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Drugs and Health Products

Guidance document on classification of veterinary drugs and livestock feeds

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Published by authority of the Minister of Health and the Minister of Agriculture and Agri-Food

(DRAFT for consultation)

Veterinary Drugs Directorate
Health Products and Food Branch
Health Canada
and
Animal Feed Division
Animal Health Directorate
Canadian Food Inspection Agency

Foreword

Guidance documents are meant to provide assistance on how to comply with the policies and governing statutes and regulations. They also serve to provide review and compliance guidance to government employees, thereby assuring that mandates are implemented in a fair, consistent and effective manner.

Guidance documents are administrative instruments not having force of law and, as such, allow for flexibility in approach. Alternate approaches to the principles and practices described in this document may be acceptable provided they are supported by adequate scientific justification. Alternate approaches should be discussed in advance with the relevant program area to ensure that applicable statutory or regulatory requirements have been met.

As a corollary to the above, it is equally important to note that Health Canada and the Canadian Food Inspection Agency (CFIA) reserve the right to request information or material, or define conditions not specifically described in this guidance, in order to allow for the adequate assessment of the safety, efficacy or quality of a product. Both Health Canada and the CFIA are committed to making sure that such requests are justifiable and that decisions are clearly documented.

This Guidance document should be read in conjunction with the accompanying notice and the relevant sections of other applicable guidelines and applicable regulations.

This Guidance document is dynamic in nature, and is offered without prejudice to future measures, which Health Canada and the CFIA might take in this area. Persons using the information in this document do so at their own risk and responsibility and are liable for their use of and any reliance on the information contained in it and any loss or damage resulting there from.

Table of contents

  1. Introduction
  2. Scope and application
  3. Guiding principles
  4. Classification criteria
  5. Classification decision process
  6. Reclassification process
  7. Implementation

List of appendices

1. Introduction

1.1 Background

In Canada, products consumed by livestock species are largely regulated as either veterinary drugs or livestock feeds.

Veterinary drugs (henceforth referred to as drugs) are regulated under the Food and Drugs Act and Regulations by Health Canada. Within Health Canada, the Veterinary Drugs Directorate (VDD) has the mandate to evaluate and monitor the safety, quality and effectiveness, to set standards and to promote the prudent use of veterinary drugs, including veterinary natural health products, administered to food-producing and companion animals. The VDD's classification of a product is guided by the requirements of the Food and Drugs Act and Regulations.

Livestock feeds (henceforth referred to as feeds) are regulated under the Feeds Act and Regulations, which are administered by the Canadian Food Inspection Agency (CFIA). The CFIA verifies that livestock feeds manufactured and sold in Canada or imported are safe, effective and are labelled appropriately. Effective feeds contribute to the production and maintenance of healthy livestock.

1.2 Definitions

Pursuant to the Food and Drugs Act, a "drug" includes any substance or mixture of substances manufactured, sold or represented for use in

  1. the diagnosis, treatment, mitigation or prevention of a disease, disorder, abnormal physiological state, or its symptoms in human beings or animals,
  2. restoring, correcting or modifying organic functions in human beings or animals, or
  3. disinfection in premises in which food is manufactured, prepared or kept.

Pursuant to the Feeds Act, a "feed" is defined as any substance or mixture of substances containing amino acids, antioxidants, carbohydrates, condiments, enzymes, fats, minerals, non-protein nitrogen products, proteins or vitamins, or pelletizing, colouring, foaming or flavouring agents and any other substance manufactured, sold or represented for use:

  1. for consumption by livestock;
  2. for providing the nutritional requirements of livestock, or;
  3. for the purpose of preventing or correcting nutritional disorders of livestock,

or any substance for use in any such substance or mixture of substances.

1.3 Context

The overlap of the definitions for these two types of products creates a challenge whereby nutritional and non-nutritional products may be classified as either a drug and a feed, or both. In the past, difficulties associated with the interpretation of the drug and feed definitions have resulted in significant industry confusion, which led to inefficiencies regarding product evaluation and approval, as well as compliance and enforcement activities. Therefore, there is a need for a clear and transparent classification process for some products intended for use in livestock species.

1.4 Purpose & objectives

The purpose of this guidance document is to present guidelines and criteria for classification in order to clarify the differences between drugs and feeds, and to assist in determining the appropriate regulatory oversight for a product destined for use in livestock species. The pursued objectives are:

  1. to improve the transparency of the classification process, to increase the consistency in decisions by regulators, and make these more predictable to stakeholders;
  2. to resolve industry confusion and to provide better guidance to manufacturers of such products regarding the appropriate regulatory department, submissions and processes for a product approval.

2. Scope and application

2.1 Scope

The classification approach presented in this document applies to a broad range of products, intended for oral consumption only and for livestock species (e.g., dairy and beef cattle, sheep, goats, chickens, turkeys, ducks, geese, rabbits, horses and swine) only, and in most types of animal production (e.g., dairy cattle vs. beef cattle, broilers chickens vs. laying hens). In some situations, products may be classified (and therefore regulated) as veterinary biologics or pest control products. Please note that these products are beyond the scope of this guidance and will not be further discussed in this document.

2.2 Application

This guidance document is applicable to products (drugs and feeds) that are subject to the pre-market evaluation process (new) and to the existing products currently sold on the Canadian market (authorized for sale). The present document is intended to be used in conjunction with other regulatory tools from Health Canada (VDD) and CFIA (e.g., feed schedules, policies, guidelines, regulations, etc.).

3. Guiding principles

For a product classification to be consistent with both regulatory mandates, the following general principles will be applied:

  1. The primary consideration will be the respect of the definitions of a drug in the Food and Drugs Act and of a feed in the Feeds Act. Guidance will be consistent with the objectives of Health Canada and CFIA and their respective regulatory frameworks, including public health and safety.
  2. The risk represented by a product does not alone qualify a substance as either a feed or a drug. The regulatory frameworks under the drug and feed legislations provide a tier of controls to mitigate the risks of the many products captured by the definitions.
  3. The determination of a drug or feed classification can result from the consideration of only one of the most pertinent classification criterion listed below, but generally requires the consideration of multiple criteria taken together as a whole.
  4. Depending on the product, some criteria may not be given equal weight in support of a classification decision.

