Information Sheet #5 for Consumers - Informing Yourself - Informing You About Natural Health Products - Health Canada

Protecting and promoting the health and safety of Canadians, their families and communities is of paramount importance to the Government of Canada. The Government is committed to ensuring that regulation of natural health products balances the protection of consumers' health and safety with the freedom to choose complementary and alternative products.

Questions and Answers

• What are natural health products?
• Why were the Natural Health Products Regulations adopted?
• How does Health Canada decide which natural health products will be authorized for sale?
• How can I tell which natural health products have been authorized for sale?
• How can I tell if a particular authorized natural health product is right for me?
• Is it safe to use a natural health product that does not have a Natural Product Number (NPN) or Homeopathic Medicine Number (DIN-HM) on the label?
• I've experienced an adverse reaction. How do I report it?

What are natural health products?

Natural health product (or NHP) is a term used in Canada to refer to a group of health products including: vitamin and mineral supplements, herbal remedies and other plant-based health products, traditional medicines (such as traditional Chinese medicines and Ayurvedic [East Indian] medicines), homeopathic medicines, fatty acids (such as omega 3, 6 and 9), probiotics and some personal care products such as antiperspirants, medicated shampoos and mouthwashes.

Why were the Natural Health Products Regulations adopted?

The Natural Health Products Regulations, which have been in force since January 1, 2004, were put in place after extensive public consultations to help assure that Canadians have access to NHPs that are safe, effective in delivering the health benefits claimed and of high quality. They do so by setting out requirements for the manufacture, packaging, labelling and importation of NHPs for sale in Canada. The Regulations have allowed for the sale in Canada of natural health products which otherwise could not receive market authorization under the Food and Drug Regulations that applied to these products prior to 2004. The Regulations outline requirements for detailed label information about NHPs because this was identified by consumers as an important element in helping them to make informed choices.

For further information on the regulation of NHPs see The Natural Health Products Regulations.

How does Health Canada decide which natural health products will be authorized for sale?

Health Canada assesses NHPs for their safety, efficacy and quality before they are authorized for sale in Canada. In assessing NHPs, Health Canada looks at the information provided by the applicant to determine whether the product formula is safe and the health benefit claims are reasonable for the proposed ingredients and dosage amounts. Health Canada assesses any risks which the product may pose, for example, when combining the NHP with other NHPs, prescription drugs or foods, or when the product is used by certain consumers such as pregnant or breast feeding women. Health Canada's assessment assures that appropriate warnings and cautions appear on the product label so that consumers can make informed choices. Health Canada also examines the practices and controls which are applied in the manufacture and processing of the NHPs to ensure that the products are of high quality (e.g. controls to prevent product contamination or a mistake involving use of an incorrect ingredient).

How can I tell which natural health products have been authorized for sale?

Canadians can identify NHPs that have been licensed for sale by Health 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 on a label means that the product has been authorized for sale in Canada and is safe and effective when used in accordance with the instructions on the label.

For further information on NHPs that have been authorized for sale in Canada see Licensed Natural Health Products Database (LNHPD).

How can I tell if a particular authorized natural health product is right for me?

Consumers are encouraged to read and follow the labels of NHPs as they contain useful information that can help them make safe and informed choices.

When an NHP is authorized for sale in Canada, the product must be labelled with key information in order for a consumer to make an informed choice about whether they should use the specific NHP. Information which must appear on the label along with the NPN or DIN-HM includes: the recommended dose amount to be taken and how (e.g. oral or topical); the health benefit of taking the product; a listing of the medicinal and non-medicinal ingredients; any cautions or warning statements about the use of the product (e.g. do not take in combination with certain other NHPs or particular prescription drugs, do not use if you have certain health conditions such as diabetes or heart disease or when pregnant or breast feeding) as well as any known adverse reactions.

Consumers who have further questions or concerns regarding the use of an NHP are encouraged to consult with a health professional such as a naturopathic doctor, a medical doctor, a pharmacist, a nurse, a dietician, etc. prior to using the product.

Is it safe to use a natural health product that does not have a Natural Product Number (NPN) or Homeopathic Medicine Number (DIN-HM) on the label?

The absence of a NPN or DIN-HM on the label means does not necessarily mean that the product is unsafe. It means that the product has not been licensed for sale and that Health Canada has not had the chance to assess the product's safety, quality or the validity of its health claims.

For assurance of safety and efficacy, Canadians who use NHPs as part of their health regime are encouraged to choose NHPs that have a NPN or DIN-HM on the label. A NPN or DIN-HM on a label means that the product has been authorized for sale in Canada and that Health Canada has verified that the product is safe and effective at delivering the health benefits claimed when used in accordance with the instructions on the label.

Prior to the adoption of the Natural Health Products Regulations, some products (e.g. vitamins and minerals) were assessed by Health Canada and issued a Drug Identification Number (DIN). Just like an NPN or a DIN-HM, a DIN on the label of an NHP means that the product has been authorized for sale in Canada and that Health Canada has verified that the product is safe and effective when used in accordance with the instructions on the label. The use of a DIN on natural health product labels is being phased out. However, some NHPs may still be found on store shelves with a DIN on the label and not an NPN or DIN-HM.

Over 25,000 NHPs have been assessed by Health Canada and licensed for sale. Others are currently under review by Health Canada.

I've experienced an adverse reaction. How do I report it?

Canadians are encouraged to report all adverse reactions directly to Health Canada. Canadians can report these reactions directly to Health Canada. When reporting a side effect, your pharmacist, doctor, naturopathic doctor, nurse or other health professional can provide information that will help you complete your report.

Reporting adverse reactions is important as doing so helps Health Canada identify rare or serious adverse reactions that were previously unknown, make changes in product safety information; issue public warnings and advisories, and/or remove unsafe products from the Canadian market.

For further information on adverse reaction reporting, see MedEffect™ Canada

For information regarding product advisories, warnings and recalls, see Advisories, Warnings and Recalls.