Product Labeling Research Articles

Quantifying protein kinetics in vivo: influence of precursor dynamics on product labeling.

Protein kinetics can be quantified by coupling stable isotope tracer methods with mass spectrometry readouts; however, interconnected decision points in the experimental design affect the complexity of the workflow and impact data interpretations. For example, choosing between a single bolus (pulse-chase) or a continuous exposure protocol influences subsequent decisions regarding when to measure and how to model the temporal labeling of a target protein. Herein, we examine the merits of in vivo tracer protocols, and we direct attention toward stable isotope tracer experiments that rely on administering a single bolus since these are generally more practical to use as compared with continuous administration protocols. We demonstrate how the interplay between precursor and product kinetics impacts downstream analytics and calculations by contrasting fast versus slow turnover precursors (e.g., 13C-leucine vs. 2H-water, respectively). Although the data collected here underscore certain advantages of using longer-lived precursors (e.g., 2H- or 18O-water), the results also highlight the influence of tracer recycling on measures of protein turnover. We discuss the impact of tracer recycling and consider how the sampling interval is critical for interpreting studies. Finally, we demonstrate that tracer recycling does not limit the ability to perform back-to-back studies of protein kinetics. It is possible to run experiments in which subjects are used as their own controls even though the precursor and product remain labeled following an initial tracer dosing.NEW & NOTEWORTHY We demonstrate a simple and robust protocol for measuring protein synthesis, the work considers problems encountered in experimental design. The logic can enable biologists with limited resources and/or can facilitate scenarios where higher throughput experiments are needed.

P-1217. Validation of Cefiderocol (FDC) Package Insert Dosing Recommendation for Patients receiving Continuous Renal Replacement Therapy (CRRT): A Prospective Multi-Center Pharmacokinetic Study

Abstract Background FDC is the first antibiotic with effluent flow rate-based dosing recommendations outlined in the product label for patients receiving CRRT including modalities such as continuous venovenous hemodiafiltration (CVVHDF). The objective of this study was to investigate the population pharmacokinetics of FDC among patients receiving CRRT and validate these novel dosing recommendations. Methods A multicenter pharmacokinetic study among critically ill patients receiving CRRT was conducted. Subsequent blood sampling was performed at steady-state, and FDC concentrations were assayed by a validated Liquid Chromatography with tandem mass spectrometry. Population pharmacokinetic analyses were conducted in Pmetrics using R. The free time above the minimum inhibitory concentration (fT>MIC) was calculated with a target of ≥75% fT >MIC associated with clinical success. Total daily area under the concentration time curve (AUCdaily) was used as a surrogate for safety and tolerability. Results Fourteen patients on CVVHDF renal support were enrolled from August 2022 until December 2023; Hartford Hospital (n=7), Banner University Medical Center (n=5), and University of Kentucky Medical Center (n=2). Average age was 55 years and majority were male (n=9). Mean body weight was 113.5 kg, and effluent flow rates ranged from 2.1 to 5.1 L/h. FDC concentrations best fitted a two-compartment model. Mean ± SD parameter estimates for clearance, volume of the central compartment, and intercompartment transfer constants (K12 and K21) were 3.5 ± 1.5 L/h, 10.7 ± 8.4 L, 3.9 ± 1.8 h-1, and 2.2 ± 2.2 h-1, respectively. With simulations based on product label dosing recommendations, all patients achieved 100% fT >MIC up to MIC 8 mg/L with an AUCdaily (mean ± SD) of 1444 ± 423 mg*h/ L (Table 1). FDC was well tolerated with no serious adverse events reported among these critically ill patients. Conclusion Based on these data, the current package insert dosing recommendations resulted in pharmacodynamically optimized FDC exposures. The simulated concentrations exceeded relevant MIC breakpoints in all patients at each effluent flow rate, and AUCdaily were within the range observed in patients not receiving CRRT in the Phase 3 clinical trials, suggestive of a safe and therapeutic profile. Disclosures Emir Kobic, BCIDP, Shionogi: Grant/Research Support|Shionogi: Speaker Bureau Melissa L. Thompson Bastin, PharmD, PhD, Baxter Healthcare: Advisor/Consultant|Baxter Healthcare: Board Member|Fresenius: Advisor/Consultant Andrew J. Fratoni, PharmD, InsightRX: Grant/Research Support Xiaoyi Ye, MD, Sanofi: Advisor/Consultant Joseph L. Kuti, PharmD, Abbvie: Advisor/Consultant|bioMerieux: Grant/Research Support|Merck: Grant/Research Support|Pfizer: Grant/Research Support|Shionogi Inc: Advisor/Consultant|Shionogi Inc: Grant/Research Support|Shionogi Inc: Honoraria|Venatorx: Grant/Research Support David P. Nicolau, PharmD, CARB-X: Grant/Research Support|Innoviva: Grant/Research Support|Innoviva: Honoraria|Merck: Advisor/Consultant|Merck: Grant/Research Support|Merck: Honoraria|Pfizer: Advisor/Consultant|Pfizer: Grant/Research Support|Pfizer: Honoraria|Shionogi: Advisor/Consultant|Shionogi: Grant/Research Support|Shionogi: Honoraria|Venatorx: Grant/Research Support Tomefa E. Asempa, PharmD, FDA/CDER: Grant/Research Support|Paratek: Grant/Research Support|Shionogi: Grant/Research Support|Spero: Grant/Research Support|VenatoRx: Grant/Research Support