Based on a complete assessment of each of the criteria identified below, the differences between drugs and feeds can be identified to facilitate a regulatory classification. Please see the document Drug/Feed classification flow chart (shown in appendix A) for a step-by-step approach to the classification process.

4. Classification criteria

4.1 Route of administration

The fact that a substance or a product is administered in feed or in water does not have a significant impact on the regulatory classification of a product.

4.2 Mode of administration

4.2.1 Product form

The product form refers to the final form in which a substance or product is available and ready for use/administration, without requiring any further manufacturing. Common product forms for therapeutic products (or "dosage" forms) include tablets, capsules, boluses, aerosols or inhalers, creams, lotions, solutions or suspensions and implants.

The form of a product is usually dependent on the route of administration of the substance in question. Most products in dosage form are considered drugs, with some exceptions, depending on other criteria (e.g., purpose, label). Products in forms that can be consumed in a voluntary manner, such as mash, liquid, pellets, flakes, free choice blocks, etc., are typically (but not exclusively) classified as feeds.

4.2.2 Forceable administration

Products for forceable administration (i.e., administered orally but via gavages or drenches) are considered drugs. However, a joint decision was made to allow pastes, pumps and non-injectable syringes that are:

  1. labelled for inclusion into feeds, and
  2. for which no drug claim is made,

to be regulated as feeds under the Feeds Act and Regulations. All products must indicate physical form in their product name (e.g., paste) in order to be considered feeds.

All other products for forceable administration will continue to be regulated as drugs.

4.3 Known medicinal ingredients

Some ingredients are inherently medicinal or therapeutic in nature, either due to their characteristics, their function (activity) and effect(s) on the organism or their purpose in the formulation. For example, some substances like penicillin, neomycin, or plant extracts like digitalin or digoxin have an intrinsic therapeutic function or activity. This knowledge is usually derived from scientific literature or reference textbooks. In the case of a multiple-ingredient product, if one or more ingredients in its composition have a therapeutic nature or effect, the product would be considered a drug. Also, some herbal ingredients have a generally recognized therapeutic use and no recorded nutritional use. These types of herbal ingredients are considered medicinal ingredients and classified as drugs.

To help identify ingredients currently considered as medicinal (therapeutic), please refer to Appendix B for a definition and an alphabetical listing of known medicinal ingredients.

4.4 Representation/Intended purpose

A key consideration for the classification of a product is its representation for use and intended purpose.

The representation for use associated with a product include indications for use (they may be explicit or implied), claims presented as a word, sentence, a picture, a symbol, a paragraph or an implication on product labels, package inserts or advertisements (including information available on the Internet), placement and location of sale. Together, these product characteristics are used to create a clear picture of what the product is and does. Representation also includes the purpose for which the purchasers/consumers perceive and use the product and its history of use. While this criterion would not be considered the only basis for a classification decision, it may be taken into account and influence the final decision.

The intended purpose of a product is the desired effect to be achieved by the administration of this product to a particular animal species during a particular situation, or under specific conditions (e.g., health or disease states). The activity or properties of the ingredient(s) present in a product are also considered to provide information on the product's intended effect.

4.4.1 Therapeutic indications (claims)/Purposes

Therapeutic claims, indications or purposes refer to the treatment of a disease, disorder or abnormal physical state; or treatment, mitigation of its symptoms; or the modification of an organic function (e.g. such as digestion). Therapeutic claims can only be made for products which have a therapeutic purpose or intent of use (i.e., drugs), and are therefore not suitable for feeds. Examples of therapeutic claims are:

  • Treatment claims (e.g., treatment of a disease (acetonemia), a condition (intoxication) or abnormal state (wounds, oedema) or its symptoms (diarrhea));
  • Control claims (e.g., control intestinal parasites, control breeding);
  • Prevention claims (e.g., prevent mastitis, prevent bacterial infections), excluding prevention of nutritional deficiency claims;
  • Therapeutic Nutrition claims (e.g., essential fatty acids reduce pruritus and dermatitis associated with allergic skin disease);
  • Animal Performance claims (production claims) not supported by a nutritional purpose or mode of action (e.g., stimulate egg production, increase litter size)

Note: This list of acceptable indications for drugs is not exhaustive and others indications or claims not acceptable for feeds would require further assessment for classification.

4.4.2 Nutritional indications (claims)/Purposes

Feeds are not intended to have any therapeutic purpose or activity. Products with such purposes are not considered feeds but are considered drugs. Feed products are typically fed for a reasonable amount of time as part of a balanced feeding program with the intent of meeting the nutritional requirements necessary for maintenance, growth and production of livestock. They can also include non-nutritive products such as flavours, pellet binders, preservatives, anti-caking agents and other products that facilitate the manufacture, storage or palatability of feeds.

Nutritional indications or purposes refer to the presence of one or more a nutrient(s) or nutritive substance(s) which are scientifically recognized for providing the nutritional requirements essential for supporting normal growth, maintenance and production in livestock species. An intended purpose that states suggests or implies that the consumption of a specific nutrient or nutritive substance significantly reduces the incidence or prevents the development of a nutritional disease; disorder or deficiency in a healthy animal may also be acceptable in this category of claims. Examples of nutritional claims that would be acceptable for feeds include:

  • Nutritional disorderMore information on nutritional disorders and  acceptable related claims can be found in Appendix C prevention claims excluding disease prevention (e.g., prevention of "white muscle disease" in cattle due to selenium deficiency; prevention of anemia due to iron deficiency in neonatal piglets, prevention of scoliosis due to vitamin C deficiency in salmonid fish);
    More information on nutritional disorders and acceptable related claims can be found in Appendix C.
  • Animal performance (Production) claims within a nutritional context (e.g., increased milk production from feeding a by-pass, amino acid (compared to unprotected source of the same nutrient);
  • Increased nutrient bioavailability (e.g., organic complex minerals claiming increased bio-availability compared to a certain inorganic source; enzymes such as phytases to increase available phosphorus).

