ARCHIVED - Information Sheet #2 for Health Care Professionals - Helping You Inform Others - 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.

Pharmacists, medical and naturopathic doctors and other health care professionals, as authoritative and trustworthy sources of health information, play a key role in helping Canadians understand and use natural health products (NHPs) safely and effectively. This role is becoming increasingly important given that more and more Canadians are using NHPs as part of their personal health care regime.

Questions and Answers

• What are "natural health products?"
• Why were the Natural Health Products Regulations adopted?
• How does Health Canada decide which NHPs will be authorized for sale?
• How can I tell which natural health products have been authorized for sale in Canada?
• How can I tell if a particular authorized natural health product is right for me?
• Is it safe to use an NHP that does not have a NPN or 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, effectivein delivering the health benefits claimedand 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.

Further information on the regulation of NHPs, see the  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?

Natural health products that have been authorized for sale by Health Canada will bear a Natural Product Number (NPN) or Homeopathic Medicine Number (DIN-HM) on the product label. A NPN or DIN-HM on the label means that the product has been assessed by Health Canada and is considered safe, of high quality and does what it claims to do.

Further information on NHPs that have been authorized for sale in Canada is the Licensed Natural Health Products Database (LNHPD).

How can I tell if a particular 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 decisions.

The type of information found on the label of licensed NHPs includes: the recommended dose, route of administration, the recommended use (i.e. its health claim), a complete list of medicinal and non-medicinal ingredients, and any risks associated with the product's use, such as cautions, warnings, contra-indications and known adverse reactions. For instance, the label will let you know if the product should not be taken at the same time with certain NHPs, prescription drugs, or food. It will also let you know if the product should not be used by some individuals such as pregnant or breastfeeding women, or by those with certain health conditions, such as diabetes or heart problems.

Consumers who have further questions or concerns regarding the use of an NHP are encouraged to consult with a health care professional like 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 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.

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 a NPN or a DIN-HM, a DIN on the label of a 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 a 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.

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