New proposed monographs for dietary supplements

Nov 16 2007

The U.S. Pharmacopeia (USP) is pleased to announce 11 new proposed monographs for dietary supplements for public notice and comment.

Six Turmeric-related monographs and three Soy Isoflavones monographs appeared in Pharmacopeial Forum (PF) 33, the issue corresponding to November/December 2007. These are Turmeric, Powdered Turmeric, Powdered Turmeric Extract, Curcuminoids, Curcuminoids Capsules, Curcuminoids Tablets, Soy Isoflavones Extract, Soy Isoflavones Capsules, and Soy Isoflavones Tablets. Two monographs for single ingredient amino acid formulations, arginine capsules and arginine tablets also appeared in PF 33. PF is the journal through which USP offers, for public review and comments, new and revised standards pertaining to the United States Pharmacopeia–National Formulary.

“USP is pleased to release these new monographs in addition to the proposed monographs on Powdered Decaffeinated Green Tea Extract and Powdered Bilberry Extract published recently in PF 33 in July 2007,” said Darrell Abernethy, M.D., Ph.D., chief science officer at USP. “This is an important step towards advancing the quality of these dietary supplements, which are increasingly used by consumers. USP welcomes comments on the new monographs from all interested parties.”

The proposed monographs contain specific and validated analytical methods that will ensure the identity of the articles and protect consumers and industry from low quality and adulterated products. For example, the proposed monograph on Powdered Bilberry Extract distinguishes the true extract from articles adulterated with azo dyes and other anthocyanin-containing botanicals. Green Tea, Turmeric and Soy Isoflavones monographs were also the subjects of a number of the 2006 National Institutes of Health research grants.

All 11 monographs address articles that are of great interest to the dietary supplements industry and to the scientific community.