SOT FDA Colloquia

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SOT FDA Colloquia on Emerging Toxicological Science: Challenges in Food and Ingredient Safety

The Evolving Research Landscape of Low- and No-Calorie Sweeteners

December 7, 2023 • Webcast • 9:00 AM–1:00 PM Eastern US, UTC-5

Co-Chairs: Anne Macgregor-Das, PhD, US FDA CFSAN, and Daniele Wikoff, PhD, ToxStrategies LLC

The Society of Toxicology (SOT) in conjunction with the US FDA Center for Food Safety and Applied Nutrition (CFSAN) have partnered to provide this colloquia series. The colloquia present scientific information that is high-quality, cutting-edge, future-oriented toxicological science to provide a well-grounded foundation to inform the work of US FDA employees. These webcasts are open to the public at no charge. These sessions are not a public forum for discussion of toxicology regulatory issues.

Webcast Registration

FDA employees are encouraged to use their FDA email address when they register and when they log into the colloquium.

Many different types of sweeteners
Many different types of sweeteners

Many different types of sweeteners used in the US are utilized broadly across food products. By law, these must be safe for consumption. Companies are responsible for ensuring the safety of ingredients and rely on standard approaches to substantiate safety. This involves utilization of standard toxicological experimental studies investigating the potential for adverse effects following acute and repeated-dose exposure, and to assess potential risk associated with use of the sweetener as intended by the ingredient use. More recently, the scientific community has begun to explore additional health outcomes and to assess novel aspects of exposure/outcome relationships via observational studies in human populations.

This colloquium will survey modern aspects of low- and no-calorie sweetener research, including the emerging literature pertaining to sweeteners and their effects on the microbiome, and the potential impact of these changes on human health; and consideration of data types other than traditional toxicology testing in animals, including epidemiological and mechanistic data. The recent re-evaluation of aspartame will serve as a case study for how these emerging studies are being considered by risk assessors. Finally, the colloquium will conclude with a panel discussion on the key issues and knowledge gaps identified by the speakers and questions from participants.

9:00 AM–9:10 AM

Welcome from US FDA
Kristi Muldoon Jacobs, PhD, Acting Director, US FDA CFSAN Office of Food Additive Safety, Rockville, MD

9:10 AM–9:50 AM

An Introduction to Low- and No-Calorie Sweetener Uses in Foods and Beverages in the US
Corey Scott, PhD, Cargill, Minneapolis, MN

9:50 am–10:30am

Low- and No-Calorie Sweeteners and Metabolic Health: A Review of the Evidence from Acute Metabolic and Endocrine Responses to Long Term Clinical Outcomes
John Sievenpiper, MD, PhD, FRCPC, University of Toronto and St. Michael’s Hospital, Toronto, Ontario, Canada

10:30 AM–10:40 AM


10:40 AM–11:20 AM

Mechanistic and Epidemiological Studies and Their Role in the Safety Assessment of Low- and No-Calorie Sweeteners
Daniele Wikoff, PhD, ToxStrategies LLC, Asheville, NC

11:20 AM–12:00 PM

Aspartame as a Case Study in Re-evaluation of Sweetener Safety by the Joint FAO/WHO Expert Committee on Food Additives
Diane Benford, PhD, Chair 96th Joint FAO/WHO Expert Committee on Food Additives, Leighton Buzzard, United Kingdom

12:00 PM–1:00 PM

Roundtable Discussion
Moderator: Anne Macgregor-Das, PhD, US FDA CFSAN
All speakers

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For registration questions contact Jim Dailey.

Anne Macgregor-Das, PhD, Co-chair

Anne Macgregor-Das, PhD, Co-chair

Dr. Anne Macgregor-Das joined the FDA in 2020 as a Biologist in the Division of Food Ingredients in the Office of Food Additive Safety. In this role, she serves as a reviewer for “Generally Recognized as Safe” (GRAS) notices as well as food and color additive petitions. She currently serves as an FDA liaison to the Institute for the Advancement of Food and Nutrition Sciences (IAFNS) on their Low- and No-Calorie Sweeteners Committee.

Dr. Macgregor-Das received a PhD in Pathobiology from the Johns Hopkins School of Medicine. She also completed a postdoctoral fellowship at Johns Hopkins researching genetic variants that contribute to the inherited susceptibility of pancreatic cancer as well as biomarker discovery for the development of early detection cancer screening tests.

Daniele Wikoff, PhD, Co-chair

Daniele Wikoff, PhD, Co-chair

Dr. Daniele Wikoff is the Health Sciences Practice Director for ToxStrategies LLC, based in Asheville, North Carolina. She specializes in the implementation of evidence-based methods in support of hazard and risk assessment applications for food ingredients and contaminants, industrial chemicals, and consumer products. She has experience evaluating toxicological and risk issues related to a wide range of agents, including low-calorie sweeteners, evidence streams (human, experimental animal, mechanistic), data types (e.g., epidemiological data and high-throughput data), and outcomes such as endocrine disruption and carcinogenicity.

Dr. Wikoff has served on the executive committees of the SOT Risk Assessment Specialty section and Food Safety Specialty section, and currently is a member of the Scientific Program Committee. She is also involved in a number of global collaborations to advance the practice of evidence-based toxicology, highlighted by her membership on the Board of Trustees and role as the Vice-Chair of the Science Advisory Council for the Evidence-Based Toxicology Collaboration, membership on a National Academy of Sciences committee, and service as an Associate Editor for Toxicological Sciences and Regulatory Toxicology and Pharmacology.

