Animal Pharm Reports
Nutraceuticals for Companion Animals
Published October 2005
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CHAPTER 1 - INTRODUCTION
Based on the knowledge that diet and health are closely linked, nutritional preparations have been used for healing purposes for thousands of years in many cultures, such as the Indian or the Chinese. In today’s Western culture, a new trend in nutrition developed in the 1990s. An ever-growing number of nutritional supplements and functional foods are becoming available not only from health professionals but also from supermarkets and health and pet shops. In North America, this new type of product was named ‘nutraceutical’, meaning a food that has the properties of a medicinal product. The new trend for self medication via nutritional means in the human field has led to an according demand from the general public as well as from veterinary professionals for dietary and complementary feed supplements for use in animals, particularly in pets and horses.
One of the major problems when dealing with this new type of product from a regulatory and marketing point of view is the fact that there is no consensus on terminologies. Terms such as ‘nutraceuticals’, ‘functional foods’, ‘dietary supplements’, ‘nutritional supplements’ and ‘health foods’ are used to describe food products with specific health benefits. Some of these terms have statutory definitions, but the most do not.
The term nutraceutical was created in 1989 by Steven DeFelice, founder and chairman of the Foundation for Innovation in Medicine (FIM), Cranford, NJ, from the words ‘nutrition’ and ‘pharmaceutical’. DeFelice defined it as ‘a substance that may be considered a food or part of a food and that provides medical or health benefits, including the prevention and treatment of disease’. In his view nutraceutical products include formulations of isolated nutrients, as well as dietary supplements, diets and herbal preparations.
In the US and Canada the term nutraceutical has been broadly accepted in the nutrition and science community as well as in the general media, although it has not yet been embodied from a regulatory point of view. There is a trend to differentiate products within the sector into nutraceutical ingredients and nutraceutical foods. Generally, the term nutraceutical is increasingly used for product sold in pills, powders and other medical formulations not generally associated with food and demonstrated to have a physiological benefit or to prevent disease. On the other hand food preparations that provide such benefits are more commonly referred to as functional or fortified foods.
In the veterinary field, the North American Veterinary Nutraceutical Council (NAVNC), a non-statutory body formed in 1996, defined a veterinary nutraceutical as ‘a non-drug substance which is produced in a purified or extracted form and administered orally to a patient to provide agents required for normal body structure and function and administered with the intent of improving the health and well-being of animals’.
Table 1.1: FDCA definitions
| Term | Definition |
| Food | An article used for food or drink for man or other animals, including articles that provide taste, aroma, or nutritive value |
| Food additive | A substance that directly or indirectly becomes a component of or affects the character of foods |
| Drug | Any substance, food or non-food, that is used to treat, cure, mitigate or prevent a disease or any non-food substance that is intended to affect the structure or function of the individual |
This definition is largely based on the attempt of the NAVNC to differentiate nutraceuticals from foods, food additives and drugs as defined in the US Food, Drug and Cosmetic Act (FDCA, see Table 1.1). In contrast to the original definition of nutraceuticals in the human field, the NAVNC definition does not state that nutraceuticals are intended for disease prevention or treatment. This is the key distinction between nutraceuticals and drugs.
Outside the US, the word nutraceutical has only been adopted sporadically. For example in Europe it is still more common to use the terms nutritional or dietary supplement to describe products such as tablets, capsules, powders, liquids or extracts, which are intended to supplement the normal diet in order to enrich it with or increase the intake of certain food ingredients.
The term ‘functional food’ was first introduced in Japan in the mid-1980s. To date, Japan is the only country that has formulated a specific regulatory approval process for this group of products. In the jurisdiction of the country, the term ‘functional food’ has been replaced by ‘foods for specified health use’. In other countries, the term does not have any official or regulatory status. However, in some countries it is commonly used by the dietary profession and by the industry. Functional food often is considered to have the same connotation as ‘nutraceutical’ or to be a subclass of the latter, being a nutraceutical that provides benefits beyond basic nutrition. However, where the term nutraceutical is defined as a purified substance presented in a dosage form (see NAVNC definition above), the term functional food can clearly be differentiated from that, being a product that is actually consumed in food form. In many countries it is much more common to use the traditional term ‘diet’ instead of functional food, and to attach prefixes to it as appropriate, eg ‘medical diet’ or ‘prescription diet’, or ‘veterinary diet’ in the animal health field.
Herbal supplements, also referred to as herbs, botanicals or herbal remedies, overlap with nutritional and dietary products. They often involve medical claims and include both phytonutrients (ie substances without a pharmaceutical effect) and phytomedicines.
In summary, the various categories of nutraceuticals can be thought of as lying on a food-drug continuum, as shown in Table 1.2. The groupings along this continuum have distinct characteristics, although there may be significant overlaps between groups.
