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How to Legally Sell Medicinal Mushrooms in Canada?

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.

How can we help

Quality Smart Solutions offers regulatory services on reviewing your mushroom formulas, submitting applications for your NHPs, reviewing your NHP labels, and writing French translations for the labels. Our experts are here to help and offer any NHP-related regulatory advice!

30 Minutes Free Consultation
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Key Components of a Cosmetic Label

What is a Cosmetic?

Cosmetics are a part of just about everyone’s life. Every day, most of us use products like soap, moisturizing creams, or shampoo. In Canada, cosmetic products are defined as “any substance or mixture of substances, manufactured, sold or represented for use in cleansing, improving or altering the complexion, skin, hair or teeth and includes deodorants and perfumes.” All cosmetic products sold in Canada must comply with the Canadian Food and Drugs Act and its Cosmetic Regulations. Before selling any cosmetic products according to section 30 of the Cosmetic Regulations, all manufacturers and importers are required to submit a fully completed Cosmetic Notification Form (CNF) to Health Canada within the first 10 days of the first sale within Canada. 

Are your Cosmetic Ingredients safe by Health Canada Standards?

Most cosmetics are safe, but they can sometimes cause health problems, like allergic reactions and skin irritation. To determine if an ingredient is safe for use in cosmetics, You must ensure that none of the ingredients are restricted as shown on the Cosmetic Ingredient Hotlist. You can also refer to Health Canada Cosmetic Safety for more information related to cosmetic safety and other adverse effects.

What are the Key Components I Need on My Cosmetic Label?

Manufacturer Name

Sometimes the consumer or other interest groups must know the identity of the party that is responsible for a product. This party is often known as the manufacturer or dealer. Therefore, cosmetic labels need to include the name of the manufacturer or dealer if they need to be contacted.

INCI Name

The INCI name refers to the International Nomenclature of Cosmetic Ingredient name. INCI is the acceptable terminology for listing ingredients on the label. The INCI names are based on Latin and considered multi-lingual therefore the French or English ingredient names do not need to be provided on the label, only the INCI names. 

Outer Label 

The outer label is often described as the outer carton label (i.e., the label on a box containing a bottle of a cosmetic product). On the outer label, the declaration of product identity must appear in both English and French on the principal display panel. The declaration must contrast both with the background of the label and all other information. All cosmetic products require the ingredient names to be listed on the outer label. Ingredients must be listed in decreasing order of predominance in their concentration by weight

Inner Label 

On the inner label, the declaration of product identity must appear in both English and French on the principal display panel. The declaration must contrast clearly with the background and all other information that appears on the label.

Obvious Identity: In certain cases, if the identity of a product such as an eyebrow pencil, an automatic mascara applicator, or a compact including powder and puff may be considered obvious, a written declaration of product identity would not be necessary. However, if the product is in an opaque container, the identity of the product must be expressed. 

Single Expressions: Certain expressions are considered officially bilingual in themselves, such as “parfum,” “eau de toilette,” or “cologne.” The requirements are the same as those for the outer labels of products that have both an outer and inner label. 

Additional Panels: The labels of some pre-packaged products are composed of one or more additional panels of the same size and prominence as the principal display panel. The product identifier may be given on the principal display panel in only one of the two official languages if it is also given in the other language on one of the other panels.

Typeface: There is no restriction concerning the typeface that may be used. The information, however, must be legible.

Net Quantity of the Product

The packaging and label should be constructed or presented in such a way that the consumer will not be misled about the quality or quantity of the product contained inside.

As required by sections 22, 23, and 36 of the Consumer Packaging and Labelling Regulations, the declaration of the net quantity of a pre-packaged product must be expressed

  • by volume when the product is a liquid, gas, or viscous substance (mL, L) 
  • by weight when the product is a solid (g, kg) 

Cosmetic Notification

Failure to notify Health Canada may result in a product being refused entry into Canada or removed from sale. A Cosmetic Notification is not a product application, evaluation, or approval procedure.  You are required to make sure that the product is classified as a cosmetic and complies with all regulatory requirements. Our Experts at Quality Smart Solutions can help review your ingredients, file your Cosmetic Notification and ensure you have a compliant label. Contact us today to learn more about how we can support your smooth entrance to market as well as your compliant needs during and aftermarket. 

References

Canada, Health. “Government of Canada.” Canada.ca, / Gouvernement Du Canada, 22 July 2020, https://www.canada.ca/en/health-canada/services/consumer-product-safety/reports-publications/industry-professionals/labelling-cosmetics.html.

Canada, Health. “Government of Canada.” Canada.ca, / Gouvernement Du Canada, 16 Feb. 2021, https://www.canada.ca/en/health-canada/services/consumer-product-safety/cosmetics/regulatory-information.html.

Branch, Legislative Services. “Consolidated Federal Laws of Canada, Consumer Packaging and Labelling Regulations.” Consumer Packaging and Labelling Regulations, 16 Nov. 2021, https://lois-laws.justice.gc.ca/eng/regulations/C.R.C.,_c._417/.

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Greens and Proteins – Food or NHP?

