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What are Nutraceuticals?
A nutraceutical is a food with a medical-health benefit, including the prevention and treatment of disease.
The term was coined in the late 1980s by Stephen DeFelice, M.D., founder and chairman of the Foundation for Innovation in Medicine.
Such foods also commonly are referred to as functional foods, signifying they and/or their components may provide a health benefit beyond basic nutrition. Examples include fruits and vegetables as well as fortified or enhanced foods. While all foods are functional in that they provide nutrients, nutraceuticals contain healthpromoting ingredients or natural components that have a potential health benefit for the body. “Functional” attributes of many traditional foods are being discovered, while new food products are being developed with beneficial components.
The concept of nutraceuticals is not entirely new, although it has evolved considerably over the years. In the early 1900s, food manufacturers in the United States began adding iodine to salt in an effort to prevent goiter (an enlargement of the thyroid gland), representing one of the first attempts at creating a functional component through fortification. Today, researchers have identified hundreds of compounds with functional qualities, and they continue to make new discoveries surrounding the complex benefits of phytochemicals (non-nutritive plant chemicals that have protective or disease preventive properties) in foods.
Nutraceuticals are hugely popular among consumers in the U.S. and other parts of the world. American sales for 2003 were an estimated $31 billion, and that figure is expected to grow substantially over the following several years. Nutraceuticals are one of the fastest-growing segments of the food industry, especially among affluent baby boomers.
In Japan, England and other countries, nutraceuticals already have become part of the dietary landscape.
Consumer interest in the relationship between diet and health has increased the demand for information on nutraceuticals. Rapid advances in science and technology, increasing health care costs, changes in food laws affecting label and product claims, an aging population and rising interest in attaining wellness through diet are among the factors fueling U.S. interest in nutraceuticals. Credible scientific research indicates many potential health benefits from food components. These benefits could expand the health claims now permitted to be identified by the Food and Drug Administration (FDA).
Traditional vs. Nontraditional
Nutraceuticals on the market today consist of both traditional foods and nontraditional foods.
Traditional nutraceuticals are simply natural, whole foods with new information about their potential health qualities. There has been no change to the actual foods, other than the way the consumer perceives them. Many — if not most — fruits, vegetables, grains, fish, dairy and meat products contain several natural components that deliver benefits beyond basic nutrition, such as lycopene in tomatoes, omega-3 fatty acids in salmon or saponins in soy. Even tea and chocolate have been noted in some studies to contain health-benefiting attributes.
Nontraditional nutraceuticals, on the other hand, are foods resulting from agricultural breeding or added nutrients and/or ingredients. Agricultural scientists are able to boost the nutritional content of certain crops through the same breeding techniques that are used to bring out other beneficial traits in plants and animals — everything from beta-carotene-enriched rice to vitamin-enhanced broccoli and soybeans.
Research currently is being conducted to improve the nutritional quality of many other crops.
Foods specially formulated with nutrients or other ingredients include products such as orange juice fortified with calcium, cereals with added vitamins or minerals and flour with added folic acid. In fact, more and more foods are being fortified with nutrients and other physiologically active components (such as plant stanols and sterols) as researchers uncover more evidence about their role in health and disease-risk reduction.
APPLICATIONS OF NUTRACEUTICALS
Numerous nutraceuticals currently are on the market. The following chart represents a sample of available nutraceuticals, their components and their potential human health benefits.
Functional foods currently on the market represent a small fraction of the possible products. The vast potential for functional foods will not be achieved without extensive scientific research to ensure the safety and efficacy of these products. Scientific literature reports almost daily on new insights into the role of existing nutrients, advances in identifying bioactive compounds and their health benefits and the intersection of genomics and nutrition science in personalized nutrition. Continued basic and applied nutritional research must pursue a more precise understanding of the mechanisms of action for known nutrients.
Many scientists agree that studies using dietary intake databases such as the National Health and Nutrition Examination Surveys (NHANES) can be useful in identifying relationships between diet and health.
