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Environmental Research Sep 2023European Union (EU) law regulates the manufacture, presentation, and sale of tobacco and related products in all member states. This study examined whether legislation... (Observational Study)
Observational Study
BACKGROUND
European Union (EU) law regulates the manufacture, presentation, and sale of tobacco and related products in all member states. This study examined whether legislation non-compliant tobacco products and electronic cigarettes were available for sale in the European market.
METHODS
We queried the EU Rapid Information System for dangerous non-food products, covering 28 current and former EU member states and 3 associated countries, also known as Rapex, for non-compliant tobacco and related products reported between 2005 and 2022.
FINDINGS
During the operation of the Rapex system, 183 violations were reported (six on tobacco, three on traditional cigarettes, and 174 on e-cigarettes). Insufficient product safety information was found in 86% of the reports on e-cigarettes and 74% of the refills. Violations regarding the volume of the liquid container were observed in 26% of the e-cigarette reports and 20% of the refill reports. Approximately 15% of the reported e-cigarettes and 17% of refill liquids exceeded permissible nicotine levels. More serious standard violations were recorded for refills than for e-cigarettes. Approximately one-third of Rapex system countries submitted no notifications.
INTERPRETATION
E-cigarettes were the most frequently reported items in the European market of tobacco and non-tobacco nicotine products. The most common concerns were inadequate product safety information, incorrect liquid container volume, and excessive nicotine concentration. Identifying the most recognized legal infringements did not require laboratory tests and was based only on packaging and the manufacturer's declaration analysis. Further studies are necessary to corroborate whether products available in countries where no violations have been reported meet EU safety standards.
Topics: Nicotine; Electronic Nicotine Delivery Systems; Tobacco Products; Europe
PubMed: 37329947
DOI: 10.1016/j.envres.2023.116429 -
Drug Discovery Today Jun 2024To introduce products in the US market, pharmaceutical companies must first obtain FDA clearance. Manufacturers might recall a product if it poses a risk of damage or... (Review)
Review
To introduce products in the US market, pharmaceutical companies must first obtain FDA clearance. Manufacturers might recall a product if it poses a risk of damage or violates FDA regulations. This study investigates the types, causes and consequences of recalls, as well as FDA participation and suitable recall strategies. We relied on the FDA website to gather recall data sets from 2012 to 2023, collecting information on the date of issuance, company and type of violation. The most frequent causes for recalls were sterility issues and inadequate compliance with current good manufacturing practices (cGMP). An examination of sterility recalls revealed two primary causes: a lack of assurance in sterility (accounting for 48% of recalls) and instances of non-sterility (making up 45% of recalls). A thorough examination of cGMP recalls revealed five primary types of violations: process control issues, inadequate storage practices, manufacturing problems, the presence of nitroso-amine impurities and concerns regarding stability. The findings demonstrate that sterility and cGMP compliance are FDA priorities. Pharmaceutical companies must, therefore, enhance quality compliance and create effective quality management systems that oversee the manufacturing process, quality control, personnel training and documentation to avoid these recalls. Companies should establish an internal compliance checklist and be prepared for the rectification process.
Topics: United States; United States Food and Drug Administration; Drug Industry; Drug Recalls; Humans; Retrospective Studies
PubMed: 38670257
DOI: 10.1016/j.drudis.2024.103993 -
World Journal of Microbiology &... Nov 2023Staphylococcus aureus is an important and leading cause of foodborne diseases worldwide. Prompt detection and recall of contaminated foods are crucial to prevent...
Staphylococcus aureus is an important and leading cause of foodborne diseases worldwide. Prompt detection and recall of contaminated foods are crucial to prevent untoward health consequences caused by S. aureus. Helix loop-mediated isothermal amplification (HAMP) is an exciting recent addition to the array of available isothermal-based nucleic acid amplification techniques. This study aimed to develop and evaluate a HAMP assay for detecting S. aureus in milk and milk products. The assay is completed in 75 minutes of isothermal temperature incubation (64 ˚C) and dye-based visual interpretation of results based on colour change. The specificity of the developed assay was ascertained using 27 S. aureus and 17 non S. aureus bacterial strains. The analytical sensitivity of the developed HAMP assay was 9.7 fg/µL of pure S. aureus DNA. The detection limit of the HAMP assay in milk (86 CFU/mL) was 1000x greater than the routinely used endpoint PCR (86 × 10 CFU/mL). The practicality of applying the HAMP assay was also assessed by analysing milk and milk product samples (n = 95) obtained from different dairy farms and retail outlets. The developed test is a more rapid, sensitive, and user-friendly method for the high-throughput screening of S. aureus in food samples and may therefore be suitable for field laboratories. To our knowledge, this is the first study to develop and evaluate the HAMP platform for detecting S. aureus.
