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In the United States, the Dietary Supplement Health and Education Act of 1994 provides this description: "The Dietary Supplement Health and Education Act of 1994 (DSHEA) defines the term "dietary supplement" to mean a product (other than tobacco) intended to supplement the diet that bears or contains one or more of the following dietary ingredients: a vitamin, a mineral, an herb or other ...
In addition, a dietary supplement cannot be approved or authorized for investigation as a new drug, antibiotic, or biologic, unless it was marketed as a food or a dietary supplement before such approval or authorization. [8] Under DSHEA, dietary supplements are deemed to be food, except for purposes of the drug definition. [8]
Under the Dietary Supplement Health and Education Act (DSHEA), passed in 1994 in the United States, the Food and Drug Administration (FDA) is not responsible for testing the risks and efficacy of dietary supplements. Manufacturers are not required to present data on the effectiveness of multivitamins or disclose known side effects to the FDA.
Substances which the FDA regulates as food are subdivided into various categories, including foods, food additives, added substances (man-made substances which are not intentionally introduced into food, but nevertheless end up in it), and dietary supplements. The specific standards which the FDA exercises differ from one category to the next.
Regulation of supplements varies widely by country. In the United States, a dietary supplement is defined under the Dietary Supplement Health and Education Act of 1994. [74] There is no FDA approval process for dietary supplements, and no requirement that manufacturers prove the safety or efficacy of supplements introduced before 1994.
Common side effects include constipation and nausea. [1] When taken by mouth high blood calcium is uncommon. [1] Calcium supplements, unlike calcium from dietary sources, appear to increase the risk of kidney stones. [1] Adults generally require about a gram of calcium a day. [1] Calcium is particularly important for bones, muscles, and nerves. [1]
Some herbs may amplify the effects of anticoagulants. [52] Certain herbs as well as common fruit interfere with cytochrome P450, an enzyme critical to much drug metabolism. [53] In a 2018 study, the FDA identified active pharmaceutical additives in over 700 analyzed dietary supplements sold as "herbal", "natural" or "traditional". [54]
[74] [75] A review did not find any effect from supplementation on the rates of non-skeletal disease, other than a tentative decrease in mortality in the elderly. [76] Vitamin D supplements do not alter the outcomes for myocardial infarction, stroke or cerebrovascular disease, cancer, bone fractures or knee osteoarthritis. [10] [77]