canadians Act (SFCA) came into effect on January 15, 2019. The SFCR consolidates 14 sets of existing food regulations into one single set of regulations to maintain consistency of regulations for your food business, reduce administrative burden and allow food business to focus on outcome-based provisions. Under the SFCR, certain food businesses will require a license to conduct one or more activities.

This is to establish a framework and improve food safety in Canada. The SFCR applies to food and food ingredients for human consumption, whether they are imported, exported, or traded within the provinces. There are new elements covered in the SFCR regarding licensing, preventive controls, and traceability. The SFCR lists out requirements to issue, renew and amend a license and rules relating to meat products. It also lists out what kind of food businesses will require a license and when they need to have one. Having the license allows the Canadian Food Inspection Agency (CFIA) to know who the manufacturers are and what activities they conduct.

Why do I need an SFCR License?

As per Part 3, Division 1 of the Safe Food for Canadian Licence Regulations. The Canadian Food Inspection Agency (CFIA) issues an SFRC license to businesses conducting food-related activities, such as manufacturing, trading, importing, or preparing food products for export or to be sent across territorial or provincial boundaries.  This CFIA SFCR license helps the agency in aligning Canada’s regulations with global food standards, identifying food businesses, and taking responsive action when their activities fail to be compliant with the regulations. Certain requirements of the SFCR License may apply in 2021 based on food type of activity, commodity, and business size.

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What is a Preventive Control Plan (PCP)?

The SFCR has a section focusing on preventive controls. These measures are to maintain food safety, reduce contamination, and ensure food that enters the Canadian market is safe. These controls cover areas including sanitation and pest control, treatments and processes, equipment, maintenance, and operation of establishments, unloading, loading, and storing food, employee competence, employee hygiene, employee health, and complaints and recalls. A preventive control plan (PCP) is written to explain how to identify and control the risks to food and food animals.

They are based on Hazard Analysis Critical Control Point (HACCP) principles and include areas related to packaging, labeling, grades, and standards of identity. Foreign suppliers and Canadian importers must explain how they meet the preventive food safety control requirements. According to SFCR section 86-89, food businesses must have and maintain a written PCP. However, some small businesses may be exceptions. This is to ensure businesses are manufacturing, exporting, and importing safe food. These measures help to identify, prevent, and correct issues during the production stage, which then protects Canadians, avoids product recalls, and continues market access with other countries that have similar requirements.

We can provide PCP plans, employee training, certification audit preparation, food safety documentation, and food safety plan development. 

Step-by-Step Guide for Preparing a Preventive Control Plan?

Here’s a step-by-step guide to help you prepare a comprehensive Preventive Control Plan:

  1. Understand Applicable Regulations:

    • Research and understand the relevant food safety regulations and standards that apply to your specific industry and region. In the United States, for instance, the Food Safety Modernization Act (FSMA) establishes preventive controls requirements for food facilities.

  2. Identify Hazards:

    • Conduct a thorough hazard analysis to identify potential biological, chemical, and physical hazards that could pose risks to food safety at each stage of your operation.

  3. Determine Preventive Controls:

    • For each identified hazard, establish preventive controls that can effectively minimize or eliminate the identified risks. Preventive controls can include process controls, sanitation practices, allergen controls, supplier verification, and more.

  4. Set Critical Control Points (CCPs):

    • Determine critical control points in your process where preventive controls are essential to prevent or eliminate hazards. These are specific points where control measures are applied to prevent, reduce, or eliminate hazards to an acceptable level.

  5. Establish Monitoring Procedures:

    • Develop procedures to monitor the effectiveness of your preventive controls at each CCP. Monitoring activities could include visual inspections, measurements, testing, and more.

  6. Implement Corrective Actions:

    • Outline steps to be taken if monitoring indicates that a preventive control is not being met or a hazard is not being adequately controlled. Corrective actions should address the root cause of the issue and prevent the product from entering commerce if necessary.

  7. Create Verification Procedures:

    • Develop procedures to verify that your preventive controls are consistently implemented and effective. Verification activities may include reviewing records, calibrating equipment, conducting internal audits, and testing samples.

  8. Establish Recordkeeping Protocols:

    • Detail the records that need to be maintained to demonstrate compliance with your preventive controls. These records should include monitoring results, corrective actions taken, verification activities, and more.

  9. Develop Supplier Approval and Verification Procedures (if applicable):

    • If you source ingredients or materials from suppliers, establish procedures for approving and verifying their safety practices and products.

  10. Train Employees:

    • Provide training to employees involved in implementing the preventive controls. They should understand their roles and responsibilities in ensuring food safety.

  11. Document the Plan:

    • Compile all the information into a comprehensive written Preventive Control Plan. This plan should be well-organized and easily accessible to relevant personnel.

