Document Type
Oral Presentation
Location
Oxford Conference Center
Event Website
https://oxfordicsb.org/
Start Date
23-4-2026 10:30 AM
End Date
23-4-2026 12:00 PM
Description
Peer-reviewed literature provides limited toxicological data on the consumption of naturally derived kratom extracts. Given the increasing use of kratom products, understanding their safety profile is critical for public health and regulatory decision-making. To address this gap, we conducted a rodent toxicology assessment and a controlled human clinical study. Human Clinical Study: Healthy male and female participants consumed specified kratom extracts daily for 14 consecutive days under controlled conditions. Clinical observations and biochemical markers were monitored throughout the study. Rodent Toxicology Study: Equivalent extract doses were administered to rodents for 90 days to evaluate subchronic exposure. Assessments included body weight, organ weights, hematology, clinical chemistry, and histopathology. These findings provide critical insights into the safety profile of kratom extracts and inform future regulatory submissions.
Recommended Citation
Swift, Sibyl, "Naturally Derived Kratom Extracts: Toxicological Evaluation in Humans and Rodents" (2026). Oxford ICSB. 38.
https://egrove.olemiss.edu/icsb/2026_ICSB/Schedule/38
Publication Date
April 2026
Accessibility Status
Searchable text
Included in
Naturally Derived Kratom Extracts: Toxicological Evaluation in Humans and Rodents
Oxford Conference Center
Peer-reviewed literature provides limited toxicological data on the consumption of naturally derived kratom extracts. Given the increasing use of kratom products, understanding their safety profile is critical for public health and regulatory decision-making. To address this gap, we conducted a rodent toxicology assessment and a controlled human clinical study. Human Clinical Study: Healthy male and female participants consumed specified kratom extracts daily for 14 consecutive days under controlled conditions. Clinical observations and biochemical markers were monitored throughout the study. Rodent Toxicology Study: Equivalent extract doses were administered to rodents for 90 days to evaluate subchronic exposure. Assessments included body weight, organ weights, hematology, clinical chemistry, and histopathology. These findings provide critical insights into the safety profile of kratom extracts and inform future regulatory submissions.
https://egrove.olemiss.edu/icsb/2026_ICSB/Schedule/38
Comments
Sibyl Swift, Ph.D., is the Principal and Owner at Swift Strategy Group, a scientific and regulatory consulting firm. She is also a Scientific & Regulatory Advisor for Johnson Foods. Dr. Swift serves on the Board of Directors and is CSO & VP Regulatory for cbdMD. As CSO for cbdMD, she directs the company’s partnerships, clinical trials, advises on regulatory matters, guides new product development and R&D, and provides guidance on good manufacturing practices. Prior to joining cbdMD, Dr. Swift was the Senior Vice President for Scientific & Regulatory Affairs at the Natural Products Association (NPA). In that role, Dr. Swift was responsible for the development and implementation of the association’s education, regulatory, and compliance and quality programs, such as the Supplement Safety and Compliance Initiative (SSCI) a cGMP program, the NPA Natural Standard, and others. She represented the association on Codex Alimentarius (an international standards organization) and provided guidance on claims reviews, substantiation, and regulatory policy. Before joining NPA, Dr. Swift was the Associate Director for Research and Strategy within the U.S. Food and Drug Administration’s (FDA) Office of Dietary Supplement Programs. As Associate Director, Dr. Swift directed the office’s research portfolio and was responsible for ensuring alignment between its science, research, compliance, enforcement, and policy initiatives. In this role, she worked on new dietary ingredient notifications, structure function claim notifications, cGMP reviews, adverse event reviews, certificates of free sale, guidance documents and other areas critical to office functions. Dr. Swift was also the co-chair of the Botanical Safety Consortium, a collaboration between scientists from government agencies, academia and industry. She also serves on the Benchmarking Committee for the Supplement Safety and Compliance Initiative (SSCI) and as co-chair for NPA’s ComPLI committee. Dr. Swift earned her Ph.D. in nutrition and M.S. in exercise physiology at Texas A&M University.