From Wikipedia, the free encyclopedia
A dietary supplement, also known as food supplement or nutritional supplement, is a preparation intended to provide nutrients, such as vitamins, minerals, fatty acids or amino acids, that are missing or are not consumed in sufficient quantity in a person's diet. Some countries define dietary supplements as foods, while in others they are defined as drugs.
 United States
In the United States, 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 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"
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.
The DSHEA gave the FDA the express responsibility to regulate the manufacturing processes of dietary supplements, and the FDA issued its first proposed rule in 2003. In June 2007 it issued its final rule, which requires all dietary supplement manufacturers to ensure by June 2010 that production of dietary supplements complies with current good manufacturing practices, and be manufactured with "controls that result in a consistent product free of contamination, with accurate labeling." In addition, the industry is now required to report to the FDA "all serious dietary supplement related adverse events." The new rules have been criticized, however, with skeptics arguing lack of FDA resources, loopholes, and an exception on quality assurance for raw material suppliers (with the burden placed on manufacturers) will lead to continued quality problems. There's also concern that supplement manufacturers and retailers will hide behind the new regulations. Prior to the rule supplements have had major quality problems, and the number of FDA investigators has declined.
The DSHEA, passed in 1994, was the subject of lobbying efforts by the manufacturers of dietary supplements. 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."
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. 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.
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.
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 could be 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 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. 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. 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.
 Permissible claims
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:
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.
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.