The University of Mississippi (Ole Miss) is the home to the National Center for Natural Products Research (NCNPR), a division of the School of Pharmacy that is funded and recognized as a Center of Excellence by the Food and Drug Administration (FDA). As part of their partnership with FDA, the NCNPR hosts the annual International Conference on the Science of Botanicals (ICSB), which draws government officials, academia, industry, trade associations, scientists, physicians, pharmacists, students, and other stakeholders from around the globe together to collaborate and share research efforts, all in an effort to improve the quality, integrity, and safety of botanicals used in consumer goods to protect public health and safety. Steven Tave (director of the Office of Dietary Supplement (ODS) Programs – Center for Food Safety and Nutrition, FDA) was the special guest and he discussed the three priorities for the ODS: 1) safety; 2) product integrity; and 3) informed decision making. The third priority “informed decision making” grabbed my attention and over the course of the week’s presentations, it was easy to identify situations in which the responsible stakeholders (commonly referred to as the “good players”) in attendance have also made it a priority to afford consumers the opportunity to make informed decisions, based on competent and reliable scientific evidence or “good science” (in the words of Tave). Through risk communication, education and collaborative efforts, responsible stakeholders assist FDA in promoting and encouraging “informed decision making.”
Green tea extract was a popular topic at the conference, with presenters discussing analytical methodologies used for chemical characterization, toxicological studies in laboratory animals, and safety assessments. Dr. Igor Koturbash (University of Arkansas) shared the university’s efforts to research and better understand the potential for hepatotoxic effects from green tea extract consumption in mouse models and educate the audience on the many variables that may impact the potential toxicity of green tea extract, such as dose, formulation, and fasted versus satiated state for animals and humans.
Dr. Hellen Oketch-Rabah (U.S. Pharmacopeia Convention) provided an update on the work that the Green Tea Extract and Hepatotoxicity (GTEH) Expert Panel is doing to better understand the potential hepatotoxicity associated with oral consumption of concentrated green tea extract. There were two great examples of promotion of “informed decision making” highlighted in the presentation. First, Dr. Oketch-Rabah took the time to explain the presentation was focused on the potential toxicity of concentrated green tea extract and not green tea. This distinction is critically important to understand as the potential adverse effects of the two products can be vastly different as a result of differences in the concentrations of chemical constituents. Dr. Oketch-Rabah also discussed how the GTEH Expert Panel has put considerable thought into how to best communicate the potential risks associated with consumption of concentrated green tea extract. The GTEH Expert Panel has decided that a cautionary label statement requirement would be added to the green tea extract monograph in order to provide consumers with information that allows for the safe use of concentrated green tea extract.
Dr. Patricia Deuster (Consortium for Health and Military Performance) caught the audience’s attention as she highlighted the U.S. Department of Defense’s efforts to ensure military personnel are only consuming safe, legal dietary supplements. Unfortunately, although there are an abundance of “good players” working daily to improve public health and safety by promoting transparency and advancing research to generate “good science” to be shared with consumers, there are also the “bad players” who sell adulterated dietary supplements or with false and misleading claims. Some military personnel are currently purchasing and consuming adulterated dietary supplements sold online and in brick-and-mortar storefronts. The products may contain stimulants and adulterants such as, but not limited to, synephrine, yohimbine, selective androgen receptor modulators (SARMs), selective estrogen receptor modulators (SERMs), prohormones, steroids, or pharmaceuticals, some of which result in military personnel experiencing adverse health effects and/or failing drug screening tests. Dr. Deuster explained how military personal oftentimes are in positions that are physically demanding, leading them to seek out products with claims that guarantee results, without being informed on the potential risks associated with low-quality, adulterated “dietary supplements” that are on the market. To address the issue and provide military personnel with resources to make informed decisions when selecting dietary supplements, the U.S. Department of Defense has initiatives such as Operation Supplement Safety, which provides military personal with information related to the safety of dietary supplements, including “Ask the Expert.” The “Ask the Expert” service allows military personnel to submit questions or concerns related to dietary supplements to be answered by experts, ensuring the military personnel are receiving reliable information related to dietary supplements.
The reality may be that there will always be “bad players” that will continue to market adulterated products with or without false and misleading claims. However, there surely are “good players” committed to providing consumers with information, based on competent and reliable scientific evidence, through risk communication, education, and collaborative efforts to promote “informed decision making” when purchasing and consuming dietary supplements.Tags: Botanicals, dietary supplements, FDA, food safety