International Dietary Supplements

Committee on Government Reform. US House of Representatives. 2001. House Government Reform Committee Six Years After the Enactment of DSHEA The Status of National and International Dietary Supplement Regulation. March 20,2001... 

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. 

The first edition1 of this book was published approximately 13 years ago. Its primary objective was to present an overview and a "roadmap" of the process of new drug discovery and development, particularly oriented to individuals or companies entering the pharmaceutical field. It was written by one of the authors (Smith), with no contributors, and drawn on Smith s experiences in the industry and field over the course of nearly 40 years. In the second edition, the scope of the first book has been expanded and technical details in the form of hard data have been included. In addition to the editors own commentary and contributions, the major part of the book is the result of contributions of experts in the industry. New chapters on risk assessment, international harmonization of drug development and regulation, dietary supplements, patent law, and entrepreneurial startup of a new pharmaceutical company have been added. Some of the important, basic operational aspects of drug discovery and development (e.g., organizational matters, staff requirements, pilot plant operations, etc.) are not repeated in this book but can be found in the first edition. 

Good. Incidence and severity of potential drug-dietary supplement interactions in primary care patients an SR057 exploratory study of 2 outpatient practices. Arch Intern Med 2004 164(6) ... 

Vessby B, Boberg M. Dietary supplementation with n-3 fatty acids may impair glucose homeostasis in patients with non-insulin-dependent diabetes melhtus. J Intern Med 1990 228(2) 165-71. 

Because creatine is regulated by the FDA as a dietary supplement and not a drug, the purity of the product is a concern. A test of 100 popular nutritional supplements conducted by the International Olympic Committee (IOC) at the German Sports University in Cologne found that 16 were adulterated with nandrolone, a steroid. Nandrolone was not a listed ingredient on the product label, and most of the creatine products tested originated in the United States. 

Comfrey (Symphytum officionale). Ointments made from comfrey are used topically for wound and bone healing. Comfrey tea and pills have been prescribed by herbalists to treat gastrointestinal ulcers and diarrhea. However, the FDA advised dietary supplement manufacturers to take comfrey off the market in 2001 because of the gathering evidence that comfrey taken internally causes severe liver toxicity. The FDA also noted the lack of evidence for comfrey s effectiveness. Comfrey should not be used by pregnant women or breastfeeding mothers. 

Research supported by Phytomedics, Inc. (Jamesburg, New Jersey) NIH Center for Dietary Supplements Research on Botanicals and Metabolic Syndrome, grant 1-P50 AT002776-01 Fogarty International Center of the NIH under U01 TW006674 for the International Cooperative Biodiversity Groups and Rutgers University. 

Kristensen SD, Schmidt EB, Dyerberg J. Dietary supplementation with n-3 polyunsaturated fatty acids and human platelet function a review with particular emphasis on implications for 171. cardiovascular disease. J. Intern. Med. 1989 225(suppl) 141-150. 

Efforts are under way to make the USP-NF more useful worldwide. Incorporation of monographs for multi-vitamin products, biotechnology-derived products, veterinary drugs, and botanicals and other dietary supplements help. The US AN and USP Dictionary of Drug Names has wide international applicability, thereby making it a repository of International Names Nomenclature (INN) and British Adopted Names (BAN), as well as U.S. Adopted Names (USAN). Pharmacopeial Forum now contains announcements of proposals from the Japanese Pharmacopeia and European Pharmacopeia for revision of standards for international harmonization. 

Favreau JT, Ryu ML, Braunstein G, Orshansky G, Park SS, Coody GL, Love LA, Fong TL. Severe hepatotoxicity associated with the dietary supplement LipoKinetix. Ann Intern Med 2002 136(8) 590-5. 

Gad SC and Gad SE (2002) Are dietary supplements safe as currently regulated . International Journal of Toxicology 22 1-8. 

Africa has been and continues to be a significant source of medicinal and aromatic plants to the world s food, drug, herb and dietary supplement market, and in the past decade numerous African plant materials have established a strong international market presenee. This book provides an exeellent opportunity to delve into the current and future eontributions that African plants can and will continue to make both internal to Africa and on the global stage. 

Ho, C.T. Simon, J.E. Shahidi F. Shao. Y., In Dietary Supplements. Ho, C.T. Shao, Y. Simon, J.E., Eds. American Chemical Society Symposium Series 925. American Chemical Society Washington, DC, 2008 2-8. International Trade Centre, ITC Trade Map http //www.trademap.org/. Ndoye, O., In Non-Timber Forest Products between Poverty Alleviation and Market Forces. Pfund, J.L. Robinson, P., Eds. Intercooperation Switzerland, 2005 14-19. 

The USP discourages the internal use of comfrey because of studies showing hepatotoxicity and carcinogenicity, and no studies have shown the benefit of taking comfrey orally (USP, 1998). The Delaney Clause of the Food, Drug and Cosmetic Act establishes no tolerance for carcinogens in foods. Even so, comfrey is considered a dietary supplement, and can be sold if labeled as such. 

Peng, C. C., Glassman, P. A., Trilli, L. E., Hayes-Hunter, J., and Good, C. B. (2004) Incidence and severity of potential drug-dietary supplement interactions in primary care patients an exploratory study of 2 outpatient practices. Arch. Intern. Med. 164, 630-636. 

Association of Analytical Communities (2003b). Guidelines for Single Laboratory Validation of Chemical Methods for Dietary Supplements and Brdanicals. AOAC International, Gaithersburg, MD. 

Anon, Guidelines for single laboratory validation of chemical methods for dietary supplements and botanicals, AOAC International, Gaithersburg MD, 2002, p. 38. 

Vos AP, van Esch B, M Rabet L, Folkerts G, Garssen J. Dietary supplementation with specific ohgosaccharide mixtures decreases parameters of allergic asthma in mice. Intern Immnnopharmacol 2007 7 1502-1507. 

Radack, K., Deck, C., and Huster, G., Dietary supplementation with low-dose fish oils lowers fibrinogen levels a randomized, double-blind controlled study, Ann. Intern. Med., Ill, 757, 1989. 

Owen, M.A.G., Waines, R, Bradley, G. and Davies, S. (2006) The effect of dietary supplementation of sodium butyrate on the growth and microflora of Clarias gariepinus (Burchell 1822). Proceedings of the XII International Symposium Fish Nutrition Feeding, May 28 - June 1, 2006 149. 

Psyllium plays an integral part in medical and human health management.lt has been used as a safe and effective laxative and can be taken internally as dietary supplement because of its low acute toxicity (4). It has been found helpful in maintaining the health of the... 

Giardino, L., Ambu, E., Savoldi, E., Rimondini, R., CassaneUi, C., Debbia, E.A., 2007. Comparative evaluation of antimicrobial efficacy of sodium hypochlOTite, MTAD, and Tetraclean against Enterococcus faecaUs biofilm. Journal of Endodontics 33, 852—855. Gilani, G.S., Xiao, C., Lee, N., 2008. Need for accurate and standardized determination of amino acids and bioactive peptides for evaluating protein quality and potential health effects of foods and dietary supplements. Journal of AOAC International 91, 894—900. 

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