Dietary Supplement Verification Program Overview Live-Webinar ... - USP

Summer 2017

Dietary Supplement Verification Program Overview Live-Webinar ? Register Today for FREE!

Please join us for a complimentary and exciting 60-minute live webinar on USP's Dietary Supplement Verification Program Overview presented by John Atwater, Ph.D., USP senior director of Verification Programs. This webinar will inform participants about USP and the Dietary Supplement Verification Program (DSVP) in order to enable them to make informed decisions about joining the program. In addition to highlighting USP standards, the webinar will provide an overview of the verification process, how the program works, and timelines.

By taking this course, you will learn about:

? USP standards and how they form the foundation of the DSVP ? Important steps and protocols in the USP verification process ? The value participation in the DSVP offers to dietary supplement

manufacturers

Who Should Participate?

? Analytical scientists ? QA/QC analysts ? R&D scientists and managers ? Manufacturing managers and operators ? Regulatory affairs specialists ? Contract manufacturers ? Potential and existing DSVP participants

Click here to learn more about our webinar and complete our registration form to attend!

New Dietary Supplements Reference Standards

Below is a list of newly released reference standards:

Botanicals

? Triolein ? Nobiletin

Non-Botanicals

? Conjugated Linoleic Acids-- Free Fatty Acids

? Cyanocobalamin (crystalline)

Reference Standards Coming Soon Botanicals

? Citrus reticulata Pericarp Dry Extract

? Coffee Fruit Dry Extract ? Coix Seed Oil Extract ? Gallic Acid

Non-Botanicals

? Annatto Seed Tocotrienols Extract

Upcoming Events and Meetings

USP's 7th Bioassay Workshop - Bioassay: A Lifecycle Approach, September 25-26, 2017, Rockville, MD Topics of the Workshop

? Overview of a Lifecycle Approach ? Bioassay Design and Development ? Bioassay Qualification ? Bioassay Performance Verification and Maintenance ? Demonstrations and Discussion Sessions with Software Vendors

International Probiotics Association (IPA) Workshop co-sponsored by USP, October 26, 2017, at Marriott Hotel in North Bethesda, MD

The IPA Probiotics Workshop, co-sponsored by USP, will cover regulatory updates, probiotics standards and advanced sciences for probiotics. The goals of the workshop are for probiotics manufacturers to understand the current regulatory landscape for probiotics, be familiar with USP probiotic standards, and be aware of the current industry practices as well as advanced sciences for QA/QC testing of probiotics.

Please click here for updates on these events.

Public Health Impact

Probiotics Expert Panel

Probiotics represent one of the fastest growing product categories in the global dietary supplement market. There has been a demand for the development of quality standards for probiotics for specific use as dietary supplements. In November 2015, USP hosted a roundtable discussion with stakeholders to discuss their needs and a path for the development of such standards. As a result, USP has since proposed and published five monographs in the United States Pharmacopeia ? National Formulary (USPNF), 4 Lactobacillus and 3 Bifidobacterium strains. In addition, in 2016, USP proposed two monographs (Bacillus coagulans GBI-30, 6086 and Bacillus coagulans GBI-30, 6086 Capsules), published in Pharmacopeial Forum - PF 43(1) - and one General Chapter ( Probiotic Tests), currently posted for public comment.

In order to capture feedback from subject matter experts for standards development, USP formed an Expert Panel (EP) for Probiotics with 15 members from academia, industry, and government agencies. The EP will provide recommendations to the Non-Botanical Dietary Supplement Expert Committee (NBDS-EC) regarding standards development for probiotics, including DNA-based identification tests, enumeration tests, limits on microbiological contaminants, and other attributes as needed. Dr. Mary Ellen Sanders has been appointed as the chair of the expert panel and Dr. Chris Elkins will serve as the FDA government liaison for the panel. For questions and to submit information, please contact Seong Jae Yoo, Ph.D., at sjy@.

