Questions from Consumers

Questions:

1. How do the Natural Health Products Regulations affect consumers?
   
   
2. Will the Regulations restrict people's access to natural health products (NHPs)?
   
   
3. How will consumers know when a natural health product has been authorized for sale by Health Canada?
   
   
4. What about costs? Will the Regulations increase the cost of natural health products (NHPs) for consumers?
   
   
5. I want to take or am taking Product XYZ. Is this product safe for me to take?
   
   
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 to Canada?

Answers:

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

The Natural Health Products Regulations will provide Canadians with ready access to a range of NHPs that are safe, effective, and of high quality, while respecting freedom of choice and philosophical and cultural diversity.

The consumer will benefit from having more information on the label to make informed decisions. As well, having the products go through regulatory approvals will increase consumer confidence in the safety and efficacy of NHPs. The pre-market review of products will assure consumers that what is on the label is what is in the bottle, and that health claims are supported by appropriate levels of evidence.

2. Will the Regulations restrict people's access to natural health products (NHPs)?

No. The Regulations should in fact increase access to these products. Moreover, once they are in effect, Canadian consumers will 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. How will consumers know when a natural health product has been authorized for sale by Health Canada?

Once assessed by Health Canada, the product label will bear an 8 digit product license number, preceded by the letters "NPN". The NPN on the label will inform consumers that the product has been reviewed by Health Canada for safety, quality and health claims. For homeopathic medicines, the label will bear the designation DIN-HM.

4. What about costs? Will the Regulations increase the cost of natural health products (NHPs) for consumers?

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

During the development of the Regulations, Health Canada consulted with industry, and performed a business impact test (BIT) to determine to what extent the industry would be impacted by the Regulations. As a result of the BIT, the Regulations (under development) were revised to address certain industry concerns; for example, the transition period for products with DINs has been extended to six years. Consumers have also indicated a willingness to pay more, provided that the products are of high quality; the government has approved a product licence; and there will be improved labelling.

Health Canada will continue to work with industry in the implementation of the Regulations, to ensure they are not overly burdensome and do not result in inappropriate expenses for the 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, development of templates that can be downloaded from the web, etc.

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

If the product in question bears a Drug Identification Number (DIN) or a Natural Product Number (NPN) or DIN-HM, it has been assessed for its 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 with therapeutic properties we recommend that you consult with 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?

The Canadian regulations are in place to ensure consumer safety. Manufacturers must obtain 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 Natural Product Number (NPN). There are many differences as to how jurisdictions approach the regulation of products.

In the United States, dietary supplements are considered as food products under the Dietary Supplements Health Education Act (DSHEA) and, as such, claims may not be made about the use of a dietary supplement to diagnose, prevent, mitigate, treat, or cure a specific disease. These products are not subject to mandatory review, approval or quality requirements, including appropriate testing for identity, purity or potency of active ingredients.

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

The Policy on Importations of Drugs for Human Use Including Natural Health Products Into Canada (POL-0019) is available from the Health Products and Food Branch Inspectorate.