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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.
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. In the United States and Canada, dietary supplements are considered a subset of foods, and are regulated accordingly. The European Commission has also established harmonized rules to help insure that food supplements are safe and properly 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 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".
The National Center for Complementary and Integrative Health (NCCIH) is a United States government agency which explores complementary and alternative medicine (CAM). It was initially created as the Office of Alternative Medicine (OAM), and renamed the National Center for Complementary and Alternative Medicine (NCCAM) before receiving its current name. NCCIH is one of the 27 institutes and centers that make up the National Institutes of Health (NIH) within the Department of Health and Human Services of the federal government of the United States.
Herbal medicine is the study of pharmacognosy and the use of medicinal plants. Plants have been the basis for medical treatments through most of human history, and such traditional medicine is still widely practiced today. Modern medicine makes use of many plant-derived compounds as the basis for evidence-based pharmaceutical drugs. Although herbalism may apply modern standards of effectiveness testing to herbs and medicines derived from natural sources, few high-quality clinical trials and standards for purity or dosage exist. The scope of herbal medicine is sometimes extended to include fungal and bee products, as well as minerals, shells and certain animal parts.
The United States Pharmacopeia (USP) is a pharmacopeia for the United States published annually by the United States Pharmacopeial Convention, a nonprofit organization that owns the trademark and also owns the copyright on the pharmacopeia itself. The USP is published in a combined volume with the National Formulary as the USP-NF. If a drug ingredient or drug product has an applicable USP quality standard, it must conform in order to use the designation "USP" or "NF". Drugs subject to USP standards include both human drugs and animal drugs. USP-NF standards also have a role in US federal law; a drug or drug ingredient with a name recognized in USP-NF is considered adulterated if it does not satisfy compendial standards for strength, quality or purity. USP also sets standards for dietary supplements and food ingredients. USP has no role in enforcing its standards; enforcement is the responsibility of the U.S. Food and Drug Administration (FDA) and other government authorities in the United States.
Controversies regarding the use of human growth hormone (HGH) as treatment method have centered on the claims, products, and businesses related to the use of growth hormone as an anti-aging therapy. Most of these controversies fall into two categories:
- Claims of exaggerated, misleading, or unfounded assertions that growth hormone treatment safely and effectively slows or reverses the effects of aging.
- The sale of products that fraudulently or misleadingly purport to be growth hormone or to increase the user's own secretion of natural human growth hormone to a beneficial degree.
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.
Velvet antler is the whole cartilaginous antler in a precalcified growth stage of the Cervidae family including the species of deer such as elk, moose, and caribou. Velvet antler is covered in a hairy, velvet-like "skin" known as velvet and its tines are rounded, because the antler has not calcified or finished developing. Velvet antler preparations are sold in China as part of traditional Chinese medicine, and in the United States and some other countries as a dietary supplement.
The nutrition facts label is a label required on most packaged food in many countries, showing what nutrients are in the food. Labels are usually based on official nutritional rating systems. Most countries also release overall nutrition guides for general educational purposes. In some cases, the guides are based on different dietary targets for various nutrients than the labels on specific foods.
Joseph Michael Mercola is an American alternative medicine proponent, osteopathic physician, and Internet business person. He markets dietary supplements and medical devices, some of which are controversial. Until 2013, Mercola operated the "Dr. Mercola Natural Health Center" in Schaumburg, Illinois. He wrote the books The No-Grain Diet and The Great Bird Flu Hoax. On his website, Mercola and colleagues advocate a number of unproven alternative health notions including homeopathy and opposition to vaccination. These positions have faced persistent criticism. Mercola is a member of the political advocacy group Association of American Physicians and Surgeons, which promotes scientifically discredited views about medicine and disease, and several other alternative medicine organizations.
Vinpocetine is a synthetic derivative of the vinca alkaloid vincamine. Vincamine is extracted from either the seeds of Voacanga africana or the leaves of Vinca minor.
The health freedom movement is a libertarian coalition that opposes regulation of health practices and advocates for increased access to "non-traditional" health care.
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.
The Nutrition Labeling and Education Act (NLEA) is a 1990 United States Federal law. It was signed into law on November 8, 1990 by President George H. W. Bush.
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.
Sulfoaildenafil (thioaildenafil) is a synthetic chemical compound that is a structural analog of sildenafil (Viagra). It was first reported in 2005, and it is not approved by any health regulation agency. Like sildenafil, sulfoaildenafil is a phosphodiesterase type 5 inhibitor.
Because of the uncertain nature of various alternative therapies and the wide variety of claims different practitioners make, alternative medicine has been a source of vigorous debate, even over the definition of "alternative medicine". Dietary supplements, their ingredients, safety, and claims, are a continual source of controversy. In some cases, political issues, mainstream medicine and alternative medicine all collide, such as in cases where synthetic drugs are legal but the herbal sources of the same active chemical are banned.
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 effectively regulated by the FDA for Good Manufacturing Practices under 21 CFR Part 111.
References
- ↑ Quack Miranda warning at Skeptic's Dictionary
- ↑ Dietary Supplements Labels FAQ Archived December 19, 2012, at the Wayback Machine , National Library of Medicine
- ↑ Quack Miranda warning at White Coat Underground, believed to be the original source of the term.
- ↑ The quack Miranda warning metastatizes, David Gorski (Orac)