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.
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!