Dietary Supplements Risk and Safety Assessment

Format	Author(s)	Title / Description	Date added	Details
	Scientific Committee, European Food Safety Authority	Botanicals and Botanical Preparations Widely Used as Food Supplements and Related Products: Coherent and Comprehensive Risk Assessment and Consumer Information Approaches Discussion paper adopted on June 23, 2004 that addresses issues related to risk assessment and consumer information on botanicals in food supplements. Includes discussion of quality and safety issues, related EC legislation, and potential future activities related to these products. (more) Publication Date: Tuesday, September 21, 2004	Sep 22, 2004
	United Kingdom Food Standards Agency	Brominated Chemicals in Farmed and Wild Fish and Shellfish and Fish Oil Dietary Supplements Report of analysis levels of brominated dioxins, polybrominated biphenyls, and brominated flame retardants present in 48 species of farmed and wild fish and shellfish as well as fish oil dietary supplements in the UK. (more) Deadline: Wednesday, February 22, 2006 Publication Date: Friday, February 17, 2006	Feb 22, 2006
	Rowlands, J. Craig; Griffiths, James C.	Considerations in Making GRAS Determinations Brief overview of the risk assessment that needs to be done to get Generally Recognized as Safe (GRAS) designation for an ingredient intended for functional foods. A key point is that GRAS determination must be made for each food or beverage in which the substance is used, each effect, and each level of use. (more) Publication Date: Monday, February 3, 2003	Jun 7, 2005
	Lindsey, Andrea T.	Dietary Supplements: Additional Resources for Professionals Bibliography of bibliographies and bibliographic databases, books, book chapters, and booklets, newsletters, web resources, and agencies and organizations that provide information on dietary supplements that would be of use to professionals. The bibliography is broken down into the categories of "General Information on Dietary Supplements," "Vitamins, Minerals and Antioxidants," "Herbs, Botanicals, Phytochemicals and Other Specific Dietary Supplements," "Ergogenic Aids," and "Safety and Consumer Protection". (more) Publication Month: July 2003	Nov 17, 2003
	Food and Drug Administration	Food Additives Permitted for Direct Addition to Food for Human Consumption; Vitamin D3 Final rule that amends the food additive regulations "to provide for the safe use of vitamin D3 as a nutrient supplement in meal replacement bars, other- type bars, and soy-protein based meal replacement beverages represented for special dietary use in reducing or maintaining body weight." Includes discussion of the safety assessment. (more) Publication Date: Wednesday, June 29, 2005	Jul 1, 2005
	Woteki, Catherine	Nutrition, Food Safety, and Risk Assessment -- A Policy-Maker's Viewpoint Remarks prepared for delivery by Dr. Catherine Woteki, Under Secretary for Food Safety, before Purdue University, West Lafayette, IN, June 18, 1998. This speech describes the process of risk assessment, including how it fits into the risk analysis process and the strengths and limitations associated with risk assessment. Two examples of the application of risk assessment are given: development of tolerable upper intake levels for nutrients and risk assessment for Salmonella Enteritidis. (more) Publication Date: Thursday, June 18, 1998	Jul 11, 2002
	Scientific Panel on Food Additives, Flavourings, Processing Aids and Materials in Contact with Food, European Food Safety Authority	Opinion of the AFC Panel Related to Calcium L-Methylfolate Opinion adopted on October 28, 2004 regarding the safety of synthetically obtained calcium L-5- methyltetrahydrofolate (L-5-MTHF-Ca) for use in foods for particular nutritional uses, food supplements, and other foods. (more) Publication Date: Tuesday, November 23, 2004	Nov 30, 2004
	Scientific Panel on Food Additives, Flavourings, Processing Aids and Materials in Contact with Food, European Food Safety Authority	Opinion of the AFC Panel Related to D-α-tocopheryl Acid Succinate as a Source of Vitamin E in Foods Intended for the General Population, Food Supplements and Foods for Particular Nutritional Uses Opinion adopted on April 26, 2005 regarding the safety and bioavailability of D- α-tocopheryl acid succinate used as a source of vitamin E in foods for particular nutritional purposes, foods intended for the general population, and food supplements. (more) Publication Date: Friday, May 20, 2005	May 24, 2005
	Scientific Panel on Food Additives, Flavourings, Processing Aids and Materials in Contact with Food, European Food Safety Authority	Opinion of the Scientific Panel on Food Additives, Flavourings, Processing Aids and Materials in Contact with Food on a request from the Commission related to the Use of Polyvinyl Alcohol as a Coating Agent for Food Supplements (Question No EFSA-Q-2005-0 Opinion adopted on December 5, 2005 resulting from a risk assessment of polyvinyl alcohol as a food additive used as film coating agent for food supplements. Summarizes the data from a variety of dietary toxicity studies. (more) Deadline: Tuesday, February 14, 2006 Publication Date: Tuesday, February 14, 2006	Feb 16, 2006
	Committee on the Framework for Evaluating the Safety of Dietary Supplements, Food and Nutrition Board, Board on Life Sciences, Institute of Medicine, National Research Council	Proposed Framework for Evaluating the Safety of Dietary Supplements Proposed framework for evaluating the safety of dietary supplement ingredients that was developed for the FDA and is released for comment. Includes discussion of the proposed framework as well as discussion of approaches used by others. Appendices include "Other Approaches to Considering the Safety of Dietary Supplements," "Existing Frameworks of Systems for Evaluating the Safety of Other Substances," "Possible Combinations of Scores," "Table of Food and Drug Administration Actions on Dietary Supplements," "Presenters at the Open Sessions of the Project on the Framework for Evaluating the Safety of Dietary Supplements," and "Biographical Sketches of Committee Members". (more) Publication Year: 2002	May 21, 2003

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