Editorial: Industry and individuals: branding, labelling, and marketing of food products

Editorial: Industry and individuals: branding, labelling, and marketing of food products

Food manufacturers’ compliance with the FDA's trans fat ban: Evidence from scanner data

AbstractWe use barcode‐level data in the US between 2012 and 2020 to document the evolution of trans fat content in manufactured food products before and after the Food and Drug Administration's (FDA) 2015 determination that trans fats are not safe for human consumption (effectively a “trans fat ban”). First, we document how the number of products containing trans fat has declined over time. Second, using detailed information on household food purchases in retail stores, we quantify the corresponding reduction in total trans fat purchases. We find that although the number of trans fat products on the market has declined over time, products with a positive trans fat content continued to exist beyond the FDA's deadline for trans fat removal. We find a larger presence of trans fat products in small‐scale retailers (Dollar and Convenience stores) than in larger outlets (mass merchandisers and warehouse clubs). Similarly, trans fat products are relatively more prevalent in private label products and in products with a local presence. While trans fat purchases have declined over time, lower income households purchase product baskets with significantly larger amounts of trans fat. The findings can be used to guide more effective and efficient enforcement efforts.

Genomic interrogation of commercial infant probiotic products for label accuracy.

To evaluate the label accuracy of commercial infant probiotic products and identify potential microbial contamination. DNA was extracted from seventeen infant probiotic products purchased from a large online vendor. Samples underwent 16S ribosomal RNA gene sequencing, QIIME analysis, and bacterial taxonomic classification. Identified bacterial species were compared with product labels for label accuracy and potential contaminants. Additionally, fungal DNA was amplified using qPCR with universal 18S fungal primers, and cultures were performed to assess viability. Over 82% of bacterial DNA extracted from samples corresponded to species listed on product labels. Contaminating bacteria were closely related species. Lot-to-lot variation in bacterial species abundance was greater in multi-strain products compared with single-strain products. Fungal DNA was detected in some samples, but culture results indicated these organisms were not viable. This pilot study highlights that most bacterial species in commercial infant probiotic products are accurately represented on labels. Single-strain products reliably match product labels whereas multi-strain products were more prone to variation of species abundance and species omission. Additionally, fungal contamination of limited samples was not viable. These findings emphasize the need for improved regulatory guidelines and standardization of probiotic products, particularly those marketed for infants. Commercial infant probiotic products were interrogated for label accuracy using 16S ribosomal RNA sequencing. Most bacterial species in commercial infant probiotic products are accurately represented on labels without pathogenic bacterial contamination. Live fungal contamination is absent. To date, no studies have interrogated infant probiotic products on this scale (other studies have been limited to single or dual strain infant probiotics). Since probiotics lack FDA regulation, this pilot study provides important information for pediatricians and consumers, further highlighting the need for improved quality control and standardization of probiotics.

