Combining Inserts With Warning Labels on Cigarette Packs to Promote Smoking Cessation: A 2-Week Randomized Trial.

BACKGROUND: Cigarette pack inserts with messages on cessation benefits and advice are a promising labeling policy that may help promote smoking cessation. PURPOSE: To assess insert effects, with and without accompanying pictorial health warning labels(HWLs), on hypothesized psychosocial and behavioral outcomes. METHODS: We conducted a 2 × 2 between-subject randomized trial (inserts with efficacy messages vs. no inserts; large pictorial HWLs vs. small text HWLs), with 367 adults who smoked at least 10 cigarettes a day. Participants received a 14-day supply of their preferred cigarettes with packs modified to reflect their experimental condition. Over 2 weeks, we surveyed participants approximately 4-5 times a day during their smoking sessions, querying feelings about smoking, level of worry about harms from smoking, self-efficacy to cut down on cigarettes, self-efficacy to quit, hopefulness about quitting, and motivation to quit. Each evening, participants reported their perceived susceptibility to smoking harms and, for the last 24 hr, their frequency of thinking about smoking harms and cessation benefits, conversations about smoking cessation or harms, and foregoing or stubbing out cigarettes before they finished smoking. Mixed-effects ordinal and logistic models were estimated to evaluate differences between groups. RESULTS: Participants whose packs included inserts were more likely than those whose packs did not include inserts to report foregoing or stubbing out of cigarettes (OR = 2.39, 95% CI = 1.36, 4.20). Otherwise, no statistically significant associations were found between labeling conditions and outcomes. CONCLUSIONS: This study provides some evidence, albeit limited, that pack inserts with efficacy messages can promote behaviors that predict smoking cessation attempts.

Cigarette pack inserts (small leaflets inside packs) with messages about quitting benefits and tips to quit may promote smoking cessation. We randomly assigned 367 adult smokers to one of four groups: control group with small health warning labels (HWLs) on the side of packs; inserts with cessation messages and small HWLs; large picture HWLs showing health effects from smoking; inserts and large picture HWLs. Participants received a 14-day supply of their preferred cigarettes in packs that reflected their assigned group. Over 2 weeks, we surveyed participants 4­5 times a day during times when they smoked, asking their feelings about smoking and smoking-related harms, confidence to reduce cigarettes and quit, hopefulness about quitting, and motivation to quit. Each evening, participants reported on the prior 24 hr: how often they thought about smoking harms and cessation benefits; conversations about smoking cessation or harms; and foregoing or stubbing out cigarettes before they finished smoking. People whose packs had inserts (with or without picture HWLs) were more likely than those whose packs did not include inserts (control group or picture HWLs only) to report foregoing or stubbing out of cigarettes. This study provides some evidence that inserts with cessation messages may promote smoking cessation.

Evaluation and risk communication of the effects of alcohol exposure on disposable procedure masks and portable air purifiers in hospital environments.

Electret technology was widely used to prevent the airborne transmission of bioaerosols during the COVID-19 pandemic and improve the filtration efficiency of masks and high-efficiency particulate air (HEPA) filters. As alcohol disinfectants are widely used in medical and welfare institutions, concerns about alcohol exposure inactivating electret exist. However, comprehensive alcohol exposure tests have not been conducted on masks and HEPA filters distributed in Japan. Twenty-five types of masks and five types of HEPA filters were subjected to a discharging process according to ISO 16890 to quantitatively elucidate the resistance to alcohol exposure. Measurements of changes in filtration efficiency and pressure drop before and after discharge show that 17 masks (68%) and four HEPA filters (80%) exhibited a significant decrease in filtration efficiency, confirming their vulnerability to alcohol. In addition, a survey (n = 500 Japanese adults, including 30 healthcare professionals) revealed that ∼90% of the general public were unaware that alcohol exposure could degrade masks and air purifiers. Furthermore, 36% of the surveyed healthcare professionals had sprayed alcohol directly onto their masks. The effectiveness of user warnings through product labels and instructions was investigated from the perspective of ensuring the safety of patients and healthcare professionals. Results revealed that the best approach was to describe the extent and duration of the adverse effects caused by disregarding precautions. Increase in awareness of healthcare professionals and general public by authorities and manufacturers through guidelines and warning labels would reduce the risk of inhaling bioaerosols caused by unintentional electret inactivation.

