GAPFA DVP Guidelines DRAFT 04 2019 V2 (002)

GAPFA GLOBAL ALLIANCE OF PET FOOD ASSOCIATIONS GUIDELINES TO SUPPORT THE DEVELOPMENT OF ADEQUATE REGULATORY FRAMEWORKS FOR DIETETIC VETERINARY PETFOOD V1 – April 2019 Table of Contents Introduction 3 1. Definition of DVPs as a separate legal category 3 a. What is DVP and why is it a distinct category? 3 b. Why DVP requires specific regulatory provisions and framework 4 c. Terminology 4 d. Definition 4 2. Nutritional content and compliance criteria 5 a. Background: general nutritional guidelines 5 b. Model nutritional criteria for specific health conditions 6 3. The role of veterinarians in diets recommendation and supervision 6 Annexes – to be developed 7 Introduction The global petfood industry continues to be faced with different rules and controls across the globe for Dietetic Veterinary Petfoods (DVPs). In some countries DVPs are not yet recognised as a distinct category of petfood which may have a negative impact on pets’ health and wellness. It is therefore important to create an appropriate regulatory framework for DVPs that will help to ensure an adequate level of protection for pets’ health and wellness and to provide an appropriate level of veterinary supervision, while securing our ability to manufacture, sell and communicate about these products in markets across the globe. Well established regulatory frameworks for DVPs are in place in Japan, Australia, USA and Europe, which will help to frame future government regulations and/or industry self-regulation for these products in other markets. The purpose of this guideline is to enable national Trade Associations to engage effectively with national authorities to shape a distinct and appropriate regulatory framework for DVPs based on an aligned regulatory model and the most appropriate elements of existing standards. The regulatory model for DVPs is based on the concept that these diets are recognised as a distinct category being different from both medicines and petfood for healthy pets. An appropriate legal framework is therefore required to ensure that DVPs meet appropriate nutritional and therapeutic needs of dogs and cats based on the latest scientific and veterinary knowledge. To this end, this guideline addresses key regulatory issues providing clear direction for external advocacy by GAPFA members on: Definition of Dietetic Veterinary Petfood and reason why it requires a specific regulatory framework. Specific nutritional content and compliance criteria for each health condition. The important role of veterinarians in recommendation and supervision of Dietetic Veterinary Petfoods. Definition of DVPs as a separate legal category What is DVP and why is it a distinct category? DVP is petfood that due to its formulation is adapted to cats and dogs with impaired metabolism through adapted levels of key nutrients or a method of manufacture, but does not contain medicines. It is therefore a category clearly distinct from both medicines and petfood for healthy pets. DVPs are nutritionally adapted to (i) specific needs (such as obesity, nutrient intolerance/adverse reactions to food …) or to (ii) temporary or irreversibly reduced physiological functions (for example renal or cardiac insufficiency, intestinal absorptive disorders, diabetes…). Differently from medicines, however, DVPs do not aim to cure a disease and do not prevent medical treatment if required by the health condition of the animal. Nevertheless DVPs are adapted to the specific nutritional requirements of pets with impaired metabolism in order to enhance the well-being and to help maintain the pet’s health taking into account the specificity of the pet’s condition. To that extent DVPs are going beyond the provision of a balanced and complete nutrition, which is the main purpose of petfood manufactured and marketed for healthy pets. Why DVP requires specific regulatory provisions and framework The legal framework that applies to petfood for healthy animals is not always applicable to DVPs and the specific characteristics and intended purpose of these diets justify a specific framework. For example, the maximum level of phosphorus that is appropriate for a pet with chronic kidney disease (CKD) is significantly lower compared to the level of phosphorus typically found in petfoods for healthy pets. Feeding an ill animal with petfood that is not adapted to CKD may in this case potentiate and worsen the animal’s condition. In addition, it is important to guarantee that claims made by DVPs are in line with recent scientific knowledge and may be subject to certain level of scrutiny that can be better achieved if clear criteria for these diets are set, ideally through legislation. Care should be taken by regulators to ensure that products marketed as DVPs have a beneficial effect on the animals that ingest them and that any claims made can be substantiated. However unnecessary burdens on manufacturers and excessive pre-market approval requirements as imposed to medicines have to be eluded given the fact that DVPs do not include substances with pharmacological effects regarded as drugs. In view of the above GAPFA supports a specific regulatory framework for DVPs that adequately addresses the key issues covered by the present document, bearing in mind the need to adapt the specific provisions to the overall local legal framework in individual markets. Terminology The term “Dietetic Veterinary Petfood” has been chosen to expresses the main elements of the category, i.e.: The term “Dietetic” refers to the specific nature of these diets The term “Veterinary” establishes a link to the important role that should be played by veterinarians in the recommendation and supervision of