Dietary Supplements Compendium 2019 Edition

Products and Services

New Dietary Supplements Reference Standards

Below is a list of newly released Reference Standards.

Herbal Medicines/ Botanical Dietary Supplements

Baicalein Baicalein 7-O-Glucuronide Chebulagic Acid Dietary Supplements Compendium 2019 Edition Coptis chinensis Rhizome Dry Extract In response to the customer feedback, coupled with evolving information needs, USP moved the Psoralen Dietary Supplements Compendium (DSC) to an online platform for the 2019 edition. DSC continues Scutellaria baicalensis Root Dry to provide in-depth, comprehensive information for all phases of development and manufacturing of Extract quality dietary supplements including quality control, quality assurance, and regulatory/compendial Terminalia chebula Fruit Dry affairs. Extract Guarana Seed Dry Extract Some of the advantages that come with the new online DSC edition include: Cullen Corylifolium Fruit Dry Extract More frequent updates to ensure access to the most current information Procyanidin B2 Customizable alerts to notify of changes to selected documents An intuitive interface to facilitate quick and easy navigation Non-Botanicals A customizable workspace with bookmarks, alerts and a viewing history beta-Glycerylphosphorylcholine Convenient, anytime, anywhere access with common browsers Conjugated Linoleic Acids – In addition to selected new and revised monographs and General Chapters from the USP-NF and Triglycerides Food Chemicals Codex issued since the previous 2015 edition, the DSC 2019 features: Creatine Docosahexaenoic Acid 24 new General Chapters Eicosapentaenoic Acid 72 new dietary ingredient and dietary supplement monographs L-alpha- 27 sets of supplementary information for botanical and nonbotanical dietary supplements Glycerophosphorylethanolamine 59 updated botanical HPTLC plates L-alpha- Revised and updated dietary intake comparison tables Glycerylphosphorylcholine Updated Dietary Supplement Verification Program manual Omega-3 Free Fatty Acids Pyrroloquinoline Quinone View this page for more information or to subscribe to the 2019 online DSC. Disodium

Reference Standards in development: Botanicals

Aegle marmelos Fruit Dry Extract Angelica sinensis Root Powder Azadirachta indica Seed Oil Azadirachta indica Seed Oil Azadirachta indica Leaf Dry Extract Berberis aristata Stem Dry Extract Bitter Orange Fruit Flavonoid Dry Extract Broccoli Seed Dry Extract Chebulinic Acid USP Call for Candidates for the 2020-2025 Cycle Chrysanthemum indicum Flower Want to contribute to the USP dietary supplement standard-setting process? Sign up here Dry Extract Chrysanthemum x morifolium USP’s public standards in the USP-NF, Dietary Supplements Compendium and Herbal Medicines Flower Dry Extract Compendium are set by volunteer experts representing the relevant subject matter, employment Citrus maxima Peel Flavonoids sector and geographical area. Through the Call for Candidates for the 2020 – 2025 cycle, USP Dry Extract invites you to share your expertise and collaborate with a global network of leaders in science and Cranberry Fruit Juice Dry health to help us establish and revise USP standards. By helping to develop and update USP Extract standards, you will impact the quality of dietary supplements and herbal medicines available to Cullen corylifolium Fruit Dry people all over the world. As a member of an Expert Committee, your knowledge, support and Extract leadership will contribute to advancing global public health by helping to improve and sustain Egeline developing healthcare systems around the world. The following information is provided to familiarize Epicatechin you with USP standard-setting processes and the role of the expert volunteers: Ginger Rhizome Carbon Click to learn more abut the responsibilities of dietary supplement and herbal medicine Dioxide Soft Extract Expert Committees and the kind of topics they work on as well as how and why to volunteer. Ginsenoside Rb1 Glucoraphanin Guarana Seed Dry Extract USP in the News Isorhamnetin–3–O–Rutinoside Isochlorogenic Acid A View John Atwater’s interview in NutraIngredients: “Third party verification Jujuboside A best way to thwart counterfeiters, expert says” Ligusticum chuanxiong Rhizome Powder Tune into John Atwater’s Podcast on Food Sleuth Radio and learn the Linarin process by which USP verifies the quality of dietary supplements and why Maca Root Extract consumers should look for the USP verified mark on supplement labels. Marmelosin Palmatine Chloride Pomegranate Fruit Dry Extract Procyanidin A2 Upcoming Events and Meetings Procyanidin B2 On November 18, 2019, USP Staff will be reporting on screening for adulteration by HPTLC at the Punicalagin Eastern Analytical Symposium at the Crowne Plaza Princeton, in conjunction with the First Rhoifolin International HPTLC Conference. Senkyunolide A Sophora japonica Flower Dry Extract

