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Dietary supplement

Dietary supplement

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A dietary supplement, also known as food supplement or nutritional supplement, is a preparation intended to supplement the diet and provide nutrient
Nutrient
A nutrient is a chemical that an organism needs to live and grow or a substance used in an organism's metabolism which must be taken in from its environment. They are used to build and repair tissues, regulate body processes and are converted to and used as energy...

s, such as vitamin
Vitamin
A vitamin is an organic compound required as a nutrient in tiny amounts by an organism. In other words, an organic chemical compound is called a vitamin when it cannot be synthesized in sufficient quantities by an organism, and must be obtained from the diet. Thus, the term is conditional both on...

s, minerals
Dietary mineral
Dietary minerals are the chemical elements required by living organisms, other than the four elements carbon, hydrogen, nitrogen, and oxygen present in common organic molecules. Examples of mineral elements include calcium, magnesium, potassium, sodium, zinc, and iodine...

, fiber
Dietary fiber
Dietary fiber, dietary fibre, or sometimes roughage is the indigestible portion of plant foods having two main components:* soluble fiber that is readily fermented in the colon into gases and physiologically active byproducts, and* insoluble fiber that is metabolically inert, absorbing water as it...

, fatty acid
Fatty acid
In chemistry, especially biochemistry, a fatty acid is a carboxylic acid with a long unbranched aliphatic tail , which is either saturated or unsaturated. Most naturally occurring fatty acids have a chain of an even number of carbon atoms, from 4 to 28. Fatty acids are usually derived from...

s, or amino acid
Amino acid
Amino acids are molecules containing an amine group, a carboxylic acid group and a side-chain that varies between different amino acids. The key elements of an amino acid are carbon, hydrogen, oxygen, and nitrogen...

s, that may be missing or may not be consumed in sufficient quantities in a person's diet
Diet (nutrition)
In nutrition, diet is the sum of food consumed by a person or other organism. Dietary habits are the habitual decisions an individual or culture makes when choosing what foods to eat. With the word diet, it is often implied the use of specific intake of nutrition for health or weight-management...

. 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
Codex Alimentarius
The Codex Alimentarius is a collection of internationally recognized standards, codes of practice, guidelines and other recommendations relating to foods, food production and food safety. Its name derives from the Codex Alimentarius Austriacus...

, a collection of internationally recognized standards, codes of practice, guidelines and other recommendations relating to food
Food
Food is any substance consumed to provide nutritional support for the body. It is usually of plant or animal origin, and contains essential nutrients, such as carbohydrates, fats, proteins, vitamins, or minerals...

s, food production and food safety
Food safety
Food safety is a scientific discipline describing handling, preparation, and storage of food in ways that prevent foodborne illness. This includes a number of routines that should be followed to avoid potentially severe health hazards....

. These texts are drawn up by the Codex Alimentarius Commission, an organization that is sponsored by the Food and Agriculture Organization
Food and Agriculture Organization
The Food and Agriculture Organization of the United Nations is a specialised agency of the United Nations that leads international efforts to defeat hunger. Serving both developed and developing countries, FAO acts as a neutral forum where all nations meet as equals to negotiate agreements and...

 of the United Nations
United Nations
The United Nations is an international organization whose stated aims are facilitating cooperation in international law, international security, economic development, social progress, human rights, and achievement of world peace...

 (FAO) and the World Health Organization
World Health Organization
The World Health Organization is a specialized agency of the United Nations that acts as a coordinating authority on international public health. Established on 7 April 1948, with headquarters in Geneva, Switzerland, the agency inherited the mandate and resources of its predecessor, the Health...

 (WHO).

European Union


The European Union
European Union
The European Union is an economic and political union of 27 independent member states which are located primarily in Europe. The EU traces its origins from the European Coal and Steel Community and the European Economic Community , formed by six countries in 1958...

's Food Supplements Directive of 2002 requires that supplements be demonstrated to be safe, both in dosages and purity. 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 claims and nutrition claims.

The dietary supplements industry in the United Kingdom
United Kingdom
The United Kingdom of Great Britain and Northern IrelandIn the United Kingdom and Dependencies, other languages have been officially recognised as legitimate autochthonous languages under the European Charter for Regional or Minority Languages...

