Supplements/supplementation food supplement definition

In the United States, the use of products, including botanicals, thought to fall within the realm of complementary and alternative medicine is very common. It is difficult to obtain reliable estimates of use or to compare many of the current publications in this area because of diverse definitions for categorizing these products (e.g., dietary supplement, food supplement, herbal medicine, natural remedy, traditional medicine, etc.) in both the United States and elsewhere. A recent report on the use of complementary and alternative medicine by U.S. adults in 2002 indicated that approximately 19% of the population used nonvitamin, nonmineral, and natural products, 19% used folk medicine, and 3% used megavitamin therapy in the past 12 months (1). 

The DSHEA classified herbal products as dietary supplements intended to supplement the diet. Also included in the definition of dietary supplement were vitamins, minerals, botanicals, amino acids, and other substances intended to supplement the diet. Dietary supplements were not considered foods or drugs and therefore were exempt for FDA oversight and the premarket approval process. For all products introduced before October 1994, the burden of proof to demonstrate safety was now in the hands of the FDA and not in the hands of the manufacturer. Products introduced after October 1994 must be proven safe by the manufacturer. Manufacturers are currently not required to submit safety and efficacy data, and there are no good manufacturing standards (GMP) in place. However, the FDA does have the authority to establish GMP standards, and they are currently under development. Preliminary proposals indicate these GMP standards will more likely reflect GMP for food rather than for drugs. 

Use of yarrow as a food additive in the United States is subject to a limitation that the finished food or beverage is thu-jone-free (CFR 2011). Dietary ingredients for use in dietary supplements, however, are specifically excluded from the federal food additive definition (U.S.C. 2010). 

Definition Consists principally of dried fish protein prepared from edible portions of fish Uses Food supplement Reguiatory FDA 21CFR 172.340 Manuf./Distrib. Amerol http //www.amerolcorp.com, Degussa AG/Health Nutrition http //www.degussa-health-nutrition, de... 

Definition Broken hulls of rice, Oryza sativa Uses Dietary fiber supplement in foods bulking agent, abrasive in cosmetics Manuf./Distrib. Doguet Rice Milling Trade Name Synonyms Aqua Pro II RB [Midwest Grain Prods. http //www.midwestgrain.com] Protex 20 t[Mid-Am. Food Sales4]... 

Probiotics are live microorganisms usually consumed in the diet through fermented dairy foods and beverages. Fuller (1991) first defined probiotics as "live microbial food supplements that beneficially affect the host by improving the intestinal microbial balance." An updated definition was released in 2002 by the FAO/ WHO, which is the most current version "Probiotics are live microorganisms which, when administered in adequate amounts, confer a health benefit to the host." Several criteria must be met when a microorganism is proposed as a probiotic strain for human use ... 

The Traws-Atlantic Business Dialogue (TABD) approved a position statement regarding dietary supplements in 2002. The TABD is a group of corporations that promote closer commercial ties between the European Union and the United States. This position statement established industrywide consensus on standards and definition of permissible claims, as well as defining what is necessary for substantiation of those claims. In keeping with the Foods Supplement Directive, the TABD dealt only with vitamins and minerals, with the understanding that some of the conclusions may be revisited when warranted for herbals, botanicals, or other dietary supplements. 

Vitamin and mineral as both foods and drugs, botanicals (approved and not approved), teas as prescription and as over-the-counter Vitamin and mineral, plants, herbs, nutritional food supplements, naturopaths and homeopathic preparations, aromatherapies No definition of dietary supplements, regulations for foods, drugs, and Kampo... 

By definition, a nutraceutical (derived from the term nutritional pharmaceutical ) is a foodstuff (fortified food or dietary supplement) that is held to provide health or medical benefits in addition to its basic nutritional value [1], Nutraceuticals derived from botanicals deliver a concentrated form of presumed bioactive agents from plants that are not generally part of the food supply. The term nutraceutical has no regulatory definition. Similarly, functional foods, as defined by the International Life Sciences Institute (ILSI), are foods that by virtue of physiologically active food components, provide health benefits beyond basic nutrition [2], For the purposes of this review, these two terms will be differentiated by the form in which they are consumed. Nutraceuticals refers to dietary supplements most often found in pill or capsule form functional foods are ingested as part of a normal food pattern. Both are intended to provide beneficial effects beyond their nutritional value, and contribute to an improved state of health and/or reduction of risk of disease. 

U.S. Food and Drug Administration. Food Labeling, Nutrient Content Claims, Definition for High Potency and Definition for Antioxidant for Use in Nutrient Content Claims for Dietary Supplements and Conventional Foods, cfsan.fda.gov/ dms/hpotguid.html. 

In the United States, the Dietary Supplement Health and Education Act (DSHEA) of 1994 (United States Public Law 103-417) amended the Federal Food, Drug and Cosmetic Act by defining as a dietary supplement any product (other than tobacco) that contains a vitamin, mineral, herb or other botanical, or amino acid and is intended as a supplement to the diet. Food is considered safe by definition, but new foods or food additives must be demonstrated to be generally recognized as... 

Within the United States, the most recent attempt to balance the interests of all involved is the Dietary Supplement Health and Education Act (DSHEA) which includes herbal products within the definition of a dietary supplement. DSHEA assures availability of supplements as long as they are not unsafe and allows producers to make certain structure and function claims on the label, but in words which do not apparently provide the exact information a consumer needs. In addition the DSHEA requires a disclaimer to appear on the label which indicates to the patient/consumer that the product has not been evaluated by the Food and Drug Administration and that it is not intended to diagnose, treat, cure or prevent disease. 

A) articles recognized in the official United States Pharmacopeia, official Homeopathic Pharmacopeia of the United States, or official National Formulary, or any supplement to any of them and (B) articles intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease in man or other animals and (C) articles (other than food) intended to affect the structure or any function of the body of man or other animals and (D) articles intended for use as a component of any articles specified in clause (A), (B), or (C). (http //wmw.fda.gov/opaccm/laws/fdcact/fdcactl. htm. Chapter II - Definitions, (g)(1))... 

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