PPT-FDA Public Meeting to Discuss the Development of a List of Pre-DSHEA Dietary Ingredients

October 3 2017 Stephanie Scarmo PhD MPH Outline Legislative background Different models for creating the list Principles Final list Legislative background Congress did not want to impose barriers to products currently on the market and thereby legislated a presumption of safety. Dr. . Divya. Central Avian Research Institute. Izatnagar. , Bareilly, U.P.243 122. in meat products . for health improvements. Meat. Meat and meat products- . proteins, vitamins, and minerals.’. Warfighters. DoD. Human Performance Resource Center. Website address: . humanperformanceresourcecenter.org . Contact e-mail: . supplements@usuhs.edu/hprc@usuhs.mil. 1. v4: 082212. Overview. Introduction . Bruce Ross. , . M.A. M.P.H.. Director, India Office. Agenda. Priorities. Challenges of globalization. cGMP. . deficiencies. Comparison. Post inspection regulatory . actions. 2. Advance Regulatory Science: the science of developing new tools, standards and approaches to assess the safety and effectiveness, quality and performance of FDA-regulated products. Webinar For. Nature’s . Sunshine . Consultants. October 20, 2011. Keeping You Safe – A Conversation with Nature’s Sunshine’s Attorney. My Contact Information. Scott Terry. scottt@natr.com. P . WHAT DO I NEED TO KNOW. Fad Diets. Americans spend $40 billion annually on dieting and dieting products. 66% American adults are overweight or obese. 41% of American adults are trying to lose weight. October 3, 2017. Charles Bell, Programs Director. Consumers Union. “Safe Harbor” . “DSHEA grandfathered all dietary supplement ingredients marketed in the United States before October 15, 1994.  These are . United Natural Products Alliance. Center for Food Safety & Applied Nutrition. College Park, Maryland. October 3, 2017. Public meeting to discuss the development of a list of . pre-DSHEA dietary ingredients. Joseph M. Betz, Ph.D.. Office of Dietary Supplements. National Institutes of Health. Disclaimer. Views expressed are my own and do not reflect the views of ODS, NIH, or HHS. Definitions. §8. New Dietary Ingredients.. Nancy Chapman MPH, RD. Executive Director, . Soyfoods Association of North America. Dietary Guidelines. I. ntended . for Americans ages 2 years and . over. Including . those at increased risk of chronic . October 2017. Is this a “safe harbor”? . Or a rabbit hole? . 2. FDA’s resources, including inspections and oversight, are dwarfed by the size and scope of the DS industry.. Already we see that adulterated and dangerous supplements, including powdered and liquid highly concentrated caffeine, . Presenter Name, Title . This program is made possible with the support of: . By the end of this presentation you will be able to:. Provide three requirements that define a dietary supplement. Describe two ways that a dietary supplement differs from prescription and over-the-counter (OTC) medicines . precision.fda.gov | precisionFDA@fda.hhs.gov | @precisionFDA. Taha A. Kass-Hout, MD, MS. FDA Chief Health Informatics . Officer. Director, FDA’s Office of Health . Informatics. David . Litwack. , PhD. Alzheimers. Therapeutics . (and Diagnostics). Mark Ammann, . Pharm.D. .. President, Catalyst Regulatory Services. September 12, 2017. Pharm.D. . University of Michigan College of Pharmacy. 27 years working in Industry. for 510(k) Submissions. Consultants and RA Experts have used these for years, but . they weren’t . called “pre-sub” . meetings.. Agenda. What is a pre-sub meeting?. Is a pre-sub meeting required for 510(k) submissions?.