Food and Drug Administration

The constituents of tobacco smoke that specifically contribute to lung cancer risk have yet to be fully identified. We evaluated associations between biomarkers of potentially harmful constituents-polycyclic aromatic hydrocarbons (PAHs), tobacco-specific nitrosamines (TSNAs), nicotine, and volatile organic compounds (VOCs)-and lung cancer incidence among US women. In a case-cohort study nested within the Sister Study (women aged 35 to 74 years at baseline, enrolled 2003 to 2009), data were obtained for a random subcohort and all remaining incident lung cancers through September 2017 (median follow-up 9.6 years), stratified by race and ethnicity (Hispanic, non-Hispanic Black, non-Hispanic White, others) and smoking status (current, former, never). The analytic sample included 356 cases and 433 non-cases. We quantified 30 biomarkers in baseline urine samples and calculated hazard ratios (HRs) for associations between one-unit increase in biomarker concentrations (log-scale) and lung cancer incidence using weighted Cox regression models adjusted for urinary creatinine and demographic, health, and lifestyle factors. Among women who were currently smoking at enrolment, positive associations were observed for biomarkers of PAHs (naphthalene, phenanthrene, pyrene, fluorene; HRs 1.4 to 5.3), TSNAs (particularly 4-(methylnitrosamino)-1-(3-pyridyl)-1-butanone (NNK); HRs : 1.3-2.2), and VOCs (xylene, acrylamide, acrylonitrile, 1,2-dibromoethane/vinyl-chloride/ethylene-oxide/acrylonitrile, acrolein, styrene/ethylbenzene, benzene, dimethylformamide/methylisocyanate, 1,3-butadiene, crotonaldehyde, isoprene; HRs : 1.6-4.4). Associations with biomarkers of most PAHs, NNK, xylene, and dimethylformamide/methylisocyanate remained after additional adjustment for smoking frequency, duration, and nicotine metabolites. In women who did not smoke, positive associations were observed for styrene/ethylbenzene and dimethylformamide/methylisocyanate biomarkers. Exposure to PAHs, TSNAs and several VOCs through tobacco smoking were associated with increased lung cancer risk among women.

Introduction: Open defecation increases the spread of diarrhoea illnesses, especially among children under five years in Ghana. Community-led total sanitation (CLTS) is an intervention implemented by the Environmental Health and Sanitation Department (EHSD) to stop open defecation. We evaluated the objectives, attributes, and usefulness of the CLTS surveillance system in the Bongo District, Upper East Region, Ghana. Methods: Adapting the Centers for Disease Control and Prevention updated guidelines for evaluating public health surveillance systems, the CLTS system was evaluated from 2019 to 2023 using a semi-structured questionnaire. Data was collected through interviews, observations and review and summarised as frequencies, proportions and text. Results: The CLTS system was triggered in 39.3% (66/168) of communities, with 56.1% (37/66) declared Open Defecation Free (ODF). About 619 latrines were constructed over the evaluation period, with 66.7% (14/21) of stakeholders interviewed having latrines in their homes and 52.4% (11/21) having handwashing facilities. About 85.7% (18/21) of community members were aware of faeco-oral transmission of diseases. Introduction of the Basic Sanitation Information System (BaSIS) data source in 2022 did not interrupt the system’s operations. All nine key informants stated that it is easy to identify an OD and ODF community using observation. Data completeness among all seven reporting units was 89.2% (34/37), with 100% reporting. The stability of the system is compromised as it largely depends on Non-Governmental Organisations (NGOs), coupled with a lack of computers for data storage. Triggering and ODF declaration took three to six months. Conclusion: The CLTS system was found to meet its objectives and is useful. It was acceptable, flexible, simple, with good data quality and representative. Reporting timeliness was good, with poor stability. The Government should provide budgetary support to the EHSD to effectively implement CLTS surveillance system.

