Dietary Supplements E-Newsletter

November 2015 What's New Quick Links

USP–NF

USP–NF Online PF Online New USP GMP Facility Audit Program DS Compendium for Dietary Supplements and Ingredients! DS Development Process Use the most authoritative source for dietary supplement Key Issues GMP audits! Read more… Donor Program Chromatographic Columns Adulteration and Fraud in Contact Us Food Ingredients and Dietary Supplements— Attend Two Key Learning USP Events Reference Standards Food Fraud Mitigation Course (Dec 2, 2015) Economically Motivated Adulteration (EMA) and food counterfeiting Dietary Supplements RS are major threats to the integrity of the nation´s food supply. The Release Notification Food Safety Modernization Act (FSMA) and a new FDA rule now requires food manufacturers to develop a Food Safety Plan and mitigate foreseeable risks. USP´s timely course will introduce users USP Near to its Food Fraud Mitigation Guidance. Read more… You

4th Adulteration Workshop (Dec 3–4, 2015) This two-day workshop—co-sponsored by the American Botanical Calendar of Events Council and the Food Protection and Defense Institute—allows User Forums attendees to explore new tools to help detect fraud and EMA, hear Global Education and about factors impacting supply chain integrity, and learn about the Training validity of DNA based methods for identity.

USP Releases New Reference Standards Arabinose (Item # 1042055) Astragalus Root Dry Extract (Item # 1044119) Calcium Succinate (Item # 1087360) Calling For Sponsors For Chondroitin Sulfate Sodium, Shark (Item # 1133569) New USP Standards For N-Acetyl-D,L-Methionine (Item # 1009978) Probiotics Ubiquinol (Item # 1705334)

• Upcoming Workshops: New Reference Standards Coming Soon Cinnamaldehyde Adulteration and Fraud in Cinnamomum cassia Twig Powder Food Ingredients and Didymin Dietary Supplements: D-Salicin Attend Two Key Learning Gallic Acid Events Hesperidin Isonaringin • Food Fraud Mitigation Lonicear macranthoides Flower Dry Extract Course (Dec 2, 2015) Lonicera japonica Flower Dry Extract • 4th Adulteration Workshop Luteolin-7-O-glucoside (Dec 3–4, 2015) Neohesperidin (Co-sponsored by: American Oleuropein Botanical Council and Food Olive Leaf Dry Extract Protection & Defense Institute) Red Clover Aerial Parts Isoflavone Aglycones Dry Extract Register for Both Events Salix spp. Bark Dry Extract and Save! Click the Register Secoxyloganin button for course and Verbascoside workshop pricing. Consult Willow Bark Dry Extract Find a Reference Standard the agenda for course Suggest a Reference Standard details and list of distinguished presenters. Monographs in Revision Bulletin (Published Sept 25, 2015. Official Nov 1, 2015) Calcium L-5-Methyltetrahydrofolate Capsules • Priority New Dietary Calcium L-5-Methyltetrahydrofolate Tablets Supplement Monographs (updated 24-Sept-2015) Monographs in PF 41(6) USP is seeking sponsors… (To be published Nov 1, 2015. Comments due by Jan 31, 2016) Read More New: Creatine • USP Dietary Salix spp. Bark ( | Dry Extract | Powder) Sodium Ferrous Citrate Supplements & Herbal Tienchi Ginseng Root and Rhizome Dry Extract (Capsules | Tablets) Medicines (DSHM) Tienchi Ginseng Root and Rhizome Powder (Capsules | Tablets) Nomenclature News Revisions: Ascorbic Acid Injection • USP Admission Histidine Evaluation of Articles Potassium Gluconate ( | Oral Solution | Tablets) Prior to Monograph Riboflavin Tablets Rutin Development Thiamine Hydrochloride Tablets Tribasic Calcium Phosphate • Expert Panel Update: <2251> Adulteration of Monographs in PF 41(5) Dietary Supplements with (Published Sept 1, 2015. Comments due by Nov 30, 2015) Drugs and Drug Analogs New: Eleuthero Root and Rhizome Dry Extract (Capsules | Tablets) Japanese Honeysuckle Flower ( | Dry Extract | Powder) Olive Leaf ( |Dry Extract | Powder) Red Clover Aerial Parts Isoflavone Aglycones Dry Extract Revisions: Ashwagandha Root Curcuminoids Eleuthero Niacin Powdered Ashwagandha Root ( | Extract) Purchase the 2015 Dietary Powdered Eleuthero ( | Extract) Supplements Powdered Red Clover Extract Compendium (DSC) Powdered St. John´s Wort Extract Powdered Turmeric ( | Extract) Schizochytrium Oil Frequently Asked Turmeric Questions (FAQ):

Read about monographs slated for PF 42(1) and PF 42(2)… Q. How should the USP Reference Standards (RS) New Monographs Under Development be used properly? Artichoke Leaf ( | Dry Extract | Powder) Coffee Green Bean Extract Can a chewable tablets Cranberry Juice-Derived Powder Q. Dried Tangerine Peel product be subjected only to Elderberry Dry Extract Disintegration testing and Eleuthero Root and Rhizome Powder (Capsules | Tablets) that there would be no need Ginkgo (Capsules | Tablet) to verify the release of the Guarana Seed ( | Dry Extract | Powder) dietary ingredients via Probiotics: Bacillus Coagulans PTA-11748, Lactobacillus Acidophilus LA-14, Lactobacillus Acidophilus NCFM, Lactobacillus Rhamnosus Dissolution test? HN001, Bacillus Coagulans 5856, Lactobacillus Paracasei LPC-37 Red Clover Tablets Published by: Szechuan Lovage Gabriel Giancaspro, Ph.D. Submit Monographs and Revisions Vice President General Chapters in PF 41(5) Foods, Dietary Supplements (Published Sept 1, 2015. Comments due by Nov 30, 2015) & Herbal Medicines Revisions: Comments and questions <2040> Disintegration and Dissolution of Dietary Supplements <2750> Manufacturing Practices for Dietary Supplements Questions? General Chapters in PF 41(6) Email: [email protected] (To be published Nov 1, 2015. Comments due by Jan 31, 2016) Phone: +1-301-816-8134 Revisions: Contact Us <481> Riboflavin Assay <531> Thiamine Assay

Donor Recognition Program (Effective January 2016) USP has expanded its Donor Recognition Program to further recognize contributors who participate in the standards-setting process and help make an impact on global health. Visit the Donor Recognition page to learn more.