Dietary Supplements Compendium 2019 Edition

The USP Dietary Supplements Compendium (DSC) provides in-depth comprehensive information for all phases of development andmanufacturing of quality dietary supplements including quality controlquality assurance and regulatorycompendial affairs

The 2019 edition of DSC has been online for more than six monthsand we are inviting feedback from those who have used it As wework on the next DSC update to be released this summer we wouldlike your feedback to guide our priorities in content and featuresenhancements What features would you like to see implementedWhat would be on the top of your list to be improved Please forwardyour comments to Anton Bzhelyansky (anbusporg)

Some of the advantages of the online DSC edition include

Annual updates to ensure access to the most currentinformationCustomizable alerts to notify of changes to bookmarkeddocumentsAn intuitive interface to facilitate quick and easy navigationA customizable workspace with bookmarks alerts and aviewing historyConvenient anytime anywhere access with common browsers

In addition to selected new and revised monographs and GeneralChapters from the USP-NF and Food Chemicals Codex issued sincethe previous edition the DSC 2019 features

24 new General Chapters79 new dietary ingredient and dietary supplement monographs27 sets of supplementary information for botanical andnonbotanical dietary ingredients59 updated botanical HPTLC plates23 New Dietary Supplements Admission Evaluation SummariesRevised and updated dietary intake comparison tablesUpdated Dietary Supplement Verification Program manualLinks to the latest industry guidances and regulatoryinformation

For more information or to order the 2019 online DSC pleaseclick here

USP Call for Candidates for the 2020-2025 Cycle

Want to contribute to the USP dietary supplement standard-settingprocess Sign up here

USPrsquos public standards in the USP-NF Dietary SupplementsCompendium and Herbal Medicines Compendium are set byvolunteer experts representing the relevant subject matteremployment sector and geographical area USP invites you to shareyour expertise and collaborate with a global network of leaders inscience and health to help us establish and revise USP standardsduring the 2020 ndash 2025 cycle By helping to develop and update USPstandards you will impact the quality of dietary supplements andherbal medicines available to people all over the world As a memberof an Expert Committee your knowledge support and leadership willcontribute to advancing global public health by helping to improve andsustain developing healthcare systems around the world Click tolearn more about USP standard-setting processes and the role of theexpert volunteers

Click to learn more abut the responsibilities of dietary supplement andherbal medicine Expert Committees and the kind of topics they workon as well as how and why to volunteer

Tell Us What You Think of Our Guide To USP-Speak

Wersquove developed a Guide to USP-Speak to help USP dietarysupplements and herbal medicines stakeholders understand keyterms abbreviations and acronyms used by USP staff whendiscussing USP dietary supplement and herbal medicine standardsThis guide is provided only for informational purposes Please providefeedback via email so we can make necessary updates to this guideand help USP and our stakeholders to collaborate effectivelyTogether wersquoll continue to work towards our common goal ofproviding trusted science-based public quality standards to helpsafeguard the supply of dietary supplements and herbal medicinesworldwide Find the Guide to USP Speak along with other helpfulresources at our Dietary Supplements and Herbal MedicinesResources webpage under Glossary

USP in the News

View Consumer Reportsrsquo article on ldquoHow to choose SupplementsWisely Third-party groups test them to ensure they contain whatrsquos onthe label and arenrsquot contaminatedrdquo

View John Atwaterrsquos interview in Nutrition IndustryExecutive ldquoIndustry Forecast An expert paneldiscusses the latest issues affecting the nutritionalingredients industryrdquo

Upcoming Events and Meetings

USP will be participating in several activities at the ICSB Oxford 2020Meeting

The probiotics session with a presentation on ldquoImproving theQuality of Probiotic ProductsrdquoA poster presentation on ldquoDevelopment and Validation of anHPLC-IPC Method for the Analysis of Glucosinolates in MacaRoot Dietary IngredientsrdquoA poster presentation on ldquoThe Safety of Bael Tree Fruit as aDietary Supplementrdquo

Past Events

American College of Toxicology

November 2019 | Phoenix Arizona

Emily Madden PhD DABT of USP presented her scientific posterentitled USP Admissions Evaluation of Coptis Species Rhizome andIndian Barberry Stem Cautionary Labeling for Drug Interactions at the40th American College of Toxicology annual meeting duringNovember 17-20 2019 in Phoenix Arizona The event afforded agreat opportunity to interact with a community of toxicologists and toshare information on processes for the USP Admission Evaluationperformed by the USP Dietary Supplements Admission EvaluationsJoint Standard Setting Subcommittee (DSAE JS3)

USP participated in the webinar State of Probiotics from the lab to thelaw to Lactobacillus presented by CRN with Natural Products InsiderKit Goldman PhD presented on USP Activities and the USPProbiotic Expert Panel

