If you hold a Natural Product Number (NPN) for a product containing vitamin B6 at a daily dose of 10 mg or higher, Health Canada has issued new requirements that affect your licence and action is required.
Health Canada’s Marketed Health Products Directorate (MHPD) has completed a Summary Safety Review (SSR) identifying a possible link between vitamin B6-containing natural health products (NHPs) and peripheral neuropathy, a type of nerve damage that can cause numbness, tingling, or pain in the hands and feet. As a result, the Multi-vitamin/Mineral Supplements monograph is being updated, and affected licence holders are expected to follow suit.
What Prompted the Review?
Health Canada’s review was triggered by an accumulation of international evidence, including a scientific study reporting cases of peripheral neuropathy in people using vitamin B6 products at daily doses well below the historically flagged threshold of 250 mg. Regulatory agencies in Australia (TGA), the Netherlands (Lareb), and the European Union (EFSA) had already flagged the issue and taken action in their own markets.
Health Canada reviewed 17 cases of peripheral neuropathy, 14 of which involved vitamin B6-containing NHPs, as well as nine published scientific studies linking the risk to doses as low as 10 mg per day. While the evidence stops short of a definitive causal link, Health Canada concluded the risk was sufficient to warrant updated label warnings across the board.
What the Monograph Update Requires
The updated monograph will require the following caution to appear on the label of any NHP providing 10 mg of vitamin B6 or more per day:
“Stop use of vitamin B6 containing product(s) and ask a health care practitioner if you develop symptoms of sensory nerve problems, such as numbness, tingling, or pain in the extremities.”
Under the NHP Management of Applications Policy (NHP MAP), licence holders who have attested to the relevant monograph are expected to align their product labels with this update within three years of monograph publication, at the next label run, or at the next post-licensing change, whichever comes first.
This Applies Even If You Didn’t Attest to the Monograph
This is an important point worth calling out directly. Health Canada has made clear that this requirement extends beyond those who attested to the Multi-vitamin/Mineral Supplements monograph. Due to the nature of the safety concern identified, all affected licence holders, including those with Class III applications who did not attest to any monograph, are expected to include this caution language on their product labels.
This is not a situation where a technicality in your application pathway exempts you from the change. If your product contains vitamin B6 at 10 mg/day or higher, the expectation applies to you.
What Are Your Options?
There are two paths forward for affected licence holders:
- Amend your licence. Submit a post-licensing amendment to update your label with the required caution language. This keeps your NPN active and your product on the market under the new requirements.
- Discontinue the licence. If you no longer wish to maintain the NPN under the updated requirements, you can submit a Discontinuation Request Form to Health Canada. This is a legitimate option if the product is no longer commercially active or if you prefer to exit the market for that SKU.
There is no option to simply do nothing. Health Canada has indicated this is a safety-driven expectation, and leaving affected licences unchanged is not consistent with the regulatory obligations of a licence holder.
How Dell Tech Can Help
At Dell Tech, we work with NHP licence holders across Canada to manage exactly this type of post-licensing change. Whether you need to prepare and submit label amendments for one product or across an entire portfolio, or whether you’ve decided discontinuation is the right call and need help filing the paperwork, our regulatory team can handle it.
If you’ve received Health Canada’s notice and aren’t sure what it means for your specific products, reach out. We’re happy to take a look and help you figure out the right path forward.