Topics: Humans; Animals; Milk; Staphylococcus aureus; Colorimetry; Nucleic Acid Amplification Techniques; Staphylococcal Infections; Hepcidins
PubMed: 37966568
DOI: 10.1007/s11274-023-03838-3 -
Journal of the Science of Food and... Jul 2023The presence of foreign materials (FM) not only reduces the commercial value of tobacco and the quality of cigarette products, but also affects the aroma and flavor of...
BACKGROUND
The presence of foreign materials (FM) not only reduces the commercial value of tobacco and the quality of cigarette products, but also affects the aroma and flavor of cigarettes. Existing tobacco deblending equipment has received little study with respect to homochromatic FM. In the present study, visible-near infrared (VIS-NIR) hyperspectral imaging technique combined with chemometrics were used to identify and visualize the homochromatic FM on the surface of thining tobacco. A comparison with conventional vision method was made to analyze the feasibility of the method. The importance of detecting FM in cut tobacco was further demonstrated by first studying the volatile organic compounds produced in cigarette mixed FM smoke and their effects on human health before conducting hyperspectral experiments.
RESULTS
The results indicated that solid-phase microextraction and gas chromatography mass spectrometry could detect volatile organic compounds in mainstream cigarette smoke that were not cigarette components and affected consumer health. Then, spectral features of the samples were extracted from hyperspectral images for building identification models to distinguish FM from cut tobacco. The visual RGB values of cut tobacco and FM were also used for the analysis of the recognition models. The results showed that the accuracy, precision and recall reached 100.00% using the back propagation artificial neural network classification model based on the principal component analysis raw wavelengths. The visualization results based on the optimal model produced clearer localization than conventional computer vision method.
CONCLUSION
The present study revealed that the VIS-NIR hyperspectral imaging technology had advantage in the detection and localization of FM on the surface of thinning tobacco, which provided a foundation for improving the quality and safety of cut tobacco production. © 2023 Society of Chemical Industry.
Topics: Humans; Nicotiana; Volatile Organic Compounds; Hyperspectral Imaging; Spectroscopy, Near-Infrared; Neural Networks, Computer
PubMed: 36840508
DOI: 10.1002/jsfa.12528 -
HIV/AIDS (Auckland, N.Z.) 2023Poor adherence to antiretroviral therapy (ART) causes drug resistance, treatment failure and death. Studies conducted among children below 15 years were limited in...
BACKGROUND
Poor adherence to antiretroviral therapy (ART) causes drug resistance, treatment failure and death. Studies conducted among children below 15 years were limited in Ethiopia in general and in the study area. Therefore, this study aimed to assess the status of children's adherence to ART and associated factors in the study area.
METHODS
We conducted a facility-based cross-sectional study from April 1 to May 10, 2020 by including 282 children <15 years. All children who received ART for at least one month and attend ART clinic during data collection period were consecutively recruited. Face-to-face interview was conducted using a standardized questionnaire. Both bivariate and multivariate logistic regression were performed. Adherence and exposure variables (i.e., sociodemographic and reason for missing) were measured by the caregivers/children's report of a one-month recall of missed doses.
RESULTS
Among 282 caregivers included with their children, 226 (80.2%) were females (mean age = 38.6 and SD = 12.35) and half (50%) of children were females. Two hundred forty six (87.2%) children were aged between 5-14 years (mean age = 8.5 and SD = 2.64), and 87.2% were adhered (≥95%) to ART in the month prior to the interview. Children whose caregivers were residing in urban were 3.3 (95% CI: 1.17, 9.63) times more adherent to ART than their counterparties. Children whose caregivers were biological parents were 2.37 (95% CI: 1.59, 3.3) times more adherent than children with non-biological parents. Children with knowledgeable caregivers about ART were 4.5 (95% CI: 1.79, 9.8) times more adherent to ART.
CONCLUSION AND RECOMMENDATION
Children's adherence to ART in our study area was sub optimal. Biological caregivers, residing in urban and being knowledgeable about ART facilitate adherence to ART. Adherence counseling targeting non-biological parents and for those who come from rural areas were recommended.
PubMed: 37497118
DOI: 10.2147/HIV.S407105 -
Frontiers in Nutrition 2023Dietary assessment is important for understanding nutritional status. Traditional methods of monitoring food intake through self-report such as diet diaries, 24-hour...
INTRODUCTION
Dietary assessment is important for understanding nutritional status. Traditional methods of monitoring food intake through self-report such as diet diaries, 24-hour dietary recall, and food frequency questionnaires may be subject to errors and can be time-consuming for the user.
