Unlike human medicine, where new scientific findings have led to a resurgence in the use of medicinal plants in drug treatment in recent years, significantly less recent scientific data and documentation on the effect and dosage of medicinal plants and medicinal plant preparations are available in veterinary medicine. Consequently, in veterinary medicine, what is known about the desired and undesirable effects of medicinal plants is based largely on traditionally handed-down empirical knowledge or on observational studies with animals. In many cases, insufficient consideration is given to the differences that are specific to animal species, while the inadmissibility of directly transferring therapeutic results from humans to different, or even all, animal species is disregarded. Such differences primarily involve the indications for, and dosage, absorption and metabolism of, herbal active substances by animals (e.g. ruminants, omnivores or carnivores). These are compounded by specific intolerabilities for herbal substances within the various animal species and animal groups.
The issue of delimitation is not just a purely theoretical question, since the assignment of a product to the various categories also has far-reaching consequences. Accordingly, the requirements governing manufacturing, processing, advertising, promotion, distribution, dispensing and monitoring of a product are regulated differently in legislation governing animal feed and medicinal products. The authorities responsible for enforcement also differ, as do the measures and sanction options available to them. Last but not least, an authorisation procedure is required for medicinal products. For these reasons, correct classification is crucially important for the manufacturer / distributor of the product.
A product that falls in the overlap between legislation on animal feed and medicinal products is always subject to one of the two laws. However, this does not mean that the product concerned can also actually be marketed as a veterinary medicinal product or animal feed. In fact, it is entirely possible that a product classified as an animal feed and accordingly subject to animal feed legislation cannot be marketed because it does not satisfy the relevant statutory standards governing animal feed. The opposite situation is also conceivable (a veterinary medicinal product cannot be marketed as such because, for example, the applicant was not able to provide the required proof of efficacy in the intended indication and animal species). In isolated cases therefore, products may fall within the scope of legislation on medicinal products or animal feed but fail to satisfy the corresponding requirements, meaning that they cannot be marketed under either set of legislation.
The Swiss Agency for Therapeutic Products, Swissmedic, and the official feed inspection division of Agroscope jointly review the classification criteria. The important factors covered by this review are the purpose and use of the product, the pharmacological and nutritional properties of the ingredients and product promotion1. Whether a specific product is ultimately classified as a veterinary medicinal product or animal feed must be determined on a case-by-case basis taking account of all factors (composition, manufacture, intended purpose, promotion, presentation, labelling and intended animal species).
Example: A plant cannot be universally classified as a veterinary medicinal product or animal feed. A classification always relates to a single, specific product and takes all factors into account (concentration of the plant in the product, plant or e.g. plant extract, intended purpose, nutritional purpose / nutrient content, presentation, promotional claims/advertising, intended animal species, pet or farm animal etc.) Once the product has been assigned a category and is thus subject to a particular set of legislation, the question then arises as to its marketability under this legislation. It is thus conceivable that the product is classified as an animal feed, but cannot be marketed as such because it does not meet the requirements of animal feed legislation.
1 Swiss Fed. Admin. Court ruling C-4612/2011 of 29 October 2013
