Safety of glucosamine, melatonin under review

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Related tags: Dietary supplement ingredients, Melatonin, Dietary supplement

The Committee on the Framework for Evaluating the Safety of Dietary
Supplements is requesting information and comment on prototype
monographs for melatonin, chromium picolinate, glucosamine, and saw
palmetto as dietary supplement ingredients, as part of the ongoing
work designed to contribute to FDA evaluation of the dietary
supplement ingredients currently on the market.

The Food Nutrition Board (FNB) of the IOM is requesting information and comment on prototype monographs for melatonin, chromium picolinate, glucosamine, and saw palmetto as dietary supplement ingredients.

The draft monographs on melatonin, glucosamine and saw palmetto were published on the IOM website​ last week, with the chromium information due to be issued tomorrow. The committee stressed that they are intended to be a concise rather than a comprehensive literature review, and to focus specifically on possible safety issues rather than these ingredients' potential role in health.

Industry representatives, government agencies, and the public, are free to offer modifications to the drafts.

The glucosamine monograph discusses alternative forms and preparations of the ingredients, as well as dosages. Safety data and clinical research is listed, along with the incidence of adverse events. Conditions for use and recommended labelling for marketing for the ingredient commonly taken to for joint healthcare also reviewed.

The monograph on saw palmetto, used mainly for prostate health, reflected low levels of adverse events and no significant drug interactions with the herb.

The report on the hormone melatonin, available in a variety of forms and taken commonly to reduce jet lag symptoms and depression, noted the adverse events such as headache and depression and even hypertension although these have been mostly seen with large doses. The report also lists some drug interactions.

The monographs are the last in a series of six being developed by the Committee on the Framework for Evaluating the Safety of DietarySupplements, a joint project of the FNB and the Board on Life Sciences of the National Research Council (NRC). The project aims to test the principles of the Proposed Framework for Evaluating the Safety of Dietary Supplements Report that was released for public comment on July 24, 2002. These principles will help the Food and Drug Administration (FDA) evaluate existing research on a variety of dietary supplement ingredients currently on the market.

The draft monographs have also been posted on the National Academies website​.

Committee members and consultants involved in developing the draft prototype monographs will meet January 29, 2003, at the National Academies, 500 Fifth Street NW, Washington, DC, Room 204. Those wishing to add additional information to the data on these ingredients can attend open sessions on January 27, or send comments to the IOM​ or National Academies​ by searching for the 'Framework for Evaluating the Safety ofDietary Supplements' project.

Related topics: Regulation

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