Reference Standards in Development

Botanicals

? Angelica sinensis Root Powder

? Baicalein ? Baicalein 7-O-Glucuronide ? Ligusticum chuanxiong

Rhizome Powder ? Scutellaria baicalensis Root

Dry Extract ? Senkyunolide A

? Z-Ligustilide

Non-Botanicals

? Calcium Citrate Malate ? Carotenes ? Diglycine ? Menaquinone-4

? Triglycine Find a Reference Standard

Suggest a Reference Standard

Purchase 2015 USP Dietary Supplements Compendium

Quality Leadership

Stakeholder Forum Meeting, Dietary Supplements

On June 7, 2017, manufacturers, service providers, and other interested parties who work with dietary supplements gathered together at USP headquarters in Rockville, Maryland for the USP Dietary Supplements Stakeholder Forum. To encourage stakeholder participation, USP offered a web-based component for those who wished to attend the meeting remotely.

USP stakeholder fora have as their main goal to provide different perspectives related to the development of standards and to gather feedback for ongoing USP efforts in the development of standards. The agenda and briefing information for this particular forum is available here.

Mr. Loren Israelsen, president of the United Natural Products Alliance (UNPA) chaired this year's forum and moderated discussions. Topics included prioritization in the development of dietary supplements standards, DNA-based methods for botanical identification, the possibility of collaboration in developing solutions to control pesticide residues in botanicals, and the Dietary Supplements Quality Collaborative, among others. Attendees also participated in a survey about USP standard-setting activities.

Below are the highlights of the discussions:

New Standards and Prioritization for Development. In response to a question of how quickly USP can respond to marketplace changes and public health concerns when establishing its priorities for standards development, USP stated that the organization uses available baseline and multi-year sales data to track changes in the marketplace. Also, the USP Dietary Supplements Admission Evaluations Joint Standard Setting Subcommittee assesses the safety of material considered for admission into USP?NF on an ongoing basis.

Pesticide Roundtable: Collaboration Model. Participants indicated that they look to USP to continue engaging with regulators on pesticide residues. USP is currently working on a peer-reviewed paper to address the issue and will continue working with regulatory agencies, manufacturers and trade associations to suggest and develop solutions on issues related to pesticide residues in botanicals.

Adulterants Database. The Adulterants Database focuses on instances of undeclared intentional addition of pharmaceutical drugs and analogs to dietary supplements. To address concerns of some participants that botanical substitution might be included, USP clarified that this was not the

Monographs

Monographs in Revision Bulletin (Posted March 31, 2017. Official April 1, 2017) ? Potassium Citrate Extended-

Release Tablets

Standards Open for Public Comment Until July 31, 2017

The standards below were published for public comment on May 1, 2017, and will receive and consider feedback until July 31, 2017. To comment, please visit: .

New Monographs

? Ascorbic Acid Chewable Gels

? Cholecalciferol Chewable Gels

? Menaquinone-4

Revised Monographs

? Methylcobalamin ? Methylcobalamin Tablets ? Omega-3-Acid Ethyl Esters

Capsules ? Taurine

Revised General Chapters

? Disintegration and Dissolution of Dietary Supplements

case and shared with the criteria used to classify substances as adulterants in the scope of the database.

Probiotics. Discussions revolved around requests from stakeholders for USP to provide flexibility on labeling probiotics at the species level rather than at the strain level to ensure proper labeling when strains from different suppliers are used.

DNA-Based Methods for Botanical Identification. Stakeholders expressed agreement with USP's intent to develop DNA-based methods for ingredient identification. These methods would be combined with complementary tests such as high performance thin layer chromatography (HPTLC), fingerprinting, chemometric techniques and morphology/microscopy-based methods to help determine identity and purity of botanicals.

