Digital Commons Network^™

Current Regulatory And Enforcement Landscape Under Mocra, Diane Mcenroe

Oxford ICSB

The Modernization of Cosmetics Regulation Act of 2022 (MoCRA) became effective December 29th, 2023 and is the most significant expansion of FDA’s authority to regulate cosmetics since the FD&C Act was enacted in 1938. MoCRA expands the FDA's authority over cosmetics and creates new compliance obligations for manufacturers. Diane McEnroe, an FDA regulatory lawyer at Sidley Austin, LLP, will provide an overview of the law and its implication for cosmetic manufacturers and marketers. The presentation will also provide an update on the current regulatory and enforcement landscape to date, including considerations about follow on litigation when there has been publicity …

Cosmetic Adverse Events And The Product Safety Landscape, Rick Kingston

Oxford ICSB

The Modernization of Cosmetics Regulation Act of 2022 (MoCRA) became effective December 29th, 2023 and is the most significant expansion of FDA’s authority to regulate cosmetics since the FD&C Act was enacted in 1938. MoCRA expands the FDA's rulemaking and enforcement authority over cosmetics and creates new compliance obligations for manufacturers. There are six key areas of the legislation including Facility Registration, Product & Ingredient Listing, Safety Substantiation, Cosmetics Labeling, and Adverse Event Reporting and Record Keeping. Each of these areas has significant implications for manufacturers and cosmetic ingredients. Given the ubiquitous presence of botanical and other naturally occurring substances …

Herbal Medicine For The Management Of Asthma In Taiwan: Insights From Big Data, Laboratory Studies, And Clinical Research, Hung-Rong Yen, Chuan-Teng Liu, Ying-Chyi Song

Oxford ICSB

Introduction: Asthma affects individuals across all age groups and poses a significant public health challenge in Taiwan, with high morbidity rates and substantial healthcare burdens. Traditional medicine theory emphasizes restoring the yin-yang balance, achieved through methods such as herbal medicine. Real-world data from Taiwan highlight the growing reliance on complementary therapies due to recurrent exacerbations and the potential side effects of conventional asthma medications. Materials and Methods: First, we analyzed the National Health Insurance Research Database, encompassing a population of 23 million in Taiwan, to identify the most commonly prescribed Chinese herbal medicines. Subsequently, we conducted in vitro experiments and …

Intoxicating Cannabinoids And Impurities In Hemp-Derived Products In Us Markets, Mahmoud Elsohly

Oxford ICSB

This talk will examine the nature and source of a number of intoxicating cannabinoids and impurities, widely available in the US and marketed as “hemp-derived” and thus promoted as legal and safe products. The presentation will elaborate on the 2018 Farm Bill, the definition of Hemp and the consequences of the interpretation of the definition on the composition of products on the market. Of particular emphasis will be the prevalence of Delta-8 THC in these products and the incorporation of their intoxicating cannabinoids.

Innovation Meets Rigor: A Case Study Of Decentralized Clinical Trials In Consumer Health Research, Belinda Tan

Oxford ICSB

Direct-to-consumer decentralized clinical trials (DCTs) conducted with mobile digital technologies and at-home or local clinical testing are accelerating rigorous clinical studies by virtualizing study activities and collecting data from mobile devices and web-based systems. Through technology automations, decentralized study designs allow for high quality and compliance with objective and subjective data collection. The result is increased study efficiency, high rigor, and more diverse participation, while generating high quality data to meet regulatory standards. Using a proprietary clinical trial software application Chloe, we conducted a double-blinded, randomized, placebo-controlled trial with optional open label extension investigating the impact of 2 doses of …

Cannabidiol And Other Minor Cannabinoids: Pharmacological Targets And Interactions With Thc., Larry Walker

Oxford ICSB

This talk will examine the pharmacology of minor phytocannabinoids, including cannabidiol (CBD) and its interactions with delta-9-tetrahydrocannabinol (THC). Of particular interest is the impact – if any – of varying ratios of THC and CBD on THC responses, and potential mechanisms for the interplay. We will also consider the pharmacology and potential therapeutic impacts of other minor cannabinoids, including cannabigerol, tetrahydrocannabivarin, and cannabichromene.

