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USP Announces Proposed Monographs for Several Important Dietary Supplements - Echinacea, Ginseng, and Lycopene

April 8, 2004 --Rockville, Md. — Supplements that contain Echinacea, Ginseng or Lycopene, are becoming increasingly more popular. USP has created several new dietary supplements monographs for these ingredients. These monographs are available for review in USP’s March–April 2004 edition of Pharmacopeial Forum (PF) Vol. 30(2).

The newly created monographs are: Echinacea purpurea Aerial Parts, and American Ginseng Capsules, American Ginseng Tablets, Asian Ginseng Capsules, and Tomato Extract Containing Lycopene Capsules. Monographs for Lycopene, Lycopene Preparation, and Lycopene Tomato Extract are published with revisions based on public comments.

The proposed revised monographs on Lycopene include the addition of a labeling section requiring the indication of whether the Lycopene product is obtained from natural sources or prepared synthetically.

These monographs appear in the In-Process Revision and the Pharmacopeial Previews sections of the PF and are scheduled to be official in the 2005 edition of the United States Pharmacopeia 28 and National Formulary 23 (USP 28–NF 23). Publication of this announcement in PF is an opportunity for the public to provide comments before the monographs are finalized.

The PF is USP’s journal of standards development and the primary vehicle for the public to provide input or comments on USP standards.

Comments on the monographs should be addressed and mailed to Dr. Gabriel Giancaspro at USP, 12601 Twinbrook Parkway, Rockville, MD 20852. Additional questions concerning dietary supplement monographs can be sent to [email protected].

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USP—Advancing Public Health Since 1820
The United States Pharmacopeia (USP) is a nonprofit, nongovernmental, standard-setting organization that advances public health by ensuring the quality and consistency of medicines, promoting the safe and proper use of medications, and verifying ingredients in dietary supplements. These standards, which are recognized worldwide, are developed by a unique process of public involvement through the contributions of volunteers representing pharmacy, medicine, and other health care professions, as well as science, academia, government, the pharmaceutical industry, and consumer organizations. For more information about USP and its four public health programs, visit

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