Nutraceutical

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Chia is grown commercially for its seeds rich in a-linolenic acid. Chia Seeds macro 1.jpg
Chia is grown commercially for its seeds rich in α-linolenic acid.

A nutraceutical or 'bioceutical' is a pharmaceutical alternative which claims physiological benefits. [1] [2] In the US, "nutraceuticals" are largely unregulated, as they exist in the same category as dietary supplements and food additives by the FDA, under the authority of the Federal Food, Drug, and Cosmetic Act. [3] [4]

Contents

Regulation

Nutraceuticals are treated differently in different jurisdictions.

Canada

Under Canadian law, a nutraceutical can either be marketed as a food or as a drug; the terms "nutraceutical" and "functional food" have no legal distinction, [5] referring to "a product isolated or purified from foods that is generally sold in medicinal forms not usually associated with food [and] is demonstrated to have a physiological benefit or provide protection against chronic disease."

United States

The terms "nutraceutical" and 'bioceutical' are not defined by US law. [6] Depending on its ingredients and the claims with which it is marketed, a product is regulated as a drug, dietary supplement, food ingredient, or food. [7] [8]

Other sources

In the global market, there are significant product quality issues. [9] 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.

Classification of nutraceuticals

Nutraceuticals are products derived from food sources that are purported to provide extra health benefits, in addition to the basic nutritional value found in foods. Depending on the jurisdiction, products may claim to prevent chronic diseases, improve health, delay the aging process, increase life expectancy, or support the structure or function of the body. [10]

Dietary supplements

Dietary supplements, such as the vitamin B supplement shown above, are typically sold in pill form. B vitamin supplement tablets.jpg
Dietary supplements, such as the vitamin B supplement shown above, are typically sold in pill form.

In the United States, the Dietary Supplement Health and Education Act (DSHEA) of 1994 defined the term: “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.” [11]

In an article written in the Functional Food in Health and Disease Journal it was seen that mitochondrial function was enhanced when subjects used various natural supplements most notably lipid Replacement Therapy (LRT). In multiple clinical studies on chronic fatigue syndrome, fibromyalgia, and other fatiguing illnesses where a majority of patients have chronic infections LRT reduced fatigue by 35-43%. [12]

Dietary supplements do not have to be approved by the U.S. Food and Drug Administration (FDA) before marketing, but companies must register their manufacturing facilities with the FDA and follow current good manufacturing practices (cGMPs). With a few well-defined exceptions, dietary supplements may only be marketed to support the structure or function of the body, and may not claim to treat a disease or condition, and must 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.” The exceptions are when the FDA has reviewed and approved a health claim. In those situations the FDA also stipulates the exact wording allowed.

Functional foods

Considered a father of Western medicine, Hippocrates advocated the healing effects of food. Hippocrates rubens.jpg
Considered a father of Western medicine, Hippocrates advocated the healing effects of food.

Functional foods are fortified or enriched during processing and then marketed as providing some benefit to consumers. 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.” [13] 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. [14]

History

The word "nutraceutical" is a portmanteau of the words "nutrition" and "pharmaceutical", coined in 1989 by Stephen L. DeFelice, founder and chairman of the Foundation of Innovation Medicine. [15] Indians, Egyptians, Chinese, and Sumerians are just a few civilizations that have used food as medicine. [16] “Let food be thy medicine.” is a common misquotation [17] attributed to Hippocrates, who is considered by some[ who? ] to be the father of Western 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. [18]

One example is a traditional Japanese drug called 'Kampo' which is derived from many medicinal plants. This test was done to investigate the pharmacological effects of functional foods and Kampo medicine. The experiments were performed using disease models. When extracts were taken from Kampo and functional foods and were administered there was a lowered pro-inflammatory rate. [19]

Criticism

Because nutraceuticals and bioceuticals are largely unregulated, these supplements are the subject of more of marketing hype than actual clinical testing, and for many, it is not even yet known whether they provide more benefits than risks for consumers. [20] For many of these products, the most compelling evidence for efficacy remains anecdotal or, at best, based on hints of benefit from small or poorly controlled studies. And when their claims do not match the evidence, there can be legal consequences. After scientists disputed the benefits of nutraceuticals like probiotics in Dannon yogurt, the company was forced to pay millions for falsely claiming its products Actimel and Activia boosted the immune system. [21] Steven Nissen, chairman of cardiology at the Cleveland Clinic, said, "The concept of multivitamin supplements was sold to Americans by an eager nutraceutical industry to generate profits. There was never any scientific data supporting their usage."

