Thinking of selling hydration products in Canada? If your product makes a therapeutic claim, you may need a Natural Product Number, or NPN. Health Canada requires companies to license hydration supplements, such as electrolyte powders and tablets as Natural Health Products (NHPs) when these products make health-related claims.
However, not all hydration products fall into this category, as some may be regulated as supplemented foods instead.
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 most often in powder or tablet format. Many use ingredients like potassium or magnesium and make claims such as “helps to maintain/support normal electrolyte balance”.
Because these therapeutic claims are linked to a health benefit, Health Canada classifies hydration products as NHPs. This means they must follow specific regulations and require a Natural Product Number (NPN) before being sold legally. So, if you have a hydration mix product, your product could be a natural health product (NHP).
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 drink powders, for example, can also require licensing, depending on their ingredients and claims.
One common roadblock is the use of ingredients not found in Health Canada’s NHPID (Natural Health Products Ingredients Database). 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 and clinical evidence to support any non-monographed health claims.
- Scientific support or evidence showing the product is safe and effective.
- Product and ingredient testing.
- Description of how the product is taken and how often, and any risk information.
For hydration products, scientific literature or Health Canada monographs often support these claims. Additionally, the product label must be established in accordance with the Natural Health Product Regulations and 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 a single monograph, may take about 60 days. More complex Class II or III submissions can take anywhere from 90 to 210 days, or longer.
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 provide recommendations on your formula based on adjusting formulas to align with Health Canada monographs
- Prepare your NPN application and submits it on your behalf
- Handle communication with Health Canada, including clarifications
- Help design compliant bilingual product labels
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
What ingredients are most commonly used for hydration products?
Ingredients such as potassium and magnesium are often used, especially when they align with Health Canada’s monographs. Still, exact forms and dosages matter, so it’s important to check the Health Canada’s NHPID (Natural Health Products Ingredients Database).
How much does it cost to get an NPN?
Health Canada fees and professional services to prepare and manage your application vary depending on your formula’s complexity and application classification.
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.
Don’t let compliance slow you down
With the right partner, navigating the compliance process becomes much easier. By understanding Health Canada’s expectations and collaborating with experienced regulatory advisors, you can stay compliant and reach the market more quickly.
Need help applying for an NPN? Contact us or visit our NPN Application Services page to learn more about our services.
