Dietary Supplements Compendium 2019 Edition In response to the customer feedback, coupled with evolving information needs, USP moved theDietary Supplements Compendium (DSC) to an online platform for the 2019 edition. DSC continuesto provide in-depth, comprehensive information for all phases of development and manufacturing ofquality dietary supplements including quality control, quality assurance, and regulatory/compendialaffairs. Some of the advantages that come with the new online DSC edition include:

More frequent updates to ensure access to the most current informationCustomizable alerts to notify of changes to selected documentsAn intuitive interface to facilitate quick and easy navigationA customizable workspace with bookmarks, alerts and a viewing historyConvenient, anytime, anywhere access with common browsers

In addition to selected new and revised monographs and General Chapters from the USP-NF andFood Chemicals Codex issued since the previous 2015 edition, the DSC 2019 features:

24 new General Chapters72 new dietary ingredient and dietary supplement monographs27 sets of supplementary information for botanical and nonbotanical dietary supplements59 updated botanical HPTLC platesRevised and updated dietary intake comparison tablesUpdated Dietary Supplement Verification Program manual

View this page for more information or to subscribe to the 2019 online DSC.

USP Call for Candidates for the 2020-2025 CycleWant to contribute to the USP dietary supplement standard-setting process? Sign up here

USP’s public standards in the USP-NF, Dietary Supplements Compendium and Herbal MedicinesCompendium are set by volunteer experts representing the relevant subject matter, employmentsector and geographical area. Through the Call for Candidates for the 2020 – 2025 cycle, USPinvites you to share your expertise and collaborate with a global network of leaders in science andhealth to help us establish and revise USP standards. By helping to develop and update USPstandards, you will impact the quality of dietary supplements and herbal medicines available topeople all over the world. As a member of an Expert Committee, your knowledge, support andleadership will contribute to advancing global public health by helping to improve and sustaindeveloping healthcare systems around the world. The following information is provided to familiarizeyou with USP standard-setting processes and the role of the expert volunteers:

Click to learn more abut the responsibilities of dietary supplement and herbal medicineExpert Committees and the kind of topics they work on as well as how and why to volunteer.

USP in the News

View John Atwater’s interview in NutraIngredients: “Third party verificationbest way to thwart counterfeiters, expert says”

Tune into John Atwater’s Podcast on Food Sleuth Radio and learn theprocess by which USP verifies the quality of dietary supplements and whyconsumers should look for the USP verified mark on supplement labels.

Upcoming Events and Meetings

On November 18, 2019, USP Staff will be reporting on screening for adulteration by HPTLC at theEastern Analytical Symposium at the Crowne Plaza Princeton, in conjunction with the FirstInternational HPTLC Conference.

Past Events

SupplySide WestOctober 15-19, 2019 | Las Vegas, NV

USP staff joined approximately 19,000 attendees and exhibitors at the SupplySide West Trade ShowOctober 15-19, 2019 in Las Vegas. Staff members met with current and potential dietary supplementmonograph sponsors, Dietary Supplement Expert Committee members, as well as with current andpotential verification customers.

The team explored new and emerging dietary ingredients, as well as topics of interest and needs ofUSP stakeholders for standard development. Other activities included a USP Roundtable onpotential approaches to quality standards for multi-ingredient products. At the American HerbalProducts Association Botanical Congress, Gabriel Giancaspro, Vice President of DietarySupplements contributed to a panel discussion on “What’s New in Aloe Vera Science andInnovation.”

Marcia Moll, Marketing Director for Dietary Supplements and Herbal Medicines at USP, participatedon a panel titled "Claims & Certifications: What do they mean and who cares?" which discussed theimportance of certifications and how they resonated with consumers and at what capacity.

USP at Complementary Medicines Australia (CMA) ConferenceOctober 9, 2019 | Sydney, Australia

The framework of “complementary medicines” in Australia covers botanicals, as well as vitamins,probiotics, minerals, sport supplements, etc. In many ways this regulatory class is similar to thedietary supplement framework in US. Also similar are the major topics involving quality standards,introduction of new ingredients, market exclusion safeguards, and permitted indications for theingredients in the low risk Listed (L) category. Australia Therapeutic Goods Administration (TGA) isin the process of broad regulatory reforms for medicines with the aim to provide a world classregulatory environment.