Approaches to the Assessment of Clinical Benefit of Treatments for Conditions That Have Heterogeneous Symptoms and Impacts: Potential Applications in Rare Disease.

OBJECTIVES: Evaluating the clinical benefit of interventions for conditions with heterogeneous symptom and impact presentations is challenging. The same condition can present differently across and within individuals over time. This occurs frequently in rare diseases. The purpose of this review was to identify (1) assessment approaches used in clinical trials to address heterogeneous manifestations that could be relevant in rare disease research and (2) US Food and Drug Administration (FDA)-approved labeling claims that used these approaches. METHODS: A targeted literature review was conducted examining peer-reviewed publications and FDA-approved labeling claims from January 2002 to July 2020, focusing on claims incorporating clinical outcome assessments. Approaches were then assessed for their potential application in rare diseases. RESULTS: A total of 6 assessment approaches were identified: composite or other multicomponent endpoints, multidomain responder index, most bothersome symptom (MBS), goal attainment scaling, sliding dichotomy, and adequate relief. A total of 59 FDA-approved labeling claims associated with these approaches were identified: composite or other multicomponent endpoints (n=49), MBS (n=9), and adequate relief (n=1). A total of 10 FDA-approved labeling claims, all using multicomponent endpoints, were identified for rare diseases. CONCLUSIONS: Multicomponent, MBS, and adequate relief have been included in FDA-approved labeling claims. Multicomponent endpoints, including composite endpoints, were the most frequent way to address heterogeneous manifestations of both common and rare diseases. MBS may be acceptable to regulators, whereas multidomain responder index is unlikely to be. The goal attainment scaling and adequate relief approaches may have potential utility in rare disease trials, assuming the theoretical and statistical challenges inherent in each approach are managed.

Safety culture and perception of warning signs of chemical hazards among hospital cleaning workers: a cross-sectional study.

BACKGROUND: Due to the type of activities and the long-term exposure to chemicals, hospital cleaning workers require the necessary knowledge about the chemicals used and proper safety culture. This study aimed to evaluate the safety culture and perception of hospital cleaning workers' warning signs of chemical hazards. METHODS: This cross-sectional study was conducted in 2022 with the participation of 68 cleaning workers with the mean age ± (SD) and work experience ± (SD) of 36.19 ± (7.619) and 9.21 ± (5.462), respectively, in four selected Tehran hospitals in Iran. After ensuring the confidentiality of the received information and completing the demographic information checklist, each participant completed Global Harmonization System (GHS) sign perception and the safety culture questionnaires in this survey. Data were analyzed using regression and Pearson correlation tests. RESULTS: This study showed that the participant's correct perception in nine cases (81.8%) of presented GHS signs was lower than the ANSI Z535.3 standard. Among the investigated signs, "Flammable substances" and "Harmful to the environment" signs had the highest, and "Skin irritant" signs had the lowest correct perception. In addition, it was found that 55 people (80.9%) had an overall positive attitude toward the safety culture. The levels of "Work environment" (83.8%) and "Information exchange" (76.5%) had the highest and lowest positive scores for safety culture. Furthermore, there is a direct and significant relationship between the overall score of safety culture and the overall perception of the symptoms of GHS (CC = 0.313, P = 0.009). CONCLUSION: According to the obtained results, it is recommended to take the necessary measures to increase the employees' perception of the signs of chemical substances and improve their safety culture.

Market survey of disposable e-cigarette nicotine content and e-liquid volume.

Inaccurate labels on some e-cigarette products have prompted calls for routine testing to monitor product label integrity. The objective of this study was to compare label statements of commercial disposable/non-chargeable e-cigarette products for nicotine concentration and e-liquid volume with analytically verified levels. Commercial e-cigarette samples were analyzed for nicotine concentration (N = 51), e-liquid volume and total nicotine content (N = 39). Twenty-three of the 51 samples analyzed for nicotine deviated from their label statements by more than ± 10%. Deviations ranged from -50.1% to + 13.9%. Thirty of the 39 samples analyzed for e-liquid volume deviated from their label statements by more than ± 10%. Deviations ranged from -62.1% to + 13.3%. Only one brand listed total nicotine on the label. In thirty-one of the 39 samples, calculated total nicotine amount in e-liquid deviated from the amounts calculated from the label metrics by more than ± 10%. Deviations ranged from -66.8% to -1.43%. These findings underscore the need for regulatory enforcement of manufacturing quality control and product labeling practices to optimize the harm reduction potential and consumer experience associated with the use of e-cigarette products.

