Registration now open.
With the recent increase in scrutiny of contaminants in dietary supplements, it is essential for industry to understand the current climate and apply best practices to protect consumer safety.
Participate in CRN's workshop to learn how companies can determine which contaminants to include in their specifications and how to set the appropriate limits.
The workshop will also include a session on testing requirements and available methods for testing heavy metals, pesticides, pyrrolizidine alkaloids, and mycotoxins.
Experts will describe the regulatory landscape for contaminants, state initiatives, and recent trends in litigation.
The workshop will conclude with a discussion on assessing hazard versus risk for contaminants, providing practical advice on how industry can effectively communicate the relevance of contaminant testing to health risks.
Learn more about presenters and agenda.
Register here
CRN Members $249 | Non-Members $399
Moderated by:
- Alex Eapen, PhD, DABT
Senior Director, R&D Scientific & Regulatory Affairs - North America, Cargill - Annahita Ghassemi, PhD, DABT
Senior Director – Global Head of Product Safety, Clinical & Scientific, Church & Dwight
With:
- Grace Bandong
Business Unit Manager, Contaminants and Inorganics, Eurofins - Lyle Burgoon, PhD
President and CEO, Raptor Pharm & Tox, Ltd. - Tara Lin Couch, PhD
Owner, TLC Regulatory and Laboratory Consulting - Binu Koshy, PhD
Scientific Liaison, USP - Tony Pavel
Partner, Keller and Heckman LLP - John Travis
Principal Technical Manager, NSF Nutrition & Wellness Programs
Agenda:
12:00 – 12:10 pm | Welcome and Introductions
Annahita Ghassemi, PhD, DABT, Church & Dwight
12:10 – 12:55 pm | Considerations for developing contaminant specifications and limits
Tara Lin Couch, PhD, TLC Regulatory and Laboratory Consulting
12:55 – 1:55 pm | Panel: testing requirements and methods
1:55 – 2:15 pm | Break
2:15 – 3:00 pm | Regulatory landscape, state initiatives, and legal considerations
Tony Pavel, Keller and Heckman
3:00 – 3:45 pm | Assessing hazard versus risk and communicating the science
Lyle Burgoon, PhD, Raptor Pharm & Tox, Ltd
3:45 – 4:00 pm | Closing remarks
Alex Eapen, PhD, DABT, Cargill
Please note, the agenda is subject to change.
Speakers:
Grace Bandong
Business Unit Manager, Contaminants and Inorganics, Eurofins
Grace Bandong is the Business Unit Manager for Contaminants for Eurofins Food Chemistry Testing (EFCT). Grace has spent over 30 years in the food and supplement industry specializing in contaminants analysis including elemental analysis, pesticide residue analysis and risk assessments. Over the years, Grace has developed contaminant-testing programs that support supplier verification for food manufacturers and recently, the hemp industry. Grace developed a process for a hazards based chemical risk assessment of ingredients that is used as a guide by companies to respond to global regulatory requirements. She is an expert chemical risk assessment for dietary supplements and food.
Grace’s role at EFCT is to oversee a team of scientists in routine analytical testing and method development. Over the last few years, her team has developed methods for emerging contaminants of concern to the infant formula, dietary supplements and botanicals markets including ethylene oxide, PFAS and adulterants in weight loss, sports nutrition and male enhancement supplements.
Grace earned her degree in Chemistry from the University of the Philippines and her MSc in Chemistry from the University of Houston.
Lyle Burgoon, PhD
President and CEO, Raptor Pharm & Tox, Ltd.
Dr. Burgoon is an award-winning and Board Certified (Fellow, Academy of Toxicological Sciences) toxicologist, biostatistician, and public speaker. Throughout his career, Dr. Burgoon has focused on using science to inform decision-making and strategy development on hard problems, including nuclear weapon impacts human, environmental and agricultural systems, forecasting possible futures where state and non-state actors develop chemical and biological weapons, and how to counter those developments. Today, Dr. Burgoon communicates science, and provides advice on critical thinking everywhere from the battlefield, the boardroom, and the courtroom. Dr. Burgoon is the President and CEO of Raptor Pharm & Tox, Ltd. In addition to his public communication and speaking work, Dr. Burgoon also leads SciDiligence, their service that helps biopharmaceutical startups signal the quality and integrity of the science underlying their products, and helping investors perform better due diligence prior to investing.
