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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, 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.
Vitamin E is a group of eight fat soluble compounds that include four tocopherols and four tocotrienols. Vitamin E deficiency, which is rare and usually due to an underlying problem with digesting dietary fat rather than from a diet low in vitamin E, can cause nerve problems. Vitamin E is a fat-soluble antioxidant which may help protect cell membranes from reactive oxygen species. Worldwide, government organizations recommend adults consume in the range of 3 to 15 mg per day. As of 2016, consumption was below recommendations according to a worldwide summary of more than one hundred studies that reported a median dietary intake of 6.2 mg per day for alpha-tocopherol.
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.
A health claim on a food label and in food marketing is a claim by a manufacturer of food products that their food will reduce the risk of developing a disease or condition. For example, it is claimed by the manufacturers of oat cereals that oat bran can reduce cholesterol, which will lower the chances of developing serious heart conditions. Vague health claims include that the food inside is "healthy," "organic," "low fat," "non-GMO," "no sugar added," or "natural".
The Reference Daily Intake (RDI) used in nutrition labeling on food and dietary supplement products in the U.S. and Canada is the daily intake level of a nutrient that is considered to be sufficient to meet the requirements of 97–98% of healthy individuals in every demographic in the United States. While developed for the US population, it has been adopted by other countries, though not universally.
Olestra is a fat substitute that adds no calories to products. It has been used in the preparation of otherwise high-fat foods 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 2000s, 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.
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 word "nutraceutical" is a portmanteau term, blending the words "nutrition" and "pharmaceutical".
Chromium deficiency is described as the consequence of an insufficient dietary intake of the mineral chromium. Chromium was first proposed as an essential element for normal glucose metabolism in 1959, and was widely accepted as being such by the 1990s. Cases of deficiency were described in people who received all of their nutrition intravenously for long periods of time.
The nutrition facts label is a label required on most packaged food in many countries, showing what nutrients and other ingredients 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.
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 Alliance for Natural Health (ANH) is an advocacy group founded in 2002 by Robert Verkerk and based in the United Kingdom. ANH was founded to raise funds to finance a legal challenge of the EU Food Supplement Directive. ANH lobbies against regulation of dietary supplements, in favour of pseudo-scientific alternative medicine, and advocates dietary and other lifestyle approaches to health. It also criticizes established science showing that Megavitamin therapy lack any health benefit.
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.
The Alliance for Natural Health USA (ANH-USA), formerly known as the American Association for Health Freedom, is a 501(c)(4) nonprofit organization dedicated to promoting alternative medicine and is associated with the libertarian health freedom movement. Located in Charlottesville, Virginia, the organization was founded in 1992 as the American Preventive Medical Association (APMA) and became a part of the international Alliance for Natural Health organization, headquartered in the United Kingdom, in 2009.
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 of their health and medical claims.
The Council for Responsible Nutrition (CRN) is a Washington D.C.-based trade association and lobbying group representing ingredient suppliers and manufacturers in the dietary supplement industry. CRN's current president and CEO is Steve M. Mister.
Vitamin B3, colloquially referred to as niacin, is a vitamin family that includes three forms or vitamers: niacin (nicotinic acid), nicotinamide (niacinamide), and nicotinamide riboside. All three forms of vitamin B3 are converted within the body to nicotinamide adenine dinucleotide (NAD). NAD is required for human life and people are unable to make it within their bodies without either vitamin B3 or tryptophan. Nicotinamide riboside was identified as a form of vitamin B3 in 2004.
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 prohibits 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 analogs, 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, treating illness, helping 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.
References
- ↑ Miller, Susan Katz (August 7, 1993). "The return of the medicine show". New Scientist.
- ↑ Carelli, Richard (December 8, 1998). "FDA Rules on Dietary Supplements are Upheld". The Philadelphia Inquirer . "a group of manufacturers, retailers"
- ↑ Williams, Lena (August 9, 1992). "F.D.A. Steps Up Effort to Control Vitamin Claims". The New York Times . "a new organization representing 25,000 vitamin makers and natural-food stores."
- ↑ Hilts, Philip J. (2004). Protecting America's Health. 0807855820. ISBN 0-8078-5582-0. p. 285
- ↑ Brody, Steven G.; P. Cameron DeVore; Bruce E. H. Johnson (2004). Advertising and Commercial Speech: A First Amendment Guide. ISBN 1-4024-0451-4.