Cigarette Packs With URLs Leading to Tobacco Company Websites: Content Analysis.

BACKGROUND: Tobacco companies include on the packaging of their products URLs directing consumers to websites that contain protobacco messages. Online media tend to be underregulated and provide the industry with an opportunity to present users with protobacco communication. OBJECTIVE: The objective of our study was to document the content of websites that were advertised on tobacco packs in 14 low- and middle-income countries. METHODS: We purchased tobacco packs from 14 low- and middle-income countries in 2013 and examined them for the presence of URLs. We visited unique URLs on multiple occasions between October 1, 2016 and August 9, 2017. We developed a coding checklist and used it to conduct a content analysis of active corporate websites to identify types of protobacco communication. The coding checklist included the presence of regulatory controls and warnings, engagement strategies, marketing appeals (eg, description of product popularity, luxury/quality, taste), corporate social responsibility programs, and image management. We coded brand websites separately and also described social media and other website types. RESULTS: We identified 89 unique URLs, of which 54 were active during the search period. We assessed 26 corporate websites, 21 brand websites, 2 nontobacco websites, and 5 social media pages. We excluded 2 corporate websites and 14 brand websites due to limited accessible content or incomplete content. Corporate social responsibility was discussed on all corporate websites, and marketing appeals were also common. Corporate websites were also more likely to include more nonspecific (12/24, 50%) than specific (7/24, 29%) health warnings. Promotions (6/7, 86%) and sociability appeals (3/7, 43%) were common on brand websites. The small number of social media webpages in our sample used gendered marketing. CONCLUSIONS: URLs appearing on tobacco packs direct consumers to websites where users are exposed to marketing that highlights the "positive" contributions of tobacco companies on corporate websites, and extensive promotions and marketing appeals on brand websites and social media pages. It is essential that marketing regulations become more comprehensive and ban all protobacco communication, a policy that is in line with articles 5.3 and 13 of the World Health Organization Framework Convention on Tobacco Control. For countries that already ban internet tobacco advertising, enforcement efforts should be strengthened. Tobacco companies' use of URLs on packs may also be compelling for plain packaging advocacy, where all branding is removed from the pack and large graphic health warning labels are the only communication on the tobacco packaging. Future research should consider including tobacco websites in marketing surveillance.

Study of serious adverse drug reactions using FDA-approved drug labeling and MedDRA.

BACKGROUND: Adverse Drug Reactions (ADRs) are of great public health concern. FDA-approved drug labeling summarizes ADRs of a drug product mainly in three sections, i.e., Boxed Warning (BW), Warnings and Precautions (WP), and Adverse Reactions (AR), where the severity of ADRs are intended to decrease in the order of BW > WP > AR. Several reported studies have extracted ADRs from labeling documents, but most, if not all, did not discriminate the severity of the ADRs by the different labeling sections. Such a practice could overstate or underestimate the impact of certain ADRs to the public health. In this study, we applied the Medical Dictionary for Regulatory Activities (MedDRA) to drug labeling and systematically analyzed and compared the ADRs from the three labeling sections with a specific emphasis on analyzing serious ADRs presented in BW, which is of most drug safety concern. RESULTS: This study investigated New Drug Application (NDA) labeling documents for 1164 single-ingredient drugs using Oracle Text search to extract MedDRA terms. We found that only a small portion of MedDRA Preferred Terms (PTs), 3819 out of 21,920 or 17.42%, were observed in a whole set of documents. In detail, 466/3819 (12.0%) PTs were in BW, 2023/3819 (53.0%) were in WP, and 2961/3819 (77.5%) were in AR sections. We also found a higher overlap of top 20 occurring BW PTs with WP sections compared to AR sections. Within the MedDRA System Organ Class levels, serious ADRs (sADRs) from BW were prevalent in Nervous System disorders and Vascular disorders. A Hierarchical Cluster Analysis (HCA) revealed that drugs within the same therapeutic category shared the same ADR patterns in BW (e.g., nervous system drug class is highly associated with drug abuse terms such as dependence, substance abuse, and respiratory depression). CONCLUSIONS: This study demonstrated that combining MedDRA standard terminologies with data mining techniques facilitated computer-aided ADR analysis of drug labeling. We also highlighted the importance of labeling sections that differ in seriousness and application in drug safety. Using sADRs primarily related to BW sections, we illustrated a prototype approach for computer-aided ADR monitoring and studies which can be applied to other public health documents.