  12. Implementation and Review:

    • Put your Preventive Control Plan into action and regularly review its effectiveness. Make updates as needed based on changes in processes, hazards, regulations, or industry best practices.

  13. FDA Registration and Compliance (U.S. Only):

    • In the United States, food facilities are required to register with the U.S. Food and Drug Administration (FDA) and comply with the regulations outlined in the Food Safety Modernization Act (FSMA).

Remember that the specific steps and requirements for creating a Preventive Control Plan can vary based on your industry, geographical location, and applicable regulations. It’s important to tailor your plan to your specific operations and seek guidance from food safety experts or regulatory authorities to ensure full compliance.

What are the benefits of a comprehensive Preventive Control Plan?

Creating a comprehensive PCP can provide numerous benefits for your food manufacturing business, including:
– Ensuring the safety of your products and protecting consumers from illness or injury.
– Meeting regulatory requirements and avoiding fines and penalties.
– Improving the efficiency and effectiveness of your manufacturing processes.
– Enhancing your reputation as a responsible and trustworthy food manufacturer.
– Providing a framework for continuous improvement and ongoing success.

What are the common mistakes to avoid when creating a Preventive Control Plan?

When creating a PCP, it’s essential to avoid common mistakes that can undermine the effectiveness of your plan. Some common mistakes to avoid include:
– Failing to conduct a thorough hazard analysis and risk assessment.
– Establishing ineffective or inappropriate preventive controls.
– Need to develop appropriate monitoring procedures for your specific manufacturing processes.
– Neglecting to establish procedures for taking corrective action in case of a problem.
– Failing to maintain accurate and up-to-date records and documentation.
– Neglecting to verify and validate the effectiveness of your PCP.
– Failing to provide adequate employee training and education.
– Failing to review and update your PCP regularly.

Resources for Creating a Preventive Control Plan

Numerous resources are available to help you create a comprehensive PCP that meets regulatory standards. Some resources to consider include:
– FDA Food Safety Modernization Act (FSMA) website
– FDA Preventive Controls for Human Food guidance document
– FDA Hazard Analysis and Risk-Based Preventive Controls for Human Food course
– FDA Food Safety Plan Builder tool
– Food Safety Preventive Controls Alliance (FSPCA) training courses

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How to Classify Your Product as a Drug, NHP, or Cosmetic

Product Classification in Canada: Drug, NHP, or Cosmetic?

Product Classification in Canada: Drug, NHP, or Cosmetic?

Learning how to classify your product correctly is one of the most important first steps when entering the Canadian market. Before you can sell or import any health, beauty, or personal care product, you need to know how it will be regulated. Whether it falls under OTC drugs, natural health products (NHPs), or cosmetics, each category comes with its own set of rules, from licensing and labelling to marketing claims and supporting evidence.

Misclassifying a product can delay your launch, result in costly recalls, or even trigger enforcement action. For example, products classified as drugs may require a Drug Identification Number (DIN) and robust clinical data, while cosmetics typically follow a lighter notification process.

Knowing what counts as a therapeutic claim, how ingredients are evaluated, and which format triggers more scrutiny can save you time and money. Keep reading to learn how to make confident classification decisions and set your product up for success.

Key decision-making criteria

Before determining whether your product is a drug, NHP, or cosmetic, it’s important to assess a few critical factors. These decision points help identify how Health Canada is likely to classify your product. 

1. Intended use and claims

What is the purpose of the product? If you’re making a therapeutic claim such as treating acne or preventing cavities, the product will likely be classified as a drug or NHP. If your claims are limited to enhancing appearance, such as “moisturizes skin,” it may be classified as a cosmetic. 

2. Ingredients and composition

Are there active pharmaceutical or medicinal ingredients involved? Health Canada considers not just the function of an ingredient, but also its concentration and whether it aligns with established monographs or requires evaluation as an active pharmaceutical ingredient (API).

3. Format and route of administration

Is the product a cream, capsule, spray, or tablet? Products taken orally or applied to mucous membranes typically fall under drugs or NHPs. Topical products may span all three categories, depending on use and claims. 

4. Site of action and target audience

Where and how the product works on the body can influence its classification. Intended use in sensitive populations like children, or long-term therapeutic use, often signals the need for drug-level review. 

Over-the-counter (OTC) drug classification in Canada

OTC Drugs are non-prescription products that help consumers manage or prevent common health conditions. These products are regulated by Health Canada as drugs under the Food and Drugs Act and must demonstrate safety, efficacy, and quality. While they do not require a prescription, they must still meet rigorous standards and be supported by solid scientific evidence. 

