Dietary supplement definition

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. 

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). 

Physician s Desk Reference (PDR) for Nonprescription Drugs, Dietary Supplements, and Herbs The Definitive Guide to OTC Medications. Montvale, NJ Thompson PDR 2006. 

The terms retinal responder and nonresponder were introduced by Hammond et al.35 to reflect differences in the magnitude of MP increases that resulted from dietary supplementation. Obviously, the term nonresponse only refers to that response seen within the context of the study. So-called nonresponders obviously responded at some point in their lives or they would have no measurable amounts of MP. Retinal response to LZ supplementation is probably better regarded as reflecting a continuum of differences rather than simply two categories of response. The most that can be definitively said at this time is that there is clearly variability in response to supplementation and that the causes for these differences are not known. 

Vitamins are small-molecular-weight organic substances that are necessary for essential biochemical reactions, growth, vitality and the normal functioning of the body. They must be supplied in the diet or in the form of dietary supplements. Central to the definition of a vitamin is that a lack of it will produce a specific deficiency syndrome, and supplying it will cure that deficiency. 

The DSHEA was a bipartisan bill cosponsored by Orrin Hatch of Utah and Tom Harkin of Iowa. First, it broadened the definition of a dietary supplement to include any product designed to supplement the diet that contained one or more of the following a vitamin, mineral, herb, botanical, amino acid, or any metabolic constituent or extract thereof. To be removed from the market, supplements must be proven unsafe by the FDA. This is in contrast to drugs, where the burden of proof (both safety and efficacy) is on the manufacturer. Supplements must contain the labeling Not evaluated... 

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. 

Products used for a therapeutic purpose are categorised as medicines, related products, herbal remedies or mediccil devices. Definitions of other categories (e.g., cosmetics, dietary supplements, herbal remedies, etc.) are also provided in the legislation and official standards and are further described in various guidelines. 

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... 

Haller and Benowitz evaluated 140 reports of ephedra-related toxicity and concluded that 31% of the cases were definitely related to ephedra toxicity and a further 31% were possibly related 47% of reports of ephedra toxicity involved cardiovascular problems and 18% involved problems with the CNS. Hypertension was the single most frequent adverse reaction, followed by palpitation, tachycardia, stroke and seizure. Ten events resulted in death and 13 events caused permanent disability. The authors concluded that use of dietary supplements that contains ephedra may pose a health risk. ... 

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. 

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). 

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