- NPN (Natural Product Number)
- DIN-HM (Homeopathic Medicine Number)
- DIN (Drug Identification Number)
These numbers will be assigned once Health Canada has assessed them for safety, effectiveness, and quality. The department within Health Canada that is responsible for developing such standards is the Natural Health Product Directorate (NHPD).
What are NHPs?
Natural Health Products are defined as being products that can be sold over-the-counter for self-care and selection. These include:
- Vitamins and minerals
- Herbal remedies
- Homeopathic medicines
- Traditional medicines (eg. traditional Chinese medicines)
- Other products (eg. amino acids and essential fatty acids)
Such standards will contain requirements for manufacturing, packaging, labelling, storing, importing, distributing and selling NHPs.
Note: It is the manufacturing, packaging, labelling etc. that is the reason for these Regulations and not the sale of natural health products by retailers.
Components of NHPs
Function refers to the manufacture and sale of products that are designed to do the following:
- The diagnosis, treatment, mitigation or prevention of a disease, disorder or abnormal physical state or its symptoms in humans
- Restoring or correcting organic functions in humans
- Modifying organic functions in humans in a manner that maintains or promotes health
Substance refers to the medicinal ingredient in a NHP.
Acceptable NHP Substances:
- A plant or a plant material, algae, bacterium, fungus, animal, or a non-human animal material:
- Plant (eg. Allium sativum or Cassia angustifolia, bark, wood, leaves, stems, roots, flowers, fruits, seeds and berries, or parts thereof)
- Plant material (eg. pollens, nucleic materials, mitochondria, chlorophyll and exudates such as resin)
- Algae (eg. Chlorella pyrenoidosa and Laminaria digitata)
- Bacterium (eg. Spirulina, a cyanobacteria)
- Fungus (eg. medicinal mushrooms such as Shiitake [Lentinus edodes] and Maitake [Grifolia frondosa])
- Animal (eg. Shark [Squalus acanthias] and Cod [Gadus morhua])
- Non-human animal material (eg. elk antler velvet, bovine colostrums, shark cartilage, and preparations from canine milk (Lac caninum)
Homeopathic Medicines must be listed in one of the following:
- Homeopathic Pharmacopoeia of the United States
- Homöopathische Arzneimittel
- Pharmacopée Française
- European Pharmacopeia
- An extract or isolate of a substance described in item 1, the primary molecular structure of which is identical to that which it had prior to its extraction or isolation.
- Extract a substance prepared by treating a plant or a plant material, an alga, a bacterium, a fungus or a non-human animal material with solvents to obtain the desired compounds (eg. a solid extract from Echinacea angustifolia, a tincture from Panax ginseng, or a fluid extract from Hypericum perforatum [St. John’s Wort])
- Isolate a purified constituent of a defined molecular structure obtained from a plant or a plant material, an alga, a bacterium, a fungus or a non-human animal material (eg. glutathione and capsaicin)
- Vitamins. Vitamins are naturally occurring organic substances required by the body to maintain health. Dietary Reference Intakes (DRIs) are the standards for referencing upper levels of vitamins but in some cases, Health Canada’s Therapeutic Products Directorate has established lower levels for vitamins. This means that the amount of vitamin in a NHP cannot be lower than this level.
Note: According to Food and Drug Regulations, Vitamin K is currently listed on Schedule F without specifying parameters. Until parameters have been established, NHPD has removed vitamin K from Schedule 1.
Vitamins include the following:
- Pantothenic acid
- Vitamin A
- Vitamin B6
- Vitamin B12
- Vitamin C
- Vitamin D
- Vitamin E
- Amino acids. Amino acid a class of organic molecule that contains amino and carboxyl groups. Amino acids form the main constituents of proteins found in a plant or a plant material, an alga, a fungus, a bacterium or a non-human animal material. NHPD acknowledges that there are other amino acids not captured under this definition.
The following are acceptable amino acids and captured under the isolate category:
- L-aspartic acid
- L-glutamic acid
- Essential Fatty Acids. Essential Fatty Acids – cannot be synthesized in the body and must be supplied either from a food or a supplement. Linoleic acid (omega-6) and alpha linolenic acid (omega-3) are essential fatty acids. All other fatty acids (such as oleic acid, conjugated linoleic acid, gamma-linoleic acid, arachidonic acid, eicosapentaenoic acid and docosahexaenoic acid) are considered extracts or isolates.
