Nutraceutical, a portmanteau of the words “nutrition” and “pharmaceutical”, is a food or food product that reportedly provides health and medical benefits, including the prevention and treatment of disease. Health Canada defines the term as "a product isolated or purified from foods that is generally sold in medicinal forms not usually associated with food. A nutraceutical is demonstrated to have a physiological benefit or provide protection against chronic disease."[1] Such products may range from isolated nutrients, dietary supplements and specific diets to genetically engineered foods, herbal products, and processed foods such as cereals, soups, and beverages. With recent developments in cellular-level nutraceutical agents, researchers, and medical practitioners are developing templates for integrating and assessing information from clinical studies on complementary and alternative therapies into responsible medical practice.[2] The term nutraceutical was originally defined by Dr. Stephen L. DeFelice, founder and chairman of the Foundation of Innovation Medicine (FIM), Crawford, New Jersey.[3] Since the term was coined by Dr. DeFelice, its meaning has been modified by Health Canada which defines nutraceutical as: a product isolated or purified from foods, and generally sold in medicinal forms not usually associated with food and demonstrated to have a physiological benefit or provide protection against chronic disease. Examples are beta-carotene and lycopene.[4] The definition of nutraceutical that appears in the latest edition of the Merriam-Webster Dictionary is as follows: A food stuff (as a fortified food or a dietary supplement) that provides health benefits.[5] Nutraceutical foods are not subject to the same testing and regulations as pharmaceutical drugs.[3] The American Nutraceutical Association works with the Food & Drug Administration in consumer education, developing industry and scientific standards for products and manufacturers, and other related consumer protection roles. The FDA provides a list of dietary supplement companies receiving warning letters about their products.[6]
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Nearly two-thirds of the American population takes at least one type of nutraceutical health product. The use of nutraceuticals, as an attempt to accomplish desirable therapeutic outcomes with reduced side effects, as compared with other therapeutic agents has met with great monetary success. The preference for the discovery and production of nutraceuticals over pharmaceuticals is well seen in pharmaceutical and biotech companies. Some of the pharmaceutical and biotech companies, which commit major resources to the discovery of nutraceuticals include Monsanto, American Home Products, Dupont, Abbott Laboratories, Warner-Lambert, Johnson & Johnson, Novartis, Metabolex, Genzyme Transgenic, PPL Therapeutics, Unigen, and Interneuron.[7] The nutraceutical industry in the US is about $86 billion. This figure is slightly higher in Europe and, in Japan, represents approximately a quarter of the $6 billion total annual food sales. 47% of the Japanese population consume nutraceuticals.[8] Even without specific financial figures, business reports continually suggest that the market is consistently growing.
One possible explanation for the growth of nutraceuticals in the United States is the aging baby-boomer population. As the average age of the citizens continues to rise, the population increases its focus on health and wellness. By halfway through the 21st century, there could be almost 142 million Americans over the age of 50, based on a projected population of nearly 400 million citizens.[9]
Although the price of some nutraceuticals may drop as generic products make their way into the market, people’s dependence on these products and their increasing availability suggests that the growth of the market shall remain stable.
The Indians, Egyptians, Chinese, and Sumerians are just a few civilizations that have provided evidence suggesting that foods can be effectively used as medicine to treat and prevent disease. Ayurveda,the 5,000 year old ancient Indian health science, have mentioned benefits of food for therapautic purpose. Documents hint that the medicinal benefits of food have been explored for thousands of years.[9] Hippocrates, considered by some to be the father of Western medicine, said that people should “Let food be thy medicine.”
The modern nutraceutical market began to develop in Japan during the 1980s. In contrast to the natural herbs and spices used as folk medicine for centuries throughout Asia, the nutraceutical industry has grown alongside the expansion and exploration of modern technology.[10]
New research conducted among food scientists show that there is more to food science than what was understood just a couple decades ago.[10] Until just recently, analysis of food was limited to the flavor of food (sensory taste and texture) and its nutritional value (composition of carbohydrates, fats, proteins, water, vitamins and minerals). However, there is growing evidence that other components of food may play an integral role in the link between food and health.
These chemical components are derived from plant, food, and microbial sources, and provide medicinal benefits valuable to long-term health. Examples of these nutraceutical chemicals include probiotics, antioxidants, and phytochemicals.
Nutraceutical products were considered alternative medicine for many years. Nutraceuticals have become a more mainstream supplement to the diet, now that research has begun to show evidence that these chemicals found in food are often effective when processed effectively and marketed correctly.
Nutraceuticals is a broad umbrella term used to describe any product derived from food sources that provides extra health benefits in addition to the basic nutritional value found in foods. Products typically claim to prevent chronic diseases, improve health, delay the aging process, and increase life expectancy.[11]
There is minimal regulation over which products are allowed to display the nutraceutical term on their labels. Because of this, the term is often used to market products with varying uses and effectiveness. The definition of nutraceuticals and related products often depend on the source. Members of the medical community desire that the nutraceutical term be more clearly established in order to distinguish between the wide varieties of products out there.[7] There are multiple different types of products that may fall under the category of nutraceuticals.