Scientists want to see similar studies developed and databases such as the Department of Agriculture foodcomponent databases expanded and updated as better analytical methods become available.
In addition to government-supported research, food companies traditionally have funded research for new food-product formulations. Incentives to the food industry would enhance greatly the development of functional foods. The research required for a functional food to meet scientific standards for efficacy is a substantial investment. Food companies do not have exclusive rights to a return on that investment, because once the health claim is documented adequately, competing companies can use the claim for their own similar products. Incentives such as a period of exclusivity or tax breaks would encourage food companies to pursue functional food development as a profitable venture.
Additional research is needed in many areas to ensure this emerging science continues to be valid and is translated rapidly into consumer-relevant products.
Labeling and Health Claims
Health claims on nutraceuticals serve to alert consumers to a food’s health potential by stating that certain foods or food substances, as part of an overall healthy diet, may reduce the risk of certain diseases.
Examples include folic acid in breakfast cereals, fiber in fruits and vegetables, calcium in dairy products and calcium or folic acid in some dietary supplements. Food and food substances can qualify for health claims only if they meet FDA requirements. The FDA initially authorized seven health claims in 1993 as part of the 1990 Nutrition Labeling and Education Act (NLEA). Since 1993, the FDA has authorized six more claims.
Under the NLEA, companies petition the FDA to consider new health claims through rule-making.
However, this process may require more than a year to complete because of the necessary scientific review and the need to issue a proposed rule to allow for public comment. In an effort to accelerate this information to consumers, the Food and Drug Administration Modernization Act of 1997 included a provision intended to expedite the process that establishes the scientific basis for health claims.
Although food manufacturers may use health claims to market their products, the intended purpose of health claims is to benefit consumers by providing information on healthful eating patterns that may help reduce the risk of heart disease, cancer, osteoporosis, high blood pressure, dental cavities or certain birth defects.
The following are the FDA-approved health claims showing a positive relationship between a certain compound and reduced risk of specific disease(s):
The remaining three FDA-approved health claims are based on diets low in “negative” nutrients in food, such as sodium. These health claims shows a relationship between certain compounds and an increased risk of disease(s):
Health claims are among the various types of claims allowed in food labeling. They show a relationship between a nutrient (or other substances in a food) and a disease or health-related condition. They differ from the more common claims that highlight a food’s nutritional content, such as “low fat,” “high fiber” and “low calorie.”
Health claims also are different from structure/function claims, which also may appear on conventional food or dietary supplement labels. Manufacturers may make statements about a food substance’s effect on the structure or function of the body — for example, “calcium builds strong bones.” Unlike health claims, structure/function claims do not deal with disease-risk reduction. Also, the FDA does not preapprove or authorize structure/function claims.
Rather, when the manufacturer uses a structure/function claim, the company is responsible for making sure the claim is truthful and not misleading.
Many academic, scientific and regulatory organizations are considering ways to establish the scientific basis to support claims (other than health claims) for the functional components of nutraceuticals. These are the five types of health-related statements allowed on food and dietary supplement labels:
A large body of credible scientific research is needed to confirm the benefits of any particular food or component. For nutraceuticals to deliver their potential health benefits, consumers must have a clear understanding of and a strong confidence level in the scientific criteria that are used to document health effects and claims.
Nutraceuticals have no official meaning and do not constitute a distinct category of foods. Most often, they are simply natural, whole foods consumers have been eating for thousands of years. As a result, the FDA regulates them in the same way they regulate all foods: The safety of ingredients must be assured in advance, and all claims must be substantiated, truthful and nonmisleading.
Safety and Efficacy
Nutraceuticals hold great potential, as evidenced by products such as Benecol, an alternative to margarine that contains plant stanol esters, which have been shown to reduce cholesterol. Yet, they also may hold the potential for harm, as was the case with ephedrine, a widely used botanical ingredient in weight-loss products. The substance was banned by the FDA after it was linked to significant adverse health effects, including heart attack and stroke.