Development of a symptom assessment in patients with myelofibrosis: qualitative study findings.

BACKGROUND: The goal of the research reported here was to understand the patient experience of living with myelofibrosis (MF) and establish content validity of the Modified Myeloproliferative Neoplasm Symptom Assessment Diary (MPN-SD). METHODS: Qualitative interviews were performed in patients with MF, including both concept elicitation and cognitive debriefing. Patients with MF were asked to spontaneously report on their signs, symptoms, and impacts of MF, as well as their understanding of the MPN-SD content, and use of the tool on an electronic platform. A supplementary literature review and meetings with MF experts were also performed. RESULTS: Twenty-three patients with MF participated in qualitative interviews. Signs and symptoms most commonly reported by ruxolitinib-experienced patients (n = 16) were: fatigue and/or tiredness (n = 16, 100%), shortness of breath (n = 11, 69%), pain below the ribs on the left side and/or stomach pain and/or abdominal pain (n = 9, 56%), and enlarged spleen (n = 9, 56%) and for ruxolitinib-naïve patients (n = 7) were: fatigue and/or tiredness (n = 6, 86%), pain below the ribs on the left side (n = 6, 86%), enlarged spleen (n = 4, 57%), full quickly/filling up quickly (n = 4, 57%), night sweats and/or general sweats (n = 4, 57%), and itching (n = 4, 57%). Patients demonstrated that they were able to read, understand, and provide meaningful responses to the MPN-SD. The final version of the MPN-SD includes the 10 most commonly reported concepts from the MF patient interviews. CONCLUSIONS: The findings demonstrate the comprehensiveness of the MPN-SD in assessing MF symptoms in both ruxolitinib-experienced and ruxolitinib-naïve patients, while remaining easy for patients to understand and complete.

[Effectiveness of cigarette-pack warning labels in capturing the attention of smokers and nonsmokersEficácia das tarjas de advertência em maços de cigarro para atrair a atenção de fumantes e não fumantes]. / Eficacia de las etiquetas de advertencia en las cajetillas de cigarrillo.

OBJECTIVE: To determine the ability of cigarette-pack warning labels, of the minimum size required by the World Health Organization, to capture the attention of smokers and nonsmokers. METHODS: In this study, 30 smokers and 30 nonsmokers completed a dot-probe task in which they simultaneously observed images of cigarette packs split in two: the top contained the cigarette brand and the bottom contained the warning label. During the task, brain activity was recorded through two event-related potentials of the negative-polarity type--the potential that occurs in the posterior-contralateral zone approximately 200 ms after a stimulus (N2pc) and the sustained posterior contralateral negativity (SPCN) response--which are indicators of early and sustained attention. RESULTS: In both groups, a greater amplitude of N2pc and SPCN potentials was found for the part of the pack containing the cigarette brand. However, during the dot-probe task, reaction times were shorter for the warning label. CONCLUSIONS: These results suggest that, initially, attention is focused on the cigarette brand, and only then on the warning label. The inability of warning labels to capture early-phase attention decreases their effectiveness, especially in smokers. We suggest that warning labels be enlarged to facilitate increased attention response.

