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New Dietary Supplements Reference Standards

Herbal Medicines/ Botanical Dietary Supplements

Annatto Seed Tocotrienols Extract Bitter Orange Fruit Flavonoids Dry Extract Chebulagic Acid Coptis chinensis Rhizome Dry Dietary Supplements Compendium 2019 Edition Extract Coptisine Chloride The USP Dietary Supplements Compendium (DSC) provides in- (-)-Epicatechin depth, comprehensive information for all phases of development and Seed Dry Extract manufacturing of quality dietary supplements including quality control, Procyanidin B2 quality assurance, and regulatory/compendial affairs. Psoralen Naringin The 2019 edition of DSC has been online for more than six months Citrus maxima Rhoifolin and we are inviting feedback from those who have used it. As we work on the next DSC update to be released this summer, we would (available soon) like your feedback to guide our priorities in content and features Non-Botanicals enhancements. What features would you like to see implemented? What would be on the top of your list to be improved? Please forward beta-Glycerylphosphorylcholine your comments to Anton Bzhelyansky ([email protected]). Conjugated Linoleic Acids – Triglycerides Some of the advantages of the online DSC edition include: Annual updates to ensure access to the most current Docosahexaenoic Acid information Eicosapentaenoic Acid Customizable alerts to notify of changes to bookmarked L-alpha- documents Glycerophosphorylethanolamine An intuitive interface to facilitate quick and easy navigation L-alpha- A customizable workspace with bookmarks, alerts and a Glycerylphosphorylcholine viewing history Oxide Convenient, anytime, anywhere access with common browsers Omega-3 Free Fatty Acids Pyrroloquinoline Quinone In addition to selected new and revised monographs and General Chapters from the USP-NF and Food Chemicals Codex issued since Disodium (PQQ) the previous edition, the DSC 2019 features: Reference Standards in development: 24 new General Chapters Botanicals 79 new dietary ingredient and monographs 27 sets of supplementary information for botanical and Aegle marmelos Fruit Dry nonbotanical dietary ingredients Extract 59 updated botanical HPTLC plates Angelica sinensis Root Powder 23 New Dietary Supplements Admission Evaluation Summaries Azadirachta indica Seed Oil Revised and updated dietary intake comparison tables Azadirachta indica Leaf Dry Updated Dietary Supplement Verification Program manual Extract Links to the latest industry guidances and regulatory Berberis aristata Stem Dry information Extract Broccoli Seed Dry Extract For more information or to order the 2019 online DSC please Chrysanthemum indicum Flower click here. 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

USP Call for Candidates for the 2020-2025 Cycle Ginsenoside Rb1 Glucoraphanin Want to contribute to the USP dietary supplement standard-setting Isorhamnetin–3–O–Rutinoside process? Sign up here Isochlorogenic Acid A Jujuboside A USP’s public standards in the USP-NF, Dietary Supplements Ligusticum chuanxiong Rhizome Compendium and Herbal Medicines Compendium are set by Powder volunteer experts representing the relevant subject matter, Linarin employment sector and geographical area. USP invites you to share Maca root extract your expertise and collaborate with a global network of leaders in Marmelosin science and health to help us establish and revise USP standards Paeoniflorin during the 2020 – 2025 cycle. By helping to develop and update USP Paeonia lactiflora Peeled Root standards, you will impact the quality of dietary supplements and herbal medicines available to people all over the world. As a member Dry Extract of an Expert Committee, your knowledge, support and leadership will Palmatine Chloride contribute to advancing global public health by helping to improve and Pomegranate Fruit Dry Extract sustain developing healthcare systems around the world. Click to Procyanidin A2 learn more about USP standard-setting processes and the role of the Punicalagin expert volunteers. Senkyunolide A Sophora japonica Flower Dry Click to learn more abut the responsibilities of dietary supplement and Extract Expert Committees and the kind of topics they work Spinosin on as well as how and why to volunteer. Trachyspermum ammi Fruit Oil Terminalia chebula Fruit Dry Tell Us What You Think of Our Guide To USP-Speak! Extract We’ve developed a Guide to USP-Speak to help USP dietary Ziziphus jujuba var. spinosa supplements and herbal medicines stakeholders understand key Seed Dry Extract terms, abbreviations, and acronyms used by USP staff when Z-Ligustilide discussing USP dietary supplement and herbal medicine standards. Non-Botanicals This guide is provided only for informational purposes. Please provide feedback via email so we can make necessary updates to this guide 1,4-Butanedisulfonic acid and help USP and our stakeholders to collaborate effectively. Calcium Magnesium Citrate Together, we’ll continue to work towards our common goal of Citrate providing trusted, science-based, public quality standards to help Citicoline safeguard the supply of dietary supplements and herbal medicines D-chiro-Inositol worldwide. Find the Guide to USP Speak, along with other helpful Hydroxocobalamin Chloride resources, at our Dietary Supplements and Herbal Medicines L-Ornithine Hydrochloride Resources webpage under Glossary. Lysine USP in the News Palm Oil Tocotrienols and Tocopherols View Consumer Reports’ article on “How to choose Supplements Pinitol Wisely. Third-party groups test them to ensure they contain what’s on S-Adenosyl-L-Methionine 1,4- the label and aren’t contaminated”. Butanedisulfonate

