Dietary Supplement – A product that is intended to supplement the diet.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. 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 bears or contains one or more of the following dietary ingredients:
Furthermore, it must be:
Regulation Pursuant to the DSHEA, the Food and Drug Administration regulates dietary supplements as foods, and not as drugs. Unlike pharmaceutical companies, supplement manufacturers are not required to prove the safety or effectiveness of their products; the FDA can take action only after a dietary supplement has been proven harmful. In addition, the purity and quality of individual brands of dietary supplements are unregulated. 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 DSHEA was the subject of extensive lobbying efforts by the manufacturers of dietary supplements. As such, the true level of popular support for the deregulation of the supplement industry is unclear. 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. Similar confusion about the implications of DSHEA was noted in an October 2002 nationwide Harris poll. Here, 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 are 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 is 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. Permissible claims 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: 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. 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. Return from Dietary Supplement to All-Day-Energy
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