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Encyclopedia > Dietary supplement

A dietary supplement is intended to supply nutrients, (vitamins, minerals, fatty acids or amino acids) that are missing or not consumed in sufficient quantity in a person's diet. This category may also include herbal supplements which claim to treat or prevent certain diseases or conditions. Image File history File links Broom_icon. ... A nutrient is either a chemical element or compound used in an organisms metabolism or physiology. ... Retinol (Vitamin A) For the record label, see Vitamin Records Vitamins are nutrients required in tiny amounts for essential metabolic reactions in the body. ... Dietary Minerals are the chemical elements required by living organisms, other than the four elements Carbon, Hydrogen, Nitrogen, and Oxygen which are omnipresent in organic molecules. ... In chemistry, especially biochemistry, a fatty acid is a carboxylic acid often with a long unbranched aliphatic tail (chain), which is either saturated or unsaturated. ... Phenylalanine is one of the standard amino acids. ... In nutrition, the diet is the sum of food consumed by a person or other organism. ... Herbal supplements are a type of dietary supplement that contain herbs, either singly or in mixtures. ...

Contents

United States

In the United States, a dietary supplement is defined under the Dietary Supplement Health and Education Act of 1994[1] (DSHEA) as a product that is intended to supplement the diet and bears or contains one or more of the following dietary ingredients: In nutrition, the diet is the sum of food consumed by a person or other organism. ...

  • a vitamin
  • a mineral
  • an herb or other botanical (excluding tobacco)
  • an amino acid
  • a dietary substance for use by people to supplement the diet by increasing the total dietary intake, or
  • a concentrate, metabolite, constituent, extract, or combination of any of the above

Furthermore, it must be: Retinol (Vitamin A) For the record label, see Vitamin Records Vitamins are nutrients required in tiny amounts for essential metabolic reactions in the body. ... Dietary Minerals are the chemical elements required by living organisms, other than the four elements Carbon, Hydrogen, Nitrogen, and Oxygen which are omnipresent in organic molecules. ... Herbs: basil Herbs (IPA: hə()b, or əb; see pronunciation differences) are plants grown for any purpose other than food, wood or beauty. ... Botany is the scientific study of plant life. ... Phenylalanine is one of the standard amino acids. ...

  • intended for ingestion in pill, capsule, tablet, powder or liquid form
  • not represented for use as a conventional food or as the sole item of a meal or diet
  • labeled as a "dietary supplement"

Pursuant to the DSHEA, the Food and Drug Administration regulates dietary supplements as foods, and not as drugs. The FDA does not approve dietary supplements based on their safety and efficacy; the FDA can take action only after a dietary supplement has been proven harmful. However, certain foods (such as infant formula and medical foods) are deemed special nutritionals because they are consumed by highly vulnerable populations and are thus regulated more strictly than the majority of dietary supplements. The FDA claims that their rationale for a lack of regulation is a "freedom to choose" by the consumer, but there are economic benefits as well. The FDA chooses not to regulate dietary supplements because clinical trials are lengthy and costly. They tend to believe that the supplement is beneficial until problems arise.[2] FDA logo The Food and Drug Administration (FDA) is an agency of the United States Department of Health and Human Services and is responsible for regulating food, dietary supplements, drugs, biological medical products, blood products, medical devices, radiation-emitting devices, veterinary products, and cosmetics in the United States. ... Oral medication A medication is any drug taken to cure or reduce the symptoms of an illness or ongoing medical condition. ... An infant being fed by bottle. ...


The claims that a dietary supplement makes are essential to its classification. If a dietary supplement claims to cure, mitigate, or treat a disease, it would be considered to be an unauthorized new drug and in violation of the applicable regulations and statutes. As the FDA states it in a response to this question in a FAQ: FAQ is an abbreviation for Frequently Asked Question(s). The term refers to listed questions and answers, all supposed to be frequently asked in some context, and pertaining to a particular topic. ...

