Premium Series: Dietary Supplement Safety: From Mice to Men—How Animal Studies Translate into Human Advisories and What You Can Do To Protect Your Company
INSIDER Premium Series
December 11, 2013 - May 31, 2014
CRN Member Price:
*Discount subject to verification. Registrants that use the CRN member discount and are not members will be charged the additional $50 towards full registration.
Non-CRN Member Price:
Companies currently doing business in the dietary supplement marketplace, as well as those marketing products or ingredients that may eventually be caught in the animal-testing net, will not want to miss this cutting edge webinar examining emerging issues as more dietary ingredients go under review for safety and toxicity.
Interpretations (sometimes with subjective or political nuances) of objective National Toxicology Program (NTP) animal testing results coming under further review by bodies such as the International Agency for Research on Cancer and the California Environmental Protection Agency Office of Environmental Health Hazard Assessment as part of its Proposition 65 Act, can pose challenges for dietary supplement ingredients suppliers and manufacturers, especially if one is not aware or equipped to get involved with real science at the right step.
Four experts—including a top-level scientist from NTP along with legal and regulatory consultants experienced in ingredient toxicity issues—will explain the process behind program assessments and share insights about what the future may hold and how your company can prepare. Additionally, speakers will provide case studies of how a product’s distinction, i.e., specifications and analysis, may set it apart or derail the public health warnings that often automatically follow the original data publication.
- Animal testing can help determine safety and efficacy of ingredients; however, results may not be directly related to human experiences.
- Interpretations of safety and toxicity tests are often different based on the reviewer's background and agenda.
- Experts will help webinar attendees understand how these safety study interpretations affect the supplement business.
James C. Griffiths, Ph.D.
Dr. Griffiths is responsible for CRN’s science-based international policy and regulatory work, and is the CRN staff liaison for CRN International (CRN-I). He has more than 25 years of experience in the area of food safety and regulatory affairs. Prior to joining CRN, he spent five years with the United States Pharmacopoeia (USP) where he managed food and dietary supplement strategic initiatives, including those related to global food and dietary supplement alliances. He began his career as a regulatory review toxicologist at the FDA’S Center for Food Safety and Applied Nutrition. His background also includes various scientific and regulatory positions at Burdock and Associates, the Flavor & Extract Manufacturers’ Association, International Specialty Products, Avon Products, and others. He has published extensively in peer-reviewed publications, and serves on the editorial board of the Journal of Excipients and Food Chemicals. He is currently serving a two-year term as president for the Toxicology and Safety Division, Institute of Food Technologists, and the Society of Toxicology’s Food Safety Specialty Section.
James Hoadley, Ph.D.
Dr. Hoadley’s distinguished career at the FDA, most recently as a Senior Regulatory Scientist in the Office of Nutritional Products, Labeling and Dietary Supplements (ONPLDS) with primary responsibilities in food label claim regulations, enabled him to gain an expertise in the areas of scientific and regulatory reviews of petitions for new health claims and nutrient content claims. He was also involved in some of the most precedent-setting health claim regulatory problems as CFSAN adapted to the FDA Modernization Act provision for authorization of food label claims. At EAS Consulting Group, LLC he provides expert consultation with clients at an international level in the areas of food safety and regulation.
Nigel Walker, Ph.D., DABT
Dr. Nigel Walker is Deputy Director of the Division of the National Toxicology Program at the National Institute of Environmental Health Sciences (NIEHS), one of National Institutes of Health (NIH). As Deputy Director of DNTP, he works with the NTP Division Director in the formulation, coordination and implementation of activities necessary to carry out the scientific missions of the National Toxicology Program (NTP). Dr. Walker’s experience covers environmental toxicology, quantitative dose response modeling and risk analysis, with particular emphasis on understanding the toxicology and carcinogenicity of mixtures, dioxins and other persistent organic pollutants, and nanoscale materials. He has over 110 peer-reviewed publications, including over thirty National Toxicology Program (NTP) bioassay Technical reports.
James R. Coughlin, Ph.D., CFS
Dr. Coughlin is an internationally recognized expert in food, nutrition and chemical safety, toxicology and regulatory affairs. His previous experience includes positions at Armour Foods and General Foods & Kraft General Foods headquarters. Dr. Coughlin is a Fellow and Certified Food Scientist of the Institute of Food Technologists, serves as an IFT Food Science Communicator and is also serving for the past decade as IFT’s Codex Subject Expert on Contaminants in Food. He served as President of the Association for Science and Information on Coffee and continues as a member of its Board, and has also served as Vice President of the International Society for Trace Element Research in Humans. He has been deeply involved with managing California Proposition 65 issues since 1986. Dr. Coughlin provides strategic scientific, toxicologic, nutritional, communications and regulatory counsel to many food, functional food, dietary supplement, chemical, and consumer products companies and their trade associations, law firms and public relations firms.
Trenton Norris, Esq.
Trent Norris, a senior partner in Arnold & Porter’s San Francisco and Silicon Valley offices, litigates complex scientific and technical disputes in the areas of consumer protection, product liability, and environmental law. In his 20 years of practice, Mr. Norris has represented hundreds of companies in Proposition 65 lawsuits and regulatory matters. Although Proposition 65 trials are unusual, Mr. Norris has tried two such cases, both of which resulted in defense victories. His cases have also resulted in a number of reported appellate decisions. Mr. Norris has been a leader in the effort to reform Proposition 65 and California’s other onerous consumer protection laws. As noted by Chambers USA, he is “renowned as one of the region’s leading experts in toxic tort and Proposition 65 matters.” His current significant Proposition 65 litigation matters involve dietary supplement and whey protein products, multivitamins, fish oil, burgers, coffee, grilled chicken, ginger, clams/oysters, snack foods, shampoos/soaps, color cosmetics, razors, and aviation fuel.
*All registration fees are non-refundable
*Content and speakers are subject to change