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Drugs and Health Products

Questions from Consumers - Regulation of Natural Health Products

The Natural Health Products Directorate (NHPD) has changed its name to the Natural and Non-prescription Health Products Directorate (NNHPD) subsequent to its recently expanded mandate to include the oversight of non-prescription and disinfectant drugs in addition to natural health products (NHPs). Please note that we are currently modifying documents to reflect this change.

Thank you for your patience and understanding.

  1. How do the Natural Health Products Regulations affect me?
  2. Do the Regulations restrict my access to natural health products?
  3. Have the Regulations increased the cost of natural health products?
  4. How will I know when a natural health product has been authorized for sale by Health Canada?
  5. I want to take (or am taking) Product XYZ. Is this product safe for me to use?
  6. Why are some products available in the United States and not in Canada?
  7. What is the process to import a natural health product for personal use into Canada?

Answers:

1. How do the Natural Health Products Regulations affect me?

The Natural Health Products Regulations give Canadians ready access to a wide range of natural health products (NHPs) that are safe, effective and of high quality.

Because of the Regulations, there is now more information on the label so you can make informed decisions. As well, because each product goes through regulatory approvals, you can be more confident in the safety and effectiveness of NHPs. The pre-market review of products will also assure that what is on the label is what is in the bottle, and that health claims are supported by proper evidence.

2. Do the Regulations restrict my access to natural health products?

No. The Regulations in fact increase your access to these products. Because of the Regulations, Canadian consumers have access to a wide variety of NHPs while having the assurance that the products on the market have been assessed for safety, quality and health claims.

3. Have the Regulations increased the cost of natural health products?

The Regulations aim to protect the health interests of consumers, but are also intended to be flexible enough for industry to develop useful, reasonably priced products.

During the development of the Regulations, Health Canada consulted with industry, assessed business impact and revised the Regulations to address industry concerns. Also, consumers indicated they were willing to pay more, as long as the products were of high quality, the government had approved a product licence, and there was improved labelling.

Health Canada has worked with industry throughout the implementation of the Regulations to make sure they are not overly burdensome and do not result in inappropriate expenses for manufacturers or consumers. Some innovations that have been introduced to help small and medium-sized businesses include: outcome-based good manufacturing practices (GMPs), a public education and outreach program, and development of templates that can be downloaded from the web.

4. How will I know when a natural health product has been authorized for sale by Health Canada?

You can identify products that have been authorized for sale in Canada by looking for the eight-digit Natural Product Number (NPN) or Homeopathic Medicine Number (DIN-HM) on the label. A NPN or DIN-HM means that the product can be legally sold in Canada and is safe and effective when used according the instructions on the label.

You can also search for licensed natural health products using Health Canada's Licensed Natural Health Products Database.

5. I want to take (or am taking) Product XYZ. Is this product safe for me to use?

If the product in question has a Natural Product Number (NPN) or Homeopathic Medicine Number (DIN-HM) on its label, it has been assessed for quality, safety and efficacy by Health Canada. The absence of one of these numbers on the label of the product means that Health Canada cannot provide such an assurance.

Please note that before taking any product, we recommend that you talk to a health care provider who is qualified and has experience with the use of these products.

6. Why are some products available in the United States and not in Canada?

There are many differences in how countries approach the regulation of health products. Canadian regulations are in place to ensure consumer safety. Manufacturers must get a product licence from Health Canada to sell their products in Canada. Health Canada assesses the product and if it deems it to be safe, effective and of high quality, will issue a licence.

In the United States, dietary supplements are considered to be food products under the Dietary Supplements Health Education Act, so claims may not be made about the use of a dietary supplement to diagnose, prevent, mitigate, treat or cure a specific disease. Also, these products are not subject to mandatory review, approval or quality requirements, and do not go through testing for identity, purity or potency of active ingredients. Therefore, they cannot be sold in Canada until they have gone through a proper assessment with Health Canada for safety and efficacy.

7. What is the process to import a natural health product for personal use into Canada?

You are encouraged to buy health products that have been authorized by Health Canada, as these products have been reviewed for safety and efficacy. You should also be sure to only buy health products from reputable or known suppliers/retailers.

If you choose to buy a health product from outside Canada (which may or may not have been reviewed and authorized by Health Canada), you should know that:

  • You are allowed to import a single course of treatment of a health product or a 90-day supply (based on the directions for use), whichever is less, as long as the product does not contain a substance listed in Schedule F of the Food and Drug Regulations.
  • The health product must be for your own personal use, the use of a person for whom you are responsible, or for use on an animal for which you are responsible.
  • The health product must meet one of the following conditions:
    • be in hospital- or pharmacy-dispensed packaging
    • be in original retail packaging
    • have the original label affixed to it which clearly indicates what the health product is and what it contains

For more information on NHP import rules, see Section 5.2 Importation for Personal Use of the Import and Export Policy for Health Products under the Food and Drug Act and its Regulations (POL-0060).

For More Information

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