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Drugs and Health Products

Definition of a Veterinary Natural Health Product (vNHP) - Workbook

August 2007

Consultation closed

About This Workbook

The following document is divided into four sections: The proposed definition, a listing of included substances, a suggestion of excluded substances, and an exploration of the implications of the definition. For each of these sections are series of questions you are encouraged to answer. You will note that the first four questions pertaining to each category of substances listed in section 2 (included substances) are general questions that are identical for every listed substance. When applicable, these general questions may be followed by one or more additional question(s).

*Please check off all identifiers that apply to you :

1.0 Proposed Definition

Veterinary Natural Health Product (vNHP)

Non-homeopathic vNHP include those substances in Schedule 1 (items 1.1 - 1.12) either singly or in combination that are manufactured, sold or represented for use in:

  1. the diagnosis, treatment, mitigation or prevention of a disease, disorder or abnormal physical state or its symptoms in animals; or
  2. restoring or correcting organic functions in animals; or
  3. modifying organic functions in animals, such as modifying those functions in a manner that maintains or promotes health.

A non-homeopathic veterinary natural health product does not include a substance set out in Schedule 2 or any combination of substances that includes a substance set out in Schedule 2.





2.0 Included Substances

Schedule 1: Included Substances

Note: All medicinal ingredients must fit a category listed on Schedule 1 to meet the definition of a vNHP.

Specific substances are stated as examples only.

  Substance Examples
1.1 Vitamins Niacin, ascorbic acid
1.2 Minerals Calcium, molybdenum
1.3 Enzymes Amylase, protease
1.4 Plants and botanical material Senna, flax seed
1.5 Amino acids Phenylalanine, methionine
1.6 Non-human animal material Elk antler velvet, green lipped mussel
1.7 Algae Blue-green alga, Laminaria digitata
1.8 Fungi Yeast, Lentinula edodes (Shiitake mushroom)
1.9 Extracts and isolates of plants, alga, fungi, fatty acids and non-human animal material Chlorophyll, alginic acid, glucosamine, fructo-oligosaccharide, lycopene, resveratrol
1.10 Fatty acids Marine lipid triglyceride, conjugated linolenic acid, omega 3-6-9
1.11 Synthetic duplicates of the above (1.1-1.10) d,l-alpha-tocopherol
1.12 Probiotics Lactobacillus acidophilus
1.13 Veterinary homeopathic medicines Arnica Montana 2X

Schedule 2: Excluded Substances

Note: Specific substances are stated as examples only.

2.1

Substances or mixtures thereof meeting the definition of a "feed" under section 2 of the Feeds Act, including single ingredient feeds listed in Schedule IV and V.

2.2

Substances listed in Schedules I to V of the Controlled Drugs and Substances Act

2.3

Substances available pursuant to a prescription, on Schedule F, Part I, except homeopathic medicines manufactured from Schedule F ingredients

2.4

Veterinary biologics regulated under:

  1. The Health of Animals Act

  2. Schedule D of the Food and Drugs Act, except for the following:

    (a) a drug that is prepared from any of the following micro-organisms, namely, an alga, a bacterium, or a fungus; and
    (b) any substance set out on Schedule D when it is prepared in accordance with the practices of homeopathic pharmacy

2.5

Radiopharmaceuticals listed in Schedule C of the Food and Drugs Act

2.6

Hormones, e.g., glucagon, insulin, secretin, estrogen, progesterone

2.7

Antimicrobials, e.g., amoxillin, cloxacillin, cefazolin, loracarbef, cefepime

2.8

Cosmetics - vNHP combination products, including products with a cosmetic claim

2.9

Medical device - vNHP combination products, including products with a medical device claim

2.10

Allopathic drug - vNHP combination products

2.11

Pesticide - vNHP combination products, including those with a pesticide claim

2.12

Semen

2.13

Bacteriophages and other viruses

2.14

Pathogenic micro-organisms

2.15

Biotechnology products

2.16

Any substance, or mixture of substances that are manufactured, sold, or represented for use in the disinfection of premises in which animals or animal products are manufactured, prepared or kept.

2.1 Vitamins

Vitamins are defined as "an organic substance needed in small amounts to maintain normal health" by the Natural Health Products Directorate's (NHPD) Overview of the Natural Health Products Regulations Guidance Document (November 2003).

The NHPD recognizes the following as vitamins:

  • Biotin
  • Folate
  • Niacin
  • Pantothenic acid
  • Riboflavin
  • Thiamine
  • Vitamin A
  • Vitamin B6
  • Vitamin B12
  • Vitamin C
  • Vitamin D
  • Vitamin E

Please note that Vitamin K is on Schedule F, Part II, and therefore is considered non-prescription for veterinary use (see article C.01.046 of the Food and Drug Regulations).













