Quality Assessment of Some Alcohol-Based Hand Sanitizers Circulating in the Federal Capital Territory, Abuja. Nigeria

Background The emergence of corona virus disease caused by SARS-COV-2 (Covid-19) and the subsequent recommendation by the World Health Organization (WHO) on the use of non-pharmaceutical measures led to an upsurge in the production and sale of hand sanitizers across the globe including Nigeria. It is important that product regulation schemes are designed in such a way as to ensure the continual quality of the products to potential clients. Hence, this paper provides an understanding of the quality of alcohol based hand sanitizers in Abuja, Nigeria. Methods A total of fifty (50) different brands of alcohol-based hand sanitizers were purchased from different pharmacies, supermarkets, and stores, within Abuja. In the laboratory, samples were checked for their label claims, NAFDAC registration number, batch number, manufacturing and expiration dates. The information was recorded in the laboratory notebook in accordance with ISO 17025 requirement, then samples were coded as SAN1 to SAN50 and assessed for pH values and Alcohol Content. Results About 40% of the circulating hand sanitizers in the market did not go through regulatory vetting, 34% of the products did not have information on the country of manufacture, 32% of the sanitizers had pH values within acceptable range, while 78% of the products contained less than 60% alcohol. Conclusion This study gives an insight into the quality of alcohol-based hand sanitizers and we suggest an urgent need for the regulatory authorities of developing countries to enhance their surveillance and control of these substandard products in the society.

Bridging the Gap: The Critical Role of Regulatory Affairs and Clinical Affairs in the Total Product Life Cycle of Pathology Imaging Devices and Software

Manufacturers of pathology imaging devices and associated software engage regulatory affairs and clinical affairs (RACA) throughout the Total Product Life Cycle (TPLC) of regulated products. A number of manufacturers, pathologists, and end users are not familiar with how RACA involvement benefits each stage of the TPLC. RACA professionals are important contributors to product development and deployment strategies because these professionals maintain an understanding of the scientific, technical, and clinical aspects of biomedical product regulation, as well as the relevant knowledge of regulatory requirements, policies, and market trends for both local and global regulations and standards. Defining a regulatory and clinical strategy at the beginning of product design enables early evaluation of risks and provides assurance that the collected evidence supports the product's clinical claims (e.g., in a marketing application), its safe and effective use, and potential reimbursement strategies. It is recommended to involve RACA early and throughout the TPLC to assist with navigating changes in the regulatory environment and dynamic diagnostic market. Here we outline how various stakeholders can utilize RACA to navigate the nuanced landscape behind the development and use of clinical diagnostic products. Collectively, this work emphasizes the critical importance of RACA as an integral part of product development and, thereby, sustained innovation.

Improving the Analysis of E-Cigarette Emissions: Detecting Human “Dry Puff” Conditions in a Laboratory as Validated by a Panel of Experienced Vapers

Introduction: E-cigarette product regulation requires accurate analyses of emissions. User behavior, including device power setting selection, should be mimicked closely when generating e-cigarette emissions in a laboratory. Excessively high power settings result in an adverse burnt off-taste, called “dry puff flavor”. This should be avoided because it results in an overestimation of toxicant levels (especially certain carbonyls). This study presents a human volunteer-validated approach to detect excessively high e-cigarette power settings by HPLC-DAD (high-performance liquid chromatography—diode array detection) carbonyl analysis. Methods: Thirteen experienced e-cigarette users evaluated whether the “dry puff flavor” was present at different power settings (10 W–25 W), recording their assessment on a 100-unit visual analog scale (VAS). They assessed e-cigarettes equipped with 1.2 Ω or 1.6 Ω coils containing menthol, vanilla or fruit-flavored e-liquids. In a machine-vaping experiment, emissions from the same liquid/coil/power setting combinations were subjected to HPLC-DAD analysis of dinitrophenol hydrazine (DNPH)-derivatized carbonyls, such as lactaldehyde and formaldehyde. A simple algorithm, based on the cutoff values for each marker, was applied to relate the dry puff flavor (as assessed by the human volunteers) to the laboratory measurements. Results: Eleven carbonyl compounds were found to agree with the human assessments. Based on the amounts of these compounds in the emissions, the dry-puff flavor did match at all combinations of e-liquids and coils examined. Dry-puff flavor was observed at different power levels with the different liquids tested. Conclusions: The described method can detect dry puff conditions and is therefore a useful tool to ensure user-relevant conditions in laboratory analyses of e-cigarette emissions. Implications: This study improves the chemical analysis of e-cigarette emissions. It offers a method to select an appropriate (i.e., user-relevant) power setting for e-cigarettes, which is a critical parameter for emission analysis and therefore important for regulatory purposes and risk assessments. Compared to the approach of using human volunteers to select appropriate power settings for different products by taste, the described method is cheaper, faster, more practical and more ethical.