Even after highly publicized events like the ephedrine ban, vast numbers of consumers continue to buy nutraceuticals. Consumers desire the increased health control these products offer and the promised health benefits. The danger is that many of these products do not provide consumers with solid information about their safety and effectiveness, possible side effects, interactions with prescription medicines or the impact they may have on existing medical conditions.
While acceptance of nutraceuticals is growing among physicians, many members of the medical and scientific communities remain concerned that many products entering the market lack adequate efficacy and safety data. Professionals on both sides of the fence agree there is an urgent need for funding to support high-quality scientific research, testing and clinical trials before nutraceuticals are introduced to consumers. Clinical research on specific nutraceutical products sold would help substantiate the potential medical or health values of these products. As a result, patients and health care professionals would know the facts about the benefit and the safety of the products being taken.
The following educational activity is intended for high school students studying nutraceuticals.
Following a lesson plan on nutraceuticals, divide students into groups and ask them to answer and discuss the following questions:
Next, supply students with various newspaper clippings and ask students to look for foods and products
that promote healthy living. Be sure to include pages from the “foods” section of the paper. Students then
should make a list of the words and phrases that are used to persuade consumers these products are healthy.
Students can share their findings with the class. This activity will help students understand the role of
advertising on food selection. Foods now and in the future will be designed to increase life spans, promote
health and fight disease.
Encourage students to continue researching the relationship between the food they eat and their health by
keeping a daily food diary. Students should note all the foods they consume, including meals and snacks,
during a one-week time period. After one week, students can bring their food journals into class and share
their findings with class members.
A Glossary of Terms
Amino acid: One of the building blocks of protein.
Antioxidant: A substance that blocks or inhibits the actions of free radicals, molecules that speed up the aging process and contribute to illness. Free radicals are found in rancid fats and oils and environmental hazards.
Arteriosclerosis: Condition in which the walls of arteries become hard and thick, sometimes interfering with blood circulation.
Botanical: A plant-based product.
Caffeic acid: An acid obtained from coffee tannin, as a yellow crystalline substance.
Carotenoids: One of the most widespread groups of naturally occurring pigments. These compounds largely are responsible for the red, yellow and orange color of fruits and vegetables and also are found in many dark green vegetables.
Chelation: A process that wraps or binds the minerals in amino acids, it uses an agent, such as the chemical compound EDTA, to remove heavy metals from the body
Complementary and alternative medicine (CAM): A group of diverse medical and health care systems, practices and products that presently are not considered part of conventional medicine. Complementary medicine is used together with conventional medicine. Alternative medicine is used in place of conventional medicine.
Dietary supplement: Congress defined the term in the Dietary Supplement Health and Education Act of 1994 as a product taken by mouth that contains a dietary ingredient intended to supplement the diet.
The dietary ingredients may include vitamins, minerals, herbs or other botanicals, amino acids or dietary substances to supplement the diet by increasing the total dietary intake. Dietary supplements can be concentrates, metabolites, constituents or extracts. They may be found in tablets, capsules, softgels, gelcaps, liquids or powders. They also can be in other forms, such as a bar; in this case, information on the label must not represent the product as a conventional food or a sole item of a meal or diet.
Dietary Supplement Health and Education Act (DSHEA): Passed in 1994, this law amended the Federal Food, Drug, and Cosmetic Act. It created a new regulatory framework for the safety and labeling of dietary supplements, placing them in a special category under the general umbrella of foods and requiring them to be labeled as dietary supplements.
Enzyme: A complex protein produced by cells that acts as a catalyst in specific biochemical reactions.
Ferulic acid: A compound, C10H10O4, related to vanillin and obtained from certain plants.
Flavonoids: A class of water-soluble plant pigments
Genetically engineered food: A food substance that has foreign genes inserted into its genetic code.
Genetic engineering can be done with plants, animals or microorganisms. Scientists can move desired genes from one plant into another and even from an animal to a plant, or vice versa.
Herb: A plant lacking a permanent woody stem.
Holistic medicine: An approach to medical care that emphasizes the study of all aspects of a person’s health, including physical, psychological, social, economic and cultural factors.