A Real-World Data Analysis of Alglucosidase Alfa in the FDA Adverse Event Reporting System (FAERS) Database.

Alglucosidase alfa for injection is used as an enzyme replacement therapy for the treatment of Pompe disease. The safety profile of alglucosidase alfa-associated adverse events requires a comprehensive evaluation. In this study, we aimed to identify drug safety alert signals and investigate the real-world safety of alglucosidase alfa to guide clinical decision making and optimize the risk-benefit balance. The adverse event reports from the first quarter of 2006 to the fourth quarter of 2023 were selected by exploring the Food and Drug Administration Adverse Event Reporting System (FAERS) database. The new and unexpected potential adverse event signals were detected using a disproportionality analysis, including the reporting odds ratio, the proportional reporting ratio, the Bayesian confidence propagation neural network, and the empirical Bayes geometric mean. Then, the Medical Dictionary for Regulatory Activities was used to systematically classify the results. After analyzing 16,945,027 adverse event reports, a total of 4326 cases of adverse events related to alglucosidase alfa were identified, spanning 27 system organ classes. A total of 359 preferred terms of adverse events for glucosidase alpha were detected. Pyrexia ranked first, followed by pneumonia, dyspnea, respiratory failure, and disease progression according to occurrence frequency. The top three system organ classes were general disorders and administration-site conditions (n = 2466), respiratory, thoracic, and mediastinal disorders (n = 1749), and infections and infestations (n = 1551). In addition to adverse effects mentioned in the product label, our study also discovered rare but high signal intensity adverse events such as chronic recurrent multifocal osteomyelitis. There are many adverse events associated with the clinical use of alglucosidase alfa, which should be closely monitored in the FAERS database. As the most effective enzyme replacement therapy for Pompe disease, it is crucial to closely monitor these adverse events. Ensuring patient safety while balancing drug effectiveness is particularly important.

High-throughput and sustainable B vitamins analysis in nutritional supplements, vegetables, and fruits via 2D carbon microfiber fractionation system coupled with mass spectrometry.

B vitamins are essential for energy metabolism, nervous health, blood production, and the immune system. Their quantification in nutritional supplements and food is mandatory to manage a correct daily intake and dosage. In this study, a fast and sustainable method for the analysis of 8B vitamins (VB1, VB2, VB3, nicotinamide, VB5, VB6, VB9, VB12) in real samples using a 2D-carbon microfiber fractionation system combined with a triple quadrupole mass spectrometer (2DμCFs-QqQ-MS/MS) is presented. The method shortens the analysis time to 5min, showing high sensitivities (LODs: 1.7-13.7ngmL-1, LOQs: 5.5-45.7ngmL-1, obtained with standard solutions), good reproducibility (RSDs <15%), and strong linear correlations (R2>0.997). When applied for B vitamin determination in nutritional supplements, results matched product label values at a 95% confidence level, with batch reproducibility never exceeding 5%. Furthermore, coupling a 2D-carbon microfiber fraction system with a quadrupole time-of-flight high-resolution mass spectrometry (2DμCFs-QTOF-HRMS) it is possible to carry out quick monitoring of B vitamin contents together with impurity evaluation in real samples.

Evaluating the scientific evidence to support mental health and well-being claims made on probiotic products.

