Consultation Summary Report on the Draft Definition of a Veterinary Natural Health Product

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Dear Stakeholder:

Thank you for your feedback regarding the proposed definition of a Veterinary Natural Health Product (vNHP). Your comments have been greatly appreciated.

A variety of stakeholders were involved with this consultation, so the opinions, expectations and issues that have been identified have been diverse.

Below you will find a brief summary of the results from the consultation on the proposed definition of a vNHP:

• 93% of respondents thought the proposed acronym "vNHP" would not elicit any confusion with "NHP," the acronym used to identify products for human use. Alternate names, such as Animal Natural Health Product (ANHP), Dietary Natural Health Product (DNHP), and VNHP with a capital V, were suggested.
• 48 % of respondents thought that the first part of the definition is not fully adequate, and should be slightly modified. For example, some people believe that a vNHP should not be used for purposes of diagnosis, or that the idea of "preventing diseases" is too wide, as it includes too many substances (e.g. feed additives). Other stakeholders think that the scope of the conditions to be covered is not wide enough and should include mental and emotional symptoms.
• Some felt that the definition is too medically oriented and believe it should instead refer to improving or supporting good health and would like to see the concept of performance/productivity enhancement included within the definition. Additionally, the expression "to maintain and promote health" should be more specific so it is clear whose health one is talking about.
• Suggestions were made to have a functional definition rather than a list of substances as categorization leads to restricting potential inclusion of newly developed substances. According to some people, a vNHP by definition should be supported by traditional use, and should be safe at 10 times the recommended dosage, minimally.
• More than the half of the people who responded agree that the route of administration should be considered as an exclusion factor. The majority felt that only oral products should be included, while others felt topical or rectal routes should also be included. It was generally identified that the injectable route was to be subject to exclusion, except within specific groups, such as homotoxicologic products manufacturers.
• Other opinions were that vNHPs used to treat specific conditions should be available upon prescription only.

The comments regarding the use of terminology was a good point and we have tried to change related documents as best we could, realizing that context plays a big role in why different terminology is used. The Veterinary Drugs Directorate will take into account your valuable comments as we strive to amend the proposed definition so that it reflects your view as we move forward with the development of an appropriate regulatory framework for vNHPs.

The following table is a summary of comments that were gathered regarding the specific substances that are expected to be a part of the definition:

