| 1. Why are Regulations required for | | | | from substances ( Schedule F or Schedule |
| natural health products? | | | | D substances) that are not otherwise |
| Prior to January 1st, 2004, natural | | | | regulated under the Natural Health |
| health products (NHPs) were sold as | | | | Products Regulations. |
| either drugs or foods under the Food and | | | | The unique designation for homeopathic |
| Drugs Act and Regulations because there | | | | medicines will enable consumers as well |
| is no other category under which to | | | | as compliance and enforcement officers |
| classify them. | | | | to identify the product as a homeopathic |
| If classified as a drug, natural health | | | | medicine. While in line with the |
| products must adhere to the drug review | | | | requirement for NHPs, these products |
| process, including proof of safety and | | | | have to meet specific Good Manufacturing |
| efficacy through clinical trials, and | | | | Practices and have standards of evidence |
| receive a Drug Identification Number | | | | that are unique to these products. |
| (DIN) to be sold. If classified as a | | | | 6. Natural health products will be |
| food, natural health products can make | | | | regulated as a subset of drugs under the |
| only very limited health claims and do | | | | Food and Drug Act. Did Health Canada |
| not provide adequate safety information | | | | examine the possibility of regulating |
| on their labels. | | | | NHPs as a distinct category separate |
| As more and more Canadians began to use | | | | from both food and drugs? |
| NHPs, it became apparent that neither | | | | Under the Food and Drugs Act, NHPs must |
| treatment (as either a drug or food) | | | | be classified as either a food or a drug |
| would be appropriate, and that a new | | | | since there is no other category in |
| policy which would directly address the | | | | which to classify them. Because NHPs are |
| unique nature of NHPs was required. The | | | | taken for therapeutic reasons and not |
| Natural Health Products Regulations have | | | | for caloric purposes or to address |
| been developed in order to address this | | | | hunger, they are more similar to drugs |
| policy requirement. | | | | than foods. |
| 2. When and how will the Regulations be | | | | Under current regulations (Food and Drug |
| implemented? | | | | Regulations) foods can make only |
| Health Canada has published the Natural | | | | limited, diet-related or nutritional |
| Health Products (NHP) Regulations in the | | | | content claims (and not treatment |
| Canada Gazette, Part II on June 18, | | | | claims, for example). As well, the |
| 2003. However, the Regulations came into | | | | current regulations do not include a |
| force January 1, 2004. | | | | complete good manufacturing practices |
| The transition provisions for the | | | | framework which is needed to ensure |
| Natural Health Product Regulations | | | | quality and safety of NHPs; and foods |
| consider a staged approach over the next | | | | are not subject to pre-market review and |
| six years. Each of the three phases | | | | assessment by HC before they can be sold |
| began in January 2004, and we envision | | | | (there are a few exceptions, e.g., |
| completing the transition over the | | | | "novel foods"). |
| following schedule: | | | | During consultations on NHPs, consumers |
| by the end of two years, all | | | | have consistently requested a system of |
| manufacturers, importers, packagers and | | | | Good Manufacting Practices, to ensure |
| labelers will employ good manufacturing | | | | what is on the label is in the bottle, |
| practices (GMPs) and have site licences; | | | | and pre-market assessment of health |
| | | | claims. While creating another category |
| by the end of six years, NHPs that | | | | distinct from both food and drugs was |
| currently have a product licence as a | | | | considered, an amendment at the level of |
| Drug Identification Number (DIN), will | | | | the Act would have been necessary. Due |
| have transferred to have a NPN or a | | | | to the timelines and legislative process |
| DIN-HM (homeopathic medicine). | | | | required for a change of this magnitude, |
| 3. What will happen to non-compliant | | | | it was decided that natural health |
| NHPs on the Canadian market? | | | | products would be considered drugs under |
| As of January 1, 2004, many | | | | the Act, but with a set of regulations |
| non-compliant NHPs will be on the | | | | specific to NHPs. |
| Canadian market. Health Canada's | | | | Health Canada is currently conducting a |
| compliance approach will be to | | | | comprehensive review of its health |
| prioritize on a risk-mitigation basis | | | | protection legislation with a view to |
| and apply focused compliance efforts | | | | replacing outdated statutes with a new |
| against categories of NHPs for which | | | | health protection legislative regime. |
| applications for product licences have | | | | The objectives of the legislative review |
| not been received by NHPD. For further | | | | are to strengthen and modernize the |
| details on the compliance approach for | | | | legislation, and to provide policy |
| NHPs please see the Compliance Policy | | | | direction in the area of health |
| for Natural Health Products. | | | | protection. The creation of additional |
| 4. What types of natural health products | | | | categories for certain classes of health |
| are affected by the Natural Health | | | | or therapeutic products may be |
| Products Regulations? | | | | considered as a part of this process. |
| Natural health products (NHPs) are | | | | 7. Why are vitamins and minerals |
| defined in the Regulations as vitamins | | | | regulated as a sub-set of drugs? |
| and minerals, herbal remedies, | | | | Vitamins and minerals are regulated as a |
| homeopathic medicines, traditional | | | | sub-set of drugs because they are |
| medicines such as Traditional Chinese | | | | considered to be natural health |
| Medicines, probiotics, and other | | | | products, which are governed by the |
| products like amino acids and essential | | | | Natural Health Products Regulations. |
| fatty acids. | | | | Previously, vitamins and minerals, in |
| Under the Regulations, the product must | | | | dosage form, were regulated as drugs |
| be safe for consideration as an | | | | under the Food and Drug Regulations. |
| over-the-counter (OTC) product. Natural | | | | However, because they are intended to be |
| health products are available for self | | | | used for health benefits, they should |
| care and self selection, and do not | | | | bear indications for use on their label |
| require a prescription to be sold. | | | | (e.g., is a factor in the maintenance of |
| Products requiring a prescription will | | | | good health). |
| continue to be regulated under the Food | | | | As recommended by the Standing Committee |
| and Drug Regulations. | | | | on Health, regulating vitamins and |
| 5. Why will homeopathic medicines bear | | | | minerals as a sub-set of drugs would |
| the designation DIN-HM, while other | | | | bring the treatment of these products |
| natural health products will bear the | | | | into line with that of other products |
| designation NPN? | | | | (such as homeopathic medicine and herbal |
| Homeopathic medicines are treated | | | | remedies) that fall within the |
| differently under the NHP Regulations in | | | | definition of a natural health product. |
| that they can contain or be manufactured | | | | |