Health Canada NNHPD Announces Consultation Period for Proposed Fees for Natural Health Products
By: Joanna Chudyk, M. Sc., Regulatory Affairs Specialist
On May 12, 2023, the NNHPD announced the beginning of a consultation period related to proposed fees for natural health products.
To participate in the consultation, visit this form on the Health Canada website. We encourage all natural health product industry stakeholders, as well as consumers, to participate.
To learn more about natural health products, current regulatory requirements and the proposed changes, continue reading.
Purpose
The purpose of the consultation period is to gather industry feedback about Health Canada’s proposal to introduce fees for natural health products. Health Canada requests feedback on the following topics:
- proposed fee structure and fee amounts
- proposed service standards and penalties for missed standards
- proposed mitigation measures, including small businesses
- proposed timeline for implementation (April 1, 2025)
- other concerns related to the fee proposal
Cost recovery will not only apply to initial registrations but an annual Right to Sell (RTS) fee of $542 will need to be paid in order to keep selling your product. Site licenses will also be charged an annual fee upwards of $20 000. These fees will have a significant impact on both small and large businesses; smaller companies will likely not be able to afford the registration and annual fees, and larger businesses will amass substantial fees to keep each NHP SKU registered.
A new NHP category has also been introduced – Class III Novel. Information on this classification is limited but it will have a detrimental impact on research and innovation in the supplement space.
Status
Health Canada is providing a 75-day consultation period. It opened on May 12 and will end on July 26, 2023. We encourage all businesses to voice their opinions as this will be the only consultation held for NHP Cost Recovery. Dell Tech is available to assist you in submitting your comments.
Next Steps
After the consultation has concluded, the proposal will be refined and then finalized. Then, a fee order will be published in the Canada Gazette, Part II. The goal is to have the fees implemented by in 2025, just months before the deadline for new labelling requirements, making it a very expensive year for all NPN holders.
Background: What is a Natural Health Product (NHP)?
Health Canada defines a Natural Health Product (NHP) as “naturally occurring substances that are used to restore or maintain good health”. This includes everything from self care products to homeopathic medicines. The full list is as follows:
vitamins and minerals
herbal remedies
homeopathic medicines
traditional medicines like Chinese and Ayurvedic (East Indian) medicines
probiotics
other products like amino acids and essential fatty acids
Natural Health Products Regulations
Natural health products are regulated by the Food and Drugs Act under the Natural Health Products Regulations. This oversight is intended to ensure the health and safety of Canadian consumers.
There are two main components for a natural health product to be compliant for sale in Canada:
- a product license, also known as a Natural Product Number (NPN)
- a site license
How Dell Tech Can Help with Natural Health Products
Dell Tech’s team of Health Canada regulatory consultants provide expert advice on NHP regulations. We work with companies large and small, from brand owners to wholesale distributors. Our services include assistance with the following topics:
- Formula Assessment
- NNHPD Monograph Evaluation
- Product Evaluation & Classification
- Label Review & Development
- Natural Product Number (NPN) Applications
- Site License Applications
- Quality Management System Support
- General Consulting on product claims
Sometimes, a single product can be registered in Canada in more than one way. One example is a shampoo, which may fall under Cosmetics or Natural Health Products, depending on the ingredients and claims. If you have a personal care product that you’re not sure how to register for sale in Canada, talk to our team today!
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