Operational Notice - Natural Products Which Modify Joint Health: Are they Veterinary Medicines?
October 2004
Which Products Require Registration?
A product requires registration if it fits the definition of a veterinary chemical product (VCP) in the Agvet Code.
Section 5(2) of the Agvet Code states that a veterinary chemical product is a substance or mixture of substances that is represented as being suitable for, or is manufactured, supplied or used for administration or application to an animal by any means, or consumption by an animal, as a way of directly or indirectly:
- preventing, diagnosing, curing or alleviating a disease or condition in the animal or an infestation of the animal by a pest; or
- curing or alleviating an injury suffered by the animal; or
- modifying the physiology of the animal so as to alter its natural development, productivity, quality or reproductive capacity or so as to make it more manageable; or
- modifying the effect of another veterinary chemical product.
Therefore a product requires registration if it makes a claim that fits the definition of a veterinary chemical product, or it contains ingredients that are used for a purpose that fits the definition of a veterinary chemical product, or both.
The Agvet Code legislation states that a veterinary chemical product does not include a substance or mixture of substances that is:
- prepared by a pharmacist in accordance with instructions of a veterinary surgeon; or
- prepared by a veterinary surgeon;
in the course of the practice, by the person preparing the substance or mixture of substances, of his or her profession as permitted by or under a law of this jurisdiction.
That is, where the relevant state legislation allows an unregistered veterinary medicine to be used by a veterinary surgeon to treat animals, the use of the substance/s will be permitted under the Agvet Code legislation.
Do Products Containing Constituents Derived from Natural Sources and Used to Modify Joint Health Require Registration?
Products applied, administered or fed to animals to modify joint health (structure/function) and containing ingredients derived from natural sources will require registration if:
- they claim to modify health, production, performance or behaviour of animals; or
- they are manufactured and supplied for the purpose of modifying the health, productivity, performance or behaviour of animals; or
- they are used for the purpose of modifying the health, productivity, performance or behaviour of animals.
Products that are administered parentally, or are applied topically to tissue other than skin (e.g. ear, eye, nose or throat), are always considered veterinary medicines and therefore require registration.
Products that have undergone processing such as extraction or fractionation to refine and/or concentrate particular components will generally require registration, unless evidence is available that their purpose is as a food, exempt food additive, or cosmetic.
Products made from whole plant or animal material and administered in feed or applied to the skin of animals, that do not claim to modify the health, productivity, performance or behaviour of animals, or do not claim to contain biologically active constituent/s, generally do not require registration, unless specified as a veterinary medicine by the APVMA.
Do products containing glycosaminoglycan (GAG), or like substances, or their precursors, require registration?
Products containing glycosaminoglycan (GAG) or like substances or their precursors, including hyaluronic acid, polysulfated glycosaminoglycan (PSGAG), pentosan polysulfate (PPS), chondroitin sulfate and glucosamine are considered to be veterinary medicines. Products containing whole green-lipped mussel (GLM), shark cartilage or abalone are also considered to be veterinary medicines because they contain significant levels of GAG.
There is good evidence available that increasing the level of GAG in joint tissues will assist in the repair of damaged joint tissues and reduce inflammation associated with non-infectious joint disease in animals. GAGs are present as active constituents in several registered products for direct injection into the joints or by parenteral injection for the treatment of joint diseases in animals.
There is some evidence available that feeding GAGs to animals, particularly glucosamine and chondroitin sulfate, will also increase the level of GAGs in joint tissues. Glucosamine, chondroitin sulfate, green-lipped mussel, shark cartilage or abalone are present as active constituents in registered products for oral administration as they may aid in the prevention and treatment of non-infectious joint diseases in animals.
These products fit the definition of a veterinary chemical product regardless of any representations or claims, and require registration by APVMA.
If evidence can be provided that the purpose of the whole green-lipped mussel (GLM), shark cartilage, bovine tracheal cartilage or abalone is to balance the diet and provide normal levels of nutrient, this will be considered on a case-by-case basis once the relevant product information is submitted (please refer to the guideline on “Does My Product Require Registration” on the APVMA website). As a guide, where the GAGs are present in a pet diet or stock food and are not associated with a claim or do not identify ingredients listed above and where the levels are below that which would yield 8 mg/kg bodyweight/day GAGs when consumed according to recommended feeding rates, the product will not require registration. The APVMA will accept levels determined according to Blumenkrantz N and G Asboe-Hansen (1973) Analytical Biochemistry 54 : 484-489 for these purposes.