 (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. In 2004, along with two British trade associations, the Alliance for Natural Health
Alliance for Natural Health
The Alliance for Natural Health is an advocacy group founded in 2002 by Robert Verkerk and based in the United Kingdom. The ANH was initially founded to raise funds to finance a legal challenge of the EU Food Supplement Directive...

 had a legal challenge to the Food Supplements Directive referred to the European Court of Justice
European Court of Justice
The Court can sit in plenary session, as a Grand Chamber of 13 judges, or in chambers of three or five judges. Plenary sitting are now very rare, and the court mostly sits in chambers of three or five judges...

 by the High Court in London. Although the European Court of Justice's Advocate General subsequently said that the bloc's plan to tighten rules on the sale of vitamins and food supplements should be scrapped, 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
Public health
Public health is "the science and art of preventing disease, prolonging life and promoting health through the organized efforts and informed choices of society, organizations, public and private, communities and individuals" . It is concerned with threats to health based on population 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. Nevertheless, the European judges did acknowledge the Advocate General's 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.

A survey of adults aged 18–64 years, conducted in 2001 in Ireland
Ireland
Ireland is an island to the northwest of continental Europe. It is the third-largest island in Europe and the twentieth-largest island on Earth...

, 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.

Russia



The Russian Ministry of Health's 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 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.

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
United States
The United States of America is a federal constitutional republic comprising fifty states and a federal district...

, a dietary supplement is defined under the Dietary Supplement Health and Education Act of 1994 (DSHEA) as a product that is intended to supplement the diet
Diet (nutrition)
In nutrition, diet is the sum of food consumed by a person or other organism. Dietary habits are the habitual decisions an individual or culture makes when choosing what foods to eat. With the word diet, it is often implied the use of specific intake of nutrition for health or weight-management...

 and contains any of the following dietary ingredients:
  • a vitamin
    Vitamin
    A vitamin is an organic compound required as a nutrient in tiny amounts by an organism. In other words, an organic chemical compound is called a vitamin when it cannot be synthesized in sufficient quantities by an organism, and must be obtained from the diet. Thus, the term is conditional both on...

  • a mineral
    Dietary mineral
    Dietary minerals are the chemical elements required by living organisms, other than the four elements carbon, hydrogen, nitrogen, and oxygen present in common organic molecules. Examples of mineral elements include calcium, magnesium, potassium, sodium, zinc, and iodine...

  • an herb
    Herb
    Except in botanical usage, an herb is "any plant with leaves, seeds, or flowers used for flavoring, food, medicine, or perfume" or "a part of such a plant as used in cooking"...

     or other botanical (excluding tobacco)
  • an amino acid
    Amino acid
    Amino acids are molecules containing an amine group, a carboxylic acid group and a side-chain that varies between different amino acids. The key elements of an amino acid are carbon, hydrogen, oxygen, and nitrogen...


  • a concentrate, metabolite, constituent, extract, or combination of any of the above


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
Steroid
A steroid is a type of organic compound that contains a characteristic arrangement of four cycloalkane rings that are joined to each other. Examples of steroids include the dietary fat cholesterol, the sex hormones estradiol and testosterone, and the anti-inflammatory drug dexamethasone.The core...

), pregnenolone
Pregnenolone
Pregnenolone is a steroid hormone involved in the steroidogenesis of progesterone, mineralocorticoids, glucocorticoids, androgens, and estrogens. As such it is a prohormone. Pregnenolone sulfate is a GABAA antagonist and increases neurogenesis in the hippocampus.-Chemistry:Like other steroids,...

 (also a steroid) and the pineal hormone melatonin
Melatonin
Melatonin , also known chemically as N-acetyl-5-methoxytryptamine, is a naturally occurring compound found in animals, plants, and microbes...

 are marketed as dietary ingredients in supplements in the US.

Regulation


The Food and Drug Administration
Food and Drug Administration
The Food and Drug Administration is an agency of the United States Department of Health and Human Services, one of the United States federal executive departments...

 (FDA) regulates dietary supplements as a category of foods, and not as drug
Medication
A pharmaceutical drug, also referred to as medicine, medication or medicament, can be loosely defined as any chemical substance intended for use in the medical diagnosis, cure, treatment, or prevention of disease.- Classification :...

s. While pharmaceutical companies are required to obtain FDA approval
New drug application
The New Drug Application is the vehicle in the United States through which drug sponsors formally propose that the Food and Drug Administration approve a new pharmaceutical for sale and marketing...