	Substance	Comments
1.1	Vitamins	The expression "small amounts" should be replaced with "appropriate amounts"; Vitamins administered in water should be included; Many stated that vitamins approved for humans should be allowed in livestock and that feed industry should not stricter than human nutrition; The definition does not distinguish between substances on schedule IV and V of the Feed Regulations. Choline, inositol, beta-carotene, lutein are not included on the list even if they are approved feed vitamins; Vitamin K should stay included within the scope of the definition.
1.2	Minerals	The word "inorganic" when used alone is too exclusive -- the definition should be modified so mineral complexes, chelates, and non-naturally-occuring forms (e.g. calcium carbonate, chromium picolinate) are considered for inclusion. Sources should be identified; CFIA's list of acceptable minerals could be used; Many people think that all minerals (e.g. clay) should be included.
1.3	Enzymes	Every type of enzymes (either non-digestive or digestive such as phytase) should be included as long as they are clearly labelled; Synthetic enzymes should be included as long as they also occur in nature; The definition should indicate that genetically modified enzymes are not included; Lecithinase/phospholipase C should be excluded.
1.4	Plants and botanical material	High-risk botanicals (HRB) and those not suitable for administration by a farmer should be available by prescription only and for use by professionals only; HRB should be included when combination with other botanicals reduce the overall risk that is associated with the final compound, such as in traditional Chinese medicines; Some want genetically modified products to be included, while other want them to remain excluded; Many people stated that botanical material that is safe for humans is also safe for food-producing animals, which is not necessarily true, as interspecies variation exists (e.g. horsetail is toxic to horses at lower levels than it is for humans); Products should be shown to be safe at levels 2 to 3 times the recommended dosage; Sponsors should submit both raw material specifications and final product specifications for bioavailability assessment.
1.5	Amino acids	Some think that synthetic proteins or L-stereoisomers should not be considered vNHPs as they do not conform to those found in nature and may have unpredictable bioactivity, while others think they should be included in the definition; Taurine should be included; Some are concerned that L-tryptophan has prescription status while being an essential nutrient for animals.
1.6	Non-human animal material	Many have shown ethical concerns on the harvesting methods that could lead to environmental damage or direct or indirect destruction of the habitat of certain living species; Some think that we need to put up a list of acceptable substances; Contamination is the main concern; Some people say that there is an overlap with ingredients on Schedules IV and V of the CFIA and that the distinction has to be made, since many feed ingredients have a health function; Animal materials should not be fed to cows.
1.7	Algae	Toxins such as arsenic, which occurs in algae, are a real problem; Most people would classify blue-green algae as bacteria rather than algae; Some algae are grown under laboratory conditions and would not be considered "mostly aquatic"; Only non toxic species should be included.
1.8	Fungi	Yeasts should not be included in this category as it is used as a probiotic; Chinese traditional medicine preparations should be included; Should not include toxic species.
1.9	Extracts and isolates of plants, alga, fungi, fatty acids and non-human animal material	Some feel that extracts and isolates should be in two separate categories; Many think that extracts and isolates should be included as subcategories of the main categories of products from which they are obtained; The definition should read "...to obtain the desired constituents" instead of "...removing constituents"; Does this category include synthetic prebiotics?; Essential oils with estrogenic effect should be excluded; A clear distinction should be made between feed and drug use; Some of theses substances are prepared without using any solvent and this should be reflected in the definition.
1.10	Fatty acids	Contamination is a problem; Arachidonic acid is essential in cats and other obligate carnivores; Some feel this is not clear.
1.11	Synthetic duplicates of the above (1.1-1.10)	Should be free of contaminants resulting from the synthesis method; Should include substances that share identical physiological properties (this means that chemical bonds and steric conformation should be the same as well) with its natural counterpart; Some think that the term "duplicate" is inappropriate as synthesis leads to molecules that can be either D or L and not only D as usually found in nature; The end product should be identical to the naturally occurring substance or liberate it after it is metabolized.
1.12	Probiotics	Probiotics and yeasts should be included here; Bacillus subtilis, Enterococcus faecium and Pediococcus acidilactici strains should be included; If they are used as silage inoculants, they should be approved for direct feeding to animals; A regulatory directive involving CFIA and VDD differentiated between feed and drug use of "viable microbials"; should this term be used instead of "probiotics;" the wording should be modified to "... normally non pathogenic" as any normal gut flora may become pathogenic in unusual circumstances; The definition should include other probiotics non indigenous to the host (i.e. isolated from other species or normally present in the soil) that may have potential benefit in animal health and/or growth promotion (e.g. Bacillus subtilis is continually consumed by some grazing animals in which it is found in a transitory manner and not recognized as resident bacteria of the gastrointestinal tract).
1.13	Veterinary homeopathic medicines	There is a lack of clarity in the definition about whether homeopathics are included or not; Controlled substances should be included in homeopathics; Examples of homeopathics should include their potencies; VDD needs some staff fluent in German; Homotoxicological and injectable homeopathic medicines should be included. They are best prescribed by professionals. Ingredients can be of natural or synthetic origin; Human homeopathic medicines should be permitted to be used in animals, especially when listed in Annex II of the EEC 2377/90; No substance properly prepared according to recognized homeopathic pharmacopeias should be excluded; Schedule F substances should be permitted; Nosodes made from pathogenic bacteria should be included.

Again, we would like to thank you for your participation in the consultation process. Please note that we have considered all the submitted comments as very constructive and rest assured that every option will be discussed and analyzed so that we can make the right decisions that will help us development a regulatory framework for vNHPs that will be in the best interest of all Canadians.

We will keep you informed as to the next steps. We would also like to invite any of you who would like to be involved as a member of an advisory committee on vNHPs to submit their candidature. When applying please consult the Terms of Reference and the Guidelines for Submitting a Nominee.