Feeds can also be non-nutritive for the following purposes or claims:

  • Nutrient preservation (e.g., forage additives, mould inhibitors, feed antioxidants) not supported by a therapeutic purpose or mode of action (please see section 4.7 on Mode of Action);
  • Facilitating agents intended to aid or improve the manufacturing or handling properties of a feed (e.g., pelleting aid, anti-caking agents, etc.) not supported by a therapeutic purpose or mode of action.

Note: Products making nutritional claims on their label will require registration with CFIA prior to import, manufacture and sale in Canada. These types of claims would be permitted for feeds provided that they are supported by adequate scientific evidence that has been assessed and approved by the CFIA's Animal Feed Division (AFD).

4.5 Composition

Although the composition of a product alone does not necessarily determine its classification, the presence of an ingredient, or its level, may aid in determining the correct regulatory classification of that product.

4.5.1 Type of ingredients

The components of a product or its ingredients are assessed to determine the activity or purpose of that product. The nature of each ingredient, its intrinsic characteristics, its physical and chemical properties, the degree of modification (e.g., compound, extract, isolate) and it associated function(s) and role(s) in the product are investigated in details to provide evidence to support the intended use of a product.

Ingredients having only a nutritional function or nutritional properties (nutritional ingredient) would generally be classified as feeds. However, some nutritional ingredients may also have non-nutritional properties. For these ingredients or products, additional criteria will be considered to determine if the ingredient is therapeutic or not. Factors such as the concentration, dosage recommendations, history of use, scientific literature, advertising, indications, species, etc., may be useful in determining the particular role of an ingredient in the formulation and the intent of use of the whole product. This may result in a nutritional ingredient being considered a medicinal ingredient and the product to be classified as a drug.

4.5.2 Concentration (or level) of ingredients

The concentration, strength or level of an ingredient may be useful in determining its particular role in the formulation and the intent (or purpose) of the ingredient in the product as a whole. An ingredient may have a particular function until it reaches a certain threshold or concentration, at which point it has a pharmacological or therapeutic effect (e.g., propylene glycol 1% or less = inactive ingredient vs. propylene glycol 50% or 100% = active ingredient).

Also, a nutritional ingredient such as a vitamin or a mineral can have a therapeutic effect at a higher amount, based on the concentration in the product and dosage recommendations (e.g., calcium, iron, copper, zinc, vitamin A, vitamin C, some plants and plant oils, etc.).

4.6 Directions for use

4.6.1 Dosage recommendations/feeding rates

The recommended dosage or rate of administration of a product may assist in identifying the therapeutic or nutritional purpose of that product. For example, a very specific dosage regimen may suggest a therapeutic purpose or intended effect for a product.

The dosage recommendations can sometimes be considered by VDD for classification of products as drugs, particularly for vitamin, mineral or electrolyte products. Although very little data is available on therapeutic levels for these products, determination of actual daily dosage allows for comparison with potentially similar therapeutic products.

For feed products, the feeding rate is used to determine if the final amount of an ingredient or nutrient received by a particular species is within or higher than regulatory standards (e.g., supplementation levels recommended by NRC, Table 4 maximums, maximum limits prescribed in Schedule IV and V of the Feeds Regulations).

4.6.2 Duration of treatment/feeding & timing of administration

The duration of treatment and timing of administration criteria do not automatically lead to a drug or feed classification.

These specifics of directions for use are usually not a useful or relevant consideration for the classification of a product as a drug. They are quite varied for drug products since they are closely associated with the animal species and the disease (or condition) for which the drugs are indicated.

In general, products considered as feeds are part of a balanced feeding program and have to be fed for a reasonable period of time, on a continuous basis. The duration of mineral or vitamin supplementation may vary according to specific physiological periods in the production life of animals. For example, a nutritional product to be fed to dairy cattle in lactation or during gestation, or a mineral product fed during the first days of life for piglets, would be consistent with a feed supplementation regime.

4.7 Mode of action

In biological terms, a mode of action (MOA) refers to the mechanism or the manner in which an action, effect or result is obtained in an organism. The MOA and its effect are often related to the chemical structure of an ingredient or substance. A substance usually exhibits its action through an interaction between that substance and a cellular constituent, usually referred as a receptor, which results in a direct response, or which blocks the response to another agent. There are many specific receptor site(s) or enzyme(s) in a body that can trigger a biological response to a substance.

4.7.1 Therapeutic modes of action

A therapeutic mode of action is the specific biochemical interaction through which an ingredient (or combination of ingredients) produces a pharmacological effect. For example, acetyl salicylic acid (chemical substance) produces an irreversible inhibition of the enzyme cyclooxygenase (MOA), which suppresses the production of prostaglandins and thromboxanes (physiological effect), thereby reducing pain and inflammation (therapeutic effect).

Similarly to a pharmacological action, immunological and metabolic actions are also considered to be biochemical interactions leading to a particular biological response. An immunological action is an action in or on the body by stimulation and/ or mobilisation of cells and/or products involved in a specific immune response. A metabolic action is an action that involves an alteration, including stopping, starting or changing the speed of the normal chemical processes participating in, and available for, normal body functions.

When an ingredient or a product has an action that restores, changes or affects the physiological function(s) of an animal beyond the generally recognized physiological effects of nutrition, this action falls within the definition of a drug as per the Food and Drugs Act and is considered to be therapeutic.