Influence of cigarillo packaging characteristics on young adults’ perceptions and intentions: findings from three online experiments

ObjectivesPackaging is an important component of tobacco marketing that influences product perceptions and use intentions. However, little research exists on cigar packaging. We leveraged variability in existing Swisher Sweets cigarillo packaging to extend the evidence base.MethodsBetween 2017 and 2019, we conducted three online experiments with 774 young adult past-year cigar smokers recruited via Amazon Mechanical Turk. After viewing Swisher package images that differed by flavour descriptor and/or colour, participants rated them on perceptions and purchase intentions. In study 1, participants viewed one of four cigarillos (‘Wild Rush Encore’, ‘Wild Rush Limited’, ‘Twisted Berry’ and ‘Strawberry’). In study 2, participants viewed two different watermelon rum-flavoured cigarillos (‘Boozy Watermelon’ and ‘Island Madness’). In study 3, participants viewed two of three ‘Wild Rush’ cigarillo versions (‘Encore’ with or without an explicit flavour descriptor or ‘Limited’).ResultsIn study 1, more participants perceived ‘Twisted Berry’ and ‘Wild Rush Limited’ as tasting good and less harsh tasting compared with ‘Wild Rush Encore’. In study 2, compared with ‘Island Madness’, more participants perceived ‘Boozy Watermelon’ as tasting good, less harsh tasting and used by younger users but less by masculine users; female participants were more likely to purchase ‘Boozy Watermelon’. In study 3, participants perceived ‘Wild Rush Encore’ with the explicit flavour descriptor as tasting better than packages without and being used by younger users but less by masculine users.ConclusionsVariations in cigarillo packaging, even among cigarillos with the same flavour, may have differential consumer appeal, suggesting packaging features should be considered in cigar product regulation.

From using heat to using work: reconceptualising the zero carbon energy transition

Recent evidence indicates that the key sources of energy for the zero carbon transition will be renewable electricity sources. The most rapidly expanding sources, photovoltaics and wind produce work, as electricity, directly rather than via heat engines. Making the assumption that these will be the dominant sources of energy in a future zero carbon system, the paper makes two new related and innovative contributions to the literature on the energy transition. First, it shows that the energy transition will be more than just a shift away from carbonaceous fuels, and that it is more usefully thought of as including a systemic shift from heat-producing to work-producing energy sources. Secondly, it shows that this enables very large improvements in the conversion efficiency of final energy, through the use of electricity and hydrogen, in particular in heating and transportation. The paper presents a thought experiment showing a reduction in final energy demand of up to 40% is likely from this effect alone. Technical standards and product regulation for end use conversion efficiency and/or service delivery efficiency seem likely to be key policy instruments.

Domestic heating with compact combination hybrids (gas boiler and heat pump): A simple English stock model of different heating system scenarios

The heat decarbonisation challenge remains substantial, competing low carbon solutions such as hydrogen and heat pumps (HPs) and the entrenched position of gas combination boilers create inertia in many markets. Hybrid appliances which can directly replace gas boilers may provide a low disruption, low-cost pathway to net zero in gas-reliant markets. Emerging compact combination (CoCo) hybrid heating appliances which combine a gas combi boiler and a small HP unit in one appliance have been modelled for the English housing stock across a range of different scenarios. CoCo hybrids offer sizeable energy demand reduction of up to 60% compared to current gas boilers, also reducing peak electrical demand by 10 GW compared to air source heat pumps. The control strategy for switching between HP and gas boiler is key in determining the scale of demand reduction. Modelling sensitivity to the HP size within CoCo hybrids showed that a 50% reduction in energy demand compared to gas boilers could be achieved with a standard 2.5 kW HP. A lack of clarity in regulation and policy incentives for hybrids exists. To drive innovation and performance improvement, product regulation for hybrids needs to be improved to support decarbonisation of heat with this promising technology. Practical Application Convenient, low disruption heat decarbonisation technology is crucial to the speed of deployment necessary to achieve net zero. This article defines the size of HP necessary to achieve rapid low disruption impact and distinguishes the types of compact hybrid which can deliver the highest decarbonisation impact while minimising in house disruption and the electrical grid impact.