Increasing interest in probiotics for mental health has led to products marketed to consumers claiming psychological benefits. This study aimed to identify mental health claims on probiotic supplements and to provide a narrative review of the scientific evidence to support these claims. Probiotic supplements with mental health claims on the product label were identified. A search of the scientific literature was performed using Google Scholar, PubMed and Cochrane Central Register of Controlled Trials. Studies were included if the primary outcome was mental health or a biomarker of mental health, if they investigated the exact probiotic strain or combination of strains as present in the product, and if the study was a trial of probiotics conducted in either humans or animals. Included studies were assessed for risk of bias. Fourteen probiotic products with mental health claims were identified containing five different strains or strain combinations. Eighteen studies relevant to the products and investigating mental health outcomes met inclusion criteria. Ten studies investigated the same combination of probiotics and provided evidence to support the claims made. Statistically significant results were not universally present for all products. The amount and quality of evidence to support claims of mental health benefits made on probiotic products is variable. The results support the need for a grading system to facilitate informed consumer decision-making when choosing a probiotic supplement to support mental health.

Using ecological momentary assessment to quantify Δ-9-tetrahydrocannabinol and cannabidiol use across different forms of cannabis: Feasibility in a sample of Canadian young adults reporting frequent cannabis use.

To establish the feasibility of using ecological momentary assessment (EMA) to estimate total quantities of Δ-9-tetrahydrocannabinol (THC) and cannabidiol (CBD) used across different forms of cannabis, and to assess the predictive validity of THC estimates for predicting acute cannabis-related consequences. 14-day EMA using a smartphone application to assess cannabis use in real time. Canada. Targeted sample of n = 42 young adults (59.52% women, mean age 25 years) reporting frequent cannabis use. Surveys completed immediately prior to cannabis use assessed the quantities, THC content and CBD content of various forms of cannabis to be used in the current session; participants also uploaded photos of the cannabis product labels when available. Surveys administered at fixed times throughout the day (84.81% completion rate) assessed acute cannabis-related consequences. Participants completed a total of 786 pre-cannabis surveys, of which 79.39% and 77.35% contained sufficient information to calculate total THC and CBD (in milligrams), respectively. High agreement was observed between participant-entered THC and CBD contents and those shown in corresponding photos of cannabis product labels. Aggregating across all products used, participants reported using an average of 141.41 [standard deviation (SD)=224.62, range = 0.00-2000.00] milligrams of THC (i.e. 28.28 standard five-milligram units) and 7.53 (SD = 34.87, range = 0.00-484.22) milligrams of CBD per day. Multilevel models revealed that participants were more likely to report acute negative consequences following sessions when their estimated THC use was higher than their typical THC use. At the between-person level, participants reporting more THC use on average across sessions were less likely to report negative consequences overall. Using ecological momentary assessment to estimate total quantities of Δ-9-tetrahydrocannabinol and cannabidiol used across different forms of cannabis appears to be feasible, with preliminary predictive validity for acute negative cannabis-related consequences.

The Impact of Health Literacy on Consumer Knowledge of Mask and Hand Sanitizer Use in Post-Pandemic Korea.

The COVID-19 pandemic increased people's reliance on masks and hand sanitizers, highlighting the critical role of health literacy (HL) in effectively using these preventive measures. This study aimed to assess how HL influences consumers' comprehension of product labels for masks and hand sanitizers in post-pandemic Korea. A cross-sectional online survey was conducted in September 2023 among 500 Korean adults aged 20-69. The participants completed a questionnaire measuring HL and their knowledge of mask and hand sanitizer labels using the Korean Health Literacy Assessment Tool. The respondents were classified into high- and low-literacy groups, and statistical analyses (chi-squared tests, t-tests, and logistic regression analyses) were employed to compare label comprehension between the groups. High HL was observed in 31.6% of participants, demonstrating significantly better label-reading habits, including greater recognition of quasi-drug designations, usage instructions, and safety precautions (p < 0.001). The logistic regression analysis revealed that high-HL participants were more likely to correctly identify mask-related information (OR 2.56, 95% CI: 1.69-3.89) and demonstrate hand sanitizer-related knowledge (OR 5.39, 95% CI: 3.31-8.77) than their counterparts. Demographic factors such as age, gender, or education showed no significant associations with label comprehension. Higher HL is strongly associated with better comprehension of mask and hand sanitizer labels, underscoring its importance in public health communication. Enhancing HL is essential in promoting the safe use of preventive products during health emergencies. Public health initiatives should prioritize improving health literacy to ensure more effective communication and safer practices during future health crises.

