Dietary Supplements A Framework for Evaluating Safety (2005) / Chapter Skim
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1 Introduction and Background
1 Introduction and Background
Pages 19-42
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. 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, 19
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As with conventional foods, dietary supplements are to be presumed safe-that is, it is assumed that they do not present a significant2 or unreasonable risk of injury or illness when consumed as recommended. 1While these are not dietary supplement categories specified by DSHEA, they illustrate the diversity of products currently marketed as dietary supplements.
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The proposed framework was to include a methodology to review data with regard to the safety of dietary supplement ingredients, taking into consideration methods other expert bodies have used to categorize and review supplement safety and efficacy issues. FDA, in its request, asked that a framework for setting priorities and evaluating the safety of dietary supplement ingredients be proposed and released for comment, followed by the development of six prototype monograph reviews using the procedures outlined in the proposed framework.
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. However, knowledge about the use prevalence and trends of dietary supplements (which include nonvitamin, nonmineral supplements)
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. The Sloan Survey explored general patterns of medication use in the ambulatory adult population from 1998 to 1999 and examined use of vitamins, minerals, botanicals, and other dietary supplements, in addition to drugs.
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With the passage of DSHEA, the burden of proof concerning the safety of dietary supplements was placed on FDA by requiring FDA to determine that a dietary supplement ingredient presents a "significant or unreasonable risk of illness or injury" (see Box 1-2) , rather than requiring a manufacturer3 to provide data supporting its safety, as is done with food additives4 (21 C.F.R.
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(1) If it is a dietary supplement or contains a dietary ingredient that- (A)
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Federal Food, Drug, and Cosmetic Act of 1938 A movement for increased regulation of ingested substances came about in the 1930s, eventually culminating in Congress passing the Federal Food, 5For clarity, FDA and its predecessors are referred to in this text simply as "FDA." The actual name Food and Drug Administration was established in 1930. Predecessors were the Bureau of Chemistry, which began in 1862, and the Food, Drug, and Insecticide Administration, which was created in 1927 when regulatory functions of the Bureau of Chemistry were separated from nonregulatory research (FDA, 2002)
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8 However, food colors and food additives must be approved by FDA via the food additive petition process; other substances added to food that are not approved via this process must be declared or affirmed to be GRAS based on intended use before they may be sold in a food product. Dietary ingredients marketed in dietary supplements are exempt from this requirement.
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. FDA did not, however, rigorously apply the FDCA's third definition of drugs, the definition that categorizes as drugs all products listed in the USP, the offical Homeopathic Pharmacopoeia of the United States, or the National Formulary.
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In general, the result of the Food Additives Amendment was to shift the burden of proof of safety for new substances added to food away from FDA and to the manufacturers (FDA, 2002)
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. Prior to the passage of DSHEA, FDA instituted action in the early 1990s against many popular dietary supplement ingredients, applying food
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. 1976 "Proxmire Amendments" Prior to the overturn by the court in 1993 of FDA's attempts to apply the food additive provisions to dietary supplements, the regulation of botanical, vitamin, and mineral supplements had been inconsistent and was based on a combination of enforcement and judicial decisions.
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not respond Postmarket No No No reporting or surveillance by industry required Burden of FDA must demonstrate FDA must demonstrate FDA must proof of significant or significant or demonstrate safety unreasonable risk of unreasonable risk of that food is harm to remove harm to prevent injurious to product from market product from being health to marketed remove product from market a DSHEA = Dietary Supplement and Health Education Act of 1994. b Here "conventional foods" refers to whole agricultural commodities.
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a rule requiring marketers of food developed through biotechnology to notify the agency at least 120 days before commercial distribution and to provide information to demonstrate that the product is as safe as its conventional counterpart. f While the final regulations for the notification procedure are not yet published, the interim policy outlined by FDA in the proposed regulations invites interested persons who determine that a substance is GRAS to notify FDA of such GRAS determinations as described in the proposed regulation 21 C.F.R.
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That the same information can simultaneously be insufficient to demonstrate safety when intended to be used as a food additive, while also insufficient to con clude that it presents a significant or unreasonable risk of illness or injury when used in a dietary supplement, presents an interesting dichotomy. The result is an FDA policy to seize, as adulterated, foods for sale to which stevia leaves or stevioside have been added, unless the items are labeled as dietary supplements.
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By this time, mounting scientific evidence had led several food companies to start promoting their conventional foods based on the potential of some of their ingredients or substances to reduce the risk of specific diseases. While not endorsed by FDA, some have purported that when similar claims were made in reference to dietary supplements, FDA responded more harshly, contending that by virtue of claims made regarding the supplement they were unapproved drugs (Pendergast, 1997)
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, resulting in botanicals and amino acids being considered as foods based on intended use, as were vitamins and minerals, which were already classified as food based on intended use. Importantly, DSHEA established a new regulatory framework for dietary supplements that limited FDA's authority over these products to that of conventional foods, as compared with its authority over food additives or new drugs (see Table 1-1 for comparison and Box 1-3 for discussion of an example)
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DSHEA also established safety standards for dietary supplements. It states that a dietary supplement will be considered adulterated (i.e., illegal)
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, which addressed health claims, nutritional support statements, substantiation files for claims and safety, and publications used in conjunction with sales. FDA Actions Following DSHEA Since a dietary supplement manufacturer is generally not required to share its basis for safety determinations with FDA before marketing, FDA determines possible safety issues from publicly available information it collects and from data that it generates in its own laboratories.
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. Good Manufacturing Practices As dietary supplements, like foods, can be contaminated with foreign toxic substances, FDA must consider more than the "inherent" safety of specific dietary supplement ingredients to adequately evaluate the potential for public health concerns.
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2003. Current good manufacturing practices in manufacturing, packing, or holding dietary ingredients and dietary supplements.
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2001. Position of the American Dietetic Association: Food fortification and dietary supplements.
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1995. The Dietary Supplement Health and Education Act.
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