Australia TGA requirements recognize USP, BP and EP as “default standards” in their laws forensuring quality of the complementary medicines. Similarly, TGA guidelines for starting materialanalytical procedure validation for complementary medicines recognize BP, USP, ChP, AOAC, andothers as sources for validated methods. According to the TGA guidelines, “If an ingredient is notsubject to a default standard or has a compositional guideline, a list of tests with acceptance criterionand analytical procedures references, should be established as a part of total control strategy toensure quality for the intended use.”

The conference in Sydney was hosted by the peak industry body for complementary medicines,Complementary Medicines Australia (CMA), which represents members across the supply chain,including manufacturers, importers, exporters, raw material suppliers, wholesalers, distributors andretailers. This year’s CMA Conference titled ‘Sustainability, Innovation and Quality’ highlighted thequality of raw materials.

Dr. Nandakumara Sarma, USP, spoke at the meeting on the topic “USP Botanical standards – acomprehensive approach to quality”. He described the USP collaboration with global stakeholdersand expert volunteers in the development of transparent public quality standards (monographs,general chapters and Reference Standards) for herbal medicines and botanical dietary supplementsthat are published in the USP Dietary Supplements Compendium and the Herbal MedicineCompendium. Considering the international commerce of botanicals across traditional systems, heemphasized the value of global public standards to help manufacturers in meeting regulatoryrequirements through science-based specifications, and to facilitate label uniformity and supply chainof quality herbal medicine and dietary supplements. His presentation is available here.

USP is looking for potential members from Australia for the 2020-2025 Expert Committee cycle. Seean article on the USP Call for Candidates in this edition of the newsletter.

USP at AOAC 133rd Annual Meeting and ExpositionSeptember 8-11, 2019 | Denver, CO

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 eventafforded a great opportunity to interact with the scientific community and learn more about advancesin analytical chemistry that are critical for the development of USP standards. USP co-chaired twoimportant symposia:

The first symposium, entitled Application of DNA Technologies and Standards in theAuthentication of Botanicals for Quality Control of Botanical Dietary Supplements, was co-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 apresentation on the development of species-specific primers for Ginseng (Asian ginseng, Americanginseng and Notoginseng), Echinacea ( E. purpurea, E. pallia, and E. angustifolia), Gingko, andBlack Cohosh (A. racemose, A.rubra, and A. podocarpa). The data demonstrated that using thespecies-specific primers under optimized amplification conditions can differentiate closely relatedspecies and can be used for orthogonal testing in combination with other botanical identification testmethods.

The second symposium entitled NMR Advancement in Quality Control and CompendialApplications, was co-chaired by Dr. Gabriel Giancaspro, Vice President of Dietary Supplements &Herbal Medicines. Dr. Giancaspro reviewed the NMR technology and its application in USPmonographs and the potential for expanding its role in identification and quantification of dietaryingredients and USP RS.

USP staff also participated in the presentation of the following scientific posters:

Revision of the USP Cranberry Liquid Preparation monograph Maria Monagasa; Joshua Bhattacharyaa; Jennifer Fedorowskia; Débora Frommenwilerb; Eike

Reichb; Gabriel Giancasproa

aUnited States Pharmacopeial Convention (USP). 12601 Twinbrook Parkway. Rockville, MD 20852.bCAMAG. Sonnenmattstrasse 11, 4132 Muttenz. Switzerland

This poster summarized the work carried out for the revision of the USP Cranberry LiquidPreparation monograph which will be proposed in the Pharmacopeial Forum (PF) 45(6) (November1, 2019). View Poster.

Anthraquinones and glycosylated dianthrone characterization by LC-UV-ESI-QToF andquantification by LC-UV in Sennosides Amanda Guiraldelli, Rafael Maranho, Nam-Cheol Kim, Maria Monagas and Gabriel GiancasproUnited States Pharmacopeial Convention (USP). 12601 Twinbrook Parkway. Rockville, MD 20852.

This poster summarized the development of a simple LC-UV method for analysis of anthraquinonesand glycosylated dianthrones in USP Sennosides RS. The material was characterized using LC-UV-ESI-QToF. The proposed new method proves to be a good alternative for the quality control of theglycosylated anthraquinones and aglycons in Sennosides extract. View poster.