Effects Of Caffeinated Green Tea Extract And Exercise In Obese Nzo/Hlltj Mice, Igor Koturbash

Oxford ICSB

Green tea extracts (GTEs) are common ingredients among dietary supplements marketed for weight loss and weight management. However, GTEs and their various catechin polyphenols have also been linked to a number of hepatotoxicity cases. The purpose of this study was to investigate, using the NZO/HlLtJ obese mouse model, the hepato- and cardiotoxic potential of a well-characterized GTE in combination with caffeine (CAF) moderate exercise (EX, 1 hour daily for the duration of 8 weeks) as well as its ability to promote weight loss. No evidence of hepato- or cardiotoxicity was noted when GTE was administered either alone or in combination …

A Randomized, Double-Blinded, Parallel, Placebo-Controlled Clinical Trial To Study The Effect And Safety Of Korean Red Ginseng Extract Powder On Cardiovascular Health Markers In Healthy Adults, Amir Rafie

Oxford ICSB

Cardiovascular disease is a prevalent condition that imposes a significant socioeconomic burden. Korean red ginseng, a medicinal plant traditionally used in Asia, has been suggested to potentially protect against cardiovascular dysfunction by improving blood flow. We conducted a randomized, double-blind, parallel, placebo-controlled trial to assess the effects of Korean Red Ginseng Extract Powder (G1899) on blood flow and platelet aggregation (primary endpoints) and other cardiovascular health markers (e.g., blood coagulation parameters) in healthy adults. Participants (N=108) were randomized in a 1:1:1 ratio to three groups: high dose (2000 mg G1899 per day), low dose (480 mg G1899 per day), and …

Functional Mushrooms Supplementation As A Prebiotic Fibre Impacting Microbiome Composition, The Gut Metabolome And Impact On The Intestinal Epithelial Barrier Integrity, Julie Daoust

Oxford ICSB

This study aimed to determine if functional mushroom preparation supplementation with Cordyceps militaris mycelium and fruiting body, Ganoderma lucidum mycelium and fruiting body, and a blend of ten species of functional mushrooms could impact gut health. The Ex Vivo model Simulator of Human Intestinal Microbial Ecosystem (SHIME®) has been used to study the behaviour of a human microbiome in response to various factors. The aim of this study was to demonstrate changes in the microbiome after supplementation with functional mushroom preparation and the resulting neuroactive metabolome using the SHIME® model. The endpoints measured were microbial fermentation activity, metabolic fingerprinting, microbial …

Caffeine-Free Plant-Based Nootropics: The Evolving Science And Regulatory Journey Of Alpinia Galanga., Deshanie Rai

Oxford ICSB

Consumer interest in using botanicals as complementary medicine to help address a variety of health benefits is rooted in the traditional use of botanicals to support for example vision performance, joint health, and mental wellbeing. With increasingly busy lifestyles, consumers are seeking ways to support their mental energy. While caffeine is a widely used nootropic, consumers are wary of consuming too much caffeine and/or it’s associated “caffeine-crash” effects, and therefore looking for plant-based nootropic alternates. Plant-derived nutraceutical research is now on the research agendas in academic and industry settings. At OmniActive Health Technologies, we are helping to address consumer health …

South African Plants With Potential Applications In Traditional Medicine For Wound Healing, Salome Mahlo

Oxford ICSB

Skin infections are primarily fungal and bacterial attacks on the skin. The aim of the study was to investigate medicinal plants used for the treatment of wound infections by the local people and traditional health practitioners. An ethnobotanical survey was conducted in the Greater Tzaneen Local Municipality, Limpopo Province to identify plant species used to treat skin infections. Guided fieldwork and a semi-structured questionnaire were used to gather information from the traditional healers. A questionnaire was designed to gather information on the common names, plant parts used, preparation, administration, and illnesses treated were recorded for each species. In the current …

Bending But Not Breaking: An Investigation Of The Relationship Between Psychological Flexibility And Suicidality In Individuals With Chronic Pain, Adalyn Mcmurray, Dr. Michael Bordieri, Phd

