Founded the same year Congress enacted the Dietary Supplement Health and Education Act (DSHEA) of 1994, NCNPR works to develop and improve quality control measures for dietary supplements, particularly botanical products.
NCNPR scientists led by Bill Gurley, PhD, recently revisited the center’s origins and accomplishments in a paper published in the Journal of Dietary Supplements. They acknowledged that while DSHEA was an independent development, it set the stage for the NCNPR to contribute significantly to botanical dietary supplement research and profoundly impact the evolution of the dietary supplement landscape.
“For nearly three decades, the NCNPR has worked, often in collaboration with the U.S. Food and Drug Administration (FDA) Center for Food Safety and Applied Nutrition (FDA/CFSAN) to monitor the quality and safety of the nation’s ever-expanding dietary supplement marketplace,” Gurley et al. wrote. “Despite its significant scientific, regulatory and public health contributions, NCNPR’s extensive capabilities and accomplishments remain largely under-recognized outside of specialized government and scientific circles.”
Reconnecting pharmacy to its roots
The paper notes that few people realize that botanicals were a mainstay of American medicine and pharmacy until shortly after WWII. At that time, the pharmaceutical industry shifted preference from multi-ingredient plant-based medicines to highly purified, single-entity, synthetic compounds.
A decline in higher pharmacognosy education (i.e., the study of plant medicines) followed, and by the time DSHEA folded botanicals into the definition of dietary supplements, there was a decades-old debility in expertise regarding the safety, quality and efficacy of botanical dietary supplements.
“Although this knowledge gap still persists, the NCNPR remains committed to conducting essential research on [botanical dietary supplements] in collaboration with both the FDA and the dietary supplement industry, aiming to close this educational void,” Gurley et al. wrote.
“In many regards, when it comes to botanically derived medicines and dietary supplements, the NCNPR has reconnected the discipline of pharmacy with its roots, not just at U.M. but across the nation.”
Housed within the Thad Cochran Research Center, the NCNPR grew out of the university’s commitment to botanical research, which dates to the establishment of the Research Institute of Pharmaceutical Sciences (RIPS) and Department of Pharmacognosy on campus in 1965.
NCNPR scientists are also researching natural products for the mitigation of infectious diseases, applications for immune and metabolic disorders, and the development of herbicides and insecticides for integrated pest management.
The center’s Maynard W. Quimby Medicinal Plant Garden cultivates over 1,500 medicinal plants on five acres of gardens and greenhouses, and it maintains a botanical repository of over 18,000 authenticated plant specimens and extracts linked to a database of over 30,000 phytochemicals and AI research capabilities. The garden is also known for growing high-quality cannabis varieties, which supply investigations into the plant’s pharmacological and therapeutic properties.
In 2020, NCNPR incorporated the U.M. Botanical Dietary Supplements Research Center as part of the National Institutes of Health (NIH) Consortium for Advancing Research on Botanicals and other Natural Products (CARBON) Program. This center-within-a-center has researched spirulina and its immune-enhancing properties, leading to the patenting of Immulina—an extract that “utilizes resident macrophage-activating lipoproteins to enhance resilience against viral infections like influenza, providing a complementary approach to current antiviral therapies.”
An FDA Center of Excellence
Recognized as a Center of Excellence by FDA since 2006, NCNPR has received government funding since 2001 to develop analytical methods for botanical formulations.
“The FDA’s longstanding research support has been pivotal in building unique resources—spanning expertise, instrumentation and global collaborations—specifically designed to address the challenges of authenticity, quality and safety in globally sourced botanical ingredients, thereby protecting consumer health,” Dr. Ikhlas Khan, director of the NCNPR, told NutraIngredients.
“This investment, coupled with our designation as an FDA Center of Excellence on botanical ingredients, has solidified our position as global leaders and allows us to effectively and positively contribute to national programs like CHAMP, DILIN, UM’s NIH CARBON Program and crucial training initiatives.”
The center has hosted an FDA training course for field inspectors, training over 700 participants since 2008, and actively promotes the work of the Botanical Safety Consortium (BSC) to evaluate the suitability of assays for botanicals as complex mixtures.
Commenting on the long-standing collaboration, an FDA spokesperson told NutraIngredients that NCNPR’s core expertise in the analysis of botanicals has been beneficial across multiple FDA-regulated product categories—including dietary supplements, cosmetic and conventional foods—and utilized by the scientific community at large.
“This expertise has been applied to FDA-specific research needs, such as developing in-chemico methods for identification and classification of potential skin sensitizers found in cosmetics and personal care products,” the spokesperson said. “Additionally, NCNPR has been a tremendous resource for supplying authenticated and verified botanical samples to assist with the FDA’s regulatory research.”
The most recent example of this was the provision of authenticated yellow oleander seeds and authenticated Mexican Hawthorne (tejocote root), which enabled the agency to develop and validate methods to identify unsafe supplements and issue warnings to the public.
Moving forward, Dr. Khan added that industry must establish rigorous quality and safety protocols for new or novel ingredients—critical for effective regulatory collaboration and a prerequisite for successful commercialization.
ICSB 2025
From April 7 to 10, NCNPR will host its 23rd Annual International Conference on the Science of Botanicals (ICSB) in conjunction with the 24th International Congress of the International Society of Ethnopharmacology (ISE). As the center’s main educational event, the conference brings together researchers, product developers, testing labs and regulators to address the most pressing global challenges in botanical research and safety.
“We will delve into cutting-edge applications of artificial intelligence for developing safer, more effective supplements and address the urgent, internationally debated case of Ashwagandha’s quality and safety, including its recent bans across numerous European nations,” Dr. Khan previewed.
Confirmed speakers this year include representatives from the World Health Organization, National Institutes of Health, Food and Drug Administration, Consortium for Health and Military Performance (CHAMP), United States Pharmacopeia, Eurofins, United Natural Products Alliance and universities from around the world.