Comprehensive analysis of adverse events associated with onasemnogene abeparvovec (Zolgensma) in spinal muscular atrophy patients: insights from FAERS database.

Onasemnogene Abeparvovec (Zolgensma) is a gene therapy for the treatment of Spinal Muscular Atrophy (SMA) with improved motor neuron function and the potential for a singular treatment. Information on its adverse drug reactions is mainly from clinical trials and real-world studies with extensive sample sizes are lacking. In this study, we analyzed the U.S. Food and Drug Administration's Adverse Event Reporting System (FAERS) database to assess the drug safety profile of Zolgensma. A total of 1951 adverse event reports associated with onasemnogene abeparvovec (Zolgensma), containing 778 import important medical event (IME) signals, were identified from the FAERS database, and multiple disproportionate analysis algorithms were used to determine the significance of these adverse events. This study identified 281 onasemnogene abeparvovec-related adverse events (AEs), including some significant adverse events not mentioned in the product labelling. Elevated liver enzymes, fever, vomiting, and thrombocytopenia were the most common adverse reactions. Most adverse events manifested within the initial month of onasemnogene abeparvovec use, especially the first 8days, but some may still occur after 1year of treatment. Sex-specific scrutiny revealed differing risk levels for adverse events among women and men. Thrombocytopenia and thrombotic microangiopathy are more common in patients weighing ≥8.5kg, and changes in renal function need to be closely monitored if thrombotic microangiopathy occurs. The above findings provide valuable insights into optimizing the utilization of onasemnogene abeparvovec, improving its effectiveness, and minimizing potential side effects, thereby greatly facilitating its practical application in clinical settings.

Disproportionate adverse event signals of selumetinib in neurofibromatosis type I: insights from FAERS.

Neurofibromatosis type 1 (NF1) is a rare neurogenetic disorder with limited treatment options. Selumetinib, a MEK1/2 inhibitor, has emerged as a promising therapy for inoperable NF1-related plexiform neurofibromas. Our retrospective pharmacovigilance study utilized the FDA Adverse Event Reporting System (FAERS) to comprehensively evaluate Selumetinib's safety profile in real-world settings. Data from the third quarter of 2020 to the fourth quarter of 2023 were analyzed, identifying 498 adverse event reports with Selumetinib as the primary suspect drug. Statistical analysis revealed disproportionate signals for skin and subcutaneous tissue disorders, eye disorders, and various congenital, familial, and genetic disorders. The most common adverse events were elevated blood creatine phosphokinase, rash, and acneiform dermatitis. Notably, several adverse events, including rhabdomyolysis, were identified but not listed on the Selumetinib product label, based on a comparison with the FDA drug labeling. The study underscores the importance of early detection and management of adverse reactions associated with Selumetinib, particularly within the initial month of treatment. These findings provide valuable insights for clinicians and regulators to ensure the safe and effective use of Selumetinib in NF1 patients.

