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, caffeine 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.
A dietary supplement is a manufactured product intended to supplement a person'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. The classes of nutrient compounds in supplements include vitamins, minerals, fiber, fatty acids, and amino acids. Dietary supplements can also contain substances that have not been confirmed as being essential to life, and so are not nutrients per se, 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.
Lovastatin, sold under the brand name Mevacor among others, is a statin medication, to treat high blood cholesterol and reduce the risk of cardiovascular disease. Its use is recommended together with lifestyle changes. It is taken by mouth.
Nootropics, colloquially brain supplements, smart drugs and cognitive enhancers, are natural, semisynthetic or synthetic compounds which purportedly improve cognitive functions, such as executive functions, attention or memory.
Anti-aging creams are predominantly moisturizer-based skin care products marketed with unproven claims of making the consumer look younger by reducing, masking or preventing signs of skin aging. Anti-aging supplements are ingestible products promoted to diminish the effects of aging, including vitamin supplements, powders, and teas.
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. In the United States, nutraceuticals are considered and regulated as a subset of foods by the Food and Drug Administration (FDA).
Leiner Health Products was a company based in Carson, California, and was one of America's largest manufacturers of vitamins, minerals, herbal nutritional supplements, and generic medications. It was founded in 1973, and was owned by North Castle Partners, a private investment firm from Connecticut.
Nutrilite is a brand of mineral, vitamin, and dietary supplements developed in 1934 by Carl F. Rehnborg. Nutrilite products are currently manufactured by Access Business Group, a subsidiary of Alticor whose products are sold via Amway worldwide. The Nutrilite brand is known as Nutriway in Denmark, Finland, Norway, Sweden, Turkey, Australia and New Zealand.
Red yeast rice, red rice koji, red fermented rice, red kojic rice, red koji rice, anka, or angkak, is a bright reddish purple fermented rice, which acquires its color from being cultivated with the mold Monascus purpureus. Red yeast rice is what is referred to as a "koji" in Japanese, meaning "grain or bean overgrown with a mold culture", a food preparation tradition going back to ca. 300 BC. In both the scientific and popular literature in English that draws principally on Japanese traditional use, red yeast rice is most often referred to as "red rice koji." English language articles favoring Chinese literature sources prefer the translation "red yeast rice."
Juice Plus is a branded line of dietary supplements. It is produced by Natural Alternatives International of San Marcos, California, for National Safety Associates. Introduced in 1993, the supplements are distributed by NSA via multi-level marketing. Juice Plus supplements contain fruit and vegetable juice extracts with added vitamins and nutrients.
Vinpocetine is a synthetic derivative of the vinca alkaloid vincamine, differing by the removal of a hydroxyl group and by being the ethyl rather than the methyl ester of the underlying carboxylic acid. Vincamine is extracted from either the seeds of Voacanga africana or the leaves of Vinca minor.
Picamilon is a drug formed by a synthetic combination of niacin and γ-aminobutyric acid (GABA). It was developed in the Soviet Union in 1969 and further studied in both Russia and Japan as a prodrug of GABA.
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.
ConsumerLab.com, LLC. is a privately held American company registered in White Plains, NY. It is a publisher of test results on health, wellness, and nutrition products. Consumer Labs is not a laboratory, but contracts studies to outside testing laboratories. It purchases dietary supplement products and other consumer goods directly from public storefronts and online retailers, contracts for testing by private laboratories, and publishes reports based on the results. It primarily derives revenue from the sale of subscriptions to its online publications, which are paywalled. Other sources of revenue include a proprietary certification program, licensing fees, contents re-publication license fees, and advertising.
Niacin/lovastatin was a drug combination used for the treatment of dyslipidemia. It was a combination of the lipid-modifying drug/vitamin niacin in extended release form and the statin drug lovastatin. The combination preparation was developed by Kos Pharmaceuticals, Inc., which was acquired by Abbott Laboratories in 2006, subsequently transferred to AbbVie Inc. when that company was spun off from Abbott in January 2013.
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.
The Dietary Supplement Health and Education Act of 1994 ("DSHEA"), is a 1994 statute of United States Federal legislation which defines and regulates dietary supplements. Under the act, supplements are regulated by the FDA for Good Manufacturing Practices under 21 CFR Part 111. The act was intended to exempt the dietary and herbal supplement industry from most FDA drug regulations, allowing them to be sold and marketed without scientific backing for their health and medical claims.
The Council for Responsible Nutrition (CRN) is a Washington D.C.-based trade association and lobbying group representing more than 180 companies that manufacture dietary ingredients and supplements, or supply services to those suppliers and manufacturers. CRN's current president and CEO is Steve M. Mister.
Consumer Health Laws are laws that ensure that health products are safe and effective and that health professionals are competent; that government agencies enforce the laws and keep the public informed; professional, voluntary, and business organizations that serve as consumer advocates, monitor government agencies that issue safety regulations, and provide trustworthy information about health products and services; education of the consumer to permit freedom of choice based on an understanding of scientific data rather than misleading information; action by individuals to register complaints when they have been deceived, misled, overcharged, or victimized by frauds.
The Proxmire Amendments were a series of legislation that prohibited the Food and Drug Administration from monitoring and limiting the potency of vitamins and minerals found in dietary supplements. The Proxmire Amendment also made it so that food supplements could not be classified as drugs, making their sale possible without a prescription from a doctor. According to a study done, "dietary supplements fall into the following categories: vitamins, minerals, herbs or other botanicals, amino acids, animal-derived products, hormones and hormone analogues, enzymes, and concentrates, metabolites, constituents, or extracts of these." They can be used by anyone wishing to purchase them as much or as little as they desire. Dietary supplements can be used to increase productivity, treat illness, help mental health such as depression and anxiety, enhancing mental abilities, building muscle, or losing weight, among many other uses. William Proxmire, a Senator for Wisconsin, was instrumental in influencing the passing the Proxmire Amendment. The Proxmire Amendment is also known as The Rogers-Proxmire Amendment of 1976, and The Vitamins and Minerals Amendments. This amendment became section 411 of the Federal Food, Drug, and Cosmetic Act.
