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1 Introduction and Background
Pages 13-28

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From page 13...
... Within its definition of supplements, DSHEA included ingredients that have not traditionally been recognized as nutrients or as having nutritional Unctions, such as botanicals and hormones (Nesheim, ~ 999~. As with conventional foods, many dietary supplements are considered to be "safe" that is, there exists a reasonable certainty of no harm when used as recommended.
From page 14...
... GENERAL BACKGROUND INFORMATION ABOUT DIETARY SUPPLEMENTS Many of the substances currently marketed as dietary supplements fall into the following categories: vitamins, minerals, herbs or other botanicals, amino acids, animal-derived products, hormones and hormone analogs, enzymes, and concentrates, metabolites, constituents, or extracts of these.2 Within each of these categories, products may be pure single entities of known or unknown chemical components, mixtures in which all or some components are known, or mixtures of unknown chemical components. National surveys such as the Third National Health and Nutrition Examination Survey and the 1 987 and ~ 992 National Health Interview Surveys indicate that 40 to 46 percent of Americans reported taking at least one vitamin or mineral supplement at some time within the month surveyed (Balluz et al., 2000; Slesinski et al., 1995~.
From page 15...
... New dietary supplement ingredients (those not marketed prior to passage of DSHEA) , however, must provide advanced notification to FDA prior to marketing.
From page 16...
... · Government regulation should have the capacity to ensure that advertising claims about the health benefits of dietary supplements are truthful (Blendon et al., 2001~. History of the Federal Regulation of Dietary Supplements A framework for the evaluation of safety of dietary supplement ingredients must be carried out within the regulatory environment under which the ingredients are to be evaluated.
From page 17...
... government to bring greater emphasis both to the safety of marketed products and to the accurate characterization of the benefits derived from their use. The ~ 906 acts resulted from a convergence of public, industry, and scientific support that was partially motivated by concern about the safety of food and patent medicines and widespread fraud in the growing food and drug industry.
From page 18...
... FDA did not filthy exploit this reasoning in fixture cases, however, and appeared to abandon this legal theory after several sHowever, food colors, binders, and other food additives must be approved for safety or determined to be generally recognized as safe (GRAS) prior to use (only the dietary supplement ingredient in a marketed supplement is exempted from food additive regulations)
From page 19...
... 19933~. Although the courts struck down FDA's effort with black currant seed oil, FDA's application of the food additive provisions to botanical products and other dietary supplement ingredients has also been considered a major precipitating factor in the eventual passage of DSHEA (Kirschman.
From page 20...
... The Nutrition' Labeling and Education Act and Health Claims With the suppression of FDA's attempts at more restrictive rulemaking, the realm of products sold as dietary supplements continued to expand and included botanicals and amino acids, as well as vitamin and mineral products. This expansion during the late 1970s and the 198Os was accompanied by reports of serious illnesses attributed to a few of the dietary supplements available at that time.
From page 21...
... (see Box IBM. More importantly, DSHEA established a new regulatory framework for dietary supplements that limits FDA's authority over these products, as compared to its authority over food additives arid drugs (see Table 1-l for comparison)
From page 22...
... D SHEA specifically exempts dietary ingredients in dietary supplement products from being regulated under the category of food additives. Because FDA does not have the authority to consider the dietary ingredients as food additives, there is no procedure for a manufacturer to obtain premarket approval or establish GRAS status.
From page 23...
... (1) If it is a dietary supplement or contains a dietary ingredient that(A)
From page 24...
... On occasion, FDA actions have led to voluntary product recall by manufacturers (East Earth Herb, 2000; FDA, 2000; Vital Nutnents, 2001~. Examples of warnings about specific dietary supplement ingredients issued in response to a variety of potential health problems identified by FDA as possible concerns are listed in Appendix D
From page 25...
... Commission on Dietary Supplement Labels.
From page 26...
... 2001. Regulation of dietary supplements in the United States: Understanding the Dietary Supplement Health and Education Act.
From page 27...
... 2000. The Health Professional 's Guide to Popular Dietary Supplements.


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