See also

Related Research Articles

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Dietary fiber or roughage is the portion of plant-derived food that cannot be completely broken down by human digestive enzymes. Dietary fibers are diverse in chemical composition, and can be grouped generally by their solubility, viscosity, and fermentability, which affect how fibers are processed in the body. Dietary fiber has two main components: soluble fiber and insoluble fiber, which are components of plant foods, such as legumes, whole grains and cereals, vegetables, fruits, and nuts or seeds. A diet high in regular fiber consumption is generally associated with supporting health and lowering the risk of several diseases.

Dietary supplement Product that provides additional source of nutrients

A dietary supplement is a manufactured product intended to supplement one's diet by taking a pill, capsule, tablet, powder or liquid. A supplement can provide nutrients either extracted from food sources or that are synthetic in order to increase the quantity of their consumption. The class of nutrient compounds includes vitamins, minerals, fiber, fatty acids and amino acids. Dietary supplements can also contain substances that have not been confirmed as being essential to life, but are marketed as having a beneficial biological effect, such as plant pigments or polyphenols. Animals can also be a source of supplement ingredients, such as collagen from chickens or fish for example. These are also sold individually and in combination, and may be combined with nutrient ingredients. In the United States and Canada, dietary supplements are considered a subset of foods, and are regulated accordingly. The European Commission has also established harmonized rules to help insure that food supplements are safe and properly labeled.

A health claim on a food label and in food marketing is a claim by a manufacturer of food products that their food will reduce the risk of developing a disease or condition. For example, it is claimed by the manufacturers of oat cereals that oat bran can reduce cholesterol, which will lower the chances of developing serious heart conditions. Vague health claims include that the food inside is "healthy", "organic", "low fat", "non-GMO", "no sugar added", or "natural".

Herbal medicine Study and use of supposed medicinal properties of plants

Herbal medicine is the study of pharmacognosy and the use of medicinal plants, which are a basis of traditional medicine. There is limited scientific evidence for the safety and efficacy of plants used in 21st century herbalism, which generally does not provide standards for purity or dosage. The scope of herbal medicine commonly includes fungal and bee products, as well as minerals, shells and certain animal parts. Herbal medicine is also called phytomedicine or phytotherapy.

Nootropic Drug, supplement, or other substance that improves cognitive function

Nootropics are drugs, supplements, and other substances that are claimed to improve cognitive function, particularly executive functions, memory, creativity, or motivation, in healthy individuals.

Glucosamine (C6H13NO5) is an amino sugar and a prominent precursor in the biochemical synthesis of glycosylated proteins and lipids. Glucosamine is part of the structure of two polysaccharides, chitosan and chitin. Glucosamine is one of the most abundant monosaccharides. Produced commercially by the hydrolysis of shellfish exoskeletons or, less commonly, by fermentation of a grain such as corn or wheat, glucosamine has many names depending on country.

A functional food is a food claimed to have an additional function by adding new ingredients or more of existing ingredients. The term may also apply to traits purposely bred into existing edible plants, such as purple or gold potatoes having decreased anthocyanin or carotenoid contents, respectively. Functional foods may be "designed to have physiological benefits and/or reduce the risk of chronic disease beyond basic nutritional functions, and may be similar in appearance to conventional food and consumed as part of a regular diet".

Cannabidiol Phytocannabinoid discovered in 1940

Cannabidiol (CBD) is a phytocannabinoid discovered in 1940. It is one of 113 identified cannabinoids in cannabis plants, along with tetrahydrocannabinol (THC), and accounts for up to 40% of the plant's extract. As of 2019, clinical research on CBD included studies related to anxiety, cognition, movement disorders, and pain, but there is insufficient high-quality evidence that cannabidiol is effective for these conditions.

Cosmeceuticals are cosmetic products with bioactive ingredients purported to have medical benefits. There are no legal requirements to prove that these products live up to their claims. The name is a portmanteau of "cosmetics" and "pharmaceuticals". "Nutricosmetics" are related dietary supplement or food or beverage products with additives that are marketed as having medical benefits that affect appearance.

Bodybuilding supplements are dietary supplements commonly used by those involved in bodybuilding, weightlifting, mixed martial arts, and athletics for the purpose of facilitating an increase in lean body mass. The intent is to increase muscle, increase body weight, improve athletic performance, and for some sports, to simultaneously decrease percent body fat so as to create better muscle definition. Among the most widely used are high protein drinks, pre-workout blends, branched-chain amino acids (BCAA), glutamine, arginine, essential fatty acids, creatine, HMB, whey protein, ZMA and weight loss products. Supplements are sold either as single ingredient preparations or in the form of "stacks" – proprietary blends of various supplements marketed as offering synergistic advantages. While many bodybuilding supplements are also consumed by the general public the frequency of use will differ when used specifically by bodybuilders. One meta-analysis concluded that – for athletes participating in resistance exercise training and consuming protein supplements for an average of 13 weeks – total protein intake up to 1.6 g/kg of body weight per day would result in an increase in strength and fat-free mass, but that higher intakes would not further contribute.