Key features of OTC drugs 

  • Contain active pharmaceutical ingredients (APIs) with known safety profiles 
  • Make therapeutic claims such as “relieves pain,” “reduces fever,” or “prevents cavities” 
  • Require a Drug Identification Number (DIN) prior to sale in Canada 
  • Must comply with Good Manufacturing Practices (GMP) and labelling standards 

Examples of OTC drugs

  • Toothpastes with fluoride that prevent cavities 
  • Anti-dandruff shampoos with medicated ingredients 
  • Antiperspirants that use aluminum-based compounds to reduce sweat 

Natural health product (NHP) classification

NHPs are a distinct category regulated under the Natural Health Products Regulations in Canada. These products contain naturally sourced ingredients and are typically used to maintain or improve health, rather than treat serious diseases. They are available without a prescription and are commonly found in health food stores, pharmacies, and online. 

Each NHP must be approved by Health Canada and receive a Natural Product Number (NPN) before being sold. Claims must reflect general health maintenance or symptom relief, and the product must meet quality, safety, and efficacy standards.  

While the regulatory pathway may be more streamlined than for drugs, NHPs still require proper documentation, compliant labelling, and evidence that supports any health claims. 

Key features of NHPs 

  • Contain medicinal ingredients like vitamins, minerals, amino acids, or herbal extracts 
  • Claims are limited to general health maintenance, symptom relief, or risk reduction 
  • Must obtain a Natural Product Number (NPN) before being sold 
  • Regulated under the Natural Health Products Regulations 

Examples

  • Melatonin tablets for sleep support 
  • Herbal creams for muscle relief 
  • Skin-lightening creams with plant-based actives 

Cosmetic classification

Cosmetics are products used to clean, beautify, or enhance appearance without offering any therapeutic benefits. Unlike drugs or NHPs, they are not intended to treat, prevent, or modify bodily functions. Although cosmetics are the least regulated among the three categories, they still need to meet specific safety, labelling, and ingredient standards before being sold in Canada. 

Health Canada requires that all cosmetic products be notified through the Cosmetic Notification Form and comply with the Cosmetic Ingredient Hotlist, which identifies prohibited or restricted substances. While these products do not require a pre-market approval, they must still be safe for use and properly labelled to avoid misleading claims.  

Failing to comply with these requirements can result in enforcement actions, especially if the product inadvertently crosses into therapeutic territory.

Key features of cosmetics 

  • Intended for external use on skin, hair, nails, teeth, or mucous membranes 
  • Make non-therapeutic claims such as “moisturizes skin” or “freshens breath” 
  • Do not require a license or approval before sale, but must be notified to Health Canada 
  • Must follow the Cosmetic Ingredient Hotlist for banned or restricted substances 

Examples

  • Lipsticks, moisturizers, shampoos, and perfumes 
  • Skin creams with cosmetic claims only, depending on ingredients 
  • Whitening toothpastes with no therapeutic claims 

Borderline product examples

Some products appear to fit multiple categories depending on their ingredients, claims, and intended use. These are known as borderline products and can be particularly challenging to classify without expert support. A product might seem like a cosmetic based on its format or appearance but could fall into the drug or NHP category if it makes a therapeutic claim or contains active ingredients. 

In these cases, even small changes in wording or formulation can significantly impact regulatory requirements. That’s why it’s essential to understand how Health Canada interprets product intent, composition, and claims when making a classification decision. 

  • Sunscreens: Cosmetic in some countries, but classified as drugs or NHPs in Canada due to their active ingredient components and disease-prevention role.
  • Anti-dandruff shampoos: Often regulated as drugs because they treat a medical condition.
  • Skin-lightening creams: May fall under NHP or drug classification depending on the active ingredient and strength.
  • Antiperspirants: Typically classified as drugs due to their effect on body functions.
  • Fluoride toothpastes: Considered drugs when cavity prevention is claimed.

What to do if your product is borderline

If you’re unsure how to classify your product, start by reviewing official monographs and guidance documents. You can also submit a Product Classification Request (PCR) to Health Canada for an official ruling.

A regulatory expert can help review your formula and marketing claims to ensure proper classification and avoid delays during the submission process.

Need help classifying your product? 

Quality Smart Solutions helps companies navigate Health Canada’s classification rules for drugs, NHPs, and cosmetics. Whether you are developing a new formula or reviewing existing claims, our regulatory experts are here to help. 

Contact us or fill out the form below to get the guidance you need and ensure your product meets all regulatory requirements in Canada.  

You can also learn more about classification rules directly from Health Canada’s official guidance. 

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Cosmetic Ingredients: Potential Presence of Toxic Substances

Potentially Toxic Ingredients in Cosmetic Products

Potentially Toxic Ingredients in Cosmetic ProductsWhat is a cosmetic?

