Nutritional supplements products

Since the U.S. Congress passed Dietary Supplement Health and Education Act in October 1994, the landscape of the dietary supplement industry has changed in the United States dramatically. In fact, as early as the late 1980s, the U.S. Pharmacopeia s elected Council of Experts (then known as the USP Committee of Revision) was evoking great interest in the development and establishment of public standards for the multitude of multivitamin and multivitamin-mineral combination products as well other nutritional supplement products marketed in the United States. 

Creosote Bush. Acute toxic hepatitis has been attributed to ingestion of chaparral, an herbal nutritional supplement product derived from the leaves of the creosote bush (Clark and Reed 1992). A 42-year-old man had icterus and jaundice after consuming three 500 mg capsules of chaparral a day for 6 weeks. Serum chemistry tests showed elevated bilirubin, gamma glutamyltranspeptidase (GGT), AST, and lactate dehydrogenase. His illness was diagnosed as hepatic dysfunction secondary to chaparral ingestion. 

Hess, B. Sherma, J. Quantitative determination of GABA in nutritional supplement products by high performance thin later chromatography. Am. Lab. (Shelton, CT) 2005,57(1), 28, 30-32, 34, 36-37. 

Niacin (vitamin B3) has broad applications in the treatment of lipid disorders when used at higher doses than those used as a nutritional supplement. Niacin inhibits fatty acid release from adipose tissue and inhibits fatty acid and triglyceride production in liver cells. This results in an increased intracellular degradation of apolipoprotein B, and in turn, a reduction in the number of VLDL particles secreted (Fig. 9-4). The lower VLDL levels and the lower triglyceride content in these particles leads to an overall reduction in LDL cholesterol as well as a decrease in the number of small, dense LDL particles. Niacin also reduces the uptake of HDL-apolipoprotein A1 particles and increases uptake of cholesterol esters by the liver, thus improving the efficiency of reverse cholesterol transport between HDL particles and vascular tissue (Fig. 9-4). Niacin is indicated for patients with elevated triglycerides, low HDL cholesterol, and elevated LDL cholesterol.3... 

M. Bioequivalence for Botanicals, Nutritional Supplements, and Nonconventional Products... 

As has been pointed out earlier in this chapter, the dietary consumption and historical medicinal use of carotenoids has been well documented. In the modern age, in addition to crocin, 3.7, and norbixin, 3.8, several carotenoids have become extremely important commercially. These include, in particular, astaxanthin, 3.6 (fish, swine, and poultry feed, and recently human nutritional supplements) lutein, 3.4, and zeaxanthin, 3.3 (animal feed and poultry egg production, human nutritional supplements) and lycopene, 3.2 (human nutritional supplements). The inherent lipophilicity of these compounds has limited their potential applications as hydrophilic additives without significant formulation efforts in the diet, the lipid content of the meal increases the absorption of these nutrients, however, parenteral administration to potentially effective therapeutic levels requires separate formulation that is sometimes ineffective or toxic (Lockwood et al. 2003). 

Isolated polynucleotide clusters from Rhodococcus opacus which encode four polypeptides possessing the activities of a NHase (a and /3 subunits), an auxiliary protein P15K that activates the NHase, and a cobalt transporter protein were expressed in Escherichia coli DSM 14459 cells [34]. Methionine nitrile was added continuously to a suspension of the transformant cells (5.6% w/v of wet cells) in phosphate buffer (50 mM, pH 7.5) at 20 °C, at a rate where the nitrile concentration did not exceed 15 g L 1 while maintaining the pH constant at 7.5. After 320 min, the nitrile was completely converted into amide, corresponding to a final product concentration of 176 gL1.4-Methylthio-a-hydroxybutyramide is readily hydrolyzed with calcium hydroxide, where the calcium salt of 4-methylthio-a-hydroxybutyric acid (MHA) can be directly used as a nutritional supplement in animal feed as an alternative to methionine or MHA. 

The business of BioZone Laboratories concerns development, manufacturing, and marketing of products and technologies, such as drugs and preparations, cosmetics, and nutritional supplements. All product lines are supported by proprietary technologies, and research and development activities are considered to be of a core importance for the business. The IP estate is also available for commercialization, particularly in the prescription area, for which several drug delivery systems and a prescription version of Inflacin were developed. 

Another difference from drug therapy is that the dosing interval of a nutritional supplement is often not a critical parameter for a positive outcome. This lack of a strong dose-response relationship is an important consideration in setting of standards for dietary supplements and is in stark contrast to the situation for drug products. 

In a typical multivitamin-mineral combination product consisting of 10-15 ingredients, it is neither practical nor necessary to require in vitro demonstration of each and every vitamin and mineral. Consequently, in a unique approach to establishing in vitro dissolution for multivitamin-mineral combination products, an index vitamin and an index mineral are identified as markers for dissolution. In an attempt to account for the many different permutations of vitamins and mineral combinations, a hierarchy of index vitamins and index minerals was arrived at and specified (5). Table 1 shows the hierarchy of index vitamins and minerals specified for demonstration of dissolution requirement in the nutritional supplements monographs in USP 25-NF20. 

After GHB was banned by the FDA in 1990 for over-the-counter use, GHB chemists tried to circumvent the ban by developing closely related chemicals called gamma butyrolactone (GBL) and 1,4-butanediol (BD). The chemical structures of GHB, GBL, and BD are shown in Figure 4.1. When GBL or BD is ingested, it is rapidly converted by the body to form GHB, and the effects become identical to that of taking regular GHB. Due to the 1990 FDA ban, manufacturers of nutritional supplements previously selling GHB quickly reformulated their product so it contained GBL and/or BD instead of the... 

Prescription Drugs OTC Drugs Vitamins and Minerals Other Nutritional Supplements Herbal Products OTC Homeopathic Products... 

The marketplace would be safer if the FDA could regulate the upper dosage limits of vitamins and minerals and could hold other nutritional supplements to at least the same standards as those for OTC drugs. But DSHEA prevents the FDA from doing this unless a product poses an imminent hazard. 

While poisonous plants on grazing lands have a significant impact on livestock production throughout the world, the natural toxins (secondary metabolites) in the plant may have multiple and diverse functions, not only for the plant world but also for the benefit of mankind. Many current pharmaceuticals have been chemically optimized from natural toxins of plant origin. New plant compounds and familiar compounds with renewed interest, e.g., nutraceuticals, herbal preparations, nutritional supplements, etc, are increasingly finding their value in human nutrition and health. 

Another commercially available product containing naturally occurring marine products is Formulaid , produced by Martek Biosciences as a nutritional supplement for infant formulas. Formulaid contains two fatty acids, arachidonic acid (ARA) and docosahexaenoic acid (DHA), extracted from a variety of marine microalgae. ARA and DHA are the most abundant polyunsaturated fatty acids found in breast milk, and they are the most important fatty acids used in the development of brain gray matter. They are especially desirable for use in infant formulas because they come from nonmeat sources and can be advertised as vegetarian additives to the product. 

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... 

Some products may be available Rx, according to distributor discretion. Most of these products are marketed as nutritional supplements. 

It is relatively easy to hide and smuggle medicines. No country can count on customs controls specialized in combating counterfeit medicines. Customs control is not helped by liberalization of international commerce and the growing number of natural products , nutritional supplements and other products non-classified as pharmaceuticals that use packaging and forms more and more similar to those of medicines. 

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