Keeping up with constantly changing regulations is a challenge for any company selling natural health products (NHPs) in Canada.
Notably, recent changes to NHP labelling standards and the introduction of potential cost recovery measures have raised numerous questions and concerns within the industry.
Regarding labelling requirements, Health Canada released an extensive list of detailed amendments, primarily focused on 4 main themes:
- Product Facts Table labelling,
- The additional requirement to declare food allergens,
- Prominently displayed label text,
- Modernized contact information.
The requirements differ if you will be getting your product license prior to June 2025, though Health Canada encourages compliance as soon as possible.
Products authorized by Health Canada before June 21, 2025, will have until June 22, 2028, to comply with the new labelling requirements.
Products authorized by Health Canada on or after June 21, 2025, are expected to comply with the new labelling requirements immediately.
In addition to labelling updates, on May 12, 2023, Health Canada released a proposal for a cost-recovery fee structure, causing significant concerns within the Canadian natural health industry. Retailers, industry members, and consumers have voiced their worries about how this may affect the commercial availability and cost of NHPs.
The proposed fee structure is scheduled for implementation on April 1, 2025.
IN BRIEF, THE COST RECOVERY PLAN INCLUDES THREE FEE CATEGORIES:
1.
Pre-market evaluation (EVAL) fees, site licensing (SL) fees, and annual right to sell (RTS) fees. EVAL fees range from $1,124 to a staggering $58,332, depending on product complexity. SL fees range from $4,784 to $40,071, based on the licensed activity.
2.
Regulatory amendment fees range from $1,124 to $8,750 for product license applications and an estimated $4,784 for site licenses.
3.
Annual RTS fees have been proposed at $542 per SKU.
The implications for the Canadian natural health product industry are significant.
At the end of September, there was a brief session between the Standing Committee on Health (HESA) and the NNHPD (Natural and Non-Prescription Health Products Directorate), where the 45,000+ public responses to the consultation were discussed. During this meeting, Health Canada mentioned that there was a potential for a new plan and fee proposal to be released. The Canadian Health Food Association (CHFA) has also launched a “Save our Supplements” campaign, in an effort to support the industry.
CHFA ESTIMATES THAT:
• 76% of brands say there is a high/very high chance they will need to pull product from the market as a result of these regulations.
• 1 in 5 companies say they are seriously considering leaving the Canadian market. Exciting new products and international brands will likely not come to Canada because the regulatory burden will be too severe.
• 66% of companies said it would have a negative impact on employment.
SNI has been a dedicated service provider to this industry for nearly 20 years and we understand the global potential of the Canadian natural health product market.
We believe this proposed cost-recovery plan needs reconsideration by Health Canada.
If you have any questions or concerns about these proposed changes and their potential impact on your business, please don't hesitate to reach out to us. We will continue to actively monitor any new developments surrounding NHP cost recovery, and its potential impact on our client’s products.