 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. 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. On September 24, 2007 the FDA has implemented a "current good manufacturing practice
Good Manufacturing Practice
"Good manufacturing practice" or "GMP" are practices and the systems required to be adapted in pharmaceutical manufacturing, quality control, quality system covering the manufacture and testing of pharmaceuticals or drugs including active pharmaceutical ingredients, diagnostics, foods,...

s" (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.

The DSHEA, passed in 1994, was the subject of lobbying
Lobbying
Lobbying is the act of attempting to influence decisions made by officials in the government, most often legislators or members of regulatory agencies. Lobbying is done by various people or groups, from private-sector individuals or corporations, fellow legislators or government officials, or...

 efforts by the manufacturers of dietary supplements and restricted the ability of the FDA to exert authority over supplements so long as manufacturers made no claims about their products treating, preventing or curing diseases. According to Consumer Reports
Consumer Reports
Consumer Reports is an American magazine published monthly by Consumers Union since 1936. It publishes reviews and comparisons of consumer products and services based on reporting and results from its in-house testing laboratory. It also publishes cleaning and general buying guides...

, "The law has left consumers without the protections surrounding the manufacture and marketing of over-the-counter or prescription medications" and it became the FDA's responsibility to prove that a supplement wasn't 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 only ever found one dietary supplement to be unsafe, the weight loss/energy supplement ephedra
Ephedra
Ephedra refers to the plant Ephedra sinica. E. sinica, known in Chinese as ma huang , has been used in traditional Chinese medicine for 5,000 years for the treatment of asthma and hay fever, as well as for the common cold...

. Discussing the legislation, Time
Time (magazine)
Time is an American news magazine. A European edition is published from London. Time Europe covers the Middle East, Africa and, since 2003, Latin America. An Asian edition is based in Hong Kong...

 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 FDA's ability to regulate them". 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
Adverse event
An adverse event is any adverse change in health or side effect that occurs in a person who participates in a clinical trial while the patient is receiving the treatment or within a previously specified period of time after the treatment has been completed.AEs in patients participating in...

s 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.

A 2001 study, published in Archives of Internal Medicine
Archives of Internal Medicine
The Archives of Internal Medicine is a peer-reviewed medical journal published twice a month by the American Medical Association. The Archives of Internal Medicine was established in 1908 and covers all aspects of internal medicine, including cardiovascular disease, geriatrics, infectious disease,...

, 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 supported pre-marketing approval by the FDA, increased oversight of harmful supplements, and greater scrutiny of the truthfulness of supplement label claims.

Quality


Under the FDA's 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". The new regulations allow FDA inspectors to look at a company's records upon request. 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". Independent certification programs exist, but these may have problems as well. United States Pharmacopeia
United States Pharmacopeia
The United States Pharmacopeia is the official pharmacopeia of the United States, published dually with the National Formulary as the USP-NF. The United States Pharmacopeial Convention is the nonprofit organization that owns the trademark and copyright to the USP-NF and publishes it every year...

 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, and it is the only certification program which conducts random off-the-shelf testing. The USP program will not certify products which contain ingredients that the USP's Dietary Supplement Information Expert Committee determines have a safety risk. ConsumerLab.com
ConsumerLab.com
ConsumerLab.com is a provider of independent test results and information to help consumers and healthcare professionals evaluate health, wellness, and nutrition products. ConsumerLab.com was founded in 1999. It is subscription fee based....

 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. 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 FDA's 2006 guidance on lead in candy, only 0.2 micrograms of lead per serving are allowed. NSF International
NSF International
NSF International is an Ann Arbor, Michigan-based not-for-profit public health and environmental organization that provides standards development, product certification, auditing, education and risk management services.-History:...

, HFL Sport Science, and the Natural Products Association (NPA) also have dietary supplement certification programs. In 1999, NPA launched the industry's first third-party Good Manufacturing Practices (GMP) certification program for dietary supplements and ingredients. Nearly 70 companies have achieved certification.

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
FAQ
Frequently asked questions are listed questions and answers, all supposed to be commonly asked in some context, and pertaining to a particular topic. "FAQ" is usually pronounced as an initialism rather than an acronym, but an acronym form does exist. Since the acronym FAQ originated in textual...