View John Atwater’s interview in Industry Monographs Executive: “Industry Forecast: An expert panel Standards Open for Public Comment until March 31, 2020 discusses the latest issues affecting the nutritional The standards below were published in ingredients industry”. PF 46(1) for public comment on January 1, 2020 and will accept public feedback until March 31, 2020. To comment, please visit: http://www.usp.org/usp- nf/pharmacopeial-forum Upcoming Events and Meetings New Monographs/General Chapters

USP will be participating in several activities at the ICSB Oxford 2020 White Peony Root Meeting: White Peony Root Powder

The session with a presentation on “Improving the White Peony Root Dry Extract

Quality of Products” Standards Open for Public Comment A poster presentation on “Development and Validation of an until May 31, 2020 The standards HPLC-IPC Method for the Analysis of Glucosinolates in Maca below will be published in PF 46 (2) for public comment on March 1, 2020 and Root Dietary Ingredients” will accept public feedback until May A poster presentation on “The Safety of Bael Tree Fruit as a 31, 2020. To comment, please visit: http://www.usp.org/usp- Dietary Supplement” nf/pharmacopeial-forum Revised Monographs/General Past Events Chapters

Vinpocetine Capsules, American College of Toxicology Vinpocetine Tablets

November 2019 | Phoenix, Arizona General Chapter <2750> Manufacturing Practices for Emily Madden, Ph.D., D.A.B.T., of USP presented her scientific poster Dietary Supplements entitled USP Admissions Evaluation of Coptis Species Rhizome and Indian Barberry Stem: Cautionary Labeling for Drug Interactions at the Standards to be published in PF 46 40th American College of Toxicology annual meeting during (3) The standards below will be November 17-20, 2019 in Phoenix, Arizona. The event afforded a published in PF 46 (3) on May 1, 2020 great opportunity to interact with a community of toxicologists and to and will accept public feedback until share information on processes for the USP Admission Evaluation July 31, 2020. To comment, please visit: performed by the USP Dietary Supplements Admission Evaluations http://www.usp.org/usp- Joint Standard Setting Subcommittee (DSAE JS3). nf/pharmacopeial-forum New Monographs/General Chapters USP participated in the webinar: State of Probiotics from the lab to the Broccoli Seed Dry Extract law to , presented by CRN with Natural Products Insider. Pomegranate Fruit Dry Extract Kit Goldman, Ph.D. presented on USP Activities and the USP Probiotic Expert Panel. New Monographs under Development Botanicals Be Part of the Standards Development Process!