Probiota In late June, USP staff presented a poster on Improving the Value of Probiotic Clinical Trials at theProbiota meeting in Vancouver, BC. View poster. 2019 NIST Workshop on Standards for Microbiome MeasurementsIn September, USP staff presented information about USP probiotic standards and their utility for thedevelopment of Live Biotherapeutic Products at the 2019 National Institute of Standards andTechnology (NIST) Workshop on Standards for Microbiome Measurements. View NIST Workshoppresentation.

Be Part of the Standards Development Process! Help shape standards specifications and test methods by sponsoring monographs or generalchapters and their supporting Reference Standards. USP doesn’t charge fees to developmonographs – all you need is a willingness to collaborate with us to help safeguard the supply chainfor supplements and ingredients. USP standards for dietary ingredients and dietary supplements area resource for public specifications and scientifically valid methods that can help in GMP complianceand in safeguarding the supply chain for supplements and ingredients. USP is seeking donations forthe following monographs:

Non-Botanical Dietary Supplement Ingredients:

Undenatured Collagen Type II

Glucoronolactone

Gamma amino butyric acid (GABA)

Keratin

Bifidobacterium Infantis

Lactobacillus plantarum 299v

Lutein esters

L-Ornithine

Pantethine

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, pleasevisit:USP Dietary Supplements and Herbal Medicines Standards Development Process or contactDietarySciStaff@USP.org.

USP Admission Evaluations of Articles Prior to Monograph Development

Before development of a quality standard for a dietary ingredient is considered, it must undergo aUSP Admission Evaluation, performed by the USP Dietary Supplements Admission Evaluations JointStandard Setting Subcommittee (DSAE JS3). The DSAE JS3 reviews information related to theingredient’s safety, relevance in the market, regulatory status, presence in other pharmacopeias andwhether 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 aminor safety concern that can be mitigated by a label caution statement in the monograph, the articleis placed in class A and is admitted for monograph development. If the article poses a serious healthrisk, 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. Membersdeliberated on and admitted Fish Oil Omega 3 Acid Ethyl Esters Concentrate, Choline Citrate, andJapanese Sophora Flower for monograph development.

For more information, please contact Hellen Oketch-Rabah, Ph.D., at hao@usp.org or EmilyMadden, Ph.D., DABT, at Emily.Madden@usp.org.

Nomenclature of Dietary Supplements

Updates from the Dietary Supplements and Herbal Medicines (DSHM) NomenclatureSubcommittee

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

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 SupplementMonographs 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 andapproval by the Nomenclature and Labeling Expert Committee. For more information on dietarysupplements nomenclature, please contact: Hellen Oketch-Rabah, Ph.D., at hao@usp.org.

Products and Services New Dietary SupplementsReference Standards Below is a list of newly releasedReference Standards. Herbal Medicines/ Botanical DietarySupplements

BaicaleinBaicalein 7-O-GlucuronideChebulagic AcidCoptis chinensis Rhizome DryExtractPsoralenScutellaria baicalensis Root DryExtractTerminalia chebula Fruit DryExtractGuarana Seed Dry ExtractCullen Corylifolium Fruit DryExtractProcyanidin B2

Non-Botanicals

beta-GlycerylphosphorylcholineConjugated Linoleic Acids –TriglyceridesCreatineDocosahexaenoic AcidEicosapentaenoic Acid L-alpha-GlycerophosphorylethanolamineL-alpha-GlycerylphosphorylcholineOmega-3 Free Fatty AcidsPyrroloquinoline QuinoneDisodium