Homeopathy: A complementary and alternative medical system. In homeopathic medicine, there is a belief that small, highly diluted quantities of medicinal substances are given to cure symptoms, when the same substances given at higher or more concentrated doses actually would cause those symptoms.
Isoflavones: A class of organic compounds and biomolecules related to the flavonoids. They act as phytoestrogens, which are thought by many to be useful in treating cancer.
Isothiocyanates: Sulfur-containing compounds that largely are responsible for the typical flavor of cruciferous vegetables.
Labeling: The product label and accompanying material that is used by a manufacturer to promote and market a specific product.
Mineral: A naturally occurring inorganic substance with a definite and predictable chemical composition and physical properties.
New dietary ingredient: A dietary ingredient not sold in the United States in a dietary supplement before Oct. 15, 1994.
Nutraceutical: The term coined in the 1990s by Dr. Stephen DeFelice, who defined it as any substance that is a food or a part of a food and provides medical or health benefits, including the prevention and treatment of disease. Such products may range from isolated nutrients, dietary supplements and specific diets to genetically engineered designer foods, herbal products and processed foods such as cereals, soups and beverages. Since the term was coined, its meaning has been modified. The term also has been defined 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.
Nutrient: Any substance that can be metabolized by an organism to give energy and build tissue.
Phenols: Also known under the older name of carbolic acid, a colorless crystalline solid with a typical sweet tarry odor.
Phytoestrogens: Compounds that occur naturally in plants (phyto) and under certain circumstances can have actions like human estrogen.
Plant stanols and sterols: Essential components of plant cell membranes that resemble cholesterol structurally. Plant sterols are present naturally in small quantities in many fruits, vegetables, nuts, seeds, cereals, legumes, vegetable oils and other plant sources. Plant stanols occur in even smaller quantities than plant sterols in many of the same sources.
Polyols: Chemical compounds containing multiple hydroxyl groups. Sugar alcohols, a class of polyols, commonly are added to foods because of their lower caloric content.
Potentiated: 1. To enhance or increase the effect of a drug. 2. To promote or strengthen a biochemical or physiological action or effect.
Prebiotics: Food substances that promote the growth of certain bacteria (generally beneficial) in the intestines.
Probiotics: Dietary supplements containing potentially beneficial bacteria or yeast.
Saponins: Any of various plant glucosides that form soapy lathers when mixed and agitated with water. They are used in detergents, foaming agents and emulsifiers.
Sulfides: Refers to several types of chemical compounds containing sulfur.
Thiols: Compounds containing the functional group composed of a sulfur atom and a hydrogen atom.
Vitamin: An organic substance essential in small quantities to normal metabolism.
The Food and Drug Administration is responsible for protecting the public health by assuring the safety, efficacy and security of human and veterinary drugs, biological products, medical devices, our nation’s food supply, cosmetics and products that emit radiation. This site contains information related to the regulation of foods, including nutraceuticals, as well as information on health claims.
The Foundation for Innovation in Medicine was established in 1976 by Stephen L. DeFelice, M.D. It is a nonprofit foundation whose purpose is to accelerate medical discovery by creating a more productive clinical research community. Use the tool bar on the left side of the Web site and click on Library to navigate through various articles, fact sheets and press releases related to nutraceuticals. Make sure to check out the links page as well.
The IFIC Foundation is the educational arm of the International Food Information Council. The IFIC’s purpose is to bridge the gap between science and communications. It collects and disseminates scientific information on food safety, nutrition and health, works with scientific experts and establishes partnerships to help translate research into understandable and useful information for opinion leaders and, ultimately, consumers. Search for “functional foods” to find fact sheets related to the general topic as well as information on specific foods and their reported health benefits.
Founded in 1939, the Institute of Food Technologists is a nonprofit scientific society with 22,000 members working in food science, food technology and related professions in industry, academia and government.
The site contains a 66-page, in-depth and authoritative report, Functional Foods: Opportunities and Challenges, which covers all topics related to nutraceuticals.
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