HEALTH CANADA: NATURAL HEALTH PRODUCTS CORNER
The information in this section is extracted from Health Canada Natural Health Products Directorate website. The objective of this section is to provide our followers with complete, reliable and trustworthy information in order for people to make an informed choice before purchasing any product.

Natural Health Product Regulation in Canada
All natural health products (NHPs) sold in Canada are subject to the Natural Health Products Regulations, which came into force on January 1, 2004.
The Regulations help give Canadians access to a wide range of natural health products that are safe, effective and of high quality.
The Natural Health Products Regulations were created after many consultations with Canadian consumers, academics, health care practitioners and industry stakeholders. They address Canadians’ concerns about NHP availability and safety,
To be legally sold in Canada, all natural health products must have a product licence, and the Canadian sites that manufacture, package, label and import these products must have site licences.
To get product and site licences, specific labelling and packaging requirements must be met, good manufacturing practices must be followed, and proper safety and efficacy evidence must be provided.
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).

ABOUT THE REGULATIONS
Licensing Requirements
The licensing requirements of the Natural Health Products Regulations apply to any person or company that manufactures, packages, labels and/or imports NHPs for commercial sale in Canada. They do not apply to health care practitioners who compound products on an individual basis for their patients, or to retailers of NHPs.

Product licensing
All natural health products must have a product licence before they can be sold in Canada. To get a licence, applicants must give detailed information about the product to Health Canada, including: medicinal ingredients, source, dose, potency, non-medicinal ingredients and recommended use(s).
Once Health Canada has assessed a product and decided it is safe, effective and of high quality, it issues a product licence along with an eight-digit Natural Product Number (NPN) or Homeopathic Medicine Number (DIN-HM), which must appear on the label. This number lets you know that the product has been reviewed and approved by Health Canada.
You can search for licensed natural health products using Health Canada’s Licensed Natural Health Products Database.
The safety and efficacy of NHPs and their health claims must be supported by proper evidence so that consumers and Health Canada know the products are indeed safe and effective. Evidence may include clinical trial data or references to published studies, journals, pharmacopoeias and traditional resources. The type and amount of supporting evidence required depends on the proposed health claim of the product and its overall risks.

Labelling
All NHPs must meet specific labelling requirements, to help you make safe and informed choices about the NHPs you choose to use. Information required on NHP labels includes:

• product name
• product licence number
• quantity of product in the bottle
• complete list of medicinal and non-medicinal ingredients
• recommended use (including purpose or health claim, route of administration and dose)
• any cautionary statements, warnings, contra-indications and possible adverse reactions associated with the product
• any special storage conditions

Site licensing
All Canadian manufacturers, packagers, labellers, and importers of natural health products must have site licenses. To get a licence, sites must maintain proper distribution records, have proper procedures for product recalls and for the handling, storage and delivery of their products, and demonstrate that they meet good manufacturing practice requirements.

Good Manufacturing Practices
Good Manufacturing Practices make sure proper standards and practices for the testing, manufacture, storage, handling and distribution of natural health products are met.
Good Manufacturing Practices are meant to ensure safe and high quality products while giving manufacturers, packagers, labellers, importers and distributors the flexibility to implement quality systems appropriate for their product lines and businesses.

How do I report unwanted side effects?
The Natural Health Products Regulations require product licence holders to monitor all adverse reactions related to their product. License holders must report serious adverse reactions to Health Canada.
Canadian consumers should report unwanted side effects (adverse reactions) to their health care provider and to Health Canada directly.
Reporting side effects is important because it helps Health Canada identify rare or serious adverse reactions, make changes in product safety information, issue public warnings and advisories, and/or remove unsafe products from the Canadian market. 

What are natural health products?
Natural health products (NHPs) are naturally occurring substances that are used to restore or maintain good health. They are often made from plants, but can also be made from animals, microorganisms and marine sources. They come in a wide variety of forms like tablets, capsules, tinctures, solutions, creams, ointments and drops.
Natural health products, often called “complementary” or “alternative” medicines, include:

1. vitamins and minerals
2. herbal remedies
3. homeopathic medicines
4. traditional medicines like traditional Chinese and Ayurvedic (East Indian) medicines
5. probiotics
6. other products like amino acids and essential fatty acids

Fast fact: 71% of Canadians have used natural health products like vitamins and minerals, herbal products, and homeopathic medicines
NHPs are used and marketed for a number of health reasons, like the prevention or treatment of an illness or condition, the reduction of health risks, or the maintenance of good health. They must be safe to be used as over-the-counter products. Products needing a prescription are regulated as drugs.

Are there risks to using natural health products?
While natural health products are generally safe and have fewer side effects than medications, they are not risk free. Risks include:

1. Manufacturing problems (like contamination, incorrect ingredients or dosage)
2. Unproven claims, which can lead people to use the wrong products for serious conditions or to delay proper treatment
3. Not enough information for people to make an informed choice (like incorrect instructions or no warnings that a product may not be suitable for certain groups)
4. Interaction with prescription drugs or other natural health products
5. Unwanted side effects, like allergic reactions

Fast fact: 12% of Canadians who use natural health products report that they have experienced unwanted side effects (adverse reactions).

How can I use natural health products safely?
Take these steps to minimize your risk:

1. Talk to a health care professional like a doctor, pharmacist or naturopath before choosing a product. This is especially important for children, pregnant or breast-feeding women, seniors, and people with serious medical conditions.
2. To prevent interactions, make sure your health care provider knows what other drugs and natural health products you are using.
3. Use approved products. Look for NPN numbers that indicate that the product is licensed.
4. Be skeptical of health-related claims that seem too good to be true. Don’t rely on ads: do your own research and talk to your health care provider.
5. Read and follow all instructions on the product label.
6. Report unwanted side effects (adverse reactions) to your health care provider and Health Canada.

How do I know if a product has been authorized?
To be licensed in Canada, natural health products must be safe, effective, of high quality and carry detailed label information to let people make safe and informed choices.
You can identify products that have been licensed for sale in Canada by looking for the eight-digit Natural Product Number (NPN) on the label.
A NPN means that the product has been authorized for sale in Canada and is safe and effective when used according the instructions on the label and effective when used according the instructions on the label.
You can search for licensed natural health products using Health Canada’s Licensed Natural Health Products Database.

What is Health Canada doing to protect me?
Health Canada assures that all Canadians have ready access to a wide range of natural health products that are safe, effective and of high quality.
We assess all natural health products before letting them be sold in Canada. We also assure they are properly manufactured (without contamination or incorrect ingredients). And we do post-market monitoring to make sure that NHP Regulations are being followed.

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.