Canadian Natural Health Product Services

What regulations are involved?

In Canada, natural health products (NHP) are regulated under the Food and Drugs Act and subsequent Natural Health Product Regulations (NHPR), which control the sale, manufacture, packaging, labelling, importation, distribution, and storage of these products.

These regulations were in force in 2004 to maintain a standard of quality for NHPs (eg ingredient purity and good manufacturing practices), and to provide standardized information to the user regarding the purpose of the product, the proper dosage and administration, and precautionary information regarding any potential side effects or risks of using the NHP.

Which type of products would this regulation apply to?

Natural health products are made from naturally occurring substances (usually plants, but are sometimes also sourced from marine life, animals, or microorganisms) and are sold over-the-counter for the restoration or maintenance of good health. They include products like vitamin/mineral supplements, probiotics, and herbal remedies, as well as many personal care items like oral care pastes and rinses, antiperspirants, and shampoos.

NHPs are regulated under the Natural Health Product Regulations if they meet the following criteria:

  1. The product contains medicinal ingredients (as specified by the regulations), is a mixture containing medicinal ingredients (as specified by the regulations), or is a traditional or homeopathic medicine.
  2. Is sold, manufactured, or represented for use in the diagnosis, treatment, mitigation, or prevention of symptoms and ailments in humans; or restoring/correcting/modifying organic functions in humans.

Products that require a prescription do not fall under the jurisdiction of the NHPR and are instead regulated as drugs.

Is this regulation mandatory?

Any person wishing to sell an NHP in Canada must obtain a company site license, a product license and a product number (either a natural product number (NPN) or homeopathic medicine number (DIN-HM)) from Health Canada to verify that the product meets safety and efficacy standards. NHPs cannot be legally sold in Canada without prior approval from Health Canada, so to expedite the application process and ease the information burden on the applicant, the Natural and Non-prescription Health Products Directorate has compiled a list of Monographs (which contain pre-cleared information regarding quality, safety, or efficacy of a medicinal ingredient) that can be referenced in the application.

What are the risks if a company chooses not to comply?

Failure to comply with the Natural Health Product Regulations could result in the consumer acting on poor or incomplete information, which could then lead to unwanted side effects, potentially dangerous interactions with prescription drugs or other NHPs, or a further decline in health if the consumer delays proper treatment or uses the wrong product for a serious condition. This in turn could incur legal expenses for the manufacturer or importer from consumers seeking compensation for damages, plus any expenses incurred from orders issued from Health Canada for non-compliance.

Inspections for non-compliance under the NHPR aim to identify the responsible party at the highest level of the supply chain, which is usually the manufacturer or importer. For example, a retailer who directly imports the product for sale is considered the Canadian importer, but if the retailer is further down the supply chain, they may be obligated to provide the inspector with the contact information of their supplier. The penalties for non-compliance are determined on a case-by-case basis depending on the area of non-compliance, but may include stop-sale orders, product recalls, issuance of public communication or communication with other regulatory agencies, and/or import refusals at the border.

How Can Nexreg Ensure Your Compliance?

Whether you are planning to register a new or Monographed NHP, Nexreg and our partners can support you throughout the NHP license application process to Health Canada.

To start, we will need the following information to review and determine the appropriate application path:

  1. Your full product formulation, specifically the active ingredients that make the product effective;
  2. The product’s physical and efficacy data (if available);
  3. The intended use and any other claims being made for this product;
  4. Directions for use; and
  5. Label dimensions and/or draft artwork

From there, we can confirm if the product meets the definition of a Monograph, if you require additional efficacy test data for registration, assist in organizing your data for submission or filling out the required paperwork, and answer any questions you may have during the application.

If you wish to submit the registration yourself but just need some general guidance, then we can also provide an NHP Registration Memo containing the basic regulatory requirements for your product in addition to the final product registration.

Lastly, we can provide guidance for your product labelling in accordance with Health Canada guidelines in a label review memo and review your product artwork for the proper label elements prior to and after Health Canada’s evaluation.