Solving climate change requires changing our food systems

Abstract Humanity is facing an important existential threat—irreversible climate change caused by human activity. Until recently, most of the proposals to address climate change have downplayed or ignored the adverse impact of food systems, especially intensive animal agriculture. This is in spite of the fact that up to a third of global greenhouse gas production to date can be attributed to animal agriculture. Recent developments at COP28 have signaled that the tide is turning, however, and that food systems are becoming part of global discussions on climate change solutions. The pressing nature of irreversible climate change requires rethinking our food systems. To solve the climate change crisis, we propose transitioning to a predominantly plant-based diet, and phasing out intensive animal agriculture as diets shift, without increasing pastoral farming. We suggest that such transformations in global food systems can be accomplished largely through education and large-scale public information campaigns, removal of subsidies, taxation to account for externalized costs of animal agriculture, improved labelling of products, and various investment/divestment drivers. Better metrics and industry benchmarks involving food and agriculture-specific performance indicators that reflect food system sustainability will be important. Increased global awareness of these issues and a change in mindset (which will drive political will) also are needed. Our current trajectory is untenable, and we must begin to turn the ship now towards sustainable food systems and diets.

A Descriptive Comparative Analysis of Safety Concerns Outlaid in the Risk Management Plans of the European Union and Japan.

This study aimed to obtain a better understanding of the characteristics of the risk management plans (RMP) and the background regulatory policies governing them, in the European Union (EU) and Japan. This was done by descriptively comparing the safety concerns (SCs) listed in the RMP and examining their relationships with product labeling. Information regarding SCs was collected from the published RMP of both the EU and Japan for the targeted products-all of which were commonly approved in both regions. The concordance rate of the SCs for each product between the EU- and Japan-RMP was calculated. The warning information for each product was collected from the product labeling, summary of product characteristics for the EU, and package insert for Japan, and compared with the SCs listed in the corresponding RMP. A total of 259 products that were approved for sale in both the EU and Japan (1998-2023), for which RMP were available in both regions, were analyzed. While 51.0% of the SCs labeled as important identified risks (IIRs) in the EU-RMP were concordant with those in the Japan-RMP, 20.4% of the SCs listed as IIRs in the Japan-RMP were concordant with those in the EU-RMP. The concordance rate between the SCs identified as IIRs and the warning information was 18.6% for the EU-RMP and 88.4% for the Japan-RMP. The low SC concordance rate between the EU- and Japan-RMP indicates a different approach to selecting RMP SCs by the two regulatory authorities.

Feed additives for methane mitigation: Regulatory frameworks and scientific evidence requirements for the authorization of feed additives to mitigate ruminant methane emissions.

This article describes the regulatory and evidence requirements necessary for the authorization of antimethanogenic feed additives (AMFA) aimed at mitigating enteric methane (CH4) emissions from ruminants. It outlines the legislation and legal procedures in Australia, Canada, the European Union, New Zealand, South Korea, the United Kingdom, and the United States as illustrative examples, offering insights for applicants seeking authorization. Additionals objectives are to highlight consequential similarities and differences in regulations and evidence requirements and offer recommendations for scientists and applicants. The pivotal role that scientific evidence plays in the evaluation and approval processes is emphasized, along with the need for applicants and researchers to understand and adhere to the specific regulations of each jurisdiction. Feed additives are regulated to ensure their safety for animals, humans, and the environment, and to verify their effectiveness for the intended use of enteric CH4 mitigation. Regulations cover various aspects, including ingredient safety, manufacturing practices, product labeling, and the establishment of permissible limits for certain substances to ensure their safe use in animal feed. Compliance with these regulations is mandatory, and they are enforced by regulatory agencies within each jurisdiction, aiming to protect animal health, promote food safety, and prevent misleading claims and unsafe practices. The assessment processes involve evaluating scientific evidence submitted by applicants, along with evaluations of quality control procedures, and record-keeping practices. The major difference in regulations is that each jurisdiction developed unique criteria to legally classify AMFA, making it challenging to satisfy all legal classifications with a single set of criteria for scientific evidence. However, numerous similarities and a universal reliance on the concept of intended use indicate consistency across all jurisdictions on the need for robust evidence for efficacy, safety, and product quality and documentation even if the type, size, duration, and location of the studies they require differ. Recommendations are made for both scientists and applicants, emphasizing the importance of designing, conducting, and reporting scientific evaluations transparently, using validated standards and methods, and communicating with regulatory bodies to ensure compliance with regulations and evidence requirements.