Scholars Week

Chronic pain is a burdensome condition that has been found to be associated with increased suicide risk, yet the mechanisms underlying this relationship remain unclear (Domenichiello & Ramsden, 2019). The present study aimed to examine the role of pain interference and psychological inflexibility in predicting past two-week suicidal thoughts among individuals with chronic pain, with psychological inflexibility explored as a potential moderator. This study also sought to replicate and extend McCracken et al. (2018) and enhance the understanding of suicidality in chronic pain populations by using the Multidimensional Psychological Flexibility Inventory (Rolffs et al., 2018b), a more psychometrically sound measure …

Publicly Available Online Data From National Adverse Event Reporting Schemes: Observations On Cases Involving ‘Ashwagandha’, Jo Barnes

Oxford ICSB

No abstract provided.

Evaluation Of Potential Hormonal Activities Of Ashwagandha (Withania Somnifera), Guenter Vollmer

Oxford ICSB

No abstract provided.

Ashwagandha: Is It Safe? A Review Of The Clinical Evidence., Thomas Brendler, Elizabeth Williamson

Oxford ICSB

Over the last decade, ashwagandha (Withania somnifera (L.) Dunal, AS) has been brought under increasing scrutiny regarding its safety for the use in food supplements, culminating in a recent recommendation for an Article 8 procedure according to Regulation (EC) No 1925/2006 in the European Union (EU). Once executed, this could lead to a ban of the use as an ingredient in food supplements. One of the regulators’ concerns is the purported lack of clinical safety data combined with evidence for what may constitute a safe daily dose. In this overwiew we assess evidence stemming from 96 clinical trials conducted over …

70 - Unmeasured Confounding In Meta-Analyses Of Observational Studies Evaluating Maternal Periodontitis And Adverse Birth Outcomes, May Salama, Abdullah Al-Taiar, Denise Claiborne, Anwar Merchant

Undergraduate Research Symposium

Background: Maternal periodontitis has been consistently linked to adverse birth outcomes (ABOs). However, a causal relationship is not established due to potential unmeasured confounding factors in observational studies and inconclusive results from randomized controlled trials. This study aimed to assess the impact of unmeasured confounding factors in meta-analyses examining associations between maternal periodontitis and preterm birth (PTB) or low birth weight (LBW).

Methods: PubMed and MEDLINE, Cochrane, Embase, and Google Scholar were searched for systematic reviews with meta-analyses of observational studies between 2002 and 2023. Systematic reviews with meta-analyses of observational studies were included if either PTB or LBW were …

The Pharmaceutical Quality Of Herbal Medicinal Products And Dietary Supplements – Assessment Of Products From Lavandula Species, Banaz Jalil, Michael Heinrich

Oxford ICSB

Several Lavandula species are important aromatic and medicinal plants with great economic value as phytopharmaceuticals, foods, in perfumery, cosmetics, and aromatherapy. The genus Lavandula comprises 39 species with many hybrids. Over 20 years ago about 400 registered cultivars were recorded (1) , with the three main cultivated species being used to produce essential oils, including fine lavender oil, spike lavender oil and lavandin oil. Lavandula angustifolia Mill. is used traditionally to treat restlessness, agitation, insomnia and intestinal discomfort linked to nervousness (2). For example, Silexan® is a high-quality fine lavender oil licensed as an active ingredient in medicines for the …

Dosage Form Performance Assessment Of Four Commercially Available Turmeric-Containing Dietary Supplements To Inform Clinical Study Design., Bill Gurley

Oxford ICSB

Clinical studies assessing structure-function claims, safety, phytochemical pharmacokinetics, or drug interaction potential of botanical dietary supplements (BDS) often overlook the disintegration and dissolution characteristics of the administered dosage form. Consequently, inadequate disintegration or dissolution profiles may prevent key study endpoints from being met. Given the high cost of clinical research, no study should proceed without first verifying the disintegration and dissolution performance of the selected dosage form. Failure to do so may compromise the study’s validity and render its findings inconclusive. Assessing dosage form performance, particularly in biorelevant media, is a cost-effective strategy that can provide critical insights for optimizing …