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

Prohibited Ingredients and Restricted Ingredients

All cosmetic products sold in Canada are required to meet the requirements listed in Food and Drugs Act and Cosmetics Regulations. Health Canada has compiled a cosmetic ingredient hotlist and identified all prohibited and restricted ingredients. Prohibited cosmetic ingredients are ingredients that must not be present in the cosmetic products sold in Canada. An example is Benzyl Chloride. Restricted cosmetic ingredients are ingredients that are permitted only within certain conditions of use or when cautionary statements are present. These cosmetic ingredients are permitted with an upper limit on concentration. For example, benzethonium chloride is not permitted in products to be applied to mucous membranes. However, it is permitted in leave-on products, at a concentration equal to or less than 0.2%, and rinse-off products, at a concentration equal to or less than 0.3%. This list gets updated periodically and it is your responsibility as the manufacturer to keep them up to date and make sure your cosmetic products and cosmetic ingredients are compliant with the regulations.

Potential Presence of Toxic Substances

Health Canada sent out a notice on behalf of Environment and Climate Change Canada on April 1, 2022, to increase awareness that some cosmetics contain prohibited toxic substances called per- and polyfluoroalkyl substances (PFAS). They are a group of chemicals used to increase the wear, durability, spread, and water and oil resistance of applied cosmetics. They are generally found in products such as foundations, liquid lipsticks, and waterproof mascaras to be wear-resistant to water and oils and long-lasting. These PFAS include perfluorooctanoic acid (PFOA), its salts and precursors; long-chain perfluorocarboxylic acids (LC-PFCAs), their salts and precursors; and perfluorooctane sulfonate (PFOS), its salts and precursors.

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Under the Canadian Environmental Protection Act, of 1999, these PFAS groups are toxic and prohibited in Canada. Precursors are defined as compounds that consist of a perfluorinated alkyl group that has the molecular formula CnF2n+1 in which n = 7 or 8 and that is directly bonded to any chemical moiety other than a fluorine, chlorine or bromine atom; compounds that consist of a perfluorinated alkyl group that has the molecular formula CnF2n+1 in which 8 ≤ n ≤ 20 and that is directly bonded to any chemical moiety other than a fluorine, chlorine or bromine atom; and compounds that contain one of the following groups: C8F17SO2, C8F17SO3 or C8F17SO2N. Under Prohibition of Certain Toxic Substances Regulations, 2012, these toxic substances are harmful to the environment or human health and can be persistent and bioaccumulative. Though they may be allowed in other countries, they are prohibited in Canada, and it is the importer’s responsibility to avoid regulatory violations in Canada.

Quality Smart Solutions offers regulatory services from registering your cosmetic products and reviewing your cosmetic ingredients. We also offer a cosmetic product label compliance solution. Our experts are here to help and offer any cosmetic-related regulatory advice!

References

https://www.canada.ca/en/health-canada/services/consumer-product-safety/cosmetics/notification-cosmetics/guidance-document-complete-cosmetic-notification-form.html#5

https://www.canada.ca/en/health-canada/services/consumer-product-safety/cosmetics/cosmetic-ingredient-hotlist-prohibited-restricted-ingredients.html

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Your Cosmetic Notification MAY get Qualified for processing in 24 hours!

Cosmetic Notifications

What is a cosmetic?

Under Section 2 of the Food and Drugs Act, a cosmetic is defined as “any substance or mixture of substances manufactured, sold or represented for use in cleaning, improving or altering the complexion, of skin, hair or teeth, and includes deodorants or perfumes.”  

This is different than drug and natural health products even though they are all regulated under the Food and Drug Act. The classification of the product depends on its function, purpose, and representation for use (such as claims or recommended purposes).

Ingredients in the formula may also help determine the classification. For example, in Canada, ingredients like corticosteroids can only be licensed as drugs whereas green tea leaf extract may be licensed as a cosmetic product.

Cosmetic Notification Form

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

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

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Improvements of Cosmetic Notifications Processing

On January 28, 2022, Health Canada notified all cosmetic stakeholders that they are improving the processing of the cosmetic notifications to make it more efficient.  Effective February 5, 2022, Health Canada will use their automated system and process new cosmetic notifications that do not contain restricted or prohibited ingredients.

Once submitted, you will receive a Cosmetic Notification Number issued by Health Canada.  Currently, Health Canada has some unprocessed cosmetic notifications, and these applicable cosmetic notifications will go through the automated system once it is activated on February 5, 2022.  

All other cosmetic notifications that contain restricted or prohibited ingredients will remain be reviewed by Health Canada officers and will not be processed using the automated system.  Keep in mind, this form is used for new products, amendments, and discontinuation of sale.

Resources:

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

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Natural Health Products Quality Characterization Guide for 2022

Natural Health Product

Natural Health Products have different characterization, identification, quantification, and purity standards that you should know about to ensure the quality of your NHPs. 

Introduction

The purpose of this guidance document is to give stakeholders directions on how to be compliant with Natural Health Products Regulations (NHPR) and meet the quality requirements. Product license holders are responsible and are expected to meet the quality requirements for all types of their Natural Health Products (NHP) that fall under the NHPR. 

