The United States Food and Drug Administration is a federal agency of the Department of Health and Human Services. The FDA is responsible for protecting and promoting public health through the control and supervision of food safety, tobacco products, dietary supplements, prescription and over-the-counter pharmaceutical drugs (medications), vaccines, biopharmaceuticals, blood transfusions, medical devices, electromagnetic radiation emitting devices (ERED), cosmetics, animal foods & feed and veterinary products.
Stevia is a natural sweetener and sugar substitute derived from the leaves of the plant species Stevia rebaudiana, native to Brazil and Paraguay.
A sugar substitute is a food additive that provides a sweet taste like that of sugar while containing significantly less food energy than sugar-based sweeteners, making it a zero-calorie or low-calorie sweetener. Artificial sweeteners may be derived through manufacturing of plant extracts or processed by chemical synthesis. Sugar substitute products are commercially available in various forms, such as small pills, powders, and packets.
A dietary supplement is a manufactured product intended to supplement one's diet by taking a pill, capsule, tablet, powder, or liquid. A supplement can provide nutrients either extracted from food sources or that are synthetic in order to increase the quantity of their consumption. The class of nutrient compounds includes vitamins, minerals, fiber, fatty acids, and amino acids. Dietary supplements can also contain substances that have not been confirmed as being essential to life, but are marketed as having a beneficial biological effect, such as plant pigments or polyphenols. Animals can also be a source of supplement ingredients, such as collagen from chickens or fish for example. These are also sold individually and in combination, and may be combined with nutrient ingredients. The European Commission has also established harmonized rules to help insure that food supplements are safe and appropriately labeled.
Ephedra is a medicinal preparation from the plant Ephedra sinica. Several additional species belonging to the genus Ephedra have traditionally been used for a variety of medicinal purposes, and are a possible candidate for the soma plant of Indo-Iranian religion. It has been used in traditional Chinese medicine, in which it is referred to as Ma Huang, for more than 2,000 years. Native Americans and Mormon pioneers drank a tea brewed from other Ephedra species, called "Mormon tea" and "Indian tea".
Olestra is a fat substitute that adds no calories to products. It has been used in the preparation of otherwise high-fat foods such as potato chips, thereby lowering or eliminating their fat content. The Food and Drug Administration (FDA) originally approved olestra for use in the US as a replacement for fats and oils in prepackaged ready-to-eat snacks in 1996, concluding that such use "meets the safety standard for food additives, reasonable certainty of no harm". In the late 1990s, olestra lost its popularity due to supposed side effects and has been largely phased out, but products containing the ingredient can still be purchased at grocery stores in some countries.
An anorectic or anorexic is a drug which reduces appetite, resulting in lower food consumption, leading to weight loss. By contrast, an appetite stimulant is referred to as orexigenic.
Anti-obesity medication or weight loss medications are pharmacological agents that reduce or control weight. These medications alter one of the fundamental processes of the human body, weight regulation, by altering either appetite, or absorption of calories. The main treatment modalities for overweight and obese individuals remain dieting and physical exercise.
A nutraceutical or bioceutical is a pharmaceutical alternative which claims physiological benefits. In the US, "nutraceuticals" are largely unregulated, as they exist in the same category as dietary supplements and food additives by the FDA, under the authority of the Federal Food, Drug, and Cosmetic Act.
The United States Federal Food, Drug, and Cosmetic Act 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, medical devices, and cosmetics. A principal author of this law was Royal S. Copeland, a three-term U.S. senator from New York. In 1968, the Electronic Product Radiation Control provisions were added to the FD&C. Also in that year the FDA formed the Drug Efficacy Study Implementation (DESI) to incorporate into FD&C regulations the recommendations from a National Academy of Sciences investigation of effectiveness of previously marketed drugs. The act has been amended many times, most recently to add requirements about bioterrorism preparations.
Sibutramine, formerly sold under the brand name Meridia among others, is an appetite suppressant which has been discontinued in many countries. Until 2010, it was widely marketed and prescribed as an adjunct in the treatment of obesity along with diet and exercise. It has been associated with increased cardiovascular events and strokes and has been withdrawn from the market in several countries and regions including Australia, Canada, China, the European Union, Hong Kong, India, Mexico, New Zealand, the Philippines, Thailand, the United Kingdom, and the United States. However, the drug remains available in some countries.
Glucomannan is a water-soluble polysaccharide that is considered a dietary fiber. It is a hemicellulose component in the cell walls of some plant species. Glucomannan is a food additive used as an emulsifier and thickener. It is a major source of mannan oligosaccharide (MOS) found in nature, the other being galactomannan, which is insoluble.
Hydroxycut is a brand of dietary supplements that is marketed as a weight loss aid. Hydroxycut was originally developed and manufactured by MuscleTech Research and Development; MuscleTech was sold to Iovate Health Sciences in 2003–2004 and declared bankruptcy in 2005; Iovate continues to use MuscleTech as a brand to market Hydroxycut.
β-Methylphenethylamine is an organic compound of the phenethylamine class, and a positional isomer of the drug amphetamine, with which it shares some properties. In particular, both amphetamine and β-methylphenethylamine are human TAAR1 agonists. In appearance, it is a colorless or yellowish liquid.
The Center for Food Safety and Applied Nutrition is the branch of the United States Food and Drug Administration (FDA) that regulates food, dietary supplements, cosmetics, drugs, biologics, medical devices, and radiological products.
Methylhexanamine is an indirect sympathomimetic drug invented and developed by Eli Lilly and Company and marketed as an inhaled nasal decongestant from 1948 until it was voluntarily withdrawn from the market in the 1970s.
The regulation of food and dietary supplements by the U.S. Food and Drug Administration is a process governed by various statutes enacted by the United States Congress and interpreted by the U.S. Food and Drug Administration ("FDA"). Pursuant to the Federal Food, Drug, and Cosmetic Act and accompanying legislation, the FDA has authority to oversee the quality of substances sold as food in the United States, and to monitor claims made in the labeling about both the composition and the health benefits of foods.
Phentermine/topiramate, sold under the brand name Qsymia, is a combination drug of phentermine and topiramate used to treat obesity. It is used together with dietary changes and exercise. If less than 3% weight loss is seen after 3 months it is recommended the medication be stopped. The weight loss is modest. Effects on heart related health problems or death is unclear.
The Chemins Company is a dietary supplement manufacturer based in Colorado Springs, Colorado. The company, founded in 1974 by James Cameron, became embroiled in a series of criminal investigations in 1994 after a woman died and more than 100 other people became ill after taking one of the company’s products marketed under the brand name Nature's Nutrition Formula One. The adverse events were later linked to the product having been tainted with ephedrine. A three-year federal investigation, which revealed that the company had doctored records, misled FDA investigators, and purposely hindered inspections, led to Cameron being sentenced to 21 months in prison and him and the company being fined $4.7 million. The company also paid out $750,000 to settle a class action lawsuit alleging that the company's protein powder supplements contained approximately half the protein content and twice the carbohydrate content listed on the label.
Pre-workout is a generic term for a range of bodybuilding supplement products used by athletes and weightlifters to enhance athletic performance. It is taken to increase endurance, energy, and focus during a workout. Pre-workout supplements contain a variety of ingredients such as caffeine and creatine, ranging by product. It can be taken in a variety of forms including capsules and powder. The first pre-workout entered the market in 1982, and since then they have grown in popularity. Some pre-workouts contain ingredients linked to adverse effects. Although these products are not banned, the Food and Drug Administration (FDA) warns consumers to be cautious when consuming pre-workout.