Table 1.2: Food-drug continuum
| Category | Description | |
| Conventional foods | Fresh or processed foods that provide nutrients | Increasing regulation; increasing effect on metabolism; increasing unit cost |
Fortified foods | Conventional foods with added nutrients, eg high-calcium milk | |
| Functional foods | Foods with a nutritional composition that provides health benefits beyond those available from basic nutrition | |
| Dietary supplements | Purified substances that can be added to the normal diet in order to provide health benefits | |
| Over-the-counter (OTC) drugs | Pharmaceutically active ingredients which are available without prescription because they have a track record of being used safely by the public | |
| Prescription drugs | Pharmaceutically active ingredients that are only available only with a prescription from a medical professional |
1.2 History
While functional foods are a relatively new phenomenon in Western cultures, they were recognised by traditional Chinese medicine (TCM) as long ago as 1000 BC. Since then, their use in the prevention and treatment of disease, as well as maintenance and improvement of health, has been an integral part of TCM. However, despite their proven effectiveness, the active components were little understood. Research is now being conducted to investigate the underlying modes of action of these compounds.
The term ‘functional food’ was first used by the Japanese Ministry of Education, Science and Culture in 1984, when the country became aware of the health problems of an aging population. At the same time, there was an increased awareness that certain foods could be useful in combating many chronic diseases. The Japanese realised the value of providing funding for basic research relating to food and health matters, and set up a mechanism whereby food manufacturers could receive official approval for the health claims they intended to make concerning their food products. Based on scientific evidence available at the time, 11 categories of foods or ingredients with potential health benefits were identified. These ranged from dietary fibre to lactobacteria and to minerals.
In 1991, the Japanese Ministry of Health and Welfare developed a policy which permitted manufacturers of certain foods to label their product as a ‘food for specific health use’, or FOSHU. The labelling was dependant on the fulfilment of criteria laid down by the Ministry, and meant that the consumer could be assured that the product would be expected to have a specific effect on health. During the first five years of this regulation being in place, 69 products were approved as FOSHU.
By 1989, the spotlight had moved to the US when the term ‘nutraceutical’ was coined by Dr Stephen DeFelice, founder and chairman of the FIM. However, the development of a nutraceutical industry in the US was delayed by the Nutrition Labeling and Education Act (NLEA) and the strict Food and Drug Administration’s (FDA) definition of the term ‘drug’. The turning point came in 1994, when the Dietary Supplement Health and Education Act (DSHEA) was passed by Congress. This Act allows claims to be made about the ability of a food or dietary supplement to affect the structure and/or function of the human body. This law offers a path for the human food industry to launch new products with health benefits, and to communicate their benefits to customers.
During the 1990s Dr DeFelice and the FIM have been promoting public awareness of nutraceuticals in the US and in advocating clinical research to prove the efficacy of nutraceuticals and thus grow the industry (DeFelice, 1995). The FIM introduced the Nutraceutical Research and Education Act (NREA) in Congress in October 1999. The NREA created a new legal category within foods. Following this Act, manufacturers could promote a direct health benefit claim for functional foods, based on proven clinical evidence. In addition, the company would be granted 10 years of exclusive marketing rights to the claim. This, of course, is comparable to, but shorter than, the period of patent protection.
The DSHEA has opened up the market for human nutraceuticals in the US, but the regulatory situation in the EU remains more restricted. Claims that a food is capable of preventing, treating or curing disease are banned for food products.
1.3 Nutraceuticals, feed additives and target animal species
Feed additives and nutraceuticals are two terms that describe the same type of products in the context of commercial livestock, ie non-drug substances fed to animals to improve their health. Feed additives are of course governed by long-established regulations. These comprise safety and efficacy studies (as for drugs) and residue studies to determine whether the food derived from these animals would be safe for human consumption.
Nutraceuticals, although consisting of a similar range of products, refers exclusively to additives given to companion animals. The market is dominated by dogs. Cats represent a much smaller market and there are also niche pet segments where appropriate food may be hard to obtain due to the small size of the market and nutritional supplements may be recommended, eg the calcium supplements given to some reptiles. Horses are also given nutritional supplements, especially those that are kept for high performance sports (racing, equestrian events). The distinction between legal supplements and illegal drugs is as important as it is with human athletes.
1.4 Comparisons between nutraceuticals for human and for animals
Nutraceutical products marketed for use in animals are largely the same as those that can be found in the human sector. These are the widely used vitamins, minerals and amino acids. The amino acid taurine, however, which does not play a significant role in human nutrition, is an essential substance for cats to prevent dilated cardiomyopathy (DCM) and is widely used as a supplement.
Joint health supplements, which mainly comprise the cartilage constituents, glucosamine and chondroitin sulphate, as well as the sulphur-donator, methyl-sulphonyl-methane (MSM), represents a major segment of nutraceuticals in both the human and the animal sector. Osteoarthritis (OA) and related arthralgic conditions are common problems in pets due to age, and particularly in dogs of large and heavy breeds. They are also common conditions in horses that are involved in sports such as racing, eventing and endurance competitions. Indeed, in the US, the use of glucosamine was common in animals before it became the subject of interest in treating human joint conditions. Essential fatty acids (EFAs) are also significant in humans and animals. Intended for use in inflammatory conditions, such as skin allergies and joint problems, the use and particularly the optimal balance between the main types of unsaturated fatty acids has become an area of considerable interest in both sectors.
Whilst there is significant overlap between the two industries of nutraceuticals for humans and animals in terms of products, they remain separate industries in terms of regulations, marketing and suppliers. Manufacturers of nutraceuticals for companion animals are distinct from those who manufacture for the human market.
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