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Drugs and Health Products

General Questions ľ Regulation of Natural Health Products

Questions:

  1. Why are regulations needed for natural health products?
  2. Natural health products are regulated as a subset of drugs under the Food and Drugs Act. Why doesn’t Health Canada regulate NHPs as a distinct category separate from both food and drugs?
  3. How have the Natural Health Products Regulations been implemented?
  4. What happens to non-compliant natural health products on the Canadian market?
  5. What types of natural health products are affected by the Natural Health Products Regulations?
  6. Why will homeopathic medicines have a DIN-HM on their label, while other natural health products will have a NPN?
  7. Why are vitamins and minerals regulated as a sub-set of drugs?

Answers:

1. Why are regulations needed for natural health products?

Before January 1st, 2004, natural health products (NHPs) were sold as either drugs or food under the Food and Drugs Act and Regulations because there was no other category under which to classify them.

If classified as a drug, natural health products must follow the drug review process (including proving safety and efficacy through clinical trials) and have a Drug Identification Number (DIN) to be sold. If classified as a food, natural health products can make only very limited health claims and do not have to provide much safety information on their labels.

As more and more Canadians began to use NHPs, it became obvious that neither classification (as either a drug or food) was appropriate, and that a new policy which would directly address the unique nature of NHPs was needed. The Natural Health Products Regulations were developed to address this need.

2. Natural health products are regulated as a subset of drugs under the Food and Drugs Act. Why doesn’t Health Canada regulate NHPs as a distinct category separate from both food and drugs?

Under the Food and Drugs Act, NHPs must be classified as either a food or a drug since there is no other category in which to classify them. Because NHPs are taken for therapeutic reasons and not for caloric purposes or to address hunger, they are more similar to drugs than food.

Under the current Food and Drug Regulations, foods can make only limited diet-related or nutritional content claims (and not treatment claims, for example). Also, the current regulations do not include a complete good manufacturing practices framework which is needed to ensure the quality and safety of NHPs. Finally, foods are generally not subject to pre-market review and assessment by Health Canada before they can be sold.

During consultations on NHPs, Canadians consistently asked for controls to make sure what is on the label is in the bottle and ensure a pre-market assessment of health claims. While creating another category distinct from both food and drugs was considered, an amendment at the level of the Act would have been necessary. Because the timelines and legislative process needed for a change of this magnitude would be long, it was decided that natural health products would be considered drugs under the Act, but with a set of regulations specific to NHPs.

Health Canada is currently conducting a comprehensive review of its health protection legislation to replace outdated statutes with a new health protection legislative regime. The objectives of the legislative review are to strengthen and modernize the legislation, and to provide policy direction in the area of health protection. The creation of additional categories for certain classes of health or therapeutic products may be considered as a part of this process.

3. How have the Natural Health Products Regulations been implemented?

The Natural Health Products Regulations came into force January 1, 2004. They were implemented using a staged approach over the course of six years, from January 2004 to January 2010.

Today, all manufacturers, importers, packagers and labellers of NHPs use good manufacturing practices (GMPs) and have site licences. All NHPs that used to have a Drug Identification Number (DIN) now have either a Natural Product Number (NPN) or a Homeopathic Medicine Number (DIN-HM). Many new and existing NHPs were assessed and granted product licenses. Over 20,000 NHPs now have product licenses, and many more continue to be evaluated.

Because Health Canada has not yet evaluated all natural health products currently on the market, products with exemption numbers can also legally be sold in Canada. The exemption number will be listed on the product label in the form EN-XXXXXX.

These products have not been fully evaluated by Health Canada, but have gone through an initial assessment to make sure that information supporting their safety, quality and efficacy has been provided, and that specific safety criteria have been met. This will allow Canadians access to the full range of NHPs they are used to while Health Canada continues to fully assess each product.

4. What happens to non-compliant NHPs on the Canadian market?

Health Canada's compliance approach is to focus on the highest risk NHPs and to take action against those NHPs for which product licence applications have not been received. For more on the compliance approach for NHPs, please see the Compliance Policy for Natural Health Products.

5. What types of natural health products are affected by the Natural Health Products Regulations

Natural health products (NHPs) are defined in the Regulations as vitamins and minerals, herbal remedies, homeopathic medicines, traditional medicines (like Traditional Chinese Medicines), probiotics, and other products like amino acids and essential fatty acids.

Under the Regulations, a natural health product must be safe to be used as an over-the-counter product. Natural health products are available for self care and self selection, and do not require a prescription to be sold. Products requiring a prescription will continue to be regulated under the Food and Drug Regulations.

6. Why will homeopathic medicines have a DIN-HM on their label, while other natural health products will have a NPN?

Homeopathic medicines are treated differently under the NHP Regulations because they can contain or be manufactured from substances (Schedule F or Schedule D substances) that are not otherwise regulated under the Natural Health Products Regulations.

The unique designation for homeopathic medicines will help consumers and compliance / enforcement officers identify the product as a homeopathic medicine. While similar to the requirements for NHPs, these products also have to meet specific Good Manufacturing Practices and unique standards of evidence.

7. Why are vitamins and minerals regulated as a sub-set of drugs?

Vitamins and minerals are regulated as a sub-set of drugs because they are considered to be natural health products, which are governed by the Natural Health Products Regulations.

Previously, vitamins and minerals, in dosage form, were regulated as drugs under the Food and Drug Regulations. However, because they are intended to be used for health benefits, they need to have instructions for use on their label.

As recommended by the Standing Committee on Health, regulating vitamins and minerals as a sub-set of drugs brings the treatment of these products into line with that of other products that fall within the definition of a natural health product (like homeopathic medicines and herbal remedies).

For More Information

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