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Executive Summary
Pages 1-12

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From page 1...
... The proposed framework is 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. The proposed framework described in this report is now being released for comment and discussion to interested organizations and individuals; it is intended that at least one open forum will be held specifically to solicit input about the framework and its process for setting priorities and categorizing dietary supplement ingredients, as well as about the process for review and 1
From page 2...
... BACKGROUND Current regulatory approaches to safety evaluation of dietary supplements in the United States are a product of several key pieces of legislation that span from the beginning to the end of the 20th century, culminating in the passage of DSHEA in ~ 994. The major controversy in considering the safety of dietary supplements has been whether supplements should be regulated as if they were conventional foods, food additives, or as drugs; foods are considered to be safe unless demonstrated otherwise, thus the government bears the burden to prove conventional foods are unsafe (see Table ES-~.
From page 3...
... . FINDINGS In preparation for developing a framework and then prototype monographs of six selected dietary supplement ingredients, the committee was also charged with reviewing methods used by other expert bodies to categorize and review safety issues related to dietary supplements.
From page 4...
... To this end, the Committee defined a "framework" for safety evaluation of dietary supplement ingredients as "the processes by which [DA can screen, set priorities, anti evaluate available information to make regulatory decisions regarding dietary supplement ingredients." In reviewing the methods used by other expert bodies to consider the safety of substances and in reviewing the discussions with the sponsors and other interested representatives, the following attributes of an ideal framework were identified: i, · it must be workable and able to be integrated into FDA's program of work; it should provide guidance to organizing diverse information already available; it should categorize the diverse substances classified as dietary supplements based on a scientifically valid metric; · it should establish a database for collection of information regarding potential safety concerns that can be updated as new information is available; and · it should provide a method to integrate diverse information into a prioritization scheme so that efforts and resources can be maximally directed toward those dietary supplement ingredients with the greatest safety concerns. Once the definition and attributes of a safety framework were understood, the committee then identified key factors that could be used in such a framework.
From page 5...
... During this phase, monograph reviews will be developed and put through the final cntical safety evaluation step of the proposed framework. PROPOSED FRAMEWORK FOR EVALUATING THE SAFETY OF DIETARY SUPPLEMENT INGREDIENTS s The Proposed Framework for Evaluatiing the Safety Dietary Supplement Ingredients consists of three steps: Step One, screening/flagging; Step Two, priority setting; and Step Three, critical safety evaluation (See Table ES-2 and Figure ESPY.
From page 7...
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From page 8...
... Scoring arid Sorting the Data A sorting matrix is proposed to consider the importance of the infonnation available for each key factor and to sort the ingredients accordingly. The available data for each of the four key factors (human data, animal data, biological activity of structurally related arid taxonomically related substances, and in vitro data)
From page 9...
... 9 TABLE ES-3 Matnx of Scores Used in Establishing Relative Priority Among Dietary Supplements Human Animal Ingredient Name Data Data Yellow plant exact 3 Vitamin X 2 Biological Activity of Structurally Related or Taxonomically Related Substances In Vitro Data 2 NADa 1 2 NAD 2 Animal tissue 2 1 1 a NAD = no appropriate data. Sorting the Ingredients by Scores After data for an increasing number of dietary supplement ingredients are reviewed and a numerical score is assigned for each of the key factors, the list of ingredients can be sorted into categories of relative priority (called Prionty Groups)
From page 10...
... After reviewing the infonnation collected in the monograph and obtained from public comment sessions, the external advisory committee should revise the monograph to create a picture of the scientific infonnation available. The advisory committee should evaluate the available scientific infonnation and reach conclusions where possible, descnbing what is known about the safety of the ingredient based on the weight of the scientific evidence.
From page 11...
... Using the framework, FDA can be both proactive and reactive, as well as provide an open and transparent process helpful to the general public and the industry. The proposed framework focuses on how to consider the safety of dietary supplement ingredients rather than offering guidance on how to consider their benefits and role in health.
From page 12...
... INGREDIENTS FOR PROTOTYPE MONOGRAPH REVIEWS The second phase of FDA's charge to the Committee on a Framework for Evaluating the Safety of Dietary Supplements is, after release of the proposed framework for comment, to develop at least six scientific reviews as prototypes for the system outlined in the framework. The six supplement ingredients selected for the prototype reviews include the following (in no particular order other than alphabetical)


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