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A dietary supplement is a manufactured product intended to supplement a person's diet by taking a pill, capsule, tablet, powder, or liquid. [2] A supplement can provide nutrients either extracted from food sources, or that are synthetic (in order to increase the quantity of their consumption).
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]
The United States Federal Food, Drug, and Cosmetic Act (abbreviated as FFDCA, FDCA, or FD&C), is a set of laws passed by Congress in 1938 giving authority to the U.S. Food and Drug Administration (FDA) to oversee the safety of food, drugs, and cosmetics.
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.
As of 2024, the FDA requires manufacturers to display the contents and %DVs of certain nutrients on packaged food or supplement labels, with the instruction: [2] The Nutrition Facts label must list total fat, saturated fat, trans fat, cholesterol, sodium, total carbohydrate, dietary fiber, total sugars, added sugars, protein, and certain vitamins and minerals.
Nutraceutical is a marketing term used to imply a pharmaceutical effect from a compound or food product that has not been scientifically confirmed or approved to have clinical benefits. [1] [2] In the United States, nutraceuticals are considered and regulated as a subset of foods (such as dietary supplements) by the Food and Drug Administration ...
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.
Common supplements to help athletes recover from exercising include protein and amino acid supplements. The main use for athletes to take dietary proteins are enhance muscle repair and growth. [ 19 ] The intake of protein is a part of the nutrient requirements for the normal athlete and is an important component of exercise training.
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