56 - Body Composition Change In Women Treated For Breast Cancer Before And 24 Months After Treatment, Aissatou Lo, Gregory Hundley Md, Leila Mabudian, Susan Workman, Ricardo Peral, Daniel Miller, Nathaniel Sean O'Connell, Amy Ladd Md

Undergraduate Research Symposium

Background: Breast cancer (BC) treatments including chemotherapy and radiation can alter body composition leading to significant changes of subcutaneous and visceral adiposity. Increases in fat impact physical health and influence survivorship outcomes such as quality of life and metabolic health. We hypothesized that breast cancer treatment could induce increases in body composition, especially abdominal fats. Objective: Investigate body composition change in women treated for breast cancer before and 24 months after treatment.

Methods: Case-control cohort study design that included 29 BC patients treated with anthracycline chemotherapy and 37 comparators without cancer.To assess body composition, abdominal MRIs were obtained at baseline …

Abstract Title: What Is Chaga? Unique Biochemistry Of The Sterile Conk., Anna Kreynes

Oxford ICSB

Fungal based supplements or functional mushrooms are growing in popularity worldwide. Among them, Chaga is attracting increasing attention for its broad immune-modulatory and anti-inflammatory properties. Chaga is unique among “mushroom” supplements as it is technically neither a mushroom (fruiting body), nor a sclerotia, as some researchers assert, but rather a sterile conk or canker that forms on trees, infected and colonized by mycelia of the pathogenic fungus Inonotus obliquus. Commonly associated with birch (Betula spp.), I. obliquus also parasitizes other hardwood species such as alder (Alnus), beech (Fagus), and ash (Fraxinus), found in boreal forests of northern Europe, Asia and …

An Update From The U.S. Drug Induced Liver Injury Network And Plans For Sentinel Surveillance For Supplement Induced Liver Injury, Victor Navarro

Oxford ICSB

Herbal and dietary supplements (HDS) are commonly used by consumers, and some have been linked to liver injury severe enough in some cases to result in transplantation and death. The U.S. Drug Induced Liver Injury is funded by the NIH to study liver injury from supplements. The DILIN investigators have identified many supplements linked to liver injury, as well as risks for the development of hepatotoxicity. The Network has also observed temporal trends in the occurrence of supplement related liver injury, some that parallel regulatory actions. In order to use these observations to promote consumer protection and supplement safety, the …

Misidentification Remains Common In Selected Historically Substituted Traditional Chinese Medicine Herbs., Wendy Applequist

Oxford ICSB

Various studies have observed that some minimally processed botanicals sold for use in Traditional Chinese Medicine are adulterated or substituted with species having similar appearance and/or traditional uses. In this study, commercial samples of several plants for which aboveground parts are used, and for which Leon & Lin’s (2017) reference work reported known substitutes, were examined. All samples of Ma Chi Xian (Portulaca oleracea), Yi Mu Cao (Leonurus japonicus), Ze Lan (Lycopus lucidus), and Zi Hua De Ding (Viola philippica) were at least mostly consistent with the stated identities, though some contained contaminants. Three of nine samples of Xi Xian …

Predicting Capture And Survival Probabilities Of The Arizona Tiger Salamander: A Comparison Of Capture-Recapture Models, Brittney Nelson

Scholars Week

Capture-recapture models are essential tools for estimating population dynamics in ecological studies. A fundamental component of these models is the capture history matrix, which records individual detection over time and serves as the basis for estimating survival and capture probabilities. This presentation explores three statistical approaches to these estimations: the Cormack-Jolly-Seber (CJS) model, the Hidden Markov Model (HMM) for CJS, and the Bayesian CJS model. The CJS model provides a likelihood-based framework for estimation, and the HMM CJS incorporates latent states into the model to account for uncertainty in detection. The Bayesian CJS extends this same analysis by integrating prior …

Sample Storage Method And Collection Time Effects On Horse Hair Cortisol Concentrations, Grace Robertson

Scholars Week

Serum cortisol concentration is the gold standard for evaluating stress in horses. However, it can be affected by circadian rhythms, environmental factors, and other excitatory events. Hair cortisol is less subject to these variables and is less invasive to collect, but there is a lack of published information on hair cortisol concentrations in horses. The objectives of this study were to examine 1) the impact of sample storage (Room temperature vs. Frozen) and 2) the effect of collection date (spring vs. fall), on cortisol concentration in equine hair. It was hypothesized that Frozen samples would yield higher concentrations than Room …

Supplement Product Quality Woes: A Call To Action, Andrew Shao

Oxford ICSB

No abstract provided.