MOAs consistent with drugs:

  • Indirect mechanism to stimulate appetite (e.g. stimulation of the CNS);
  • Mode of action in both feed and animals (e.g., antimicrobial substance at a high concentration);
  • Any mode of action inside the animal, not related to the digestive process;
  • Specific internal mechanism of action, such as:
    • modification of cells or cellular functions;
      (e.g., insulin stimulate cells to absorb blood glucose)
    • modification of a protein, enzyme, amino-acid, or its activity;
    • modification of an organ or its activity;
      (e.g., decrease size of thyroid or decrease its activity)
    • modification, elimination or blocking of a metabolic pathway;
  • Bio-regulation mechanisms (e.g., bio-feedback) which controls expression and/or modification of some biological components;
  • Artificial stimulation (activation) of the non-specific (innate) immune system:
    1. Recognition phase:
      • production of an increase number of immunological cells or proteins;
      • activation of the complement reactions;
    2. Elimination phase:
      • increased phagocytic activity of immunological cells;
      • increased cytotoxic activity of immunological cells;
      • increase in cellular migration and in the inflammatory reaction
        Excluding the mechanisms resulting in the development of an adaptative or acquired immunity (an immunological response or the modulation of an immune response to an infectious agent) in animals, which are associated with the veterinary biologics (e.g., vaccines, antibody products).
  • Action on the intestinal flora (substance/product not absorbed by the body and acting directly within the intestinal lumen) that may have some prophylactic/therapeutic effect.

Note: This list of acceptable modes of action for drugs is not exhaustive. Other modes of actions would require a description and further assessment for classification.

4.7.2 Nutritional modes of action

A nutritional mode of action could be defined as a process where recognized nutrientsIn the context of  feeds, a nutrient can be defined as any  substance that can be metabolized by an animal to give energy and build or  maintain tissue to meet scientifically recognized nutrient requirements. There are six types of nutrients: minerals, vitamins,  fats, protein, carbohydrates and water (when supplied at essential nutrient levels), are digested/absorbed by the animal to maintain normal physiological functions, resulting in minor differences in biological activity and without a significant and lasting change or modification on the cellular, tissue, organic and metabolic reactions of the body. This process usually results in established and recognized physiological rates of growth, maintenance and/or production characteristics for healthy livestock species.

In the context of feeds, a nutrient can be defined as any substance that can be metabolized by an animal to give energy and build or maintain tissue to meet scientifically recognized nutrient requirements. There are six types of nutrients: minerals, vitamins, fats, protein, carbohydrates and water.

MOAs consistent with feeds:

  • Action directly in the feed itself, before consumption, to improve or conserve the nutrient content of the feed , to aid or improve in the manufacturing or handling of the feed and to change the colour or smell of feeds (e.g., mould inhibitors, pellet binders, flow agents, colouring agents, flavouring agents);
  • Action limited to the normal digestive process of feeds (e.g., absorption of mineral and vitamins through the intestinal mucosa).

Note: This list of acceptable mechanisms of action for feeds is not exhaustive.

The MOA criterion may not always be a definitive one and should be evaluated in conjunction with other criteria such as the physiological particulars of the intended species (e.g., ruminants vs. non-ruminants), intent of use and concentrations of ingredients, before a final classification decision can be reached.

5. Classification decision process

We encourage sponsors to initiate the classification process of their products by using the present guidance document, flowchart and other appendices. After self-assessing that a product would be classified as a drug, they can contact the VDD for information on submission requirements. The Veterinary Drugs section of Health Canada's website can also be consulted for additional information.

Once a product is determined to be a feed, they can proceed to submit a registration application to the Animal Feed Division (AFD) of CFIA. Please refer to Next link will take you to another Web site CFIA's website for information on the registration process.

If classification questions remain or issues arise after the review of this guidance, sponsors should contact VDD, as a single-window contact for classification. VDD will consult the AFD for information sharing, discussion and a classification decision. The applicant will be informed in writing of the final decision concerning the regulatory classification of a product. Drug decisions will be communicated by VDD; feed decisions will be communicated by AFD.

A classification template has been developed to facilitate the organization and presentation by the industry of the necessary information for an accurate product classification. This template is shown in Appendix D.  To obtain an electronic version of the template, please contact VDD.

Classification requests from industry should include a cover letter, the completed template and the related supporting documentation. All classification requests should be submitted in writing (mail, e-mail or fax) to VDD at the coordinates below:

Veterinary Drugs Directorate
Health Canada
11 Holland Avenue, Suite 14
Ottawa, ON K1A 0K9
Address Locator: 3000A
Fax: 613-957-3861
Tel: 613-954-5687

e-mail: vetdrugs-medsvet@hc-sc.gc.ca

6. Reconsideration process

VDD and CFIA will create a joint classification committee in order to discuss and address industry requests for reconsideration of the regulatory classification of veterinary products. Any reconsideration request should be submitted in writing to VDD at the above address and be accompanied with a valid scientific rationale, as well as the appropriate supportive documentation.

7. Implementation

This guidance document will come into effect as of the online publication date of (effective date TBD). The publication, coordination and implementation of this guidance document of understanding will be the joint responsibility of Health Canada=s VDD and the CFIA's AFD.  For questions or additional information on the content of this document, please contact VDD.

Appendix A

Drug/Feed classification flow chart

Drug/Feed classification flow chart

N.B.: Classification is contextual and cannot always be achieved by way of yes/no answers.

Appendix B

Known medicinal ingredients

B.1 Definition: A known medicinal ingredient is a substance, part of a substance or a combination of substances associated with a therapeutic (medicinal) property or pharmacological effect, which has been scientifically studied and recognized and which has already been classified as such by Health Canada and CFIA.