A Real-World Pharmacovigilance Study of FDA Adverse Event Reporting System Events for Obeticholic Acid.

Based on the Adverse Event Reporting System (FAERS) data from the US FDA, this study mined the adverse drug reactions of obeticholic acid (OCA) in the real world and provided reference for clinical safe drug use. Adverse event reports for OCA from the second quarter of 2016 to the third quarter of 2023 were extracted. The analysis for adverse reaction signal detection was conducted using reporting odds ratio, proportional reporting ratio, Bayesian confidence propagation neural network, and multi-item gamma Poisson shrinker methods. A total of 5661 OCA-related adverse event reports were collected, and 105 OCA-related adverse reaction signals were obtained, involving 14 systems, among which 46 new signals were not previously mentioned in the product labeling. Severe adverse event of OCA accounted for a relatively high proportion (1445 cases, 25.53%), among which the number of hospitalization reports was the largest (1042 cases, 18.41%). The top five adverse events were pruritus, fatigue, constipation, elevated blood alkaline phosphatase, and abdominal distention. The top five adverse reaction signals intensity were abnormal blood alkaline phosphatase, abnormal ratio of albumin globulin, spider nevus, combined with abnormal bilirubin, and γ-abnormal glutamyl transferase. Based on the pharmacovigilance study of the FAERS database, it is necessary to strengthen the clinical medication monitoring of OCA, so as to provide reference for effective pharmaceutical monitoring and rational clinical medication.

PLACEBO MARKETING TOWARDS CONSUMER EXPECTATION AND PRODUCT INTEGRITY AMONG HEALTH SUPPLEMENTS USERS IN CAVITE

The study aimed to determine the placebo marketing towards consumer expectation and product integrity among health supplement users in Cavite. This also determines the participants' perception of placebo effect marketing in their consumer expectation about the performance and reliability of the product, ease of use, value for money, and emotional connection towards its consumers. The participant's perception of placebo effect marketing on product integrity in terms of transparency and expectation versus reality. It employed a descriptive-correlational research design using a survey questionnaire administered through Google Forms, considering 120 health supplement users in Cavite. For this study, the researcher also used statistical methods including frequency distribution, mean, percentage, and standard deviation. A Likert scale that used to assess participants' perceptions of marketing strategies and their influence on health supplement use and expectations. Results show that the participants towards the placebo marketing strategies have effectively created a positive initial impression among health supplement users in Cavite. These strategies, such as professional endorsements, scientific language, and attractive packaging, make products seem reliable and valuable. This means that while marketing can create strong first impressions, it is difficult to keep these impressions once the product is used. Results also show a gap between what the marketing promises and what the products actually deliver and to keep consumers' trust and uphold the brand's integrity, companies need to ensure that their marketing claims match the actual benefits of their products. For the sake of brand integrity, businesses should prioritize transparency in product labeling by providing clear and accurate information about ingredients, testing procedures, and certifications. For consumers, it is recommended to remain critical and informed when evaluating health supplement claims. The study emphasizes the need for ethical marketing practices to foster trust and loyalty in the health supplement industry.

Ocular surface disease related to tisotumab vedotin-tftv.

To report a series of patients who developed ocular surface disease related to tisotumab vedotin-tftv (TV), an antibody-drug conjugate (ADC) approved for the treatment of recurrent or metastatic cervical cancer. This was a multicenter retrospective chart review study of patients who developed ocular surface disease related to TV between April 1st, 2022 to August 31st, 2023. Five patients were identified who developed ocular surface disease while on TV. All patients received a standard ocular adverse event prophylaxis regimen with each infusion per the product label, including a cool ocular compress, topical vasoconstrictor, topical steroid, and artificial tears. All five patients developed conjunctival subepithelial fibrosis. Two patients developed bilateral pseudomembranous conjunctivitis, one of whom subsequently developed conjunctival scarring. Two patients developed a bilateral culture positive conjunctivitis, which responded to topical antibiotics. One patient developed bilateral infectious keratitis and was treated with partial thickness corneal transplantation of both eyes. TV can be associated with ocular surface disease, including conjunctival scarring and infectious keratitis. Some cases may require surgical intervention. Oncologists and ophthalmologists should be aware of the possibility of these ocular complications, especially as more ADCs are approved. Further studies are required to determine toxicity mechanisms as well as optimal prophylaxis and management strategies.