Spinosin Trachyspermum ammi Fruit Oil Terminalia chebula Fruit Dry Past Events Extract Ziziphus jujuba var. spinosa SupplySide West Seed Dry Extract October 15-19, 2019 | Las Vegas, NV Z-Ligustilide

USP staff joined approximately 19,000 attendees and exhibitors at the SupplySide West Trade Show Non-Botanicals October 15-19, 2019 in Las Vegas. Staff members met with current and potential dietary supplement monograph sponsors, Dietary Supplement Expert Committee members, as well as with current and 1,4-Butanedisulfonic Acid potential verification customers. Calcium Magnesium Citrate Choline Citrate The team explored new and emerging dietary ingredients, as well as topics of interest and needs of Citicoline USP stakeholders for standard development. Other activities included a USP Roundtable on D-chiro-Inositol potential approaches to quality standards for multi-ingredient products. At the American Herbal Hydroxocobalamin Chloride Products Association Botanical Congress, Gabriel Giancaspro, Vice President of Dietary L-Ornithine Hydrochloride Supplements contributed to a panel discussion on “What’s New in Aloe Vera Science and Lysine Innovation.” Pyrroloquinoline quinone (PQQ) Pinitol Marcia Moll, Marketing Director for Dietary Supplements and Herbal Medicines at USP, participated S-Adenosyl-L-Methionine 1,4- on a panel titled "Claims & Certifications: What do they mean and who cares?" which discussed the Butanedisulfonate importance of certifications and how they resonated with consumers and at what capacity. Monographs Standards Open for Public Comment until November 30, 2019 The standards below were published in PF 45(5) for public comment on September 1, 2019 and will accept public feedback until November 30, 2019. To comment, please visit: http://www.usp.org/usp- nf/pharmacopeial-forum

New Monographs/General Chapters

Bifidobacterium bifidium Bifidobacterium longum subsp longum Lactobacillus reuteri Water-Soluble Vitamins Preparation

USP at Complementary Medicines Australia (CMA) Conference Revised Monographs/General October 9, 2019 | Sydney, Australia Chapters Aztec Marigold Zeaxanthin The framework of “complementary medicines” in Australia covers botanicals, as well as vitamins, Extract probiotics, minerals, sport supplements, etc. In many ways this regulatory class is similar to the Lactobacillus rhamnosus dietary supplement framework in US. Also similar are the major topics involving quality standards, HN001 introduction of new ingredients, market exclusion safeguards, and permitted indications for the ingredients in the low risk Listed (L) category. Australia Therapeutic Goods Administration (TGA) is Standards Open for Public in the process of broad regulatory reforms for medicines with the aim to provide a world class Comment until January 31, 2020 regulatory environment. The standards below will be published in PF 45(6) for public comment on Australia TGA requirements recognize USP, BP and EP as “default standards” in their laws for November 1, 2019 and will accept ensuring quality of the complementary medicines. Similarly, TGA guidelines for starting material public feedback until January 31, analytical procedure validation for complementary medicines recognize BP, USP, ChP, AOAC, and 2020. To comment, please visit: others as sources for validated methods. According to the TGA guidelines, “If an ingredient is not http://www.usp.org/usp- subject to a default standard or has a compositional guideline, a list of tests with acceptance criterion nf/pharmacopeial-forum and analytical procedures references, should be established as a part of total control strategy to ensure quality for the intended use.” New Monographs/General Chapters

The conference in Sydney was hosted by the peak industry body for complementary medicines, Sour Jujube Seed Complementary Medicines Australia (CMA), which represents members across the supply chain, Sour Jujube Seed Powder including manufacturers, importers, exporters, raw material suppliers, wholesalers, distributors and Sour Jujube Seed Dry Extract retailers. This year’s CMA Conference titled ‘Sustainability, Innovation and Quality’ highlighted the Cranberry Fruit Juice Dry quality of raw materials. Extract Cranberry Fruit Juice Dr. Nandakumara Sarma, USP, spoke at the meeting on the topic “USP Botanical standards – a Concentrate comprehensive approach to quality”. He described the USP collaboration with global stakeholders Revised Monographs/General and expert volunteers in the development of transparent public quality standards (monographs, Chapters general chapters and Reference Standards) for herbal medicines and botanical dietary supplements that are published in the USP Dietary Supplements Compendium and the Herbal Medicine Cranberry Liquid Preparation Compendium. Considering the international commerce of botanicals across traditional systems, he emphasized the value of global public standards to help manufacturers in meeting regulatory Standards Open for Public requirements through science-based specifications, and to facilitate label uniformity and supply chain Comment until March 31, 2020 of quality herbal medicine and dietary supplements. His presentation is available here. The standards below will be published in PF 46(1) for public comment on USP is looking for potential members from Australia for the 2020-2025 Expert Committee cycle. See January 1, 2020 and will accept public an article on the USP Call for Candidates in this edition of the newsletter. feedback until March 31, 2020. To comment, please visit: USP at AOAC 133rd Annual Meeting and Exposition http://www.usp.org/usp- September 8-11, 2019 | Denver, CO nf/pharmacopeial-forum