B.2 List of known medicinal ingredients

Many known medicinal ingredients are already listed in the Schedule F part I and Schedule F part II of the Food and Drug Regulations. Following their regulatory approval, prescription drugs for veterinary use are listed on Schedule F, Part I and non-prescription drugs for veterinary  use appear on Schedule F, Part II. Schedule F part I and II will be repealed in a near future and replaced with a Health Canada administrative list of prescription drugs (see note below). This list should be consulted to help confirm the drug regulatory classification of a substance or product. An updated list will be available on the Internet for ease of reference.

(Internet link to be provided in future once upcoming changes to Schedule F are implemented)

(N.B.: As a result of the recent omnibus budget, Schedule F parts I and II will be replaced by an administrative drug list. It is predicted this change will come into force by the spring 2013. The details of this change are being developed and this Guidance will be updated once the administrative drug list comes into effect.)

B.3 List of substances currently classified as medicinal ingredients by VDD and CFIA

(in alphabetical order)

Many substances considered known medicinal ingredients may not appear on the above mentioned list, as it does not include all veterinary (and human) drug substances available over-the-counter (OTC) in Canada. Therefore, the list below has been created to capture the substances not listed anywhere, for which a regulatory status as medicinal ingredients, when intended for oral administration in animals, has already been determined. However, some medicinal ingredients may also have a non-medicinal purpose, depending of the concentration (level) or other factors. For your information, the list contains these "exceptions", which are ingredients listed on the Feeds Schedules IV and V in the Feed Regulations and used in feeds for non-medicinal purposes.

Important notes:

  1. The following list has been developed ONLY for the purpose of this document, in order to facilitate product classification. It should not be considered as an exhaustive and complete list. However, it is our commitment to update/revise it on a regular basis.
  2. Classifications associated with proprietary information have not been included in this list.
List of substances currently classified as medicinal ingredients by VDD and CFIA
Name of medicinal ingredient Synonym(s) Exception(s)
(as approved feed ingredients)

Table 1 footnotes

Table 1 footnote a

When associated with therapeutic claims (examples of such claims given in brackets

Return to table 1 footnote a referrer

Table 1 footnote b

When associated with a therapeutic concentration/level (determined level identified in brackets)

Return to table 1 footnote b referrer

Table 1 footnote c

When intended for use in a species with no nutritional requirement (particular species indicated in brackets)

Return to table 1 footnote c referrer

A
Achillea millefolium
(whole plant)
Yarrow, Wound wort  
Activated charcoal    
Adenosine-5-monophosphate 5-adenylic acid  
Aloe vera
(whole plant)
   
Alpha-galactosidase    
Arabinogalactan    
Arctium lappa
(whole plant, leaf, except fruit extract (antioxidant)
Burdock  
Attapulgite Table 1 footnote a, Table 1 footnote b
(a: treatment of non-infectious diarrhea in calves)
(b: 25,8 mg/kg BW and more)
  Schedule IV, item 8.118
Anticaking agent: max 0.25% finished feed
Emulsifier: max 2.5% of a liquid feed supplement
Arsenical    
B
Belladone
(homeopathic substance)
Atropa belladonna, deadly nightshade  
Bentonite Table 1 footnotea, Table 1 footnote b
(a: prevention or treatment of diarrhea)
(b: approx 400 mg/ml and more)
Next link will take you to another Web site Montmorillonite Schedule IV, items 8.5, 8.6, and 8.89
Anticaking agent or pelleting aid: max. 2% total diet
Bituminosulphonates    
Borage oil Borago officinalis seed oil  
Boswellia serrata Boswellia  
Bromelain    
C
Calcium glucoheptonate    
Calcium levulinate    
Calcium pidolate    
Calcium salts,
when sold for the treatment of hyperphosphatemia
   
Calendula officinalis
(whole plant)
Pot Marigold  
Carnitine, salts and derivatives L-carnitine, Levocarnitine L-carnitine: Schedule IV, item 5.6.16
Swine feeds: as an amino acid, max. 0.1% total ration
Carya basilike Black walnut hull powder,
Juglans nigra powder
 
Centella asiatica,
(whole plant, extract and active principles thereof)
   
Cetyl myristoleate Next link will take you to another Web site Myristoleic acid (Next link will take you to another Web site cetyl Next link will take you to another Web site ester of)  
Chamazulene Chamomille extract  
Chondroitin sulfate    
Chromium Table 1 footnote a
(for regulation of glycemia)
  Chromium Yeast dehydrated: Schedule IV, item 6.38
Approved as a source of chromium for first lactation dairy cows at a level not to exceed 0.4 mg/kg chromium in the complete feed.
Chromium proprionate: Schedule IV, item 6.47
Approved for growing swine at level not to exceed 0.2 mg/kg of chromium in the complete feed.
Coenzyme Q10    
Copper calcium edetate    
Copper glycinate    
Copper sulfateTable 1 footnote a,Table 1 footnote c
(for the treatment of aspergillosis and hexamitasis in poultry)
  Table IV: Maximum allowed in complete swine feeds is 125 ppm of copper.
Cranberry extract Table 1 footnote a, (dry)
(prevent urinary tract infections)
   
D
N, N-dimethylglycine. Dimethylglycine hydrochloride  
E
Echinacea angustifolia Echinacea purpurea, American Cone Flower, Purple Cone Flower  
Eleutherococcus senticosus Siberian Ginseng, Eleuthero  
Ephedrine hydrochloride    
Epidermal growth factor EGF  
Equisetum arvense Horsetail,  
Eucalyptus globulus
(whole plant, essential oil)
 