OBJETIVO: Determinar a capacidade das tarjas de advertência com o tamanho mínimo exigido pela Organização Mundial da Saúde (OMS) de atrair a atenção de fumantes e não fumantes. MÉTODOS: A amostra do estudo consistiu de 30 fumantes e 30 não fumantes que foram testados com uma tarefa de sondagem (dot-probe task) em que tiveram de observar simultaneamente imagens de um maço de cigarro dividido ao meio: a parte superior continha a marca do cigarro e a parte inferior continha a tarja de advertência. Durante o teste, foi registrada a atividade cerebral com a análise de potenciais evocados relacionados a eventos do tipo potencial negativo que ocorre em cerca de 200 ms na área posterior contralateral ao estímulo (N2pc) e da ocorrência de negatividade contralateral posterior sustentada (SPCN, em inglês), que são indicadores de atenção mais rápida e sustentada. RESULTADOS: Em ambos os grupos de participantes foi observada maior amplitude dos potenciais N2pc e SPCN na parte do maço que continha a marca. Porém, o tempo de reação na tarefa de sondagem foi menor diante da tarja de advertência. CONCLUSÕES: Os resultados deste estudo sugerem que, ao início, a atenção é dirigida à marca do cigarro e depois à tarja de advertência. A incapacidade da tarja de advertência de atrair a atenção nas primeiras fases diminui sua eficácia, sobretudo entre os fumantes. Recomenda-se aumentar o tamanho das tarjas de advertência para estimular um incremento na resposta de atenção.

Inconsistent excipient listings in DailyMed: implications for drug safety.

Excipients, or inactive ingredients, are a frequent cause of medication intolerance and allergy. Patients and clinicians concerned about medication allergies and sensitivities rely on the U.S. National Library of Medicine's DailyMed for accurate lists of excipients. Based on our anecdotal discovery of several examples of excipient omissions, we wished to examine the accuracy of DailyMed's listings more systematically in a sample of commonly prescribed medications. The objective of the study is to identify the frequency of inconsistency of excipient reporting within the DailyMed website. We performed a database audit of the Structured Product Labeling XML file provided by the drug manufacturer to the Food and Drug Administration and DailyMed for two randomly selected formulations of each of 50 commonly prescribed medications. For each of the 100 formulations, we compared the excipients listed in the "Description" to those in the "Ingredients and Appearance" sections in DailyMed. The Structured Product Labeling data file provided by the drug manufacturer contained internal inconsistencies of excipients in 39% of the formulations examined. Despite the use of Structured Product Labeling, the drug manufacturer's medication labels provided to the FDA and reported by DailyMed often contain conflicting information about inactive ingredients. Patients with allergies and excipient sensitivity should be aware of these discrepancies and consult multiple sections of the label to identify potential allergy-inducing inactive ingredients.

US FDA's Dose Optimization Postmarketing Requirements and Commitments of Oncology Approvals and the Impact on Product Labels from 2010 to 2022: An Emerging Landscape from Traditional to Novel Therapies.

BACKGROUND: Dose optimization is a focal point of many US Food and Drug Administration (FDA) drug approvals. We sought to understand the impact of the FDA's Postmarketing Commitments/Postmarketing Requirements (PMCs/PMRs) on dose optimization and prescriber labeling for oncology drugs. METHODS: Publicly available information was aggregated for all FDA oncology drug approvals between January 1, 2010, and December 31, 2022. Study completion dates were compared to product labeling before and after PMC/PMR fulfillment dates to evaluate labeling changes associated with dose-related PMCs/PMRs. Data were analyzed individually (2010-2015 and 2016-2022) due to differences in available information. RESULTS: From 2010 to 2015, 14 of 42 (33.3%) new molecular entities (NMEs) had dose-related PMCs/PMRs, with 6 of 14 (42.9%) resulting in a relevant label change. From 2016 to 2022, of the 314 new or supplemental applications approved, 21 had dose-related PMCs/PMRs (6.7%), which trended upward over time; 71.4% of dose-related PMCs/PMRs were NMEs. Kinase inhibitors (KIs) and antibody/peptide drug conjugates (ADCs/PDCs) were the most affected drug classes. Ten of the 21 approvals with dose-related PMCs/PMRs fulfilled their dosing PMCs/PMRs, and 3 of the 10 (30%) had relevant label changes. CONCLUSION: Most dose-related PMRs/PMCs were issued for NMEs. Of these, KIs and ADCs/PDCs were highly represented, reflecting their novelty and greater uncertainty around their safety profile. PMC/PMR issuance broadly increased over time. With the implementation of the FDA's Project Optimus in 2021, it remains to be seen whether fewer dose-related PMCs/PMRs emerge in future due to enhanced dose optimization in the premarketing setting.

Cigarette packaging, warnings, prices, and contraband: A discrete choice experiment among smokers in Ontario, Canada.