New Monographs/General Chapters USP staff from the Dietary Supplement and Herbal Medicines (DSHM) team participated in the 133rd AOAC Annual Meeting & Exposition in September 8-11, 2019 in Denver, Colorado. The event White Peony Root afforded a great opportunity to interact with the scientific community and learn more about advances White Peony Root Powder in analytical chemistry that are critical for the development of USP standards. USP co-chaired two White Peony Root Dry Extract important symposia: Revised Monographs/General The first symposium, entitled Application of DNA Technologies and Standards in the Chapters Authentication of Botanicals for Quality Control of Botanical Dietary Supplements, was co- None chaired by Dr. Nandakumara Sarma, Director of Dietary Supplement & Herbal Medicines Standards. In this symposium, Dr. Ning Zhang, USP Scientist III from Research & Innovation, gave a New Monographs under presentation on the development of species-specific primers for Ginseng (Asian ginseng, American Development ginseng and Notoginseng), Echinacea ( E. purpurea, E. pallia, and E. angustifolia), Gingko, and Botanicals Black Cohosh (A. racemose, A.rubra, and A. podocarpa). The data demonstrated that using the species-specific primers under optimized amplification conditions can differentiate closely related Ajowan Fruit species and can be used for orthogonal testing in combination with other botanical identification test Ajowan Fruit Powder methods. Ajowan Fruit Dry Extract Aloe Vera Leaf Juice The second symposium entitled NMR Advancement in Quality Control and Compendial Aloe Vera Leaf Juice Applications, was co-chaired by Dr. Gabriel Giancaspro, Vice President of Dietary Supplements & Concentrate Herbal Medicines. Dr. Giancaspro reviewed the NMR technology and its application in USP Aloe Vera Leaf Dry Juice monographs and the potential for expanding its role in identification and quantification of dietary Black Cumin Seed Oil ingredients and USP RS. Broccoli Seed Dry Extract Cranberry Fruit Dry Juice USP staff also participated in the presentation of the following scientific posters: Feverfew Leaf Extract Gastrodia (Gastrodia elata) Revision of the USP Cranberry Liquid Preparation monograph Rhizome Gastrodia (Gastrodia elata) Maria Monagasa; Joshua Bhattacharyaa; Jennifer Fedorowskia; Débora Frommenwilerb; Eike Rhizome Powder b a Reich ; Gabriel Giancaspro Gastrodia (Gastrodia elata) aUnited States Pharmacopeial Convention (USP). 12601 Twinbrook Parkway. Rockville, MD 20852. Rhizome Dry extract bCAMAG. Sonnenmattstrasse 11, 4132 Muttenz. Switzerland Siler (Saposhnikovia divaricata) Root This poster summarized the work carried out for the revision of the USP Cranberry Liquid Siler (Saposhnikovia divaricata) Preparation monograph which will be proposed in the Pharmacopeial Forum (PF) 45(6) (November Root Powder 1, 2019). View Poster. Siler (Saposhnikovia divaricata) Root Dry Extract Anthraquinones and glycosylated dianthrone characterization by LC-UV-ESI-QToF and Maca Root Powder quantification by LC-UV in Sennosides Maca Root Gelatinized Powder Amanda Guiraldelli, Rafael Maranho, Nam-Cheol Kim, Maria Monagas and Gabriel Giancaspro Maca Root Extract United States Pharmacopeial Convention (USP). 12601 Twinbrook Parkway. Rockville, MD 20852. Neem Seed Neem Seed Powder This poster summarized the development of a simple LC-UV method for analysis of anthraquinones Neem Seed Oil and glycosylated dianthrones in USP Sennosides RS. The material was characterized using LC-UV- Neem Leaf ESI-QToF. The proposed new method proves to be a good alternative for the quality control of the Neem Leaf Powder glycosylated anthraquinones and aglycons in Sennosides extract. View poster. Neem Leaf Dry Extract Pomegranate Fruit Dry Extract Probiota Red Clover Tablets In late June, USP staff presented a poster on Improving the Value of Probiotic Clinical Trials at the Non-Botanicals Probiota meeting in Vancouver, BC. View poster. Astaxanthin Ester Capsules 2019 NIST Workshop on Standards for Microbiome Measurements beta-Hydroxy-beta- In September, USP staff presented information about USP probiotic standards and their utility for the Methylbutyric acid (HMB) development of Live Biotherapeutic Products at the 2019 National Institute of Standards and Bifidobacterium longum subsp Technology (NIST) Workshop on Standards for Microbiome Measurements. View NIST Workshop infantis presentation. Calcium 3-hydroxy-3- methylbutyrate Choline Citrate Be Part of the Standards Development Process! GABA Help shape standards specifications and test methods by sponsoring monographs or general Hydrolyzed Collagen chapters and their supporting Reference Standards. USP doesn’t charge fees to develop Inositol Niacinate monographs – all you need is a willingness to collaborate with us to help safeguard the supply chain Lactobacillus casei for supplements and ingredients. USP standards for dietary ingredients and dietary supplements are Levocarnitine Tartrate a resource for public specifications and scientifically valid methods that can help in GMP compliance Lutein Esters and in safeguarding the supply chain for supplements and ingredients. USP is seeking donations for Lysine the following monographs: Mineral Ascorbates