Eucalyptus polybractea Blue-leaf mallee  
Eupatorium perfoliatum
(whole plant)
Boneset, Feverwort, Thoroughwort  
Ergot alkaloids and their salts Claviceps purpurea  
Eurycoma longifolia Malaysian Ginseng  
F
Fenugreek cotyledon    
Filipendula ulmaria Meadowsweet  
Folic acidTable 1 footnote a, Table 1 footnote b
(a: prevention of birth defects in pregnant animals; treatment of pancreatic insufficiency, femoral thrombo-embolism; for use with drugs interfering with folate absorption; for prevention or treatment of enteritis)
Vitamin B9 Schedule IV, item 7.1.10
Vitamin: Minimum requirements (NRC) = 0.2 - 0.6 mg/kg of diet for swine and poultry (upper limit is 1000x)
G
Gamma oryzanol Table 1 footnote a
(to stimulate release of testosterone and growth hormone, antioxidant, antacid, stimulate immune system)
Rice bran oil, Rice bran extract, Oryza sativa L. Schedule IV , Part I 4.5.22
Rice bran oil
Energy feed.
Gingko biloba Gingko, Maidenhair tree  
Glucosamine hydrochloride    
Glucosamine sulfate    
L-Glutamine Table 1 footnote a
(to preserve intestinal mucosa, to help cellular repair)
   
Green-lipped mussel GLM, Perna canaliculus  
H
Hamamelis virginiana
(whole plant,extract)
Hammelis,
Witch Hazel
 
Harpagophytum procumbens Devil's Claw root  
Hemp Table 1 footnote a
(stalks, seed, oil, which contain below 0.3% THC)
(to stimulate immune system, reduce inflammation, etc.)
(over 0.3 % THC = controlled substance)
Cannabis sativa  
Hesperidin Bioflavonoid, Bioflavonoid complex, Bioflavonoid extract, Citrus bioflavonoid Schedule V, item 14.7.
Neohespiridin dihydrochalcone (a derivative of hesperidin) is approved as a flavor ingredient. Not to exceed100 ppm in the feed.
Humic acids and their sodium salts Table 1 footnote a
(immunostimulant, antiviral, antioxidant)
Humate  
Hyaluronic acid    
Hydrogen peroxide    
Hydroxocobalamin (crystalline form) Vitamin B12a  
I
Inosine    
J
Juglans nigra
(whole plant)
Black Walnut  
K
Kaolin Table 1 footnote b
(more than 2.5 % in product)
  Schedule IV, item 8.87
Anticaking agent: max. 2.5% of finished feed
L
Larch arabinoglactan    
Lobelia inflata Lobelia, Indian Tobacco  
M
Melatonine    
Methylsulfonylmethane MSM  
Milk Thistle Silybum marianum  
Mineral oil Table 1 footnote b
(concentration of 100%)
Heavy mineral oil Schedule IV, item 8.33
Dust control/lubricant:
Max. 0.6% in complete diet
Max. 3% in mineral premixes and mineral feeds
Morinda citrifolia
(whole plant,
leaves, root, fruit extract)
Noni plant  
Morus nigra Black Mulberry  
N
     
O
Oregano oil Table 1 footnote b
(50 ppm and more in complete feed)
  Schedule V, item 15.1 (Part II)
Flavouring ingredient:
Less than 50 ppm in complete feed
Oxygen (medical gas or in dosage form)    
P
Pancreatic enzymes (Amylase, lipase, protease)  
Papaver rhoeas Red Poppy Seeds, Corn Poppy  
Pau-d'arco Handroanthus impetiginosus, Red Lapacho, Taheebo, Trumpet Bush.  
Peppermint oil Table 1 footnote a
(to stimulate immune system and control instestinal bacterial overgrowth)
Mentha x piperita Schedule V, item 16.20
Flavouring ingredient:
Max. 100 ppm in the complete diet/feed
Peumus boldus Boldea fragrans  
Potassium bromide    
Propylene glycol Table 1 footnote b
(100-130 grams/cow/day around calving)
  Schedule IV, item 8.43
Emulsifying agent
Typical use rates: 0.01-0.02%
Psyllium
(whole plant, seed, husk)
Plantago ovata Schedule IV, Part II, item 8.55
Psyllium seed husk approved as a dietary source of fibre, not to exceed 2.0% of the total diet.
Q
Quercertin Elytrigia repens, Quack Grass  
Quinine hydrochloride    
Quinine sulfate    
R
Raspberry Leaves
(dry, powder)
Leaves of Rubus idaeus  
Rehmannia glutinosa Chinese Floxglove  
Rumex crispus Yellow Dock  
S
S-Adenosylmethionine SAMe  
Saw palmetto
(whole plant, liposterolic extract, fruit extract)
Serenoa repens  
Sea buckthorn
(whole plant, plant juice, fruit oil)
Hippophae rhamnoides  
Shark cartilage Squalus acanthias  
Sodium bicarbonate Table 1 footnote a   Schedule IV, item 6.71
Mineral feed: approved source of sodium for livestock feeds; also used as an ingredient in buffer feeds for dairy cows and beef cattle on high grain diets.
Sodium diacetate Table 1 footnote a
(to control salmonella in animals)
  Schedule IV, item 8.55
Used in mould inhibitor products
Sodium hyaluronate    
Sodium salicylate    
Sodium selenite Table 1 footnote a
(treatment of muscular dystrophy)
  Schedule IV, item 6.77 (Part I)
Mineral Feed: approved source of selenium. The regulatory maximum is 0.3 mg/kg in the total diet for most livestock; 0.1 mg/kg for fish and rabbits
Solidago virgaurea Golden Rod  
Spirulina maxima,
Spirulina platensis
(whole plant)
Arthrospira platensis, Blue Green Algae, AFA  
Streptococcus thermophilus extract    
Symphytum officinale Comfrey  
T
Tannic acid    
Taxifolin    
Thymus nucleic acid    
Thyroactive casein Thyroprotein  
Trimethylglycine TMG, betaine  
Tussilago farfara Coltsfoot  
U
Ulmus rubra Slippery elm  
Urtica dioica
(whole plant, extracted juice)
Common nettle, Stinging nettle,  
Uva ursi
(dry leaves, leaf powder, liquid extract)
Arctostaphylos uva-ursi,
Bear's grape, bearberry
 
