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Supplements

In the United States, a dietary supplement is defined under the Dietary Supplement Health and Education Act of 1994^[2] (DSHEA) as a product that is intended to supplement the diet and contains any of the following dietary ingredients:

• 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 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"

The hormones DHEA (a steroid), pregnenolone (also a steroid) and the pineal hormone melatonin are marketed as dietary supplements in the US.^[3][4]

[edit] Regulation

Pursuant to the DSHEA, the Food and Drug Administration (FDA) regulates dietary supplements as foods, and not as drugs. While pharmaceutical companies are required to obtain FDA approval proving the safety or effectiveness of their products prior to their entry into the market, dietary supplements, like food, do not need to be pre-approved by FDA before they can enter the market.^[5]

Dietary supplement manufacturers will, however, be required by June 2010 to ensure that all production of dietary supplements must comply with current good manufacturing practices, and be manufactured with "controls that result in a consistent product free of contamination, with accurate labeling."^[6] In addition, the industry is now required to report to the FDA "all serious dietary supplement related adverse events."

The DSHEA, passed in 1994, was the subject of lobbying efforts by the manufacturers of dietary supplements.^[7][8] At the time of its passage DSHEA received strong support from consumer grassroots organizations, and Members of Congress. In recognition of this, President Bill Clinton, on signing DSHEA into law, stated that "After several years of intense efforts, manufacturers, experts in nutrition, and legislators, acting in a conscientious alliance with consumers at the grassroots level, have moved successfully to bring common sense to the treatment of dietary supplements under regulation and law." He also noted that the passage of DSHEA "speaks to the diligence with which an unofficial army of nutritionally conscious people worked democratically to change the laws in an area deeply important to them" and that "In an era of greater consciousness among people about the impact of what they eat on how they live, indeed, how long they live, it is appropriate that we have finally reformed the way Government treats consumers and these supplements in a way that encourages good health."^[9]

Popular support may have been based on a misunderstanding of the situation after the deregulation of the supplement industry. A large survey by the AARP, for example, found that 77% of respondents (including both users and non-users of supplements) believed that the federal government should review the safety of dietary supplements and approve them before they can be marketed to consumers.^[10] In an October 2002 nationwide Harris poll, 59% of respondents believed that supplements had to be approved by a government agency before they could be marketed; 68% believed that supplements had to list potential side effects on their labels; and 55% believed that supplement labels could not make claims of safety without scientific evidence. All of these beliefs were incorrect as a result of provisions of the DSHEA.^[11]

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 supported pre-marketing approval by the FDA, increased oversight of harmful supplements, and greater scrutiny of the truthfulness of supplement label claims.^[12]

[edit] Permissible claims

The claims that a dietary supplement makes are essential to its classification.

The United States of America (commonly referred to as the United States, the U.S., the USA, or America) is a federal constitutional republic comprising fifty states and a federal district. The country is situated mostly in central North America, where its forty-eight contiguous states and Washington, D.C., the capital district, lie between the Pacific and Atlantic Oceans, bordered by Canada to the north and Mexico to the south. The state of Alaska is in the northwest of the continent, with Canada to its east and Russia to the west across the Bering Strait. The state of Hawaii is an archipelago in the mid-Pacific. The country also possesses several territories, or insular areas, scattered around the Caribbean and Pacific.

At 3.79 million square miles (9.83 million km²) and with about 305 million people, the United States is the third or fourth largest country by total area, and third largest by land area and by population. The United States is one of the world's most ethnically diverse and multicultural nations, the product of large-scale immigration from many countries.^[7] The U.S. economy is the largest national economy in the world, with an estimated 2008 gross domestic product (GDP) of US$14.3 trillion (23% of the world total based on nominal GDP and almost 21% at purchasing power parity).^[4][8]

The nation was founded by thirteen colonies of Great Britain located along the Atlantic seaboard. On July 4, 1776, they issued the Declaration of Independence, which proclaimed their independence from Great Britain and their formation of a cooperative union. The rebellious states defeated Great Britain in the American Revolutionary War, the first successful colonial war of independence.^[9] A federal convention adopted the current United States Constitution on September 17, 1787; its ratification the following year made the states part of a single republic with a strong central government. The Bill of Rights, comprising ten constitutional amendments guaranteeing many fundamental civil rights and freedoms, was ratified in 1791.

