Dr. Endres is currently the Co-Founder and Co-CEO for GRASroots Consulting™, LLC, where he coordinates scientific and regulatory consulting projects with respect to FDA and FTC regulatory requirements for food ingredients. These include independent GRAS conclusions, FDA GRAS notifications, FDA New Dietary Ingredient notifications, FDA Food and Color Additive Petitions, as well as myriad other technical projects. He was the chief scientific officer and toxicologist for AIBMR Life Sciences, Inc. in Seattle, Washington 2006–2025. At AIBMR he managed a team of scientific and regulatory consultants specializing in the natural products and functional foods industries with a focus on preparing GRAS Independent Conclusions, helping to bring numerous innovative ingredients to markets safely.
Dr. Endres earned a degree in naturopathic medicine at Bastyr University in Kenmore, Washington in 2004 and is licensed by Washington State Department of Health as a physician. He is a full member of the Society of Toxicology (SOT). Dr. Endres has been a member of numerous expert panels since 2006 assembled for the evaluation of GRAS conclusions. He meets frequently with FDA Division of Food Ingredients, Office of Pre-Market Additive Safety, Office of Food Chemical Safety, Dietary Supplements, and Innovation, Human Foods Program—formerly Office of Food Additive Safety (OFAS) in College Park, MD for GRAS pre-submission meetings. Dr. Endres has been a contributing author on nearly 70 publications, including numerous safety assessments published in academic journals specializing in toxicology. He has been the monitoring scientist since 2006 for OECD-compliant comprehensive toxicological safety assessments designed to study the safety of chronic oral consumption of ingredients to be added to foods and dietary supplements. Dr. Endres has been on the Editorial Advisory Boards for Nutritional Outlook since 2011 and was on the Executive Advisory Board for Vitafoods Europe for several years. He was one of 33 voting members on the NSF International Joint Committee to develop Publicly Available Standards (PAS) for GRAS on behalf of the Grocery Manufacturers Association (GMA).
Prior to his current research and regulatory consulting work, Dr. Endres was involved in cancer research conducted at the Bastyr University Research Institute (BURI) and Fred Hutchinson Cancer Research Center—both located in Seattle, Washington. He screened various botanical extracts for their inhibitory effects on the growth and viability of various human cancer cell lines using indicators of apoptosis induction. He has also been the recipient of grants to present research in the United Kingdom at Westminster University, Middlesex University, and Oxford Natural Products. He also presented research at various venues, including American Medical Association sponsored conferences where, in 2001, he received an Award of Excellence in Research. Dr. Endres was a teaching assistant in laboratory chemistry and a research assistant in natural products research, with an emphasis on production, purification, and analytical chemistry of whole plant extracts while attending Bastyr University. In his early career, Dr. Endres spent a number of years as the general manager, and in charge of all operations, for several natural food stores and distributors (1983-1996). He has many personal interests, such as electronics, physics, making contacts globally using his ham radio transceivers, the art of fine cooking, and studying German and Hungarian languages.
John Endres, ND
Dr. Clewell is a co-founder of GRASroots Consulting™ and a recognized expert in U.S. food and dietary supplement regulatory science. Prior to founding GRASroots Consulting™, she served as Senior Vice President of Scientific and Regulatory Affairs at AIBMR Life Sciences, where she led scientific strategy and regulatory submissions for a broad portfolio of ingredients.
Dr. Clewell earned her Bachelor of Science in Biology from Indiana University Bloomington and her doctoral degree in Naturopathic Medicine from Bastyr University. She maintains an active physician license in the State of Washington and has been a Diplomate of the American Board of Toxicology since 2016. She is a full member of both the Society of Toxicology (SOT) and the American College of Toxicology (ACT), and has served on numerous independent expert panels supporting GRAS conclusions.
With more than 19 years of experience in natural products regulatory consulting, Dr. Clewell specializes in the preparation of GRAS independent conclusion dossiers, FDA GRAS Notifications, and New Dietary Ingredient (NDI) notifications. She is the author of numerous peer-reviewed scientific publications, book chapters, and trade articles, with a primary focus on the toxicological evaluation and safety assessment of food ingredients. Her work also includes critical evaluation of scientific literature supporting ingredient efficacy and regulatory compliance, as well as hands-on leadership of complex, multidisciplinary projects.
Dr. Clewell brings a unique blend of clinical, research, and regulatory expertise. Her research background includes early work in translational initiation using Saccharomyces cerevisiae as a model system at Indiana University, followed by five years as a research technician and laboratory manager in Dr. Karla Kirkegaard’s laboratory at the University of Colorado Boulder and Stanford University, where she studied the biochemistry of poliovirus and hepatitis C virus replication. She remained actively engaged in research throughout her doctoral training.
Dr. Clewell is the past president of the Indiana Association of Naturopathic Physicians and is a current member of the Colorado Association of Naturopathic Doctors.
Outside of her professional work, Dr. Clewell enjoys spending time outdoors hiking and skiing, reading both fiction and non-fiction, making music on guitar and voice, practicing French, and especially spending time with her family and close friends.
Amy Clewell, ND, DABT
Dr. Modica specializes in toxicological safety assessment and U.S. FDA regulatory pathways for food and dietary ingredients. She has extensive experience authoring and reviewing independent conclusions of GRAS, FDA GRAS notifications, and FDA New Dietary Ingredient (NDI) notifications, serves on independent GRAS expert panels, and conducts comprehensive toxicology and clinical literature reviews, feasibility assessments, and weight-of-evidence safety evaluations. A Diplomate of the American Board of Toxicology and full member of the Society of Toxicology, she has contributed to multiple peer-reviewed toxicological safety publications, including evaluations of novel food ingredients.
She works closely with ingredient manufacturers, brand owners, and regulatory teams to develop scientifically robust, defensible dossiers aligned with FDA regulatory expectations. Known for her ability to translate complex toxicological and regulatory science into clear, decision-ready documentation, Dr. Modica supports clients through early feasibility assessment, regulatory strategy development, and submission-ready safety dossiers.
Dr. Modica earned a Bachelor of Science with high honors in Cellular and Molecular Biology from the University of Michigan, where her honors distinction was based on her published basic science research in developmental neurobiology. She later earned her Doctor of Naturopathic Medicine degree from Bastyr University. Earlier in her career, she worked in management consulting and medical device industries as a business analyst and trainer, experience that informs her focused approach to scientific and regulatory consulting. She maintains an active naturopathic medical license in the state of Washington and continues limited practice
Vickie Modica, ND, DABT
Bean Choi, ND, LAc
Dr. Choi is a regulatory professional with experience supporting safety assessments, regulatory submissions, and compliance activities across the food, dietary supplement, and ingredient sectors. She holds a Bachelor’s degree in Physiology from the University of Washington, where she developed a strong foundation in biological and chemical sciences, followed by a Masters in Acupuncture and Oriental Medicine and a Doctorate in Naturopathic Medicine, with advanced training in toxicology, pharmacology, and risk assessment.
Throughout her career, she has maintained a strong interest in pharmacognosy and plant constituents, with particular focus on the safety and regulatory evaluation of botanicals. She has extensive experience preparing peer-reviewed scientific manuscripts, technical reports, and regulatory documents, translating complex data into clear, well-supported narratives for both regulatory and scientific audiences. In addition to her regulatory expertise, she has gained hands-on experience in the production and manufacturing of herbal supplements, providing practical insight into ingredient sourcing, quality considerations, and formulation processes.