<title>Abstract</title> Background Nigeria has adopted comprehensive tobacco control legislation, including the National Tobacco Control Act (NTCA) 2015 and Tobacco Control Regulations 2019, yet continues to experience high tobacco-related morbidity and a substantial illicit cigarette market. Institutional fragmentation and weak enforcement capacity, compounded by evolving obligations under the WHO Framework Convention on Tobacco Control (FCTC) and the Protocol to Eliminate Illicit Trade in Tobacco Products, undermine effective implementation. Methods A desk-based qualitative policy and regulatory analysis was conducted using three complementary approaches: (1) comparative legal mapping of Nigeria's tobacco control framework against core WHO FCTC and Illicit Trade Protocol obligations; (2) thematic synthesis of WHO guidance, treaty decisions, and peer-reviewed evidence on institutional arrangements for tobacco regulation; and (3) an implementation-readiness assessment of the National Agency for Food and Drug Administration and Control (NAFDAC) across key capacity domains. Results The analysis identified five interrelated structural gaps: fragmented institutional authority; absence of a central product regulator; weak supply-chain and illicit trade control; inadequate protection from tobacco industry interference; and a regulatory vacuum for emerging nicotine products. Nigeria's current ministry-led configuration constrains compliance with WHO FCTC Articles 9, 10, 11, and 15, while NAFDAC already possesses significant laboratory, port-of-entry, and digital traceability capacity developed through pharmaceutical regulation. Conclusion Reconfiguring Nigeria's tobacco control architecture to assign NAFDAC a central technical regulatory mandate, while retaining health policy stewardship within the Federal Ministry of Health (FMoH), offers a legally feasible and context-appropriate pathway to strengthen enforcement, meet evolving treaty expectations, and reduce tobacco-related harms.

The Nutrition Facts label is a useful tool for consumers to achieve a healthy diet. This study aimed to develop and test a theoretical framework examining factors that may influence consumers' use of the Nutrition Facts label, using a nationally representative sample. Analyses of cross-sectional, nationally representative 2019 Food and Drug Administration Food Safety and Nutrition Survey data included developing a theoretical framework adopting key constructs from 2 health behavior theories-the Integrated Behavior Model and the Theory of Planned Behavior-to test research hypotheses. Participants were 2041 US adults who participated in the 2019 Food and Drug Administration Food Safety and Nutrition Survey, Nutrition Version. Consumers' use of the Nutrition Facts label, health habits, self-efficacy, attitude, knowledge and skills, economic conditions, health status, potential exposure to the Nutrition Facts label, age, sex, education, race/ethnicity, and urbanicity were measured. A structural equation model was used. Eighty-seven percent of respondents reported having used the Nutrition Facts labels on food packages. Among all factors tested, self-efficacy has the strongest positive relationship with consumers' use of the label (standardized regression estimate = .67; P < .001). Findings also suggest that people living in urban areas are more likely to report using the Nutrition Facts label (standardized regression estimate = .11; P = .02). Results suggest that although knowledge and skills and attitude are not directly associated with consumers' label use, the relationship between these 3 constructs is strongly mediated by self-efficacy (standardized regression estimates = .38; P < .001 and .10; P = .01, respectively). Furthermore, individuals with better health status and more exposure to the Nutrition Facts label are more likely to have higher levels of self-efficacy (standardized regression estimates = .34; P < .001 and .28; P < .001, respectively). This study highlights the vital role self-efficacy plays in the theoretical model determining consumers' use of the Nutrition Facts label. The results also shed light on the factors that are important to consider when developing strategies to increase self-efficacy for Nutrition Facts label use and target populations for education and intervention.

Cosmetic wipes are made for multiple functions, baby care, hand washing, feminine and personal cleansing, removing makeup, and applying products such as deodorants and sunless tanners among other uses. Despite the presence of preservatives, cosmetic wipes can become contaminated during processing steps and usage, which may lead to skin infections and other health issues for consumers. No validated method exists for the microbiological testing of cosmetic wipes. The goal of this study was to develop and validate a specific sample preparation method for the quantitative detection of microorganisms in cosmetic wipes for inclusion in the FDA Biological Analytical Manual (BAM). Ten wipe types differing in their composition and preservative combinations were inoculated with Bacillus cereus spore suspensions at three concentration levels and aged for 14 days. Three extraction methods were compared: mBAM1g (reference method using 1 g samples), mBAMww (whole wipe method based on BAM Chapter 23), and ISOww (whole wipe method based on ISO method without Tween 80). For commercial wipes, mBAMww and ISOww, using whole wipes, performed similarly (p ≥ 0.05) or significantly better (p &lt; 0.05) than mBAM1g. For laboratory-made wipes, 1 g samples showed higher recovery rates than whole wipes, likely due to cell loss during aging. Inoculation method and preservatives affect microbial distribution, survival, and recovery rates. T80 may have a positive effect on the recovery of B. cereus from wipes. This study recommends mBAMww for the microbiological analysis of cosmetic wipes.