Tara Lin Couch, PhD
Owner, TLC Regulatory and Laboratory Consulting
Tara Lin Couch, Ph.D., is an Analytical/Organic Chemist who also possesses a B.S. in Mathematics. Dr. Couch has exceptional analytical abilities and more than 35 years of diverse laboratory and regulatory experience in academic, field, contract and manufacturing environments. She is a sought-after expert on issues pertaining to quality control in pharmaceutical, dietary supplement, tobacco manufacturing, and the cannabis industries. As a consultant, Dr. Couch assists with the development, improvement and implementation of quality systems that are scientifically sound, efficient, practical and compliant with FDA regulations. To evaluate this regulatory compliance, she performs mock FDA inspections, gap analyses, and contractor and laboratory audits to Current Good Manufacturing Practices (cGMPs) and other applicable statutory requirements. She also helps clients with the conduct of FDA regulatory surveillance, follow-up, and pre-approval inspections including preparation efforts, direct support, and responding to FDA related communications such as the initial Form 4003 – Inspection Records Requests, Form 483 - List of Observations, Warning Letters, Consent Decrees, Deficiency Letters, and other information requests. In addition, Dr. Couch provides cGMP and laboratory trainings via seminar, webinar and on-site presentations. Dr. Couch earns the respect of colleagues and loyalty of clients with her unwavering commitment to quality, exceptional work ethic, and use of her vast experience to thoughtfully create a pragmatic, customized compliance strategy for each client.
Binu Koshy, PhD
Scientific Liaison, USP
Dr. Binu Koshy is currently the Team lead and Senior Scientist in the Department of Dietary Supplements and Herbal Medicines at United States Pharmacopeia (USP). He joined USP in 2019 and is involved in providing leadership to and scientific supervision of scientists developing dietary ingredient and dietary supplement standards and related activities, including admission (safety) evaluations. He is also involved in developing documentary and reference standards for non-botanical dietary supplements, especially probiotics and proteins.
Before joining USP, Koshy worked at a contract dietary supplement manufacturing facility under various capacities. He was responsible for setting up a microbiology lab and standardized microbiology QC procedures based on FDA-BAM and USP for testing dietary ingredients and supplements. As a Director, Quality Control, he was responsible for managing the Quality unit. He has vast experience in product formulation, method development, and testing dietary supplement products.
Dr. Koshy received his Ph.D. in Biological Sciences from Indian Institute of Science (IISc), Bangalore, India, and completed his postdoctoral research where he studied differential gene expression patten in Candida albicans using Microarray. He has presented at a number of scientific conferences and published peer-reviewed articles.
Tony Pavel
Partner, Keller and Heckman LLP
Anthony (Tony) Pavel is a partner at Keller and Heckman LLP, in Washington, DC. Tony guides clients through a comprehensive array of food and drug regulatory matters with his extensive knowledge of U.S. Food and Drug Administration (FDA) regulations related to food, food additives and ingredients, dietary supplements, and cosmetics. In addition to FDA matters, Tony assists clients with issues related to the U.S. Federal Trade Commission (FTC), the U.S. Department of Agriculture (USDA), and other regulatory bodies around the world. Prior to joining Keller and Heckman, Tony was in private practice at a major international law firm, followed by in-house positions leading a global food law team at a major food, agricultural, and industrial products producer and Deputy General Counsel, Global Food Law for a consumer biology startup. Tony’s in-house corporate experience helped shape his approach to practical, actionable advice and effective solutions for clients. Tony is frequently invited to speak at domestic and global conferences on food ingredients, food additives, and related policy matters.
John Travis
Principal Technical Manager, NSF Nutrition & Wellness Programs
John Travis is a Principal Technical Manager for the Nutrition & Wellness programs at NSF. In that role, he creates and advises on certification policy and standard setting activities for dietary supplements, functional foods and personal care products. He also provides technical guidance for certification efforts, with an emphasis on Certified for Sport®. In his previous role as a Senior Research Scientist, he had more than 25 years of experience as an analytical chemist specializing in the analysis of dietary supplements. Travis focused on analyzing dietary supplement products for various contaminants, emerging drugs and harmful compounds as well as verifying ingredient identity and label claims. He is a member of the AOAC, sitting on their Official Methods Board as well as chairing the OMB Committee on Statistics.
Moderators:
Alex Eapen, PhD, DABT
Senior Director, R&D Scientific & Regulatory Affairs - North America, Cargill
Alex is the Senior Director of the Scientific & Regulatory Affairs Team – North America at Cargill. He has over 25 years of experience as a toxicologist and risk assessor for FDA-regulated products. Additionally, Alex is an adjunct faculty at the University of Minnesota College of Continuing and Professional studies. He serves on numerous academic advisory boards as well as several scientific and trade organizations representing the food industry. He is also a diplomate of the American Board of Toxicology.
Annahita Ghassemi, PhD, DABT
Senior Director – Global Head of Product Safety, Clinical & Scientific, Church & Dwight
Annahita Ghassemi is the Senior Director and Global Head of Toxicology, Safety, and Clinical Affairs at Church & Dwight Co., Inc. In this global role, she leads product safety and clinical claim substantiation for a wide range of products, including dietary supplements, Class I and II medical devices, cosmetics, OTC drugs, laundry products, household cleaners, and pet care products worldside. Annahita collaborates with researchers in various fields such as dentistry, dermatology, allergy, nutrition, and both women's and men's health. She has published numerous peer-reviewed research articles and has actively contributed to several trade association committees.
Annahita holds an MS in Physiology and a PhD in Toxicology from the University of Connecticut. She is also a board-certified toxicologist. Her career began at Procter & Gamble, where she managed the global safety of laundry, household, and cosmetic products for nine years.