Dietary supplements defined

Finally, a white paper entitled Use of Marker Compounds in Manufacturing and Labeling Botanically Derived Dietary Supplements defines and discusses several of the constituents that naturally occur in herbs and that are selected for special attention by a researcher or manufacturer. The largest part of this document is devoted to evaluating the benefits and pitfalls of identifying these compounds in research, manufacturing, and marketing. 

Unfortunately, many clinical studies evaluating the efficacy of dietary supplements are flawed. Some of the flaws in the studies include non-randomization, being unblinded, lack of standardized products, small sample sizes, short treatment durations, and poorly defined inclusion and exclusion criteria. Many studies do not give detailed information about the dietary supplement used. When an herb is studied, the following information should be described plant species, part(s) used, product form (e.g., powdered crude herb, aqueous extract, ethanol extract, or aqueous alcohol extract) with stated proportions of water to alcohol, specifically extracted fractions, and quantities or concentrations used [48]. 

FDCA defines drugs as articles intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease and articles (other than food) intended to affect the structure or any function of the body. Therefore, a product becomes a drug based upon its intended use and not upon its composition or source [26]. A pharmacist may violate the FDCA if he or she recommends and sells a dietary supplement for the treatment of a particular disease—the pharmacist would be indicating the product as an unapproved drug. However, if the pharmacist is not selling the product, the FDCA would not be violated. 

What defines a dietary supplement versus a drug As defined by Congress in the Dietary Supplement Health and Education Act (which became law in 1994), a dietary supplement is a product (other than tobacco) that ... 

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. 

Nutrients enter into biological processes that are not characterized by a well-defined dose-response relationship. Therefore, in many cases, the dietary supplement itself is not expected to exhibit a characteristic dose-response curve. 

In contrast to vitamin and mineral products, which are chemically well-defined, the biopharmaceutical quality and behavior of botanical dosage forms marketed as dietary supplements are often not well documented. In most cases,... 

A marine nutraceutical is defined as a marine-derived substance that can be used as a dietary supplement or a food ingredient that provides a medicinal or health benefit beyond basic nutrition [Barrow, C.. and F. Shahidi (2008). Marine Nutraceuticals and Functional Foods. CRC Press. 494 pp.] Cosmoceuticals are cosmetic products with drug-like benefits conferred by ingredients such as vitamins, phytochemicals, enzymes, antioxidants, and essential oils. 

The kind of natural products listed in the table above, however, are not defined in the United States today as drugs hut as dietary supplements, nutritional supplements, natural foods, or some similar nondrug product. Such products are not subject to the same standards of testing as are synthetic drugs. They are regulated by the Dietary Supplement Health and Education Act (DSHEA) of 1994 (Public Law 103-417). According to that law, the makers of natural products used... 

Dietary Supplement Health and Education Act(1994) Established standards with respect to dietary supplements but prohibited full FDA review of supplements and botanicals as drugs. Required the establishment of specific ingredient and nutrition information labeling that defines dietary supplements and classifies them as part of the food supply but allows unregulated advertising. 

Because of the problems that resulted from self-regulation, another law, the Dietary Supplement and Non-Prescription Drug Consumer Protection Act, was approved in 2006. This law requires manufacturers, packers, or distributors of supplements to submit reports of serious adverse events to the FDA. Serious adverse events are defined as death, a life-threatening event, hospitalization, a persistent or significant disability or incapacity, congenital anomaly or birth defect, or an adverse event that requires medical or surgical intervention to prevent such outcomes based on reasonable medical judgment. If this requirement were enforced, and consumers cooperated, these reports would make it possible to identify trends in adverse effects and would help to alert the public to safety issues. 

United States Congress passes Dietary Supplement Health and Education Act, which expressly defines a dietary supplement as a vitamin, a mineral, an herb or other botanical, an amino acid, or any other dietary substance. This law prohibits claims that herbs can treat diseases or disorders, but it allows more general health claims about the effect of herbs on the structure or function of the body or about the well-being they induce. Under this law, the FDA bears the burden of having to prove an herbal is unsafe before restricting its use. This law also establishes the Office of Dietary Supplements within the National Institutes of Health to promote and compile research on dietary supplements. 

The public needs to be educated about the concept of frequency of exposure and the degree of risk. In this context, the emphasis on greater variety in the diet needs to be expanded to explain the ability of dietary constituents to enhance each others beneficial effects thus providing a more nutritionally desirable diet, as well as to neutralize the adverse effects of some constituents. Furthermore, the potentially adverse effects of large doses of dietary supplements needs to be emphasized just as much as the potential benefits of supplementation under certain well defined conditions. 

Industrial conjugated linoleic acid (CLA) is a poorly defined blend of compounds (102). Early commercial syntheses focused on maximizing total CLA content. Many early products were rich in CLA but contained a number of positional isomers. Market demand has now shifted for a product that contains two predominant isomers, specifically 9,ll-c,t-octadecadienoic acid and 10,12-tc-octadecadienoic acid. It is not surprising that alkali isomerization produced some undesirable positional isomers of CLA. In 1970, Mounts and Dutton (103) had shown unequivocally that when potassium t-butoxide was used, at least four positional isomers of CLA were produced. It was not until 1997, after the use of CLA as a dietary supplement... 

The FDA has jurisdiction over prescription drug advertising and promotion, while the FTC has jurisdiction over the advertising and promotion of over-the-counter (OTC) medicines, as well as dietary supplements and medical devices (other than restricted devices as defined in the FD C Act). The FDA retains full jurisdiction over the labeling of all medical products, including OTC drugs and dietary supplements. 

The term dietary supplement is defined under regulation 2 of the Dietary Supplements Regulations 1985 and includes any edible substance, in a controlled dosage form, which is intended to supplement the intake of substances normally derived from food. 

The boundciry between a cosmetic or dietary supplement and a related product (i.e., having a secondary therapeutic purpose) is sometimes difficult to define. If a primary therapeutic claim is made for a cosmetic or dietary supplement, the product becomes a medicine. The NZ Regulatory Guidelines provide guidance on the t es of products which, when sold without any therapeutic clciims and do not contain any substance listed in the First Schedule of the Medicines Regulations 1984, are considered to be cosmetics (e.g., antiperspirants, sunscreens, cleansers, etc.). 

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