Reference Standards indevelopment:Botanicals

Aegle marmelos Fruit DryExtractAngelica sinensis Root PowderAzadirachta indica Seed OilAzadirachta indica Seed OilAzadirachta indica Leaf DryExtractBerberis aristata Stem DryExtractBitter Orange Fruit FlavonoidDry ExtractBroccoli Seed Dry ExtractChebulinic AcidChrysanthemum indicum FlowerDry ExtractChrysanthemum x morifoliumFlower Dry ExtractCitrus maxima Peel FlavonoidsDry ExtractCranberry Fruit Juice DryExtractCullen corylifolium Fruit DryExtractEgelineEpicatechinGinger Rhizome CarbonDioxide Soft ExtractGinsenoside Rb1GlucoraphaninGuarana Seed Dry ExtractIsorhamnetin–3–O–RutinosideIsochlorogenic Acid AJujuboside ALigusticum chuanxiongRhizome PowderLinarinMaca Root ExtractMarmelosinPalmatine ChloridePomegranate Fruit Dry ExtractProcyanidin A2Procyanidin B2PunicalaginRhoifolinSenkyunolide ASophora japonica Flower DryExtractSpinosinTrachyspermum ammi Fruit OilTerminalia chebula Fruit DryExtractZiziphus jujuba var. spinosaSeed Dry ExtractZ-Ligustilide

Non-Botanicals

1,4-Butanedisulfonic AcidCalcium Magnesium CitrateCholine CitrateCiticolineD-chiro-InositolHydroxocobalamin ChlorideL-Ornithine HydrochlorideLysinePyrroloquinoline quinone (PQQ)PinitolS-Adenosyl-L-Methionine 1,4-Butanedisulfonate

MonographsStandards Open for PublicComment until November 30, 2019The standards below were publishedin PF 45(5) for public comment onSeptember 1, 2019 and will acceptpublic feedback until November 30,2019. To comment, please visit:http://www.usp.org/usp-nf/pharmacopeial-forum

New Monographs/General Chapters

Bifidobacterium bifidiumBifidobacterium longum subsplongumLactobacillus reuteriWater-Soluble VitaminsPreparation

Revised Monographs/GeneralChapters

Aztec Marigold ZeaxanthinExtractLactobacillus rhamnosusHN001

Standards Open for PublicComment until January 31, 2020The standards below will be publishedin PF 45(6) for public comment onNovember 1, 2019 and will acceptpublic feedback until January 31,2020. To comment, please visit:http://www.usp.org/usp-nf/pharmacopeial-forum New Monographs/General Chapters

Sour Jujube SeedSour Jujube Seed PowderSour Jujube Seed Dry ExtractCranberry Fruit Juice DryExtractCranberry Fruit JuiceConcentrate

Revised Monographs/GeneralChapters

Cranberry Liquid Preparation

Standards Open for PublicComment until March 31, 2020The standards below will be publishedin PF 46(1) for public comment onJanuary 1, 2020 and will accept publicfeedback until March 31, 2020. Tocomment, please visit:http://www.usp.org/usp-nf/pharmacopeial-forum

New Monographs/General Chapters

White Peony RootWhite Peony Root PowderWhite Peony Root Dry Extract

Revised Monographs/GeneralChapters

None

New Monographs underDevelopmentBotanicals

Ajowan FruitAjowan Fruit PowderAjowan Fruit Dry ExtractAloe Vera Leaf JuiceAloe Vera Leaf JuiceConcentrateAloe Vera Leaf Dry JuiceBlack Cumin Seed OilBroccoli Seed Dry ExtractCranberry Fruit Dry JuiceFeverfew Leaf ExtractGastrodia (Gastrodia elata)RhizomeGastrodia (Gastrodia elata)Rhizome PowderGastrodia (Gastrodia elata)Rhizome Dry extractSiler (Saposhnikovia divaricata) RootSiler (Saposhnikovia divaricata)Root PowderSiler (Saposhnikovia divaricata)Root Dry ExtractMaca Root PowderMaca Root Gelatinized PowderMaca Root ExtractNeem SeedNeem Seed PowderNeem Seed OilNeem LeafNeem Leaf PowderNeem Leaf Dry ExtractPomegranate Fruit Dry ExtractRed Clover Tablets

Non-Botanicals

Astaxanthin Ester Capsulesbeta-Hydroxy-beta-Methylbutyric acid (HMB)Bifidobacterium longum subspinfantisCalcium 3-hydroxy-3-methylbutyrateCholine CitrateGABAHydrolyzed CollagenInositol NiacinateLactobacillus caseiLevocarnitine TartrateLutein EstersLysineMineral AscorbatesMineral BisglycinatesNative CollagenOil-soluble Vitamins PreparationPhytosterol EstersPlant SterolsRice ProteinS-Adenosyl-L-Methionine 1,4-ButanedisulfonateTocotrienolsZeaxanthin Preparation

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