Through the NPN application, the product license applicant provides attestation and confirms that the product will be manufactured, packaged, labeled, imported, distributed, and stored in accordance with good manufacturing practices (GMPs). Health Canada has developed several tools in regard to ingredient-specific quality and specification requirements, such as the Natural Health Products Ingredients Database (NHPID), Finished Product Specifications (FPS), and NNHPD pre-cleared monograph. 

License holders may also follow applicable pharmacopeias rather than the tools listed above if it is more appropriate for the ingredient or product.

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Characterization, identification, and quantification standards

The Natural and Non-Prescription Health Products Directorate (NNHPD) requires the characterization of medicinal ingredients to evaluate evidence of its identity, which relates to the safety and efficacy of the Natural Health Product. The characterization could be the ingredient’s distinguishing features or special qualities. Examples are chemicals (e.g. isolates, synthetic duplicates), processed ingredients, and extracts (e.g. fortified extracts, standardized extracts). Depending on the type of ingredient, identity testing may also be required and may be performed at the raw material or finished product stage. This is to determine the correct ingredient or plant species/plant parts from adulterants. 

The finished Natural Health Product specifications should list the quantity per dosage unit of all medicinal ingredients. Tolerance limits should be 80-120% of label amount or conform to the applicable pharmacopeial standards. It could be either Quantification by assay (tested at finished product stage) or Quantification by input, depending on the characterization of medicinal ingredients. 

Purity standards

The NHPR requires the finished product specifications to list out the information related to the purity of the Health Canada Natural Health Products. This means to include test methods and tolerance limits for Microbial Contaminants and Chemical Contaminants. If this is tested at the raw material stage, it is not required to repeat the test again at the finished product stage as long as GMPs are in place to prevent additional contaminants. 

Microbial contaminants testing includes Total viable aerobic plate count, Contaminating fungi (yeast and mold), Salmonella SPP, Escherichia coli, Staphylococcus aureus, and Pseudomonas aeruginosa. Chemical contaminants are elemental impurities such as heavy metals. This can be tested individually, or as total heavy metals with acceptable test methods in NHPID, Pharmacopeial, or internationally accepted 

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methods. Topical products have different requirements for heavy metal limits. Depending on the ingredients in the Natural Health Product, other contaminants testing include aflatoxin, cyanobacterial toxins, animal hormones, pesticide residues, solvent residues, antibiotic residues, radioactivity, oxidative stability, and marine oil contaminants.

Additional tests and criteria

Product license holders must ensure all non-medicinal ingredients are within restrictions in NHPID and are used in quantities to support the purpose of its use. Other performance tests may be required depending on the nature of the product, including Disintegration, Dissolution, Uniformity of dosage units, Antimicrobial effectiveness testing, and Stability testing.

Resources:

https://www.canada.ca/en/health-canada/services/consumer-product-safety/reports-publications/industry-professionals/labelling-cosmetics.html#three2

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Therapeutic vs. Non-Therapeutic Claims Classification Guide

Therapeutic Claim, Cosmetic, NHP

What is a claim?

A claim is a representation for sale. It can be presented as “a word, a sentence, a picture, a symbol, a paragraph or an implication on product labels, package inserts or advertisements, including company websites”. It explains what the product is for and what it does. There are two types of health claims: Therapeutic Claim and Non-Therapeutic Claim. Depending on the health claims, your product can be classified as a cosmetic, NHP, or drug.

Therapeutic Claims

These are claims that must be reviewed by the Natural and Non-prescription Health Products Directorate (NNHPD) prior to receiving its market authorization such as Drug Identification Number (DIN) or Natural Product Number (NPN). These claims can be used in advertising or marketing of the product and must be supported through evidence. Examples are: “Stimulates hair growth”, “Prevent hair loss”, and “Eliminates dandruff”.

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Non-Therapeutic Claims

These are claims that are made on product labels and its advertisements. Though they must be true and accurate, they do not require review and authorization from Health Canada prior to use. Examples are: “Strengthens hair”, “Healthy Hair”, and “Removes loose dandruff flakes”.

Classification of your product

In order to classify your product, your product must meet one of the definitions above. Product risk, public health safety, and applicable regulatory framework must also be taken into consideration. Two main factors in determining product classification include representation and composition of the product.

Representation and Composition of your product

The classification of your product depends on two main factors: Representation and Composition. Representation can be its function, purpose, and representation for use (such as proposed claims). Composition of your product is the ingredients and their concentrations contained in the formula. For example, in Canada, ingredients like corticosteroids can only be licensed as drugs whereas Green Tea Leaf Extract may be licensed as an NHP or cosmetic product. However, composition alone may not be sufficient in determining its product classification.

Resources:

https://www.canada.ca/en/health-canada/services/consumer-product-safety/reports-publications/industry-professionals/labelling-cosmetics.html#three2
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How to Legally Sell Medicinal Mushrooms in Canada?