Chromium deficiency is described as the consequence of an insufficient dietary intake of the mineral chromium. Chromium was first proposed as an essential element for normal glucose metabolism in 1959, and was widely accepted as being such by the 1990s. Cases of deficiency were described in people who received all of their nutrition intravenously for long periods of time.

Vinpocetine

Vinpocetine is a synthetic derivative of the vinca alkaloid vincamine. Vincamine is extracted from either the seeds of Voacanga africana or the leaves of Vinca minor.

Diosmin

Diosmin, a flavone glycoside of diosmetin, is manufactured from citrus fruit peels as a phlebotonic non-prescription dietary supplement used to aid treatment of hemorrhoids or chronic venous diseases, mainly of the legs.

The Center for Food Safety and Applied Nutrition is the branch of the United States Food and Drug Administration (FDA) that regulates food, dietary supplements, cosmetics, drugs, biologics, medical devices, and radiological products.

Nutrition Labeling and Education Act of 1990 US law

The Nutrition Labeling and Education Act (NLEA) is a 1990 United States Federal law. It was signed into law on November 8, 1990 by President George H. W. Bush.

Liquid oxygen supplements are products that claim to add extra oxygen to the human body, most often through a chemical process in the digestive system, like the breakdown of hydrogen peroxide or magnesium peroxide. While the FDA describes these products as being inert, and has penalized some producers who made explicit medical claims, it has not prohibited their sale.

Dietary Supplement Health and Education Act of 1994

The Dietary Supplement Health and Education Act of 1994 ("DSHEA"), is a 1994 statute of United States Federal legislation which defines and regulates dietary supplements. Under the act, supplements are effectively regulated by the FDA for Good Manufacturing Practices under 21 CFR Part 111.

Antioxidative stress is an overabundance of bioavailable antioxidant compounds that interfere with the immune system's ability to neutralize pathogenic threats. The fundamental opposite is oxidative stress, which can lead to such disease states as coronary heart disease or cancer.

Pre-workout is a generic term for a range of bodybuilding supplement products used by athletes and weightlifters to enhance athletic performance. It is taken to increase endurance, energy, and focus during a workout. Pre-workout supplements contain a variety of ingredients such as caffeine and creatine, ranging by product. It can be taken in a variety of forms including capsules and powder. The first pre-workout entered the market in 1982, and since then they have grown in popularity. Some pre-workouts contain ingredients linked to adverse effects. Although these products are not banned, the Food and Drug Administration (FDA) warns consumers to be cautious when consuming pre-workout.

The Proxmire Amendment US legislation related to dietary supplements

The Proxmire Amendments were a series of legislation that prohibits the Food and Drug Administration from monitoring and limiting the potency of vitamins and minerals found in dietary supplements. The Proxmire Amendment also made it so that food supplements could not be classified as drugs, making their sale possible without a prescription from a doctor. According to a study done, "dietary supplements fall into the following categories: vitamins, minerals, herbs or other botanicals, amino acids, animal-derived products, hormones and hormone analogs, enzymes, and concentrates, metabolites, constituents, or extracts of these." They can be used by anyone wishing to purchase them as much or as little as they desire. Dietary supplements can be used to increase productivity, treating illness, helping mental health such as depression and anxiety, enhancing mental abilities, building muscle, or losing weight, among many other uses. William Proxmire, a Senator for Wisconsin, was instrumental in influencing the passing the Proxmire Amendment. The Proxmire Amendment is also known as The Rogers-Proxmire Amendment of 1976, and The Vitamins and Minerals Amendments. This amendment became section 411 of the Federal Food, Drug, and Cosmetic Act.

References

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  12. Nicolson, Garth L.; Settineri, Robert; Ellithorpe, Rita R. (2014-01-25). "Neurodegenerative and Fatiguing Illnesses, Infections and Mitochondrial Dysfunction: Use of Natural Supplements to Improve Mitochondrial Function". Functional Foods in Health and Disease. 4 (1): 23–65. doi: 10.31989/ffhd.v4i1.26 . ISSN   2160-3855.
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Further reading

Books
Review articles on possible health benefits