Diane Benford, PhD

Diane Benford, PhD

Dr. Diane Benford is a toxicologist with particular expertise in risk assessment. Until 2017, she was head of the Risk Assessment Unit at the United Kingdom Food Standards Agency. Her role also included acting as scientific secretary to the Committee on Toxicity of Chemicals in Food, Consumer Products, and the Environment and part of the joint secretariat to its sister committees on Mutagenicity and Carcinogenicity. In a personal capacity Diane was a member of the Scientific Panel on Contaminants in the Food Chain of the European Food Safety Authority (EFSA) from 2005 to 2015, acting as chair of the panel for the final 3-year term of office. She is now a member and vice-chair of the EFSA Scientific Committee. She has participated in meetings of Joint FAO/WHO Expert Committee on Food Additives (JECFA) since 2001, firstly as a WHO Temporary Advisor and since 2013 as a member, including acting as chair or vice-chair on several occasions. She chaired the 2023 re-evaluation of aspartame.

Corey Scott, PhD

Corey Scott, PhD

Dr. Corey Scott is a Principal Nutrition Scientist with Cargill in Minneapolis, Minnesota, where he leads global nutritional research on sweeteners and carbohydrates. Prior to this role, he was Global Nutrition Manager for Lipid Nutrition BV in The Netherlands, focusing on clinical research involving novel lipids for early life nutrition, weight management, and diabetes. Dr. Scott has also worked for General Mills in Golden Valley, Minnesota, as a nutrition scientist at The Bell Institute of Health and Nutrition. He currently serves as a steering team member and work package leader for Project SWEET (a five-year EU Consortium project evaluating sweeteners). He is the chair of the Institute for the Advancement of Food and Nutrition Sciences low- and non-caloric sweetener committee, chair of The North Carolina Agricultural and Life Sciences at North Carolina State University Technical Advisory and Finance committee, and an industry advisor for the University and Industry Consortium/Foundation for Food and Agriculture Research Sally Rockey Fellowship. Dr. Scott holds a doctorate degree in food science and nutrition from The Ohio State University, a master’s degree in chemistry from North Carolina A&T State University, and a bachelor’s degree in chemistry from The University of North Carolina at Chapel Hill.

John Sievenpiper, MD, PhD, FRCPC

John Sievenpiper, MD, PhD, FRCPC

Dr. Sievenpiper is a clinician scientist who holds appointments as a professor in the Departments of Nutritional Sciences and Medicine and the Lifestyle Medicine Lead in the MD Program at the University of Toronto. He is also a staff physician in the Division of Endocrinology and Metabolism, lead of the Toronto 3D Knowledge Synthesis and Clinical Trials Unit, and scientist in the La Ka Shing Knowledge Institute at St. Michael’s Hospital. Dr. Sievenpiper completed his MSc, PhD, and postdoctoral fellowship training in the Department of Nutritional Sciences at the University of Toronto. He completed his MD at St. Matthew’s University, followed by residency training in medical biochemistry at McMaster University, leading to his certification as a Fellow of the Royal College of Physicians of Canada (FRCPC).

He has established an internationally recognized research program focused on using randomized controlled trials and epidemiological approaches to address questions of clinical and public health importance in relation to diet and cardiometabolic disease prevention. A particular interest is in the role of sugars, carbohydrate quality, and plant-based dietary patterns. He is directly involved in knowledge translation with appointments to the nutrition guidelines committees of Diabetes Canada, European Association for the Study of Diabetes, Canadian Cardiovascular Society, and Obesity Canada. Dr. Sievenpiper is the recipient of numerous awards including an Insulin 100 Emerging Leader Award, Khursheed Jeejeebhoy Award, Canadian Nutrition Society (CNS) Young Investigator Award, PSI Foundation Graham Farquharson Knowledge Translation Fellowship, Diabetes Canada Clinician Scientist Award, Banting and Best Diabetes Centre Sun Life Financial New Investigator Award, and Canadian Institutes of Health Research–Institute of Nutrition, Metabolism, and Diabetes/CNS–New Investigator Partnership Prize. He has authored more than 250 scientific papers and 17 book chapters.

  • David C. Dorman, DVM, PhD, DABT, DABVT, ATS, Colloquium Series Chair, North Carolina State University, Raleigh, NC
  • Jason R. Richardson, PhD, DABT, ATS, Colloquium Series Co-chair, Florida International University, Miami Beach, FL
  • Jason L. Aungst, PhD, FDA Liaison, US FDA, College Park, MD
  • Omari Bandele, PhD, FDA Liaison, US FDA, Rockville, MD
  • Suzanne C. Fitzpatrick, PhD, DABT, US FDA, College Park, MD
  • Esther M. Haugabrooks, PhD, The Coca-Cola Company, Atlanta, GA
  • Rayetta Henderson, PhD, ToxStrategies Inc., Katy, TX
  • Willie McKinney, PhD, DABT, McKinney Regulatory Science Advisors, LLC, Henrico, VA
  • Jeffrey J. Yourick, PhD, DABT, ATS, US FDA, Laurel, MD
  • Chidozie Amuzie, Johnson and Johnson, Toronto, Canada, Council Contact
  • Betty Eidemiller, PhD, SOT Staff Liaison, Reston, VA