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

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

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

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

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

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

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

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

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

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

Classification Review:

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

Safe Foods for Canadians Regulations Note:

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

How can we help

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

30 Minutes Free Consultation
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FDA Issues Sodium Reduction Final Guidance

On October 13, 2021, the U.S. Food and Drug Administration (FDA) issued final guidance for the food industry that provides voluntary, short-term (2.5 years) sodium reduction targets for a broad range of processed, packaged, and prepared foods to help reduce the amount of sodium in the U.S. food supply.

It is widely known that humans require small amounts of sodium as part of the daily diet, however, consuming too much sodium can increase the risk of high blood pressure and heart disease. Most dietary sodium (over 70%) comes from eating packaged and prepared foods—not from table salt added to food when cooking or eating. The food supply contains too much sodium and Americans who want to consume less sodium can have a difficult time doing so. That is why the U.S. Food and Drug Administration is working with the food industry to make reasonable reductions in sodium across a wide variety of foods. 

The sodium reduction targets in the guidance are designed to support decreasing average daily sodium intake by about 12%—from approximately 3,400 milligrams (mg) to 3,000 mg per day. Hopefully, this reduction results in tens of thousands of fewer cases of heart disease and stroke and billions saved in healthcare costs. The FDA believes these targets are feasible to achieve in two and a half years and covers both manufactured foods and foods prepared by commercial establishments, such as restaurants.

sodium_proccess

The FDA has modified the voluntary sodium targets, timeframe, certain food categories, and descriptions in the final guidance. The guidance extends the milestone date for the short-term goals from 2 years in the draft guidance to 2.5 years from the publication of the final guidance.

The FDA is not finalizing the long-term (10-year) sodium reduction targets. The agency plans to continue its dialogue with the industry, monitor and evaluate progress in achieving the short-term targets, and expects to issue revised subsequent targets in a few years to facilitate a gradual, iterative process to reduce sodium intake. 

How we can help

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

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

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End of DEL transition period for Hand Sanitizers

In the wake of the COVID-19 pandemic, preventive measures and a healthy lifestyle with an efficient immune system were suggested by the World Health Organization (WHO) to fight and stay safe from COVID-19. Adaptation of effective hand hygiene is vital, as advised by WHO to wash or sanitize your hands frequently with soap or >60% alcoholic hand sanitiser, respectively. The recommendation is based on fast, effective, and broad-spectrum antimicrobial activity combined with easy availability and considered safe. It is therefore not surprising to see the demand for hand sanitiser go threw the roof immediately after the preventive declaration was made. 

In Canada, Health Canada responded with an interim and expedited licencing approach for the production of and distribution of alcohol-based hand sanitisers to facilitate increased access to safe and effective hand sanitizers. The interim measure simplifies the application process and prioritizes the review process for both site licenses (Drug Establishment Licence, DEL) and product licenses. 

Given the interim nature of the DEL issued under this interim measure, certain GMP requirements for natural health products (NHPs) were waived during this period. Specifically, stability testing was not required; a quality assurance report or other forms of evidence required as part of the standard process was not required; and for products containing more than 50% alcohol, finished product testing for microbiological contaminants was not required. Many other stringent GMP requirements for safety and efficacy were however retained to ensure the production of safe and effective hand sanitizers.

Consolidating on the interim order and as the demand for alcohol-based hand sanitizers stabilized, Health Canada through the Natural and Non-Prescription Health Products Directorate (NNHPD) announced in March 2021 the intention to bring an end to the Covid-19 interim order. Specifically, Health Canada set forth to end the temporary COVID-19 site licences (COVID-19 SL) for manufacturing, packaging, labelling and/or importing alcohol-based hand sanitizers on September 30, 2021. It therefore meant Health Canada was lifting flexibilities for drug establishment licences (DELs) under the Interim Order Respecting Drugs, Medical Devices and Foods for a Special Dietary Purpose in Relation to COVID-19. Furthermore, a DEL will now be required to conduct licensable activities for designated hand sanitizers (fabricate, package/label, test, import, or distribute) and a six-month transition period was provided to allow interim SL holders to apply for a valid DEL to continue producing hand sanitizer. Otherwise, an interim SL holder is required to stop manufacturing, importing, packaging, labelling, or distributing alcohol-based hand sanitizers.

Considering that the Drug Establishment Licence (DEL) transition period for designated hand sanitizers ended on September 1, 2021, companies that failed to apply for a DEL (or to amend a DEL) must cease all licensable activities related to designated hand sanitizers that were authorized under the Interim Order Respecting Drugs, Medical Devices and Foods for a Special Dietary Purpose in Relation to COVID-19. However, if you would like to continue manufacturing, importing, packaging, labelling, or distributing alcohol-based hand sanitizers, you need to apply for a new DEL and wait for approval to conduct these licensable activities. Contact Quality Smart Solutions for assistance!

References

Expedited access to disinfectants, hand sanitizers and personal protective equipment to help limit the spread of COVID-19, as well as swabs for testing https://healthycanadians.gc.ca/recall-alert-rappel-avis/hc-sc/2020/72623a-eng.php

Interim Order Respecting Drugs, Medical Devices and Foods for a Special Dietary Purpose in Relation to COVID-19. https://www.canada.ca/en/health-canada/services/drugs-health-products/compliance-enforcement/covid19-interim-order-drugs-medical-devices-special-foods.html

World Health Organization, 2020. WHO guidelines on hand hygiene in health care: first global patient safety challenge clean care is safer care. Geneva: the Organization [cited 2020 Apr 08]