In the 19th century, the United States acquired land from France, Spain, the United Kingdom, Mexico, and Russia, and annexed the Republic of Texas and the Republic of Hawaii. Disputes between the agrarian South and industrial North over states' rights and the expansion of the institution of slavery provoked the American Civil War of the 1860s. The North's victory prevented a permanent split of the country and led to the end of legal slavery in the United States. By the 1870s, the national economy was the world's largest.^[10] The Spanish–American War and World War I confirmed the country's status as a military power. In 1945, the United States emerged from World War II as the first country with nuclear weapons, a permanent member of the United Nations Security Council, and a founding member of NATO.

A federal republic is a federation of states with a republican form of government. A federation is the central government. The states in a federation also maintain all political sovereignty that they do not yield to the federation. Usage of the term republic is inconsistent but, as a minimum, it means a state or federation of states that does not have a monarch as head of state.

In English, before the merger of the two German states in 1990, the phrase "Federal Republic" was often used to refer to West Germany (within its pre-1990 borders), in contrast with the German Democratic Republic, otherwise called East Germany.

[edit] List of federal republics

[edit] Contemporary

[edit] Historic

• Republic of the Seven United Netherlands (1581–1795)
• United Provinces of Central America (1824-1840)
• "Great Colombia" (1819-1831), later Colombia (federal republic until 1886; unitary republic after 1886)
• Weimar Republic (German Empire 1919-1933)
• Federal Republic of Cameroon (République Fédérale du Cameroun) (1961-1972)
• Czechoslovakia (1969-1992)
• Union of Soviet Socialist Republics (1922-1991)
• Yugoslavia (1945-2003)
• Serbia and Montenegro (2003-2006)
• Uganda (1962-1966)

A federation (Latin: foedus, covenant) is a union comprising a number of partially self-governing states or regions united by a central ("federal") government. In a federation, the self-governing status of the component states is typically constitutionally entrenched and may not be altered by a unilateral decision of the central government.

The form of government or constitutional structure found in a federation is known as federalism (see also federalism as a political philosophy). It can be considered the opposite of another system, the unitary state. The government of Germany with sixteen federated Länder is an example of a federation, whereas neighboring Austria and its Bundesländer was a unitary state with administrative divisions that became federated, and neighboring France by contrast has always been unitary.

Federations may be multi-ethnic, or cover a large area of territory, although neither is necessarily the case. Federations are most often founded on an original agreement between a number of sovereign states based on mutual concerns or interests. The initial agreements create a stability that encourages other common interests and each brings the disparate territories closer and gives them all even more common ground. At some time this is recognized and a movement is organized to merge more closely. Other times, especially when common cultural factors are at play such as ethnicity and language, some of these steps in this pattern are expedited and compressed.

The international council for federal countries, the Forum of Federations ^[1], is based in Ottawa, Ontario, Canada. It helps share best practices amongst countries with federal systems of government, and currently includes nine countries as partner governments.

[edit] Federations and other forms of state

A map of the United States of America, showing its fifty constituent states.

A map of the United Mexican States (Mexico), showing its thirty one constituent states and the Federal District.

In a federation the component states are regarded as in some sense sovereign, insofar as certain powers are reserved to them that may not be exercised by the central government. However, a federation is more than a mere loose alliance of independent states. The component states of a federation usually possess no powers in relation to foreign policy and so they enjoy no independent status under international law.

Some federations are called asymmetric because some states have more autonomy than others. An example of such a federation is Malaysia, in which Sarawak and Sabah entered the federation on different terms and conditions to the states of Peninsular Malaysia.

A federation often emerges from an initial agreement between a number of separate states. The purpose can be the will to solve mutual problems or to provide for mutual defence, or to create a nation state for an ethnicity spread over several states.

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