Thinking of selling hydration products in Canada? If so, there’s one important thing you’ll need first: a Natural Product Number, or NPN. Health Canada requires companies to license hydration supplements, such as electrolyte powders, tablets, and drink mixes, as Natural Health Products (NHPs). No NPN, no legal sales.
Not sure where to begin? You’re not alone. The process of getting an NPN can seem complicated. What ingredients are allowed? What documents do you need to demonstrate that your product is effective and safe? How do you even submit an application? The good news is that once you understand the steps, it becomes much more manageable. So, let’s walk through it together.
What are hydration products, and why are they regulated?
Hydration products help restore fluids, electrolytes, and nutrients lost through physical activity, heat, or dehydration. You’ll find them as powders, tablets, rehydration solutions, or even enhanced beverages. Many use ingredients like sodium, potassium, magnesium, or glucose and make claims such as “supports hydration” or “helps replenish electrolytes.”
These claims relate to health benefits, so Health Canada places hydration products in the NHPs category. This means they must follow specific regulations and require a Natural Product Number (NPN) before being sold legally. Therefore, if you mention benefits like faster recovery or fluid balance, your product likely falls into this category.
What is an NPN, and why do hydration products need one?
An NPN is an eight-digit number issued by Health Canada to show that a Natural Health Product meets safety, quality, and effectiveness standards. In other words, it confirms your product has gone through a proper review process.
When your hydration product promotes electrolyte balance, fluid replenishment, or recovery, it crosses into the territory of regulated health claims. That’s why you need to go through the NPN application process, even if your product looks like a simple drink mix.
Common roadblocks to approval
Some businesses assume NPNs are only required for capsules or pills. However, that’s not the case. Products marketed as beverages or wellness solutions can also require licensing, depending on their ingredients and claims.
One common roadblock is the use of ingredients not found in Health Canada’s Licensed Natural Health Products Database (LNHPD). Even if the ingredient is common, if it exceeds permitted dosages or uses an unapproved form, your application could be delayed or rejected.
What is required for a successful NPN application?
To obtain approval, you must prepare thorough product documentation. This includes:
- Full formulation details with ingredient source and dosage
- Specific health claims you plan to make
- Scientific support or evidence showing the product is safe and effective
- Description of how the product is taken and how often
For hydration products, scientific literature or Health Canada monographs often support these claims. Additionally, the product label must follow formatting and content guidelines, including bilingual requirements.
How to submit your application to Health Canada
Once you’ve gathered all your documentation, you’ll submit your application through the Natural and Non-prescription Health Products Directorate (NNHPD) portal. Health Canada will then review the file, assess the information provided, and issue a decision.
If your submission meets all requirements, you’ll get your NPN. But if there are issues or missing details, they’ll request clarification or reject the file. This is why having a complete, accurate application is so important.
How long does it take to get an NPN?
Processing times depend on the application class. Class I applications, which follow existing monographs closely, may take about 60 days. More complex Class II or III submissions can take anywhere from 90 to 210 days.
To stay updated, you can check current timelines on the Health Canada NHP application page.
How we help you get your NPN faster
At Quality Smart Solutions, we help clients bring hydration and wellness products to market in Canada, quickly and compliantly. Our regulatory team can:
- Review and optimize your formula based on the latest monograph requirements
- Prepare and submit a complete NPN application package
- Handle Health Canada questions and post-submission responses
- Assist with bilingual label design that meets regulatory requirements
We know the process inside and out. That’s why, whether you’re launching your first hydration product or expanding your line, we’ll guide you through every step to avoid delays.
Frequently asked questions
Can I sell hydration products in Canada without an NPN?
No, you can’t legally sell hydration products in Canada without an NPN if they make any health-related claims. Health Canada requires products like electrolyte drinks or powders to be licensed as Natural Health Products.
What ingredients are most commonly accepted for hydration products?
Ingredients such as sodium, potassium, magnesium, calcium, and glucose are often accepted, especially when they align with Health Canada’s monographs. Still, exact forms and dosages matter, so it’s important to check the Licensed Natural Health Products Database (LNHPD).
Do flavoured waters or sports drinks need an NPN?
It depends on how they’re marketed. If the label or advertising suggests a health benefit like “boosts hydration” or “replenishes electrolytes,” then yes, an NPN is required.
How much does it cost to get an NPN?
Health Canada doesn’t charge a submission fee, but professional services to prepare and manage your application may vary depending on your formula’s complexity.
Can I use clinical studies from other countries to support my claims?
Sometimes. International studies can be used, but they must meet Health Canada’s evidence requirements. Our team can help you determine what data is acceptable.