V
Valeriana officinalis
(whole plant)
Valerian root  
Verbena officinalis
(whole plant)
Vervain  
Vitamin CTable 1 footnote b, Table 1 footnote c
(b: 5.5 mg/g and higher )
(c: in poultry)
L-ascorbic acid
or L-ascorbate
Schedule IV, item 7.1.2
Vitamin Product
Acceptable levels are those in accordance to NRC requirements
Vitamin K1 Phytonadione  
Vitex agnus-castus
(whole plant)
Monk's Pepper, Chasteberry, Chastetree  
W
White willow
(whole plant, stem bark)
Salix alba  
Y
     
Yucca shidigera extract Table 1 footnote a
(for osteoarthritis, for gastric disorders)
  Schedule IV, item 8.61 (Part II)
Odour control agent
Typical usage rates: 20-40 g/tonne of complete feed
Z
Zeolites Aluminosilicate minerals Schedule IV (Part II)
As an approved flow/anticaking agent: not to exceed 2% of the complete feed.
Calcium sodium aluminosilicate and Sodium aluminosilicate are listed in part I of Schedule IV as anticaking agents at a level not to exceed 2% of the complete feed.
Zinc Table 1 footnote a, Table 1 footnote b
(a: for the treatment of diarrhea)
(b: 2 mg/g (2,000 mg/kg) and higher)
  Schedule IV
Zinc oxide, as single feed ingredient (source of zinc)
Table 4 maximum: 500 mg/kg of zinc in complete feeds

Note to sponsors:

If your product contains a substance that is not present in the lists in sections B.2 and B.3 of this appendix, and you wish to ascertain the classification of this substance, the template shown in Appendix D can be submitted to VDD for classification purposes. For any additional guidance, please contact VDD.

Appendix C

Nutritional disorders

1. Definitions:

  • Disease: An impairment of the normal state of the living animal or plant body or one of its parts that interrupts or modifies the performance of the vital functions, which is typically manifested by distinguishing signs and symptoms, and is a response to environmental factors (as malnutrition, industrial hazards, or climate), to specific infective agents (as worms, bacteria, toxins, or viruses), to inherent defects of the organism (as genetic anomalies), or to combinations of these factors.
    (Reference: Merriam-Webster Medical Dictionary)

    In short, a disease refers to damage to an organ, part, structure, or system of the body such that it does not function properly or a state of health leading to such dysfunction.
    Examples: heart disease, diabetes, bile duct obstruction.
  • Nutrient: As defined under section 4.7.2 "Nutritional Mode of Actions" (second paragraph), a nutrient can be defined as any substance that can be metabolized by an animal to give energy and build or maintain tissue to meet scientifically recognized nutrient requirements. There are six types of nutrients: minerals, vitamins, fats, protein, carbohydrates and water.
  • Nutritional disorder: Condition caused by a deficiency of a particular nutrient in the feed.  It includes micro- and macronutrients of minerals and vitamins, carbohydrates, fats and proteins. Also known as nutritional deficiency disease.
    (Reference: Baillère & Tindall Veterinary Dictionary).

    Nutritional disorders can be caused by an insufficient intake of feed or of certain nutrients, by an inability of the body to absorb and use nutrients, or by overconsumption of certain feeds. Examples include anemia caused by an insufficient intake of iron, and impaired sight because of inadequate intake of vitamin A.
  • Tonic or Conditioner: As defined under Section 2. (1) Interpretation of the Feeds Regulations 1983, a tonic or condition means a mineral feed formulated and represented for the correction of a specified nutrient deficiency or to aid recovery from a specified nutrient deficiency and is for use only while the condition persists. (e.g., single-ingredient product of magnesium, or zinc).

2. Criteria:

  • Criteria for a nutritional disorder:
    1. Presence of deficiency in diet of a specific nutrient;
    2. Cause/effect relationship between clinical signs of disease and absence of     nutrient in the diet;
    3. Diet supplementation prevents and/or resolves the condition

All criteria need to be met for a condition to be considered a nutritional disorder.

Criteria Feed vs. Drug
Feed Drug
Diet deficiency Abnormal requirement from animal (deficiency due to disease state)
Interference between nutrients in diet Lack of absorption from the body
(due to disease state)
Physiological (normal) increase in animal requirements Abnormal requirement from animal
(secondary to disease)
Relevant species (species with recognized nutritional need) Species with no recognized deficiency or dietary requirement
Ingredients from approved and recognized feed source of vitamin/mineral New source may have other properties or purposes
Scientific data supporting a nutritional purpose for a specific nutrient Scientific data supporting a therapeutic (drug) purpose for a specific nutrient

If one of the above drug criteria is met, the ingredient would be excluded from a feed classification and considered a drug ingredient.

3. Table of nutritional disorders

The objective of the following table is to provide stakeholders with examples of indications (claims) associated with recognized nutritional disorders which would be acceptable for the classification of products as feeds. The disorders are nutritional deficiencies of essential minerals and/or vitamins for the specified livestock species.

Important notes:

  • Some pathological conditions are not considered to be nutritional disorders.
    Examples of such conditions are: post-parturient hypocalcemia (milk fever), acetonemia (ketosis) or pregnancy toxemia; laminitis; abomasal displacement
    ; enterotoxemia; urolithiasis (urinary calculi).
  • Only for products not involving administration by force.
  • Any treatment claim or therapeutic indication associated with these nutritional conditions (diseases) would result in the product being classified as a DRUG.
  • Prevention/correction claims would be acceptable for feeds under the following situations:
    1. Prevention:
      1. when it is intended to meet nutritional requirements, and
      2. when it is intended to prevent a nutritional disorder caused by a deficiency in one specific nutrient, by a modification of the diet.
    2. Correction:
      • when referring to the correction of a specific nutritional disorder caused by a deficiency in one specific nutrient, by modification of the diet.
    3. Nutrient supplementation from approved nutritional sources are used (i.e., Schedule IV of the Feeds Regulations)

- Please note that products making such claims on their label will require registration with CFIA prior to import, manufacture and sale in Canada.

