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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 (Cannabis 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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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.

How We Can Help

Quality Smart Solutions offers regulatory services from registering your cosmetic products to reviewing your cosmetic labels. Our experts are here to help and offer any cosmetic-related regulatory advice!

30 Minutes Free Consultation
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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.

How We Can Help

QSS offers regulatory services for your animal food or drug products to make sure they are in compliance with the applicable regulations. Contact us today to learn more!

30 Minutes Free Consultation
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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!

How We Can Help

Our Experts at Quality Smart Solutions also offer to support your needs for 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!

30 Minutes Free Consultation
Source: www.canada.ca