- A synthetic duplicate of a substance described in any of items 2 to 5. Synthetic duplicate a substance that shares an identical chemical structure and pharmacological properties with its natural counterpart (eg. vitamin E – DL alpha-tocopherol).
A semi-synthetic substance may also be acceptable as a natural health product provided it shares an identical chemical structure and pharmacological properties with its natural counterpart. A semi-synthetic substance is produced by a process that chemically changes a related starting material that has been extracted or isolated from a plant or a plant material, an alga, a fungus or a non-human animal material (eg. ginsenosides the starting compound is betulafolienetriol).
- Minerals. Minerals are naturally occurring solid, inorganic substances that have a definite and predictable chemical composition and physical properties.
- Probiotics. Probiotics are a mixed-culture of live micro-organisms that benefit the natural flora of humans. A probiotic is limited to non-pathogenic microorganisms (eg. Lactobacillus acidophilus)
Unacceptable NHP Substances:
- A substance set out in Schedule C to the Food and Drugs Act.
- Schedule C substances include radiopharmaceuticals and drugs other than radionuclides sold or represented for use in the preparation of radiopharmaceuticals. These substances are regulated by the Food and Drugs Act (see sections 12 and 30) and the Food and Drug Regulations.
- A substance set out in Schedule D to the Food and Drugs Act (biologics). The following are Schedule D substances:
- Allergenic substances used for the treatment or diagnosis of allergenic or immunological diseases
- Anterior pituitary extracts
- Blood and blood derivatives
- Drugs obtained by recombinant DNA procedures
- Drugs, other than antibiotics, prepared from micro-organisms
- Human plasma collected by plasmapheresis
- Immunizing agents
- Monoclonal antibodies, their conjugates and derivatives
- Sensitivity discs and sensitivity tablets
- Snake venom
The following are excluded even though they may contain Schedule D substances:
- a drug that is prepared from any of the following micro-organisms, namely, an alga, a bacterium or a fungus
- any substance set out in Schedule D, when it is prepared in accordance with the practices of homeopathic pharmacy
- A substance regulated under the Tobacco Act is not permissible as NHPs (eg. chewing tobacco and smoking tobacco).
- A substance set out in Schedules I to V of the Controlled Drugs and Substances Act are not acceptable as NHPs. Only the following substances are permissible as NHPs:
- Benzyl methyl ketone
- Lysergic acid
- A substance that is administered by puncturing the dermis. Such substances are not acceptable as NHPs. However, substances administered by means of insertion into cavities and canals of the body, such as suppositories, are permissible.
- An antibiotic prepared from an alga, bacterium, fungus, or a synthetic duplicate of that antibiotic. Such an antibiotic is regulated by the Food and Drugs Act and Food and Drug Regulations and not acceptable as a NHP.
Dosage Form and Bulk Herbs
Manufacturers, packagers, labellers, distributors and importers who handle bulk or loose natural health products are subject to the requirements of the Natural Health Products Regulations. A policy for bulk herbs will set out the labelling requirement for bulk herbs ready for use by the consumer. Further guidance on this issue will be forthcoming.
NHPD recognizes that consumers may find it difficult to distinguish between foods and NHPs. To help product licence applicants, NHPD has developed a list of dosage forms which suggest that a product is a NHP. Industry may use this list as a guide. NHPD uses this list for tracking to ensure consistency in its databases, which is updated regularly.
NHPD is also developing a list of herbs that will always be considered NHPs regardless of dosage form.
Hybrid NHPs are ones that contain a drug, food, cosmetic, or medical device, in addition to the NHP.
A hybrid product may be subject to one or more of the Natural Health Products Regulations, Food and Drug Regulations, Cosmetics Regulations, or Medical Devices Regulations, depending on the ingredients, primary purpose, and health claims of that product. However, drug-natural health product combinations are always regulated as drugs under the Food and Drugs Act and Food and Drug Regulations.
Recognizing the potential complexity and diversity of hybrid products, NHPD classifies them on a case-by-case basis. The NHPD is participating in a broader Health Canada initiative with respect to the classification of health products.