Ajowan Fruit Help shape standards specifications and test methods by sponsoring Ajowan Fruit Powder monographs or General Chapters and their supporting Reference Ajowan Fruit Dry Extract Standards. USP doesn’t charge fees to develop monographs – all you Aloe Vera Leaf Juice need is a willingness to collaborate with us to help safeguard the Aloe Vera Leaf Juice supply chain for supplements and ingredients. USP standards for Concentrate dietary ingredients and dietary supplements are a resource for public Aloe Vera Leaf Dry Juice specifications and scientifically valid methods that can help in GMP compliance and in safeguarding the supply chain for supplements and Black Cumin Seed Oil ingredients. USP is seeking donations for the following monographs: Cranberry Fruit Dry Juice Feverfew Leaf Extract Botanical Dietary Supplement Ingredients Gastrodia (Gastrodia elata) Rhizome Acai Gastrodia (Gastrodia elata) Cuminum cyminum Rhizome Powder Dandelion Root Hops Gastrodia (Gastrodia elata) Horehound Rhizome Dry extract Melissa officinalis Siler (Saposhnikovia divaricata) Root Siler (Saposhnikovia divaricata) Root Powder Non-Botanical Dietary Supplement Ingredients: Siler (Saposhnikovia divaricata) Glucuronolactone Root Dry Extract Histidine Maca root powder Lactobacillus plantarum 299v Maca root gelatinized powder Lutein esters Maca root extract L-Ornithine Neem Seed Pantethine Neem Seed Powder Salmon Oil Neem Seed Oil Soy Protein Neem Leaf Zeaxanthin preparation Neem Leaf Powder Neem Leaf Dry Extract Red Clover Tablets Non-Botanical Dosage Forms (Finished Dietary Supplements): Red Asian Root and Rhizome Cyanocobalamin capsules Red Asian Ginseng Root and , capsules Magnesium Citrate capsules Rhizome Powder Menaquinone 4 tablets and capsules Red Asian Ginseng Root and Methylcobalamin orally disintegrating tablets Rhizome Dry Extract

Omega-3-Triglyceride chewable gels (gummies) Non-Botanicals Plant Sterol tablets Plant Sterols and Stanols Ester Capsules Astaxanthin ester capsules S-Adenosyl-L-Methionine Disulfate Tosylate tablets beta-Hydroxy-beta- Omega-3-Acid Triglycerides with D capsules Methylbutyric acid (HMB) longum subsp

infantis For more information on how to donate and a complete list of Calcium 3-hydroxy-3- requested monographs, please visit: USP Dietary Supplements and methylbutyrate Herbal Medicines Standards Development Process or Choline Citrate contact [email protected]. GABA Hydrolyzed Collagen USP Admission Evaluations of Articles Prior to Monograph Inositol Niacinate Development Levocarnitine Tartrate Before development of a quality standard for a dietary ingredient is Lutein Esters considered, it must undergo a USP Admission Evaluation, performed Lysine by the USP Dietary Supplements Admission Evaluations Joint Ascorbates Standard Setting Subcommittee (DSAE JS3). The DSAE JS3 reviews Mineral Bisglycinates information related to the ingredient’s safety, relevance in the market, Native Collagen regulatory status, presence in other pharmacopeias and whether the Oil-soluble Preparation article poses a serious health risk when used as a dietary supplement. Palm Oil Tocotrienols and If the article does not pose a serious health risk or poses a minor Tocopherols safety concern that can be mitigated by a label caution statement in Phytosterol Esters the monograph, the article is placed in class A and is admitted for Plant sterols monograph development. If the article poses a serious health risk, it is Rice protein placed in class B and is not admitted for monograph development. S-Adenosyl-L-Methionine 1,4- Butanedisulfonate The DSAE JS3 held a face-to-face working meeting on Tuesday, December 10th, 2019. Members deliberated on and admitted Zeaxanthin Preparation Bifidobacterium bifidum Bb-06, Bifidobacterium longum subsp. Hydrolyzed Keratin longum Bl-05, Lactobacillus rhamnosus GG, Lactobacillus reuteri 1E1, Bacillus calusii Bael Tree Ripe Fruit, and Cranberry Fruit (ingredients derived from) Streptococcus thermophilus for monograph development.The DSAE JS3 will meet via Webex on Lactobacillus salivarius Thursday March 12th, 2020, to deliberate on S-Adenosyl-L- Lactobacillus plantarum Methionine 1,4-Butanedisulfonate, Sour Jujube Seed and White New General Chapter under Peony Root. Comments on the safety of these ingredients are Development welcome.For more information, please contact Hellen Oketch-Rabah, Ph.D., at [email protected] or Emily Madden, Ph.D., DABT, General Chapter <2740> at [email protected]. Manufacturing Practices for Dietary Ingredients

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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:

Apigenin Bifidobacterium longum subsp. Infantis Black Cumin Seed Thymoquinone Oil Cranberry Fruit Juice Dry Extract Capsules Lactobacillus casei Neem Leaf Neem Leaf Dry Extract Neem Leaf Powder Palm Oil Tocotrienols and Tocopherols Red Asian Ginseng Root and Rhizome Powder Red Asian Ginseng Root and Rhizome Red Asian Ginseng Root and Rhizome Dry Extract Rice Bran Oil Tocotrienols and Tocopherols

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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