In Canada, despite substantial decline, tobacco use remains the leading risk factor responsible for mortality and morbidity. There is overwhelming evidence that higher tobacco taxes reduce tobacco use, even if high taxes create an incentive to avoid or evade tobacco taxes. Recently, in addition to taxes, plain and standardized packaging and printing a warning on each cigarette have been lauded to reduce tobacco use. In November 2019, Canada became the country with the most comprehensive cigarette packaging regulations; and in June 2022, Canada proposed to print health warnings on individual cigarettes, the first jurisdiction to ever do so. The regulations came into force on August 1, 2023, and are being implemented through a stepwise approach. Our objective was to examine the effects of plain and standardized packaging, warning on cigarettes, price, and the availability of illicit cigarettes on intention to purchase and risk perceptions. We conducted a discrete choice experiment, and examined heterogeneity in preferences using latent class models among smokers in Ontario, Canada. We found that using latent class analyses was essential in quantifying preferences for attributes of cigarettes and cigarette packs. First, nearly half of smokers stated a preference for cheaper illicit cigarettes in a branded pack without any health warnings, regardless of the licit cigarette alternatives. For about 20% of respondents, plain packaging and especially warning on cigarette sticks decreased the probability of stating a purchasing preference for these alternatives. Third, about a third of respondents chose competing alternatives with mostly one attribute in mind, price. Lastly, none of the products and attributes seem to have significantly influenced risk perception. Our findings attest to the importance of prices and taxes, to the potential of warnings on cigarette sticks to control tobacco use, and indicate that efforts to restrict the availability of illicit cigarettes may yield substantial benefits.

Socioeconomic and Demographic Factors Associated with the Influence of the Food Traffic Light Labeling on the Decision of the Adult Population of Ecuador to Purchase Processed Foods, 2018.

To determine the socioeconomic and demographic factors associated with the influence of the nutritional traffic light (NTL) on the decision to purchase processed foods using information from the National Health and Nutrition Survey (ENSANUT) 2018 of Ecuador, a cross-sectional and analytical study based on a secondary analysis of the information from the ENSANUT 2018 was performed. We collected data from 25,932 participants 18 years of age or older who knew or had seen the NTL, and for whom complete information on the variables of interest for the study was available. The "Influence of the NTL on the purchase decision of processed foods" was the outcome variable of the study. Generalized linear models of the Poisson family, with log link, were used to assess the association between socioeconomic factors and outcome, using crude (PR) and adjusted (aPR) prevalence ratios, with 95% confidence intervals (CI) and a p-value < 0.05. Participants who understood the NTL (aPR: 2.49; 95% CI: 2.19-2.83), with a higher educational level (aPR: 1.33; 95% CI: 1.09-1.61), women (aPR 1.06; 95% CI: 1.01-1.10), and who had a partner (aPR 1.09; 95% CI: 1.04-1.14) were more likely to be influenced by the NTL when deciding to purchase processed foods, compared to people who did not understand the NTL, who had no educational level or who only attended a literacy center, were men, and those without a partner. The inhabitants of the coastal region (aPR: 0.92; 95% CI: 0.88-0.97), the Amazon (aPR 0.93; 95% CI: 0.88-0.98), and the insular region (aPR 0.76; 95% CI: 0.68-0.84) had few probabilities of being influenced by the NTL in the decision to purchase processed foods, in comparison with the residents of the highlands. Similarly, compared to non-poor people, poor people had a lower probability of being influenced by the NTL (aPR 0.89; 95% CI: 0.82-0.97). Factors associated with the influence of NTL on the decision to purchase processed foods were identified. It is recommended to reformulate and focus awareness strategies for using the NTL to purchase processed foods by taking into account the associated factors.

Safety and risks of CBD oils purchased online: unveiling uncertain quality and vague health claims.

