Many foreign natural health product (NHP) companies are interested in entering the Canadian market but are discouraged by the regulatory burden associated with obtaining a Natural Product Number (NPN), obtaining a Natural Health Product Site Licence, and complying with Canada's comprehensive Natural Health Products Regulations.
An increasingly discussed business model involves selling products directly to Canadian consumers under Health Canada's personal importation policy. When structured properly, this model may allow Canadian consumers to legally import certain natural health products for their own personal use without the product requiring an NPN or the foreign manufacturer obtaining a Canadian site licence.
However, businesses should proceed with caution. Health Canada carefully distinguishes between genuine personal importation and commercial importation. If a business crosses that line, the shipment may be treated as an unlawful commercial import, exposing both the product and the business to enforcement action.
What Is Personal Importation?
Health Canada's guidance permits Canadian residents and visitors to import certain health products for their own personal use without the product being licensed in Canada.
Health Canada explains that personal use means the product is:
- for your own use;
- for the use of a person or animal under your care; or
- for the use of a person or animal travelling with you.
Health Canada's Personal Use Importation Guidance can be found here:
For natural health products, personal importation generally permits a quantity of no more than a 90-day supply (or one course of treatment, whichever is less), based on the product's directions for use.
Why Foreign NHP Companies Are Interested in This Model
For companies located outside Canada, direct-to-consumer sales through personal importation may avoid some of the regulatory requirements applicable to commercial imports.
Where properly structured, the model may avoid the need for:
- a Canadian Natural Product Number (NPN);
- a Canadian Natural Health Product Site Licence;
- Canadian importer licensing requirements; and
- certain commercial import requirements.
However, this pathway only works where the facts genuinely support personal importation.
Businesses cannot simply label commercial shipments as “personal use.”
The Company Must Generally Remain Outside Canada
One of the most important considerations is that the seller should generally operate from outside Canada.
Typically this means:
- the company is incorporated outside Canada;
- inventory is stored outside Canada;
- shipments originate outside Canada;
- orders are fulfilled from outside Canada; and
- products are shipped directly to the Canadian consumer.
Using Canadian warehouses, Canadian fulfillment centres, or Canadian inventory may significantly increase the likelihood that Health Canada considers the activity to be commercial importation.
The Shipment Must Be for an Individual Consumer
Health Canada's policy focuses on products imported by individuals for their own personal use.
Accordingly, shipments should generally:
- be addressed to an individual consumer;
- be ordered by that consumer;
- contain no more than a 90-day supply;
- be intended solely for that consumer's own use.
Importation of larger quantities may be viewed as commercial importation.
No Advertising or Promotional Materials Should Accompany the Shipment
One of the most overlooked aspects of Health Canada's commercial importation guidance is that a shipment accompanied by advertising or promotional materials may itself be considered a commercial import.
Health Canada's Commercial Importation Guidance specifically identifies shipments accompanied by materials used for advertising or promotion as potentially commercial imports.
The guidance is available here:
Businesses should therefore avoid including:
- brochures;
- catalogues;
- promotional inserts;
- coupons;
- discount cards;
- marketing flyers;
- sales literature; or
- similar promotional materials
inside shipments intended to qualify as personal importation.
The 90-Day Supply Rule Is Important
Health Canada generally considers a personal import to consist of no more than a 90-day supply (or one course of treatment, whichever is less).
If a shipment exceeds that quantity, Health Canada may determine that it is commercial rather than personal.
Similarly, repeated shipments to the same individual may become problematic.
Health Canada specifically states that multiple shipments received within a 90-day period whose combined quantity exceeds a 90-day supply may be treated as commercial importation.
Businesses should therefore monitor shipment frequency and quantities carefully.
Commercial Importation Is Broadly Defined
Health Canada's commercial importation guidance illustrates how easily activities may become commercial imports.
Examples include shipments destined for:
- retailers;
- distributors;
- healthcare professionals;
- independent sales contractors;
- persons intending to export the products;
- persons intending to resell or give away products;
- shipments containing promotional materials; or
- shipments exceeding personal use quantities.
Importantly, Health Canada notes that its list is not exhaustive, and other factors may also be considered.
This means businesses should avoid relying on any single factor when assessing compliance.
