Natural Health Products on the Listing of Drugs Currently Regulated as New Drugs (April 1999 edition) and their Compliance Priority Categories
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June 1, 2004
Definition of a Natural Health Product:
A substance set out in Schedule 1 to the Natural
Health Products Regulations or a combination of substances in which
all the medicinal ingredients are substances set out in Schedule 1, a
homeopathic medicine or a traditional medicine, that is manufactured,
sold, or represented for use in:
- 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; or
- modifying organic functions in humans, such as modifying those functions in a manner that maintains or promotes health.
SCHEDULE 1: INCLUDED NATURAL HEALTH PRODUCT SUBSTANCES:
- A plant or a plant material, an alga, a bacterium, a fungus or a non-human animal material
- 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
- Any of the following vitamins:
biotin
folate
niacin
pantothenic acid
riboflavin
thiamine
vitamin A
vitamin B6
vitamin B12
vitamin C
vitamin D
vitamin E
- An amino acid
- An essential fatty acid
- A synthetic duplicate of a substance described in any of items 2 to 5
- A mineral
- A probiotic
However, a natural health product does not include a substance set out in Schedule 2, any combination of substances that includes a substance set out in Schedule 2 or a homeopathic medicine or a traditional medicine that is or includes a substance set out in Schedule 2, with the exceptions noted in Schedule 2.
SCHEDULE 2: EXCLUDED NATURAL HEALTH PRODUCT SUBSTANCES
- A substance set out in Schedule C to the Act. (radiopharmaceuticals)
- A substance set out in Schedule D to the Act (biologics), except for the following:
- a drug that is prepared from any of the following micro-organisms, namely, an alga, a bacterium or a fungus; and
- any substance set out on Schedule D when it is prepared in accordance with the practices of homeopathic pharmacy
- A substance regulated under the Tobacco Act
- A substance set out in any of Schedules I to V of the Controlled Drugs and Substances Act
- A substance that is administered by puncturing the dermis
- An antibiotic prepared from an alga, a bacterium or a fungus or a synthetic duplicate of that antibiotic.
Furthermore, the sale of the product, under the Food
and Drug Regulations, must not be required to be pursuant to a
prescription when it is sold other than in accordance with section C.01.043
of those Regulations (i.e., no Schedule F substances unless it is a homeopathic
medicine).
To be classified as an NHP, a derivative of a Schedule 1 substance must act as a source material (the substance from which the ingredient was derived) or prodrug (a compound that is transformed in the human system into the same active substance of a related drug by chemical or metabolic means) that yields the original Schedule 1 substance's active ingredient during absorption into the body, and/or have been prepared to improve the stability of the substance under environmental conditions such as moisture, light, temperature, acidity or alkalinity, etc., and/or to improve the solubility and/or to improve absorption of the parent molecule into the body (e.g. calcium chloride, vitamin A palmitate). Derivatives of Schedule 1 substances that differ in their other pharmacological properties (distribution in the body, metabolism, excretion, mechanism of action and/or relationship between drug concentration and effect) from the natural parent molecule (e.g. acetylsalicylic acid) are not considered to be natural health product substances. If both the derivatizing and parent portions of the compound are Schedule 1 substances that have pharmacological activity, e.g. chromium polynicotinate which is a source of chromium (III) and nicotinic acid, the substance will be evaluated as a combination NHP. Thus, salts and derivatives of the substances listed below that are interpreted as NHPs according to the above criteria are considered to be included in the New Drugs list with the relevant Compliance Priority category.
Compliance Priorities:
Note that all herbs on the New Drugs list with the qualifier "except as per THM Policy" now fall under Compliance Priority 4, not Priority 1. Homeopathic medicines containing substances on the New Drugs list fall under Compliance Priority 6.
Compliance priorities and actions are described in the "Compliance Policy for Natural Health Products" and further explained in the "Natural Health Products Compliance Guide" published at http://www.hc-sc.gc.ca/hpfb-dgpsa/nhpd-dpsn/compliance_e.html.