Introduction: The unmet need for highly effective, naturally derived products with minimal side effects results in the over-popularity of ever-newer medicinal plants. In the middle of 2010, products containing cannabidiol (CBD), one of the special metabolites of Cannabis sativa, started to gain popularity. For consumers and healthcare providers alike, the legal context surrounding the marketing of CBD products is not entirely clear, and the safety of using some products is in doubt. Companies in the online medicinal product market profit from the confusion around CBD oils. Methods: In our study, we employed a complex method known as risk-based safety mapping of the online pharmaceutical market, which included health claim content analysis of online stores, test purchases, and labeling and quantitative analysis of the CBD content. Results: There were discovered 16 online retailers selling an average of 2-7 goods and CBD oils with a concentration of 3%-5% (30-50 mg/mL) CBD. The majority (n/N = 10/16, 62.5%) displayed potential health-related benefits indirectly on their website, and in the case of one web shop (n/N = 1/16, 6.3%), we detected COVID-19-related use. Altogether, 30 types of purported "indications" were collected. A total of 12 CBD oil products were test-purchased from online retailers in December 2020. Upon evaluating the packaging and product information, we noticed that three products (n/N = 3/12, 25%) lacked instructions on use, hence increasing the risk of inappropriate application and dosing. The cannabidiol content was quantified using UHPLC. The measured CBD concentrations of the products ranged from 19.58 mg/mL to 54.09 mg/mL (mean 35.51 mg/mL, median 30.63 mg/mL, and SD ± 12.57 mg/mL). One (8.33%) product was underlabeled, five (41.67%) were over-labeled, and only every second product (50%) was appropriately labeled based on the quantitative assessment of CBD concentration. Discussion: Further research and quality control are necessary to establish the regulatory context of the usage and classification of CBD and other cannabinoids in nonmedicinal products (e.g., food supplements), as authorities and policymakers worldwide struggle with the uncertainties surrounding CBD products.

A Narrative Review of the Efficacy and Design of Safety Labels on Tobacco Products to Promote the Use of Safety Labels on Alcohol Products in Canada.

Alcohol is consumed by approximately three-quarters of Canadians. Alcohol causes acquired liver disease, increases the risk of cancer, has detrimental effects on mental health, and leads to adverse pregnancy outcomes. Alcohol-related morbidity and mortality are high, and urgent public health measures are warranted to prevent and control these. Tobacco safety labels have been shown in numerous studies to reduce tobacco consumption. Much can be learned from the design of tobacco safety labels in creating promising alcohol safety labels that can possibly help reduce alcohol consumption. The aim of this paper is to review the efficacy of tobacco safety labels in reducing tobacco consumption and the design of tobacco safety labels and to propose a promising design for alcohol safety labels based on our findings. English peer-reviewed papers published in western countries since 2000 were searched on PubMed and Google Scholar. Keywords and synonyms were used to search pertinent papers, which were subsequently screened by title and abstract and fully reviewed if relevant. Findings from studies comparing designs of safety labels on alcohol and tobacco products are similar. Graphics, higher emotion content, and greater size are associated with greater attention, awareness, negative emotions, intention to quit, and reduction in consumption. Mixed results are found for testimonials containing safety labels on tobacco products. It is unclear whether testimonials on alcohol safety labels reduce alcohol consumption or not. Safety labels with specific information, such as tobacco-related costs and alcohol-related cancer risks, are more effective in reducing tobacco consumption. In conclusion, preliminary alcohol safety labels show promise. Large safety labels with graphics and high emotional content appear to be most effective and may reduce alcohol consumption.

Progress and challenges in tobacco control policies in Mexico, 2003-2017: an approach using the Tobacco Control Scale.

The study aims to assess the implementation of tobacco control policies in Mexico from 2003 through 2017 using the Tobacco Control Scale (TCS). The TCS is a research tool widely used in the European region. It facilitates assessment of tobacco control policy implementation based on six cost-effective interventions: tobacco taxes, smoke-free policies, advertising bans, public spending on the information campaign, health warnings, and smoking cessation treatment, reflecting results in a total score between 0 and 100. From 2003 through 2017, Mexico's total score improved from 24/100 to 55/100, with substantial progress in raising tobacco taxes, 11 subnational smoke-free laws, and with placement on cigarette packs of large health warnings with pictograms. Progress in tobacco control policies implemented in this period corresponds with a decrease in smoking prevalence across Mexico. This tool is useful for monitoring tobacco policy implementation in low- and middle-income countries and be used for advocacy purposes to enforce and improve tobacco control legislation.

Microscopic examination of dog chews: correlation of histological findings to product labeling.