2.2 Minerals

The Natural Health Products Directorate (NHPD) has defined a mineral as "a naturally occurring, solid, inorganic substance with a definite and predictable chemical composition and physical properties". With this definition of mineral, there were several ingredients and products captured which were not intended (e.g., sodium fluoride, aluminum hydroxide, electrolytes, bentonite, etc). The Veterinary Drugs Directorate (VDD) is proposing the term "mineral supplement" with the intent to include minerals which supplement the diet and that are required to maintain health.

Examples of mineral supplements include:

  • Calcium gluconate
  • Nickel
  • Molybdenum



















2.3 Enzymes

The Natural Health Products Directorate (NHPD) has defined an enzyme as "a protein that acts as a catalyst, increasing the rate at which a specific biochemical reaction occurs. Enzymes may be derived from a plant or a plant material, an alga, a bacterium, a fungus, or a non-human animal material".

Examples of enzymes include:

  • Amylase
  • Lipase
  • Hemicellulase
  • Protease



















2.4 Plants and botanical material

The Natural Health Products Directorate (NHPD) has defined a plant as "a member of the biological Kingdom Plantae, consisting of complex multicellular eukaryotes with a cell wall composed primarily of cellulose. They usually produce their own food by photosynthesis using chlorophylls a and b (secondarily lost in parasites), are mostly terrestrial and have multicellular reproductive structures producing dependent embryos. Plant material is material obtained from a plant, including pollens, nucleic materials, mitochondria, chlorophyll and exudates such as resin."

Examples of plants and botanical material include:

  • Artemisia vulgaris (mugwort)
  • Cimifuga racemosa (black cohosh)
  • Melissa officinalis (lemon balm)
  • Mentha x piperita (peppermint)













2.5 Amino acids

The Natural Health Products Directorate (NHPD) has defined an amino acid as "a class of organic molecules containing amino and carboxylic groups, forming the chief constituents of proteins found in a plant or a plant material, an alga, a bacterium, a fungus, or a non-human animal material". Please note that L-tryptophan is considered a prescription product (as it is listed on Schedule F, Part I).

Examples of amino acids:

  • Alanine
  • Aspartic acid
  • Lysine
  • Arginine
  • Cysteine














2.6 Non-human animal material

The Natural Health Products Directorate (NHPD) has defined non-human animal material as "a body part or secretion obtained from an animal other than a human and used in the preparation of a natural health product". Please note that non-human animal material intended as feeds for animals would not be captured as a veterinary natural health product.

Examples of non-human animal material:

  • Oyster shell
  • Shark cartilage
  • Elk antler velvet
  • Royal jelly














2.7 Algae

The Natural Health Products Directorate (NHPD) has defined an alga to be "a member of one of the protist biological Kingdoms. It consists of unicellular, colonial or relatively simple multicellular eukaryotes, and has a cell wall containing cellulose or silica. Algae usually produce their own food by photosynthesis, and are mostly aquatic."

The Veterinary Drugs Directorate (VDD) would include cyanobacteria in the definition of an alga.

Examples of algae include:

  • Chlorella pyrenoidosa (chlorella)
  • Palmaria palmata (dulse)
  • Laminaria digitata (kelp)
  • Spirulina














2.8 Fungi

The Natural Health Products Directorate (NHPD) has defined fungus as "a member of the biological Kingdom Fungi. A fungus consists mainly of complex multicellular eukaryotes that have a cell wall composed primarily of chitin. Fungi are heterotrophs that absorb nutrients from their surroundings by decomposing organic materials. They reproduce by unicellular spores produced sexually or asexually."

Examples of fungi include:

  • Lentinus edodes (shiitake mushroom)
  • Grifolia frondosa (maitake mushroom)
  • Saccharomyces cerevisiae (yeast)













2.9 Extracts and isolates of plants, algae, fungi, fatty acids and non-human animal material

The Natural Health Products Directorate (NHPD) has defined an extract as "a substance prepared by treating a plant or a plant material, an alga, a bacterium, a fungus, or non-human animal material with solvents to remove any constituents". An isolate is defined as "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".

The Veterinary Drugs Directorate (VDD's) definition of a vNHP would include extracts and isolates of plants, alga, fungi, fatty acids, and non-human animal material. It will exclude bacterial isolates and extracts, for example Staphylococcus aureus, Enterococci, and Pseudomonas aeruginosa.

Examples of extracts and isolates include:

  • Thymus gland extract
  • Soy isoflavones
  • Evening primrose oil
  • Alginic acid

















2.10 Fatty acids

The NHP Regulations has a category for essential fatty acids. Other fatty acids are considered either extracts or isolates. The Natural Health Products Directorate (NHPD) has defined essential fatty acids as substances which "cannot be synthesized from the body and have to be supplied through the diet or a supplement. Current knowledge indicates that there are only two essential fatty acids: linoleic acid and alpha-linolenic acid". Note that this definition is based on human physiology and therefore interspecies variation may exist.

Nevertheless, the Veterinary Drugs Directorate (VDD) intends to include other fatty acids along with the above-mentioned essential fatty acids.