METHODS
This paper presents a semi-automatic dietary assessment tool we developed - a desktop application called Image to Nutrients (I2N) - to process sensor-detected eating events and images captured during these eating events by a wearable sensor. I2N has the capacity to offer multiple food and nutrient databases (e.g., USDA-SR, FNDDS, USDA Global Branded Food Products Database) for annotating eating episodes and food items. I2N estimates energy intake, nutritional content, and the amount consumed. The components of I2N are three-fold: 1) sensor-guided image review, 2) annotation of food images for nutritional analysis, and 3) access to multiple food databases. Two studies were used to evaluate the feasibility and usefulness of I2N: 1) a US-based study with 30 participants and a total of 60 days of data and 2) a Ghana-based study with 41 participants and a total of 41 days of data).
RESULTS
In both studies, a total of 314 eating episodes were annotated using at least three food databases. Using I2N's sensor-guided image review, the number of images that needed to be reviewed was reduced by 93% and 85% for the two studies, respectively, compared to reviewing all the images.
DISCUSSION
I2N is a unique tool that allows for simultaneous viewing of food images, sensor-guided image review, and access to multiple databases in one tool, making nutritional analysis of food images efficient. The tool is flexible, allowing for nutritional analysis of images if sensor signals aren't available.
PubMed: 37575335
DOI: 10.3389/fnut.2023.1191962 -
PeerJ. Computer Science 2024Opinion mining is gaining significant research interest, as it directly and indirectly provides a better avenue for understanding customers, their sentiments toward a...
Opinion mining is gaining significant research interest, as it directly and indirectly provides a better avenue for understanding customers, their sentiments toward a service or product, and their purchasing decisions. However, extracting every opinion feature from unstructured customer review documents is challenging, especially since these reviews are often written in native languages and contain grammatical and spelling errors. Moreover, existing pattern rules frequently exclude features and opinion words that are not strictly nouns or adjectives. Thus, selecting suitable features when analyzing customer reviews is the key to uncovering their actual expectations. This study aims to enhance the performance of explicit feature extraction from product review documents. To achieve this, an approach that employs sequential pattern rules is proposed to identify and extract features with associated opinions. The improved pattern rules total 41, including 16 new rules introduced in this study and 25 existing pattern rules from previous research. An average calculated from the testing results of five datasets showed that the incorporation of this study's 16 new rules significantly improved feature extraction precision by 6%, recall by 6% and F-measure value by 5% compared to the contemporary approach. The new set of rules has proven to be effective in extracting features that were previously overlooked, thus achieving its objective of addressing gaps in existing rules. Therefore, this study has successfully enhanced feature extraction results, yielding an average precision of 0.91, an average recall value of 0.88, and an average F-measure of 0.89.
PubMed: 38435547
DOI: 10.7717/peerj-cs.1821 -
PDA Journal of Pharmaceutical Science... 2023In the wake of a series of outbreaks of finished pharmaceutical product-related complex (Bcc) human infections worldwide, the United States Food and Drug Administration...
Design, Development, and Validation of a Culture-Independent Nucleic Acid Diagnostics Method for the Rapid Detection and Quantification of the Complex in Water with an Equivalence to ISO/TS 12869:2019.
In the wake of a series of outbreaks of finished pharmaceutical product-related complex (Bcc) human infections worldwide, the United States Food and Drug Administration (FDA) in 2017, and subsequently in 2021, issued advisory notifications to the pharmaceutical industry for stringent Bcc testing requirements for pharmaceutical manufacturing processes and for finished pharmaceutical products prior to release to the marketplace. The advisory notifications highlight non-sterile aqueous finished pharmaceutical products as being a major culprit associated with many of these human infection events. As such, there has been a significant number of Bcc-contaminated finished product recalls resulting in company revenue losses, delayed finished product release, finished product shortages for patients, and manufacturing plant shutdowns coupled with company reputational damage. With many of the finished product recall events, pharmaceutical grade water and/or manufacturing facility water distribution systems were identified as the primary origin source of Bcc contamination. Testing and monitoring regimes currently employed to identify Bcc contamination of water associated with pharmaceutical manufacturing are often limited by costly, laborious, lengthy, and nonspecific traditional microbial culture-based methodologies. Presently FDA approved, European Conformity (CE) marked, and International Organization for Standardization (ISO) standard microbial culture-independent rapid, quantitative, specific, and sensitive nucleic acid diagnostics (NAD) methodologies are now gaining greater widespread acceptance in their routine usage in testing laboratories. Here we present the development of a rapid (<4 hours from sample in to result out) single test culture-independent Bcc NAD method, incorporating a quantitative real-time polymerase chain reaction (qPCR) assay. This method can be used for the detection and simultaneous identification of all 24 Bcc species currently assigned, directly from water samples. This culture-independent Bcc NAD method is validated to the testing method equivalent of the ISO/TS 12869:2019 standard, which is a widely used rapid culture-independent NAD method for detecting Gram-negative species in water.