Consolidated Shipments May Still Be Permitted
Health Canada recognizes that foreign businesses may consolidate multiple individual personal shipments into a single courier shipment.
This may be acceptable where:
- each shipment belongs to a different consumer;
- each shipment is separately packaged;
- each shipment contains its own invoice;
- each shipment independently qualifies as personal importation.
However, Health Canada also considers additional factors, including who is arranging orders, distribution, and shipment.
Simply consolidating shipments does not automatically prevent them from being treated as commercial imports.
Canadian Marketing May Create Additional Risk
Companies using the personal importation pathway should carefully consider how they market products to Canadians.
Although Health Canada's guidance primarily discusses promotional materials accompanying shipments, businesses should also consider broader regulatory issues involving:
- targeted Canadian advertising;
- Canadian influencers;
- Canadian affiliates;
- Canadian sales representatives;
- Canadian distributors; and
- Canadian fulfillment arrangements.
Depending on the facts, these activities may contribute to an overall conclusion that the business is effectively operating commercially within Canada.
This Is Not a Loophole
The personal importation policy was designed to allow individuals to obtain health products for their own use.
It was not designed to facilitate large-scale commercial sales into Canada.
Businesses attempting to structure around Canadian licensing requirements should carefully evaluate whether their proposed model genuinely fits within Health Canada's published guidance.
Where the facts indicate commercial importation, the product may require:
- a Natural Product Number (NPN);
- a Natural Health Product Site Licence;
- compliant Canadian labelling;
- authorized importation; and
- compliance with the Food and Drugs Act and Natural Health Products Regulations.
Advantages of a Properly Structured Personal Importation Model
Where appropriate, personal importation may offer several commercial advantages.
Potential benefits include:
- avoiding the cost of obtaining an NPN;
- avoiding Canadian site licensing;
- faster market entry;
- testing Canadian demand before pursuing full market authorization;
- reduced regulatory overhead.
However, these benefits only exist where the model genuinely satisfies Health Canada's personal importation guidance.
Legal Advice Is Strongly Recommended
Determining whether a business model qualifies as personal importation is highly fact-specific.
Issues that frequently require legal analysis include:
- shipping arrangements;
- inventory location;
- Canadian marketing;
- order fulfilment;
- customer relationships;
- payment flows;
- shipment quantities;
- repeat orders; and
- corporate structure.
Small operational differences may significantly affect whether Health Canada considers shipments personal or commercial.
How Substance Law Can Help
Substance Law advises Canadian and international businesses on Natural Health Product compliance, importation strategies, product classification, licensing requirements, regulatory enforcement, and Health Canada compliance.
We assist businesses in evaluating whether proposed cross-border sales models align with Health Canada's published guidance and help companies determine when full Canadian licensing may be required.
Frequently Asked Questions About Personal Importation of Natural Health Products
Can Canadians import natural health products for personal use?
Yes. Health Canada generally permits individuals to import certain natural health products for their own personal use, subject to its published guidance.
Can a foreign company sell natural health products directly to Canadians?
Potentially. Depending on how the business operates, a foreign company may be able to sell products that Canadian consumers personally import. However, businesses must carefully avoid creating a commercial importation model.
Does a personal import require an NPN?
Generally, products imported by an individual under Health Canada's personal importation policy do not require a Canadian Natural Product Number.
Does a foreign company need a Canadian Site Licence?
Not necessarily. Where products are genuinely imported by individuals under the personal importation policy, Canadian site licensing requirements may not apply. However, businesses should obtain legal advice before relying on this pathway.
Can promotional brochures be included in shipments?
Generally, they should not. Health Canada's commercial importation guidance specifically identifies shipments accompanied by advertising or promotional materials as a factor indicating commercial importation.
How much product can be imported?
Health Canada generally considers a personal use quantity to be no more than a 90-day supply or one course of treatment, whichever is less.
Can multiple shipments be sent to the same customer?
Repeated shipments whose combined quantity exceeds a 90-day supply over a 90-day period may be treated by Health Canada as commercial importation.
Is personal importation a way to avoid Canadian regulation?
No. Personal importation is a specific policy intended for genuine personal use. Businesses should not assume it provides a blanket exemption from Canadian health product regulation. Whether a business model qualifies depends on the specific facts.
