Health Canada is Considering a New Regulatory Pathway for CBD Products in 2025
Health Canada is about to make a groundbreaking move with its Discussion Paper Towards a Pathway for Health Products Containing Cannabidiol. This proposal outlines a new regulatory framework that could allow consumers access to CBD products without a prescription. So, what lies ahead for products with CBD in Canada? Will the government soon tag them as Natural Health Products (NHPs)? And will cannabis businesses be ready to adapt to the shift? Read on to find out!
Key Takeaways
- Health Canada is proposing a new regulatory framework that may allow CBD products to be sold without a prescription.
- CBD products could fall under the Natural Health Products (NHP) category, pending public and industry feedback.
- Pre-market approval and strong scientific evidence will be required for all CBD health products.
- Proposed rules include strict labeling, GMP site licensing, and THC limits of no more than 0.001%.
- The consultation is open until June 5, 2025, and Health Canada is encouraging stakeholder input.
Regulatory Timeline For CBD Products In Canada
Since 2018, CBD-containing products that are not sold through the cannabis framework are treated as prescription drugs under the Food and Drugs Act, alongside antidepressants, antibiotics, and opiate painkillers. Under the Cannabis Act, Canada legalized recreational and medical cannabis, including CBD. However, it prohibits the sale of OTC products containing CBD in health stores or pharmacies.
Only licensed producers and authorized retail or medical dispensaries may conduct cannabis activities (including manufacturing, distributing, and selling CBD products). The initial recreational market offered oils and flowers; edibles, topicals, and extracts followed a year later.
In 2020, consumers and industry stakeholders expressed their interest in the reclassification of CBD products to NHPs. The Food and Drugs Act (FDA) regulates NHPs, or Natural Health Products, a category of products for health-related purposes. Talks about CBD being considered as an ingredient for NHPs eventually began.
Health Canada began looking into a possible regulatory approach in March 2025, wherein CBD products could be accessible to Canadians by prescription. They are inviting stakeholders and consumers to take part in the discussion process by sharing feedback until June 5, 2025.
Are CBD Products Canada’s Next Natural Health Products?
The main reason for CBD’s potential reclassification to NHP is its safe and nonpsychoactive nature, as verified by the Scientific Advisory Committee. As independent policy advisors for Health Canada, the Committee plays a crucial role in providing scientific and clinical advice. Their findings help in establishing clear-cut rules for cannabis product retail without practitioner oversight.
In 2021, the Committee agreed that CBD (and other non-intoxicating phytocannabinoids) may be appropriate for self-care as long as there is sufficient evidence of their efficacy, safety, and quality. The following year, the Committee published a detailed report on Health Products Containing Cannabis. They notably concluded that for humans:
CBD is safe and tolerable for short-term use (a maximum of 30 days) at doses from 20 to 200 mg/day through oral administration.
CBD products must include an advisory on the label stating CBD’s:
- Potential with other drugs, alcohol, and other compounds.
- Contraindication for people who are pregnant, lactating, or with allergies.
- Reported side effects even at a low dose.
- Suggested dosage and instructions for use.
- CBD is not habit-forming.
New Rules, New Opportunities: Who Benefits?
While CBD remains one of the most popular cannabis products, sales have slowed and reached a plateau since 2022. The latest forecast from Statista projects a 1.87% decline in CBD product revenues from 2025 to 2029. That being said, the looming regulatory change can be crucial to reversing the trend. Health Canada’s new regulatory pathway will be advantageous to stakeholders and the general public in a multitude of ways.
- Consumers can have non-prescription access to natural health products containing CBD (NHPCC).
- Manufacturers can expect a more streamlined approval process for products, therefore shortening the time it takes for a product to hit the market.
- Researchers won’t need to undergo special protocols to obtain CBD for research.
- The shift to non-prescription status also normalizes its presence in the health and wellness space, which can likely increase public awareness.
What Canada’s Proposed Rules Could Mean For The CBD Market
Currently, only pharmacies and licensed cannabis retailers can sell products with CBD. The new rules that would allow CBD products to be classified as NHPs could permit the sale of CBD products by other businesses. Here are some key points from what Health Canada is proposing:
- All CBD products need to secure pre-market approval before running advertisements and/or hitting the shelves. This will mostly entail safety and efficacy testing.
- Health Canada requires solid scientific evidence pertaining to health claims linked to a CBD product. In some cases, confirmatory (phase 3) trials may be needed, depending on what health claims are being made.
- CBD products must comply with all NHP regulations concerning licensing, labeling, and packaging.
- Licensed producers need to provide a Certificate of Analysis for CBD as a raw material before being manufactured for NHPCC.
- THC levels will still not exceed 10 milligrams per kilogram or 0.001% of the formula.
- Veterinary products with CBD may also be non-prescription. However, the proposed rules limit sales to veterinary clinics to ensure veterinarian oversight.
Site-Specific Licensing Considerations
In the proposed rules, manufacturers handling NHPCCs must secure NHP site licenses and follow good manufacturing practices (GMP) standards. Meanwhile, licensed cultivators must continue to meet the production practices set in the Cannabis Regulations.
Health Canada is exploring specific regulations for transporting CBD between licensed cannabis producers and NHP site license holders. They are also considering allowing a single site to hold multiple CBD licenses if they’re manufacturing CBD products. This approach can likely reduce the risk of unauthorized use, ensuring that raw cannabis intended for NHP products remains secure.
How Do These Changes Affect Your Cannabis Business?
Health Canada’s proposed pathway for CBD products represents a significant shift in how cannabis businesses may operate and expand. If adopted, the changes will open up a new market segment outside the current cannabis framework, giving businesses the opportunity to enter the Natural Health Product (NHP) space.
This transition could allow licensed producers and manufacturers to develop CBD products aimed at the wellness and self-care market, reaching consumers through pharmacies, health food stores, and other non-cannabis retail channels. However, it also introduces new compliance requirements, such as site licensing under NHP regulations, rigorous product testing, and pre-market review processes that businesses need to be ready for.
Now is the time to assess how current operations, product formulations, and manufacturing practices align with NHP standards. Preparing early will be key to gaining a first-mover advantage in a redefined CBD marketplace.
How CannDelta Can Help
If you’re thinking about getting ahead of the changes to CBD regulations, CannDelta is here to help. We work with cannabis and health product businesses across Canada to navigate complex regulatory environments and get products to market faster.
Our team includes former Health Canada regulators and industry professionals who understand both the cannabis space and the Natural Health Product (NHP) framework. We’ll help you figure out what these proposed changes mean for your business and guide you through every step, from product assessments and evidence preparation to NHP site licensing and pre-market submissions.
Frequently Asked Questions
How Can I give Feedback on Health Canada's Proposed CBD Regulations?
You can submit feedback to Health Canada through the online feedback form or by emailing nnhpd.consultation-dpsnso@hc-sc.gc.ca. Make sure you have read the discussion paper, Towards a Pathway for Health Products Containing Cannabidiol. The questions at the end of the paper shall help you apply the information to your cannabis business and identify potential challenges and opportunities.
Will the New Regulations Allow Companies to Make Health Claims about CBD Products?
CBD product health claims will be permitted only when supported by sufficient evidence and approved by Health Canada as part of the pre-market review. Although the proposal removes the prescription requirement for CBD products, its proposed reclassification, Natural Health Products (NHPs), are still subject to strict labeling regulations. Health Canada requires manufacturers to supply adequate evidence that can provide evidence of safety and efficacy before any health claims or any retail operations.
