USP Dietary Supplements Expert Committees News

From Dietary Supplements e-Newsletter - September 2009

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The guggul monographs were published in the 2nd Supplement to USP32-NF27 and are scheduled to become official on December 1, 2009. The Grape Seeds Oligomeric Proanthocyanidins monograph will be published with modifications based on the comments received for the PF proposal. It will appear in USP33-NF 28 later in 2009 and become official on May 1, 2010. The Ashwagandha and Boswellia serrata monographs were published for comments in PF 35(4), July-August 2009; and the Andrographis monographs will be available for comments in PF 35(5), September-October 2009. Standard monographs for Garcinia gummi-gutta (G. cambogia) and Bacopa were drafted and will be appearing in PF in early 2010. Monographs for fenugreek, borage oil (refined), gotu Kola, maca, and forskohlii are under development. The committee will be developing monographs for articles of Traditional Chinese Medicines in collaboration wit! h the Chinese Pharmacopeia. A similar collaboration was initiated with the Indian Pharmacopeia for articles used in the Ayurvedic system of medicine. The committee will meet at USP headquarters in Rockville, MD, USA, on Tuesday, November 17, 2009. Interested parties are welcome to attend as observers, and according to the USP Open Meeting Policy.

The committee invites 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 is responsible for the standards of botanical articles in USP-NF and the Dietary Supplements Compendium (DSC). These articles include dietary supplements and dietary ingredients, as well as active pharmaceutical ingredients, drug products, and excipients.

A major revision of the dietary supplement safety review protocol was conducted recently through public consultation. The revised Admission Criteria and Safety Classification for Dietary Supplements was posted at www.usp.org/USPNF/notices/USPRevisedAdmissionCriteria.html. Also posted is an update on the labeling for USP Powdered Decaffeinated Green Tea Extract monograph: www.usp.org/USPNF/notices/updateUSPGreenTeaExtractMonograph.html.

Safety issues concerning nanonutritionals are of interest for the committee. The committee is currently working on safety profiles for red yeast rice, melatonin, stevia, Centella asiatica, maca, Coleus forskohlii, and Bacopa monnieri. Public input on these projects is welcome. For more information, please contact Dandapantula Sarma ().

This committee reviews the safety profile for dietary ingredients as part of the process for determining their admission into USP-NF and DSC. The committee also regularly monitors safety information of dietary ingredients with existing USP-NF and DSC monographs to detect significant safety signals, which may trigger a reevaluation of their safety profile.

New and revised monographs published in the 2nd Supplement to USP32-NF27 and scheduled to become official on December 1, 2009, include Fish Oil Containing Omega-3 Acids, with Content of EPA and DHA (revised); Glutamic Acid (new); Ground Limestone (new); and Alpha Lipoic Acid (revised), including extensive changes to the determination of impurities. Inclusion of new ICP methodology for minerals in supplements will be in USP33-NF 28 appearing later in 2009 and becoming official on May 1, 2010. New monographs for Crypthecodinium Cohnni Oil and Schizochytrium Oil were published for comments in PF 35(4), July-August 2009; and the Omega-3 Acid Ethyl Esters monograph will be available for comments in PF 35(5), September-October 2009. Monographs for rutin, glutathione, quercetin, and zeaxanthin are under development. In addition, modernization of the Vitamin E monograph, Assay for alpha tocopherol, is under way with a draft undergoing validation. The committee will be developing monographs for articles of selenium yeast and beta glucans in collaboration with industry. The committee will meet at USP headquarters in Rockville, MD, USA, on Thursday, October 1, 2009. Interested parties are welcome to attend as observers, and according to the USP Open Meeting Policy. For more information, please contact Curtis Phinney ().

This committee is responsible for the standards of non-botanical, nutritional, and electrolyte articles in USP-NF and DSC. These articles include dietary supplements and dietary ingredients, as well as active pharmaceutical ingredients, drug products and excipients, and related General Chapters.

USP Dietary Supplements-Performance Standards Expert Committee

A new dissolution test for Vitamin A in dietary supplement tablets will be presented by Dr. Natalia Davydova, USP scientific liaison, during the 2009 AAPS Annual Meeting, November 8-12, Los Angeles, CA, USA (Poster # T3005, Tuesday, November 10, 1-5 p.m.). Three revisions to General Chapter <2040> were published in PF 35(4), July-August 2009 for comments: (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-Released (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 for soft shell capsules with lipophilic contents. Additional revisions to the Chapter will be published in PF 35(6), November-December 2009. The committee ! will meet on Thursday, December 3, 2009, at USP headquarters in Rockville, MD, USA. Interested parties are welcome to attend as observers, and according to the USP Open Meeting Policy.

The committee welcomes interested parties to participate in the development of dissolution tests for the following botanical dosage forms: Cat's Claw capsules/tablets, Red Clover tablets, Black Cohosh tablets, Ginseng capsules and tablets, Soy Isoflavones capsules and tablets. For more information, please contact Natalia Davydova ().

This committee develops standards related to performance tests (Disintegration and Dissolution) for dietary supplements.

Upcoming revision proposals include

1. General Chapter <2030> Supplemental Information for Articles of Botanical Origin, add information for Elm (Ulmus rubra) to the existing information (PF 35(6) November-December 2009)
2. General Chapter <561> Articles of Botanical Origin, revisions to two chemical tests in PF 35(6), November-December 2009
   • a. Test for Aflatoxins: a new sample clean-up protocol with immunoaffinity column, additional HPTLC method, and HPLC analysis
   • b. Test for Pesticides: revised protocol. The committee welcomes input on the best approach for pesticides control in dietary supplements.
3. General Chapter <2750> Manufacturing Practices for Dietary Supplements, is being updated to harmonize with the CGMP requirements (21CFR111) along with additional recommendations from USP (PF 35(5), September-October, 2009).

Future revisions and new chapters

1. Chapter for Food Irradiation (detection methods)
2. Screening protocol for adulterants
3. Additional articles for General Chapter <2030>

The committee will meet on Monday, October 19, 2009, at USP headquarters in Rockville, MD, USA. Interested parties are welcome to attend as observers, and according to the USP Open Meeting Policy.

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 ().

This committee is responsible for the creation and updating of general chapters specifically related to dietary supplements in USP-NF and DSC.

The above segment provides news of various recent 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 90 days from the publication date and deadlines are published for each issue of PF unless otherwise stated in the individual briefing. 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 invite interested parties to participate in creating new public standards and updating the existing ones.