Table of nutritional disorders
Nutritional disorders Species Acceptable indications for feeds
Ariboflavinosis or Riboflavin (vitamin B2) Deficiency Swine, poultry As an aid in the prevention of riboflavin deficiency"
Biotin Deficiency Swine, poultry, fish "As an aid in the prevention of biotin deficiency"
"Broken Back Disease"
(or "Scoliosis")
Salmonid Fish "Prevention of scoliosis due to vitamin C" deficiency in salmonid fish"
Choline Deficiency Swine, poultry, fish "As an aid in the prevention of choline deficiency"
Cyanocobalamin
(Vitamin B12 ) Deficiency
Swine, poultry "As an aid in the prevention of vitamin B12 deficiency"
Goiter Cattle, swine, poultry "As an aid in the prevention of iodine deficiency"; "Prevention of goiter due to iodine deficiency in cattle"
"Hemorrhagic Disease" Swine, poultry "As an aid in the prevention of vitamin K deficiency"
Nutritional Anemia
(Iron deficiency)
Swine, horses, poultry "As an aid in the prevention of anemia due to iron deficiency."
Nutritional Myopathy
("White Muscle Disease")
Exudative Diathesis
Cattle, goats, sheep, horses, swine, fish
Poultry
"As an aid in the prevention of vitamin E and/or selenium deficiencies"
Nutritional Secondary Hyperparathyroidism
(Osteomalacia/
Osteochondrosis)
Horses, poultry, "Prevention of calcium deficiency in horses or poultry"
Pantothenic acid (vitamin B5) Deficiency Swine "As an aid in the prevention of pantothenic acid deficiency."
Pellagra Swine, poultry "As an aid in the prevention of niacin deficiency"
Perosis & Chondrodystrophy Poultry "As an aid in the prevention of manganese deficiency"
Phosphorus Deficiency All mammalian species and poultry "As an aid in the prevention of phosphorus deficiency"
Polioencephalomalacia
or Polyneuritis
Horses, cattle, goats, poultry "As an aid in the prevention of thiamine (vitamin B1) deficiency"
Pyridoxine Deficiency Swine, poultry, fish "As an aid in the prevention pyridoxine deficiency in pigs, poultry and fish"
Rickets Cattle, swine, poultry "As an aid in the prevention vitamin D deficiency in younger (non-adult) animals"
Xerophthalmia (Night Blindness) Cattle, horses, swine, poultry "For the prevention of xerophthalmia due to vitamin A deficiency"
Zinc Deficiency Swine, horses, poultry, calves "As an aid in the in the prevention of zinc deficiency"

References:

  1. Merck Veterinary Manual 2009 and online edition.
  2. Herd Health Food Animal Production Medicine, Radostits, Leslie and Fetrow, 3rd edition 2001, and 2nd edition 1994, W.B. Saunders Company.

Appendix D

This HTML document is not a form. Its purpose is to display the information as found on the form for viewing purposes only. If you wish to use the form, you must use the alternate format below.

Help on accessing alternative formats, such as Portable Document Format (PDF), Microsoft Word and PowerPoint (PPT) files, can be obtained in the alternate format help section.

Product classification information template
(landscape format to be used for printing)

Information template for veterinary product classification requests

Notes:

  1. Please note that the information below is to be sent to VDD for classification purposes only and should not be confused with an official submission for product approval. Following the assessment of this information, VDD will provide the applicant with an official regulatory classification and the related regulatory requirements, or appropriate regulatory guidance for approval (in the case of a classification other than a veterinary drug).
  2. Please be assured that the information provided will be treated as confidential and protected at security level B.
  3. All shaded fields have to be completed by the applicant. Please indicate when a field is not applicable.
    A product classification decision will not be made without adequate and complete information being provided.

A. Mandatory Information:

(to be submitted with this document)

  • Copy of the proposed label
  • Copy of any advertising material (with source of the publication)

B. Product Information:

(to be completed by manufacturer, sponsor or consultant)

1. Brand name

2. Purpose/ Intent of use

3. Indications (claims)
(including intended species)

4. Dosage form and mode of administration

  • Tablets
  • Capsules
  • Chewables
  • Granules
  • Powder
  • Soluble Powder
  • Solution
  • Suspension
  • Concentrate
  • Cream
  • Ointment
  • Shampoo
  • Other (please specify):
  • Added to pet food/livestock feed
  • Added to drinking water
  • Direct (forced) oral administration
  • Parenteral
  • Other (please specify):

5. Complete formulation of the product

(including medicinal and non-medicinal ingredients, along with the purpose and quantitative amount of each ingredient in the formulation)

Ingredient(s)
Medicinal:
Non-medicinal
:
Purpose
Quantity

5. a) For each ingredient that is a chemical:

  1. CAS (Chemical Abstracts Service) Number:
  2. Chemical formula:

5. b) For each ingredient that is a plant, plant material or micro-organism:

  1. Common name:
  2. Latin binomial name:
  3. For plants, part(s) used:
  4. or bacteria, strain used:

5. c)

  1. If extract:
    • extraction ratio
    • crude equivalent
    • short description of manufacturing process
  2. If essential oil:
  • complete formulation (% of pure essential oil, % any other oil, etc.)

6. Mode of action
(as documented or postulated)

7. Complete directions for use and/or Dosage recommendations

8. International regulatory status, if this product is approved in another country
(e.g., Europe, Australia, United States)

9. Any other product information considered to be relevant

C. Additional Information:

(Please enclose with this document)

  • For each section, supporting documentation and references
  • Available research documentation (including source) pertaining to each active ingredient
  • List of comparable (similar) products (with labels), if available
  • Available information about the regulatory status of similar products
  • Available supporting documentation from a regulatory authority

(September 2012 version)