File CT image stack of a multivitamin tablet by Abtei, Germany ogv image stack of a multivitamin tablet "A-Z" by German company Abtei.]] A dietary supplement also known as food supplement or nutritional supplement is a preparation intended to supplement the diet and provide nutrient , such as vitamin , Dietary mineral Dietary fiber fatty acid , or amino acid , that may be missing or may not be consumed in sufficient quantities in a persons diet (nutrition) Some countries define dietary supplements as foods, while in others they are defined as drugs or natural health products. Supplements containing vitamins or dietary minerals are included as a category of food in the Codex Alimentarius a collection of internationally recognized standards, codes of practice, guidelines and other recommendations relating to food , food production and food safety These texts are drawn up by the Codex Alimentarius Commission an organization that is sponsored by the Food and Agriculture Organization of the United Nations (FAO) and the World Health Organization (WHO).

European Union

The European Union s Food Supplements Directive of 2002 requires that supplements be demonstrated to be safe, both in dosages and in purity.http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uriCELEX:32002L0046:EN:HTML 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] Only those supplements that have been proven to be safe may be sold in the bloc without prescription. As a category of food, food supplements cannot be labeled with drug claims but can bear health claim and nutrition claims.http://ec.europa.eu/food/food/labellingnutrition/claims/index_en.htm European Commission website: Food Safety - Labelling & Nutrition - Health & Nutrition Claims] The dietary supplements industry in the United Kingdom (UK), one of the 27 countries in the bloc, strongly opposed the Directive. In addition, a large number of consumers throughout Europe, including over one million in the UK, and many doctors and scientists, had signed petitions by 2005 against what are viewed by the petitioners as unjustified restrictions of consumer choice.http://www.timesonline.co.uk/article/0,,13509-1690686,00.html "Controversial EU vitamins ban to go ahead" (the Times, July 12 2005)] In 2004, along with two British trade associations, the Alliance for Natural Health had a legal challenge to the Food Supplements Directivehttp://eur-lex.europa.eu/pri/en/oj/dat/2002/l_183/l_18320020712en00510057.pdf EU Food Supplements Directive] referred to the European Court of Justice by the High Court in London.http://news.bbc.co.uk/1/hi/health/3445503.stm Court victory for vitamin firms BBC News] Published 30 January 2004. Accessed 29 April 2007. Although the European Court of Justices Advocate General subsequently said that the blocs plan to tighten rules on the sale of vitamins and food supplements should be scrapped,http://news.bbc.co.uk/1/hi/health/4411929.stm EU health foods crackdown wrong BBC News.] Published 5 April 2005. Accessed 29 April 2007. he was eventually overruled by the European Court, which decided that the measures in question were necessary and appropriate for the purpose of protecting [[public health]]. ANH, however, interpreted the ban as applying only to synthetically produced supplements—and not to vitamins and minerals normally found in or consumed as part of the diet.[http://news.bbc.co.uk/1/hi/health/4670971.stm Vitamin controls backed by EuropeBBC News.] Published 12 July 2005. Accessed 29 April 2007. Nevertheless, the European judges did acknowledge the Advocate Generals concerns, stating that there must be clear procedures to allow substances to be added to the permitted list based on scientific evidence. They also said that any refusal to add a product to the list must be open to challenge in the courts.http://www.guardian.co.uk/uk_news/story/0,,1526892,00.html EU court backs health supplements ban The Guardian] Published 12 July 2005. Accessed 6 October 2007. A survey of adults aged 18–64 years, conducted in 2001 in Ireland suggested that, with the possible exception of niacin (flushing) and vitamin B6 (neuropathy), there appears to be little risk of the occurrence of adverse effects due to excessive consumption of vitamins in this population, based on current dietary practices.lt;/ref>

Russia

The Russian Ministry of Healths order number 1898, dated 15 April 1997 and titled "Concerning the procedure for the examination and health certification of Active Dietary Supplements", states the following: : As a rule, BADSs are foodstuffs with clinically proven effectiveness. BADSs not only are recommended for prophylactics but can be included into a complex therapy for the prevention of pharmaceutical therapys 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 with heightened requirements for some normal dietary components (for example, sportsmen). Later, they were employed as preventive medicines against chronic diseases.

