258 - dietary supplements structures

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. 

Israelsen LD, Blumenthal M. FDA issues final rules for structure/function claims for dietary supplements under DSHEA. HerbalGram 48 32-38, 2000. 

In accordance with the provisions of the Dietary supplement Health and Education Act 1994, in the United States botanical dosage forms can be marketed as dietary supplements provided the label makes no medical claim however, structure-function claim is allowed. In most countries other than the United States, botanical preparations are regulated as drugs thus posing a different set of challenges. This fact must be taken into consideration in standard setting. 

Ca is a comparatively difficult element for the body to absorb and digest. It is essentially only available for consumption associated with various other moieties (e.g., citrate, phosphate, and other anions). Each Ca source has unique physical, structural, and chemical properties such as mass, density, coordination chemistry, and solubility that are largely determined by the anions associated with the Ca +. Aqueous solubility of various Ca salts can vary markedly and comparisons are frequently made under standardized conditions. The water solubility of CCM is moderate when ranked versus other Ca sources frequently used as dietary supplements and food/beverage fortificants. The solubility of CCM (6 2 3 molar ratio) is 1.10-g salt in 100 ml of H2O at 25 °C (Fox et ah, 1993a). Table 6.4 lists the solubility of various Ca sources in water at specific temperatures, and also includes some information on potential sensory characteristics. 

Similar to drugs, dietary supplements can make claims to affect the structure or function of the body. However, supplements are specifically prohibited from making disease claims. A dietary supplement bearing structure or function claims is also required to carry the following disclaimer on the product label The FDA has not evaluated this claim. This product is not intended to diagnose, mitigate, treat, cure or prevent disease (19). 

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 molecular structure of ephedra resembles that of amphetamine, a stimulant. Dietary supplement product manufacturers often mixed caffeine with ephedra. Some experts believe that caffeine probably enhances or heightens ephedra s stimulant effects. Ephedra may also be combined with other herbs in supplements, depending on the desired effects. 

The regulation of Echinacea products in the United States would fall under the Dietary Supplement Health and Education Act of 1994 (DSHEA). In the United States, statutory 403 (a)(1) of the Federal Food, Drug, and Cosmetic Act prohibits labeling that is false or misleading. Under DSHEA, a structure/-function claim can be made, provided the claim meets the criteria set forth in statutory 403(r)(6). Structure/function claims are permissible if a specific disease is not targeted, unless reviewed by FDA. A structure/function claim such as supports the immune system would be acceptable whereas alleviates the common cold or flu would not be acceptable for Echinacea because the claim targets a specific disease state (i.e., cold or flu). 

Although it has been recognized for over A century that certain diseases occur when the diet is restricted, and can be prevented by additions to the diet (such as lime juice for the prevention of scurvy), the identification of the essential lood factors as chemical substances rvas not made until a few years ago. Progress in the isolation of these substances and in the determination of their structure has been rapid in recent years, and many of the vitamins are now being made synthetically, for use as dietary supplements. It is usually possible for a diet to be obtained that provides all of the essendal food substances in satisfactory amounts, bur in some cases it is wise to have the diet supplemented by vitamin preparations. 

With selenium or Vitamin E deficient diets, repeated exposure to silver (76 ppm in the drinking water for 52 days) in rats elicited hepatic necrosis and ultra-structural changes in the liver indicative of oxidative damage. This toxicity may be related to a silver-induced selenium deficiency and impairment of synthesis of the enzyme glutathione peroxidase. Dietary supplementation with selenium or Vitamin E prevented such changes. Mice exposed to silver nitrate in the drinking water for 4 months exhibited... 

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