Be Part of the Standards Development Process

Help shape standards specifications and test methods by sponsoringmonographs or General Chapters and their supporting ReferenceStandards USP doesnrsquot charge fees to develop monographs ndash all youneed is a willingness to collaborate with us to help safeguard thesupply chain for supplements and ingredients USP standards fordietary ingredients and dietary supplements are a resource for publicspecifications and scientifically valid methods that can help in GMPcompliance and in safeguarding the supply chain for supplements andingredients USP is seeking donations for the following monographs

Botanical Dietary Supplement Ingredients

AcaiCuminum cyminumDandelion RootHopsHorehoundMelissa officinalis

Non-Botanical Dietary Supplement Ingredients

GlucuronolactoneHistidineLactobacillus plantarum 299vLutein estersL-OrnithinePantethineSalmon OilSoy ProteinZeaxanthin preparation

Non-Botanical Dosage Forms (Finished Dietary Supplements)

Cyanocobalamin capsulesGlucosamine Chondroitin Sulfate Sodium capsulesMagnesium Citrate capsulesMenaquinone 4 tablets and capsulesMethylcobalamin orally disintegrating tabletsOmega-3-Triglyceride chewable gels (gummies)Plant Sterol tabletsPlant Sterols and Stanols Ester CapsulesS-Adenosyl-L-Methionine Disulfate Tosylate tabletsOmega-3-Acid Triglycerides with Vitamin D capsules

For more information on how to donate and a complete list ofrequested monographs please visit USP Dietary Supplements andHerbal Medicines Standards Development Process orcontact DietarySciStaffUSPorg

USP Admission Evaluations of Articles Prior to MonographDevelopment

Before development of a quality standard for a dietary ingredient isconsidered it must undergo a USP Admission Evaluation performedby the USP Dietary Supplements Admission Evaluations JointStandard Setting Subcommittee (DSAE JS3) The DSAE JS3 reviewsinformation related to the ingredientrsquos safety relevance in the marketregulatory status presence in other pharmacopeias and whether thearticle poses a serious health risk when used as a dietary supplement

If the article does not pose a serious health risk or poses a minorsafety concern that can be mitigated by a label caution statement inthe monograph the article is placed in class A and is admitted formonograph development If the article poses a serious health risk it isplaced in class B and is not admitted for monograph development

The DSAE JS3 held a face-to-face working meeting on TuesdayDecember 10th 2019 Members deliberated on and admittedBifidobacterium bifidum Bb-06 Bifidobacterium longum subsplongum Bl-05 Lactobacillus rhamnosus GG Lactobacillus reuteri 1E1Bael Tree Ripe Fruit and Cranberry Fruit (ingredients derived from)for monograph developmentThe DSAE JS3 will meet via Webex onThursday March 12th 2020 to deliberate on S-Adenosyl-L-Methionine 14-Butanedisulfonate Sour Jujube Seed and WhitePeony Root Comments on the safety of these ingredients arewelcomeFor more information please contact Hellen Oketch-RabahPhD at haousporg or Emily Madden PhD DABTat EmilyMaddenusporg

Products amp Services

New Dietary Supplements ReferenceStandards

Herbal Medicines Botanical DietarySupplements

Annatto Seed Tocotrienols

Extract

Bitter Orange Fruit Flavonoids

Dry Extract

Chebulagic Acid

Coptis chinensis Rhizome Dry

Extract

Coptisine Chloride

(-)-Epicatechin

Guarana Seed Dry Extract

Procyanidin B2

Psoralen

Naringin

Citrus maxima Rhoifolin

(available soon)

Non-Botanicals

beta-Glycerylphosphorylcholine

Conjugated Linoleic Acids ndash

Triglycerides

Creatine

Docosahexaenoic Acid

Eicosapentaenoic Acid

L-alpha-

Glycerophosphorylethanolamine

L-alpha-

Glycerylphosphorylcholine

Magnesium Oxide

Omega-3 Free Fatty Acids

Pyrroloquinoline Quinone

Disodium (PQQ)