China

In China, prior to market entry, manufacturers must register dietary supplements with the State Food and Drug Administration (SFDA). The process requires investments of both time and money. After market entry, the registration is valid for five years and then must be renewed. The SFDA has a list of 27 approved functional claims that manufacturers of dietary supplements are allowed to make when registering a product. The process involves a strict testing protocol, including animal and human studies. To a large degree, it is similar to the approval of pharmaceuticals.

United States

In the United States a dietary supplement is defined under the Dietary Supplement Health and Education Act of 1994 lt;ref>http://www.fda.gov/opacom/laws/dshea.html US Dietary Supplement Health and Education Act of 1994] (DSHEA) as a product that is intended to supplement the diet (nutrition) and contains any of the following dietary ingredients: *a vitamin *a Dietary mineral *an herb or other botanical (excluding tobacco) *an amino acid *a concentrate, metabolite, constituent, extract, or combination of any of the above *a substance historically used by man to supplement the diet Furthermore, it must also conform to the following criteria: *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"

Examples of dietary ingredients

The hormones DHEA (a steroid , pregnenolone (also a steroid) and the pineal hormone melatonin are marketed as dietary ingredients in supplements in the US.lt;/ref>lt;/ref>

Regulation

The Food and Drug Administration (FDA) regulates dietary supplements as a category of foods, and not as medication . While pharmaceutical companies are required to obtain FDA new drug application which involves assessing the risks and benefits prior to their entry into the market, dietary supplements do not need to be pre-approved by FDA before they can enter the market.lt;/ref> Instead, manufacturers and distributors who wish to market dietary supplements that contain a "new dietary ingredient" (defined as "a vitamin; a mineral; a herb or other botanical; an amino acid; a dietary substance for use by man to supplement the diet by increasing total dietary intake; or a concentrate, metabolite, constituent, extract, or combination of any of the above dietary ingredients" not marketed before October 15, 1994) must notify the FDA beforehand. The notification requires information indicating the ingredient is safe, and the ingredient can not be marketed (sold or delivered for sale) for seventy-five days following filing the information. During this time, the agency reviews the information for adequacy and safety concerns; fifteen days after the this period (ninety days after the information was filed), the FDA posts nonproprietary information on their website. Listing the information means the ingredient can be marketed, but does not mean it is necessarily safe.lt;/ref> On September 24, 2007 the FDA has implemented a "current good manufacturing practice " (GMP) policy to ensure dietary supplements "are produced in a quality manner, do not contain contaminants or impurities, and are accurately labeled" and covers the manufacturing, packaging, labelling, and storing of supplements, with requirements for quality control, design and construction of manufacturing plants, testing of ingredients and final products, record keeping, and complaints processes.lt;/ref> The DSHEA, passed in 1994, was the subject of lobbying efforts by the manufacturers of dietary supplements and restricted the ability of the FDA to exert authority over supplements as long as manufacturers made no claims about their products treating, preventing, or curing diseases. According to [[Consumer Reports]] "The law has left consumers without the protections surrounding the manufacture and marketing of over-the-counter or prescription medications" and it became the FDAs responsibility to prove that a supplement is not safe. While pharmaceutical manufacturers must demonstrate their products are effective as well as being safe, supplement manufacturers are not required to demonstrate efficacy. The FDA has ever found only one dietary supplement to be unsafe, the weight loss/energy supplement ephedra lt;/ref> Discussing the legislation, Time (magazine) referred to the DSHEA as "ill-conceived and reprehensible", that "gives the industry virtually to market products defined as dietary supplements, while severely limiting the FDAs ability to regulate them".lt;/ref> The DSHEA was heavily lobbied for by the supplement industry, and was criticized for exposing the public to worthless compounds that bilked consumers out of money to no benefit. Because of the requirements put into place by the DSHEA, the FDA must demonstrate that individual supplements are unsafe using their adverse event reporting system, which it is estimated captures only 1% of all adverse events linked to supplements. The FDA has also lacked the funding to undertake the rigorous tests to meet the standards for a supplement to be considered "hazardous" and, thus, removed from the market; in the one situation where this standard was reached (ephedra), the agency faced significant opposition from the supplement industry and the United States Congress, instead limiting themselves to making announcements about problematic supplement safety records on their website.lt;/ref> A 2001 study, published in [[Archives of Internal Medicine]] found broad public support for greater governmental regulation of dietary supplements than was currently permitted by DSHEA. The researchers found that a majority of Americans support pre-marketing approval by the FDA, increased oversight of harmful supplements, and greater scrutiny of the truthfulness of supplement label claims.lt;/ref>