Digitization Of Hptlc Chromatograms For Chemometric Analysis, Menglian Zhang, Jianghao Sun

Oxford ICSB

HPTLC has been a major analytical tool for the botanical industry for many years. Its strength has been the ability to provide multiple chromatograms for parallel visual comparison of standards and samples. It’s weakness has been the lack of digitization to allow objective chemometric analysis of the data. Two studies are presented: analysis of 3 species of Echinacea (E. angustifolia, E. palida, and E. purpurea) and analysis of cranberry supplements, fruits, and juices (35 supplements, 8 dried fruits, and 4 juices). Accurate comparison of the patterns of the chromatograms required pre-processing: removing initial and final peaks, derivatization, alignment of samples …

Simultaneous Botanical Identification And Marker Compound Assay By High Performance Thin Layer Chromatography, James Kababick, Stacy Wise, Christine Goularte

Oxford ICSB

21 CFR part 111 (the Dietary Supplement cGMPs) require identity testing on all dietary ingredients. In many cases, botanicals are also standardized to selected marker compounds and require potency testing to ensure products meet label claim. We present a novel approach to combining the identification and assay testing into one analytical run utilizing High Performance Thin Layer Chromatography. The method eliminates the need for subsequent assay testing and greatly reduces chemical waste in the laboratory saving both time and money. Case studies will be presented.

Foraging For Methods: The Right Hptlc Method For The Right Spec, Khanh Tran, Sidney Sudberg, Anthony Fontana

Oxford ICSB

High Performance Thin Layer Chromatography (HPTLC) is a well-established analytical technique widely utilized for botanical and fungal identification. Mushrooms are known for their bioactive compounds (beta-glucans, sterols, and triterpenoids) that can have a wide range of human health benefits, such as boosting the immune system, antioxidant, and anti-inflammatory among others. The method selection for mushrooms is dependent on the species of mushroom, the compound(s) of interest, form of material, as well as standardization of extracts. Over 15 different mushroom species were analyzed by various methods by HPTLC, for both mycelia and fruiting body.

Rooted In Quality: Elevating Standards In Botanical Supplements, Katie Banaszewski

Oxford ICSB

The botanical supplement industry is currently navigating a landscape that demands an unwavering commitment to high standards of quality, transparency, and sustainability. This sector faces a host of challenges alongside new opportunities, particularly emphasizing the vital role of quality assurance in preserving the integrity of botanical products. To ensure the authenticity of botanical ingredients and safeguard consumer health, advanced scientific testing techniques have become indispensable. Methods such as DNA barcoding, mass spectrometry, and NMR spectroscopy play crucial roles in verifying the purity and identity of these natural products. Furthermore, as the market increasingly prioritizes ethical consumption, there is a growing …

Innovative Integration Of Hptlc And Ai For Detecting Adulteration And Ensuring Quality In European Elder Berry Products, Maria Monagas, Wilmer Perera, Roy Upton, Eike Reich, Tiên Do

Oxford ICSB

European Elder berry, Sambucus nigra L. has a long history of traditional use as a cold and flu remedy. Since COVID-19 pandemic, the increased demand and limited supply have increased adulteration risk. Major concerns related to adulteration are substitution of Elder berry with black rice extract, addition of synthetic dyes and species mislabeling. HPTLC analysis of a total of 167 samples from different types of ingredients marketed as containing S. nigra was conducted, including whole fruits, juice concentrates, dry juices, fruit powders, liquid extracts, aqueous extracts and Dietary Supplements (DS) products (capsules and syrups). Related species (S. cerulea, S. canadensis, …