Natural Health Product Regulations

Medicinal Mushrooms in powder, capsule or liquid form can be licensed as Natural Health Product (NHP) in Canada. To sell NHP legally in Canada, you must have received a Natural Product Number (NPN) and have the product sold with a Bilingual label and packaging.

What is a Natural Health Product (NHP)?

An NHP is regulated by the Natural and Non-prescription Health Products Directorate (NNHPD) under the Natural Health Products Regulations. Under the regulations, it is defined as products containing naturally occurring substances including Probiotics, Herbal remedies, Vitamins and minerals, Homeopathic medicines, Traditional medicines (e.g. Traditional Chinese and Ayurvedic medicines), and other substances (e.g. amino acids and essential fatty acids). These products are used to treat or prevent an illness, reduce health risks, and maintain general good health. 

What is a Natural Product Number (NPN)?

All NHPs must have a product license and the Canadian site must have a site license to conduct activities including manufacturing, packaging, labelling, and/or importing in Canada. Prior to selling the product, the company must submit NHP applications for Health Canada to review and assess its safety, efficacy, and quality. Once it has been approved, Health Canada will authorize the product license and give permission for the company to sell the NHPs in Canada. This product license comes with an eight-digit NPN, and this number is required to be present on the front panel of the NHP label.

What is the NHP Label requirement?

All NHPs must have a bilingual NHP label that is compliant to the NHP Regulations. This is to ensure the NHP is labelled and packaged according to regulations to help consumers make more informed choices about the NHP they take. There is a list of specific requirements and information that must appear on the NHP labels, both inner and outer, and the information is based on the product license you received from Health Canada, including dosage form, recommended purpose, risk information, medicinal ingredients, non-medicinal ingredients, and product license holder information.

What is Natural Health Products Ingredients Database (NHPID)?

NHPID is a database that Health Canada built to store pre-cleared information approved by the Natural and Non-prescription Health Products Directorate (NNHPD). The NHPID provides details to the approved medicinal ingredients, non-medicinal ingredients, non-NHP ingredients, and NNHPD single ingredient and product monographs which contain dose information, recommended purpose and risk information. The NHPID also includes a search engine and allows you to navigate the database with ingredient terminologies such as NHPID name, common/proper name, and chemical abstracts service (CAS) numbers. Many mushroom medicinal ingredients such as Maitake, Lion’s Mane, Chaga, Shiitake, and Turkey Tail are already registered in NHPID and have pre-cleared supporting information in the Mushrooms Product Monograph.

References:

https://www.canada.ca/en/health-canada/services/drugs-health-products/natural-non-prescription/regulation/about-products.html

https://www.canada.ca/en/health-canada/services/drugs-health-products/natural-non-prescription/regulation.html#a2

https://www.canada.ca/en/health-canada/services/drugs-health-products/natural-non-prescription/applications-submissions/online-solution/ingredients-database.html

https://www.canada.ca/en/health-canada/services/drugs-health-products/natural-non-prescription/legislation-guidelines/guidance-documents/labelling.html

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How to sell Hemp Oil Health Products in Canada?

What is Hemp Seed Oil categorized as in Canada?

In Canada, Hemp (Canna Sativa) seed oil can be categorized as a Natural Health Product (NHP), which means it is regulated by Health Canada under the Natural Health Products Regulations. Under the regulations, NHPs are defined as products containing naturally occurring substances including probiotics, herbal remedies, vitamins and minerals, homeopathic medicines, traditional medicines (e.g. Traditional Chinese and Ayurvedic medicines), and other substances (e.g. amino acids and essential fatty acids). These products are used to treat or prevent an illness, reduce health risk, and maintain general good health. Hemp seed oil is currently listed under the “Multiple Ingredient Fixed Oil Products – Oral Product Monograph” with Health Canada.

Natural Health Products Ingredients Database

The Natural Health Products Ingredients Database (NHPID) is a database that Health Canada built to store pre-cleared information approved by the Natural and Non-prescription Health Products Directorate (NNHPD). 

According to the NHPID, to use hemp seed oil as a medicinal ingredient, in a natural health product, this ingredient “must not contain more than 10 parts per million delta-9-Tetrahydrocannabinol (THC), or phytocannabinoids that have been isolated or concentrated. The determination of the THC concentration must take into account the potential to convert delta-9-tetrahydrocannabinolic acid (THCA) to THC.” 

The finished product containing hemp seed oil must have a tolerance requirement of <10 ppm for THC, and zero or not detected for cannabidiol (CBD). The database also indicates that “Hemp derivatives must also be compliant with the Industrial Hemp Regulations (IHR). All sources of hemp falling under the IHR are expected to be of an approved cultivar, defined in the IHR as any variety of industrial hemp set out in the List of Approved Cultivars, published by the Government of Canada on its website, as amended from time to time.” 