Quality

Under the FDAs final rule on good manufacturing practices, quality is defined as meaning "that the dietary supplement consistently meets the established specifications for identity, purity, strength, and composition and has been manufactured, packaged, labeled, and held under conditions to prevent adulteration under section 402(a)(1), (a)(2), (a)(3), and (a)(4) of the Federal Food, Drug, and Cosmetic Act".FDA. (2007). http://www.accessdata.fda.gov/scripts/oc/ohrms/dailylist.cfm?yr2007&mn6&dy25 Final Rules: Current Good Manufacturing Practice in Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements]. Federal Register The new regulations allow FDA inspectors to look at a companys records upon request.Dickinson A, Shao A. (2007). http://www.naturalproductsinsider.com/articles/07aug27feat1.html The Evolution of Dietary Supplement GMPs]. Natural Products Insider However, enforcement is difficult given the number of supplement manufacturers and the 16% decline in FDA investigators from 2003 to 2006. Much of the contamination is due to poor raw ingredients. Suppliers provide certificates of analysis stating that they have tested the material. Under the 2003 proposed rule, manufacturers would have been required to retest the supplied ingredients. Under the final rule, testing for identity is always required. Other retesting is not required if the manufacturer has verified the reliability of the ingredient supplier. In the U.S., contamination and false labeling are "not uncommon".lt;/ref> Independent certification programs exist, but these may have problems as well. United States Pharmacopeia manages the Dietary Supplement Verification Program (DSVP). Its USP Verified Mark seal indicates that the product has been tested for integrity, purity, dissolution, and safe manufacturing,USP. http://www.usp.org/USPVerified/dietarySupplements/ USP Verified Dietary Supplements]. and it is the only certification program that conducts random off-the-shelf testing. The USP program will not certify products that contain ingredients that the USPs Dietary Supplement Information Expert Committee determines have a safety risk.USP. http://www.usp.org/USPVerified/dietarySupplements/faq.html Frequently Asked Questions about USP Verification Program for Dietary Supplements]. ConsumerLab com randomly tests some dietary supplements and makes the results available to subscribers. It has reported that 25% of the supplements it tests have problems, and for multivitamins about half had problems.OConnell J. (2007). http://www.menshealth.com/cda/article.do?siteMensHealth&channelnutrition&categoryvitamins.supplements&conitem899d9a8e051b4110VgnVCM10000013281eac____&page3# The untold dietary-supplement scandal]. Mens Health. In 2008 ConsumerLab criticized the USP for proposing a 10 microgram perdaily serving limit on lead in dietary supplements and drugs. It noted that under the FDAs 2006 guidance on lead in candy, only 0.2 micrograms of lead per serving are allowed.ConsumerLab.com. (2008). http://www.consumerlab.com/news/USP_Lead_Limit/12_8_2008/ ConsumerLab.com Asks USP to Adopt Safer Lead Limits for Drugs and Supplements]. NSF International NSF International. http://www.nsf.org/consumer/dietary_supplements/dietary_certification.asp?programDietarySup The Importance of Certification]. HFL Sport Science,Mathews AW. (2009-9-03). http://online.wsj.com/article/SB20001424052970204731804574390840811949538.html#modtodays_us_nonsub_marketplace Whats Really in Supplements? ]. Wall Street Journal and the Natural Products Association (NPA)NPA. http://www.npainfo.org/gmp Quality Assurance Programs] also have dietary supplement certification programs. In 1999, NPA launched the industrys first third-party Good Manufacturing Practices (GMP) certification program for dietary supplements and ingredients. Nearly 70 companies have achieved certification.http://www.nutraceuticalsworld.com/contents/view_breaking-news/2011-07-11/association-responds-to-supplement-safety-concerns "Association Responds to Supplement Safety Concerns." Nutraceuticals World. July 11, 2011]