A dietary supplement is a product that contains nutrients derived from food products that are concentrated in liquid or capsule form. The Dietary Supplement Health and Education Act (DSHEA) of 1994 defined generally what constitutes a dietary supplement. “A dietary supplement is a product taken by mouth that contains a "dietary ingredient" intended to supplement the diet. The "dietary ingredients" in these products may include: vitamins, minerals, herbs or other botanicals, amino acids, and substances such as enzymes, organ tissues, glandulars, and metabolites. Dietary supplements can also be extracts or concentrates, and may be found in many forms such as tablets, capsules, softgels, gelcaps, liquids, or powders.”[12]
Dietary supplements do not have to be approved by the U.S. Food and Drug Administration (FDA) before marketing. Although supplements claim to provide health benefits, products usually include a label that says: “These statements have not been evaluated by the Food and Drug Administration. This product is not intended to diagnose, treat, cure, or prevent any disease.”
Functional foods are designed to allow consumers to eat enriched foods close to their natural state, rather than by taking dietary supplements manufactured in liquid or capsule form. Functional foods have been either enriched or fortified, a process called nutrification. This practice restores the nutrient content in a food back to similar levels from before the food was processed. Sometimes, additional complementary nutrients are added, such as vitamin D to milk.
Health Canada defines functional foods as “ordinary food that has components or ingredients added to give it a specific medical or physiological benefit, other than a purely nutritional effect.”[4] In Japan, all functional foods must meet three established requirements: foods should be (1) present in their naturally-occurring form, rather than a capsule, tablet, or powder; (2) consumed in the diet as often as daily; and (3) should regulate a biological process in hopes of preventing or controlling disease.[13]
Medical foods aren’t available as an over-the-counter product to consumers.[14] The FDA considers medical foods to be “formulated to be consumed or administered internally under the supervision of a physician, and which is intended for the specific dietary management of a disease or condition for which distinctive nutritional requirements, on the basis of recognized scientific principles, are established by medical evaluation.”[13] Nutraceuticals and supplements do not meet these requirements and are not classified as Medical Foods.
Medical foods can be ingested through the mouth or through tube feeding. Medical foods are always designed to meet certain nutritional requirements for people diagnosed with specific illnesses. Medical foods are regulated by the FDA and will be prescribed/monitored by medical supervision.
According to a report written for the United States Congress entitled "Agriculture: A Glossary of Terms, Programs, and Laws", “(Farmaceuticals) is a melding of the words farm and pharmaceuticals. It refers to medically valuable compounds produced from modified agricultural crops or animals (usually through biotechnology). Proponents believe that using crops and possibly even animals as pharmaceutical factories could be much more cost effective than conventional methods (i.e., in enclosed manufacturing facilities) and also provide agricultural producers with higher earnings…
“At issue in the United States has been whether the current system for regulating biotechnology is adequate for ensuring the safety (to humans, animals and crops, and the environment) of newly emerging applications, such as farmaceuticals… The term farmaceuticals is more frequently associated, in agricultural circles, with medical applications of genetically engineered crops or animals.”[15]
The following is an incomplete list of foods with reported medicinal value:
In addition, many botanical and herbal extracts such as ginseng, garlic oil, etc. have been developed as nutraceuticals. Nutraceuticals are often used in nutrient premixes or nutrient systems in the food and pharmaceutical industries.
Unlike pharmaceutical drugs, within the United States, nutraceutical products are widely available and monitored with the same level of scrutiny as "dietary supplements". Within the oversight of the Federal Food & Drug Administration, unlike many other countries such as Canada, the use of broad-based definitions creates inconsistent credibility distinguishing the standards, function, and effectiveness between "nutraceuticals" and "dietary supplements". Within this loose regulatory oversight, legitimate companies producing nutraceuticals provide credible scientific research to substantiate their manufacturing standards, products, and consumer benefits and differentiate their products from "dietary supplements".
Despite the international movement within the industry, professional organizations, academia, and health regulatory agencies to add specific legal and scientific criterion to the definition and standards for nutraceuticals, within the United States the term is not regulated by FDA. The FDA still uses a blanket term of "dietary supplement" for all substances without distinguishing their efficacy, manufacturing process, supporting scientific research, and increased health benefits.
In 2005, the National Academies Institute of Medicine and National Research Council created a blue-ribbon committee to create an improved framework for the Federal Food & Drug Administration to evaluate dietary supplements. Though the improved framework fails to distinguish between "nutraceuticals" and "dietary supplements". With the continued use of a broad definition and lacking greater distinction, a cost-effective and scientifically based framework was needed to evaluate the safety of "dietary supplements" including those consumer products recognized internationally as "nutraceuticals".[18]
In the global market, there are significant product quality issues[19] Nutraceuticals from the international market may claim to use organic or exotic ingredients, yet the lack of regulation may compromise the safety and effectiveness of products. Companies looking to create a wide profit margin may create unregulated products overseas with low-quality or ineffective ingredients.
Bioavailability, which can be thought of as the "absorption rate" of a supplement product, is one of the main challenges in finding effective nutraceutical products. Among unprocessed foods, not all foods are broken down and digested as effectively. Nutraceuticals with poor absorption rates results in nutrients being disposed from the body without providing any nutritional or medicinal benefit.
Similar to pharmaceuticals, part of the effectiveness of nutraceuticals may be attributed to the placebo effect. Consumers using nutraceuticals may inaccurately credit their use of nutraceuticals for healing illness, when the body is often able to recover on its own. Opponents to this argument -Such as Nobel Prize winning chemist Linus Pauling and Dr.Abrahm Hoffer (Phd & Md)- state that the availability of these nutrients may in fact encourage the healing mechanism; sick individuals may require more nutrients to "trigger" the mechanism.[20]