Is it legal to market a dietary supplement product as a treatment or cure for a specific disease or condition?
No, a product sold as a dietary supplement and promoted on its label or in labeling* as a treatment, prevention or cure for a specific disease or condition would be considered an unapproved--and thus illegal--drug. To maintain the product's status as a dietary supplement, the label and labeling must be consistent with the provisions in the Dietary Supplement Health and Education Act (DSHEA) of 1994.
*Labeling refers to the label as well as accompanying material that is used by a manufacturer to promote and market a specific product.

Dietary supplements are permitted to make structure/function claims. These are broad claims that the product can support the structure or function of the body (e.g., "glucosamine helps support healthy joints"). The FDA must be notified of these claims within 30 days of their first use, and there is a requirement that these claims be substantiated.


Other claims that required approval from FDA include health claims and qualified health claims. Health claims are permitted to be made if they meet the requirements for the claims found in the applicable regulations. Qualified health claims can be made through a petition process, including scientific information, if FDA has not approved a prior petition.


European Union

The Food Supplements Directive[3] requires that supplements be demonstrated to be safe, both in quantity and quality. Some vitamins are essential in small quantities but dangerous in large quantities. Some herbal remedies, notably St Johns Wort, may interact with drugs or render them less effective. Such an issue has been raised in the case of oral contraceptives. Consequently, only those supplements that have been proven to be safe may be sold without prescription. In practice, the number of reported incidents with food supplements is nevertheless low. Binomial name Hypericum perforatum Linnaeus, St Johns wort used alone refers to the species Hypericum perforatum, also known as Klamath weed or Goat weed, but is used with qualifiers to refer to any species of the genus Hypericum. ...


In Europe, it is also an established notion that food supplements should not be labeled with drug claims but can bear - to a degree that differs from one member state to the other - health claims. Health claims on food labels are claims by manufacturers of food products that their food will reduce the risk of developing a disease or condition. ...


Legal challenge

The dietary supplements industry in Europe strongly opposed the Directive. A large number of consumers throughout Europe, including over one million in the UK, and many doctors and scientists, have signed petitions against what are viewed by the petitioners as unjustified restrictions of consumer choice [4]. The European Court of Justice ruled[5] on 12 July 2005 that the Directive is valid, although the court's own Advocate General advised that the declaration was invalid under EU law [4]. The court made clear, however, that it must be possible for manufacturers to add vitamins and minerals to the list of ingredients of a food supplement, that refusal must be on scientific grounds, and that there should be a right to appeal. European Court of Justice building, Luxembourg The Court of Justice of the European Communities, usually called the European Court of Justice (ECJ), is the highest court of the European Union (EU). ...


Russia

Russian legislation, Ministry of Health's order number 117 dated as of 15 April, 1997, under the title "Concerning the procedure for the examination and health certification of Biologically Active Dietary Supplements", provides the usage of the following terminology:

As a rule, BADSs are foodstuffs with clinically proven effectiveness. BADSs are recommended not only for prophylactics, but can be included into a complex therapy for the prevention of pharmaceutical therapy's side effects and for the achievement of complete remission.

The development of BADSs and their applications has been very fast moving. They were originally considered as dietary supplements for people who had heightened requirements for some normal dietary components (for example, sportsmen). Later, they were employed as preventive medicines against chronic diseases.


Criticisms of vitamin supplementation

Regular supplementation with vitamin E, beta carotene and vitamin A may increase mortality by four, seven and sixteen percent respectively.[6] The same study found that vitamin C and selenium had no effect, positive or negative on longevity. Tocopherol, or vitamin E, is a fat-soluble vitamin in eight forms that is an important antioxidant. ... Carotene is responsible for the orange colour of the carrots and many other fruits and vegetables. ... Vitamin A is an essential human nutrient. ... For other uses, see Vitamin C (disambiguation). ... Se redirects here. ...