This list of approved cultivars for 2021 growing season can be found in here: 

Natural Product Number

Like other NHPs, products containing hemp seed oil must have a product license and the Canadian site must have a site license to conduct activities including manufacturing, packaging, labeling, and/or importing in Canada. Prior to selling the product, the company must submit an Natural Product Number (NPN) application for Health Canada to review and assess the product’s safety, efficacy, and quality. Once it has been approved, Health Canada will issue the product a product license and give permission for the company to sell the NHP in Canada. This product license comes with an eight-digit Natural Product Number (NPN), and this number is required to be present on the front panel of the NHP label.

NHP Label

All NHPs must have a bilingual NHP label that is compliant with the NHP Regulations. This is to ensure the NHP is labeled and packaged according to regulations to help consumers make more informed choices about the NHP they take. There is a list of specific requirements and information that must appear on the NHP labels, both inner and outer, and the information is based on the product license received from Health Canada, including dosage form, recommended purpose, risk information, medicinal ingredients, non-medicinal ingredients, and product license holder information.

How can we help

QSS offers North American regulatory services for submitting applications for your NHPs, preparing French translations, reviewing your NHP labels. Our experts are here to help and offer any NHP-related regulatory advice!

30 Minutes Free Consultation

References:

http://webprod.hc-sc.gc.ca/nhpid-bdipsn/ingredReq.do?id=4497&lang=eng

https://www.canada.ca/en/health-canada/services/drugs-medication/cannabis/producing-selling-hemp/commercial-licence.html

http://webprod.hc-sc.gc.ca/nhpid-bdipsn/atReq.do?atid=multiple.oil&lang=eng

https://laws-lois.justice.gc.ca/eng/regulations/SOR-98-156/page-1.html#h-1

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News

Proposal to Amend the Cosmetic Regulations

What is a Cosmetic?

Under Section 2 of the Food and Drugs Act, a cosmetic is defined as “any substance or mixture of substances manufactured, sold or represented for use in cleaning, improving or altering the complexion, skin, hair or teeth, and includes deodorants and perfumes.”. This is different from a drug or natural health product, even though they are all regulated under the Food and Drug Act. 

The classification of a product depends on its function, purpose, and representation for use (such as claims that are made for the product on the product label). Ingredients in the formula may also help determine the classification. For example, in Canada, ingredients like corticosteroids can only be licensed as drugs whereas green tea leaf extract may be licensed as a cosmetic product or natural health product.

What is the proposal on?

Currently, stakeholders can use the word “perfume” in the Cosmetic Notification Form and on cosmetic labels to represent the overall fragrance ingredients that are used to produce or mask a particular odour. Alternatively, they can list each fragrance ingredient individually under the ingredient list. On July 16, 2021, Health Canada opened a consultation and proposed to amend the Cosmetic Regulations to eliminate the use of “perfume” so that the industry must list individual fragrance ingredients.

This purpose of this change is to disclose allergens and give consumers more detailed information, allowing them to make better decisions when purchasing cosmetic products. Other amendments to the regulations include administrative updates and improving cosmetics oversight including terminology clarification for risk management purposes and enhancing cosmetic compliance (e.g. one’s responsibility on Health Canada’s safety evidence request).

The Importance of Cosmetic Safety

Even though most cosmetic products are generally safe for use, some of them may still cause health problems such as allergic reactions and skin irritation. To use cosmetics safely, you should always read safety information on the label, especially hazard symbols. If there are directions of use present on the label, you should follow carefully to avoid misuse, which may result in rashes, burns, or eye damage. 

Cosmetics should be kept out of reach of children, as they may be poisonous if swallowed. If swallowed, you should contact a Poison Control Centre or call 411. If it is a spray product, do not spray near a flame or source of heat, which may cause fires and explosions. Although some cosmetics have preservatives, you should still keep them clean to avoid bacteria growing. You can do so by washing your hands before using makeup, not sharing makeup, not adding water to dilute makeup, and keeping your cosmetics stored in a dry, dark area.

If there are changes in colour, smell, or texture of the product, do not use it. Hypoallergenic cosmetics are less likely to cause allergic reactions, but still could do so. If any allergic reaction occurs, stop use, and consult a healthcare practitioner. For certain products such as hair dyes, you may be asked to do a patch test prior to use to ensure cosmetic safety. You could also report cosmetic incidents by submitting a Consumer Product Incident Report on Health Canada’s website.

Categories
Blog

Animal Supplements in the USA

Animal Supplements in the USA – What You Need to Know

How are animal supplements regulated in the USA?

Dietary supplements are regulated under the Dietary Supplement Health and Education Act of 1994 (DSHEA). The U.S. Food and Drug Administration (FDA)’s Center for Veterinary Medicine (CVM) confirms that the DHSEA does not apply to animal products. Therefore, animal supplements are not regulated as dietary supplements in the USA, but rather as food, or drugs, depending on the intended use. 