:


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 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, particularly on poorly regulated commercial websites. For example, the compound hydrazine sulfate
Hydrazine sulfate
Hydrazine sulfate is the salt of hydrazine and sulfuric acid. Known by the trade name Sehydrin, it is a chemical compound that has been used as an alternative medical treatment for the loss of appetite and weight loss which is often associated with cancer...

 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.

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.

See also


  • Cosmeceutical
    Cosmeceutical
    Cosmeceuticals refers to the combination of cosmetics and pharmaceuticals. Cosmeceuticals are cosmetic products with biologically active ingredients purporting to have medical or drug-like benefits....

  • Essential nutrient
    Essential nutrient
    An essential nutrient is a nutrient required for normal body functioning that either cannot be synthesized by the body at all, or cannot be synthesized in amounts adequate for good health , and thus must be obtained from a dietary source...

  • Food additive
    Food additive
    Food additives are substances added to food to preserve flavor or enhance its taste and appearance.Some additives have been used for centuries; for example, preserving food by pickling , salting, as with bacon, preserving sweets or using sulfur dioxide as in some wines...

  • Food fortification
    Food fortification
    Food fortification or enrichment is the process of adding micronutrients to food. It can be purely a commercial choice to provide extra nutrients in a food, or sometimes it is a public health policy which aims to reduce numbers of people with dietary deficiencies in a population.Diets that lack...

  • Food processing
    Food processing
    Food processing is the set of methods and techniques used to transform raw ingredients into food or to transform food into other forms for consumption by humans or animals either in the home or by the food processing industry...

  • Health freedom movement
  • Herbalism
    Herbalism
    Herbalism is a traditional medicinal or folk medicine practice based on the use of plants and plant extracts. Herbalism is also known as botanical medicine, medical herbalism, herbal medicine, herbology, herblore, and phytotherapy...

  • Medicinal mushrooms
    Medicinal mushrooms
    Medicinal mushrooms are mushrooms, or mushroom extracts, that are used or studied as possible treatments for diseases. Lentinula edodes , Grifola frondosa , Ganoderma lucidum , and Cordyceps, have a history of medicinal use spanning millennia in parts of Asia...

  • Megavitamin therapy
    Megavitamin therapy
    Megavitamin therapy is the use of large doses of vitamins, often many times greater than the recommended dietary allowance in the attempt to prevent or treat diseases...

  • Multivitamin
    Multivitamin
    A multivitamin is a preparation intended to supplement a human diet with vitamins, dietary minerals, and other nutritional elements. Such preparations are available in the form of tablets, capsules, pastilles, powders, liquids, and injectable formulations...

  • Naturopathic medicine
    Naturopathic medicine
    Naturopathy, or Naturopathic Medicine, is a form of alternative medicine based on a belief in vitalism, which posits that a special energy called vital energy or vital force guides bodily processes such as metabolism, reproduction, growth, and adaptation...

  • Nutraceutical
    Nutraceutical
    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...

  • Nutrients (journal)
    Nutrients (journal)
    Nutrients is a monthly peer-reviewed academic journal that presents research in the fields of nutrients, nutraceuticals and nutritional supplements.This open access e-journal publishes reviews, research papers and short communications...

  • Nutrification (aka food enrichment or fortification)
  • Nutritional genomics
    Nutritional genomics
    Nutritional genomics is a science studying the relationship between human genome, nutrition and health.It can be divided into two disciplines:*Nutrigenomics: studies the effect of nutrients on health through altering genome, proteome, metabolome and the resulting changes in...

  • Nutrition Labeling and Education Act of 1990
  • Orthomolecular medicine
    Orthomolecular medicine
    Orthomolecular medicine is a form of complementary and alternative medicine that seeks to maintain health and prevent or treat diseases by optimizing nutritional intake and/or prescribing supplements...

  • Revital
    Revital
    Revital is a brand of health supplement owned and marketed over the counter by Ranbaxy Laboratories Ltd division-Ranbaxy Consumer Global Healthcare. Revital is available in India and some African and APAC countries. It is the largest selling vitamins, minerals supplement in India.-History:Revital...

  • Snake oil
    Snake oil
    Snake oil is a topical preparation made from the Chinese Water Snake , which is used to treat joint pain. However, the most common usage of the phrase is as a derogatory term for quack medicine...



Further reading


External links