Examples of fatty acids include:

  • Linoleic acid
  • Docosahexaenoic acid (DHA)
  • Alpha-linoleic acid
  • Eicosapentaenoic acid (EPA)













2.11 Synthetic duplicates

The NHP Regulations define synthetic duplicates as "a substance that shares an identical chemical structure and pharmacological properties with its natural counterpart".

Examples of substances manufactured synthetically include:

  • d, l-alpha-tocopherol
  • Methylsulfonylmethane (MSM)
  • Coenzyme Q10
















2.12 Probiotics

The NHP Regulations defines a probiotic as "a monoculture or mixed culture of live micro-organisms that benefit the microbiota indigenous to humans. A probiotic is limited to non-pathogenic micro-organisms."

The Veterinary Drugs Directorate (VDD) definition would pertain to animals, and be limited to micro-organisms normally present in the digestive tract of domestic animals.

Examples of probiotics include:

  • Lactobacillus acidophilus
  • Lactobacillus plantarum
  • Bifidobacterium bifidum
  • Lactobacillus rhamnosus













2.13 Veterinary homeopathic medicines

The Veterinary Drugs Directorate (VDD) has defined veterinary homeopathic medicines as medicines that are manufactured from or contain medicinal ingredients only those substances or sources referenced in the Homeopathic Pharmacopoeia of the United States (HPUS), the Homöopathische Arzneibuch (HAB), the Pharmacopée française (PhF), European Pharmacopoeia, or the British Homeopathic Pharmacopoeia as they are amended from time to time, and that are prepared in accordance with these pharmacopoeias including requirements pertaining to: medicinal ingredient, maximum over-the-counter or external use concentration, and manufacturing methods.

Examples of homeopathic medicines include:

  • Ferrum phosphoricum
  • Sepia officinalis
  • Pulsatilla













3.0 Excluded Substances

The following is a list of ingredients which would be excluded from the definition of a veterinary natural health product. For each category, please indicate if you agree that the corresponding substance should be excluded from the definition, by marking the corresponding empty space with an (X). We welcome your comments on the categories, and ask that you include other categories that may have been overlooked or substances not suitable to be considered a veterinary natural health product.

Substance I agree that this should be excluded from the definition (X)
Substances or mixtures thereof meeting the definition of a "feed" under section 2 of the Feeds Act, including single ingredient feeds listed in Schedule IV and V
Schedules I to V of the Controlled Drugs and Substances Act
Schedule F, Part I of the Food and Drug Regulations (except homeopathic medicines)
Veterinary biologics regulated under The Health of Animals Act and Schedule D of the Food and Drugs Act, except for the following: (a) a drug that is prepared from any of the following micro-organisms, namely, an alga, a bacterium, or a fungus; and (b) any substance set out on Schedule D when it is prepared in accordance with the practices of homeopathic pharmacy
Schedule C of the Food and Drugs Act (radiopharmaceuticals)
Hormones
Antimicrobials
Cosmetics - vNHP combination products
Medical device - vNHP combination products
Allopathic drug - vNHP combination products
Pesticide - vNHP combination products
Semen
Bacteriophage and other viruses
Pathogenic micro-organisms
Biotechnology products











4.0 Implications of the Definition

The definition of a veterinary natural health product and scope of ingredients encompassed in the definition will have implications on the manufacturing, use and potentially to the access to vNHPs. Therefore, the following questions are designed to explore the impact and implications of the definition of a veterinary natural health product with respect to access to products and to explore the possibility of a history of traditional use of natural health products in animals.











Future Consultations

Thank you! Your comments and feedback are very important to us, and greatly appreciated. Your suggestions will provide additional considerations in shaping the definition of a veterinary natural product.

This is the first step in creating an appropriate regulatory framework for veterinary natural health products, and we look forward to receiving your input in future consultations.

Notice of Confidentiality of Personal information

The following personal information provided in this form is protected under the Privacy Act. The information would allow us to contact you during future consultations and inform you on the implementation of the new vNHP regulatory framework. If you provide the personal information, it is voluntary and will only be used for purposes of contacting you for future consultations on this topic. The personal information will not be shared with other parties and will not be used for any other purpose. Please note that you can contact us at vNHP-PSNv_consultations@hc-sc.gc.ca in the future to correct your personal information.

Please indicate whether you would be interested in participating in future consultations during the development of a new regulatory framework for vNHPs.








Please send your comments by November 30th, 2007 to:

Veterinary Drugs Directorate
Health Products and Food Branch
Holland Cross Complex
Ground Floor, Suite 14
11 Holland Avenue, A.L.: 3000A
Ottawa ON K1A 0K9
E-mail: vNHP-PSNv_consultations@hc-sc.gc.ca

Please indicate whether you would like to be informed of the implementation of the new vNHP regulatory framework.








Please visit the VDD Web site for latest developments on this project.