Open Forum/Survey. Below are some of the main topics and challenges for stakeholders, based on the responses to the survey on current development of standards for dietary supplements:

? It is increasingly difficult to determine the differences between synthetic and natural ingredients;

? There is a strong interest in chewable gels standards; ? There is a need for DNA-based methods for botanical identification.

Industry stakeholders are looking to USP to develop a more centralized way of DNA testing, thereby reducing unnecessary expansion and duplicative efforts; ? Some supplement companies cannot afford to buy expensive equipment for the latest modernization methods and suggested that USP staff encourage discussions on this topic and new ways to look at method modernization; ? There is overall support for the USP Adulterants Database; ? There is strong support to develop monographs for traditional Chinese Medicines ? There is still a lack of clarity about how to sponsor monographs

In response to the survey's results, USP identified key areas to consider in the near future, including better clarification of what monograph sponsorship means and more engagement with industry stakeholders in discussions that involve definition of natural vs. synthetic ingredients and modernization of public standards.

For more information about USP stakeholder fora, please contact Jacqueline Starkes.

Standards Open for Public Comment Until September 30, 2017

The standards below were published for public comment on July 3, 2017, and will receive and consider feedback until Sept 30, 2017. To comment, please visit: .

New Monographs

? Sichuan Lovage Rhizome

? Sichuan Lovage Rhizome Powder

Revised Monographs

? Krill Oil

New Monographs Under Development

Botanicals

? Bitter Orange Peel Flavonoids Dry Extract

? Chrysanthemum Flower ? Chrysanthemum Flower Dry

Extract ? Chrysanthemum Flower

Powder ? Cranberry Juice-Derived

Powder ? Dong Quai Root ? Dong Quai Root Powder ? Guarana Seed ? Guarana Seed Dry Extract ? Guarana Seed Powder ? Red Clover Tablets ? Saccharomyces boulardii ? Wild Chrysanthemum Flower ? Wild Chrysanthemum Flower

Dry Extract

? Wild Chrysanthemum Flower

Powder

USP Roundtable on Cranberry Standards Development: Outcomes, Recommendations and Next Steps

On June 22, 2017, USP hosted the Cranberry Standards Roundtable. The goal was to discuss testing procedures and Reference Standards (RSs) needed to develop standards for cranberry dietary ingredients and supplements in terms of identification, purity, strength, and possible contaminants. The anticipated outcomes were to receive feedback and recommendations from stakeholders about USP?NF cranberry ingredient monograph approaches. Below is a summary of the recommendations and next steps from the roundtable:

1. USP should develop new monographs for the different types of cranberry ingredients: juice-derived (spray-dried powders and dry extracts), skin-based powders and whole berry powders

2. The modernization of the current USP Cranberry Preparation monograph is of relevance to the industry as this is an important article of commerce and the starting raw material for the manufacture of juice-derived powders.

3. Monographs for each type of juice-derived ingredient (spraydried powders and dry extracts) should be developed first, followed by whole berry powders and skin-based powders.

4. USP should develop RS materials for the identification and quantification of cranberry ingredients, including procyanidin A2 and PAC fractions

5. USP seeks support from stakeholders to gather specification sheets, certificates of analysis, manufacturing process

Non-Botanicals

? Bacillus coagulans ? Calcium Magnesium Citrate ? Choline Citrate ? Cyanocobalamin Chewable

Gels ? D-chiro-Inositol ? Oil-and Water-Soluble

Vitamins with Minerals Chewable Gels ? Omega-3 Free Fatty Acids ? Pyrroloquinoline Quinone Sodium ? S-Adenosyl-L-methionine 1,4-Butanedisulfonate ? Vitamins with Minerals Oral Powder ? Plant sterols ? Plant Sterols and Stanols Esters

Published by: Gabriel Giancaspro, Ph.D. Vice President Science?Dietary Supplements & Herbal Medicines

Contact Gabriel Giancaspro

Questions? Contact Us: contact-us Phone: +1-800-227-8772 Website:

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