09.01.02
IOM Proposes A Framework For
Evaluating The Safety Of Dietary
Supplement Ingredients
The Institute of Medicine (IOM) of the National Academies, Washington, D.C., recently created a proposed framework for evaluating the safety of dietary supplements. FDA requested that a committee of experts (1) develop a proposed framework for categorizing and prioritizing dietary supplement ingredients sold in the U.S. based on safety issues, (2) describe a process for developing a system of scientific reviews with specifications for evaluating the safety of dietary supplement ingredients and (3) utilize the proposed framework to develop at least six scientific reviews or monographs as prototypes for the system after release of the proposed framework. The proposed framework includes a methodology to review data with regard to 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 is now available 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 evaluation of information in the development of the prototype monographs. Based on a review of comments received and experience gained from completion of the prototype monographs, the proposed framework will be modified as appropriate. This final report will also include the six prototype monograph reviews as examples of how the framework as revised can be implemented.
Evaluating The Safety Of Dietary
Supplement Ingredients
The Institute of Medicine (IOM) of the National Academies, Washington, D.C., recently created a proposed framework for evaluating the safety of dietary supplements. FDA requested that a committee of experts (1) develop a proposed framework for categorizing and prioritizing dietary supplement ingredients sold in the U.S. based on safety issues, (2) describe a process for developing a system of scientific reviews with specifications for evaluating the safety of dietary supplement ingredients and (3) utilize the proposed framework to develop at least six scientific reviews or monographs as prototypes for the system after release of the proposed framework. The proposed framework includes a methodology to review data with regard to 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 is now available 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 evaluation of information in the development of the prototype monographs. Based on a review of comments received and experience gained from completion of the prototype monographs, the proposed framework will be modified as appropriate. This final report will also include the six prototype monograph reviews as examples of how the framework as revised can be implemented.