Table of New Drug List NHP Substances and Compliance Priority Category:
| SUBSTANCE |
PRIORITY |
| Adenosine and its salts when manufactured, sold, or represented for use as an NHP (see definition above) |
1 |
Amino acids as isolates present as single ingredients or in a configuration other than completed protein, other than as lipotropic factors, when manufactured, sold, or represented for use as an NHP (see definition above), specifically:
Arginine
Lysine
Methionine
Ornithine
Phenylalanine
Tyrosine
(Note: L-tryptophan and L-carnitine are on Schedule F so not NHPs) |
1 |
| Ammonium Chloride |
1 |
| Ammonium Molybdate |
1 |
| Aspartates |
1 |
| Atropine and its salts (oral dosage forms; not in ophthalmic or parenteral preparations which are on Schedule F) |
1 |
| Azelaic acid |
1 |
| Betaine and its salts (other than when sold or recommended for the treatment of homocystinuria which is on Schedule F) |
1 |
| Boron (oral) |
1 |
| Caffeine / Ephedrine |
Risk known |
| Calcium Acetate for the control of hyperphosphatemia |
1 |
| Caprylic Acid when manufactured, sold, or represented for use as an NHP (see definition above) |
1 |
| Chitosan |
1 |
| Chondroitin and its salts when manufactured, sold, or represented for use as an NHP (see definition above) |
1 |
| Chymopapain |
1 |
| Co-enzyme Q-10 (other than as a source of Co-enzyme Q-10 or Ubiquinone) |
1 |
| Coryceptin (Jing Ahi Dongchongxiacao) |
1 |
| Devil's Claw when manufactured, sold, or represented for use as an NHP (see definition above) |
4 |
| Dibencozide (other than source of Vitamin B12) |
1 |
| Dimethylglycine (DMG) |
1 |
| Docosahexanoic Acid (DHA) when isolated or concentrated and sold as a single ingredient or added to other ingredients in a product that is manufactured, sold, or represented for use as an NHP (see definition above) |
1 |
| Dong Quai when manufactured, sold, or represented for use as an NHP (see definition above) |
4 |
| Eicosapentaenoic Acid (EPA) when isolated or concentrated and sold as a single ingredient or added to other ingredients in a product that is manufactured, sold, or represented for use as an NHP (see definition above) |
1 |
| Evening Primrose Oil when manufactured, sold, or represented for use as an NHP (see definition above) |
4 |
| Ferulic Acid |
1 |
| Fluoride and its salts |
1 |
| Fluoride and its salts in chewing gum for osteoporosis, ostospongiosis and the treatment and prevention of gingivitis and plaque |
1 |
| Galactose |
1 |
| Galactose / Palmitic Acid |
1 |
| Gamma Amino Butyric Acid (GABA) |
1 |
| Gamma Oryzanol |
1 |
| Germanium |
1 |
| Ginseng when manufactured, sold, or represented for use as an NHP (see definition above) |
4 |
| Ginseng / Guarana / Bee Pollen when manufactured, sold, or represented for use as an NHP (see definition above) |
4 |
| Glucomannan when manufactured, sold, or represented for use as an NHP (see definition above) |
1 |
| Glucosamine when manufactured, sold, or represented for use as an NHP (see definition above) |
1 |
| Heparin (topical use) |
1 |
| Hyaluronidase |
1 |
| Hydrocortisone-17-valerate (topical) |
1 |
| Hydrocortisone / Allantoin (topical) |
1 |
| Hydrocortisone / Urea (topical) |
1 |
| Hydroquinone / Retinoic Acid (topical) |
1 |
| Hydroxycitric Acid |
1 |
| Hyoscine Butylbromide (as a source of hyoscine / scopolamine) |
1 |
| Iron Dextran |
1 |
| Kava when manufactured, sold, or represented for use as an NHP (see definition above) |
risk known |
| Kola Nitida when manufactured, sold, or represented for use as an NHP (see definition above) |
4 |
| Magnesium Pyrrolidone |
1 |
| Melatonin |
1 |
| Melatonin / Vitamin E |
1 |
| Methyl Salicylate (spray) |
1 |
| Nicotinamide (except as a vitamin supplement) |
1 |
| Nicotine (patch or gum) |
1 |
| Octacosanol |
1 |
| Omega-3 Fatty Acids, EPA and DHA when isolated or concentrated and sold as a single ingredient or added to other ingredients in a product that is manufactured, sold, or represented for use as an NHP (see definition above) |
1 |
| Pangamic Acid and its salts when manufactured, sold, or represented for use as an NHP (see definition above) |
1 |
| Papain (topical) |
1 |
| Pau D'Arco (Taheebo Tea) when manufactured, sold, or represented for use as an NHP (see definition above) |
4 |
| Peppermint Oil (enteric coated capsules) |
2 |
| Permethrin |
1 |
| Picolinates |
1 |
| Plant sterols when isolated or concentrated and sold as a single ingredient or added to other ingredients in a product that is manufactured, sold, or represented for use as an NHP (see definition above) |
1 |
| Polynicotinates |
1 |
| Propolis (for Herpes) |
4 |
| Quinidine Bisulfate |
1 |
| Quinidine Gluconate (oral modified release preparation) |
1 |
| Retinoic Acid |
1 |
| Sanguinarine (as antiplaque agent) |
risk known |
| Selenious Acid |
1 |
| Selenomethionine |
1 |
| Silicon (except as a mineral supplement) |
1 |
| Silver Nitrate (topical ointment) |
1 |
| Squalene |
1 |
| Stannous Fluoride (for gingivitis / plaque) |
1 |
| Streptokinase |
1 |
| Superoxide Dismutase (SOD) |
1 |
| Trichosanthin |
1 |
| Ursodiol |
1 |
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