USP unleashes 11 new monographs for industry comments
for dietary supplements for public notice and comment.
These proposed monographs contain validated analytical methods to ensure the identity of the articles and protect consumers and industry from low quality and adulterated products. Industry advocates frequently cite that there are not enough of these available to companies or shared between companies, thereby potentially jeopardizing the quality of ingredients available on the market. "This is an important step towards advancing the quality of these dietary supplements, which are increasingly used by consumers," said Darrell Abernethy, USP chief science officer. "USP welcomes comments on the new monographs from all interested parties." Of the 11 monographs in question, there are six turmeric-related monographs: for turmeric, powdered turmeric, powdered turmeric extract, curcuminoids, curcuminoids capsules and curcuminoids tablets. The three soy isoflavones monographs are soy isoflavones extract, soy isoflavones capsules, and soy isoflavones tablets. In addition, USP has two monographs for single ingredient amino acid formulations, arginine capsules and arginine tablets also appeared in PF 33(6). The proposed monographs appear in the current issue of Pharmacopeial Forum, the journal through which USP offers, for public review and comments, new and revised standards pertaining to the United States Pharmacopeia-National Formulary. The monographs follow closely on the heels of the proposed monographs USP issued in July on powdered decaffeinated green tea extract and powdered bilberry extract. According to USP, these monographs contain appropriate cases of identity masking. For example, it says the proposed monograph on powdered bilberry extract distinguishes the true extract from articles adulterated with azo dyes and other anthocyanin-containing botanicals.