Permissible claims

If a dietary supplement claims to cure, mitigate, or treat a disease, it would be considered an unauthorized new drug and in violation of the applicable regulations and statutes. As the FDA states, in a response to this question, in a FAQ

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 products 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 hormone melatonin helps establish normal sleep patterns"). 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. In reality, misleading claims about supplements are common, in particular on poorly regulated commercial websites.http://www.ftc.gov/bcp/edu/pubs/consumer/health/hea07.shtm Miracle Health Claims: Add a Dose of Skepticism] Federal Trade Commissionlt;/ref> For example, the compound hydrazine sulfate is sold as a dietary supplement in the USA and promoted as a treatment for cancer, despite little evidence that it is either safe or effective.lt;/ref>lt;/ref> Other claims that require 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.

See also

* Cosmeceutical * Essential nutrient * Food additive * Food fortification * Food processing * Health freedom movement * Herbalism * Medicinal mushrooms * Megavitamin therapy * Multivitamin * Naturopathic medicine * Nutraceutical * Nutrients (journal) * Nutrification (aka food enrichment or fortification) * Nutritional genomics * Nutrition Labeling and Education Act of 1990 * Orthomolecular medicine *Revital * Snake oil

References

Further reading

*http://www.nal.usda.gov/fnic/pubs/bibs/gen/dietarysupplementsconsumers06.pdf Dietary Supplements: General Resources for Consumers (PDF|131 KB)], Food and Nutrition Information Center, United States National Agricultural Library List of resources that provides an overview of herbal and dietary supplements, including use, regulation, research, and cautionary information. *http://www.nutrition.gov/nal_display/index.php?info_center11&tax_level2&tax_subject393&topic_id1939&&placement_default0 Questions to Ask Before Taking Vitamin and Mineral Supplements], http://www.nutrition.gov Nutrition.gov].

External links

* http://www.naturalstandard.com/ Natural Standard Research Collaboration] * http://www.nlm.nih.gov/medlineplus/druginfo/herb_All.html Dietary Supplements Labels Database], from the United States National Library of Medicine * http://ods.od.nih.gov/Health_Information/IBIDS.aspx International Bibliographic Information on Dietary Supplements database] from the U.S. National Institutes of Health Office of Dietary Supplements and USDA National Agricultural Library * http://www.cfsan.fda.gov/~dms/supplmnt.html Dietary Supplement Information] from the U.S. Food and Drug Administration * http://nccam.nih.gov/health/bottle/ Whats in the Bottle? An Introduction to Dietary Supplements], from the U S National Center for Complementary and Alternative Medicine * http://nccam.nih.gov/health/supplement-safety/ Safety information on herbal supplements], from the U.S. National Institutes of Health * http://www.iom.edu/?id4829&redirect0 Use of Complementary and Alternative Medicine (CAM) by the American Public]: A report of the Institute of Medicine * * http://www.ahrq.gov/clinic/epcindex.htm#dietsup EPC Evidence Reports on Dietary Supplements] Category Dietary supplements ar مكملات غذائية ca Complement dietètic cs Doplněk stravy da Kosttilskud de Nahrungsergänzungsmittel es Suplemento dietético fr Complément alimentaire hi खाद्य पूरक it Integratore alimentare he תוסף תזונה nl Voedingssupplement ja サプリメント no Kosttilskudd pl Suplement diety pt Suplemento alimentar ru Биологически активные добавки sl Prehransko dopolnilo sr Дијететски суплементи fi Lisäravintoaine sv Kosttillskott th ผลิตภัณฑ์เสริมอาหาร uk Біологічно активні добавки zh 膳食补充剂
#Disclaimer: This page is based on the copyrighted Wikipedia article  - This entry is from Wikipedia, the leading user-contributed encyclopedia. It may not have been reviewed by professional editors see full disclaimer. This article is licensed under the Creative Commons Attribution/Share-Alike License.