What are Animal Supplements/Feed?

Animal (pet) food or feed products are regulated by the CVM and they are defined as “animal food ingredient, to become part of an ingredient or food, or added to an animal’s drinking water”. The Federal Food, Drug, and Cosmetic Act (FD&C Act) sets requirements in sections 402 and 403 on food and products may be deemed adulterated or misbranded if requirements are not satisfied. For example, false information on food labels, unsanitary food packaging, and animal feed containing poisonous substances. 

The FD&C Act states that any substance added or going to be part of the animal food, directly or indirectly, must follow food additive regulation or be Generally Recognized as Safe (GRAS) for that intended use. Examples of GRAS animal feed ingredients are forages, grains, and most of the vitamins and minerals. Other substances that do not appear in final animal food products but to give flavour or texture may also be considered food additives. The approved food additive list for animal feed can be found in 21 CFR 573 and partial GRAS list for animal feed can be found in 21 CFR 582 and 584. 

What Claims Can I Make For My Product?

The FD&C Act states that if the product contains structure function claims or its intended use is to cure, treat, prevent, or mitigate disease, the product is considered a new animal drug. All new animal drugs require approval through New Animal Drug Application by providing evidence on its safety and efficacy for its intended use. Food labels can have statements on the label regarding the product’s nutrition, aroma, or taste. The CVM publishes policy and permits some health information on the animal food label such as urinary tract health and dental health. These claims require approval by CVM before they can go on the label. All claims need to be truthful and accurate in the indicated species.

How Does the FDA Enforce Animal Supplements?

The FDA will flag “animal supplement” products that are being marketed as foods, but make egregious claims, for example, intending to treat a disease. Other examples include shelf-life evaluation, mislabelling, and containing unapproved substances or additives (e.g. CBD). The FDA may issue warning letters to businesses making these claims without proper substantiation. If this is the case, work closely with the FDA and see what changes are required to the product.

Categories
Blog

How to sell a Dietary Supplement NHP on Amazon.ca (or online in Canada)

How to Sell Dietary Supplements or NHPs on Amazon or Other Online Platforms in Canada?

What is an NHP?

In Canada, a Natural Health Product (NHP) is regulated by Health Canada under the Natural Health Products Regulations. Under the regulations, it is defined as products containing naturally occurring substances including probiotics, herbal remedies, vitamins and minerals, homeopathic medicines, traditional medicines (e.g. Traditional Chinese and Ayurvedic medicines), and other substances (e.g. amino acids and essential fatty acids). These products are used to treat or prevent an illness, reduce health risk, and maintain general good health. In the U.S., the Food and Drug Administration (FDA) refers this type of product as a Dietary Supplement.

Natural Health Products Ingredients Database

Natural Health Products Ingredients Database (NHPID) is a database that Health Canada built to store pre-cleared information approved by the Natural and Non-prescription Health Products Directorate (NNHPD). The NHPID provides details to the approved medicinal ingredients, non-medicinal ingredients, non-NHP ingredients, and NNHPD single ingredient and product monographs which contain dose information, recommended purpose and risk information. The NHPID also includes a search engine and allows you to navigate the database with ingredient terminology such as NHPID name, common/proper name, and chemical abstracts service (CAS) numbers. The NHPID can be updated by submitting Issue Form requests and this is a service offered by QSS.

Natural Product Number

All NHPs must have a product license and the Canadian site must have a site license to conduct activities including manufacturing, packaging, labeling, and/or importing in Canada. Prior to selling the product, the company must submit NHP applications for Health Canada to review and assess its safety, efficacy, and quality. Once it has been approved, Health Canada will authorize the product license and give permission for the company to sell the NHPs in Canada. This product license comes with an eight-digit Natural Product Number (NPN) or Homeopathic Medicine Number (DIN-HM), and this number is required to be present on the front panel of the NHP product label.

NHP Label

All NHPs must have a bilingual NHP label that is compliant with the NHP Regulations. This is to ensure the NHP is labelled and packaged according to regulations to help consumers make more informed choices about the NHP they take. There is a list of specific requirements and information that must appear on the NHP labels, both inner and outer, and the information is based on the product license you received from Health Canada, including dosage form, recommended purpose, risk information, medicinal ingredients, non-medicinal ingredients, and product license holder information.

Amazon Requirements

To sell on Amazon Canada, the product must have a bilingual NHP label and packaging and an NPN number, which means it must be licensed and have received market authorization from Health Canada. The listing and description of the product must also be truthful and accurate and not have misleading claims and marketing information. QSS offers regulatory services on submitting Issue Form, submitting applications for your NHPs, preparing French translations and reviewing your NHP labels. Our experts are here to help and offer any NHP-related regulatory advice!
Source: www.canada.ca
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