Health Literacy, Label Comprehension, and Consumer Perceptions of Quasi-Drug Information Among Korean Adults: A Cross-Sectional Study.

Health literacy (HL) is crucial in understanding labels of healthcare products. This study aimed to evaluate HL and its impact on comprehending quasi-drug labels, assess consumer perceptions of key label elements and their perceived importance, and provide actionable recommendations for improving label design and health communication. An online cross-sectional survey of 500 Korean adults (aged 20-69) was conducted in September 2023 using proportionate stratified sampling based on the 2020 Korean Census. HL was assessed using the Korean Rapid Estimate of Adult Literacy in Medicine (REALM-K). The survey included demographic data, quasi-drug usage patterns, comprehension of 63 quasi-drug terms, and perceptions of label elements. A 5-point Likert scale was used to assess the importance, agreement, and need for improvement of label elements, and statistical analyses included descriptive statistics, chi-square tests, t-tests, Pearson correlation, and logistic regression. Most participants had inadequate HL (68.4%). Adequate HL is strongly associated with higher comprehension of quasi-drug terms (r = 0.783, p < 0.001). Older age (60-69 years, AOR = 5.97, 95% CI: 1.74-20.48) and adequate HL (AOR = 28.54, 95% CI: 9.68-84.15) positively influenced comprehension. Participants with adequate HL rated the importance of label elements, such as "ingredient name" (mean = 4.02, SD = 0.79, p = 0.015) and "contraindications" (mean = 4.68, SD = 0.57, p < 0.001), higher than those with inadequate HL. Significant disparities exist in the comprehension and perceived importance of quasi-drug label elements based on HL levels among Korean adults. Findings emphasize the need for targeted strategies, such as using simplified language and visual aids, to enhance label comprehension. These interventions could improve public health outcomes by increasing understanding of quasi-drug information across diverse HL levels. Future research should focus on developing and testing these targeted interventions to bridge the identified comprehension gap.

Incorporation of anthocyanin into zein nanofibrous films by electrospinning: Structural characterization, functional properties, and ammonia color-responsiveness.

Green electrospinning for the production of freshness-indicating labels, employing entirely natural biopolymers and pigments, holds significance in the development of intelligent food packaging. This study aimed to prepare zein (Z) fibrous film (FF) incorporated with varying concentrations of anthocyanin (A; 0-0.5%) through green electrospinning. Furthermore, we evaluated their structural characteristics, functional properties, and color responsiveness to ammonia. With an increase in A concentration from 0% to 0.5%, the average thickness and fiber diameter of the electrospun Z-FF increased from 68.6μm to 102.0μm and from 582.1nm to 690.7nm, respectively. At A concentration of 0.2%, the A content and loading efficiency of electrospun ZA-FF exhibited the most optimal values (6.8mg/g and 39.4%). Surface hydrophobicity, thermodynamic properties, and mechanical characteristics of ZA-FF were significantly improved, attributable to changes in their secondary and crystal structures from the interaction of Z and A. In the ammonia color-responsiveness test, an obvious color change with ΔE values of 13.1 and 20.0 was observed for Z-FF incorporated with A at concentrations of 0.2% and 0.5%, respectively. This study provides novel insights into the development of Z-based freshness-indicating labels via green electrospinning for intelligent food packaging, especially in livestock and marine products.