The purpose of this study was to use routine morphologic-based staining techniques to examine the histology of commercially labeled rawhide and rawhide-free dog chew products and compare the results to the product labeling. Ten dog chew products were examined by light microscopy using hematoxylin and eosin and Masson's trichrome stains. The products were labeled by the manufacturer as rawhide, beef hide, beef chew/rawhide free, and rawhide free. Four of the products were composed of two separate materials, a main chew roll and a second substance (filler) which was coated on or between the layers of the main chew roll. These materials were processed independently. Microscopically, a variety of tissues and materials were identified including collagen, skeletal muscle, fat, plant material, and starch. The products and their fillers were separated into four distinct groups based on microscopic appearance. The components identified in eight of the products appeared consistent with the product labeling. Two products labeled as rawhide free appeared similar to the dermis and this was inconsistent with product labeling. Masson's trichrome stain was not helpful in distinguishing tissue types in the tested products and this may have been due to the heat processing the products underwent during manufacturing. Bacteria and/or fungi were identified by microscopy in the H&E stained sections in four rawhide-free products.

Accurate quantification of TiO2 nanoparticles in commercial sunscreens using standard materials and orthogonal particle sizing methods for verification.

The implementation and enforcement of product labeling obligation as required, for example, by the cosmetic product regulation, needs simple and precise validated analytical methods. This also applies to the analysis of nanoparticles in products such as cosmetics. However, the provision of such methods is often hampered by inaccurate sizing due to unwanted nanoparticle changes, interference of matrix components with sizing and interactions between nanoparticles and analytical instrumentation. It is, therefore, necessary to develop appropriate sample preparation methods that preserve NP properties and reduce or remove matrix compounds that interfere with sizing. Further, accurate particle size analysis of samples containing unknown and possibly multiple nanoparticulate constituents is needed. In this study, we evaluated three sample preparation methods to identify and quantify TiO2 nanoparticles in sunscreens. Specifically, we used a combination of ultracentrifugation and hexane washing, thermal destruction of the matrix, and surfactant assisted particle extraction. The method accuracy was assessed by two internal reference samples: pristine TiO2 nanoparticles (NM104) and similar TiO2 nanoparticles dispersed in a sunscreen matrix. The PSDs were determined using an asymmetrical flow field-flow fractionation hyphenated with multi-angle light scattering and inductively coupled plasma-mass spectroscopy. Particle sizing was based on size calibration of the particle retention time in the AF4. Computation of radius of gyration from MALS data was used as an orthogonal particle sizing approach to verify ideal elution and particle size data from the AF4 calibration. Among the three tested sample preparation methods surfactant assisted particle extraction revealed TiO2 nanoparticle recoveries of above 90% and no increase in particle size due to sample preparation was observed. Finally, the sample preparation methods were applied to two commercial sunscreen samples revealing the existence of TiO2-NP < 100 nm. Conclusively, the surfactant assisted particle extraction method can provide valid data for TiO2-NPs in sunscreen and possibly for cosmetic samples of similar matrix.

Parabens in stretch mark creams: A source of exposure in pregnant and lactating women.

Parabens are widely used as antimicrobial preservatives in personal care products (PCPs). Stretch mark cream is widely used by pregnant and lactating women for the treatment of striae gravidarum. This can be a potential source of paraben exposure, not only to pregnant/lactating women but also to fetuses/newborns. Little is known, however, with regard to the occurrence of parabens in stretch mark creams. In this study, we analyzed eight parabens and their metabolites in 31 popular stretch mark creams originated from various countries including China. The concentrations of Σparaben (sum of eight parabens/metabolites) ranged from 0.007 to 1630 µg/g, with mean and median values of 453 and 273 µg/g, respectively. Methyl- and propyl-parabens accounted for >95% of Σparaben concentrations. We examined the measured paraben concentrations against ingredients listed on the product labels. Parabens were listed as ingredients in those creams that contained concentrations >100 µg/g except for four samples with such high concentrations. Six cream samples that were labeled 'paraben-free' contained trace levels (0.007-9.92 µg/g) of these preservatives. Mean dermal ∑paraben exposure dose from the use of stretch mark creams (30.6 µg/kg bw/day) was well below the current acceptable daily intake value (5 mg/kg bw/day). In comparison to diet and indoor dust ingestion pathways, paraben-laden stretch mark cream may be a major source of paraben exposure in pregnant and lactating women. This study provides information on parabens and other preservatives in stretch mark creams and measures to reduce exposures during pregnancy and lactation.