Mineral Bisglycinates Non-Botanical Dietary Supplement Ingredients: Native Collagen Undenatured Collagen Type II Oil-soluble Vitamins Preparation Phytosterol Esters Glucoronolactone Plant Sterols Rice Protein Gamma amino butyric acid (GABA) S-Adenosyl-L-Methionine 1,4- Butanedisulfonate Keratin Tocotrienols Bifidobacterium Infantis Zeaxanthin Preparation

Lactobacillus plantarum 299v Click here to Find a Lutein esters Reference Standard

L-Ornithine To Suggest a Reference Pantethine Standard, click here.

Rice protein isolate

Salmon Oil

Zeaxanthin preparation

Non-Botanical Dosage Forms (Finished Dietary Supplements):

Cyanocobalamin capsules

Glucosamine, Chondroitin Sulfate Sodium capsules

Magnesium Citrate capsules

Menaquinone 4 tablets or capsules

Methylcobalamin orally disintegrating tablets

Omega-3-Triglyceride chewable gels (gummies)

Plant Sterol tablets

S-Adenosyl-L-Methionine Disulfate Tosylate tablets

For more information on how to donate and a complete list of requested monographs, please visit: USP Dietary Supplements and Herbal Medicines Standards Development Process or contact [email protected].

USP Admission Evaluations of Articles Prior to Monograph Development

Before development of a quality standard for a dietary ingredient is considered, it must undergo a USP Admission Evaluation, performed by the USP Dietary Supplements Admission Evaluations Joint Standard Setting Subcommittee (DSAE JS3). The DSAE JS3 reviews information related to the ingredient’s safety, relevance in the market, regulatory status, presence in other pharmacopeias and whether the article poses a serious health risk when used as a dietary supplement.

If the review described above indicates that the article does not pose a serious health risk or poses a minor safety concern that can be mitigated by a label caution statement in the monograph, the article is placed in class A and is admitted for monograph development. If the article poses a serious health risk, it is placed in class B and is not admitted for monograph development.

The DSAE JS3 held a working meeting via Webex on Tuesday, August 27th, 2019. Members deliberated on and admitted Fish Oil Omega 3 Acid Ethyl Esters Concentrate, Choline Citrate, and Japanese Sophora Flower for monograph development.

For more information, please contact Hellen Oketch-Rabah, Ph.D., at [email protected] or Emily Madden, Ph.D., DABT, at [email protected].

Nomenclature of Dietary Supplements

Updates from the Dietary Supplements and Herbal Medicines (DSHM) Nomenclature Subcommittee

DSHM Nom JSC met in June and August 2019 and recommended the following monograph titles for approval:

Aloe Vera Leaf Juice

Aloe Vera Leaf Juice Concentrate

Aloe Vera Leaf Dry Juice

Aloe Vera Leaf Dry Juice Preparation

Bacillus clausii

Collagen Type II

Devil's Claw Root

Devil's Claw Root Dry Extract

Lutein Esters

Gastrodia Rhizome

Gastrodia Rhizome Powder

Gastrodia Rhizome Dry Extract

Cranberry Fruit Juice Concetrate

Siler Root

Siler Root Powder

Siler Root Dry Extract

DSHM Nom JSC revised the Guideline for Assigning Titles to USP Dietary Supplement Monographs available at http://www.usp.org/sites/default/files/usp/document/get- involved/submission-guidelines/guideline-for-assigning-titles-to-usp-dietary-supplement- monograph.pdf. The revised guideline is currently available at the above link after review and approval by the Nomenclature and Labeling Expert Committee. For more information on dietary supplements nomenclature, please contact: Hellen Oketch-Rabah, Ph.D., at [email protected].

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