USP Dietary Supplements Expert Committees News

From Dietary Supplements e-Newsletter - May 2009

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This segment provides news of the various activities of the USP Dietary Supplements Expert Committees and of the USP standards-setting activities. USP publishes new standards and revisions in Pharmacopeial Forum (PF) for public comments. The period for comments is normally 105 days from the publication date. However, USP has an open policy for continuous revision of its standards, and comments on all existing standards are welcome at any time. The various USP Dietary Supplements Expert Committees collaborate worldwide with industry, other pharmacopeias, academia, professional organizations, and government agencies to develop dietary supplements standards. The committees are inviting interested parties to join and participate in creating new public standards and updating the existing ones.

This committee is responsible for the standards of botanical articles in USP–NF. These articles include dietary supplements and dietary ingredients, as well as active pharmaceutical ingredients, drug products, and excipients. The most recent standards for botanical articles developed by the committee include those for turmeric, curcuminoids, and soy isoflavones (official in the current USP 32–NF 27); guggul (to become official in the Second Supplement to USP 32–NF 27); and grape seeds oligomeric proanthocyanidins (to become official in USP 33–NF 28). New standards to be published for public comments include those for ashwagandha and Boswellia serrata in PF 35(4), July–August, 2009; and andrographis in PF 35(5), September–October, 2009. The committee is inviting interested parties to submit proposals for the following monographs under development: aloe vera gel, cranberry proanthocyanidins & extract, elderberry flowers & berry, noni juice, spirulina, and artemisia. For more information, please contact Maged Sharaf ().

This committee reviews the safety profile for dietary ingredients as part of the process for determining their admission into the USP–NF and DSC. The committee also regularly monitors safety information of dietary ingredients with existing USP–NF monographs to detect significant safety signals, which may trigger a review of their safety profile. The recent safety reviews of dietary ingredients included borage oil, Garcinia cambogia, and flax lignans. The committee is currently working on the safety profiles for melatonin, stevia, Centella asiatica, and Bacopa monnieri. Public input on these dietary ingredients is welcome. For more information, please contact Dan Sarma ().

This committee is responsible for standards of dietary supplements and dietary ingredients of synthetic, semisynthetic, or natural non-botanical origin. New monograph proposals include ground limestone, zinc gluconate tablets, and vitamin A oral liquid preparation. Important revisions to the minerals capsules and related monographs were published in PF 34(6). These revisions allow for the use of inductively coupled plasma (ICP) techniques for the analysis of minerals. The standards under development by the committee include omega-3 ethyl esters, selenium yeast, beta glucans, sodium iron EDTA, schizochytrium oil, and Crypthecodenium cohnii oil (the latter two as sources of DHA). The committee welcomes public input on these standards. For more information, please contact Curtis Phinney ().

This committee develops standards related to performance tests (Disintegration and Dissolution) for dietary supplements. The following three revisions to General Chapter <2040> are being proposed in the next issue of PF: (1) Narrower specifications for the beaker used in Apparatus B in the Disintegration section, to reduce inter-laboratory variation in disintegration times; (2) A new test for Delayed-Release (Enteric-Coated) Soft Shell Capsules is included in the Disintegration section; and (3) a new flow cell chamber for USP Apparatus 4 is introduced in the Dissolution section for potential use with soft-shell capsules with lipophilic contents. For more information, please contact Natalia Davydova ().

This committee is responsible for the creation and update of general chapters specifically related to dietary supplements in USP–NF. The committee is currently preparing revisions of General Chapters <2750> Manufacturing Practices for Dietary Supplements, <2030> Supplemental Information for Articles of Botanical Origin, and of the aflatoxin and pesticide tests in <561> Articles of Botanical Origin. The committee is developing new chapters for the detection of ionizing radiation and for heavy metals in dietary supplements. The committee welcomes public comments and assistance in its mission to develop new USP general chapters for dietary supplements and keep the present chapters updated to the latest scientific advancements. For more information, please contact Yoshi Tokiwa ().