Reference Standards indevelopmentBotanicals

Aegle marmelos Fruit Dry

Extract

Angelica sinensis Root Powder

Azadirachta indica Seed Oil

Azadirachta indica Leaf Dry

Extract

Berberis aristata Stem Dry

Extract

Broccoli Seed Dry Extract

Chrysanthemum indicum Flower

Dry Extract

Chrysanthemum x morifolium

Flower Dry Extract

Cranberry Fruit Juice Dry

Extract

Cullen corylifolium Fruit Dry

Extract

Egeline

Ginger Rhizome Carbon Dioxide

Soft Extract

Ginsenoside Rb1

Glucoraphanin

Isorhamnetinndash3ndashOndashRutinoside

Isochlorogenic Acid A

Jujuboside A

Ligusticum chuanxiong Rhizome

Powder

Linarin

Maca root extract

Marmelosin

Paeoniflorin

Paeonia lactiflora Peeled Root

Dry Extract

Palmatine Chloride

Pomegranate Fruit Dry Extract

Procyanidin A2

Punicalagin

Senkyunolide A

Sophora japonica Flower Dry

Extract

Spinosin

Trachyspermum ammi Fruit Oil

Terminalia chebula Fruit Dry

Extract

Ziziphus jujuba var spinosa

Seed Dry Extract

Z-Ligustilide

Non-Botanicals

14-Butanedisulfonic acid

Calcium Magnesium Citrate

Choline Citrate

Citicoline

D-chiro-Inositol

Hydroxocobalamin Chloride

L-Ornithine Hydrochloride

Lysine

Palm Oil Tocotrienols and

Tocopherols

Pinitol

S-Adenosyl-L-Methionine 14-

Butanedisulfonate

MonographsStandards Open for Public Commentuntil March 31 2020The standards below were published inPF 46(1) for public comment onJanuary 1 2020 and will accept publicfeedback until March 31 2020 Tocomment please visithttpwwwusporgusp-nfpharmacopeial-forumNew MonographsGeneral Chapters

White Peony Root

White Peony Root Powder

White Peony Root Dry Extract

Standards Open for Public Commentuntil May 31 2020 The standardsbelow will be published in PF 46 (2) forpublic comment on March 1 2020 andwill accept public feedback until May31 2020 To comment please visithttpwwwusporgusp-nfpharmacopeial-forumRevised MonographsGeneralChapters

Vinpocetine Capsules

Vinpocetine Tablets

General Chapter lt2750gt

Manufacturing Practices for

Dietary Supplements

Standards to be published in PF 46

(3) The standards below will be

published in PF 46 (3) on May 1 2020

and will accept public feedback until

July 31 2020 To comment please visit

httpwwwusporgusp-

nfpharmacopeial-forumNew MonographsGeneral Chapters

Broccoli Seed Dry Extract

Pomegranate Fruit Dry Extract

New Monographs underDevelopmentBotanicals

Ajowan Fruit

Ajowan Fruit Powder

Ajowan Fruit Dry Extract

Aloe Vera Leaf Juice

Aloe Vera Leaf Juice

Concentrate

Aloe Vera Leaf Dry Juice

Black Cumin Seed Oil

Cranberry Fruit Dry Juice

Feverfew Leaf Extract

Gastrodia (Gastrodia elata)

Rhizome

Gastrodia (Gastrodia elata)

Rhizome Powder

Gastrodia (Gastrodia elata)

Rhizome Dry extract

Siler (Saposhnikovia divaricata)

Root

Siler (Saposhnikovia divaricata)

Root Powder

Siler (Saposhnikovia divaricata)

Root Dry Extract

Maca root powder

Maca root gelatinized powder

Maca root extract

Neem Seed

Neem Seed Powder

Neem Seed Oil

Neem Leaf

Neem Leaf Powder

Neem Leaf Dry Extract

Red Clover Tablets

Red Asian Ginseng Root and

Rhizome

Red Asian Ginseng Root and

Rhizome Powder

Red Asian Ginseng Root and

Rhizome Dry Extract

Non-Botanicals

Astaxanthin ester capsules

beta-Hydroxy-beta-

Methylbutyric acid (HMB)

Bifidobacterium longum subsp

infantis

Calcium 3-hydroxy-3-

methylbutyrate

Choline Citrate

GABA

Hydrolyzed Collagen

Inositol Niacinate

Lactobacillus casei

Levocarnitine Tartrate

Lutein Esters

Lysine

Mineral Ascorbates

Mineral Bisglycinates

Native Collagen

Oil-soluble Vitamins Preparation

Palm Oil Tocotrienols and

Tocopherols

Phytosterol Esters

Plant sterols

Rice protein

S-Adenosyl-L-Methionine 14-

Butanedisulfonate

Zeaxanthin Preparation

Hydrolyzed Keratin

Bacillus calusii

Streptococcus thermophilus

Lactobacillus salivarius

Lactobacillus plantarum

New General Chapter underDevelopment

General Chapter lt2740gt

Manufacturing Practices for

Dietary Ingredients

Find a Reference Standard

Suggest a Reference Standard

Nomenclature of Dietary SupplementsUpdates 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

ApigeninBifidobacterium longum subsp InfantisBlack Cumin Seed Thymoquinone OilCranberry Fruit Juice Dry Extract CapsulesLactobacillus caseiNeem LeafNeem Leaf Dry ExtractNeem Leaf PowderPalm Oil Tocotrienols and TocopherolsRed Asian Ginseng Root and Rhizome PowderRed Asian Ginseng Root and RhizomeRed Asian Ginseng Root and Rhizome Dry ExtractRice Bran Oil Tocotrienols and Tocopherols

DSHM Nom JSC revised the Guideline for Assigning Titles to USP Dietary Supplement Monographs availableat httpwwwusporgsitesdefaultfiles uspdocumentget-involvedsubmission-guidelinesguideline-for-assigning-titles-to-usp-dietary-supplement-monographpdf The revised guideline is currently available at the above link after review and approval by theNomenclature and Labeling Expert Committee For more information on dietary supplements nomenclature please contactHellen Oketch-Rabah PhD at haousporg

Forward to a Colleague or Friend

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