Rural Residents’ Participation Intention in Community Forestry-Challenge and Prospect of Community Forestry in Sri Lanka

The contribution of local communities has become widely recognized as a better alternative in forest management than the traditional command-based control approach. However, several years later of implementation, most programs were failed due to a lack of community participation, imposing an uncertain future for community forestry. This paper examines rural Sri Lankans’ participation intention in community forestry (CF) program by using the Probit regression model. Randomly selected 300 individuals representing both CF members and non-CF members were interviewed for the study. The study results indicate that rural residents’ intention in future CF program negatively correlated with the participation status (CF membership) of individuals. Accordingly, CF members show less participation intention in future CF program than non-CF members. Socio-economic variables such as education level (p < 0.01) and the occupation of head of the household (p < 0.05) and total household income (p < 0.01) have significant influences on individuals’ participation intention in CF. In addition, non-monetary benefits derived from CF and perception on the product regulation and conflict mitigation are also appeared to significantly and positively affect villagers’ intention. The findings also revealed the knowledge gap on the purpose of the CF program and CF policy design. Hence, require immediate attention to improve awareness. Moreover, failure to raise local people’s participation intention in CF may indicate inadequate or ineffective government policies. Therefore, the Department of Forest Conservation should take sound measures to ensure that community-based forest management policies are consistently implemented at different administrative levels across the country and its rightness should be evaluated strictly.

Comparison of generic drug registration strategies between health Canada and Gulf Cooperation Council

Recently, generic drug products have played an increasingly important role in the health care system globally, especially in the developing world, as they provide for an effective and more affordable alternative for healthcare professional. Generic drug products are proven therapeutically equivalent to the corresponding innovator’s product, and hence can be substituted in clinical practice. The Gulf Cooperation Council’s pharmaceutical market is known to be semi-regulated market when compared with Health Canada and the United States of America drug regulatory market. Product regulation in Gulf Cooperation Council and Health Canada are challenging task in comparison to EU and USA. This study aimed to understand the generic drug registration comparison of Health Canada and Gulf Cooperation Council’s. The aim of this study was achieved by review of the Health Canada and Gulf Cooperation council guidelines and publications. Health Canada and Gulf Cooperation council follows Common Technical Document format and also emphasizes on safety, quality and efficacy of the drug. In summary Gulf Cooperation council and Health Canada offers lucrative market for Indian pharmaceutical manufacturer and the process of registration has been simplified by centralized procedure.

A Brief History of Biomedical Products Regulation

The history of biomedical product regulation is a history of hard-won progress. Often, only after tragedy, has regulatory statute caught up to drugs with horrid side effects or medical devices that offer no benefit but may do harm. Harmful or questionable products slip through cracks in regulatory statutes and are brought to market quickly and prolifically, while regulators play catch up and must demonstrate harms before being enabled to police or regulate them. A notable present-day example is e-cigarettes, a multi-billion-dollar industry with clearly questionable marketing practices, which arrived and grew quickly without any form of premarket regulatory obligation. Similarly, digital health tools are proliferating, and most are yet to be subject to premarket regulation. This chapter provides a brief history of biomedical-products regulation with a focus on benefit-risk determination and its impacts on regulatory policy.

A Comparison of Current Regulatory Frameworks for Nutraceuticals in Australia, Canada, Japan, and the United States.

The nutraceutical market is growing and the demand for products is increasing. Consumers are looking for cheaper alternatives to prescription medications as well as health products to supplement their dietary intake on a regular basis. Many countries classify these products into different categories based on their health claims. The purpose of this review is to compare and contrast the differences of regulatory frameworks in countries of similar status in regard to nutraceutical products: vitamins, minerals, herbal supplements, and probiotics. This review also takes into consideration the aspects of nutraceutical safety in relation to government regulations. It is evident that further discussion is indicated with regard to the harmonization of nutraceutical product regulation in a global context in order to promote and protect public health. This literature review selected 27 documents for a review using a systematic search of internet databases and search engines including PUBMED and Google Scholar. These documents were reviewed and synthesized for data relating to nutraceutical regulation within the four different countries of focus. Outcomes included information on safety and toxicity, drug interactions, classification of products, and regulatory processes for nutraceutical product approval in each country.