these diets, as is currently the case in the USA. At the same time, this term avoids any explicit reference to ‘therapeutic’, ‘prescribed’ or other similar terms that may suggest a closer connection to medicines. This terminology does not find correspondence in existing legal frameworks yet. The final terminology to be used may need to be adapted to the local circumstances and it is not decisive that this will be the terminology chosen. Definition The need for a definition of DVPs in the legislation may depend on the concrete circumstances. However, it is always important to ensure clarity in the communication of the scope of the regulatory framework intended and for that purpose a clear definition will be important independently of whether it will be as such integrated into the legislative text. Definition to be developed. Nutritional content and compliance criteria Background: general nutritional guidelines Complete and balanced petfoods are formulated to meet nutritional requirements recommended for the corresponding life-stages. Two fully developed and periodically reviewed, practical nutritional guidelines are established and widely recognized: In the EU, the European Petfood Federation (FEDIAF, found at www.fediaf.org) has developed FEDIAF Nutritional Guidelines for Cats and Dogs (FEDIAF). This is a complete set of guidelines, available online and reviewed on a regular basis based on existing and new research. In the US, the Association of American Feed Control Officials (AAFCO, found at www.aafco.org) annually publishes its Official Publication (AAFCO), which contains a complete set of methods for nutritional adequacy substantiation along with a recommended set of nutrient profiles for products at various life stages. The AAFCO and FEDIAF nutritional guidance are complete and available to be utilized by regions/associations looking to establish nutritional guidelines for cat and dog food products, as recommended by GAPFA. FEDIAF and AAFCO guidelines must each individually be considered in their entirety and used as a whole, because each system has its own set of internal assumptions. The above considerations, however, only apply to petfoods for healthy animals and are not directly applicable to DVPs, which may apply different essential nutrient specifications depending on the intended use of the products. Various diseases and pathologic processes can modify metabolic pathways in pets, therefore modifying their nutritional needs. DVPs take these specific nutritional needs into account. Specific nutritional criteria which will differ from general guidance are therefore required for these products. DVPs are designed to address a range of health conditions, notably: Chronic insufficiencies: renal, cardiac, liver Regulation of glucose supply (Diabetes mellitus) Reduction of copper in the liver Reduction of ingredient and nutrient intolerances Urinary stones: struvite, oxalate, cysteine, urate Reduction of acute intestinal absorptive disorders, maldigestion Regulation of lipid metabolism (hyperlipidaemia) Reduction of excessive bodyweight Nutritional restoration, convalescence Support of skin function (dermatosis) Model nutritional criteria for specific health conditions Proposed approach In view of the above, clear nutritional criteria for each health condition should be established in order to promote legal certainty at the same time that an adequate level of protection for the pet’s health is ensured. Given that each DVP is designed for a particular use and is therefore different from other products, the nutritional criteria for DVPs should be established through a positive list that clearly indicates the authorised associated health claims and the nutritional characteristics required to substantiate them. Reference to EU PARNUTs regulation – tbd How to address the entry of new products into the market outside of existing PARNUTs? Should provide an approach here The role of veterinarians in diets recommendation and supervision As mentioned above, DVPs are very different from petfood for healthy animals as it is nutritionally adapted to specific needs or to temporary or irreversibly reduced physiological functions. Veterinary supervision therefore plays a key role to ensure that a DVP to be consumed by a dog or cat is appropriate, is correctly administered and fulfils its purpose. Incorrect use of these diets may have a - potentially serious - negative impact on the animal’s health and pet owners on their own are not well placed to make the necessary judgments. In particular: Use of a DVP in sick puppies or kittens requires a tailored veterinary assessment of benefits versus risk ratio; Use of a DVP based on a wrong (self-made) diagnosis could be detrimental to pets; Use of a DVP without having been informed of accompanying recommendations can potentially mislead the pet owner on diet efficacy; Use of a DVP without having been informed of accompanying recommendations may worsen the disease signs; Choice of a DVP for a dog or cat with multiple pathologies generally requires a veterinary assessment of respective severity of each disease. The regulatory framework for DVPs in a market should therefore reflect the important role played by veterinarians. This may be achieved either by a legal requirement that mandates veterinarian supervision for the sale of DVPs or through industry standards or other enforcement mechanisms that may be foreseen at local level. Annexes – to be developed Overview of DVP regulatory framework and standards in selected countries Country by country overview Labelling requirements Route to market – pre-market approval vs ex-post controls How to use the guidelines / stakeholder engagement strategy Key messages