Notes

  1. ^ US Dietary Supplement Health and Education Act of 1994
  2. ^ Nestle, Marion (2002), Food Politics, University of California Press, Ltd. 
  3. ^ Directive 2002/46/EC of the European Parliament and of the Council of 10 June 2002 on the approximation of the laws of the Member States relating to food supplements
  4. ^ a b "Controversial EU vitamins ban to go ahead" (the Times, July 12 2005)
  5. ^ The Court confirms the validity of the Community Directive on food supplements (Press release)
  6. ^ Bjelakovic, G.; Nikolova, D., Gluud, L.L., Simonetti, R.G. & Gluud, C. (2007). "Mortality in Randomized Trials of Antioxidant Supplements for Primary and Secondary Prevention". Journal of the American Medical Association 297: 842-857. Retrieved on 2007-04-23. 

2007 (MMVII) is the current year, a common year starting on Monday of the Gregorian calendar and the CE era. ... April 23 is the 113th day of the year in the Gregorian calendar (114th in leap years). ...

See also

Whole food supplements comprise a unique class within the food supplement industry. ... Many supplements come in capsule form. ... The Codex Alimentarius (Latin for food code or food book) is a collection of internationally recognized standards, codes of practice, guidelines and other recommendations relating to foods, food production and food safety under the aegis of consumer protection. ... Therapeutic foods are food designed for specific, usually nutritional, therapeutic purposes. ... An essential nutrient is a nutrient required for normal body functioning that cannot be synthesized by the body. ... Functional food or medicinal food is any fresh or processed food claimed to have a health-promoting and/or disease-preventing property beyond the basic nutritional function of supplying nutrients, although there is no consensus on an exact definition of the term. ... Health claims on food labels are claims by manufacturers of food products that their food will reduce the risk of developing a disease or condition. ... The term health freedom movement is used to describe the loose coalition of consumers and alternative medicine providers around the world who are pushing for unhindered freedom of choice in healthcare. ... Many diseases in humans are thought to be directly or indirectly related to nutrition, These include, but are not limited to, deficiency diseases, caused by a lack of essential nutrients. ... Dietary Minerals are the chemical elements required by living organisms, other than the four elements Carbon, Hydrogen, Nitrogen, and Oxygen which are omnipresent in organic molecules. ... Nutraceutical is a portmanteau of [Nutrition] and [pharmaceutical] and refers to foods thought to have a beneficial effect on human health. ... A nutrient is either a chemical element or compound used in an organisms metabolism or physiology. ... The updated USDA food pyramid, published in 2005, is a general nutrition guide for recommended food consumption. ... Chinese food therapy (Simplified Chinese: 食疗; Traditional Chinese: 食療; pinyin: Shí Liáo) is a practice of healing using natural foods instead of medications. ... Retinol (Vitamin A) For the record label, see Vitamin Records Vitamins are nutrients required in tiny amounts for essential metabolic reactions in the body. ...

External links


  Results from FactBites:
 
Dietary Supplements: An Advertising Guide for Industry (8773 words)
Although there is no requirement that a dietary supplement claim be supported by any specific number of studies, the replication of research results in an independently-conducted study adds to the weight of the evidence.
Dietary supplement advertisers should be aware that the use of newspaper articles, abstracts of scientific studies, or other "third party literature" to promote a particular brand or product can have an impact on how consumers interpret an advertisement and on what claims the advertiser will be responsible for substantiating.
Marketers of dietary supplements should be familiar with the requirements under both DSHEA and the FTC Act that labeling and advertising claims be truthful, not misleading and substantiated.
Glyconutrient Supplements (967 words)
Dietary supplements refer to products made up of one or more of the essential nutrients such as vitamins, minerals, and protein.
What this means is that when choosing whether to use dietary supplements, the consumers and, manufacturers have the responsibility of checking the safety of the dietary supplements and determining the truthfulness of the label claims.
Consumers cannot assume that dietary supplements are safe, pure, or that the quantities of active ingredients are listed on their labels--the nutritional supplement industry is largely unregulated.
  More results at FactBites »

 
 

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