Artificial intelligence offers transformative potential for global health, yet regulatory disparities threaten equitable adoption. This brief examines whether the World Health Organization's Prequalification (PQ) framework should extend to AI. We highlight limitations of applying static product paradigms to dynamic systems, outline targeted reforms, and propose a reimagined PQ4AI that balances global technical assurance with local regulatory accountability to foster safe, effective, and equitable deployments.

The COVID-19 pandemic posed a major public health challenge with varying devastating effects on the global community. Vaccination is the most effective measure in combating this pandemic. A major challenge, especially in resource-limited settings, was the shortage of the vaccines. However, evidence by WHO in the use of fractionated doses in combating yellow fever prompted the evaluation of the safety and immunogenicity of fractionated doses of COVID-19 vaccines (ChAd0x1, AD26.COV2.S, and BNT162B2) among Nigerian adults (18-65years). This is a multi-center, non-inferiority randomized, triple-blind trial involving 1812 COVID-19 vaccine naïve participants. Six hundred four eligible participants will be randomized into each of the three vaccine arms of ChAd0x1, AD26.COV2.S, and BNT162B2 COVID-19 vaccine. 151 participants will be randomized each into the 25% and 50% fractionated dose and 300 in the standard full dose arm for the ChAd0x1 and AD26.COV2.S group. In the BNT162B2 group, 201 participants will be randomized into the 50% fractionated dose and 403 into the standard dose arms. The efficacy (immunogenicity) will be evaluated by collecting blood samples at baseline (day 0) and day 28 after immunization to determine the geometric mean fold rise (GMFR) of ≥ 2.5 within the range of 20% non-inferiority to the standard dose of anti-SARS-CoV-2 S antibody response detected by ELISA termed as seroconversion. Safety and adverse events will be evaluated through active evaluation during the first 72h of vaccine administration and on days 14 and 28 of clinic visits. The trial will also assess secondary immunogenicity variables of 50% plaque plaalite reduction neutralization by antibodies against SARS-CoV-2 variants (α, δ, and κ) and cytokines production (IFNα, γ, and IL-2 producing CD4 and CD8 T lymphocytes). The proposed trial will allow for a comprehensive understanding of the immunologic responses and safety profile of fractional doses compared to full doses of COVID-19 vaccines among Nigerian adults. In addition, this will guide policy implementation for prompt vaccination of the population to maximize access to the limited vaccines available during the COVID-19 pandemic or future epidemics/pandemics. The study is registered at the Pan African Clinical Trials Registry (PACTR), a primary registry in the WHO International Clinical Trial Platforms. PACTR202206754734018. Registered on June 1, 2022, Accessible at: https://pactr.samrc.ac.za/ Trial Sponsor: Open Philanthropy.

Integrated One Health surveillance is pivotal to Africa's future health security, particularly in preventing and managing zoonotic and environmental health threats. The One Health strategy recognizes the interconnectedness of human, animal, and environmental health, allowing a holistic framework for tracking and responding to emerging and re-emerging pathogens. The One Health approach facilitates cross-sectoral data sharing and enhances surveillance, enabling the early detection and response to potential outbreaks. This proactive approach shifts the paradigm from reactive crisis management to preventive containment strategies. However, challenges such as funding gaps, limited infrastructure, limited diagnostic capacity, and weak multi-sectoral and cross-border collaborations remain. This perspective paper aims to 1) explore the effectiveness of integrated One Health surveillance in early detection and response to zoonotic diseases and environmental threats in Sub-Saharan Africa (SSA), and 2) identify key challenges and proposed solutions to strengthen regional health security. A multisectoral laboratory working group (MLWG) emerged as a pillar to enable active surveillance targeting humans, animals, and the environment. This paper highlighted essential strategies for enhancing One Health surveillance in SSA in light of the recent Marburg virus disease in Rwanda. It emphasizes environmental sampling through animal excreta and wastewater surveillance for early zoonotic detection, advocates for point-of-care polymerase chain reaction (PCR) testing platforms, and multiplex models to improve decentralized diagnostics. With 48% of African nations incorporating One Health in national agendas, a unified continental framework is needed to support broader adoption and advance regional health security.