Topics: Humans; Burkholderia cepacia complex; Nucleic Acids; Water; NAD; Burkholderia Infections; Reference Standards; Pharmaceutical Preparations
PubMed: 36822644
DOI: 10.5731/pdajpst.2021.012728 -
Food and Chemical Toxicology : An... Aug 2023Considering the genotoxic and cancerogenic nature of aflatoxin M1 (AFM1), its presence in milk and dairy products may pose health risks for consumers. The chronic...
Considering the genotoxic and cancerogenic nature of aflatoxin M1 (AFM1), its presence in milk and dairy products may pose health risks for consumers. The chronic exposure was calculated using a two-dimensional (second order) Monte Carlo model. Results of 13 722 milk and dairy product samples analysed in the 2015-2022 period were used. Milk and dairy products intake information was collected with a Food Frequency Questionnaire (FFQ) validated by a 24-h recall-based method. Risk characterization was done by calculation of the Margin of Exposure (MOE) and by calculation of AFM1 induced number of hepatocellular carcinoma (HCC) cases. Mean AFM1 Estimated Daily Intake (EDI) was highest in children at 0.336 (CI: 0.294-0.385) ng kg bw day, followed by adolescents with 0.183 (CI: 0.164-0.204), then adult females with 0.161 (CI: 0.146-0.179) and finally adult males with lowest EDI of 0.126 (CI: 0.115-0.139) ng kg bw day. MOE values based on mean EDI for all population groups were above risk associated threshold and the number of possible HCC cases was in the range of 0.0002-0.0021 cases per year for 10 individuals. The results suggest low health risks due to AFM1 exposure for the whole population. Still, this risk is not non-existent, especially for children as they have a higher ratio of the population exposed to risk associated AFM1 levels, with MOE values below risk indicating threshold starting at 77.5th percentile.
Topics: Adult; Male; Child; Female; Adolescent; Humans; Animals; Aflatoxin M1; Dietary Exposure; Carcinoma, Hepatocellular; Serbia; Food Contamination; Liver Neoplasms; Milk
PubMed: 37343714
DOI: 10.1016/j.fct.2023.113906 -
Neurology. Clinical Practice Jun 2024Headache is an adverse event associated with the use of proton pump inhibitors (PPIs). Recently, migraine has emerged more specifically as a potential adverse event with...
BACKGROUND AND OBJECTIVES
Headache is an adverse event associated with the use of proton pump inhibitors (PPIs). Recently, migraine has emerged more specifically as a potential adverse event with PPI use. The objectives of this work were to capitalize on existing data to evaluate the association between migraine and severe headache prevalence and use of acid-suppression therapy, including PPIs, H2 receptor antagonists (H2RAs), and generic antacids; to compare risk from PPIs vs H2RAs; and to assess for potential mitigation by a dietary factor affected by acid-suppression therapy.
METHODS
Data from adults in the 1999-2004 National Health and Nutrition Examination Survey were used for this cross-sectional analysis. Acid-suppression therapy use was identified from self-report confirmed by product packaging review. Respondents who endorsed migraine or severe headache in the past 3 months were classified in the migraine or severe headache group. Dietary intake of magnesium was determined using one 24-hour recall interview. Multivariable logistic regression models were generated to analyze the relationship between acid-suppression therapy use and migraine or severe headache, and an interaction test was conducted to evaluate whether migraine or severe headache prevalence differed in relation to nutritional magnesium intake across acid-suppression therapy users and nonusers.
RESULTS
In 11,818 US adults, the use of acid-suppression therapy was associated with higher odds of migraine or severe headache for all types of acid-suppression therapy and use of any type, as compared with those who did not use acid-suppression therapy: use of PPIs (70% higher), H2RAs (40% higher), and generic antacids (30% higher). Differences between acid-suppression therapy were not significant. An interaction was observed for H2RA use and magnesium intake ( = 0.024).
DISCUSSION
These observations in US adults agree with previous findings that migraine or severe headache is a potential adverse event of PPIs, the most efficacious and most frequently used type of acid suppressing medication, and further suggest that other classes of acid suppressing medications (H2RAs and generic antacids) may also be implicated for migraine and severe headache. Future prospective analyses are needed to investigate migraine risk associated with acid suppressing medications while current evidence is sufficient to evaluate patients with migraine in light of recent deprescribing advice for PPIs.
PubMed: 38682005
DOI: 10.1212/CPJ.0000000000200302